Regulatory Agenda, 41214-41224 [2021-14870]

Download as PDF 41214 Federal Register / Vol. 86, No. 144 / Friday, July 30, 2021 / UA: Reg Flex Agenda The Department of Health and Human Services (HHS) is the Federal Office of the Secretary government’s lead agency for protecting the health of all Americans and 21 CFR Ch. I providing essential human services. HHS enhances the health and well25 CFR Ch. V being of Americans by promoting effective health and human services and 42 CFR Chs. I–V by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services. 45 CFR Subtitle A; Subtitle B, Chs. II, This Agenda presents the regulatory III, and XIII activities that the Department expects to Regulatory Agenda undertake in the foreseeable future to advance this mission. The purpose of AGENCY: Office of the Secretary, HHS. the Agenda is to encourage more ACTION: Semiannual Regulatory Agenda. effective public participation in the regulatory process. The regulatory actions forecasted in this Agenda reflect SUMMARY: The Regulatory Flexibility Act the priorities of the Biden-Harris of 1980 and Executive Order (E.O.) Administration and HHS Secretary 12866 require the semiannual issuance Xavier Becerra. Accordingly, this of an inventory of rulemaking actions Agenda contains rulemakings aimed at under development throughout the advancing equity and ensuring Department, offering for public review nondiscrimination in health; ending the summarized information about COVID–19 public health emergency; forthcoming regulatory actions. enhancing access to quality, affordable FOR FURTHER INFORMATION CONTACT: health care; addressing child welfare and maternal health; safeguarding the Karuna Seshasai, Executive Secretary, quality of medical products; protecting Department of Health and Human the public health by reducing tobacco Services, 200 Independence Avenue use; revising prior actions that are SW, Washington, DC 20201; (202) 690– inconsistent with the policy of this 5627. SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration; and supporting other priority areas. Please note that because the Department’s most recent Statement of Regulatory Priorities was published in Fall 2020 and under a previous Administration, it no longer reflects the views of the Department or this Administration. The Department will have the opportunity to issue a new Statement of Regulatory Priorities reflecting its policy direction alongside the Fall 2021 Agenda. At present, more information about the policy priorities of the Biden-Harris Administration is available through Executive Orders, Presidential Memoranda, other Presidential Actions, regulatory actions, and sub-regulatory guidance issued by the Biden-Harris Administration since January 20, 2021. 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. Karuna Seshasai, Executive Secretary to the Department. OFFICE OF THE SECRETARY—PROPOSED RULE STAGE Regulation Identifier No. Sequence No. Title 85 ...................... Limiting the Effect of Exclusions Implemented Under the Social Security Act (Rulemaking Resulting From a Section 610 Review). 0991–AC11 OFFICE FOR CIVIL RIGHTS—PROPOSED RULE STAGE Regulation Identifier No. Sequence No. Title 86 ...................... Rulemaking on Discrimination on the Basis of Disability in Critical Health and Human Services Programs or Activities (Rulemaking Resulting From a Section 610 Review). 0945–AA15 OFFICE OF THE NATIONAL COORDINATOR FOR HEALTH INFORMATION TECHNOLOGY—COMPLETED ACTIONS Regulation Identifier No. Sequence No. Title 87 ...................... Information Blocking and the ONC Health IT Certification Program: Extension of Compliance Dates and Timeframes in Response to the COVID–19 Public Health Emergency. 0955–AA02 lotter on DSK11XQN23PROD with PROPOSALS8 CENTERS FOR DISEASE CONTROL AND PREVENTION—FINAL RULE STAGE Regulation Identifier No. Sequence No. Title 88 ...................... Control of Communicable Diseases; Foreign Quarantine ............................................................................... VerDate Sep<11>2014 19:22 Jul 29, 2021 Jkt 250001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 E:\FR\FM\30JYP8.SGM 30JYP8 0920–AA75 Federal Register / Vol. 86, No. 144 / Friday, July 30, 2021 / UA: Reg Flex Agenda 41215 FOOD AND DRUG ADMINISTRATION—PROPOSED RULE STAGE Sequence No. 89 90 91 92 93 94 95 96 97 ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... Regulation Identifier No. Title National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers .. Certain Requirements Regarding Prescription Drug Marketing (203 Amendment) ........................................ Medication Guide; Patient Medication Information .......................................................................................... Requirements for Tobacco Product Manufacturing Practice ........................................................................... Administrative Detention of Tobacco Products ................................................................................................ Nutrient Content Claims, Definition of Term: Healthy ..................................................................................... Revocation of Uses of Partially Hydrogenated Oils in Foods ......................................................................... Tobacco Product Standard for Characterizing Flavors in Cigars .................................................................... Conduct of Analytical and Clinical Pharmacology, Bioavailability and Bioequivalence Studies ..................... 0910–AH11 0910–AH56 0910–AH68 0910–AH91 0910–AI05 0910–AI13 0910–AI15 0910–AI28 0910–AI57 FOOD AND DRUG ADMINISTRATION—FINAL RULE STAGE Regulation Identifier No. Sequence No. Title 98 ...................... 99 ...................... Mammography Quality Standards Act ............................................................................................................. Amendments to the List of Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act. 0910–AH04 0910–AH81 FOOD AND DRUG ADMINISTRATION—LONG-TERM ACTIONS Regulation Identifier No. Sequence No. Title 100 .................... Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, Neutral Manner in Advertisements in Television and Radio Format. Sunlamp Products; Amendment to the Performance Standard ...................................................................... General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products ............ Nicotine Toxicity Warnings ............................................................................................................................... Requirements For Additional Traceability Records for Certain Foods ............................................................ 101 102 103 104 .................... .................... .................... .................... 0910–AG27 0910–AG30 0910–AH14 0910–AH24 0910–AI44 FOOD AND DRUG ADMINISTRATION—COMPLETED ACTIONS Regulation Identifier No. Sequence No. Title 105 .................... 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 CENTERS FOR MEDICARE & MEDICAID SERVICES—PROPOSED RULE STAGE Regulation Identifier No. Sequence No. Title 106 .................... Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (CMS–4192). CY 2022 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS–1751) (Section 610 Review). CY 2022 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS–1753) (Section 610 Review). Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2022 Rates (CMS–1752) (Section 610 Review). Medicare Advantage and Medicare Prescription Drug Benefit Program Payment Policy (CMS–4198) ......... 107 .................... 108 .................... 109 .................... 110 .................... 0938–AU30 0938–AU42 0938–AU43 0938–AU44 0938–AU59 lotter on DSK11XQN23PROD with PROPOSALS8 CENTERS FOR MEDICARE & MEDICAID SERVICES—FINAL RULE STAGE Regulation Identifier No. Sequence No. Title 111 .................... 112 .................... Requirements Related to Surprise Billing; Part II (CMS–9908) ...................................................................... Requirements Related to Surprise Billing; Part I (CMS–9909) ....................................................................... VerDate Sep<11>2014 19:22 Jul 29, 2021 Jkt 250001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 E:\FR\FM\30JYP8.SGM 30JYP8 0938–AU62 0938–AU63 41216 Federal Register / Vol. 86, No. 144 / Friday, July 30, 2021 / UA: Reg Flex Agenda CENTERS FOR MEDICARE & MEDICAID SERVICES—LONG-TERM ACTIONS Regulation Identifier No. Sequence No. Title 113 .................... Durable Medical Equipment Fee Schedule, Adjustments to Resume the Transitional 50/50 Blended Rates to Provide Relief in Non-Competitive Bidding Areas (CMS–1687) (Section 610 Review). Requirements for Long-Term Care Facilities: Regulatory Provisions to Promote Increased Safety (CMS– 3347) (Section 610 Review). 114 .................... 0938–AT21 0938–AT36 CENTERS FOR MEDICARE & MEDICAID SERVICES—COMPLETED ACTIONS Regulation Identifier No. Sequence No. Title 115 .................... 116 .................... Most Favored Nation (MFN) Model (CMS–5528) (Completion of a Section 610 Review) ......................... Medicaid; Reducing Provider and Patient Burden by Improving Prior Authorization Processes and Promoting Patients’ Electronic Access to Health Information (CMS–9123). CY 2021 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS–1734) (Completion of a 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) (Completion of a Section 610 Review). Promoting Electronic Access to Health Information for Patients and for Medicare- and Medicaid-Participating Providers and Suppliers (CMS–0057). 117 .................... 118 .................... 119 .................... 0938–AT91 0938–AT99 0938–AU10 0938–AU12 0938–AU53 ADMINISTRATION FOR CHILDREN AND FAMILIES—PROPOSED RULE STAGE Title 120 .................... Updating Native Employment Works Requirements (Rulemaking Resulting From a Section 610 Review). DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Office of the Secretary (OS) Proposed Rule Stage lotter on DSK11XQN23PROD with PROPOSALS8 Regulation Identifier No. Sequence No. 85. Limiting the Effect of Exclusions Implemented Under the Social Security Act (Rulemaking Resulting From a Section 610 Review) Legal Authority: 5 U.S.C. 301; 31 U.S.C. 6101 Abstract: Exclusions implemented under the Social Security Act prevent individuals convicted of certain crimes or individuals whose health care licenses have been revoked from participating in Federal health care programs. Instead of only being barred from participating in all Federal healthcare programs, certain regulatory provisions have resulted in these type of exclusion actions being given an overly broad government-wide effect, and excluded parties have been barred from participating in all Federal procurement and non-procurement actions. However, because Social Security Act exclusions are not issued under an agency’s suspension and debarment authority, they do not stop individuals from participating in all Federal procurement and non-procurement actions. For an agency to bar individuals from participating in all procurement and VerDate Sep<11>2014 19:22 Jul 29, 2021 Jkt 250001 non-procurement activities, it must exercise its suspension and debarment authority under the Federal Acquisition Regulation or the Nonprocurement Common Rule. This rulemaking would remove the regulatory provisions at issue, in order to align the regulation with the intent of the Social Security Act and current practice. Timetable: Action Date NPRM .................. FR Cite 08/00/21 Regulatory Flexibility Analysis Required: No. Agency Contact: Tiffani Redding, Program Analyst, Department of Health and Human Services, Office of the Secretary, 200 Independence Avenue SW, Washington, DC 20201, Phone: 202 205–4321, Email: tiffani.redding@ hhs.gov. RIN: 0991–AC11 PO 00000 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Office for Civil Rights (OCR) Proposed Rule Stage 86. Rulemaking on Discrimination on the Basis of Disability in Critical Health and Human Services Programs or Activities (Rulemaking Resulting From a Section 610 Review) Legal Authority: Sec. 504 of the Rehabilitation Act of 19 Abstract: This proposed rule would revise regulations under, among other statutes, section 504 of the Rehabilitation Act of 1973 to address unlawful discrimination on the basis of disability in certain vital HHS-funded health and human services programs. Covered topics include nondiscrimination in life-sustaining care, organ transplantation, suicide prevention services, child welfare programs and services, health care value assessment methodologies, accessible medical equipment, auxiliary aids and services, Crisis Standards of Care and other relevant health and human services activities. Timetable: Action NPRM .................. Frm 00004 Fmt 4701 Sfmt 4702 0970–AC83 E:\FR\FM\30JYP8.SGM 30JYP8 Date 09/00/21 FR Cite Federal Register / Vol. 86, No. 144 / Friday, July 30, 2021 / UA: Reg Flex Agenda Regulatory Flexibility Analysis Required: No. Agency Contact: Carla Carter, Supervisory Civil Rights Analyst, Department of Health and Human Services, Office for Civil Rights, 200 Independence Avenue SW, Washington, DC 20201, Phone: 800 368–1019, Email: ocrmail@hhs.gov. RIN: 0945–AA15 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Office of the National Coordinator for Health Information Technology (ONC) Completed Actions 87. Information Blocking and the ONC Health IT Certification Program: Extension of Compliance Dates and Timeframes in Response to the COVID– 19 Public Health Emergency Legal Authority: 42 U.S.C. 300jj–11; 42 U.S.C. 300jj–14; . . . Abstract: In light of COVID–19, ONC issued an interim final rule with comment period (IFC) that gives health IT developers and health care providers flexibilities to effectively respond to the serious public health threats posed by the spread of COVID–19. The IFC extends certain applicability and compliance dates and timeframes in the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule (ONC Cures Act Final Rule), including applicability and compliance dates for the information blocking provisions, certain 2015 Edition health IT certification criteria, and Conditions and Maintenance of Certification requirements under the ONC Health IT Certification Program. The IFC also updated certain standards and made technical corrections and clarifications to the ONC Cures Act Final Rule, which was published in the Federal Register on May 1, 2020. Completed: lotter on DSK11XQN23PROD with PROPOSALS8 Reason Date Interim Final Rule Interim Final Rule Comment Period End. Final Action— Agency Expects No Further Action. 11/04/20 01/04/21 FR Cite 85 FR 70064 05/25/21 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Michael Lipinski, Phone: 202 690–7151. RIN: 0955–AA02 VerDate Sep<11>2014 19:22 Jul 29, 2021 Jkt 250001 DEPARTMENT OF HEALTH AND HUUMAN SERVICES (HHS) Centers for Disease Control and Prevention (CDC) Final Rule Stage 88. Control of Communicable Diseases; Foreign Quarantine Legal Authority: 42 U.S.C. 264; 42 U.S.C. 265 Abstract: This rulemaking amends current regulation to enable CDC to require airlines to collect and provide to CDC certain data elements regarding passengers and crew arriving from foreign countries under certain circumstances. Timetable: Action Date Interim Final Rule Effective. Interim Final Rule Interim Final Rule Comment Period End. Final Action ......... FR Cite 02/07/20 02/12/20 03/13/20 85 FR 7874 04/00/22 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Ashley C. Altenburger JD, Public Health Analyst, Department of Health and Human Services, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS: H 16–4, Atlanta, GA 30307, Phone: 800 232–4636, Email: dgmqpolicyoffice@cdc.gov. RIN: 0920–AA75 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Proposed Rule Stage 89. National Standards for the Licensure of Wholesale Drug Distributors and Third–Party Logistics Providers Legal Authority: Pub. L. 113–54 Abstract: The rulemaking, once finalized, will establish standards for State licensing of prescription drug wholesale distributors and third-party logistics providers. The rulemaking will also establish a Federal system for wholesale drug distributor and thirdparty logistics provider licensing for use in the absence of a State licensure program. Timetable: Action Date NPRM .................. PO 00000 Frm 00005 Fmt 4701 09/00/21 Sfmt 4702 FR Cite 41217 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Aaron Weisbuch, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Building 51, Room 4261, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796–9362, Email: aaron.weisbuch@fda.hhs.gov. RIN: 0910–AH11 90. Certain Requirements Regarding Prescription Drug Marketing (203 Amendment) Legal Authority: Pub. L. 113–54 Abstract: The Food and Drug Administration (FDA) is amending the regulations at 21 CFR 203 to remove provisions no longer in effect and incorporate conforming changes following enactment of the Drug Supply Chain Security Act (DSCSA). In this proposed rulemaking, the Agency is amending the regulations to clarify provisions and avoid causing confusion with the new standards for wholesale distribution established by DSCSA. Timetable: Action NPRM .................. Date FR Cite 09/00/21 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Aaron Weisbuch, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Building 51, Room 4261, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796–9362, Email: aaron.weisbuch@fda.hhs.gov. RIN: 0910–AH56 91. Medication Guide; Patient Medication Information 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 E:\FR\FM\30JYP8.SGM 30JYP8 41218 Federal Register / Vol. 86, No. 144 / Friday, July 30, 2021 / UA: Reg Flex Agenda understood format to help patients use their prescription drug products safely and effectively. Timetable: Action Date NPRM .................. FR Cite 10/00/21 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 92. Requirements for Tobacco Product Manufacturing Practice Legal Authority: 21 U.S.C. 371; 21 U.S.C. 387b; 21 U.S.C. 387f Abstract: The rule is proposing to establish tobacco product manufacturing practice (TPMP) requirements for manufacturers of finished and bulk tobacco products. This proposed rule, if finalized, would set forth requirements for the manufacture, pre-production design validation, packing, and storage of a tobacco product. This proposal would help prevent the manufacture and distribution of contaminated and otherwise nonconforming tobacco products. This proposed rule provides manufacturers with flexibility in the manner in which they comply with the proposed requirements while giving FDA the ability to enforce regulatory requirements, thus helping to assure the protection of public health. Timetable: Action Date lotter on DSK11XQN23PROD with PROPOSALS8 NPRM .................. FR Cite 10/00/21 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Matthew Brenner, Senior Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, 10903 New Hampshire Avenue, Building 71, Room G335, Silver Spring, MD 20993, Phone: 877 287–1373, Fax: 240 276–3904, Email: ctpregulations@fda.hhs.gov. RIN: 0910–AH91 93. Administrative Detention of Tobacco Products Legal Authority: 21 U.S.C. 334; 21 U.S.C. 371 Abstract: The FDA is proposing regulations to establish requirements for VerDate Sep<11>2014 19:22 Jul 29, 2021 Jkt 250001 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 tobacco products encountered during inspections that are believed to be adulterated or misbranded until FDA has had time to consider the appropriate action to take and, where appropriate, to initiate a regulatory legal action. Timetable: Action Date NPRM .................. FR Cite 12/00/21 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. Lauren Belcher, 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 94. Nutrient Content Claims, Definition of Term: Healthy Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 343; 21 U.S.C. 371 Abstract: The proposed rule would update the definition for the implied nutrient content claim ‘‘healthy’’ to be consistent with current nutrition science and federal dietary guidelines. The proposed rule would revise the requirements for when the claim ‘‘healthy’’ can be voluntarily used in the labeling of human food products so that the claim reflects current science and dietary guidelines and helps consumers maintain healthy dietary practices. Timetable: Action Date NPRM .................. FR Cite 09/00/21 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Vincent De Jesus, Nutritionist, Department of Health and Human Services, Food and Drug PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 Administration, Center for Food Safety and Applied Nutrition, (HFS–830), Room 3D–031, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402–1774, Fax: 301 436– 1191, Email: vincent.dejesus@ fda.hhs.gov. RIN: 0910–AI13 95. Revocation of Uses of Partially Hydrogenated Oils in Foods 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 NPRM .................. Date FR Cite 10/00/21 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 96. Tobacco Product Standard for Characterizing Flavors in Cigars Legal Authority: 21 U.S.C. 387g Abstract: Evidence shows that flavored tobacco products, especially those that are sweet, appeal to youth and also shows that youth may be more likely to initiate tobacco use with such products. Characterizing flavors in cigars, such as strawberry, grape, orange, and cocoa, enhance taste and make them easier to use. Nearly one million youth in the United States use flavored cigars, placing these youth at risk for cigar-related disease and death. This proposed rule is a tobacco product E:\FR\FM\30JYP8.SGM 30JYP8 Federal Register / Vol. 86, No. 144 / Friday, July 30, 2021 / UA: Reg Flex Agenda standard that would ban characterizing flavors in all cigars. We are taking this action to reduce the tobacco-related death associated with cigars. Timetable: Action Date ANPRM ............... ANPRM Comment Period End. NPRM .................. FR Cite 03/21/18 07/19/18 I 08/00/21 83 FR 12294 I Regulatory Flexibility Analysis Required: Yes. Agency Contact: Samantha LohCollado, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, Building 71, Room G335, Silver Spring, MD 20993, Phone: 877 287– 1373, Fax: 877 287–1426, Email: ctpregulations@fda.hhs.gov. RIN: 0910–AI28 97. Conduct of Analytical and Clinical Pharmacology, Bioavailability and Bioequivalence Studies Legal Authority: 21 U.S.C. 355; 21 U.S.C. 371; 21 U.S.C. 374; 42 U.S.C. 262 Abstract: FDA is proposing to amend 21 CFR 320, in certain parts, and establish a new 21 CFR 321 to clarify FDA’s study conduct expectations for analytical and clinical pharmacology, bioavailability (BA) and bioequivalence (BE) studies that support human research and marketing applications for human drug and biological products. The proposed rule would specify needed basic study conduct requirements to enable FDA to ensure those studies are conducted appropriately and to verify the reliability of study data from those studies. This regulation would align with FDA’s other good practice regulations, would also be consistent with current industry best practices, and would harmonize the regulations more closely with related international regulatory expectations. Timetable: Action Date lotter on DSK11XQN23PROD with PROPOSALS8 NPRM .................. FR Cite 03/00/22 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Brian Joseph Folian, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, Building 51, Room 5215, Silver Spring, MD 20993–0002, Phone: 240 402–4089, Email: brian.folian@fda.hhs.gov. RIN: 0910–AI57 VerDate Sep<11>2014 19:22 Jul 29, 2021 Jkt 250001 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Final Rule Stage 98. Mammography Quality Standards Act 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 will 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 ............ I 84 FR 11669 I Fmt 4701 NPRM .................. NPRM Comment Period End. Final Rule ............ Date 09/05/19 12/04/19 I FR Cite 84 FR 46688 12/00/21 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Rosilend Lawson, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, Building 51, Room 5197, Silver Spring, MD 20993, Phone: 240 402–6223, Email: rosilend.lawson@ fda.hhs.gov. RIN: 0910–AH81 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Long-Term Actions 99. Amendments to the List of Bulk Drug Substances That Can Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act Legal Authority: 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 353a; 21 U.S.C. 355; 21 U.S.C. 371; . . . Abstract: FDA has issued a regulation creating a list of bulk drug substances (active pharmaceutical ingredients) that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), although they are neither the subject of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph nor components of FDA-approved drugs (the 503A Bulks List). FDA has proposed to amend the 503A Bulks List by placing five additional bulk drug substances on the list. FDA has also identified 26 bulk drug substances that Frm 00007 Action Food and Drug Administration (FDA) Regulatory Flexibility Analysis Required: Yes. Agency Contact: Jean M. Olson, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, Building 66, Room 5506, Silver Spring, MD 20993, Phone: 301 796–6579, Email: jean.olson@ fda.hhs.gov. RIN: 0910–AH04 PO 00000 FDA has considered and proposed not to include on the 503A Bulks List. Additional substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of a future rulemaking. Timetable: FR Cite 03/28/19 06/26/19 09/00/21 41219 Sfmt 4702 100. Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, Neutral Manner in Advertisements in Television and Radio Format Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 352; 21 U.S.C. 355; 21 U.S.C. 360b; 21 U.S.C. 371; . . . Abstract: The Food and Drug Administration (FDA) is amending its regulations concerning direct-toconsumer (DTC) advertisements of prescription drugs. Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major risks in what is sometimes called the major statement. The rule would revise the regulation to reflect the statutory requirement require that in DTC advertisements for human drugs in television or radio format, the major statement relating to the side effects and contraindications of an advertised prescription drug be presented in a clear, conspicuous, and neutral manner. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required. Timetable: Action NPRM .................. E:\FR\FM\30JYP8.SGM 30JYP8 Date 03/29/10 FR Cite 75 FR 15376 41220 Federal Register / Vol. 86, No. 144 / Friday, July 30, 2021 / UA: Reg Flex Agenda Action Date NPRM Comment Period End. NPRM Comment Period Reopened. NPRM Comment Period End. NPRM Comment Period Reopened. NPRM Comment Period Reopened End. Final Rule ............ FR Cite 06/28/10 01/27/12 77 FR 4273 02/27/12 03/29/12 77 FR 16973 04/09/12 05/00/22 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Suzanna Boyle, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, WO 51, Room 3214, Silver Spring, MD 20993, Phone: 240 402–4723, Email: suzanna.boyle@ fda.hhs.gov. RIN: 0910–AG27 101. Sunlamp Products; Amendment to the Performance Standard Legal Authority: 21 U.S.C. 360ii; 21 U.S.C. 360kk; 21 U.S.C. 393; 21 U.S.C. 371 Abstract: FDA is updating the performance standard for sunlamp products and ultraviolet lamps for use in these 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 lotter on DSK11XQN23PROD with PROPOSALS8 NPRM .................. NPRM Comment Period End. Final Rule ............ FR Cite 12/22/15 03/21/16 I 05/00/22 80 FR 79505 I 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 VerDate Sep<11>2014 19:22 Jul 29, 2021 Jkt 250001 102. General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products 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. Timetable: Action Date NPRM .................. NPRM Comment Period End. Final Rule ............ FR Cite 12/22/15 03/21/16 I 05/00/22 80 FR 79493 I 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 103. Nicotine Toxicity Warnings Legal Authority: 21 U.S.C. 301 et seq.; 21 U.S.C. 331; 21 U.S.C. 371; 21 U.S.C. 387f; . . . Abstract: This rule would establish acute nicotine toxicity 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 increase consumer awareness and knowledge of the risks of acute toxicity due to accidental nicotine exposure from nicotine-containing eliquids in tobacco products. Timetable: PO 00000 Frm 00008 Fmt 4701 Sfmt 4702 Action NPRM .................. Date FR Cite 08/00/22 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Samantha LohCollado, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, Building 71, Room G335, Silver Spring, MD 20993, Phone: 877 287– 1373, Fax: 877 287–1426, Email: ctpregulations@fda.hhs.gov. RIN: 0910–AH24 104. Requirements for Additional Traceability Records for Certain Foods Legal Authority: sec. 204 of the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111–353) (21 U.S.C. 2223(d)); sec. 701(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(a)); sec. 361 of the Public Health Service Act (42 U.S.C. 264) Abstract: This rule will establish additional recordkeeping requirements for facilities that manufacture, process, pack, or hold foods that are designated as high-risk foods. Timetable: Action NPRM .................. NPRM Comment Period End. NPRM Comment Period Extended. NPRM Comment Period End. Final Rule ............ Date FR Cite 09/23/20 01/21/21 85 FR 59984 12/18/20 85 FR 82393 02/22/21 11/00/22 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Katherine Vierk, Director, Division of Public Health Informatics and Analytics, Department of Health and Human Services, Food and Drug Administration, 5001 Campus Drive, CPK1, Room 2B014, HFS–005, College Park, MD 20740, Phone: 240 402–2122, Email: katherine.vierk@ fda.hhs.gov. RIN: 0910–AI44 E:\FR\FM\30JYP8.SGM 30JYP8 Federal Register / Vol. 86, No. 144 / Friday, July 30, 2021 / UA: Reg Flex Agenda DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Completed Actions 105. 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 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. 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. Completed: Reason Date Withdrawn From the Unified Agenda—This RIN is Being Pursued via Formal Rulemaking Process. FR Cite 06/01/21 Centers for Medicare & Medicaid Services (CMS) Proposed Rule Stage lotter on DSK11XQN23PROD with PROPOSALS8 Date NPRM .................. 106. Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (CMS–4192) Legal Authority: 42 U.S.C. 1395w Abstract: This proposed rule would strengthen and improve the Medicare Jkt 250001 FR Cite 09/00/21 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Christian Bauer, Director, Division of Part D Policy, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C1–26–16, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786–6043, Email: christian.bauer@cms.hhs.gov RIN: 0938–AU30 107. CY 2022 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS–1751) (Section 610 Review) 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, 2022. Additionally, this rule proposes updates to the Quality Payment Program. Timetable: Date NPRM .................. DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) 19:22 Jul 29, 2021 Action Action Regulatory Flexibility Analysis Required: Yes. Agency Contact: Terri Wenger, Phone: 240 402–2371, Email: terri.wenger@ fda.hhs.gov. RIN: 0910–AI40 VerDate Sep<11>2014 Advantage (MA or Part C) and Medicare Prescription Drug Benefit (Part D) programs, codify existing sub regulatory guidance, and implement any statutory changes (if necessary) for contract year 2023. Timetable: FR Cite 06/00/21 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Gift Tee, Director, Division of Physician Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, 7500 Security Boulevard, MS: C1–09– 07, Baltimore, MD 21244, Phone: 410 786–9316, Email: gift.tee@cms.hhs.gov. RIN: 0938–AU42 108. CY 2022 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS–1753) (Section 610 Review) 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 PO 00000 Frm 00009 Fmt 4701 Sfmt 4702 41221 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 NPRM .................. Date FR Cite 06/00/21 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–AU43 109. Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2022 Rates (CMS–1752) (Section 610 Review) 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 implements changes arising from our continuing experience with these systems. In addition, the rule establishes new requirements or revises existing requirements for quality reporting by specific Medicare providers. Timetable: Action NPRM .................. NPRM Comment Period End. Final Action ......... Date 05/10/21 06/28/21 FR Cite 86 FR 25070 10/00/21 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: C4–03–18, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786–6504, Email: donald.thompson@cms.hhs.gov. E:\FR\FM\30JYP8.SGM 30JYP8 41222 Federal Register / Vol. 86, No. 144 / Friday, July 30, 2021 / UA: Reg Flex Agenda RIN: 0938–AU44 110. • Medicare Advantage and Medicare Prescription Drug Benefit Program Payment Policy (CMS–4198) Legal Authority: 42 U.S.C. 1395w Abstract: This proposed rule would codify long-established Medicare Advantage and Part D payment policies that are outside the scope of the annual Advance Notice/Rate Announcement. Timetable: Action Date NPRM .................. FR Cite 01/00/22 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Jennifer Shapiro, Director, Medicare Plan Payment Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C1–13–18, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786–7407, Email: jennifer.shapiro@cms.hhs.gov. RIN: 0938–AU59 111. • Requirements Related to Surprise Billing; Part II (CMS–9908) Legal Authority: Pub. L. 116–260, Division BB, title I and title II Abstract: This interim final rule with comment would implement additional protections against surprise medical bills under the No Surprises Act, including provisions related to the independent dispute resolution processes. Timetable: lotter on DSK11XQN23PROD with PROPOSALS8 FR Cite 08/00/21 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Deborah Bryant, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Consumer Information and Insurance Oversight, MS: W08–134, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 301 493–4293, Email: deborah.bryant@cms.hhs.gov. RIN: 0938–AU62 VerDate Sep<11>2014 19:22 Jul 29, 2021 Jkt 250001 Date Interim Final Rule With Comment. FR Cite 07/00/21 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Lindsey Murtagh, Director, Market–Wide Regulation Division, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Consumer Information and Insurance Oversight, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 301 492–4106, Email: lindsey.murtagh@cms.hhs.gov. RIN: 0938–AU63 Long-Term Actions Final Rule Stage Interim Final Rule Action Centers for Medicare & Medicaid Services (CMS) Centers for Medicare & Medicaid Services (CMS) Date Legal Authority: Pub. L. 116–260, Division BB, title I and title II Abstract: This interim final rule with comment would implement certain protections against surprise medical bills under the No Surprises Act. Timetable: DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Action 112. • Requirements Related to Surprise Billing; Part I (CMS–9909) 113. Durable Medical Equipment Fee Schedule, Adjustments To Resume the Transitional 50/50 Blended Rates To Provide Relief in Non-Competitive Bidding Areas (CMS–1687) (Section 610 Review) 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: PO 00000 Frm 00010 Fmt 4701 Sfmt 4702 Action Interim Final Rule Interim Final Rule Comment Period End. Continuation Notice. Final Action to be Merged With 0938–AU17. Date FR Cite 05/11/18 07/09/18 83 FR 21912 04/26/21 86 FR 21949 05/00/22 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 114. Requirements for Long-Term Care Facilities: Regulatory Provisions To Promote Increased Safety (CMS–3347) (Section 610 Review) 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 in order to support the provision of safe care and preserve access to care. Timetable: Action NPRM .................. NPRM Comment Period End. Final Action ......... Date 07/18/19 09/16/19 FR Cite 84 FR 34737 07/00/22 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Diane Corning, 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: 410 786–8486, Email: diane.corning@cms.hhs.gov. RIN: 0938–AT36 E:\FR\FM\30JYP8.SGM 30JYP8 Federal Register / Vol. 86, No. 144 / Friday, July 30, 2021 / UA: Reg Flex Agenda DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Completed Actions 115. Most Favored Nation (MFN) Model (CMS–5528) (Completion of a Section 610 Review) Legal Authority: Social Security Act, sec. 1115A Abstract: This interim final rule with comment period (IFC) implements the Most Favored Nation (MFN) Model, a new Medicare payment model under section 1115A of the Social Security Act (the Act). The MFN Model tests whether more closely aligning payment for Medicare Part B drugs and biologicals (hereafter, referred to as drugs) with international prices and removing incentives to use higher-cost drugs can control unsustainable growth in Medicare Part B spending without adversely affecting quality of care for beneficiaries. Timetable: Action Date ANPRM ............... ANPRM Comment Period End. Interim Final Rule Interim Final Rule Effective. Interim Final Rule Comment Period End. FR Cite 10/30/18 12/31/18 83 FR 54546 11/27/20 11/27/20 85 FR 76180 01/26/21 lotter on DSK11XQN23PROD with PROPOSALS8 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Laura Strawbridge, Director, Division of Ambulatory Payment Models, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare and Medicaid Innovation, 7500 Security Boulevard, MS: WB–06– 05, Baltimore, MD 21244, Phone: 410 786–7400, Email: mfn@cms.hhs.gov. RIN: 0938–AT91 116. Medicaid; Reducing Provider and Patient Burden by Improving Prior Authorization Processes and Promoting Patients’ Electronic Access to Health Information (CMS–9123) Legal Authority: 42 U.S.C. 1302 Abstract: This final rule places new requirements on state Medicaid and CHIP fee-for-service (FFS) programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs) to improve the electronic exchange of health care data, and streamline processes related to prior authorization, VerDate Sep<11>2014 19:22 Jul 29, 2021 Jkt 250001 while continuing CMS’ drive toward interoperability, and reducing burden in the health care market. In addition, on behalf of the Department of Health and Human Service (HHS), the Office of the National Coordinator for Health Information Technology (ONC) is adopting certain specified implementation guides (IGs) needed to support the Application Programming Interface (API) policies included in this rule. Each of these elements plays a key role in reducing overall payer and provider burden and improving patient access to health information. Completed: Reason Date NPRM .................. Withdrawn ........... 12/18/20 03/17/21 FR Cite 85 FR 82586 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Alexandra Mugge, Phone: 410 786–4457, Email: alexandra.mugge@cms.hhs.gov. RIN: 0938–AT99 117. CY 2021 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS–1734) (Completion of a Section 610 Review) 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, 2021. Additionally, this rule updates the Quality Payment Program. Timetable: Action Date NPRM .................. NPRM Comment Period End. Final Action ......... Final Action Effective. FR Cite 08/17/20 10/05/20 85 FR 50074 12/28/20 01/01/21 85 FR 84472 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 PO 00000 Frm 00011 Fmt 4701 Sfmt 4702 41223 118. CY 2021 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS–1736) (Completion of a Section 610 Review) 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 implements 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 ......... Final Action Effective. Date FR Cite 08/12/20 10/05/20 85 FR 48772 12/29/20 01/01/21 85 FR 85866 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–AU12 119. Promoting Electronic Access to Health Information for Patients and for Medicare-and Medicaid-Participating Providers and Suppliers (CMS–0057) Legal Authority: 42 U.S.C. 1395hh Abstract: The proposed rule would also revise requirements that select Medicare- and Medicaid-participating providers and suppliers must meet for continued participation in the Medicare and Medicaid programs by requiring increased patient electronic access to their health care information. This proposed rule would also improve the electronic exchange of health information among the identified providers and suppliers, and finally, this proposed rule would improve patient safety by establishing patient identity management requirements for the identified providers and suppliers. Completed: E:\FR\FM\30JYP8.SGM 30JYP8 41224 Federal Register / Vol. 86, No. 144 / Friday, July 30, 2021 / UA: Reg Flex Agenda Reason Date Withdrawn ........... FR Cite 03/17/21 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Alexandra Mugge, Phone: 410 786–4457, Email: alexandra.mugge@cms.hhs.gov RIN: 0938–AU53 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Administration for Children and Families (ACF) Proposed Rule Stage 120. Updating Native Employment Works Requirements (Rulemaking Resulting From a Section 610 Review) lotter on DSK11XQN23PROD with PROPOSALS8 Legal Authority: 42 U.S.C. 612 VerDate Sep<11>2014 19:22 Jul 29, 2021 Jkt 250001 Abstract: The rule would update NEW regulations at 45 CFR part 287 to avoid inconsistencies and reflect the changes that have been made to the NEW statute and Administration for Children and Families (ACF) grant policy and procedures since the current regulation’s publication on February 18, 2000. In particular, the regulations need to address changes made in section 404(e) of the Social Security Act as amended in 1999, Uniform Administrative Requirements, Cost Principles, and Audit Requirement for HHS Awards (45 CFR part 75)—Part 75 Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards, Public Law 106–107, the ‘‘Federal Financial Assistance Management, Improvement Act of 1999’’ (Nov. 20, 1999), and various minor technical changes. While some of these changes have been addressed and communicated to the PO 00000 Frm 00012 Fmt 4701 Sfmt 9990 public and grantees via program instructions and information memoranda, the regulations themselves are now inconsistent with current law and policy. Timetable: Action NPRM .................. Date FR Cite 12/00/21 Regulatory Flexibility Analysis Required: No. Agency Contact: Tonya Ann Davis, Program Specialist, Department of Health and Human Services, Administration for Children and Families, 330 C Street SW, Room 3020, Washington, DC 20201, Phone: 202 401– 4851, Email: tonya.davis@acf.hhs.gov. RIN: 0970–AC83 [FR Doc. 2021–14870 Filed 7–29–21; 8:45 am] BILLING CODE 4150–03–P E:\FR\FM\30JYP8.SGM 30JYP8

Agencies

[Federal Register Volume 86, Number 144 (Friday, July 30, 2021)]
[Unknown Section]
[Pages 41214-41224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14870]



[[Page 41213]]

Vol. 86

Friday,

No. 144

July 30, 2021

Part VIII





Department of Health and Human Services





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Semiannual Regulatory Agenda

Federal Register / Vol. 86, No. 144 / Friday, July 30, 2021 / UA: Reg 
Flex Agenda

[[Page 41214]]


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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: Karuna Seshasai, 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. 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. 
The purpose of the Agenda is to encourage more effective public 
participation in the regulatory process. The regulatory actions 
forecasted in this Agenda reflect the priorities of the Biden-Harris 
Administration and HHS Secretary Xavier Becerra. Accordingly, this 
Agenda contains rulemakings aimed at advancing equity and ensuring 
nondiscrimination in health; ending the COVID-19 public health 
emergency; enhancing access to quality, affordable health care; 
addressing child welfare and maternal health; safeguarding the quality 
of medical products; protecting the public health by reducing tobacco 
use; revising prior actions that are inconsistent with the policy of 
this Administration; and supporting other priority areas.
    Please note that because the Department's most recent Statement of 
Regulatory Priorities was published in Fall 2020 and under a previous 
Administration, it no longer reflects the views of the Department or 
this Administration. The Department will have the opportunity to issue 
a new Statement of Regulatory Priorities reflecting its policy 
direction alongside the Fall 2021 Agenda. At present, more information 
about the policy priorities of the Biden-Harris Administration is 
available through Executive Orders, Presidential Memoranda, other 
Presidential Actions, regulatory actions, and sub-regulatory guidance 
issued by the Biden-Harris Administration since January 20, 2021.
    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.

Karuna Seshasai,
Executive Secretary to the Department.

              Office of the Secretary--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
85........................  Limiting the Effect of             0991-AC11
                             Exclusions Implemented
                             Under the Social Security
                             Act (Rulemaking Resulting
                             From a Section 610
                             Review).
------------------------------------------------------------------------


              Office for Civil Rights--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
86........................  Rulemaking on                      0945-AA15
                             Discrimination on the
                             Basis of Disability in
                             Critical Health and Human
                             Services Programs or
                             Activities (Rulemaking
                             Resulting From a Section
                             610 Review).
------------------------------------------------------------------------


 Office of the National Coordinator for Health Information Technology--
                            Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
87........................  Information Blocking and           0955-AA02
                             the ONC Health IT
                             Certification Program:
                             Extension of Compliance
                             Dates and Timeframes in
                             Response to the COVID-19
                             Public Health Emergency.
------------------------------------------------------------------------


      Centers for Disease Control and Prevention--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
88........................  Control of Communicable            0920-AA75
                             Diseases; Foreign
                             Quarantine.
------------------------------------------------------------------------


[[Page 41215]]


            Food and Drug Administration--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
89........................  National Standards for the         0910-AH11
                             Licensure of Wholesale
                             Drug Distributors and
                             Third-Party Logistics
                             Providers.
90........................  Certain Requirements               0910-AH56
                             Regarding Prescription
                             Drug Marketing (203
                             Amendment).
91........................  Medication Guide; Patient          0910-AH68
                             Medication Information.
92........................  Requirements for Tobacco           0910-AH91
                             Product Manufacturing
                             Practice.
93........................  Administrative Detention           0910-AI05
                             of Tobacco Products.
94........................  Nutrient Content Claims,           0910-AI13
                             Definition of Term:
                             Healthy.
95........................  Revocation of Uses of              0910-AI15
                             Partially Hydrogenated
                             Oils in Foods.
96........................  Tobacco Product Standard           0910-AI28
                             for Characterizing
                             Flavors in Cigars.
97........................  Conduct of Analytical and          0910-AI57
                             Clinical Pharmacology,
                             Bioavailability and
                             Bioequivalence Studies.
------------------------------------------------------------------------


             Food and Drug Administration--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
98........................  Mammography Quality                0910-AH04
                             Standards Act.
99........................  Amendments to the List of          0910-AH81
                             Bulk Drug Substances That
                             Can Be Used To Compound
                             Drug Products in
                             Accordance With Section
                             503A of the Federal Food,
                             Drug, and Cosmetic Act.
------------------------------------------------------------------------


             Food and Drug Administration--Long-Term Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
100.......................  Direct-to-Consumer                 0910-AG27
                             Prescription Drug
                             Advertisements:
                             Presentation of the Major
                             Statement in a Clear,
                             Conspicuous, Neutral
                             Manner in Advertisements
                             in Television and Radio
                             Format.
101.......................  Sunlamp Products;                  0910-AG30
                             Amendment to the
                             Performance Standard.
102.......................  General and Plastic                0910-AH14
                             Surgery Devices:
                             Restricted Sale,
                             Distribution, and Use of
                             Sunlamp Products.
103.......................  Nicotine Toxicity Warnings         0910-AH24
104.......................  Requirements For                   0910-AI44
                             Additional Traceability
                             Records for Certain Foods.
------------------------------------------------------------------------


             Food and Drug Administration--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
105.......................  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.
------------------------------------------------------------------------


      Centers for Medicare & Medicaid Services--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
106.......................  Contract Year 2023 Policy          0938-AU30
                             and Technical Changes to
                             the Medicare Advantage
                             and Medicare Prescription
                             Drug Benefit Programs
                             (CMS-4192).
107.......................  CY 2022 Revisions to               0938-AU42
                             Payment Policies Under
                             the Physician Fee
                             Schedule and Other
                             Revisions to Medicare
                             Part B (CMS-1751)
                             (Section 610 Review).
108.......................  CY 2022 Hospital                   0938-AU43
                             Outpatient PPS Policy
                             Changes and Payment Rates
                             and Ambulatory Surgical
                             Center Payment System
                             Policy Changes and
                             Payment Rates (CMS-1753)
                             (Section 610 Review).
109.......................  Hospital Inpatient                 0938-AU44
                             Prospective Payment
                             Systems for Acute Care
                             Hospitals; the Long-Term
                             Care Hospital Prospective
                             Payment System; and FY
                             2022 Rates (CMS-1752)
                             (Section 610 Review).
110.......................  Medicare Advantage and             0938-AU59
                             Medicare Prescription
                             Drug Benefit Program
                             Payment Policy (CMS-4198).
------------------------------------------------------------------------


       Centers for Medicare & Medicaid Services--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
111.......................  Requirements Related to            0938-AU62
                             Surprise Billing; Part II
                             (CMS-9908).
112.......................  Requirements Related to            0938-AU63
                             Surprise Billing; Part I
                             (CMS-9909).
------------------------------------------------------------------------


[[Page 41216]]


       Centers for Medicare & Medicaid Services--Long-Term Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
113.......................  Durable Medical Equipment          0938-AT21
                             Fee Schedule, Adjustments
                             to Resume the
                             Transitional 50/50
                             Blended Rates to Provide
                             Relief in Non-Competitive
                             Bidding Areas (CMS-1687)
                             (Section 610 Review).
114.......................  Requirements for Long-Term         0938-AT36
                             Care Facilities:
                             Regulatory Provisions to
                             Promote Increased Safety
                             (CMS-3347) (Section 610
                             Review).
------------------------------------------------------------------------


       Centers for Medicare & Medicaid Services--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
115.......................  Most Favored Nation (MFN)          0938-AT91
                             Model (CMS-5528)
                             (Completion of a Section
                             610 Review).
116.......................  Medicaid; Reducing                 0938-AT99
                             Provider and Patient
                             Burden by Improving Prior
                             Authorization Processes
                             and Promoting Patients'
                             Electronic Access to
                             Health Information (CMS-
                             9123).
117.......................  CY 2021 Revisions to               0938-AU10
                             Payment Policies Under
                             the Physician Fee
                             Schedule and Other
                             Revisions to Medicare
                             Part B (CMS-1734)
                             (Completion of a Section
                             610 Review).
118.......................  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)
                             (Completion of a Section
                             610 Review).
119.......................  Promoting Electronic               0938-AU53
                             Access to Health
                             Information for Patients
                             and for Medicare- and
                             Medicaid-Participating
                             Providers and Suppliers
                             (CMS-0057).
------------------------------------------------------------------------


      Administration for Children and Families--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
120.......................  Updating Native Employment         0970-AC83
                             Works Requirements
                             (Rulemaking Resulting
                             From a Section 610
                             Review).
------------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Office of the Secretary (OS)

Proposed Rule Stage

85. Limiting the Effect of Exclusions Implemented Under the Social 
Security Act (Rulemaking Resulting From a Section 610 Review)

    Legal Authority: 5 U.S.C. 301; 31 U.S.C. 6101
    Abstract: Exclusions implemented under the Social Security Act 
prevent individuals convicted of certain crimes or individuals whose 
health care licenses have been revoked from participating in Federal 
health care programs. Instead of only being barred from participating 
in all Federal healthcare programs, certain regulatory provisions have 
resulted in these type of exclusion actions being given an overly broad 
government-wide effect, and excluded parties have been barred from 
participating in all Federal procurement and non-procurement actions. 
However, because Social Security Act exclusions are not issued under an 
agency's suspension and debarment authority, they do not stop 
individuals from participating in all Federal procurement and non-
procurement actions. For an agency to bar individuals from 
participating in all procurement and non-procurement activities, it 
must exercise its suspension and debarment authority under the Federal 
Acquisition Regulation or the Nonprocurement Common Rule. This 
rulemaking would remove the regulatory provisions at issue, in order to 
align the regulation with the intent of the Social Security Act and 
current practice.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   08/00/21  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: No.
    Agency Contact: Tiffani Redding, Program Analyst, Department of 
Health and Human Services, Office of the Secretary, 200 Independence 
Avenue SW, Washington, DC 20201, Phone: 202 205-4321, Email: 
[email protected].
    RIN: 0991-AC11

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Office for Civil Rights (OCR)

Proposed Rule Stage

86. Rulemaking on Discrimination on the Basis of Disability in Critical 
Health and Human Services Programs or Activities (Rulemaking Resulting 
From a Section 610 Review)

    Legal Authority: Sec. 504 of the Rehabilitation Act of 19
    Abstract: This proposed rule would revise regulations under, among 
other statutes, section 504 of the Rehabilitation Act of 1973 to 
address unlawful discrimination on the basis of disability in certain 
vital HHS-funded health and human services programs. Covered topics 
include non-discrimination in life-sustaining care, organ 
transplantation, suicide prevention services, child welfare programs 
and services, health care value assessment methodologies, accessible 
medical equipment, auxiliary aids and services, Crisis Standards of 
Care and other relevant health and human services activities.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   09/00/21  .......................
------------------------------------------------------------------------


[[Page 41217]]

    Regulatory Flexibility Analysis Required: No.
    Agency Contact: Carla Carter, Supervisory Civil Rights Analyst, 
Department of Health and Human Services, Office for Civil Rights, 200 
Independence Avenue SW, Washington, DC 20201, Phone: 800 368-1019, 
Email: [email protected].
    RIN: 0945-AA15

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

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

Completed Actions

87. Information Blocking and the ONC Health IT Certification Program: 
Extension of Compliance Dates and Timeframes in Response to the COVID-
19 Public Health Emergency

    Legal Authority: 42 U.S.C. 300jj-11; 42 U.S.C. 300jj-14; . . .
    Abstract: In light of COVID-19, ONC issued an interim final rule 
with comment period (IFC) that gives health IT developers and health 
care providers flexibilities to effectively respond to the serious 
public health threats posed by the spread of COVID-19. The IFC extends 
certain applicability and compliance dates and timeframes in the 21st 
Century Cures Act: Interoperability, Information Blocking, and the ONC 
Health IT Certification Program Final Rule (ONC Cures Act Final Rule), 
including applicability and compliance dates for the information 
blocking provisions, certain 2015 Edition health IT certification 
criteria, and Conditions and Maintenance of Certification requirements 
under the ONC Health IT Certification Program. The IFC also updated 
certain standards and made technical corrections and clarifications to 
the ONC Cures Act Final Rule, which was published in the Federal 
Register on May 1, 2020.
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
Interim Final Rule..................   11/04/20  85 FR 70064
Interim Final Rule Comment Period      01/04/21  .......................
 End.
Final Action--Agency Expects No        05/25/21  .......................
 Further Action.
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Michael Lipinski, Phone: 202 690-7151.
    RIN: 0955-AA02

DEPARTMENT OF HEALTH AND HUUMAN SERVICES (HHS)

Centers for Disease Control and Prevention (CDC)

Final Rule Stage

88. Control of Communicable Diseases; Foreign Quarantine

    Legal Authority: 42 U.S.C. 264; 42 U.S.C. 265
    Abstract: This rulemaking amends current regulation to enable CDC 
to require airlines to collect and provide to CDC certain data elements 
regarding passengers and crew arriving from foreign countries under 
certain circumstances.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Interim Final Rule Effective........   02/07/20  .......................
Interim Final Rule..................   02/12/20  85 FR 7874
Interim Final Rule Comment Period      03/13/20  .......................
 End.
Final Action........................   04/00/22  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Ashley C. Altenburger JD, Public Health Analyst, 
Department of Health and Human Services, Centers for Disease Control 
and Prevention, 1600 Clifton Road NE, MS: H 16-4, Atlanta, GA 30307, 
Phone: 800 232-4636, Email: [email protected].
    RIN: 0920-AA75

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Proposed Rule Stage

89. National Standards for the Licensure of Wholesale Drug Distributors 
and Third-Party Logistics Providers

    Legal Authority: Pub. L. 113-54
    Abstract: The rulemaking, once finalized, will establish standards 
for State licensing of prescription drug wholesale distributors and 
third-party logistics providers. The rulemaking will also establish a 
Federal system for wholesale drug distributor and third-party logistics 
provider licensing for use in the absence of a State licensure program.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   09/00/21  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Aaron Weisbuch, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, Building 51, Room 4261, 10903 New 
Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-9362, Email: 
[email protected].
    RIN: 0910-AH11

90. Certain Requirements Regarding Prescription Drug Marketing (203 
Amendment)

    Legal Authority: Pub. L. 113-54
    Abstract: The Food and Drug Administration (FDA) is amending the 
regulations at 21 CFR 203 to remove provisions no longer in effect and 
incorporate conforming changes following enactment of the Drug Supply 
Chain Security Act (DSCSA). In this proposed rulemaking, the Agency is 
amending the regulations to clarify provisions and avoid causing 
confusion with the new standards for wholesale distribution established 
by DSCSA.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   09/00/21  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Aaron Weisbuch, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, Building 51, Room 4261, 10903 New 
Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-9362, Email: 
[email protected].
    RIN: 0910-AH56

91. Medication Guide; Patient Medication Information

    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

[[Page 41218]]

understood format to help patients use their prescription drug products 
safely and effectively.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   10/00/21  .......................
------------------------------------------------------------------------

    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

92. Requirements for Tobacco Product Manufacturing Practice

    Legal Authority: 21 U.S.C. 371; 21 U.S.C. 387b; 21 U.S.C. 387f
    Abstract: The rule is proposing to establish tobacco product 
manufacturing practice (TPMP) requirements for manufacturers of 
finished and bulk tobacco products. This proposed rule, if finalized, 
would set forth requirements for the manufacture, pre-production design 
validation, packing, and storage of a tobacco product. This proposal 
would help prevent the manufacture and distribution of contaminated and 
otherwise nonconforming tobacco products. This proposed rule provides 
manufacturers with flexibility in the manner in which they comply with 
the proposed requirements while giving FDA the ability to enforce 
regulatory requirements, thus helping to assure the protection of 
public health.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   10/00/21  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Matthew Brenner, Senior Regulatory Counsel, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Tobacco Products, 10903 New Hampshire Avenue, Building 71, 
Room G335, Silver Spring, MD 20993, Phone: 877 287-1373, Fax: 240 276-
3904, Email: [email protected].
    RIN: 0910-AH91

93. Administrative Detention of Tobacco Products

    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 tobacco 
products encountered during inspections that are believed to be 
adulterated or misbranded until FDA has had time to consider the 
appropriate action to take and, where appropriate, to initiate a 
regulatory legal action.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/00/21  .......................
------------------------------------------------------------------------

    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].
    Lauren Belcher, 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

94. Nutrient Content Claims, Definition of Term: Healthy

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 343; 21 
U.S.C. 371
    Abstract: The proposed rule would update the definition for the 
implied nutrient content claim ``healthy'' to be consistent with 
current nutrition science and federal dietary guidelines. The proposed 
rule would revise the requirements for when the claim ``healthy'' can 
be voluntarily used in the labeling of human food products so that the 
claim reflects current science and dietary guidelines and helps 
consumers maintain healthy dietary practices.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   09/00/21  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Vincent De Jesus, Nutritionist, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Food Safety and Applied Nutrition, (HFS-830), Room 3D-031, 5100 Paint 
Branch Parkway, College Park, MD 20740, Phone: 240 402-1774, Fax: 301 
436-1191, Email: [email protected].
    RIN: 0910-AI13

95. Revocation of Uses of Partially Hydrogenated Oils in Foods

    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................................   10/00/21  .......................
------------------------------------------------------------------------

    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

96. Tobacco Product Standard for Characterizing Flavors in Cigars

    Legal Authority: 21 U.S.C. 387g
    Abstract: Evidence shows that flavored tobacco products, especially 
those that are sweet, appeal to youth and also shows that youth may be 
more likely to initiate tobacco use with such products. Characterizing 
flavors in cigars, such as strawberry, grape, orange, and cocoa, 
enhance taste and make them easier to use. Nearly one million youth in 
the United States use flavored cigars, placing these youth at risk for 
cigar-related disease and death. This proposed rule is a tobacco 
product

[[Page 41219]]

standard that would ban characterizing flavors in all cigars. We are 
taking this action to reduce the tobacco-related death associated with 
cigars.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
ANPRM...............................   03/21/18  83 FR 12294
ANPRM Comment Period End............   07/19/18  .......................
NPRM................................   08/00/21  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Samantha LohCollado, Regulatory Counsel, Department 
of Health and Human Services, Food and Drug Administration, 10903 New 
Hampshire Avenue, Building 71, Room G335, Silver Spring, MD 20993, 
Phone: 877 287-1373, Fax: 877 287-1426, Email: 
[email protected].
    RIN: 0910-AI28

97. Conduct of Analytical and Clinical Pharmacology, Bioavailability 
and Bioequivalence Studies

    Legal Authority: 21 U.S.C. 355; 21 U.S.C. 371; 21 U.S.C. 374; 42 
U.S.C. 262
    Abstract: FDA is proposing to amend 21 CFR 320, in certain parts, 
and establish a new 21 CFR 321 to clarify FDA's study conduct 
expectations for analytical and clinical pharmacology, bioavailability 
(BA) and bioequivalence (BE) studies that support human research and 
marketing applications for human drug and biological products. The 
proposed rule would specify needed basic study conduct requirements to 
enable FDA to ensure those studies are conducted appropriately and to 
verify the reliability of study data from those studies. This 
regulation would align with FDA's other good practice regulations, 
would also be consistent with current industry best practices, and 
would harmonize the regulations more closely with related international 
regulatory expectations.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   03/00/22  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Brian Joseph Folian, Regulatory Counsel, Department 
of Health and Human Services, Food and Drug Administration, 10903 New 
Hampshire Avenue, Building 51, Room 5215, Silver Spring, MD 20993-0002, 
Phone: 240 402-4089, Email: [email protected].
    RIN: 0910-AI57

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Final Rule Stage

98. Mammography Quality Standards Act

    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 will 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..........................   09/00/21  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Jean M. Olson, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, 10903 New 
Hampshire Avenue, Building 66, Room 5506, Silver Spring, MD 20993, 
Phone: 301 796-6579, Email: [email protected].
    RIN: 0910-AH04

99. Amendments to the List of Bulk Drug Substances That Can Be Used to 
Compound Drug Products in Accordance With Section 503A of the Federal 
Food, Drug, and Cosmetic Act

    Legal Authority: 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 353a; 21 
U.S.C. 355; 21 U.S.C. 371; . . .
    Abstract: FDA has issued a regulation creating a list of bulk drug 
substances (active pharmaceutical ingredients) that can be used to 
compound drug products in accordance with section 503A of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act), although they are neither the 
subject of an applicable United States Pharmacopeia (USP) or National 
Formulary (NF) monograph nor components of FDA-approved drugs (the 503A 
Bulks List). FDA has proposed to amend the 503A Bulks List by placing 
five additional bulk drug substances on the list. FDA has also 
identified 26 bulk drug substances that FDA has considered and proposed 
not to include on the 503A Bulks List. Additional substances nominated 
by the public for inclusion on this list are currently under 
consideration and will be the subject of a future rulemaking.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   09/05/19  84 FR 46688
NPRM Comment Period End.............   12/04/19  .......................
Final Rule..........................   12/00/21  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Rosilend Lawson, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, 10903 New 
Hampshire Avenue, Building 51, Room 5197, Silver Spring, MD 20993, 
Phone: 240 402-6223, Email: [email protected].
    RIN: 0910-AH81

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Long-Term Actions

100. Direct-to-Consumer Prescription Drug Advertisements: Presentation 
of the Major Statement in a Clear, Conspicuous, Neutral Manner in 
Advertisements in Television and Radio Format

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 352; 21 
U.S.C. 355; 21 U.S.C. 360b; 21 U.S.C. 371; . . .
    Abstract: The Food and Drug Administration (FDA) is amending its 
regulations concerning direct-to-consumer (DTC) advertisements of 
prescription drugs. Prescription drug advertisements presented through 
media such as TV and radio must disclose the product's major risks in 
what is sometimes called the major statement. The rule would revise the 
regulation to reflect the statutory requirement require that in DTC 
advertisements for human drugs in television or radio format, the major 
statement relating to the side effects and contraindications of an 
advertised prescription drug be presented in a clear, conspicuous, and 
neutral manner. This rule also establishes standards for determining 
whether the major statement in these advertisements is presented in the 
manner required.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   03/29/10  75 FR 15376

[[Page 41220]]

 
NPRM Comment Period End.............   06/28/10  .......................
NPRM Comment Period Reopened........   01/27/12  77 FR 4273
NPRM Comment Period End.............   02/27/12  .......................
NPRM Comment Period Reopened........   03/29/12  77 FR 16973
NPRM Comment Period Reopened End....   04/09/12  .......................
Final Rule..........................   05/00/22  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Suzanna Boyle, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, 10903 New 
Hampshire Avenue, WO 51, Room 3214, Silver Spring, MD 20993, Phone: 240 
402-4723, Email: [email protected].
    RIN: 0910-AG27

101. Sunlamp Products; Amendment to the Performance Standard

    Legal Authority: 21 U.S.C. 360ii; 21 U.S.C. 360kk; 21 U.S.C. 393; 
21 U.S.C. 371
    Abstract: FDA is updating the performance standard for sunlamp 
products and ultraviolet lamps for use in these 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..........................   05/00/22  .......................
------------------------------------------------------------------------

    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

102. General and Plastic Surgery Devices: Restricted Sale, 
Distribution, and Use of Sunlamp Products

    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.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/22/15  80 FR 79493
NPRM Comment Period End.............   03/21/16  .......................
Final Rule..........................   05/00/22  .......................
------------------------------------------------------------------------

    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

103. Nicotine Toxicity Warnings

    Legal Authority: 21 U.S.C. 301 et seq.; 21 U.S.C. 331; 21 U.S.C. 
371; 21 U.S.C. 387f; . . .
    Abstract: This rule would establish acute nicotine toxicity 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 increase consumer 
awareness and knowledge of the risks of acute toxicity due to 
accidental nicotine exposure from nicotine-containing e-liquids in 
tobacco products.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   08/00/22  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Samantha LohCollado, Regulatory Counsel, Department 
of Health and Human Services, Food and Drug Administration, 10903 New 
Hampshire Avenue, Building 71, Room G335, Silver Spring, MD 20993, 
Phone: 877 287-1373, Fax: 877 287-1426, Email: 
[email protected].
    RIN: 0910-AH24

104. Requirements for Additional Traceability Records for Certain Foods

    Legal Authority: sec. 204 of the FDA Food Safety Modernization Act 
(FSMA) (Pub. L. 111-353) (21 U.S.C. 2223(d)); sec. 701(a) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(a)); sec. 361 of 
the Public Health Service Act (42 U.S.C. 264)
    Abstract: This rule will establish additional recordkeeping 
requirements for facilities that manufacture, process, pack, or hold 
foods that are designated as high-risk foods.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   09/23/20  85 FR 59984
NPRM Comment Period End.............   01/21/21  .......................
NPRM Comment Period Extended........   12/18/20  85 FR 82393
NPRM Comment Period End.............   02/22/21  .......................
Final Rule..........................   11/00/22  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Katherine Vierk, Director, Division of Public 
Health Informatics and Analytics, Department of Health and Human 
Services, Food and Drug Administration, 5001 Campus Drive, CPK1, Room 
2B014, HFS-005, College Park, MD 20740, Phone: 240 402-2122, Email: 
[email protected].
    RIN: 0910-AI44


[[Page 41221]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Completed Actions

105. 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

    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. 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.
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
Withdrawn From the Unified Agenda--    06/01/21  .......................
 This RIN is Being Pursued via
 Formal Rulemaking Process.
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Terri Wenger, Phone: 240 402-2371, Email: 
[email protected].
    RIN: 0910-AI40

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Proposed Rule Stage

106. Contract Year 2023 Policy and Technical Changes to the Medicare 
Advantage and Medicare Prescription Drug Benefit Programs (CMS-4192)

    Legal Authority: 42 U.S.C. 1395w
    Abstract: This proposed rule would strengthen and improve the 
Medicare Advantage (MA or Part C) and Medicare Prescription Drug 
Benefit (Part D) programs, codify existing sub regulatory guidance, and 
implement any statutory changes (if necessary) for contract year 2023.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   09/00/21  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Christian Bauer, Director, Division of Part D 
Policy, Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, MS: C1-26-16, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-6043, Email: 
[email protected]
    RIN: 0938-AU30

107. CY 2022 Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Medicare Part B (CMS-1751) (Section 610 
Review)

    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, 2022. Additionally, this rule 
proposes updates to the Quality Payment Program.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/00/21  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Gift Tee, Director, Division of Physician Services, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, 7500 Security Boulevard, MS: 
C1-09-07, Baltimore, MD 21244, Phone: 410 786-9316, Email: 
[email protected].
    RIN: 0938-AU42

108. CY 2022 Hospital Outpatient PPS Policy Changes and Payment Rates 
and Ambulatory Surgical Center Payment System Policy Changes and 
Payment Rates (CMS-1753) (Section 610 Review)

    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................................   06/00/21  .......................
------------------------------------------------------------------------

    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-AU43

109. Hospital Inpatient Prospective Payment Systems for Acute Care 
Hospitals; the Long-Term Care Hospital Prospective Payment System; and 
FY 2022 Rates (CMS-1752) (Section 610 Review)

    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 implements changes 
arising from our continuing experience with these systems. In addition, 
the rule establishes new requirements or revises existing requirements 
for quality reporting by specific Medicare providers.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   05/10/21  86 FR 25070
NPRM Comment Period End.............   06/28/21  .......................
Final Action........................   10/00/21  .......................
------------------------------------------------------------------------

    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: C4-03-18, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-6504, Email: 
[email protected].

[[Page 41222]]

    RIN: 0938-AU44

110.  Medicare Advantage and Medicare Prescription Drug Benefit 
Program Payment Policy (CMS-4198)

    Legal Authority: 42 U.S.C. 1395w
    Abstract: This proposed rule would codify long-established Medicare 
Advantage and Part D payment policies that are outside the scope of the 
annual Advance Notice/Rate Announcement.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   01/00/22  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Jennifer Shapiro, Director, Medicare Plan Payment 
Group, Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, MS: C1-13-18, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-7407, Email: 
[email protected].
    RIN: 0938-AU59

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Final Rule Stage

111.  Requirements Related to Surprise Billing; Part II (CMS-
9908)

    Legal Authority: Pub. L. 116-260, Division BB, title I and title II
    Abstract: This interim final rule with comment would implement 
additional protections against surprise medical bills under the No 
Surprises Act, including provisions related to the independent dispute 
resolution processes.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Interim Final Rule..................   08/00/21  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Deborah Bryant, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Consumer Information and Insurance 
Oversight, MS: W08-134, 7500 Security Boulevard, Baltimore, MD 21244, 
Phone: 301 493-4293, Email: [email protected].
    RIN: 0938-AU62

112.  Requirements Related to Surprise Billing; Part I (CMS-
9909)

    Legal Authority: Pub. L. 116-260, Division BB, title I and title II
    Abstract: This interim final rule with comment would implement 
certain protections against surprise medical bills under the No 
Surprises Act.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Interim Final Rule With Comment.....   07/00/21  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Lindsey Murtagh, Director, Market-Wide Regulation 
Division, Department of Health and Human Services, Centers for Medicare 
& Medicaid Services, Center for Consumer Information and Insurance 
Oversight, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 301 
492-4106, Email: [email protected].
    RIN: 0938-AU63

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Long-Term Actions

113. Durable Medical Equipment Fee Schedule, Adjustments To Resume the 
Transitional 50/50 Blended Rates To Provide Relief in Non-Competitive 
Bidding Areas (CMS-1687) (Section 610 Review)

    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.
Continuation Notice.................   04/26/21  86 FR 21949
Final Action to be Merged With 0938-   05/00/22  .......................
 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

114. Requirements for Long-Term Care Facilities: Regulatory Provisions 
To Promote Increased Safety (CMS-3347) (Section 610 Review)

    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 in order to support the provision of safe care and preserve 
access to 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: Diane Corning, 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-
8486, Email: [email protected].
    RIN: 0938-AT36


[[Page 41223]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Completed Actions

115. Most Favored Nation (MFN) Model (CMS-5528) (Completion of a 
Section 610 Review)

    Legal Authority: Social Security Act, sec. 1115A
    Abstract: This interim final rule with comment period (IFC) 
implements the Most Favored Nation (MFN) Model, a new Medicare payment 
model under section 1115A of the Social Security Act (the Act). The MFN 
Model tests whether more closely aligning payment for Medicare Part B 
drugs and biologicals (hereafter, referred to as drugs) with 
international prices and removing incentives to use higher-cost drugs 
can control unsustainable growth in Medicare Part B spending without 
adversely affecting quality of care for beneficiaries.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
ANPRM...............................   10/30/18  83 FR 54546
ANPRM Comment Period End............   12/31/18  .......................
Interim Final Rule..................   11/27/20  85 FR 76180
Interim Final Rule Effective........   11/27/20  .......................
Interim Final Rule Comment Period      01/26/21  .......................
 End.
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Laura Strawbridge, Director, Division of Ambulatory 
Payment Models, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Center for Medicare and Medicaid 
Innovation, 7500 Security Boulevard, MS: WB-06-05, Baltimore, MD 21244, 
Phone: 410 786-7400, Email: [email protected].
    RIN: 0938-AT91

116. Medicaid; Reducing Provider and Patient Burden by Improving Prior 
Authorization Processes and Promoting Patients' Electronic Access to 
Health Information (CMS-9123)

    Legal Authority: 42 U.S.C. 1302
    Abstract: This final rule places new requirements on state Medicaid 
and CHIP fee-for-service (FFS) programs, Medicaid managed care plans, 
CHIP managed care entities, and Qualified Health Plan (QHP) issuers on 
the Federally-facilitated Exchanges (FFEs) to improve the electronic 
exchange of health care data, and streamline processes related to prior 
authorization, while continuing CMS' drive toward interoperability, and 
reducing burden in the health care market. In addition, on behalf of 
the Department of Health and Human Service (HHS), the Office of the 
National Coordinator for Health Information Technology (ONC) is 
adopting certain specified implementation guides (IGs) needed to 
support the Application Programming Interface (API) policies included 
in this rule. Each of these elements plays a key role in reducing 
overall payer and provider burden and improving patient access to 
health information.
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/18/20  85 FR 82586
Withdrawn...........................   03/17/21  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Alexandra Mugge, Phone: 410 786-4457, Email: 
[email protected].
    RIN: 0938-AT99

117. CY 2021 Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Medicare Part B (CMS-1734) (Completion 
of a Section 610 Review)

    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, 2021. Additionally, this rule updates 
the Quality Payment Program.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   08/17/20  85 FR 50074
NPRM Comment Period End.............   10/05/20  .......................
Final Action........................   12/28/20  85 FR 84472
Final Action Effective..............   01/01/21  .......................
------------------------------------------------------------------------

    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

118. CY 2021 Hospital Outpatient PPS Policy Changes and Payment Rates 
and Ambulatory Surgical Center Payment System Policy Changes and 
Payment Rates (CMS-1736) (Completion of a Section 610 Review)

    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 
implements 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................................   08/12/20  85 FR 48772
NPRM Comment Period End.............   10/05/20  .......................
Final Action........................   12/29/20  85 FR 85866
Final Action Effective..............   01/01/21  .......................
------------------------------------------------------------------------

    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-AU12

119. Promoting Electronic Access to Health Information for Patients and 
for Medicare-and Medicaid-Participating Providers and Suppliers (CMS-
0057)

    Legal Authority: 42 U.S.C. 1395hh
    Abstract: The proposed rule would also revise requirements that 
select Medicare- and Medicaid-participating providers and suppliers 
must meet for continued participation in the Medicare and Medicaid 
programs by requiring increased patient electronic access to their 
health care information. This proposed rule would also improve the 
electronic exchange of health information among the identified 
providers and suppliers, and finally, this proposed rule would improve 
patient safety by establishing patient identity management requirements 
for the identified providers and suppliers.
    Completed:

[[Page 41224]]



------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
Withdrawn...........................   03/17/21  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Alexandra Mugge, Phone: 410 786-4457, Email: 
[email protected]
    RIN: 0938-AU53

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Administration for Children and Families (ACF)

Proposed Rule Stage

120. Updating Native Employment Works Requirements (Rulemaking 
Resulting From a Section 610 Review)

    Legal Authority: 42 U.S.C. 612
    Abstract: The rule would update NEW regulations at 45 CFR part 287 
to avoid inconsistencies and reflect the changes that have been made to 
the NEW statute and Administration for Children and Families (ACF) 
grant policy and procedures since the current regulation's publication 
on February 18, 2000. In particular, the regulations need to address 
changes made in section 404(e) of the Social Security Act as amended in 
1999, Uniform Administrative Requirements, Cost Principles, and Audit 
Requirement for HHS Awards (45 CFR part 75)--Part 75 Uniform 
Administrative Requirements, Cost Principles, and Audit Requirements 
for HHS Awards, Public Law 106-107, the ``Federal Financial Assistance 
Management, Improvement Act of 1999'' (Nov. 20, 1999), and various 
minor technical changes. While some of these changes have been 
addressed and communicated to the public and grantees via program 
instructions and information memoranda, the regulations themselves are 
now inconsistent with current law and policy.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/00/21  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: No.
    Agency Contact: Tonya Ann Davis, Program Specialist, Department of 
Health and Human Services, Administration for Children and Families, 
330 C Street SW, Room 3020, Washington, DC 20201, Phone: 202 401-4851, 
Email: [email protected].
    RIN: 0970-AC83

[FR Doc. 2021-14870 Filed 7-29-21; 8:45 am]
BILLING CODE 4150-03-P

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