A Collaboration with the University of Pittsburgh
Issued by Health and Human Services Department

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Petition for rulemaking. SUMMARY: The Food and Drug Administration (FDA or we) is announcing that Arcadia Biosciences, Inc. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of gamma-linolenic acid (GLA) … [read more]

Start Preamble Start Printed Page 40278 AGENCY: Office of the Secretary, HHS. ACTION: Semiannual Regulatory Agenda. SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order (EO) 12866 require the semiannual issuance of an inventory of rulemaking actions under development throughout the Department, offering for public review summarized information … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notification; petition for rulemaking; correction. SUMMARY: The Food and Drug Administration (FDA or we) is correcting a notice that appeared in the Federal Register of Wednesday, July 26, 2017 (82 FR 34615). The document announced that we have filed a … [read more]

Start Preamble AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice of proposed rulemaking; further delay of effective date. SUMMARY: The Health Resources and Services Administration (HRSA) Start Printed Page 39554administers section 340B of the Public Health Service Act (PHSA), which is referred to as the “340B Drug Pricing … [read more]

Start Preamble Start Printed Page 39310 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. SUMMARY: This proposed rule proposes to cancel the Episode Payment Models (EPMs) and Cardiac Rehabilitation (CR) incentive payment model and to rescind the regulations governing these models. It also proposes to … [read more]

Start Preamble AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. SUMMARY: The Affordable Care Act requires aggregate reductions to state Medicaid Disproportionate Share Hospital (DSH) allotments annually beginning with fiscal year (FY) 2018. This proposed rule delineates a methodology to implement the annual allotment reductions. … [read more]

Start Preamble Start Printed Page 35270 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. SUMMARY: This proposed rule updates the home health prospective payment system (HH PPS) payment rates, including the national, standardized 60-day episode payment rates, the national per-visit rates, and the non-routine medical … [read more]

Start Preamble Start Printed Page 34615 AGENCY: Food and Drug Administration, HHS. ACTION: Notification; petition for rulemaking. SUMMARY: The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by the Juice Products Association, proposing that the food additive regulations be amended to … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notification; petition for rulemaking. SUMMARY: The Food and Drug Administration (FDA or we) is announcing that Zinpro Corp. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of zinc-L-selenomethionine as a … [read more]

Start Preamble Start Printed Page 33950 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. SUMMARY: This major proposed rule addresses changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies. DATES: To be assured consideration, comments must be received at … [read more]

Start Preamble Start Printed Page 33558 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. SUMMARY: This proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 to implement changes arising from … [read more]

Start Preamble AGENCY: Centers for Disease Control and Prevention, HHS. ACTION: Denial of petitions for addition of health conditions. SUMMARY: On February 22, 2017, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 016) to add Parkinson's disease and parkinsonism, including manganese-induced parkinsonism, to … [read more]

Start Preamble Start Printed Page 31190 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. SUMMARY: This rule proposes to update and make revisions to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2018, as well as to update the payment … [read more]

Start Preamble Start Printed Page 30010 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. SUMMARY: The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) established the Quality Payment Program for eligible clinicians. Under the Quality Payment Program, eligible clinicians can participate via one of … [read more]

Start Preamble AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Request for information; correction. SUMMARY: This document corrects an error that appeared in the request for information notice published in the Federal Register on June 12, 2017 entitled “Reducing Regulatory Burdens Imposed by the Patient Protection and … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; notification of availability. SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Use of Electronic Records and Electronic Signatures in Clinical Investigations under our regulations—Questions and Answers.” … [read more]

Start Preamble AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Advance notice of proposed rulemaking with comment; extension of comment period. SUMMARY: This document extends the comment period for the advance notice of proposed rulemaking with comment entitled “Medicare Program; Prospective Payment System and Consolidated Billing for … [read more]

Start Preamble AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Request for information. SUMMARY: The Department of Health and Human Services (HHS) is actively working to reduce regulatory burdens and improve health insurance options under Title I of the Patient Protection and Affordable Care Act. Executive Order … [read more]

Start Preamble AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. SUMMARY: This proposed rule would revise the requirements that Long-Term Care (LTC) facilities must meet to participate in the Medicare and Medicaid programs. Specifically, it would remove provisions prohibiting binding pre-dispute arbitration and strengthen requirements … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notice of petition. SUMMARY: The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Glo Eyes, LLC, proposing that the color additive regulations be amended to provide for the safe use of … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notice of petition. SUMMARY: The Food and Drug Administration (FDA) is announcing that BASF Corp. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of formic acid as a feed acidifying … [read more]

Start Preamble Correction In proposed rule document 2017-08428 beginning on page 20690 in the issue of Wednesday, make the following correction: On page 20705, in table 6, the heading for columns two and three, should respectively read “Rural Facility A (Spencer Co., IN)” and “Urban Facility B (Harrison Co., … [read more]

Start Preamble Start Printed Page 20980 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Advance notice of proposed rulemaking with comment. SUMMARY: We are issuing this advance notice of proposed rulemaking (ANPRM) to solicit public comments on potential options we may consider for revising certain aspects of … [read more]

Start Preamble Start Printed Page 20847 AGENCY: Food and Drug Administration, HHS. ACTION: Notification; denial of petition. SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is denying a petition, submitted by the Natural Resources Defense Council, Center for Food Safety, Clean Water Action, Children's Environmental Health … [read more]

Start Preamble Start Printed Page 21014 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. SUMMARY: This proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2018. It also proposes to revise … [read more]

Start Preamble Start Printed Page 20690 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. SUMMARY: This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2018 as required by the statute. As required by section 1886(j)(5) … [read more]

Start Preamble Start Printed Page 20750 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. SUMMARY: This proposed rule would update the hospice wage index, payment rates, and cap amount for fiscal year (FY) 2018. Additionally, this rule proposes changes to the hospice quality reporting program, … [read more]

Start Preamble Start Printed Page 18268 AGENCY: Food and Drug Administration, HHS. ACTION: Notice of petition. SUMMARY: The Food and Drug Administration (FDA or we) is announcing that the Canadian Oilseed Processors Association has filed a petition proposing that the food additive regulations be amended to provide for the … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notice of petition. SUMMARY: The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by the Environmental Defense Fund, Earthjustice, Environmental Working Group, Center for Environmental Health, Healthy Homes Collaborative, Health Justice Project … [read more]

Start Preamble Start Printed Page 16150 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. SUMMARY: This proposed rule would delay the effective date for the final rule entitled “Medicare and Medicaid Programs: Conditions of Participation for Home Health Agencies” published in the Federal Register on … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; extension of comment period. SUMMARY: The Food and Drug Administration (FDA or the Agency) is extending the comment period for the proposed rule that appeared in the Federal Register of January 23, 2017. In the proposed rule, FDA … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notice of petition. SUMMARY: The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by DSM Biomedical, proposing that the color additive regulations be amended to provide for the safe use of high … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notification; reopening of comment period. SUMMARY: The Food and Drug Administration (FDA or we) is reopening the comment period for the notice entitled “Fruit Juice and Vegetable Juice as Color Additives in Food; Draft Guidance for Industry” that appeared in … [read more]

Start Preamble AGENCY: Centers for Disease Control and Prevention, HHS. ACTION: Denial of petition for addition of a health condition. SUMMARY: On September 29, 2016, the Administrator of the World Trade Center (WTC) Health Program received a petition to add autoimmune diseases, including rheumatoid arthritis, to the List of … [read more]

Start Preamble AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. SUMMARY: This rule proposes changes that would help stabilize the individual and small group markets. This proposed rule would amend standards relating to special enrollment periods, guaranteed availability, and the timing of the annual open … [read more]

Start Preamble Start Printed Page 10868 AGENCY: Food and Drug Administration, HHS. ACTION: Notification of public meeting; request for comments. SUMMARY: The Food and Drug Administration (FDA or we) is announcing the following public meeting entitled “Use of the Term `Healthy' in the Labeling of Human Food Products.” The … [read more]

Start Preamble Correction In proposed rule document 2016-27848, appearing on pages 86467-86488 in the issue of Wednesday, November 30, 2016, make the following corrections: On page 86467, in the first column, in the DATES section, and on page 86481 in the third column, in the fourth full paragraph following … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled “Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of … [read more]

Start Preamble Start Printed Page 8004 AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA) is proposing a tobacco product standard that would establish a limit of N-nitrosonornicotine (NNN) in finished smokeless tobacco products. FDA is taking this action because NNN is … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Reopening of comment period related to public hearing; availability of memorandum. SUMMARY: The Food and Drug Administration (FDA) is reopening the comment period for the notification of public hearing, published in the Federal Register of September 1, 2016 (81 FR … [read more]

Start Preamble AGENCY: Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Denial of petition for rulemaking. SUMMARY: In accordance with section 2114(c)(2)(B) of the Public Health Service Act, 42 U.S.C. 300aa-14(c)(2)(B), notice is hereby given concerning the reasons for not conducting a rulemaking … [read more]

Start Preamble AGENCY: Substance Abuse and Mental Health Services Administration, HHS. ACTION: Supplemental notice of proposed rulemaking. SUMMARY: On Feb. 9, 2016, the Substance Abuse and Mental Health Services Administration (SAMHSA) published a Notice of Proposed Rulemaking (NPRM) that proposed policy changes to update and modernize the Confidentiality of … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a revised draft guidance for industry entitled “Control of Listeria monocytogenes in Ready-To-Eat Foods.” The revised draft guidance is intended for any … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability; extension of comment period. SUMMARY: The Food and Drug Administration (FDA or we) is extending the comment period for the notice of availability of a draft guidance entitled “Scientific Evaluation of the Evidence on the Beneficial Physiological … [read more]

Start Preamble AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. SUMMARY: This proposed rule would specify the qualifications needed for qualified practitioners to furnish and fabricate, and qualified suppliers to fabricate prosthetics and custom-fabricated orthotics; accreditation requirements that qualified suppliers must meet in order to … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notification; extension of comment period. SUMMARY: The Food and Drug Administration (FDA or we) is extending the comment period for a docket to receive information and comments on the use of the term “healthy” in the labeling of human food … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notice of petition; reopening of the comment period. SUMMARY: The Food and Drug Administration (FDA) is reopening the comment period for the notice of petition, published in the Federal Register of November 8, 2016 (81 FR 78528), proposing that the … [read more]

Start Preamble AGENCY: Office of Inspector General (OIG), HHS. ACTION: Notice of intent to develop regulations. SUMMARY: In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notice solicits proposals and recommendations for developing new, and modifying existing, safe harbor provisions … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a revised draft guidance for industry entitled “Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry.” The revised draft guidance … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA or Agency) is proposing a regulation to identify an initial list of bulk drug substances that can be used to compound drug products in accordance with certain compounding provisions of the … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled “Fruit Juice and Vegetable Juice as Color Additives in Food.” The draft guidance, when finalized, will help … [read more]

Start Preamble AGENCY: Centers for Disease Control and Prevention, HHS. ACTION: Denial of petition for addition of a health condition. SUMMARY: On April 11, 2016, the Administrator of the World Trade Center (WTC) Health Program received two petitions (combined into Petition 012) to add atherosclerosis to the List of … [read more]

Start Preamble AGENCY: Department of Health and Human Services. ACTION: Notice of proposed rulemaking. SUMMARY: The Department of Health and Human Services (HHS or Department), through the National Institutes of Health (NIH), proposes to exempt, from certain requirements of the Privacy Act, a subset of records in a new … [read more]

Start Preamble Start Printed Page 86467 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. SUMMARY: This proposed rule proposes to implement provisions of the Medicaid statute pertaining to Medicaid eligibility and appeals. This proposed rule continues our efforts to assist states in implementing Medicaid and … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance entitled “Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-digestible Carbohydrates Submitted as a … [read more]

Start Preamble AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. SUMMARY: This proposed rule addresses changes, consistent with the CMCS Informational Bulletin (CIB) concerning “The Use of New or Increased Pass-Through Payments in Medicaid Managed Care Delivery Systems,” published on July 29, 2016, to the … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notice of withdrawal. SUMMARY: The Food and Drug Administration (FDA) is announcing the withdrawal of two proposed rules that published in the Federal Register more than 5 years ago. These proposed rules are no longer considered viable candidates for final … [read more]

Start Preamble AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Request for information. SUMMARY: This request for information seeks information and data on additional reforms and policy options that we can consider to accelerate the provision of home and community-based services (HCBS) to Medicaid beneficiaries taking into … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled “Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry.” This draft guidance contains 15 … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notice of petition. SUMMARY: The Food and Drug Administration (FDA) is announcing that Novus International, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of poly (2-vinylpyridine-co-styrene) as a nutrient … [read more]

Start Preamble AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. SUMMARY: This proposed rule would update fire safety standards for Medicare and Medicaid participating ESRD facilities, adopt the 2012 edition of the Life Safety Code and eliminate references in our regulations to all earlier editions … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notification of request for comments. SUMMARY: The Food and Drug Administration (FDA or we) is announcing the establishment of a docket to receive comments, particularly data and other information, on the appropriate reference amount customarily consumed (RACC) and product category … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled “Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; extension of comment period. SUMMARY: The Food and Drug Administration (FDA) is extending the comment period for the proposed rule that appeared in the Federal Register of August 24, 2016. In the proposed rule, FDA requested comments on … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; supplemental notice of proposed rulemaking. SUMMARY: The Food and Drug Administration (FDA or we) is proposing to amend our 2012 document entitled “New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food.” The document proposed … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulation on uses of ozone-depleting substances (ODSs), including chlorofluorocarbons (CFCs), to remove the designation for certain products as “essential uses” under the … [read more]

Start Preamble AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice of meeting. SUMMARY: This document announces a listening session to solicit input from stakeholders regarding our implementation of section 704 of the Comprehensive Addiction and Recovery Act of 2016 (CARA), which includes provisions to permit Part … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. Start Printed Page 74369 SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulation on uses of ozone-depleting substances (ODSs), including chlorofluorocarbons (CFCs), to remove the designation for certain products as … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulations to revise the list of drug products that have been withdrawn or removed from the market because the drug products or components … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA) is proposing to implement provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require electronic submission of the device label and package insert of certain home-use devices … [read more]

Start Preamble Start Printed Page 69740 AGENCY: Food and Drug Administration, HHS. ACTION: Notice of petition. SUMMARY: The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Wm. Wrigley Jr. Company, proposing that the color additive regulations be amended to provide … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notice of petition. SUMMARY: The Food and Drug Administration (FDA) is announcing that BASF Corp., as a part of their petition (FAP 2286) proposing that the food additive regulations be amended to provide for the safe use of feed grade … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notification; establishment of docket; request for comments. SUMMARY: The Food and Drug Administration (FDA or we) is announcing the establishment of a docket to receive information and comments on the use of the term “healthy” in the labeling of human … [read more]

Start Preamble AGENCIES: Office of Inspector General (OIG) and Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. SUMMARY: This proposed rule would amend the regulation governing State Medicaid Fraud Control Units (MFCUs or Units). The proposed rule would incorporate statutory changes affecting the MFCUs as well … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notice of petition. SUMMARY: The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by McCormick & Company, Inc., proposing that the color additive regulations be amended to provide for the safe use … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background A. Title X Background B. State Restrictions on Subrecipients C. Litigation II. Proposed Rule III. Regulatory Impact Analysis A. Introduction B. Summary of the Proposed Rule C. Need for the Proposed Rule … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents Acronyms and Abbreviations I. Executive Summary II. Background A. Legislative and Regulatory Overview 1. Premium Stabilization Programs 2. Program Integrity 3. Exchanges 4. Essential Health Benefits and Actuarial Value 5. Market … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents A. WTC Health Program Statutory Authority B. Approval To Submit Document to the Office of the Federal Register C. Petition 013 D. Administrator's Determination on Petition 013 Footnotes DATES: Back to Top … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Purpose and Scope of the Public Hearing III. Attendance and Registration IV. Notice of Public Hearing Under 21 CFR Part 15 V. Transcripts Footnotes DATES: Back to … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Paperwork Reduction Act of 1995 III. Electronic Access DATES: Back to Top Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Introduction II. Background III. Description of the Proposed Rule A. Disqualification Proceedings (§ 511.1(c)(1)) B. Ineligibility To Receive Any Test Article (§ 511.1(c)(2)) C. Reinstatement (§ 511.1(c)(6)) IV. Regulatory Hearing before the … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents I. Executive Summary A. Purpose of the Proposed Rule B. Summary of the Major Provisions of the Proposed Rule C. Legal Authority D. Costs and Benefits II. … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents I. Executive Summary A. Purpose of the Proposed Rule B. Summary of the Major Provisions of the Proposed Rule C. Legal Authority D. Costs and Benefits II. … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Paperwork Reduction Act of 1995 III. Electronic Access DATES: Back to Top Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Solicitation of Comments III. Collection of Information Requirements Footnotes DATES: Back to Top To be assured consideration, comments must be received at one of the addresses provided below, no later than … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Executive Summary A. Purpose of Regulatory Action B. Summary of Major Provisions C. Costs II. Public Participation III. Background A. History and Scope of Rulemaking B. WTC Health Program Statutory Authority IV. Summary … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents Acronyms I. Executive Summary A. Purpose B. Summary of Key Economic Provisions 1. Compliance Oversight Requirements 2. Monitoring and Oversight of PACE Organizations C. Summary of Costs and Benefits II. Background … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background A. Legislative History B. Hospital-Specific DSH Limit C. The 2008 DSH Final Rule and Subsequent Policy Guidance II. Specific Proposed Regulatory Changes A. Treatment of Payments Associated With Dual Eligibles and Medicaid … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Executive Summary A. Purpose of the Action B. Summary of Major Provisions C. Summary of Costs and Benefits II. Public Participation III. Background A. Legal Authority B. Historical Background for This Rulemaking IV. … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Summary of the Proposed Regulations Subpart C—Administrative Dispute Resolution § 10.20 340B Administrative Dispute Resolution Panel § 10.21 Claims Covered Entity Claims Manufacturer Claims § 10.23 Final agency decision III. Regulatory Impact Analysis Executive Orders 12866 and … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Summary of Errors in the Preamble III. Waiver of Proposed Rulemaking and Delay in Effective Date IV. Correction of Errors DATES: Back to Top The proposed rule published July 15, 2016 (81 … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top FDA is reopening the comment period on the notice of filing of a food additive petition published on May 20, 2016 (81 FR 31877). Submit either … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Executive Summary A. Purpose of the Proposed Rule B. Summary of the Major Provisions of the Regulatory Action II. Direct Final Rulemaking III. Purpose and Legal Authority A. Purpose … [read more]

  Correction In proposed rule document 2016-15188 beginning on page 42802 in the issue of Thursday, June 30, 2016, make the following corrections: 1. On page 42851, in the third column, in the ninth line from the bottom, “2035” should read “2015”. 2. On page 42852, in the table, … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Electronic Access Alphabetical List of Acronyms Table of Contents I. Executive Summary A. Purpose B. Summary of the Major Provisions 1. Model Overview—EPM Episodes of Care 2. Model Scope 3. Payment 4. Similar, Previous, … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Solicitation of Comments A. Notification to Issuers Without Self-Certification B. Other Approaches With Respect to Insured Plans Described in the Supplemental Briefing C. Self-Insured Plans III. Collection of Information Requirements Footnotes … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents Regulations Text Acronyms Addenda Available Only Through the Internet on the CMS Web Site CPT (Current Procedural Terminology) Copyright Notice I. Executive Summary and Background A. Executive Summary 1. Purpose 2. … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Electronic Access Addenda Available Only Through the Internet on the CMS Web Site Alphabetical List of Acronyms Appearing in This Federal Register Document Table of Contents Regulation Text I. Summary and Background A. Executive … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Background Paperwork Reduction Act Regulatory Flexibility Act Executive Order 12866 Determination Unfunded Mandates Reform Act of 1995 Determination Executive Order 13132 Determination List of Subjects in 45 CFR Part 75 DATES: Back to Top … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Executive Summary A. Purpose B. Summary of Major Provisions C. Summary of Impacts II. Public Participation Comments Invited III. Background IV. Summary of SNPRM V. Collection of Information Requirements VI. Regulatory Impact Analysis … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Abbreviations Section 1557 of the Affordable Care Act Table of Contents I. Background II. General Provisions of the Proposed Regulations A. Precedential Final Decisions of the Secretary B. Attorney Adjudicators C. Application of 405 … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents Acronyms I. Executive Summary A. Purpose B. Summary of the Major Provisions C. Summary of Costs and Transfers II. Background A. Statutory Background B. System for Payment of Home Health Services … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents I. Executive Summary A. Purpose of the Proposed Rule B. Summary of the Major Provisions of the Proposed Rule C. Legal Authority D. Costs and Benefits II. … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Electronic Access Table of Contents Acronyms I. Executive Summary A. Purpose 1. End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) 2. Coverage and Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Abandonment DATES: Back to Top The food additive petition was filed on May 11, 2016. Submit either electronic or written comments by August 29, 2016. ADDRESSES: Back … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents I. Executive Summary A. Purpose of the Regulatory Action B. Summary of the Major Provisions of the Regulatory Action in Question C. Effectiveness D. Safety E. Active … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Acronyms I. Background A. Introduction B. Regulatory History 1. Medicaid Eligibility Quality Control (MEQC) Program 2. Payment Error Rate Measurement (PERM) Program 3. 2010 Final Rule: Revisions to MEQC and PERM To Meet the … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Acronyms Table of Contents I. Background A. Executive Summary B. Statutory Basis and Purpose of the Conditions of Participation for Hospitals and Critical Access Hospitals C. Why revise the conditions of participation? II. Provisions … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Abandonment DATES: Back to Top The food additive petition was filed on May 16, 2016. Submit either electronic or written comments by August 15, 2016. ADDRESSES: Back … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: The OPEN Government Act The E-FOIA ACT Additional Changes Regulatory Analysis Executive Order 12866 Regulatory Flexibility Act Unfunded Mandates Reform Act of 1995 Executive Order 12612 Paperwork Reduction Act List of Subjects in 45 … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background General Statutory Background and Enactment of ACA Expatriate Health Plans, Expatriate Health Plan Issuers and Qualified Expatriates IRS Notice 2015-43 IRS Notices 2015-29 and 2016-14 Excepted Benefits Short-Term, Limited-Duration Insurance Coverage Prohibition … [read more]

  Table of Contents Back to Top FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: Back to Top Kelly Randolph, Center for Food Safety and Applied Nutrition (HFS-275), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1188. SUPPLEMENTARY INFORMATION: Back to Top In … [read more]

  Table of Contents Back to Top FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Summary of Errors A. Summary of Errors in the Preamble B. Summary of Errors in the Addendum IV. Correction of Errors A. Corrections of Errors in the Preamble B. Corrections of Errors in … [read more]

  Table of Contents Back to Top FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Office for Civil Rights (OCR) Final Rule Stage 104. Nondiscrimination Under the Patient Protection and Affordable Care Act DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Office of the National … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top FDA is extending the comment period on the proposed rule published April 25, 2016 (81 FR 24386). Submit either electronic or written comments by July 25, … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Amendment of 21 CFR Parts 175, 176, 177, and 178 § 175.105 Adhesives § 175.300 Resinous and Polymeric Coatings § 175.320 Resinous and Polymeric Coatings for Polyolefin Films § 176.170 Components of Paper and Paperboard … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Significance of Guidance III. Paperwork Reduction Act of 1995 IV. Electronic Access Tables Back to Top Table 1—Estimated Annual Reporting Burden 1 DATES: Back to Top Although you … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Significance of Draft Guidance III. Paperwork Reduction Act of 1995 IV. Electronic Access DATES: Back to Top Although you can comment on any guidance at any time … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Significance of Guidance III. Electronic Access DATES: Back to Top Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Back to Top You … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Paperwork Reduction Act of 1995 III. Electronic Access DATES: Back to Top Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Back to … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Significance of Guidance III. Electronic Access DATES: Back to Top Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Back to Top You … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Purpose and Format of the Regional Outreach Meetings III. How To Participate in the Public Meeting Tables Back to Top Table 1—Information on Participation in the Meeting DATES: Back to Top … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Acronyms Table of Contents Executive Summary 1. Purpose 2. Summary of the Major Provisions (a) MIPS (b) APMs 3. Summary of Costs & Benefits I. Background A. Physician and Practitioner Payment Under Medicare 1. … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Enforcement III. Paperwork Reduction Act of 1995 IV. Electronic Access DATES: Back to Top Submit either electronic or written comments on FDA guidances at any time. ADDRESSES: … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Executive Summary A. Purpose of the Proposed Rule B. Summary of the Major Provisions of the Proposed Rule C. Legal Authority D. Costs and Benefits II. Companion Document to … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Abandonment DATES: Back to Top Submit either electronic or written comments by June 28, 2016. ADDRESSES: Back to Top You may submit comments as follows: Electronic Submissions … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents Acronyms I. Executive Summary for this Proposed Rule A. Purpose B. Summary of the Major Provisions C. Summary of Impacts II. Background A. Hospice Care B. History of the Medicare Hospice … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Electronic Access Electronic Access Tables Available Only Through the Internet on the CMS Web Site Acronyms Table of Contents I. Executive Summary and Background A. Executive Summary 1. Purpose and Legal Authority 2. Summary … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background DATES: Back to Top FDA is extending the comment period on the document published March 4, 2016 (81 FR 11477). Submit either electronic or written comments by June … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents A. WTC Health Program Statutory Authority B. Approval To Submit Document to the Office of the Federal Register C. Petition 011 D. Administrator's Determination on Petition 011 Footnotes DATES: Back to Top … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Executive Summary A. Purpose B. Summary of Major Provisions C. Summary of Impacts Table of Contents Acronyms, Abbreviations, and Short Forms I. Background A. Historical Overview of the IRF PPS B. Provisions of the … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Availability of Certain Tables Exclusively Through the Internet on the CMS Web Site Table of Contents Acronyms I. Executive Summary A. Purpose B. Summary of Major Provisions C. Summary of Cost and Benefits II. … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Executive Summary Purpose of the Proposed Rule Legal Authority Summary of the Major Provisions of the Proposed Rule Costs and Benefits of the Proposed Rule Table of Contents I. Background … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Draft Guidances III. Purpose and Scope of the Public Hearing IV. Attendance and Registration V. Notice of Hearing Under 21 CFR Part 15 VI. Transcripts Footnotes DATES: … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top FDA is extending the comment period on the four draft guidances announced in the Federal Register (see SUPPLEMENTARY INFORMATION). Submit either electronic or written comments by … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Ceiling Price for a Covered Outpatient Drug Exception New Drug Price Estimation Definition of “Knowing and Intentional” DATES: Back to Top The comment period for the proposed rule published on June 17, 2015 (80 … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top Submit either electronic or written comments by May 18, 2016. ADDRESSES: Back to Top You may submit comments as follows: Electronic Submissions Back to Top Submit … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Contents I. Background Adoption and Foster Care Automated Reporting System (AFCARS) Indian Child Welfare Act Use of AFCARS Data II. Statutory Authority III. Public Participation IV. Consultation and Regulation Development V. Section-by-Section Discussion of … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Why is FDA publishing this proposed rule? III. Legal Authority IV. Analysis of Environmental Impact V. Economic Analysis of Impacts VI. Paperwork Reduction Act of 1995 VII. … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents I. Executive Summary A. Purpose and Scope of the Proposed Rule B. Summary of the Major Provisions of the Proposed Rule C. Legal Authority D. Costs and … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents A. WTC Health Program Statutory Authority B. Approval To Submit Document to the Office of the Federal Register C. Petition 010 D. Administrator's Determination on Petition 010 Footnotes DATES: Back to Top … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents Acronyms I. Executive Summary A. Purpose B. Summary of Major Provisions C. Summary of Impacts II. Public Participation Comments Invited III. Background A. Opioid Use Disorder B. Medication-Assisted Treatment (MAT) C. … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Footnotes DATES: Back to Top Written comments are not being solicited. FOR FURTHER INFORMATION CONTACT: Back to Top Dr. Narayan Nair, MD, Acting Director, Division of Injury Compensation Programs (DICP), Healthcare Systems Bureau, Health Resources … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top The color additive petition was filed on February 19, 2016. FOR FURTHER INFORMATION CONTACT: Back to Top Laura Dye, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents I. Background A. History of Powdered Gloves and Their Regulation B. Citizen Petitions C. Scope of the Ban D. Legal Standard II. Evaluation of Data and Information … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top The food additive petition was filed on February 12, 2016. FOR FURTHER INFORMATION CONTACT: Back to Top Chelsea Trull, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top The comment period for the notice published in the January 26, 2016 Federal Register (81 FR 4239) is extended to May 10, 2016. ADDRESSES: Back to Top Because of staff … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents Acronyms I. Executive Summary A. Purpose B. Summary of Major Provisions 1. Model Overview 2. Model Scope 3. Model Payment 4. Overlap With Ongoing CMS Efforts C. Economic Effects II. Participation … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background A. Statutory and Regulatory Authorities B. Regulatory History of the Device II. Recommendation of the Panel A. Identification B. Recommended Classification of the Panel C. Summary of Reasons … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Purpose and Scope of the Public Hearing III. Notice of Hearing Under 21 CFR Part 15 DATES: Back to Top The public hearing will be held on … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Issues for Consideration A. Proposed Definitions of Third-Party and OEM Activities B. Evaluation of Risk Associated With These Third-Party and OEM Activities III. Paperwork Reduction Act of … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background—Regulatory Authorities II. Regulatory History of the Device III. Dates New Requirements Apply IV. Device Subject to This Proposal Multiple Use Blood Lancet for Multiple Patient Use (21 CFR … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Regulatory History of the Device III. Device Description IV. Proposed Reclassification A. Single Patient Use Only Blood Lancets B. Multiple Patient Use Blood Lancets V. Public Health … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Commonly Used Acronyms Table of Contents I. Executive Summary A. Purpose of Regulatory Action B. Summary of Major Provisions 1. ONC Direct Review of Certified Health IT 2. ONC-Authorized Testing Laboratories 3. Transparency and … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background A. Statutory and Regulatory Authorities B. Regulatory History of the Devices II. Panel Recommendation A. Identification B. Recommended Classification of the Panel C. Risks to Health and Special … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Executive Summary and Background A. Executive Summary 1. Purpose and Need for Regulatory Action 2. Summary of the Major Provisions 3. Summary of Costs and Benefits B. General Overview 1. Medicare 2. Medicaid … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top We are extending the comment period on the notice of filing of a food additive petition published on January 4, 2016 (81 FR 42). Submit either … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top FDA is reopening the comment period on the proposed rule published November 18, 2015 (80 FR 71990). Submit either electronic or written comments by April 25, … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents Acronyms I. Executive Summary A. Purpose B. Summary of the Major Provisions C. Summary of Impacts II. Background A. Significant Technology Changes B. Statutory and Rulemaking History III. Provisions of This … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Acronyms I. Executive Summary and Background A. Executive Summary 1. Purpose 2. Summary of the Major Provisions 3. Summary of Costs and Benefits B. Background II. Provisions of the Proposed Regulations A. Integrating Regional … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Provisions of the Proposed Regulations A. Non-Public Analyses 1. Additional Analyses 2. Limitations on the Qualified Entities With Respect to the Sale and Provision of Non-Public Analyses 3. Limitations on the … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Provisions of This Proposed Regulation A. Definitions B. Threshold Cost C. Compliance With PRC Regulations D. Alternate Resources E. Reimbursement Procedure F. Recovery of CHEF Reimbursement Funds III. Collection of Information … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background—Regulatory Authorities A. Reclassification B. Requirement for Premarket Approval Application II. Regulatory History of the Device III. Device Description IV. Proposed Reclassification V. Risks to Health VI. Summary of … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top Submit either electronic or written comments on information collection issues under the PRA by February 22, 2016. ADDRESSES: Back to Top Submit comments on information collection issues to the Office … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Public Participation II. Background A. Legal Authority B. Historical Background to This Rulemaking III. Summary of Proposed Changes A. Definitions B. Proposed Changes to the List of Select Agents Coxiella burnetii (42 CFR … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top January 14, 2016, from 11 a.m.-12:30 p.m. (EST). ADDRESSES: Back to Top 5600 Fishers Lane, Conference Room 08SWH01, Rockville, Maryland 20857 (and via audio conference call and Adobe Connect). FOR … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Amendment of § 172.515 III. Establish a Zero Tolerance DATES: Back to Top The food additive petition was filed on August 17, 2015. Submit either electronic or written … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background—Regulatory Authorities A. Reclassification B. Requirement for Premarket Approval Application II. Regulatory History of the Device III. Device Description IV. Proposed Reclassification V. Risks to Health VI. Summary of Reasons for Reclassification VII. … [read more]

  Table of Contents Back to Top FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: Back to Top Lori Jo Churchyard, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911. SUPPLEMENTARY INFORMATION: Back … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top FDA is extending the comment period for a docket to receive information and comments on the use of the term “natural” in the labeling of human … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Contents I. Executive Summary II. Background A. Child Care and Development Fund B. Discussion of Changes Made in This Proposed Rule C. Effective Date III. Statutory Authority IV. Provisions of Proposed Rule Subpart A—Goals, … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents I. Executive Summary Purpose of the Regulatory Action Summary of the Major Provisions of the Regulatory Action Costs and Benefits II. Background A. Regulatory History 1. Fixed-Combination … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background A. OIG Safe Harbor Provisions B. OIG Special Fraud Alerts C. Section 205 of the Health Insurance Portability and Accountability Act of 1996 II. Solicitation of Additional New Recommendations and Proposals A. … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background and Legal Authority II. Risks Posed by the Device A. Increased Skin Cancer Risk From Cumulative, Repeated UV Radiation Exposure B. Ocular Injury C. Discomfort, Pain, and Tenderness … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Executive Summary Purpose of the Regulatory Action Summary of the Major Provisions of the Regulatory Action in Question Costs and Benefits Table of Contents I. Background II. Contents of the Proposed Regulation A. Overview … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Workforce Innovation and Opportunity Act of 2014 II. Programs Authorized by Title II of the Rehabilitation Act of 1973, as Amended by WIOA A. Disability, Independent Living, and Rehabilitation Research Projects and Centers … [read more]

  Table of Contents Back to Top FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Office for Civil Rights (OCR) Proposed Rule Stage 244. Nondiscrimination Under the Patient Protection and Affordable Care Act DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents Acronyms and Abbreviations I. Executive Summary II. Background A. Legislative and Regulatory Overview 1. Premium Stabilization Programs 2. Program Integrity 3. Exchanges 4. Essential Health Benefits and Actuarial Value 5. Market … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top The comment period for the proposed rule published on September 25, 2015 (80 FR 57756) is extended. Submit either electronic or written comments by December 30, … [read more]

  Table of Contents Back to Top AGENCIES: DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Department of Defense; Department of Education; Department of Veterans Affairs; Environmental Protection Agency; Department of Health and Human Services; National Science Foundation; and Department of Transportation. DATES: Back to Top The comment period … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top The food additive petition was filed on October 15, 2015. FOR FURTHER INFORMATION CONTACT: Back to Top Chelsea Trull, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Executive Summary Purpose of the Rule Table of Contents I. Background A. Why do we need this proposed rule? B. What are fermented or hydrolyzed foods? C. Why are there … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background A. Regulatory Authorities B. Regulatory History—Background of the Device II. Panel Recommendation A. Classification Recommendation B. Summary of Reasons and Data To Support the Recommendations III. Proposed Classification … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Workforce Innovation and Opportunity Act of 2014 Background Programs Amended by WIOA Overview of the Independent Living Program Independent Living Services Centers for Independent Living Statewide Independent Living Councils Indicators of Minimum Compliance … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background A. What has been FDA's position regarding the use of the term “natural?” B. What recent events prompted FDA to request comment? II. Request for Comments and Information … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top ACF reopens the comment period for notice of proposed rulemaking entitled, “Comprehensive Child Welfare Information System” published on August 11, 2015 (80 FR 48200). Submit either electronic or written comments … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Acronyms Table of Contents I. Background A. Overview B. Legislative History II. Provisions of the Proposed Regulations A. Hospital Discharge Planning 1. Design (Proposed § 482.43(a)) 2. Applicability (Proposed § 482.43(b)) 3. Discharge Planning … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Provisions of the Request for Information A. Access to Care Data Collection and Methodology B. Access to Care Thresholds/Goals C. Alternative Processes for Access Concerns D. Access to Care Measures 1. … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Reopening of Comment Period DATES: Back to Top Submit either electronic or written comments on the draft guidance by April 29, 2016. ADDRESSES: Back to Top You … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Reopening of Comment Period DATES: Back to Top Submit either electronic or written comments on the draft guidance by April 29, 2016. ADDRESSES: Back to Top You … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Paperwork Reduction Act of 1995 III. Electronic Access DATES: Back to Top Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Reopening of Comment Period DATES: Back to Top Submit either electronic or written comments on the draft guidance by April 29, 2016. ADDRESSES: Back to Top You … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Draft Guidances III. Purpose and Scope of the Public Hearing IV. Attendance and Registration V. Notice of Hearing Under 21 CFR Part 15 VI. Transcripts DATES: Back … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top This food additive petition was filed on October 1, 2015. Submit either electronic or written comments on the petitioner's environmental assessment by November 27, 2015. ADDRESSES: … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents A. WTC Health Program Statutory Authority B. Petition 009 C. Administrator's Determination on Petition 009 Footnotes DATES: Back to Top The Administrator of the WTC Health Program is denying this petition for … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents I. Background II. Provisions of the Proposed Methodology A. Overview of the Funding Methodology and Calculation of the Payment Amount Equation 1: Estimated PTC by Rate Cell Equation 2: Estimated CSR … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background DATES: Back to Top Submit either electronic or written comments on the supplemental proposed rule and related documents by October 23, 2015. ADDRESSES: Back to Top You may … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top The comment period for the October 1, 2015 RFI (80 FR 59102) is extended to November 17, 2015. To be assured consideration, written or electronic comments on the October 1, … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Statutory Authority II. Public Participation III. Organization of the NPRM IV. Background V. Consultation and the Development of the NPRM VI. Scope of the Proposed Rule VII. Section-by-Section Discussion of the Regulatory Provisions … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Regulatory Authorities II. Regulatory History and Description of the Devices III. Proposed Regulation IV. Risks to Health A. Pediatric Medical Crib B. Medical Bassinet V. Establishment of Special Controls … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background A. The Merit-Based Incentive Payment System (MIPS) B. Alternative Payment Models C. Technical Assistance to Small Practices and Practices in Health Professional Shortage Areas II. Solicitation of Comments A. The Merit-Based Incentive … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents Acronyms I. Executive Summary and Background A. Executive Summary 1. Purpose and Legal Authority 2. Summary of the Major Provisions of This Proposed Rule 3. Summary of Costs and Benefits B. … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: Executive Summary Purpose of the Proposed Rule Summary of the Major Provisions of the Regulatory Action Costs and Benefits SUPPLEMENTARY INFORMATION: I. Background A. Definition of “Tobacco Product” B. Drug/Device/Combination Product Definitions … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Purpose and Format of the Public Meeting III. How To Participate in the Public Meeting IV. Transcripts and Recorded Video Tables Back to Top Table 1—Information on Participation in the Meeting … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Legal Authority III. Description of the Proposed Rule IV. Proposed Effective Date V. Economic Analysis of Impacts VI. Analysis of Environmental Impact VII. Paperwork Reduction Act of … [read more]

  Table of Contents Back to Top FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: Back to Top Charlotte Christin, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-3708. SUPPLEMENTARY INFORMATION: Back to Top In FR … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Paperwork Reduction Act of 1995 III. Comments IV. Electronic Access DATES: Back to Top Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top The comment period for the proposed rule published on July 16, 2015 (80 FR 42168), is reopened and ends on October 14, 2015. ADDRESSES: Back to Top In commenting, please … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents I. Executive Summary A. Purpose of Regulatory Action B. Summary of Major Provisions C. Costs and Benefits II. Public Participation III. Background A. WTC Health Program Statutory Authority B. Methods Used … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Updated Information DATES: Back to Top We are extending the comment period that was scheduled to close on September 25, 2015, until October 13, 2015. ADDRESSES: Back … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Request for Comments DATES: Back to Top FDA is reopening the comment period on the notice of public hearing published March 27, 2015 (80 FR 16327), and … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Executive Summary Executive Summary Purpose of the Regulatory Action Summary of the Major Provisions of the Proposed Regulatory Action Estimated Costs and Benefits I. The Rationale for Modernizing the Common Rule A. The Changing … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background Subpart A—General Provisions Purpose and Effective Date (§ 92.1) Application (§ 92.2) Relationship to Other Laws (§ 92.3) Definitions (§ 92.4) Assurances Required (§ 92.5) Remedial Action and Voluntary Action (§ 92.6) … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Summary of Errors III. Waiver of 60-Day Comment Period IV. Correction of Errors DATES: Back to Top This correction is effective on September 2, 2015. FOR FURTHER INFORMATION CONTACT: Back to Top … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Description of the Proposed Rule A. Basis for the Designation of Distinguishable Names for Certain Biological Products 1. Safe Use 2. Pharmacovigilance 3. Additional Benefits of Consistent … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Summary of Errors III. Correction of Errors Tables Back to Top Table 16—Example of Potential Performance Periods for Pre- and Post-Operative THA/TKA Voluntary Data Submission DATES: Back to Top The comment due … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Requests for Comments and Information A. General Information About Submitting Comments B. Public Availability of Comments C. Information Identifying the Person Submitting the Comment DATES: Back to … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Summary of Errors III. Correction of Errors DATES: Back to Top The comment due date for the proposed rule published in the Federal Register on July 10, 2015 (80 FR 39839) remains … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top Submit either electronic or written comments on the petitioner's request for categorical exclusion from preparing an environmental assessment or environmental impact statement by September 14, 2015. ADDRESSES: Back to Top … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Public Participation II. Statutory Authority III. Summary of Proposed Rule IV. Regulatory Assessment Requirements A. Executive Order 12866 and Executive Order 13563 B. Regulatory Flexibility Act C. Paperwork Reduction Act D. Small Business … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top ACF extends the comment period for notice of proposed rulemaking entitled, “Head Start Performance Standards” published on June 19, 2015 (80 FR 35430), to September 17, 2015. Submit either electronic … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Executive Summary per Executive Order 13563 Purpose of the NPRM The Need for Regulatory Action and How the Action Will Meet That Need Statutory Authority for the NPRM Summary of the Major Provisions … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Overview of Proposed Rule A. Purpose of the Proposed Rule B. Proposed Amendments to HHS Equal Treatment Regulations 1. Direct and Indirect Federal Financial Assistance 2. Inherently Religious Activities 3. Pass-Through … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Summary of Errors III. Correction of Errors Tables Back to Top Table 9—CY 2016 Case-Mix Payment Weights DATES: Back to Top Comments on the proposed rule published on July 10, 2015 (80 … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Paperwork Reduction Act of 1995 III. Comments IV. Electronic Access DATES: Back to Top Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Background Findings Findings That Result in Additions or Changes to the Table Findings That Do Not Result in Changes to the Table Because the Injury Is Already on the Table Findings That Do Not … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Comments III. References DATES: Back to Top The comment period for the proposed rule published March 3, 2014 (79 FR 11879), is reopened for the limited purpose … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Executive Summary Purpose of the Regulatory Action Summary of the Major Provisions of the Regulatory Action in Question Costs and Benefits I. Background A. NFL/SFL Proposed Rule B. Public Outreach … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents I. Background A. Introduction B. Accreditation of Third-Party Auditors Proposed Rule C. Regulatory Use of Certifications Under FSMA D. Reimbursement (User Fee) Program Under Section 808(c)(8) of … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top Submit either electronic or written comments on the petitioner's request for categorical exclusion from preparing an environmental assessment or environmental impact statement by August 17, 2015. ADDRESSES: Back to Top … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Public Participation II. Background A. Historical Background for This Proposed Rulemaking B. Legal Authorities III. Alternatives Considered III. Regulatory Analyses A. Executive Orders 12866 and 13563 B. Regulatory Flexibility Act C. Paperwork Reduction … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Acronyms Table of Contents I. Background A. Executive Summary 1. Purpose 2. Summary of the Major Provisions Basis and Scope (§ 483.1) Definitions (§ 483.5) Resident Rights (§ 483.10) Facility Responsibilities (§ 483.11) *New … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents Acronyms Addenda Available Only Through the Internet on the CMS Web Site CPT (Current Procedural Terminology) Copyright Notice I. Executive Summary and Background A. Executive Summary 1. Purpose 2. Summary of … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Electronic Access Alphabetical List of Acronyms Table of Contents I. Executive Summary A. Purpose B. Summary of the Major Provisions 1. Model Overview: LEJR Episodes of Care 2. Model Scope 3. Payment 4. Similar … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents A. WTC Health Program Statutory Authority B. Petition 008 C. Administrator's Determination on Petition 008 Footnotes DATES: Back to Top The Administrator of the WTC Health Program is denying this petition for … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents Regulations Text Acronyms I. Executive Summary A. Purpose B. Summary of the Major Provisions C. Summary of Costs and Transfers II. Background A. Statutory Background B. System for Payment of Home … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Electronic Access Addenda Available Only Through the Internet on the CMS Web site Alphabetical List of Acronyms Appearing in This Federal Register Document Table of Contents I. Summary and Background A. Executive Summary of … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Executive Summary Purpose of the Proposed Rule Statement of Legal Authority Summary of the Major Provisions of the Proposed Rule Costs and Benefits I. Background II. Current Methods for Ensuring … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Requests for Comments and Information A. Nicotine Exposure Warnings B. Child-Resistant Packaging C. Other Actions and Considerations III. Comments A. General Information About Submitting Comments B. Public … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Electronic Access Addenda Are Only Available Through the Internet on the CMS Web site Table of Contents Acronyms I. Executive Summary A. Purpose 1. End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) 2. End-Stage … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Listed Uses That May No Longer Be Considered Essential A. Sterile Aerosol Talc Administered Intrapleurally by Thoracoscopy for Human Use (21 CFR 2.125(e)(4)(ix)) B. Drug Products That … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Public Participation II. Legal Authority III. Background A. Inadmissibility and the Medical Examination B. Applicability of Part 34 C. Legislative and Regulatory History of Part 34 IV. Rationale for Proposed Regulatory Action A. … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents I. Executive Summary II. Tables III. Background Statutory Authority and Requirements Expert and Stakeholder Consultation Overview of Major Proposed Revisions to Head Start Performance Standards IV. Discussion of Proposed Rule Program … [read more]

  Table of Contents Back to Top FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) Completed Actions 99. SAMHSA USER FEES FOR PUBLICATIONS DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Proposed … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Summary of the Proposed Regulations Subpart A—General Provisions § 10.1Purpose § 10.2Summary of 340B Drug Pricing Program § 10.3Definitions Subpart B—340B Ceiling Price § 10.10Ceiling Price for a Covered Outpatient Drug … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Request for Comments DATES: Back to Top FDA is extending the comment period on the notice of public hearing published March 27, 2015 (80 FR 16327). Submit … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents A. WTC Health Program Statutory Authority B. Petition 007 C. Administrator's Determination on Petition 007 Footnotes DATES: Back to Top The Administrator of the WTC Health Program is denying this petition for … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Significance of Guidance III. Paperwork Reduction Act of 1995 IV. Comments V. Electronic Access DATES: Back to Top Although you can comment on any guidance at any time (see 21 CFR … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents Acronyms I. Medicaid Managed Care A. Background B. Provisions of the Proposed Regulations 1. Alignment With Other Health Coverage Programs a. Marketing (§ 438.104) b. Appeals and Grievances (§ 438.400, § … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Solicitation of Comments III. Response to Comments DATES: Back to Top To be assured consideration, written or electronic comments must be received at one of the addresses provided below, no later … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Executive Summary Purpose of Proposed Rule Summary of Major Provisions Costs and Benefits I. Background II. Proposed Regulations A. Records and Reports—Conforming Changes (Proposed § 514.80(b)(4)(i)) B. Annual Sponsor Reports … [read more]

  Correction In proposed rule document 2015-09245 beginning on page 24324 in the issue of Thursday, April 30, 2015 make the following correction(s): On page 24324, in the second column, in the DATES section, “June 29, 2015” should read “June 16, 2015”. [FR Doc. C1-2015-09245 Filed 5-4-15; 8:45 am] … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents Acronyms I. Executive Summary for This Proposed Rule A. Purpose B. Summary of the Major Provisions C. Summary of Impacts II. Background A. Hospice Care B. History of the Medicare Hospice … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top The notice of proposed rulemaking published at 78 FR 29442, May 20, 2013, is withdrawn, effective immediately. FOR FURTHER INFORMATION CONTACT: Back to Top Andrew Williams, Director, Office of Child Care … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Availability of Certain Tables Exclusively Through the Internet on the CMS Web Site Acronyms I. Executive Summary A. Purpose B. Summary of the Major Provisions C. Summary of Impacts II. Background A. Overview of … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Executive Summary Purpose of the Regulatory Action Summary of the Major Provisions of the Regulatory Action in Question Effectiveness Safety Active Ingredients Costs and Benefits Table of Contents I. Introduction … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Footnotes DATES: Back to Top Written comments are not being solicited. FOR FURTHER INFORMATION CONTACT: Back to Top Avril M. Houston, MD, MPH, Director, Division of Injury Compensation Programs, Healthcare Systems Bureau, HRSA, Parklawn Building, … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Electronic Access Tables Available Only Through the Internet on the CMS Web site Acronyms Table of Contents I. Executive Summary and Background A. Executive Summary 1. Purpose and Legal Authority 2. Summary of the … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Executive Summary A. Purpose B. Summary of Major Provisions C. Summary of Impacts Table of Contents Acronyms, Abbreviations, and Short Forms I. Background A. Historical Overview of the IRF PPS B. Provisions of the … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Request for Comments DATES: Back to Top FDA is extending the comment period on the proposed rule published February 6, 2015 (80 FR 6802). Submit either electronic … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top The color additive petition was filed on March 19, 2015. FOR FURTHER INFORMATION CONTACT: Back to Top Salome Bhagan, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Availability of Certain Tables Exclusively Through the Internet on the CMS Web Site Table of Contents Acronyms I. Executive Summary A. Purpose B. Summary of Major Provisions C. Summary of Cost and Benefits II. … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Executive Summary A. Purpose B. Summary of the Major Provisions C. Summary of Costs and Benefits II. Background A. Legislative History and Statutory Authority B. Program Affected III. Provisions of the Proposed Regulations … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Acronyms I. Executive Summary and Background A. Executive Summary 1. Purpose of Regulatory Action a. Need for Regulatory Action b. Legal Authority for the Regulatory Action 2. Summary of Major Provisions a. Aligning Meaningful … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. What is the background of this Proposed Rule? II. Why is FDA publishing this companion Proposed Rule? III. What is the legal authority for this Proposed Rule? IV. What … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Acronyms, Abbreviations, and Short Forms Table of Contents I. Executive Summary II. Background A. Introduction III. Provisions of the Proposed Rule A. Meaning of Terms (§ 438.900, § 440.395, § 457.496) B. Parity Requirements … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Executive Summary Purpose of the Proposed Rule Summary of the Major Provisions of the Proposed Rule Costs and Benefits Table of Contents I. Background A. The Public Health Security and … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top Effective April 2, 2015, ACF announces its intent to issue a SNPRM. FOR FURTHER INFORMATION CONTACT: Back to Top Kathleen McHugh, Children's Bureau, Administration on Children, Youth and Families, (202) 401-5789 … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Acronyms I. Executive Summary and Background A. Executive Summary 1. Purpose of Regulatory Action a. Need for Regulatory Action b. Legal Authority for the Regulatory Action 2. Summary of Major Provisions a. Meaningful Use … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Commonly Used Acronyms Table of Contents I. Executive Summary A. Purpose of Regulatory Action B. Summary of Major Provisions 1. Overview of the 2015 Edition Health IT Certification Criteria 2. Definitions a. Base EHR … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background A. Homeopathic Products and the Federal Food, Drug, and Cosmetic Act B. Homeopathic Drugs and the OTC Drug Review C. FDA's Compliance Policy Guide D. Growth in the Sale of Drugs Labeled … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Amendment of § 176.170 DATES: Back to Top The food additive petition was filed on January 7, 2015. FOR FURTHER INFORMATION CONTACT: Back to Top Paul Honigfort, Center for Food Safety and … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Amendment of 21 CFR 177.1210 III. Revocation of TOR Exemption No. 2005-006 IV. Issue of a New Regulation in 21 CFR 189 Subpart D V. Comments DATES: … [read more]

  Correction In Proposed Rule Document 2015-01666, pages 6801-6896, publishing in the Issue of Friday, February 6, 2015, make the following corrections: 1. On page 6807, in the second column in Table 1, the heading should read: Proposed Changes See section of this document (identified in parentheses) for more … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Request for Comments DATES: Back to Top FDA is extending the comment period on the proposed rule published on December 18, 2014 (79 FR 75506). Submit either … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. FY 2013 Regulatory Science Priorities III. FY 2014 Regulatory Science Priorities IV. FY 2015 Regulatory Science Priorities V. Purpose and Scope of the June 5, 2015, Public Hearing VI. Notice of … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Proposed Rule Part 301—HHS Acquisition Regulation System Part 302—Definitions of Words and Terms Part 303—Improper Business Practices and Personal Conflicts of Interest Part 304—Administrative Matters Part 305—Publicizing Contract Actions Part 306—Competition … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Public Participation II. Background III. Proposed Changes to 42 CFR Part 73, Modifications to the List of Select Agents and Toxins Being Considered A. Coxiella burnetii B. Rickettsia prowazekii C. Bacillus anthracis Pasteur … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Regulatory Background A. Regulatory and Statutory Framework B. FDA's Review of Ecamsule II. Safety Data Considerations for OTC Sunscreen Products Containing Ecamsule A. Human Safety Data 1. Human Irritation, … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Regulatory Background A. Regulatory and Statutory Framework B. FDA's Review of Enzacamene II. Safety Data Considerations for OTC Sunscreen Products Containing Enzacamene A. Human Safety Data 1. Human Irritation, … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Registration and Requests for Oral Presentations III. Streaming Webcast of the Public Meeting IV. Comments V. Transcripts VI. Reference DATES: Back to Top Meeting. The public meeting … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top Comments on the NPRM must be received before 5 p.m. EST on March 23, 2015 in order to ensure we will be able to consider the comments when preparing the … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Contents I. Executive Summary per Executive Order 13563 (1) Purpose of the AFCARS NPRM (2) Summary of the Major Provisions of the NPRM (3) Costs and Benefits II. Background on Foster Care and Adoption … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents Executive Summary Purpose of the Regulatory Action Summary of the Major Provisions of the Regulatory Action Costs and Benefits I. Background I.A. Hatch-Waxman Amendments I.B. Requirements for … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top The color additive petition was filed on December 22, 2014. FOR FURTHER INFORMATION CONTACT: Back to Top Ellen Anderson, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. How To Participate in the Public Meeting III. Comments, Transcripts, and Recorded Video IV. Reference Tables Back to Top Table 1—Information on Participation in the Meeting and … [read more]

  Correction FR proposed rule document 2015-00205 beginning on pages 1478 in the issue of Monday, January 12, 2015, was never placed on public inspection and was published in error. It should be removed. [FR Doc. C1-2015-00205 Filed 1-12-15; 4:15 pm] BILLING CODE 1505-01-D … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top The comment period for the proposed rule published in the December 5, 2014 Federal Register (79 FR 72160) is extended to February 4, 2015. ADDRESSES: Back to Top Because of … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. How To Participate in the Public Meeting III. Comments, Transcripts, and Recorded Video IV. Reference Tables Back to Top Table 1—Information on Participation in the Meeting and … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top Submit either electronic or written comments on the petitioner's request for categorical exclusion from preparing an environmental assessment or environmental impact statement by February 5, 2015. ADDRESSES: Back to Top … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Executive Summary Purpose of the Regulatory Action Summary of the Major Provisions of the Regulatory Action Costs and Benefits I. Background II. Description of the Proposed Rule A. Current Exceptions … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background A. OIG Safe Harbor Provisions B. OIG Special Fraud Alerts C. Section 205 of the Health Insurance Portability and Accountability Act of 1996 II. Solicitation of Additional New Recommendations and Proposals A. … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Overview of the Proposed Regulations A. Requirement To Provide a Summary of Benefits and Coverage 1. Providing the SBC a. Provision of the SBC by an Issuer to a Plan b. … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Paperwork Reduction Act of 1995 III. Comments IV. Electronic Access DATES: Back to Top Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that … [read more]

  Table of Contents Back to Top AGENCIES: DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Overview of These Proposed Regulations A. Requirements of These New Proposed Regulations 1. Covers Additional Benefits 2. Limited in Amount 3. Nondiscrimination 4. Plan Eligibility Requirements 5. Reporting B. Pilot … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents Executive Summary Purpose of the Regulatory Action Summary of the Major Provisions of the Regulatory Action Costs and Benefits I. Background A. How do “Prescription Drug Labeling”, … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: A. WTC Health Program Statutory Authority B. Petition 006 C. Administrator's Determination on Petition 006 Footnotes DATES: Back to Top The Administrator of the WTC Health Program is denying this petition for the addition of … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents I. Background A. United States v. Windsor Decision B. Statutory and Regulatory Authority II. Provisions of the Proposed Regulations A. Ambulatory Surgical Centers Condition for Coverage—Patient Rights (§ 416.50) B. Hospice … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents Regulations Text Acronyms CPT (Current Procedural Terminology) Copyright Notice I. Executive Summary and Background A. Executive Summary 1. Purpose 2. Summary of the Major Provisions 3. Summary of Costs and Benefits … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Provisions of the Proposed Rule III. Collection of Information Requirements IV. Regulatory Impact Statement List of Subjects in 42 CFR Part 136 PART 136—INDIAN HEALTH Subpart I—Limitation on Charges for Health … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top The comment period is extended to 5 p.m. Eastern Standard Time on January 7, 2015. ADDRESSES: Back to Top In commenting, please refer to file code CMS-3819-P. Because of staff … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents Acronyms I. Executive Summary II. Background A. Legislative and Regulatory Overview 1. Premium Stabilization Programs 2. Program Integrity 3. Exchanges 4. Essential Health Benefits, Actuarial Value 5. Market Rules 6. Rate … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Executive Summary Purpose of This Regulatory Action Summary of the Major Provisions of the Regulatory Action Applicable Clinical Trial Responsible Party Registration Expanded Access Information Results Submission Adverse Events Updates and Other Required Information … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Paperwork Reduction Act of 1995 III. Comments IV. Electronic Access DATES: Back to Top Submit either electronic or written comments on FDA guidances at any time. ADDRESSES: Back to Top Submit … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top The proposed rule published July 2, 2014 (79 FR 37687) is corrected as of November 17, 2014. FOR FURTHER INFORMATION CONTACT: Back to Top Edisa Gozun, Center for Drug Evaluation and … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Submission of Comments Statutory Authority Background Effective Date and Potential Impact on State Law Tribal Impact Statement Section-by-Section Discussion of the Provisions of This Proposed Rule Topic 1: Procedures To Promote Program Flexibility, Efficiency … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background—Regulatory Authorities A. Reclassification B. Requirement for Premarket Approval Application II. Regulatory History of the Device III. Device Description IV. Proposed Reclassification V. Risks to Health VI. Summary of … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Provisions of the Proposed Regulations III. Collection of Information Requirements IV. Response to Comments V. Regulatory Impact Statement List of Subjects in 42 CFR Part 493 PART 493—LABORATORY REQUIREMENTS DATES: Back … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top Submit either electronic or written comments on the petitioner's request for categorical exclusion from preparing an environmental assessment or environmental impact statement by December 8, 2014. ADDRESSES: Back to Top … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: A. WTC Health Program Statutory Authority B. Petition 005 C. Administrator's Determination on Petition 005 Footnotes DATES: Back to Top The Administrator of the WTC Health Program is denying this petition for the addition of … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Overview of Requested Feedback A. General Regulatory Topics of Interest B. Special Topics of Interest III. Conclusion DATES: Back to Top Comments on this ANPRM must be received by January 29, … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. How To Participate in the Public Meeting III. Comments, Transcripts, and Recorded Video Tables Back to Top Table 1—Information on Participation in the Meeting and on Submitting Comments to the Rulemaking … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Paperwork Reduction Act of 1995 III. Comments IV. Electronic Access DATES: Back to Top Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents I. Background II. Provisions of the Proposed Methodology A. Overview of the Funding Methodology and Calculation of the Payment Amount 1. Equation 1: Estimated PTC by Rate Cell 2. Equation 2: … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top The color additive petition was filed on September 22, 2014. FOR FURTHER INFORMATION CONTACT: Back to Top Molly A. Harry, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top The color additive petition was filed on August 21, 2014. FOR FURTHER INFORMATION CONTACT: Back to Top Ellen Anderson, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top Submit either electronic or written comments on the petitioner's request for categorical exclusion from preparing an environmental assessment or environmental impact statement by November 17, 2014. ADDRESSES: Back to Top … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Introduction Health Disparities II. Background A. The Home Health Benefit B. Previous HHA Conditions of Participation Rules C. Transforming the HHA Conditions of Participation III. Provisions of the Proposed Rule A. Overview B. … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top The food additive petition was filed on August 11, 2014. FOR FURTHER INFORMATION CONTACT: Back to Top Teresa A. Croce, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: Executive Summary A. Need For Regulatory Action B. Summary of Major Provisions 1. Anti-Kickback Statute and Safe Harbors 2. Civil Monetary Penalty Authorities C. Costs and Benefits SUPPLEMENTARY INFORMATION: I. Background A. Anti-Kickback Statute and Safe … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents Executive Summary Purpose of the Supplemental Notice of Proposed Rulemaking Summary of the Major Provisions of the Supplemental Notice of Proposed Rulemaking Costs and Benefits I. Background … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents Executive Summary Purpose and Coverage of the Supplemental Notice of Proposed Rulemaking Summary of the Major Provisions of the Supplemental Notice of Proposed Rulemaking Costs and Benefits … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents Executive Summary Purpose and Coverage of the Supplemental Notice of Proposed Rulemaking Summary of the Major Provisions of the Supplemental Notice of Proposed Rulemaking Costs and Benefits … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents Executive Summary Purpose of the Supplemental Notice of Proposed Rulemaking Summary of the Revisions to the Proposed Rule Costs and Benefits I. Background A. Proposed Rule on … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background—Regulatory Authorities II. Regulatory History of the Device III. Device Description IV. Proposed Reclassification V. Risks to Health VI. Summary of Reasons for Reclassification VII. Summary of Data Upon … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background—Regulatory Authorities II. Regulatory History of the Device and the Device Description III. Proposed Reclassification and Summary of Reason for Reclassification IV. Risks to Health V. Summary of Data … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background—Regulatory Authorities II. Regulatory History of the Device A. EPPG Devices B. PSA Devices III. Device Description A. EPPG Devices B. PSA Devices IV. Proposed Reclassification A. EPPG Devices … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background—Regulatory Authorities II. Withdrawal of the Proposed Rule III. Proposed Reclassification IV. Reference DATES: Back to Top The proposed rule is withdrawn on September 15, 2014. FOR FURTHER INFORMATION CONTACT: Back to Top Hina … [read more]

  Table of Contents Back to Top FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: Back to Top Lori J. Churchyard, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. SUPPLEMENTARY INFORMATION: Back … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top The food additive petition and the citizen petition were withdrawn on July 30, 2014. FOR FURTHER INFORMATION CONTACT: Back to Top Molly A. Harry, Center for Food Safety and Applied Nutrition … [read more]

  Table of Contents Back to Top AGENCIES: DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Provisions of the Proposed Regulations Defining a Closely Held For-Profit Entity Religious Objection To Providing Coverage for Some or All of the Contraceptive Services Required To Be Covered. Other Potential … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Executive Summary Purpose and Coverage of the Proposed Rule Summary of the Major Provisions of the Proposed Rule Costs and Benefits I. Background II. Appropriate Controls Would Remain in Place … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top Submit either electronic or written comments on the petitioner's request for categorical exclusion from preparing an environmental assessment or environmental impact statement by September 22, 2014. ADDRESSES: Back to Top … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Purpose and Scope of the Public Hearing A. GDUFA Implementation: Draft Guidance Documents B. GDUFA Implementation Related to Generic Drug Exclusivity C. GDUFA Implementation and Potential First Generics III. Attendance, Registration, … [read more]

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