Regulatory Agenda, 71129-71139 [2019-26539]

Download as PDF Vol. 84 Thursday, No. 247 December 26, 2019 Part VII Department of Health and Human Services khammond on DSKJM1Z7X2PROD with PROPOSALS7 Semiannual Regulatory Agenda VerDate Sep<11>2014 18:18 Dec 23, 2019 Jkt 250001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\26DEP7.SGM 26DEP7 71130 Federal Register / Vol. 84, No. 247 / Thursday, December 26, 2019 / UA: Reg Flex Agenda Ann C. Agnew, Executive Secretary, Department of Health and Human Office of the Secretary Services, 200 Independence Avenue SW, Washington, DC 20201; (202) 690– 21 CFR Ch. I 5627. SUPPLEMENTARY INFORMATION: The 25 CFR Ch. V Department of Health and Human Services (HHS) is the Federal 42 CFR Chs. I–V government’s lead Agency for protecting the health of all Americans and 45 CFR Subtitle A; Subtitle B, Chs. II, providing essential human services, III, and XIII especially for those who are least able to help themselves. HHS enhances the Regulatory Agenda health and well-being of Americans by promoting effective health and human AGENCY: Office of the Secretary, HHS. ACTION: Semiannual Regulatory Agenda. services and by fostering sound, sustained advances in the sciences SUMMARY: The Regulatory Flexibility Act underlying medicine, public health, and of 1980 and Executive Order (E.O.) social services. This Agenda presents the regulatory 12866 require the semiannual issuance activities that the Department expects to of an inventory of rulemaking actions undertake in the foreseeable future to under development throughout the advance this mission. HHS has an Department, offering for public review agencywide effort to support the summarized information about Agenda’s purpose of encouraging more forthcoming regulatory actions. FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF HEALTH AND HUMAN SERVICES effective public participation in the regulatory process. For example, to encourage public participation, we regularly update our regulatory web page (https://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. 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 https:// www.RegInfo.gov. Ann C. Agnew, Executive Secretary to the Department. OFFICE FOR CIVIL RIGHTS—FINAL RULE STAGE Regulation Identifier No. Sequence No. Title 230 .................... Nondiscrimination in Health and Health Education Programs or Activities (Reg Plan Seq No. 44) ............. 0945–AA11 References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register. OFFICE OF THE NATIONAL COORDINATOR FOR HEALTH INFORMATION TECHNOLOGY—FINAL RULE STAGE Regulation Identifier No. Sequence No. Title 231 .................... 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program (Reg Plan Seq No. 45). 0955–AA01 References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register. FOOD AND DRUG ADMINISTRATION—PROPOSED RULE STAGE Sequence No. 232 233 234 235 236 237 238 .................... .................... .................... .................... .................... .................... .................... Regulation Identifier No. Title Postmarketing Safety Reporting Requirements for Human Drug and Biological Products ............................ Over-the-Counter (OTC) Drug Review—Cough/Cold (Antihistamine) Products ............................................. Medication Guide; Patient Medication Information .......................................................................................... Testing Standards for Batteries and Battery Management Systems in Battery-Operated Tobacco Products Requirements for Tobacco Product Manufacturing Practice (Reg Plan Seq No. 47) .................................... Nutrient Content Claims, Definition of Term: Healthy (Reg Plan Seq No. 48) .............................................. Revocation of Uses of Partially Hydrogenated Oils in Foods ......................................................................... 0910–AA97 0910–AF31 0910–AH68 0910–AH90 0910–AH91 0910–AI13 0910–AI15 References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register. khammond on DSKJM1Z7X2PROD with PROPOSALS7 FOOD AND DRUG ADMINISTRATION—FINAL RULE STAGE Sequence No. 239 240 241 242 243 244 .................... .................... .................... .................... .................... .................... VerDate Sep<11>2014 Regulation Identifier No. Title Sunscreen Drug Products For Over-The-Counter-Human Use; Final Monograph ......................................... Sunlamp Products; Amendment to the Performance Standard ...................................................................... Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods ..................................................... Mammography Quality Standards Act; Amendments to Part 900 Regulations .............................................. General and Plastic Surgery Devices: Sunlamp Products .............................................................................. Required Warnings for Cigarette Packages and Advertisements ................................................................... 18:18 Dec 23, 2019 Jkt 250001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 E:\FR\FM\26DEP7.SGM 26DEP7 0910–AF43 0910–AG30 0910–AH00 0910–AH04 0910–AH14 0910–AI39 Federal Register / Vol. 84, No. 247 / Thursday, December 26, 2019 / UA: Reg Flex Agenda 71131 FOOD AND DRUG ADMINISTRATION—FINAL RULE STAGE—Continued Regulation Identifier No. Sequence No. Title 245 .................... Milk and Cream Product and Yogurt Products, Final Rule to Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and to Amend the Standard for Yogurt. 0910–AI40 FOOD AND DRUG ADMINISTRATION—LONG-TERM ACTIONS Regulation Identifier No. Sequence No. Title 246 .................... 247 .................... Acute Nicotine Toxicity Warnings for E-Liquids ............................................................................................... Adminstrative Detention of Tobacco Products ................................................................................................ 0910–AH24 0910–AI05 FOOD AND DRUG ADMINISTRATION—COMPLETED ACTIONS Regulation Identifier No. Sequence No. Title 248 .................... 249 .................... 250 .................... Over-the-Counter (OTC) Drug Review—Laxative Drug Products ................................................................... Over-the-Counter (OTC) Drug Review—Weight Control Products ................................................................. Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products. Combinations of Bronchodilators With Expectorants; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use. Topical Antimicrobial Drug Products for Over-the-Counter Human Use: Final Monograph for Consumer Antiseptic Rub Products. 251 .................... 252 .................... 0910–AF38 0910–AF45 0910–AG18 0910–AH16 0910–AH97 CENTERS FOR MEDICARE & MEDICAID SERVICES—PROPOSED RULE STAGE Regulation Identifier No. Sequence No. Title 253 .................... CY 2021 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS–1734–P) (Section 610 Review). Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2021 Rates (CMS–1735–P) (Section 610 Review). CY 2021 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS–1736–P) (Section 610 Review). 254 .................... 255 .................... 0938–AU10 0938–AU11 0938–AU12 CENTERS FOR MEDICARE & MEDICAID SERVICES—FINAL RULE STAGE Regulation Identifier No. Sequence No. Title 256 .................... CY 2020 Home Health Prospective Payment System Rate Update and Quality Reporting Requirements (CMS–1711–F) (Section 610 Review). CY 2020 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS–1715–F) (Section 610 Review). CY 2020 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS–1717–F) (Section 610 Review). 257 .................... 258 .................... 0938–AT68 0938–AT72 0938–AT74 khammond on DSKJM1Z7X2PROD with PROPOSALS7 CENTERS FOR MEDICARE & MEDICAID SERVICES—LONG-TERM ACTIONS Regulation Identifier No. Sequence No. Title 259 .................... Durable Medical Equipment Fee Schedule, Adjustments to Resume the Transitional 50/50 Blended Rates to Provide Relief in Non-Competitive Bidding Areas (CMS–1687–F) (Section 610 Review). Requirements for Long-Term Care Facilities: Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction (CMS–3347–F) (Section 610 Review). 260 .................... 0938–AT21 0938–AT36 CENTERS FOR MEDICARE & MEDICAID SERVICES—COMPLETED ACTIONS Regulation Identifier No. Sequence No. Title 261 .................... 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). VerDate Sep<11>2014 18:18 Dec 23, 2019 Jkt 250001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 E:\FR\FM\26DEP7.SGM 26DEP7 0938–AS21 71132 Federal Register / Vol. 84, No. 247 / Thursday, December 26, 2019 / UA: Reg Flex Agenda CENTERS FOR MEDICARE & MEDICAID SERVICES—COMPLETED ACTIONS—Continued Title 262 .................... FY 2020 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates (CMS–1712–F). Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2020 Rates (CMS–1716–F) (Section 610 Review). 263 .................... DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Office for Civil Rights (OCR) Final Rule Stage 230. Nondiscrimination in Health and Health Education Programs or Activities Regulatory Plan: This entry is Seq. No. 44 in part II of this issue of the Federal Register. RIN: 0945–AA11 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) 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). Timetable: Office of the National Coordinator for Health Information Technology (ONC) Final Rule Stage 231. 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Regulatory Plan: This entry is Seq. No. 45 in part II of this issue of the Federal Register. RIN: 0955–AA01 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Proposed Rule Stage 232. Postmarketing Safety Reporting Requirements for Human Drug and Biological Products khammond on DSKJM1Z7X2PROD with PROPOSALS7 Regulation Identifier No. Sequence No. 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; 42 U.S.C. 264; 42 U.S.C. 300aa–25; 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 360f; 21 U.S.C. 360i to 360j; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 379 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 VerDate Sep<11>2014 18:18 Dec 23, 2019 Jkt 250001 Action Date NPRM .................. NPRM Comment Period Extended. NPRM Comment Period End. NPRM Comment Period Extension End. Reproposing NPRM. 03/14/03 06/18/03 FR Cite 68 FR 12406 07/14/03 10/14/03 06/00/20 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: jane.baluss@fda.hhs.gov. RIN: 0910–AA97 233. 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 as part PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 0938–AT69 0938–AT73 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 Reopening of Administrative Record. Comment Period End. NPRM (Amendment) (Common Cold). Date 08/25/00 FR Cite 65 FR 51780 11/24/00 12/00/19 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: janice.adams-king@fda.hhs.gov. RIN: 0910–AF31 234. Medication Guide; 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. E:\FR\FM\26DEP7.SGM 26DEP7 Federal Register / Vol. 84, No. 247 / Thursday, December 26, 2019 / UA: Reg Flex Agenda 237. Nutrient Content Claims, Definition of Term: Healthy Timetable: Action Date NPRM .................. FR Cite 06/00/20 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: chris.wheeler@fda.hhs.gov. RIN: 0910–AH68 235. Testing Standards for Batteries and Battery Management Systems in Battery-Operated Tobacco Products E.O. 13771 Designation: Regulatory. Legal Authority: 21 U.S.C. 301 et. seq.; 21 U.S.C. 371; 21 U.S.C. 387b; 21 U.S.C. 387g; 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 including a battery management system for ENDS using batteries and protective housing for replaceable 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 nonuser replaceable battery as well as products that include a user replaceable battery. Timetable: Action Date khammond on DSKJM1Z7X2PROD with PROPOSALS7 NPRM .................. FR Cite 05/00/20 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Nathan Mease, 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: ctpregulations@ fda.hhs.gov. RIN: 0910–AH90 236. Requirements for Tobacco Product Manufacturing Practice Regulatory Plan: This entry is Seq. No. 47 in part II of this issue of the Federal Register. RIN: 0910–AH91 VerDate Sep<11>2014 18:18 Dec 23, 2019 Jkt 250001 Regulatory Plan: This entry is Seq. No. 48 in part II of this issue of the Federal Register. RIN: 0910–AI13 238. Revocation of Uses of Partially Hydrogenated Oils in Foods E.O. 13771 Designation: Regulatory. Legal Authority: 21 U.S.C. 321; 21 U.S.C. 341; 21 U.S.C. 342; 21 U.S.C. 343; 21 U.S.C. 348; 21 U.S.C. 371; 21 U.S.C. 379e Abstract: In the Federal Register of June 17, 2015 (80 FR 34650), we published a declaratory order announcing our final determination that there is no longer a consensus among qualified experts that partially hydrogenated oils (PHOs) are generally recognized as safe (GRAS) for any use in human food. In the Federal Register of May 21, 2018 (83 FR 23382), we denied a food additive petition requesting that the food additive regulations be amended to provide for the safe use of PHOs in certain food applications. We are now proposing to update our regulations to remove all mention of partially hydrogenated oils from FDA’s GRAS regulations and as an optional ingredient in standards of identity. We are also proposing to revoke all prior sanctions for uses of PHOs in food. Timetable: Action Date NPRM .................. FR Cite 03/00/20 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Ellen Anderson, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, HFS–265, 4300 River Road, College Park, MD 20740, Phone: 240 402–1309, Email: ellen.anderson@fda.hhs.gov. RIN: 0910–AI15 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Final Rule Stage 239. Sunscreen Drug Products for Overthe-Counter—Human Use; Final Monograph 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 final rule will describe the conditions of use under which OTC PO 00000 Frm 00005 Fmt 4701 Sfmt 4702 71133 sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded. Consistent with the Sunscreen Innovation Act, we expect that these conditions will include sunscreen dosage forms and maximum SPF values. The preamble of the final rule will also indicate which sunscreen active ingredients FDA has deferred further rulemaking on while data supporting the GRASE status of those ingredients is developed. Timetable: Action ANPRM (Sunscreen and Insect Repellent). ANPRM Comment Period End. NPRM (UVA/ UVB). NPRM Comment Period End. Final Action (UVA/ UVB). NPRM (Effectiveness). NPRM (Effectiveness) Comment Period End. ANPRM (Dosage Forms). ANPRM (Dosage Forms) Comment Period End. NPRM .................. NPRM Comment Period End. NPRM Extension of Comment Period. NPRM Extension of Comment Period End. Final Rule ............ Date 02/22/07 FR Cite 72 FR 7941 05/23/07 08/27/07 72 FR 49070 12/26/07 06/17/11 76 FR 35620 06/17/11 76 FR 35672 09/15/11 06/17/11 76 FR 35669 09/15/11 02/26/19 06/27/19 84 FR 6204 04/18/19 84 FR 16222 06/27/19 09/00/20 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 Avenue, WO 22, Room 5491, Silver Spring, MD 20993, Phone: 240 402–4246, Fax: 301 796–9841, Email: kristen.hardin@fda.hhs.gov. RIN: 0910–AF43 240. 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 E:\FR\FM\26DEP7.SGM 26DEP7 71134 Federal Register / Vol. 84, No. 247 / Thursday, December 26, 2019 / UA: Reg Flex Agenda 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 NPRM .................. NPRM Comment Period End. Final Rule ............ 12/22/15 03/21/16 FR Cite 80 FR 79505 06/00/20 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 5454, Silver Spring, MD 20993, Phone: 301 796–5678, Email: ian.ostermiller@ fda.hhs.gov. RIN: 0910–AG30 241. Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed 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: khammond on DSKJM1Z7X2PROD with PROPOSALS7 Action Date NPRM .................. NPRM Comment Period Reopened. NPRM Comment Period End. NPRM Comment Period Reopened End. NPRM Comment Period Reopened. VerDate Sep<11>2014 11/18/15 01/22/16 FR Cite 80 FR 71990 81 FR 3751 02/22/16 18:18 Dec 23, 2019 Date NPRM Comment Period Reopened End. Final Rule ............ FR Cite 04/25/16 12/00/19 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, HFS 820, 5001 Campus Drive, College Park, MD 20740, Phone: 240 402–2371, Fax: 301 436–2636, Email: carol.dlima@ fda.hhs.gov. RIN: 0910–AH00 242. 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 amending its regulations governing mammography. The amendments would update the regulations issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). 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 healthcare providers. Timetable: Action Date NPRM .................. NPRM Comment Period End. Final Rule ............ 03/28/19 06/26/19 FR Cite 84 FR 11669 09/00/20 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: erica.payne@fda.hhs.gov. RIN: 0910–AH04 243. General and Plastic Surgery Devices: Sunlamp Products 02/16/16 02/23/16 Action 81 FR 8869 Jkt 250001 E.O. 13771 Designation: Regulatory. Legal Authority: 21 U.S.C. 360j(e) Abstract: This rule will apply device restrictions to sunlamp products. Sunlamp products include ultraviolet PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 (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 will apply device restrictions to sunlamp products. Timetable: Action NPRM .................. NPRM Comment Period End. Final Rule ............ Date 12/22/15 03/21/16 FR Cite 80 FR 79493 06/00/20 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 5454, Silver Spring, MD 20993, Phone: 301 796–5678, Email: ian.ostermiller@ fda.hhs.gov. RIN: 0910–AH14 244. Required Warnings for Cigarette Packages and Advertisements E.O. 13771 Designation: Regulatory. Legal Authority: 15 U.S.C. 1333; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 387c; 21 U.S.C. 387e; 21 U.S.C. 387i; Pub. L. 111–31, secs. 201 and 202, 123 Stat. 1776 Abstract: This rule will require color graphics depicting the negative health consequences of smoking to accompany textual warning statements on cigarette packages and in cigarette advertisements. As directed by Congress in the Family Smoking Prevention and Tobacco Control Act, which amends the Federal Cigarette Labeling and Advertising Act, the rule will require these new cigarette health warnings to occupy the top 50 percent of the area of the front and rear panels of cigarette packages and at least 20 percent of the area of cigarette advertisements. The original rule FDA issued in 2011 was vacated by the U.S. Court of Appeals for the District of Columbia Circuit in August 2012 (R.J. Reynolds Tobacco Co. v. United States Food & Drug Admin., 696 F.3d 1205 D.C. Cir. 2012). E:\FR\FM\26DEP7.SGM 26DEP7 Federal Register / Vol. 84, No. 247 / Thursday, December 26, 2019 / UA: Reg Flex Agenda Timetable: Action Date NPRM .................. NPRM Comment Period End. Final Rule ............ 08/16/19 10/15/19 FR Cite 84 FR 42754 03/00/20 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Courtney Smith, Senior 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: 301 796–3894, Fax: 301 595–1426, Email: ctpregulations@ fda.hhs.gov. RIN: 0910–AI39 245. Milk and Cream Product and Yogurt Products, Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt E.O. 13771 Designation: Deregulatory. Legal Authority: 21 U.S.C. 321; 21 U.S.C. 336; 21 U.S.C. 341; 21 U.S.C. 343; 21 U.S.C. 348; 21 U.S.C. 371(e); 21 U.S.C. 379e Abstract: This final rule amends the standard of identity for yogurt and revokes the standards of identity for lowfat yogurt and nonfat yogurt. It modernizes the standard for yogurt to allow for technological advances, to preserve the basic nature and essential characteristics of yogurt, and to promote honesty and fair dealing in the interest of consumers. Section 701(e)(1), of the Federal Food, Drug, and Cosmetic Act requires that the amendment or repeal of the definition and standard of identity for a dairy product proceed under a formal rulemaking process. Such is consistent with the formal rulemaking provisions of the Administrative Procedures Act (5 U.S.C. 556 and 557). Although, standard practice is not to include formal rulemaking in the Unified Agenda, this rule is included to highlight the deregulatory work in this space. Timetable: khammond on DSKJM1Z7X2PROD with PROPOSALS7 Action Date ANPRM ............... ANPRM Comment Period End. NPRM .................. NPRM Comment Period End. Final Rule ............ FR Cite 07/03/03 10/01/03 68 FR 39873 01/15/09 04/29/09 74 FR 2443 05/00/20 Regulatory Flexibility Analysis Required: Yes. VerDate Sep<11>2014 18:18 Dec 23, 2019 Jkt 250001 Agency Contact: Terri Wenger, Food Technologist, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, College Park, MD 20740, Phone: 240 402–2371, Email: terri.wenger@ fda.hhs.gov. RIN: 0910–AI40 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: DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Long-Term Actions 246. Acute Nicotine Toxicity Warnings for E-Liquids 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 requirements for liquid nicotine and nicotinecontaining 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 nicotinecontaining e-liquids in tobacco products. Timetable: Action Date NPRM .................. FR Cite 03/00/21 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Courtney Smith, Senior 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: 301 796–3894, Fax: 301 595–1426, Email: ctpregulations@ fda.hhs.gov. RIN: 0910–AH24 247. Adminstrative Detention of Tobacco Products E.O. 13771 Designation: Other. Legal Authority: 21 U.S.C. 334; 21 U.S.C. 371 Abstract: The FDA 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 PO 00000 Frm 00007 Fmt 4701 Sfmt 4702 71135 Action NPRM .................. Date FR Cite 11/00/20 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Nathan Mease, 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: ctpregulations@ fda.hhs.gov. RIN: 0910–AI05 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Completed Actions 248. 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. Completed: Action Withdrawn ........... Date FR Cite 10/23/19 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Janice Adams-King, Phone: 301 796–3713, Fax: 301 796– 9899, Email: janice.adams-king@ fda.hhs.gov. RIN: 0910–AF38 249. Over-the-Counter (OTC) Drug Review—Weight Control Products E.O. 13771 Designation: Regulatory. E:\FR\FM\26DEP7.SGM 26DEP7 71136 Federal Register / Vol. 84, No. 247 / Thursday, December 26, 2019 / UA: Reg Flex Agenda 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. Completed: Action Date Withdrawn ........... FR Cite 10/23/19 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Janice Adams-King, Phone: 301 796–3713, Email: janice.adams-king@fda.hhs.gov. RIN: 0910–AF45 250. 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. Completed: khammond on DSKJM1Z7X2PROD with PROPOSALS7 Action Date Withdrawn ........... FR Cite 10/23/19 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Michael Bernstein, Phone: 301 796–3478, Email: michael.bernstein@fda.hhs.gov. RIN: 0910–AG18 VerDate Sep<11>2014 18:18 Dec 23, 2019 Jkt 250001 251. Combinations of Bronchodilators With Expectorants; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Overthe-Counter Human Use E.O. 13771 Designation: Regulatory. Legal Authority: 21 U.S.C. 321(p); 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 will propose changes to the final monograph for Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products to address cough/cold drug products containing an oral bronchodilator (ephedrine and its salts) in combination with any expectorant. Completed: Action Date Withdrawn ........... FR Cite 10/23/19 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Janice Adams-King, Phone: 301 796–3713, Fax: 301 796– 9899, Email: janice.adams-king@ fda.hhs.gov. RIN: 0910–AH16 252. Topical Antimicrobial Drug Products for Over-the-Counter Human Use: Final Monograph for Consumer Antiseptic Rub 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. 360 and 361; 21 U.S.C. 371; 21 U.S.C. 374 and 375; 21 U.S.C. 379; 42 U.S.C. 216; 42 U.S.C. 241 and 242; 42 U.S.C. 262 Abstract: This final rule finalizes part of the 1994 tentative final monograph (TFM) for over-the-counter (OTC) antiseptic drug products that published in the Federal Register of June 17, 1994, (the 1994 TFM). The final rule is part of the ongoing review of OTC drug products conducted by FDA. In this final rule, we address whether certain active ingredients used in OTC consumer antiseptic products intended for use without water (referred to as consumer antiseptic rubs) are eligible for evaluation under the OTC Drug Review for use in consumer antiseptic rub products. Completed: PO 00000 Frm 00008 Fmt 4701 Sfmt 4702 Action Final Rule ............ Final Rule Effective. Date 04/12/19 04/13/20 FR Cite 84 FR 14847 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Anita Kumar, Phone: 301 796–1032, Email: anita.kumar@ fda.hhs.gov. RIN: 0910–AH97 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Proposed Rule Stage 253. • CY 2021 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS–1734–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, 2021. Additionally, this rule proposes updates to the Quality Payment Program. Timetable: Action NPRM .................. Date FR Cite 06/00/20 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Marge Watchorn, Deputy 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: 410 786–4361, Email: marge.watchorn@cms.hhs.gov. RIN: 0938–AU10 254. • Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2021 Rates (CMS–1735–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 E:\FR\FM\26DEP7.SGM 26DEP7 71137 Federal Register / Vol. 84, No. 247 / Thursday, December 26, 2019 / UA: Reg Flex Agenda 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 NPRM .................. FR Cite 04/00/20 255. • CY 2021 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS–1736–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 also update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. Timetable: Date khammond on DSKJM1Z7X2PROD with PROPOSALS7 NPRM .................. FR Cite 06/00/20 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 VerDate Sep<11>2014 18:18 Dec 23, 2019 Jkt 250001 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Final Rule Stage Regulatory Flexibility Analysis Required: Yes. Agency Contact: Donald Thompson, 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: donald.thompson@cms.hhs.gov. RIN: 0938–AU11 Action 21244, Phone: 410 786–4617, Email: marjorie.baldo@cms.hhs.gov. RIN: 0938–AU12 256. CY 2020 Home Health Prospective Payment System Rate Update and Quality Reporting Requirements (CMS– 1711–F) (Section 610 Review) E.O. 13771 Designation: Regulatory. Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395(hh) Abstract: This annual final rule updates the payment rates under the Medicare prospective payment system for home health agencies. In addition, this rule finalizes changes to the Home Health Value-Based Purchasing (HHVBP) Model and to the Home Health Quality Reporting Program (HH QRP). Timetable: Action Date NPRM .................. NPRM Comment Period End. Final Action ......... 07/18/19 09/09/19 FR Cite 84 FR 34598 11/00/19 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Hillary Loeffler, Director, Division of Home Health and Hospice, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C5–07–22, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786–0456, Email: hillary.loeffler@cms.hhs.gov. RIN: 0938–AT68 257. CY 2020 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS–1715–F) (Section 610 Review) E.O. 13771 Designation: Regulatory. Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh Abstract: This annual final rule revises payment polices under the Medicare physician fee schedule, and makes other policy changes to payment under Medicare Part B. These changes apply to services furnished beginning January 1, 2020. Additionally, this rule finalizes updates to the Quality Payment Program. Timetable: PO 00000 Frm 00009 Fmt 4701 Sfmt 4702 Action NPRM .................. NPRM Comment Period End. Final Action ......... Date 08/14/19 09/27/19 FR Cite 84 FR 40482 11/00/19 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Marge Watchorn, Deputy 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: 410 786–4361, Email: marge.watchorn@cms.hhs.gov. RIN: 0938–AT72 258. CY 2020 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS–1717–F) (Section 610 Review) E.O. 13771 Designation: Regulatory. Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh Abstract: This annual final rule revises the Medicare hospital outpatient prospective payment system to implement statutory requirements and changes arising from our continuing experience with this system. The rule describes changes to the amounts and factors used to determine payment rates for services. In addition, the rule finalizes changes to the ambulatory surgical center payment system list of services and rates. This rule also updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. Timetable: Action NPRM .................. NPRM Comment Period End. Final Action ......... Date 08/09/19 09/27/19 FR Cite 84 FR 39398 11/00/19 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Elise Barringer, 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: 410 786–9222, Email: elise.barringer@cms.hhs.gov. RIN: 0938–AT74 E:\FR\FM\26DEP7.SGM 26DEP7 71138 Federal Register / Vol. 84, No. 247 / Thursday, December 26, 2019 / UA: Reg Flex Agenda DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Long-Term Actions 259. Durable Medical Equipment Fee Schedule, Adjustments To Resume the Transitional 50/50 Blended Rates To Provide Relief in Non-Competitive Bidding Areas (CMS–1687–F) (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 final rule follows the interim final rule that published May 11, 2018, and extended the end of the transition period from June 30, 2016, to December 31, 2016 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). In addition, the interim rule amended the regulation to resume the transition period for items furnished from August 1, 2017, through December 31, 2018. The interim rule also made technical amendments to existing regulations for DMEPOS items and services to exclude infusion drugs used with DME from the DMEPOS CBP. Timetable: Action Date Interim Final Rule Interim Final Rule Comment Period End. Final Action to be Merged With 0938–AU17. 05/11/18 07/09/18 83 FR 21912 khammond on DSKJM1Z7X2PROD with PROPOSALS7 Date NPRM .................. NPRM Comment Period End. Final Action ......... 07/18/19 09/16/19 FR Cite 84 FR 34737 07/00/22 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Ronisha Blackstone, 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, Phone: 410 786–6882, Email: ronisha.blackstone@cms.hhs.gov. RIN: 0938–AT36 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) 05/00/21 Completed Actions 260. Requirements for Long-Term Care Facilities: Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction (CMS–3347–F) (Section 610 Review) E.O. 13771 Designation: Deregulatory. Legal Authority: secs.1819 and 1919 of the Social Security Act; sec.1819(d)(4)(B) and 1919(d)(4)(B) of 18:18 Dec 23, 2019 Action FR Cite Regulatory Flexibility Analysis Required: Yes. 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: alexander.ullman@cms.hhs.gov. RIN: 0938–AT21 VerDate Sep<11>2014 the Social Security Act; sec. 1819(b)(1)(A) and 1919 (b)(1)(A) of the Social Security Act Abstract: This final rule reforms the requirements that long-term care facilities must meet to participate in the Medicare and Medicaid programs that CMS has identified as unnecessary, obsolete, or excessively burdensome on facilities. This rule increases the ability of healthcare professionals to devote resources to improving resident care by eliminating or reducing requirements that impede quality care or that divert resources away from providing highquality care. Timetable: Jkt 250001 261. 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. Completed: PO 00000 Frm 00010 Fmt 4701 Sfmt 4702 Reason Continuation Notice. Final Action— Merged With 0938–AT23. Final Action Effective. Final Action— Merged With 0938–AS59. Final Action Effective. Date FR Cite 06/11/19 84 FR 27069 09/30/19 84 FR 51732 11/29/19 09/30/19 84 FR 51836 11/29/19 Regulatory Flexibility Analysis Required: No. Agency Contact: Scott Cooper, Phone: 410 786–9465, Email: scott.cooper@ cms.hhs.gov. RIN: 0938–AS21 262. FY 2020 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates (CMS–1712–F) E.O. 13771 Designation: Other. Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395f; 42 U.S.C. 1395g; 42 U.S.C. 1395hh; . . . Abstract: This annual final rule updates the prospective payment rates for inpatient psychiatric facilities (IPF) with discharges beginning on October 1, 2019. The rule also includes updates to the IPF Quality Reporting Program. Completed: Reason NPRM .................. Final Action ......... Final Action Effective. Date 04/23/19 08/06/19 10/01/19 FR Cite 84 FR 16948 84 FR 38424 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Sherlene Jacques, Phone: 410 786–0510, Email: sherlene.jacques@cms.hhs.gov. RIN: 0938–AT69 263. Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; The Long-Term Care Hospital Prospective Payment System; and FY 2020 Rates (CMS–1716–F) (Section 610 Review) E.O. 13771 Designation: Regulatory. Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh Abstract: This annual final rule revises the Medicare hospital inpatient and long-term care hospital prospective payment systems for operating and capital-related costs. This rule would implements changes arising from our continuing experience with these systems. In addition, the rule establishes new requirements or revises existing E:\FR\FM\26DEP7.SGM 26DEP7 Federal Register / Vol. 84, No. 247 / Thursday, December 26, 2019 / UA: Reg Flex Agenda requirements for quality reporting by specific Medicare providers. Completed: Reason Date khammond on DSKJM1Z7X2PROD with PROPOSALS7 NPRM .................. Final Action ......... Final Action Effective. VerDate Sep<11>2014 05/03/19 08/16/19 10/01/19 18:18 Dec 23, 2019 FR Cite 84 FR 19158 84 FR 42044 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Donald Thompson, Phone: 410 786–6504, Email: donald.thompson@cms.hhs.gov. RIN: 0938–AT73 [FR Doc. 2019–26539 Filed 12–23–19; 8:45 am] BILLING CODE 4150–03–P Jkt 250001 PO 00000 Frm 00011 Fmt 4701 Sfmt 9990 E:\FR\FM\26DEP7.SGM 26DEP7 71139

Agencies

[Federal Register Volume 84, Number 247 (Thursday, December 26, 2019)]
[Unknown Section]
[Pages 71129-71139]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26539]



[[Page 71129]]

Vol. 84

Thursday,

No. 247

December 26, 2019

Part VII





Department of Health and Human Services





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Semiannual Regulatory Agenda

Federal Register / Vol. 84 , No. 247 / Thursday, December 26, 2019 / 
UA: Reg Flex Agenda

[[Page 71130]]


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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 agencywide 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 (https://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.
    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 https://www.RegInfo.gov.

Ann C. Agnew,
Executive Secretary to the Department.

                Office for Civil Rights--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
230.......................  Nondiscrimination in               0945-AA11
                             Health and Health
                             Education Programs or
                             Activities (Reg Plan Seq
                             No. 44).
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.


 Office of the National Coordinator for Health Information Technology--
                            Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
231.......................  21st Century Cures Act:            0955-AA01
                             Interoperability,
                             Information Blocking, and
                             the ONC Health IT
                             Certification Program
                             (Reg Plan Seq No. 45).
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.


            Food and Drug Administration--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
232.......................  Postmarketing Safety               0910-AA97
                             Reporting Requirements
                             for Human Drug and
                             Biological Products.
233.......................  Over-the-Counter (OTC)             0910-AF31
                             Drug Review--Cough/Cold
                             (Antihistamine) Products.
234.......................  Medication Guide; Patient          0910-AH68
                             Medication Information.
235.......................  Testing Standards for              0910-AH90
                             Batteries and Battery
                             Management Systems in
                             Battery-Operated Tobacco
                             Products.
236.......................  Requirements for Tobacco           0910-AH91
                             Product Manufacturing
                             Practice (Reg Plan Seq
                             No. 47).
237.......................  Nutrient Content Claims,           0910-AI13
                             Definition of Term:
                             Healthy (Reg Plan Seq No.
                             48).
238.......................  Revocation of Uses of              0910-AI15
                             Partially Hydrogenated
                             Oils in Foods.
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.


             Food and Drug Administration--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
239.......................  Sunscreen Drug Products            0910-AF43
                             For Over-The-Counter-
                             Human Use; Final
                             Monograph.
240.......................  Sunlamp Products;                  0910-AG30
                             Amendment to the
                             Performance Standard.
241.......................  Food Labeling; Gluten-Free         0910-AH00
                             Labeling of Fermented or
                             Hydrolyzed Foods.
242.......................  Mammography Quality                0910-AH04
                             Standards Act; Amendments
                             to Part 900 Regulations.
243.......................  General and Plastic                0910-AH14
                             Surgery Devices: Sunlamp
                             Products.
244.......................  Required Warnings for              0910-AI39
                             Cigarette Packages and
                             Advertisements.

[[Page 71131]]

 
245.......................  Milk and Cream Product and         0910-AI40
                             Yogurt Products, Final
                             Rule to Revoke the
                             Standards for Lowfat
                             Yogurt and Nonfat Yogurt
                             and to Amend the Standard
                             for Yogurt.
------------------------------------------------------------------------


             Food and Drug Administration--Long-Term Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
246.......................  Acute Nicotine Toxicity            0910-AH24
                             Warnings for E-Liquids.
247.......................  Adminstrative Detention of         0910-AI05
                             Tobacco Products.
------------------------------------------------------------------------


             Food and Drug Administration--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
248.......................  Over-the-Counter (OTC)             0910-AF38
                             Drug Review--Laxative
                             Drug Products.
249.......................  Over-the-Counter (OTC)             0910-AF45
                             Drug Review--Weight
                             Control Products.
250.......................  Electronic Distribution of         0910-AG18
                             Prescribing Information
                             for Human Prescription
                             Drugs Including
                             Biological Products.
251.......................  Combinations of                    0910-AH16
                             Bronchodilators With
                             Expectorants; Cold,
                             Cough, Allergy,
                             Bronchodilator, and
                             Antiasthmatic Drug
                             Products for Over-the-
                             Counter Human Use.
252.......................  Topical Antimicrobial Drug         0910-AH97
                             Products for Over-the-
                             Counter Human Use: Final
                             Monograph for Consumer
                             Antiseptic Rub Products.
------------------------------------------------------------------------


      Centers for Medicare & Medicaid Services--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
253.......................  CY 2021 Revisions to               0938-AU10
                             Payment Policies Under
                             the Physician Fee
                             Schedule and Other
                             Revisions to Medicare
                             Part B (CMS-1734-P)
                             (Section 610 Review).
254.......................  Hospital Inpatient                 0938-AU11
                             Prospective Payment
                             Systems for Acute Care
                             Hospitals; the Long-Term
                             Care Hospital Prospective
                             Payment System; and FY
                             2021 Rates (CMS-1735-P)
                             (Section 610 Review).
255.......................  CY 2021 Hospital                   0938-AU12
                             Outpatient PPS Policy
                             Changes and Payment Rates
                             and Ambulatory Surgical
                             Center Payment System
                             Policy Changes and
                             Payment Rates (CMS-1736-
                             P) (Section 610 Review).
------------------------------------------------------------------------


       Centers for Medicare & Medicaid Services--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
256.......................  CY 2020 Home Health                0938-AT68
                             Prospective Payment
                             System Rate Update and
                             Quality Reporting
                             Requirements (CMS-1711-F)
                             (Section 610 Review).
257.......................  CY 2020 Revisions to               0938-AT72
                             Payment Policies Under
                             the Physician Fee
                             Schedule and Other
                             Revisions to Medicare
                             Part B (CMS-1715-F)
                             (Section 610 Review).
258.......................  CY 2020 Hospital                   0938-AT74
                             Outpatient PPS Policy
                             Changes and Payment Rates
                             and Ambulatory Surgical
                             Center Payment System
                             Policy Changes and
                             Payment Rates (CMS-1717-
                             F) (Section 610 Review).
------------------------------------------------------------------------


       Centers for Medicare & Medicaid Services--Long-Term Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
259.......................  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-
                             F) (Section 610 Review).
260.......................  Requirements for Long-Term         0938-AT36
                             Care Facilities:
                             Regulatory Provisions to
                             Promote Program
                             Efficiency, Transparency,
                             and Burden Reduction (CMS-
                             3347-F) (Section 610
                             Review).
------------------------------------------------------------------------


       Centers for Medicare & Medicaid Services--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
261.......................  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).

[[Page 71132]]

 
262.......................  FY 2020 Inpatient                  0938-AT69
                             Psychiatric Facilities
                             Prospective Payment
                             System Rate and Quality
                             Reporting Updates (CMS-
                             1712-F).
263.......................  Hospital Inpatient                 0938-AT73
                             Prospective Payment
                             Systems for Acute Care
                             Hospitals; the Long-Term
                             Care Hospital Prospective
                             Payment System; and FY
                             2020 Rates (CMS-1716-F)
                             (Section 610 Review).
------------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Office for Civil Rights (OCR)

Final Rule Stage

230. Nondiscrimination in Health and Health Education Programs or 
Activities

    Regulatory Plan: This entry is Seq. No. 44 in part II of this issue 
of the Federal Register.
    RIN: 0945-AA11

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Office of the National Coordinator for Health Information Technology 
(ONC)

Final Rule Stage

231. 21st Century Cures Act: Interoperability, Information Blocking, 
and the ONC Health IT Certification Program

    Regulatory Plan: This entry is Seq. No. 45 in part II of this issue 
of the Federal Register.
    RIN: 0955-AA01

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Proposed Rule Stage

232. 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; 42 U.S.C. 264; 42 U.S.C. 300aa-25; 
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 360f; 21 U.S.C. 360i to 360j; 21 U.S.C. 
371; 21 U.S.C. 374; 21 U.S.C. 379
    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).
    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
Reproposing NPRM....................   06/00/20
------------------------------------------------------------------------

    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

233. 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 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)......   12/00/19
------------------------------------------------------------------------

    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

234. Medication Guide; 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.

[[Page 71133]]

    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/00/20
------------------------------------------------------------------------

    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

235. Testing Standards for Batteries and Battery Management Systems in 
Battery-Operated Tobacco Products

    E.O. 13771 Designation: Regulatory.
    Legal Authority: 21 U.S.C. 301 et. seq.; 21 U.S.C. 371; 21 U.S.C. 
387b; 21 U.S.C. 387g; 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 including a 
battery management system for ENDS using batteries and protective 
housing for replaceable 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................................   05/00/20
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Nathan Mease, 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

236. Requirements for Tobacco Product Manufacturing Practice

    Regulatory Plan: This entry is Seq. No. 47 in part II of this issue 
of the Federal Register.
    RIN: 0910-AH91

237. Nutrient Content Claims, Definition of Term: Healthy

    Regulatory Plan: This entry is Seq. No. 48 in part II of this issue 
of the Federal Register.
    RIN: 0910-AI13

238. Revocation of Uses of Partially Hydrogenated Oils in Foods

    E.O. 13771 Designation: Regulatory.
    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 341; 21 U.S.C. 342; 21 
U.S.C. 343; 21 U.S.C. 348; 21 U.S.C. 371; 21 U.S.C. 379e
    Abstract: In the Federal Register of June 17, 2015 (80 FR 34650), 
we published a declaratory order announcing our final determination 
that there is no longer a consensus among qualified experts that 
partially hydrogenated oils (PHOs) are generally recognized as safe 
(GRAS) for any use in human food. In the Federal Register of May 21, 
2018 (83 FR 23382), we denied a food additive petition requesting that 
the food additive regulations be amended to provide for the safe use of 
PHOs in certain food applications. We are now proposing to update our 
regulations to remove all mention of partially hydrogenated oils from 
FDA's GRAS regulations and as an optional ingredient in standards of 
identity. We are also proposing to revoke all prior sanctions for uses 
of PHOs in food.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   03/00/20
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Ellen Anderson, Consumer Safety Officer, Department 
of Health and Human Services, Food and Drug Administration, HFS-265, 
4300 River Road, College Park, MD 20740, Phone: 240 402-1309, Email: 
[email protected].
    RIN: 0910-AI15

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Final Rule Stage

239. Sunscreen Drug Products for Over-the-Counter--Human Use; Final 
Monograph

    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 final rule will describe the conditions of use under 
which OTC sunscreen monograph products are generally recognized as safe 
and effective (GRASE) and not misbranded. Consistent with the Sunscreen 
Innovation Act, we expect that these conditions will include sunscreen 
dosage forms and maximum SPF values. The preamble of the final rule 
will also indicate which sunscreen active ingredients FDA has deferred 
further rulemaking on while data supporting the GRASE status of those 
ingredients is developed.
    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................................   02/26/19  84 FR 6204
NPRM Comment Period End.............   06/27/19
NPRM Extension of Comment Period....   04/18/19  84 FR 16222
NPRM Extension of Comment Period End   06/27/19
Final Rule..........................   09/00/20
------------------------------------------------------------------------

    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 Avenue, WO 22, Room 5491, Silver Spring, 
MD 20993, Phone: 240 402-4246, Fax: 301 796-9841, Email: 
[email protected].
    RIN: 0910-AF43

240. 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

[[Page 71134]]

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..........................   06/00/20
------------------------------------------------------------------------

    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 5454, Silver Spring, MD 20993, Phone: 301 796-5678, Email: 
[email protected].
    RIN: 0910-AG30

241. Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed 
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 End....   02/22/16
NPRM Comment Period Reopened........   02/23/16  81 FR 8869
NPRM Comment Period Reopened End....   04/25/16
Final Rule..........................   12/00/19
------------------------------------------------------------------------

    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, HFS 820, 5001 Campus Drive, 
College Park, MD 20740, Phone: 240 402-2371, Fax: 301 436-2636, Email: 
[email protected].
    RIN: 0910-AH00

242. 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 amending its regulations governing mammography. 
The amendments would update the regulations issued under the 
Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, 
Drug, and Cosmetic Act (FD&C Act). 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 healthcare providers.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   03/28/19  84 FR 11669
NPRM Comment Period End.............   06/26/19
Final Rule..........................   09/00/20
------------------------------------------------------------------------

    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

243. General and Plastic Surgery Devices: Sunlamp Products

    E.O. 13771 Designation: Regulatory.
    Legal Authority: 21 U.S.C. 360j(e)
    Abstract: This rule will 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 will 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..........................   06/00/20
------------------------------------------------------------------------

    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 5454, Silver Spring, MD 20993, Phone: 301 796-5678, Email: 
[email protected].
    RIN: 0910-AH14

244. Required Warnings for Cigarette Packages and Advertisements

    E.O. 13771 Designation: Regulatory.
    Legal Authority: 15 U.S.C. 1333; 21 U.S.C. 371; 21 U.S.C. 374; 21 
U.S.C. 387c; 21 U.S.C. 387e; 21 U.S.C. 387i; Pub. L. 111-31, secs. 201 
and 202, 123 Stat. 1776
    Abstract: This rule will require color graphics depicting the 
negative health consequences of smoking to accompany textual warning 
statements on cigarette packages and in cigarette advertisements. As 
directed by Congress in the Family Smoking Prevention and Tobacco 
Control Act, which amends the Federal Cigarette Labeling and 
Advertising Act, the rule will require these new cigarette health 
warnings to occupy the top 50 percent of the area of the front and rear 
panels of cigarette packages and at least 20 percent of the area of 
cigarette advertisements. The original rule FDA issued in 2011 was 
vacated by the U.S. Court of Appeals for the District of Columbia 
Circuit in August 2012 (R.J. Reynolds Tobacco Co. v. United States Food 
& Drug Admin., 696 F.3d 1205 D.C. Cir. 2012).

[[Page 71135]]

    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   08/16/19  84 FR 42754
NPRM Comment Period End.............   10/15/19
Final Rule..........................   03/00/20
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Courtney Smith, Senior 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: 301 
796-3894, Fax: 301 595-1426, Email: [email protected].
    RIN: 0910-AI39

245. Milk and Cream Product and Yogurt Products, Final Rule To Revoke 
the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the 
Standard for Yogurt

    E.O. 13771 Designation: Deregulatory.
    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 336; 21 U.S.C. 341; 21 
U.S.C. 343; 21 U.S.C. 348; 21 U.S.C. 371(e); 21 U.S.C. 379e
    Abstract: This final rule amends the standard of identity for 
yogurt and revokes the standards of identity for lowfat yogurt and 
nonfat yogurt. It modernizes the standard for yogurt to allow for 
technological advances, to preserve the basic nature and essential 
characteristics of yogurt, and to promote honesty and fair dealing in 
the interest of consumers. Section 701(e)(1), of the Federal Food, 
Drug, and Cosmetic Act requires that the amendment or repeal of the 
definition and standard of identity for a dairy product proceed under a 
formal rulemaking process. Such is consistent with the formal 
rulemaking provisions of the Administrative Procedures Act (5 U.S.C. 
556 and 557). Although, standard practice is not to include formal 
rulemaking in the Unified Agenda, this rule is included to highlight 
the de-regulatory work in this space.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
ANPRM...............................   07/03/03  68 FR 39873
ANPRM Comment Period End............   10/01/03
NPRM................................   01/15/09  74 FR 2443
NPRM Comment Period End.............   04/29/09
Final Rule..........................   05/00/20
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Terri Wenger, Food Technologist, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Food Safety and Applied Nutrition, 5001 Campus Drive, College Park, MD 
20740, Phone: 240 402-2371, Email: [email protected].
    RIN: 0910-AI40

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Long-Term Actions

246. Acute Nicotine Toxicity Warnings for E-Liquids

    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 
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................................   03/00/21
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Courtney Smith, Senior 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: 301 
796-3894, Fax: 301 595-1426, Email: [email protected].
    RIN: 0910-AH24

247. Adminstrative Detention of Tobacco Products

    E.O. 13771 Designation: Other.
    Legal Authority: 21 U.S.C. 334; 21 U.S.C. 371
    Abstract: The FDA 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................................   11/00/20
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Nathan Mease, 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-AI05

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Completed Actions

248. 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.
    Completed:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Withdrawn...........................   10/23/19
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Janice Adams-King, Phone: 301 796-3713, Fax: 301 
796-9899, Email: [email protected].
    RIN: 0910-AF38

249. Over-the-Counter (OTC) Drug Review--Weight Control Products

    E.O. 13771 Designation: Regulatory.

[[Page 71136]]

    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.
    Completed:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Withdrawn...........................   10/23/19
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Janice Adams-King, Phone: 301 796-3713, Email: 
[email protected].
    RIN: 0910-AF45

250. 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.
    Completed:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Withdrawn...........................   10/23/19
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Michael Bernstein, Phone: 301 796-3478, Email: 
[email protected].
    RIN: 0910-AG18

251. 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. 321(p); 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 will propose changes to the final monograph for Cold, Cough, 
Allergy, Bronchodilator, and Antiasthmatic Drug Products to address 
cough/cold drug products containing an oral bronchodilator (ephedrine 
and its salts) in combination with any expectorant.
    Completed:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Withdrawn...........................   10/23/19
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Janice Adams-King, Phone: 301 796-3713, Fax: 301 
796-9899, Email: [email protected].
    RIN: 0910-AH16

252. Topical Antimicrobial Drug Products for Over-the-Counter Human 
Use: Final Monograph for Consumer Antiseptic Rub 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. 360 and 361; 21 U.S.C. 371; 21 U.S.C. 374 
and 375; 21 U.S.C. 379; 42 U.S.C. 216; 42 U.S.C. 241 and 242; 42 U.S.C. 
262
    Abstract: This final rule finalizes part of the 1994 tentative 
final monograph (TFM) for over-the-counter (OTC) antiseptic drug 
products that published in the Federal Register of June 17, 1994, (the 
1994 TFM). The final rule is part of the ongoing review of OTC drug 
products conducted by FDA. In this final rule, we address whether 
certain active ingredients used in OTC consumer antiseptic products 
intended for use without water (referred to as consumer antiseptic 
rubs) are eligible for evaluation under the OTC Drug Review for use in 
consumer antiseptic rub products.
    Completed:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Final Rule..........................   04/12/19  84 FR 14847
Final Rule Effective................   04/13/20
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Anita Kumar, Phone: 301 796-1032, Email: 
[email protected].
    RIN: 0910-AH97

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Proposed Rule Stage

253.  CY 2021 Revisions to Payment Policies Under the Physician 
Fee Schedule and Other Revisions to Medicare Part B (CMS-1734-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, 2021. Additionally, this rule 
proposes updates to the Quality Payment Program.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/00/20
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Marge Watchorn, Deputy 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: 410 786-4361, 
Email: [email protected].
    RIN: 0938-AU10

254.  Hospital Inpatient Prospective Payment Systems for Acute 
Care Hospitals; the Long-Term Care Hospital Prospective Payment System; 
and FY 2021 Rates (CMS-1735-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

[[Page 71137]]

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................................   04/00/20
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Donald Thompson, 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-AU11

255.  CY 2021 Hospital Outpatient PPS Policy Changes and 
Payment Rates and Ambulatory Surgical Center Payment System Policy 
Changes and Payment Rates (CMS-1736-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 also 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................................   06/00/20
------------------------------------------------------------------------

    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-AU12

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Final Rule Stage

256. CY 2020 Home Health Prospective Payment System Rate Update and 
Quality Reporting Requirements (CMS-1711-F) (Section 610 Review)

    E.O. 13771 Designation: Regulatory.
    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395(hh)
    Abstract: This annual final rule updates the payment rates under 
the Medicare prospective payment system for home health agencies. In 
addition, this rule finalizes changes to the Home Health Value-Based 
Purchasing (HHVBP) Model and to the Home Health Quality Reporting 
Program (HH QRP).
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/18/19  84 FR 34598
NPRM Comment Period End.............   09/09/19
Final Action........................   11/00/19
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Hillary Loeffler, Director, Division of Home Health 
and Hospice, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Center for Medicare, MS: C5-07-22, 7500 
Security Boulevard, Baltimore, MD 21244, Phone: 410 786-0456, Email: 
[email protected].
    RIN: 0938-AT68

257. CY 2020 Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Medicare Part B (CMS-1715-F) (Section 
610 Review)

    E.O. 13771 Designation: Regulatory.
    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
    Abstract: This annual final rule revises payment polices under the 
Medicare physician fee schedule, and makes other policy changes to 
payment under Medicare Part B. These changes apply to services 
furnished beginning January 1, 2020. Additionally, this rule finalizes 
updates to the Quality Payment Program.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   08/14/19  84 FR 40482
NPRM Comment Period End.............   09/27/19
Final Action........................   11/00/19
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Marge Watchorn, Deputy 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: 410 786-4361, 
Email: [email protected].
    RIN: 0938-AT72

258. CY 2020 Hospital Outpatient PPS Policy Changes and Payment Rates 
and Ambulatory Surgical Center Payment System Policy Changes and 
Payment Rates (CMS-1717-F) (Section 610 Review)

    E.O. 13771 Designation: Regulatory.
    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
    Abstract: This annual final rule revises the Medicare hospital 
outpatient prospective payment system to implement statutory 
requirements and changes arising from our continuing experience with 
this system. The rule describes changes to the amounts and factors used 
to determine payment rates for services. In addition, the rule 
finalizes changes to the ambulatory surgical center payment system list 
of services and rates. This rule also updates and refines the 
requirements for the Hospital Outpatient Quality Reporting (OQR) 
Program and the ASC Quality Reporting (ASCQR) Program.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   08/09/19  84 FR 39398
NPRM Comment Period End.............   09/27/19
Final Action........................   11/00/19
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Elise Barringer, 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: 410 786-9222, Email: 
[email protected].
    RIN: 0938-AT74


[[Page 71138]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Long-Term Actions

259. Durable Medical Equipment Fee Schedule, Adjustments To Resume the 
Transitional 50/50 Blended Rates To Provide Relief in Non-Competitive 
Bidding Areas (CMS-1687-F) (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 final rule follows the interim final rule that 
published May 11, 2018, and extended the end of the transition period 
from June 30, 2016, to December 31, 2016 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). In addition, the interim rule amended the 
regulation to resume the transition period for items furnished from 
August 1, 2017, through December 31, 2018. The interim rule also made 
technical amendments to existing regulations for DMEPOS items and 
services to exclude infusion drugs used with DME from the DMEPOS CBP.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Interim Final Rule..................   05/11/18  83 FR 21912
Interim Final Rule Comment Period      07/09/18
 End.
Final Action to be Merged With 0938-   05/00/21
 AU17.
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    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

260. Requirements for Long-Term Care Facilities: Regulatory Provisions 
To Promote Program Efficiency, Transparency, and Burden Reduction (CMS-
3347-F) (Section 610 Review)

    E.O. 13771 Designation: Deregulatory.
    Legal Authority: secs.1819 and 1919 of the Social Security Act; 
sec.1819(d)(4)(B) and 1919(d)(4)(B) of the Social Security Act; sec. 
1819(b)(1)(A) and 1919 (b)(1)(A) of the Social Security Act
    Abstract: This final rule reforms the requirements that long-term 
care facilities must meet to participate in the Medicare and Medicaid 
programs that CMS has identified as unnecessary, obsolete, or 
excessively burdensome on facilities. This rule increases the ability 
of healthcare professionals to devote resources to improving resident 
care by eliminating or reducing requirements that impede quality care 
or that divert resources away from providing high-quality care.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/18/19  84 FR 34737
NPRM Comment Period End.............   09/16/19
Final Action........................   07/00/22
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Ronisha Blackstone, 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, Phone: 410 786-
6882, Email: [email protected].
    RIN: 0938-AT36

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Completed Actions

261. 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.
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
Continuation Notice.................   06/11/19  84 FR 27069
Final Action--Merged With 0938-AT23.   09/30/19  84 FR 51732
Final Action Effective..............   11/29/19
Final Action--Merged With 0938-AS59.   09/30/19  84 FR 51836
Final Action Effective..............   11/29/19
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: No.
    Agency Contact: Scott Cooper, Phone: 410 786-9465, Email: 
[email protected].
    RIN: 0938-AS21

262. FY 2020 Inpatient Psychiatric Facilities Prospective Payment 
System Rate and Quality Reporting Updates (CMS-1712-F)

    E.O. 13771 Designation: Other.
    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395f; 42 U.S.C. 1395g; 
42 U.S.C. 1395hh; . . .
    Abstract: This annual final rule updates the prospective payment 
rates for inpatient psychiatric facilities (IPF) with discharges 
beginning on October 1, 2019. The rule also includes updates to the IPF 
Quality Reporting Program.
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/23/19  84 FR 16948
Final Action........................   08/06/19  84 FR 38424
Final Action Effective..............   10/01/19
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Sherlene Jacques, Phone: 410 786-0510, Email: 
[email protected].
    RIN: 0938-AT69

263. Hospital Inpatient Prospective Payment Systems for Acute Care 
Hospitals; The Long-Term Care Hospital Prospective Payment System; and 
FY 2020 Rates (CMS-1716-F) (Section 610 Review)

    E.O. 13771 Designation: Regulatory.
    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
    Abstract: This annual final rule revises the Medicare hospital 
inpatient and long-term care hospital prospective payment systems for 
operating and capital-related costs. This rule would implements changes 
arising from our continuing experience with these systems. In addition, 
the rule establishes new requirements or revises existing

[[Page 71139]]

requirements for quality reporting by specific Medicare providers.
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   05/03/19  84 FR 19158
Final Action........................   08/16/19  84 FR 42044
Final Action Effective..............   10/01/19
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Donald Thompson, Phone: 410 786-6504, Email: 
[email protected].
    RIN: 0938-AT73

[FR Doc. 2019-26539 Filed 12-23-19; 8:45 am]
BILLING CODE 4150-03-P

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