| Page Range | 27126-27135 | |
| FR Document | 2018-11239 |
[Federal Register Volume 83, Number 112 (Monday, June 11, 2018)] [Unknown Section] [Pages 27126-27135] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-11239] [[Page 27125]] Vol. 83 Monday, No. 112 June 11, 2018 Part VII Department of Health and Human Services ----------------------------------------------------------------------- Semiannual Regulatory Agenda Federal Register / Vol. 83 , No. 112 / Monday, June 11, 2018 / Unified Agenda [[Page 27126]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary 21 CFR Ch. I 25 CFR Ch. V 42 CFR Chs. I-V 45 CFR Subtitle A; Subtitle B, Chs. II, III, and XIII Regulatory Agenda AGENCY: Office of the Secretary, HHS. ACTION: Semiannual regulatory agenda. ----------------------------------------------------------------------- SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order (E.O.) 12866 require the semiannual issuance of an inventory of rulemaking actions under development throughout the Department, offering for public review summarized information about forthcoming regulatory actions. FOR FURTHER INFORMATION CONTACT: Ann C. Agnew, Executive Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201; (202) 690-5627. SUPPLEMENTARY INFORMATION: The Department of Health and Human Services (HHS) is the Federal government's lead agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. HHS enhances the health and well-being of Americans by promoting effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services. This Agenda presents the regulatory activities that the Department expects to undertake in the foreseeable future to advance this mission. HHS has an agency-wide effort to support the Agenda's purpose of encouraging more effective public participation in the regulatory process. For example, to encourage public participation, we regularly update our regulatory web page (http://www.HHS.gov/regulations) which includes links to HHS rules currently open for public comment, and also provides a ``regulations toolkit'' with background information on regulations, the commenting process, how public comments influence the development of a rule, and how the public can provide effective comments. HHS also actively encourages meaningful public participation in its retrospective review of regulations through a comment form on the HHS retrospective review web page (http://www.HHS.gov/RetrospectiveReview). The rulemaking abstracts included in this paper issue of the Federal Register cover, as required by the Regulatory Flexibility Act of 1980, those prospective HHS rulemakings likely to have a significant economic impact on a substantial number of small entities. The Department's complete Regulatory Agenda is accessible online at http://www.RegInfo.gov. Ann C. Agnew, Executive Secretary to the Department. Office for Civil Rights--Proposed Rule Stage ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 83........................ HIPAA Privacy Rule: 0945-AA08 Changing Requirement to Obtain Acknowledgment of Receipt of the Notice of Privacy Practices. 84........................ Nondiscrimination in 0945-AA11 Health Programs or Activities. ------------------------------------------------------------------------ Office of the National Coordinator for Health Information Technology-- Proposed Rule Stage ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 85........................ Health Information 0955-AA01 Technology: Certification and Interoperability Enhancements. ------------------------------------------------------------------------ Food and Drug Administration--Proposed Rule Stage ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 86........................ Over-the-Counter (OTC) 0910-AF31 Drug Review--Cough/Cold (Antihistamine) Products. 87........................ Sunscreen Drug Products 0910-AF43 For Over-The-Counter- Human Use; Tentative Final Monograph. 88........................ Mammography Quality 0910-AH04 Standards Act; Amendments to Part 900 Regulations. 89........................ Medication Guides; Patient 0910-AH68 Medication Information. 90........................ Testing Standards for 0910-AH90 Batteries and Battery Management Systems in Electronic Nicotine Delivery Systems. 91........................ Administration Detention 0910-AI05 of Tobacco Products. ------------------------------------------------------------------------ Food and Drug Administration--Final Rule Stage ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 92........................ Postmarketing Safety 0910-AA97 Reporting Requirements for Human Drug and Biological Products. 93........................ Label Requirement for Food 0910-AF61 That Has Been Refused Admission Into the United States. 94........................ Laser Products; Amendment 0910-AF87 to Performance Standard. 95........................ Food Labeling; Gluten-Free 0910-AH00 Labeling of Fermented, Hydrolyzed, or Distilled Foods. ------------------------------------------------------------------------ [[Page 27127]] Food and Drug Administration--Long-Term Actions ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 96........................ Over-the-Counter (OTC) 0910-AF35 Drug Review--External Analgesic Products. 97........................ Over-the-Counter (OTC) 0910-AF36 Drug Review--Internal Analgesic Products. 98........................ Over-the-Counter (OTC) 0910-AF38 Drug Review--Laxative Drug Products. 99........................ Over-the-Counter (OTC) 0910-AF45 Drug Review--Weight Control Products. 100....................... Over-the-Counter (OTC) 0910-AG12 Drug Review--Pediatric Dosing for Cough/Cold Products. 101....................... Electronic Distribution of 0910-AG18 Prescribing Information for Human Prescription Drugs Including Biological Products. 102....................... Sunlamp Products; 0910-AG30 Amendment to the Performance Standard. 103....................... General and Plastic 0910-AH14 Surgery Devices: Sunlamp Products. 104....................... Combinations of 0910-AH16 Bronchodilators With Expectorants; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the- Counter Human Use. 105....................... Nicotine Exposure Warning 0910-AH24 and Child-Resistant Packaging for Liquid Nicotine, Nicotine- Containing E-Liquids, and Other Tobacco Products. ------------------------------------------------------------------------ Food and Drug Administration--Completed Actions ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 106....................... Human Subject Protection; 0910-AG48 Acceptance of Data From Clinical Investigations for Medical Devices. 107....................... Safety and Effectiveness 0910-AH40 of Healthcare Antiseptics; Topical Antimicrobial Drug Products for Over-the- Counter Human Use. ------------------------------------------------------------------------ Centers for Medicare & Medicaid Services--Proposed Rule Stage ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 108....................... Regulatory Provisions to 0938-AT23 Promote Program Efficiency, Transparency, and Burden Reduction (CMS- 3346-P). 109....................... FY 2019 Prospective 0938-AT24 Payment System and Consolidated Billing for Skilled Nursing Facilities (SNFs) (CMS- 1696-P). 110....................... Hospital Inpatient 0938-AT27 Prospective Payment System for Acute Care Hospitals and the Long- Term Care Hospital Prospective Payment System and FY 2019 Rates (CMS-1694-P) (Section 610 Review). 111....................... CY 2019 Hospital 0938-AT30 Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1695- P) (Section 610 Review). 112....................... CY 2019 Revisions to 0938-AT31 Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1693-P) (Section 610 Review). ------------------------------------------------------------------------ Centers for Medicare & Medicaid Services--Final Rule Stage ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 113....................... Durable Medical Equipment 0938-AT21 Fee Schedule, Adjustments to Resume the Transitional 50/50 Blended Rates to Provide Relief in Non-Competitive Bidding Areas (CMS-1687- IFC) (Section 610 Review). ------------------------------------------------------------------------ Centers for Medicare & Medicaid Services--Long-Term Actions ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 114....................... Hospital and Critical 0938-AS21 Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care (CMS-3295-F) (Rulemaking Resulting From a Section 610 Review). ------------------------------------------------------------------------ Centers for Medicare & Medicaid Services--Completed Actions ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 115....................... CY 2019 Notice of Benefit 0938-AT12 and Payment Parameters (CMS-9930-F) (Completion of a Section 610 Review). ------------------------------------------------------------------------ [[Page 27128]] DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Office for Civil Rights (OCR) Proposed Rule Stage 83. HIPAA Privacy Rule: Changing Requirement To Obtain Acknowledgment of Receipt of the Notice of Privacy Practices E.O. 13771 Designation: Deregulatory. Legal Authority: Health Insurance Portability and Accountability (HIPAA) Act of 1996, Pub. L. 104-191 Abstract: The propsed rule would change the requirement that health care providers make a good faith effort to obtain from individuals a written acknowledgment of receipt of the provider's notice of privacy practices, and if not obtained, to document its good faith efforts and the reason the acknowledgment was not obtained. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 09/00/18 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Andra Wicks, Health Information Privacy Specialist, Department of Health and Human Services, Office for Civil Rights, 200 Independence Avenue SW, Washington, DC 20201, Phone: 202 774-3081, TDD Phone: 800 537-7697, Email: [email protected]. RIN: 0945-AA08 84.Nondiscrimination in Health Programs or Activities E.O. 13771 Designation: Deregulatory. Legal Authority: Sec. 1557 of the Patient Protection and Affordable Care Act (42 U.S.C. 18116) Abstract: The proposed rule implements Section 1557 of the Patient Protection and Affordable Care Act (PPACA), which prohibits discrimination on the basis of race, color, national origin, sex, age, or disability under any health program or activity receiving Federal financial assistance, or under any program or activity that is administered by the Department of Health and Human Services or by an entity established under title I of the PPACA. The proposed rule applies the enforcement mechanisms provided for and available under Title VI of the Civil Rights Act of 1964 (42 U.S.C. 2000d et seq.), Title IX of the Education Amendments of 1972 (20 U.S.C. 1681 et seq.), the Age Discrimination Act of 1975 (42 U.S.C. 6101 et seq.), and Section 504 of the Rehabilitation Act (29 U.S.C. 794). Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 07/00/18 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Maya Noronha, Special Advisor, Department of Health and Human Services, Office for Civil Rights, 200 Independence Avenue SW, Room 516E, Washington, DC 20201, Phone: 202 568-0028, Email: [email protected]. RIN: 0945-AA11 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Office of the National Coordinator for Health Information Technology (ONC) Proposed Rule Stage 85. Health Information Technology: Certification and Interoperability Enhancements E.O. 13771 Designation: Regulatory. Legal Authority: Pub. L. 114-255 Abstract: The rulemaking would update the ONC Health IT Certification Program (Program) by implementing certain provisions of the 21st Century Cures Act, including conditions and maintenance of certification requirements for health information technology (IT) developers, the voluntary certification of health IT for use by pediatric healthcare providers, health information network voluntary attestation to the adoption of a trusted exchange framework and common agreement in support of network-to-network exchange, and reasonable and necessary activities that do not constitute information blocking. The rulemaking would also modify the Program through other complementary means to advance health IT certification and interoperability. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 09/00/18 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Michael Lipinski, Director, Regulatory Affairs Division, Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, Mary E. Switzer Building, 330 C Street SW, Washington, DC 20201, Phone: 202 690-7151. RIN: 0955-AA01 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Proposed Rule Stage 86. Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products E.O. 13771 Designation: Deregulatory. Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371 Abstract: FDA will be proposing a rule to add the common cold indication to certain over-the-counter (OTC) antihistamine active ingredients. This proposed rule is the result of collaboration under the U.S.-Canada Regulatory Cooperation Council (RCC) as part of efforts to reduce unnecessary duplication and differences. This pilot exercise will help determine the feasibility of developing an ongoing mechanism for alignment in review and adoption of OTC drug monograph elements. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ Reopening of Administrative Record.. 08/25/00 65 FR 51780 Comment Period End.................. 11/24/00 ....................... NPRM (Amendment) (Common Cold)...... 11/00/18 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Janice Adams-King, Regulatory Health Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3713, Fax: 301 796-9899, Email: [email protected]. RIN: 0910-AF31 87. Sunscreen Drug Products for Over-the-Counter-Human Use; Tentative Final Monograph E.O. 13771 Designation: Deregulatory. Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371 Abstract: The proposed rule will address the general recognition of safety and effectiveness (GRASE) status of the 16 sunscreen monograph ingredients and describe data gaps that FDA believes need to be filled in order for FDA to permit the continued marketing of these ingredients without submitting new drug applications for premarket [[Page 27129]] review. Consistent with the Sunscreen Innovation Act, we also expect to address sunscreen dosage forms and maximum SPF values. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ ANPRM (Sunscreen and Insect 02/22/07 72 FR 7941 Repellent). ANPRM Comment Period End............ 05/23/07 ....................... NPRM (UVA/UVB)...................... 08/27/07 72 FR 49070 NPRM Comment Period End............. 12/26/07 ....................... Final Action (UVA/UVB).............. 06/17/11 76 FR 35620 NPRM (Effectiveness)................ 06/17/11 76 FR 35672 NPRM (Effectiveness) Comment Period 09/15/11 ....................... End. ANPRM (Dosage Forms)................ 06/17/11 76 FR 35669 ANPRM (Dosage Forms) Comment Period 09/15/11 ....................... End. NPRM................................ 12/00/18 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Kristen Hardin, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., WO 22, Room 5491, Silver Spring, MD 20993, Phone: 240 402-4246, Fax: 301 796-9841, Email: [email protected]. RIN: 0910-AF43 88. Mammography Quality Standards Act; Amendments to Part 900 Regulations E.O. 13771 Designation: Regulatory. Legal Authority: 21 U.S.C. 360i; 21 U.S.C. 360nn; 21 U.S.C. 374(e); 42 U.S.C. 263b Abstract: FDA is proposing to amend its regulations governing mammography. The amendments would update the regulations issued under the Mammography Quality Standards Act of 1992 (MQSA). FDA is taking this action to address changes in mammography technology and mammography processes that have occurred since the regulations were published in 1997 and to address breast density reporting to patient and health care providers. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 08/00/18 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Erica Payne, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Avenue, WO 66, Room 5522, Silver Spring, MD 20993, Phone: 301 796-3999, Fax: 301 847- 8145, Email: [email protected]. RIN: 0910-AH04 89. Medication Guides; Patient Medication Information E.O. 13771 Designation: Regulatory. Legal Authority: 21 U.S.C. 321 et seq.; 42 U.S.C. 262; 42 U.S.C. 264; 21 U.S.C. 371 Abstract: The proposed rule would amend FDA medication guide regulations to require a new form of patient labeling, Patient Medication Information, for submission to and review by the FDA for human prescription drug products and certain blood products used, dispensed, or administered on an outpatient basis. The proposed rule would include requirements for Patient Medication Information development and distribution. The proposed rule would require clear and concisely written prescription drug product information presented in a consistent and easily understood format to help patients use their prescription drug products safely and effectively. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 02/00/19 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Chris Wheeler, Supervisory Project Manager, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, Building 51, Room 3330, Silver Spring, MD 20993, Phone: 301 796-0151, Email: [email protected]. RIN: 0910-AH68 90. Testing Standards for Batteries and Battery Management Systems in Electronic Nicotine Delivery Systems E.O. 13771 Designation: Regulatory. Legal Authority: 21 U.S.C. 301 et. seq.; 21 U.S.C. 371; 21 U.S.C. 387(b); 21 U.S.C. 387(g); 21 U.S.C. 387i Abstract: This rule would propose to establish a product standard to require testing standards for batteries used in electronic nicotine delivery systems (ENDS) and require design protections through a battery management system for ENDS using batteries. This product standard would protect the safety of users of battery-powered tobacco products and will help to streamline the FDA premarket review process, ultimately reducing the burden on both manufacturers and the Agency. The proposed rule would be applicable to tobacco products that include a non-user replaceable battery as well as products that include a user replaceable battery. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 12/00/18 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Colleen Lee, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, WO 71, Room G335, Silver Spring, MD 20993, Phone: 877 287-1373, Email: [email protected]. RIN: 0910-AH90 91. Administration Detention of Tobacco Products E.O. 13771 Designation: Other. Legal Authority: 21 U.S.C. 334; 21 U.S.C. 371 Abstract: The Food and Drug Administration is proposing regulations to establish requirements for the administrative detention of tobacco products. This action, if finalized, would allow FDA to administratively detain tobacco products encountered during inspections that an officer or employee conducting the inspection has reason to believe are adulterated or misbranded. The intent of administrative detention is to protect public health by preventing the distribution or use of violative tobacco products until FDA has had time to consider the appropriate action to take and, where appropriate, to initiate a regulatory action. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 11/00/18 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Darin Achilles, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335, Silver Spring, MD 20993, Phone: 877 287-1373, Fax: 301 595-1426, Email: [email protected]. [[Page 27130]] RIN: 0910-AI05 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Final Rule Stage 92. Postmarketing Safety Reporting Requirements for Human Drug and Biological Products E.O. 13771 Designation: Regulatory. Legal Authority: 42 U.S.C. 216; 42 U.S.C. 241; 42 U.S.C. 242a; 42 U.S.C. 262 and 263; 42 U.S.C. 263a to 263n; 42 U.S.C. 264; 42 U.S.C. 300aa; 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 360b to 360j; 21 U.S.C. 361a; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 375; 21 U.S.C. 379e; 21 U.S.C. 381 Abstract: The final rule would amend the postmarketing safety reporting regulations for human drugs and biological products including blood and blood products in order to better align FDA requirements with guidelines of the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH); and to update reporting requirements in light of current pharmacovigilance practice and safety information sources and enhance the quality of safety reports received by FDA. These revisions were proposed as part of a single rulemaking (68 FR 12406) to clarify and revise both premarketing and postmarketing safety reporting requirements for human drug and biological products. Premarketing safety reporting requirements were finalized in a separate final rule published on September 29, 2010 (75 FR 59961). This final rule applies to postmarketing safety reporting requirements. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 03/14/03 68 FR 12406 NPRM Comment Period Extended........ 06/18/03 ....................... NPRM Comment Period End............. 07/14/03 ....................... NPRM Comment Period Extension End... 10/14/03 ....................... Final Rule.......................... 12/00/18 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Jane E. Baluss, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6278, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3469, Fax: 301 847-8440, Email: [email protected]. RIN: 0910-AA97 93. Label Requirement for Food That Has Been Refused Admission Into the United States E.O. 13771 Designation: Deregulatory. Legal Authority: 15 U.S.C. 1453 to 1455; 21 U.S.C. 321; 21 U.S.C. 342 and 343; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381; 42 U.S.C. 216; 42 U.S.C. 264 Abstract: The final rule will require owners or consignees to label imported food that is refused entry into the United States. The label will read, ``UNITED STATES: REFUSED ENTRY.'' The proposal describes the label's characteristics (such as its size) and processes for verifying that the label has been affixed properly. We are taking this action to prevent the introduction of unsafe food into the United States, to facilitate the examination of imported food, and to implement section 308 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188). Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 09/18/08 73 FR 54106 NPRM Comment Period End............. 12/02/08 ....................... NPRM; Withdrawal.................... 08/00/18 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Anthony C. Taube, Branch Chief, Department of Health and Human Services, Food and Drug Administration, Office of Regulatory Affairs, Office of Regional Operations, 12420 Parklawn Drive, ELEM-4051, Rockville, MD 20857, Phone: 240 420-4565, Fax: 703 261-8625, Email: [email protected]. RIN: 0910-AF61 94. Laser Products; Amendment to Performance Standard E.O. 13771 Designation: Deregulatory. Legal Authority: 21 U.S.C. 360hh to 360ss; 21 U.S.C. 371; 21 U.S.C. 393 Abstract: FDA is proposing to amend the 2013 proposed rule for the performance standard for laser products, which will amend the performance standard for laser products to achieve closer harmonization between the current standard and the recently amended International Electrotechnical Commission (IEC) standard for laser products and medical laser products. The amendment is intended to update FDA's performance standard to reflect advancements in technology. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 06/24/13 78 FR 37723 NPRM Comment Period End............. 09/23/13 ....................... NPRM; Withdrawal.................... 08/00/18 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Erica Payne, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Avenue, WO 66, Room 5522, Silver Spring, MD 20993, Phone: 301 796-3999, Fax: 301 847- 8145, Email: [email protected]. RIN: 0910-AF87 95. Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods E.O. 13771 Designation: Regulatory. Legal Authority: Sec. 206 of the Food Allergen Labeling and Consumer Protection Act; 21 U.S.C. 343(a)(1); 21 U.S.C. 321(n); 21 U.S.C. 371(a) Abstract: This final rule would establish requirements concerning ``gluten-free'' labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients. These additional requirements for the ``gluten-free'' labeling rule are needed to help ensure that individuals with celiac disease are not misled and receive truthful and accurate information with respect to fermented or hydrolyzed foods labeled as ``gluten-free.'' Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 11/18/15 80 FR 71990 NPRM Comment Period Reopened........ 01/22/16 81 FR 3751 NPRM Comment Period End............. 02/16/16 ....................... NPRM Comment Period Reopened........ 02/22/16 81 FR 8869 NPRM Comment Period Reopened End.... 04/25/16 ....................... Final Rule.......................... 12/00/18 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Carol D'Lima, Staff Fellow, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Room 4D022, [[Page 27131]] HFS 820, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-2371, Fax: 301 436-2636, Email: [email protected]. RIN: 0910-AH00 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Long-Term Actions 96. Over-the-Counter (OTC) Drug Review--External Analgesic Products E.O. 13771 Designation: Regulatory. Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The final action addresses the 2003 proposed rule on patches, plasters, and poultices. The proposed rule will address issues not addressed in previous rulemakings. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM............................. To Be Determined ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Janice Adams-King, Regulatory Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3713, Email: [email protected]. RIN: 0910-AF35 97. Over-the-Counter (OTC) Drug Review--Internal Analgesic Products E.O. 13771 Designation: Regulatory. Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 379e Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective, and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action addresses acetaminophen safety. The second action addresses products marketed for children under 2 years old and weight- and age-based dosing for children's products. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM (Amendment) (Required Warnings 12/26/06 71 FR 77314 and Other Labeling). NPRM Comment Period End............. 05/25/07 ....................... Final Action (Required Warnings and 04/29/09 74 FR 19385 Other Labeling). Final Action (Correction)........... 06/30/09 74 FR 31177 Final Action (Technical Amendment).. 11/25/09 74 FR 61512 ----------------------------------- NPRM (Amendment) (Acetaminophen).... To Be Determined ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Janice Adams-King, Regulatory Health Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3713, Fax: 301 796-9899, Email: [email protected]. RIN: 0910-AF36 98. Over-the-Counter (OTC) Drug Review--Laxative Drug Products E.O. 13771 Designation: Regulatory. Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective, and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The final rule listed will address the professional labeling for sodium phosphate drug products. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ Final Action (Granular Psyllium).... 03/29/07 72 FR 14669 NPRM (Professional Labeling--Sodium 02/11/11 76 FR 7743 Phosphate). NPRM Comment Period End............. 03/14/11 ....................... ----------------------------------- Final Rule.......................... To Be Determined ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Janice Adams-King, Regulatory Health Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3713, Fax: 301 796-9899, Email: [email protected]. RIN: 0910-AF38 99. Over-the-Counter (OTC) Drug Review--Weight Control Products E.O. 13771 Designation: Regulatory. Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The final action finalizes the 2005 proposed rule for weight control products containing phenylpropanolamine. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM (Phenylpropanolamine).......... 12/22/05 70 FR 75988 NPRM Comment Period End............. 03/22/06 ....................... NPRM (Benzocaine)................... 03/09/11 76 FR 12916 NPRM Comment Period End............. 06/07/11 ....................... ----------------------------------- Final Action (Phenylpropanolamine).. To Be Determined ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Janice Adams-King, Regulatory Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3713, Email: [email protected]. RIN: 0910-AF45 [[Page 27132]] 100. Over-the-Counter (OTC) Drug Review--Pediatric Dosing for Cough/ Cold Products E.O. 13771 Designation: Regulatory. Legal Authority: 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective, and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action will propose changes to the final monograph to address safety and efficacy issues associated with pediatric cough and cold products. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ To Be Determined ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Janice Adams-King, Regulatory Health Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3713, Fax: 301 796-9899, Email: [email protected]. RIN: 0910-AG12 101. Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products E.O. 13771 Designation: Other. Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 358; 21 U.S.C. 360; 21 U.S.C. 360b; 21 U.S.C. 360gg to 360ss; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 379e; 42 U.S.C. 216; 42 U.S.C. 241; 42 U.S.C. 262; 42 U.S.C. 264 Abstract: This rule would require electronic package inserts for human drug and biological prescription products with limited exceptions, in lieu of paper, which is currently used. These inserts contain prescribing information intended for healthcare practitioners. This would ensure that the information accompanying the product is the most up-to-date information regarding important safety and efficacy issues about these products. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 12/18/14 79 FR 75506 NPRM Comment Period Extended........ 03/09/15 80 FR 12364 NPRM Comment Period End............. 03/18/15 ....................... NPRM Comment Period Extended End.... 05/18/15 ....................... ----------------------------------- Final Rule.......................... To Be Determined ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Michael Bernstein, Supervisory Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6240, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3478, Email: [email protected]. RIN: 0910-AG18 102. Sunlamp Products; Amendment to the Performance Standard E.O. 13771 Designation: Fully or Partially Exempt. Legal Authority: 21 U.S.C. 360ii; 21 U.S.C. 360kk; 21 U.S.C. 393; 21 U.S.C. 371 Abstract: FDA is updating the performance standard for sunlamp products to improve safety, reflect new scientific information, and work towards harmonization with international standards. By harmonizing with the International Electrotechnical Commission, this rule will decrease the regulatory burden on industry and allow the Agency to take advantage of the expertise of the international committees thereby also saving resources. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 12/22/15 80 FR 79505 NPRM Comment Period End............. 03/21/16 ....................... Final Rule.......................... 12/00/19 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Ian Ostermiller, Regulatory Counsel, Center for Devices and Radiological Health, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, WO 66, Room 5515, Silver Spring, MD 20993, Phone: 301 796-5678, Email: [email protected]. RIN: 0910-AG30 103. General and Plastic Surgery Devices: Sunlamp Products E.O. 13771 Designation: Regulatory. Legal Authority: 21 U.S.C. 360j(e) Abstract: This rule would apply device restrictions to sunlamp products. Sunlamp products include ultraviolet (UV) lamps and UV tanning beds and booths. The incidence of skin cancer, including melanoma, has been increasing, and a large number of skin cancer cases are attributable to the use of sunlamp products. The devices may cause about 400,000 cases of skin cancer per year, and 6,000 of which are melanoma. Beginning use of sunlamp products at young ages, as well as frequently using sunlamp products, both increases the risk of developing skin cancers and other illnesses, and sustaining other injuries. Even infrequent use, particularly at younger ages, can significantly increase these risks.This rule would apply device restrictions to sunlamp products. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 12/22/15 80 FR 79493 NPRM Comment Period End............. 03/21/16 ....................... Final Rule.......................... 12/00/19 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Ian Ostermiller, Regulatory Counsel, Center for Devices and Radiological Health, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, WO 66, Room 5515, Silver Spring, MD 20993, Phone: 301 796-5678, Email: [email protected]. RIN: 0910-AH14 104. Combinations of Bronchodilators With Expectorants; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the- Counter Human Use E.O. 13771 Designation: Regulatory. Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective, and not misbranded. After a final monograph (i.e. final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. These actions address cough/cold drug products containing an oral bronchodilator (ephedrine and its salts) in combination with any expectorant. [[Page 27133]] Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM (Amendment).................... 07/13/05 70 FR 40232 NPRM Comment Period End............. 11/10/05 ....................... Final Action (Technical Amendment).. 03/19/07 72 FR 12730 ----------------------------------- Final Rule.......................... To Be Determined ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Janice Adams-King, Regulatory Health Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3713, Fax: 301 796-9899, Email: [email protected]. RIN: 0910-AH16 105. Nicotine Exposure Warning and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquids, and Other Tobacco Products E.O. 13771 Designation: Regulatory. Legal Authority: 21 U.S.C. 301 et seq.; 21 U.S.C. 331; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 387 Abstract: This rule would establish nicotine exposure warning and child-resistant packaging requirements for liquid nicotine and nicotine-containing e-liquid(s) that are made or derived from tobacco and intended for human consumption, and potentially for other tobacco products including, but not limited to, novel tobacco products such as dissolvables, lotions, gels, and drinks. This action is intended to protect users and non-users from accidental exposures to nicotine- containing e-liquids in tobacco products Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 03/00/20 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Courtney Smith, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, Document Control Center, Building 71, Room G335, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 877 287- 1373, Fax: 301 595-1426, Email: [email protected]. RIN: 0910-AH24 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Completed Actions 106. Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices E.O. 13771 Designation: Deregulatory. Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 360; 21 U.S.C. 360c; 21 U.S.C. 360e; 21 U.S.C. 360i; 21 U.S.C. 360j; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381; 21 U.S.C. 393; 42 U.S.C. 264; 42 U.S.C. 271; . . . Abstract: This rule updates FDA's requirements for accepting clinical data used to bring new medical devices to market as part of fulfilling FDA's mission. While helping to ensure the quality and integrity of clinical trial data and the protection of study participants, this rule should reduce burden on industry by avoiding the need for on-site inspections. This rule parallels the drug regulation, which should further reduce burden by having a harmonized approach. Under this new rule, a device applicant would provide FDA with information about the conduct of their study such as, the research sites where the study was conducted, the investigators who conducted the study, a summary of the protocol, information about how informed consent from the study participants was obtained, and information about the ethics committee that reviewed the study. (If such information is not available, the sponsor may explain why and request a waiver.) Completed: ------------------------------------------------------------------------ Reason Date FR Cite ------------------------------------------------------------------------ Final Action........................ 02/21/18 83 FR 7366 Final Action Effective.............. 02/21/19 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Soma Kalb, Phone: 301 796-6359, Email: [email protected]. RIN: 0910-AG48 107. Safety and Effectiveness of Healthcare Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use E.O. 13771 Designation: Regulatory. Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360b to 360f; 21 U.S.C. 360j; 21 U.S.C. 360hh to 360ss; 21 U.S.C. 371; 21 U.S.C. 374 to 375; 21 U.S.C. 379e; 42 U.S.C. 241; 42 U.S.C. 262; . . . Abstract: This rulemaking addresses whether FDA considers certain active ingredients in over-the-counter (OTC) healthcare antiseptic hand wash and healthcare antiseptic products to be generally recognized as safe and effective. If FDA determines that the ingredient is not generally recognized as safe and effective, a manufacturer will not be able to market the product unless it submits and receives approval of a new drug application. Completed: ------------------------------------------------------------------------ Reason Date FR Cite ------------------------------------------------------------------------ Final Action........................ 12/20/17 82 FR 60474 Final Action Effective.............. 12/20/18 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Michelle Jackson, Phone: 301 796-0923, Email: [email protected]. RIN: 0910-AH40 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Proposed Rule Stage 108. Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction (CMS-3346-P) E.O. 13771 Designation: Deregulatory. Legal Authority: 42 U.S.C. 263a; 42 U.S.C. 273; 42 U.S.C. 1302; 42 U.S.C. 1320a-7; . . . Abstract: This proposed rule would reform Medicare regulations that are unnecessary, obsolete, or excessively burdensome on healthcare providers and suppliers. This rule would increase the ability of healthcare professionals to devote resources to improving patient care by eliminating or reducing requirements that impede quality patient care or that divert resources away from furnishing high quality patient care. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 05/00/18 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Alpha-Banu Huq, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, MS: S3- 02-01, 7500 Security Boulevard, Baltimore, MD 21244, [[Page 27134]] Phone: 410 786-8687, Email: [email protected]. RIN: 0938-AT23 109. FY 2019 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (SNFS) (CMS-1696-P) E.O. 13771 Designation: Deregulatory. Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh Abstract: This annual proposed rule would update the payment rates used under the prospective payment system for SNFs for fiscal year 2019. The rule also includes proposals for the SNF Quality Reporting Program (QRP) and for the Skilled Nursing Facility Value-Based Purchasing (VBP) Program that will affect Medicare payment to SNFs. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 05/00/18 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Bill Ullman, Technical Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C5-06-27, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-5667, Fax: 410 786-0765, Email: [email protected]. RIN: 0938-AT24 110. Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY 2019 Rates (CMS-1694-P) (Section 610 Review) E.O. 13771 Designation: Other. Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh Abstract: This annual proposed rule would revise the Medicare hospital inpatient and long-term care hospital prospective payment systems for operating and capital-related costs. This proposed rule would implement changes arising from our continuing experience with these systems. In addition, the rule proposes to establish new requirements or revise existing requirements for quality reporting by specific Medicare providers. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 05/00/18 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Donald Thompson, Deputy Director, Division of Acute Care, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C4-08-06, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-6504, Email: [email protected]. RIN: 0938-AT27 111. CY 2019 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1695-P) (Section 610 Review) E.O. 13771 Designation: Other. Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh Abstract: This annual proposed rule would revise the Medicare hospital outpatient prospective payment system to implement statutory requirements and changes arising from our continuing experience with this system. The proposed rule describes changes to the amounts and factors used to determine payment rates for services. In addition, the rule proposes changes to the ambulatory surgical center payment system list of services and rates. This proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 06/00/18 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Marjorie Baldo, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C4-03-06, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4617, Email: [email protected]. RIN: 0938-AT30 112. CY 2019 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1693-P) (Section 610 Review) E.O. 13771 Designation: Other. Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh Abstract: This annual proposed rule would revise payment polices under the Medicare physician fee schedule, and make other policy changes to payment under Medicare Part B. These changes would apply to services furnished beginning January 1, 2019. Additionally, this rule proposes updates to the third and future years of the Quality Payment Program. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 06/00/18 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Ryan Howe, Director, Division of Practitioner Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C4-01-15, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-3355, Email: [email protected]. RIN: 0938-AT31 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Final Rule Stage 113. Durable Medical Equipment Fee Schedule, Adjustments To Resume the Transitional 50/50 Blended Rates To Provide Relief in Non-Competitive Bidding Areas (CMS-1687-IFC) (Section 610 Review) E.O. 13771 Designation: Other. Legal Authority: 42 U.S.C. 1302, 1395hh, and 1395rr(b)(l)); Pub. L. 114-255, sec. 5004(b), 16007(a) and 16008 Abstract: This interim final rule with comment period extends the end of the transition period for phasing in adjustments to the fee schedule amounts for certain durable medical equipment (DME) and enteral nutrition paid in areas not subject to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP) from June 30, 2016, to December 31, 2016. In addition, this interim final rule with comment period amends the regulation to resume the transition period for items furnished from August 1, 2017, through December 31, 2018. This interim final rule with comment period also makes technical amendments to existing regulations for DMEPOS items and services to exclude infusion drugs used with DME from the DMEPOS CBP. Finally, this interim final rule with comment period also requests information on issues related to adjustments to DMEPOS fee schedules, alternatives for ensuring budget neutrality of oxygen payment classes, and current rules under the DMEPOS CBP. Timetable: [[Page 27135]] ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ Interim Final Rule.................. 05/00/18 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Undetermined. Agency Contact: Alexander Ullman, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C5-07-26, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-9671, Email: [email protected]. RIN: 0938-AT21 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Long-Term Actions 114. Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care (CMS-3295-F) (Rulemaking Resulting From a Section 610 Review) E.O. 13771 Designation: Regulatory. Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh and 1395rr Abstract: This final rule updates the requirements that hospitals and critical access hospitals (CAHs) must meet to participate in the Medicare and Medicaid programs. These final requirements are intended to conform the requirements to current standards of practice and support improvements in quality of care, reduce barriers to care, and reduce some issues that may exacerbate workforce shortage concerns. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 06/16/16 81 FR 39447 NPRM Comment Period End............. 08/15/16 ....................... Final Action........................ 06/00/19 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: No. Agency Contact: CDR Scott Cooper, Senior Technical Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, Mail Stop S3-01-02, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786- 9465, Email: [email protected]. RIN: 0938-AS21 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Completed Actions 115. CY 2019 Notice of Benefit and Payment Parameters (CMS-9930-F) (Completion of a Section 610 Review) E.O. 13771 Designation: Deregulatory. Legal Authority: Pub. L. 111-148, title I Abstract: This final rule sets forth payment parameters and provisions related to the risk adjustment and risk adjustment data validation programs; cost-sharing parameters; and user fees for Federally-facilitated Exchanges and State-based Exchanges on the Federal platform. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 11/02/17 82 FR 51052 NPRM Comment Period End............. 11/27/17 ....................... Final Action........................ 04/17/18 83 FR 16930 Final Action Effective.............. 06/18/18 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Lindsey Murtagh, Senior Policy Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Consumer Information and Insurance Oversight, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 301 492-4106, Email: [email protected]. RIN: 0938-AT12 [FR Doc. 2018-11239 Filed 6-8-18; 8:45 am] BILLING CODE 4850-03-P
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Unknown Section | |
| Action | Semiannual regulatory agenda. | |
| Contact | Ann C. Agnew, Executive Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201; (202) 690-5627. | |
| FR Citation | 83 FR 27126 | |
| CFR Citation | 21 Title 21 CFR Chapter I 25 Title 25 CFR Chapter V |