83 FR 1860 - Regulatory Agenda
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary Federal Register Volume 83, Issue 9 (January 12, 2018)
Office of the Secretary
Federal Register Volume 83, Issue 9 (January 12, 2018)
| Page Range | 1860-1870 | |
| FR Document | 2017-28220 |
[Federal Register Volume 83, Number 9 (Friday, January 12, 2018)] [Unknown Section] [Pages 1860-1870] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-28220] [[Page 1859]] Vol. 83 Friday, No. 9 January 12, 2018 Part VII Department of Health and Human Services ----------------------------------------------------------------------- Semiannual Regulatory Agenda Federal Register / Vol. 83 , No. 9 / Friday, January 12, 2018 / Unified Agenda [[Page 1860]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary 21 CFR Ch. I 25 CFR Ch. V 42 CFR Chs. I-V 45 CFR Subtitle A; Subtitle B, Chs. II, III, and XIII Regulatory Agenda AGENCY: Office of the Secretary, HHS. ACTION: Semiannual regulatory agenda. ----------------------------------------------------------------------- SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order (E.O.) 12866 require the semiannual issuance of an inventory of rulemaking actions under development throughout the Department, offering for public review summarized information about forthcoming regulatory actions. FOR FURTHER INFORMATION CONTACT: Ann C. Agnew, Executive Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201; (202) 690-5627. SUPPLEMENTARY INFORMATION: The Department of Health and Human Services (HHS) is the Federal government's lead agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. HHS enhances the health and well-being of Americans by promoting effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services. This Agenda presents the regulatory activities that the Department expects to undertake in the foreseeable future to advance this mission. HHS has an agency-wide effort to support the Agenda's purpose of encouraging more effective public participation in the regulatory process. For example, to encourage public participation, we regularly update our regulatory web page (http://www.HHS.gov/regulations) which includes links to HHS rules currently open for public comment, and also provides a ``regulations toolkit'' with background information on regulations, the commenting process, how public comments influence the development of a rule, and how the public can provide effective comments. HHS also actively encourages meaningful public participation in its retrospective review of regulations through a comment form on the HHS retrospective review web page (http://www.HHS.gov/RetrospectiveReview). The rulemaking abstracts included in this paper issue of the Federal Register cover, as required by the Regulatory Flexibility Act of 1980, those prospective HHS rulemakings likely to have a significant economic impact on a substantial number of small entities. The Department's complete Regulatory Agenda is accessible online at http://www.RegInfo.gov. Ann C. Agnew, Executive Secretary to the Department. Office for Civil Rights--Proposed Rule Stage ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 227....................... HIPAA Privacy Rule: 0945-AA08 Changing Requirement to Obtain Acknowledgment of Receipt of the Notice of Privacy Practices. ------------------------------------------------------------------------ Office of the National Coordinator for Health Information Technology-- Proposed Rule Stage ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 228....................... Health Information 0955-AA01 Technology: Interoperability and Certification Enhancements (Reg Plan Seq No. 26). ------------------------------------------------------------------------ References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register. Food and Drug Administration--Proposed Rule Stage ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 229....................... Sunscreen Drug Products 0910-AF43 For Over-The-Counter- Human Use; Tentative Final Monograph. 230....................... Laser Products; Amendment 0910-AF87 to Performance Standard. 231....................... Mammography Quality 0910-AH04 Standards Act; Regulatory Amendments (Reg Plan Seq No. 29). 232....................... Medication Guides; Patient 0910-AH68 Medication Information (Reg Plan Seq No. 32). ------------------------------------------------------------------------ References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register. Food and Drug Administration--Final Rule Stage ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 233....................... Postmarketing Safety 0910-AA97 Reporting Requirements for Human Drug and Biological Products. 234....................... Label Requirement for Food 0910-AF61 That Has Been Refused Admission Into the United States. 235....................... Human Subject Protection; 0910-AG48 Acceptance of Data From Clinical Investigations for Medical Devices. 236....................... Food Labeling; Gluten-Free 0910-AH00 Labeling of Fermented, Hydrolyzed, or Distilled Foods. 237....................... Safety and Effectiveness 0910-AH40 of Healthcare Antiseptics; Topical Antimicrobial Drug Products for Over-the- Counter Human Use. ------------------------------------------------------------------------ [[Page 1861]] Food and Drug Administration--Long-Term Actions ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 238....................... Over-the-Counter (OTC) 0910-AF31 Drug Review--Cough/Cold (Antihistamine) Products. 239....................... Over-the-Counter (OTC) 0910-AF35 Drug Review--External Analgesic Products. 240....................... Over-the-Counter (OTC) 0910-AF36 Drug Review--Internal Analgesic Products. 241....................... Over-the-Counter (OTC) 0910-AF38 Drug Review--Laxative Drug Products. 242....................... Over-the-Counter (OTC) 0910-AF45 Drug Review--Weight Control Products. 243....................... Over-the-Counter (OTC) 0910-AG12 Drug Review--Pediatric Dosing for Cough/Cold Products. 244....................... Electronic Distribution of 0910-AG18 Prescribing Information for Human Prescription Drugs Including Biological Products. 245....................... Investigational New Drug 0910-AH07 Applications Requirements for Conventional Foods, Dietary Supplements, and Cosmetics. 246....................... General and Plastic 0910-AH14 Surgery Devices: Sunlamp Products. 247....................... Combinations of 0910-AH16 Bronchodilators With Expectorants; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the- Counter Human Use. ------------------------------------------------------------------------ Food and Drug Administration--Completed Actions ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 248....................... Current Good Manufacturing 0910-AB88 Practice in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements. 249....................... Updated Standards for 0910-AG09 Labeling of Pet Food. 250....................... Supplemental Applications 0910-AG94 Proposing Labeling Changes for Approved Drugs and Biological Products. 251....................... Radiology Devices; 0910-AH03 Designation of Special Controls for the Computed Tomography X-Ray System. ------------------------------------------------------------------------ Centers for Medicare & Medicaid Services--Proposed Rule Stage ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 252....................... CY 2019 Notice of Benefit 0938-AT12 and Payment Parameters (CMS-9930-P) (Section 610 Review). 253....................... Regulatory Provisions to 0938-AT23 Promote Program Efficiency, Transparency, and Burden Reduction (CMS- 3346-P) (Reg Plan Seq No. 37). 254....................... FY 2019 Prospective 0938-AT24 Payment System and Consolidated Billing for Skilled Nursing Facilities (SNFs) (CMS- 1696-P). 255....................... Hospital Inpatient 0938-AT27 Prospective Payment System for Acute Care Hospitals and the Long- Term Care Hospital Prospective Payment System and FY 2019 Rates (CMS-1694-P) (Section 610 Review) (Reg Plan Seq No. 38). 256....................... CY 2019 Hospital 0938-AT30 Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1695- P) (Section 610 Review). 257....................... CY 2019 Revisions to 0938-AT31 Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1693-P) (Section 610 Review). ------------------------------------------------------------------------ References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register. Centers for Medicare & Medicaid Services--Final Rule Stage ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 258....................... Durable Medical Equipment 0938-AT21 Fee Schedule, Adjustments to Resume the Transitional 50/50 Blended Rates to Provide Relief in Non-Competitive Bidding Areas (CMS-1687- IFC) (Section 610 Review). ------------------------------------------------------------------------ Centers for Medicare & Medicaid Services--Long-Term Actions ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 259....................... Hospital and Critical 0938-AS21 Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care (CMS-3295-F) (Rulemaking Resulting From a Section 610 Review). ------------------------------------------------------------------------ [[Page 1862]] Centers for Medicare & Medicaid Services--Completed Actions ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 260....................... Hospital Inpatient 0938-AS98 Prospective Payment Systems for Acute Care Hospitals and the Long- Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2018 Rates (CMS-1677-F) (Completion of a Section 610 Review). 261....................... CY 2018 Revisions to 0938-AT02 Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B; Medicare Shared Savings Program Requirements; Medicare Diabetes Prevention Program (CMS- 1676-F) (Completion of a Section 610 Review). 262....................... CY 2018 Hospital 0938-AT03 Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1678- FC) (Completion of a Section 610 Review). ------------------------------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Office for Civil Rights (OCR) Proposed Rule Stage 227.HIPAA Privacy Rule: Changing Requirement To Obtain Acknowledgment of Receipt of the Notice of Privacy Practices E.O. 13771 Designation: Deregulatory. Legal Authority: Health Insurance Portability and Accountability (HIPAA) Act of 1996, Pub. L. 104-191 Abstract: The propsed rule would change the requirement that health care providers make a good faith effort to obtain from individuals a written acknowledgment of receipt of the provider's notice of privacy practices, and if not obtained, to document its good faith efforts and the reason the acknowledgment was not obtained. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 09/00/18 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Andra Wicks, Health Information Privacy Specialist, Department of Health and Human Services, Office for Civil Rights, 200 Independence Avenue SW, Washington, DC 20201, Phone: 202 774-3081, TDD Phone: 800 537-7697, Email: [email protected]. RIN: 0945-AA08 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Office of the National Coordinator for Health Information Technology (ONC) Proposed Rule Stage 228. Health Information Technology: Interoperability and Certification Enhancements Regulatory Plan: This entry is Seq. No. 26 in part II of this issue of the Federal Register. RIN: 0955-AA01 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Proposed Rule Stage 229. Sunscreen Drug Products for Over-the-Counter-Human Use; Tentative Final Monograph E.O. 13771 Designation: Deregulatory. Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371 Abstract: The proposed rule will address the general recognition of safety and effectiveness (GRASE) status of the 16 sunscreen monograph ingredients and describe data gaps that FDA believes need to be filled in order for FDA to permit the continued marketing of these ingredients without submitting new drug applications for premarket review. Consistent with the Sunscreen Innovation Act, we also expect to address sunscreen dosage forms and maximum SPF values. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ ANPRM (Sunscreen and Insect 02/22/07 72 FR 7941 Repellent). ANPRM Comment Period End............ 05/23/07 ....................... NPRM (UVA/UVB)...................... 08/27/07 72 FR 49070 NPRM Comment Period End............. 12/26/07 ....................... Final Action (UVA/UVB).............. 06/17/11 76 FR 35620 NPRM (Effectiveness)................ 06/17/11 76 FR 35672 NPRM (Effectiveness) Comment Period 09/15/11 ....................... End. ANPRM (Dosage Forms)................ 06/17/11 76 FR 35669 ANPRM (Dosage Forms) Comment Period 09/15/11 ....................... End. NPRM................................ 08/00/18 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Sharon Coleman, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 6212, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-2490, Fax: 301 796- 9899, Email: [email protected]. RIN: 0910-AF43 230. Laser Products; Amendment to Performance Standard E.O. 13771 Designation: Regulatory. Legal Authority: 21 U.S.C. 360hh to 360ss; 21 U.S.C. 371; 21 U.S.C. 393 Abstract: FDA is proposing to amend the 2013 proposed rule for the performance standard for laser products, which will amend the performance standard for laser products to achieve closer harmonization between the current standard and the recently amended International Electrotechnical Commission (IEC) standard for laser products and medical laser products. The amendment is intended to update FDA's performance standard to reflect advancements in technology. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 06/24/13 78 FR 37723 [[Page 1863]] NPRM Comment Period End............. 09/23/13 ....................... NPRM (Reproposal)................... 10/00/18 ....................... ----------------------------------- Final Action........................ To Be Determined ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Erica Blake-Payne, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, WO 66, Room 5522, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3999, Fax: 301 847- 8145, Email: [email protected]. RIN: 0910-AF87 231. Mammography Quality Standards Act; Regulatory Amendments Regulatory Plan: This entry is Seq. No. 29 in part II of this issue of the Federal Register. RIN: 0910-AH04 232. Medication Guides; Patient Medication Information Regulatory Plan: This entry is Seq. No. 32 in part II of this issue of the Federal Register. RIN: 0910-AH68 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Final Rule Stage 233. Postmarketing Safety Reporting Requirements for Human Drug and Biological Products E.O. 13771 Designation: Regulatory. Legal Authority: 42 U.S.C. 216; 42 U.S.C. 241; 42 U.S.C. 242a; 42 U.S.C. 262 and 263; 42 U.S.C. 263a to 263n; 42 U.S.C. 264; 42 U.S.C. 300aa; 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 360b to 360j; 21 U.S.C. 361a; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 375; 21 U.S.C. 379e; 21 U.S.C. 381 Abstract: The final rule would amend the postmarketing safety reporting regulations for human drugs and biological products including blood and blood products in order to better align FDA requirements with guidelines of the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH); and to update reporting requirements in light of current pharmacovigilance practice and safety information sources and enhance the quality of safety reports received by FDA . These revisions were proposed as part of a single rulemaking (68 FR 12406) to clarify and revise both premarketing and postmarketing safety reporting requirements for human drug and biological products. Premarketing safety reporting requirements were finalized in a separate final rule published on September 29, 2010 (75 FR 59961). This final rule applies to postmarketing safety reporting requirements. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 03/14/03 68 FR 12406 NPRM Comment Period Extended........ 06/18/03 ....................... NPRM Comment Period End............. 07/14/03 ....................... NPRM Comment Period Extension End... 10/14/03 ....................... Final Rule.......................... 10/00/18 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Jane E. Baluss, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6278, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3469, Fax: 301 847-8440, Email: [email protected]. RIN: 0910-AA97 234. Label Requirement for Food That Has Been Refused Admission Into the United States E.O. 13771 Designation: Fully or Partially Exempt. Legal Authority: 15 U.S.C. 1453 to 1455; 21 U.S.C. 321; 21 U.S.C. 342 and 343; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381; 42 U.S.C. 216; 42 U.S.C. 264 Abstract: The final rule will require owners or consignees to label imported food that is refused entry into the United States. The label will read, ``UNITED STATES: REFUSED ENTRY.'' The proposal describes the label's characteristics (such as its size) and processes for verifying that the label has been affixed properly. We are taking this action to prevent the introduction of unsafe food into the United States, to facilitate the examination of imported food, and to implement section 308 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188). Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 09/18/08 73 FR 54106 NPRM Comment Period End............. 12/02/08 ....................... Final Action........................ 07/00/18 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Anthony C. Taube, Branch Chief, Department of Health and Human Services, Food and Drug Administration, Office of Regulatory Affairs, Office of Regional Operations, 12420 Parklawn Drive, ELEM-4051, Rockville, MD 20857, Phone: 240 420-4565, Fax: 703 261-8625, Email: [email protected]. RIN: 0910-AF61 235. Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices E.O. 13771 Designation: Deregulatory. Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 360; 21 U.S.C. 360c; 21 U.S.C. 360e; 21 U.S.C. 360i; 21 U.S.C. 360j; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381; 21 U.S.C. 393; 42 U.S.C. 264; 42 U.S.C. 271; . . . Abstract: This rule updates FDA's requirements for accepting clinical data used to bring new medical devices to market as part of fulfilling FDA's mission. While helping to ensure the quality and integrity of clinical trial data and the protection of study participants, this rule should generally reduce burden on industry by avoiding the need for on-site inspections. This rule parallels the drug regulation, which should further reduce burden by having a harmonized approach. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 02/25/13 78 FR 12664 NPRM Comment Period End............. 05/28/13 ....................... Final Action........................ 03/00/18 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Soma Kalb, Biomedical Engineer, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Heath, Building 66, Room 1534, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-6359, Email: [email protected]. RIN: 0910-AG48 236. Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods E.O. 13771 Designation: Regulatory. [[Page 1864]] Legal Authority: Sec. 206 of the Food Allergen Labeling and Consumer Protection Act; 21 U.S.C. 343(a)(1); 21 U.S.C. 321(n); 21 U.S.C. 371(a) Abstract: FDA was required by statute to establish criteria for the voluntary labeling of food as ``gluten-free'' to assist consumers with celiac disease who must avoid gluten in their diet. In 2013, FDA issued a final rule on gluten-free'' labeling that established criteria for when food may be labeled ``gluten-free.'' The final rule included methods that FDA would use for testing for the presence of gluten, which are appropriate for many food types, but not for fermented and hydrolyzed foods. FDA then issued a proposed rule entitled ``Gluten- Free Labeling of Fermented or Hydrolyzed Foods'' to propose requirements for maintenance of certain records that provide alternative means for the agency to verify that manufacturers of fermented and hydrolyzed foods have complied with the federal criteria for foods voluntarily labeled ``gluten-free.'' Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 11/18/15 80 FR 71990 NPRM Comment Period Reopened........ 01/22/16 81 FR 3751 NPRM Comment Period End............. 02/16/16 ....................... NPRM Comment Period Reopened........ 02/22/16 81 FR 8869 NPRM Comment Period Reopened End.... 04/25/16 ....................... Final Rule.......................... 10/00/18 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Carol D'Lima, Staff Fellow, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Room 4D022, HFS 820, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-2371, Fax: 301 436- 2636, Email: [email protected]. RIN: 0910-AH00 237. Safety and Effectiveness of Healthcare Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use E.O. 13771 Designation: Regulatory. Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360b-360f; 21 U.S.C. 371; 21 U.S.C. 374 to 375; 21 U.S.C. 379e; 21 U.S.C. 360j; 42 U.S.C. 241; 42 U.S.C. 262; 21 U.S.Cl. 360hh-360ss; . . . Abstract: This rulemaking addresses whether FDA considers certain active ingredients in over the counter (OTC) healthcare antiseptic hand wash and healthcare antiseptic products to be generally recognized as safe and effective. If FDA determines that the ingredient is not generally recognized as safe and effective, a manufacturer will not be able to market the product unless it submits and receives approval of a new drug application. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 05/01/15 80 FR 25166 NPRM Comment Period End............. 10/28/15 ....................... Final Action........................ 01/00/18 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Michelle Jackson, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-0923, Email: [email protected]. RIN: 0910-AH40 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Long-Term Actions 238. Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products E.O. 13771 Designation: Deregulatory. Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371 Abstract: FDA will be proposing a rule to add the common cold indication to certain over-the-counter (OTC) antihistamine active ingredients. This proposed rule is the result of collaboration under the U.S.-Canada Regulatory Cooperation Council (RCC) as part of efforts to reduce unnecessary duplication and differences. This pilot exercise will help determine the feasibility of developing an ongoing mechanism for alignment in review and adoption of OTC drug monograph elements. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ Reopening of Administrative Record.. 08/25/00 65 FR 51780 Comment Period End.................. 11/24/00 ....................... NPRM (Amendment) (Common Cold)...... 11/00/18 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Janice Adams-King, Regulatory Health Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3713, Fax: 301 796-9899, Email: [email protected]. RIN: 0910-AF31 239. Over-the-Counter (OTC) Drug Review--External Analgesic Products E.O. 13771 Designation: Regulatory. Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The final action addresses the 2003 proposed rule on patches, plasters, and poultices. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ To Be Determined ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Janice Adams-King, Regulatory Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3713, Email: [email protected]. RIN: 0910-AF35 240. Over-the-Counter (OTC) Drug Review--Internal Analgesic Products E.O. 13771 Designation: Regulatory. Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 379e Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective, and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC [[Page 1865]] drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The action addresses acetaminophen safety. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM (Amendment) (Required Warnings 12/26/06 71 FR 77314 and Other Labeling). NPRM Comment Period End............. 05/25/07 ....................... Final Action (Required Warnings and 04/29/09 74 FR 19385 Other Labeling). Final Action (Correction)........... 06/30/09 74 FR 31177 Final Action (Technical Amendment).. 11/25/09 74 FR 61512 ----------------------------------- NPRM (Amendment) (Acetaminophen).... To Be Determined ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Janice Adams-King, Regulatory Health Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3713, Fax: 301-796-9899, Email: [email protected]. RIN: 0910-AF36 241. Over-the-Counter (OTC) Drug Review--Laxative Drug Products E.O. 13771 Designation: Regulatory. Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective, and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The final rule listed will address the professional labeling for sodium phosphate drug products. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ Final Action (Granular Psyllium).... 03/29/07 72 FR 14669 NPRM (Professional Labeling--Sodium 02/11/11 76 FR 7743 Phosphate). NPRM Comment Period End............. 03/14/11 ----------------------------------- Final Rule.......................... To Be Determined ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Janice Adams-King, Regulatory Health Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301- 796-3713, Fax: 301 796-9899, Email: [email protected]. RIN: 0910-AF38 242. Over-the-Counter (OTC) Drug Review--Weight Control Products E.O. 13771 Designation: Regulatory. Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first final rule finalizes the 2005 proposed rule for weight control products containing phenylpropanolamine. The second final rule will finalize the proposed rule for weight control products containing benzocaine. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM (Phenylpropanolamine).......... 12/22/05 70 FR 75988 NPRM Comment Period End............. 03/22/06 ....................... NPRM (Benzocaine)................... 03/09/11 76 FR 12916 NPRM Comment Period End............. 06/07/11 ----------------------------------- Final Action (Phenylpropanolamine).. To Be Determined ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Janice Adams-King, Regulatory Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3713, Email: [email protected]. RIN: 0910-AF45 243. Over-the-Counter (OTC) Drug Review--Pediatric Dosing for Cough/ Cold Products E.O. 13771 Designation: Regulatory. Legal Authority: 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective, and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action will propose changes to the final monograph to address safety and efficacy issues associated with pediatric cough and cold products. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ To Be Determined ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Janice Adams-King, Regulatory Health Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3713, Fax: 301 796-9899, Email: [email protected]. RIN: 0910-AG12 244. Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products E.O. 13771 Designation: Other. Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 353; 21 U.S.C. 355; 21 U.S.C. 358; 21 U.S.C. 360; 21 U.S.C. 360b; 21 U.S.C. 360gg to 360ss; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 379e; 42 U.S.C. 216; 42 U.S.C. 241; 42 U.S.C. 262; 42 U.S.C. 264 Abstract: This rule would require electronic package inserts for human drug and biological prescription products with limited exceptions, in lieu of paper, which is currently used. These inserts contain prescribing information intended for healthcare practitioners. This would ensure that the information accompanying the product is the most up-to-date information regarding important safety and efficacy issues about these products. [[Page 1866]] Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 12/18/14 79 FR 75506 NPRM Comment Period Extended........ 03/09/15 80 FR 12364 NPRM Comment Period End............. 03/18/15 ....................... NPRM Comment Period Extended End.... 05/18/15 ....................... ----------------------------------- Final Rule.......................... To Be Determined ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Emily Gebbia, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6226, Silver Spring, MD 20993, Phone: 240 402-0980, Email: [email protected]. Michael Bernstein, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6240, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3478, Fax: 301 847-8440, Email: [email protected]. RIN: 0910-AG18 245. Investigational New Drug Applications Requirements for Conventional Foods, Dietary Supplements, and Cosmetics E.O. 13771 Designation: Deregulatory. Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 353; 21 U.S.C. 355(i); 21 U.S.C. 371(a); 42 U.S.C. 262(a) Abstract: Researchers conducting studies of FDA-regulated products involving human subjects must, in some circumstances, meet requirements set out in FDA's Investigational New Drug (IND) Application regulations. The proposed rule would exempt sponsors of certain studies that evaluate a drug use of a product that is lawfully marketed as a conventional food, dietary supplement, or cosmetic from being required to submit an IND application under circumstances when the study does not present a potential for significant risk to the health, safety, or welfare of the human subjects. The proposed rule is intended to broaden the regulatory criteria for studies exempt from IND requirements and provide clarity and consistency regarding when studies evaluating drug uses of products that are lawfully marketed as conventional foods, dietary supplements, or cosmetics are subject to IND review. The proposed rule would also streamline some IND application requirements for certain studies that do not qualify for the new exemption. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ To Be Determined ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Ebla Ali Ibrahim, Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Building 51, Room 6302, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3691, Email: [email protected]. RIN: 0910-AH07 246. General and Plastic Surgery Devices: Sunlamp Products E.O. 13771 Designation: Regulatory. Legal Authority: 21 U.S.C. 360j(e) Abstract: This rule would apply device restrictions to sunlamp products. 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 sunlamp product use at young ages, as well as frequently using sunlamp products, both increase 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. Sunlamp products incorporate ultraviolet (UV) lamps and include devices such as UV tanning beds and booths. People who use sunlamp products are at increased risk of developing skin cancer and other illnesses, and sustaining injuries. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 12/22/15 80 FR 79493 NPRM Comment Period End............. 03/21/16 ----------------------------------- Final Rule.......................... To Be Determined ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Ian Ostermiller, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Building 66, Room 5515, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-5678, Email: [email protected]. RIN: 0910-AH14 247. Combinations of Bronchodilators With Expectorants; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the- Counter Human Use E.O. 13771 Designation: Regulatory. Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective, and not misbranded. After a final monograph (i.e. final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. These actions address cough/cold drug products containing an oral bronchodilator (ephedrine and its salts) in combination with any expectorant. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM (Amendment).................... 07/13/05 70 FR 40232 NPRM Comment Period End............. 11/10/05 ....................... Final Action (Technical Amendment).. 03/19/07 72 FR 12730 ----------------------------------- Final Rule.......................... To Be Determined ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Janice Adams-King, Regulatory Health Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3713, Fax: 301 796-9899, Email: [email protected]. RIN: 0910-AH16 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Completed Actions 248. Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements E.O. 13771 Designation: Deregulatory. Legal Authority: 21 U.S.C. 321; 21 U.S.C. 342; 21 U.S.C. 343; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381; 21 U.S.C. 393; 42 U.S.C. 264 [[Page 1867]] Abstract: The Food and Drug Administration published a final rule in the Federal Register of June 25, 2007 (72 FR 34752), on current good manufacturing practice (CGMP) regulations for dietary supplements. FDA also published an Interim Final Rule in the same Federal Register (72 FR 34959) that provided a procedure for requesting an exemption from the final rule requirement that the manufacturer conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient. This IFR allows for submission to, and review by, FDA of an alternative to the required 100 percent identity testing of components that are dietary ingredients, provided certain conditions are met. This IFR also establishes a requirement for retention of records relating to the FDA's response to an exemption request. Completed: ------------------------------------------------------------------------ Reason Date FR Cite ------------------------------------------------------------------------ Withdrawn........................... 10/18/17 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Linda Kahl, Phone: 240 402-2784, Fax: 240-402-2657, Email: [email protected]. RIN: 0910-AB88 249. Updated Standards for Labeling of Pet Food E.O. 13771 Designation: Other. Legal Authority: 21 U.S.C. 343; 21 U.S.C. 371; Pub. L. 110-85, sec 1002(a)(3) Abstract: FDA is proposing updated standards for the labeling of pet food that include nutritional and ingredient information, as well as style and formatting standards. FDA is taking this action to provide pet owners and animal health professionals more complete and consistent information about the nutrient content and ingredient composition of pet food products. Completed: ------------------------------------------------------------------------ Reason Date FR Cite ------------------------------------------------------------------------ Withdrawn........................... 11/22/17 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: William Burkholder, Phone: 240 402-5900, Email: [email protected]. RIN: 0910-AG09 250. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products E.O. 13771 Designation: Other. Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 352; 21 U.S.C. 353; 21 U.S.C. 355; 21 U.S.C. 371; 42 U.S.C. 262; . . . Abstract: This rule would amend the regulations regarding new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license application (BLAs) to revise and clarify procedures for changes to the labeling of an approved drug to reflect certain types of newly acquired information in advance of FDA's review of such change. Completed: ------------------------------------------------------------------------ Reason Date FR Cite ------------------------------------------------------------------------ Withdrawn........................... 09/29/17 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Janice L. Weiner, Phone: 301 796-3601, Fax: 301 847-8440, Email: [email protected]. RIN: 0910-AG94 251. Radiology Devices; Designation of Special Controls for the Computed Tomography X-Ray System E.O. 13771 Designation: Other. Legal Authority: 21 U.S.C. 360c Abstract: The proposed rule would establish special controls for the computed tomography (CT) X-ray system. A CT X-ray system is a diagnostic X-ray imaging system intended to produce cross-sectional images of the body through use of a computer to reconstruct an image from the same axial plane taken at different angles. High doses of ionizing radiation can cause acute (deterministic) effects such as burns, reddening of the skin, cataracts, hair loss, sterility, and, in extremely high doses, radiation poisoning. The design of a CT X-ray system should balance the benefits of the device (i.e., the ability of the device to produce a diagnostic quality image) with the known risks (e.g., exposure to ionizing radiation). FDA is establishing proposed special controls, which are necessary to provide reasonable assurance of the safety and effectiveness of a class II CT X-ray system. Completed: ------------------------------------------------------------------------ Reason Date FR Cite ------------------------------------------------------------------------ Withdrawn........................... 09/29/17 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Erica Blake-Payne, Phone: 301 796-3999, Fax: 301 847-8145, Email: [email protected]. RIN: 0910-AH03 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Proposed Rule Stage 252. CY 2019 Notice of Benefit and Payment Parameters (CMS-9930-P) (Section 610 Review) E.O. 13771 Designation: Deregulatory. Legal Authority: Pub. L. 111-148, Title I Abstract: This proposed rule sets forth payment parameters and provisions related to the risk adjustment and risk adjustment data validation programs; cost-sharing parameters and cost-sharing reductions; and user fees for Federally-facilitated Exchanges and State-based Exchanges on the Federal platform. It proposes changes that would enhance the role of States related to essential health benefits and qualified health plan (QHP) certification; and would provide States with additional flexibility in the operation and establishment of Exchanges, including the Small Business Health Options Program (SHOP) Exchanges. It includes proposed changes to the required functions of the Small Business Health Options Programs; actuarial value for stand- alone dental plans; the rate review program; the medical loss ratio program; eligibility and enrollment; exemptions; and other related topics. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 11/00/17 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Lindsey Murtagh, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Consumer Information and Insurance Oversight, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 301 492-4106, Email: [email protected]. RIN: 0938-AT12 253. Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction (CMS-3346-P) Regulatory Plan: This entry is Seq. No. 37 in part II of this issue of the Federal Register. RIN: 0938-AT23 [[Page 1868]] 254. FY 2019 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (SNFS) (CMS-1696-P) E.O. 13771 Designation: Fully or Partially Exempt. Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh Abstract: This annual proposed rule would update the payment rates used under the prospective payment system for SNFs for fiscal year 2019. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 04/00/18 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Bill Ullman, Technical Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C5-06-27, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-5667, Fax: 410 786-0765, Email: [email protected]. RIN: 0938-AT24 255. Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY 2019 Rates (CMS-1694-P) (Section 610 Review) Regulatory Plan: This entry is Seq. No. 38 in part II of this issue of the Federal Register. RIN: 0938-AT27 256. CY 2019 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1695-P) (Section 610 Review) E.O. 13771 Designation: Fully or Partially Exempt. 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. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 06/00/18 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Lela Strong, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C4-05-13, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-3213, Email: [email protected]. RIN: 0938-AT30 257. CY 2019 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1693-P) (Section 610 Review) E.O. 13771 Designation: Fully or Partially Exempt. Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh Abstract: This annual proposed rule would revise payment polices under the Medicare physician fee schedule, and make other policy changes to payment under Medicare Part B. These changes would apply to services furnished beginning January 1, 2019. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 06/00/18 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Ryan Howe, Director, Division of Practitioner Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C4-01-15, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-3355, Email: [email protected]. RIN: 0938-AT31 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Final Rule Stage 258. Durable Medical Equipment Fee Schedule, Adjustments To Resume the Transitional 50/50 Blended Rates To Provide Relief in Non- Competitive Bidding Areas (CMS-1687-IFC) (Section 610 Review) E.O. 13771 Designation: Fully or Partially Exempt. Legal Authority: 42 U.S.C. 1302, 1395hh, and 1395rr(b)(l)); Pub. L. 114-255, sec. 5004(b), 16007(a), 16008 Abstract: This interim final rule with comment period extends the end of the transition period for phasing in adjustments to the fee schedule amounts for certain durable medical equipment (DME) and enteral nutrition paid in areas not subject to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP) from June 30, 2016, to December 31, 2016. In addition, this interim final rule with comment period amends the regulation to resume the transition period for items furnished from August 1, 2017, through December 31, 2018. This interim final rule with comment period also makes technical amendments to existing regulations for DMEPOS items and services to exclude infusion drugs used with DME from the DMEPOS CBP. Finally, this interim final rule with comment period also requests information on issues related to adjustments to DMEPOS fee schedules, alternatives for ensuring budget neutrality of oxygen payment classes, and current rules under the DMEPOS CBP. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ Interim Final Rule.................. 11/00/17 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Undetermined. Agency Contact: Alexander Ullman, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C5-07-26, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-9671, Email: [email protected]. RIN: 0938-AT21 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Long-Term Actions 259. Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care (CMS-3295-F) (Rulemaking Resulting From a Section 610 Review) E.O. 13771 Designation: Regulatory. Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh and 1395rr Abstract: This final rule updates the requirements that hospitals and critical access hospitals (CAHs) must meet to participate in the Medicare and Medicaid programs. These final requirements are intended to conform the requirements to current standards of practice and support improvements in quality of care, reduce barriers to care, [[Page 1869]] and reduce some issues that may exacerbate workforce shortage concerns. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 06/16/16 81 FR 39447 NPRM Comment Period End............. 08/15/16 Final Action........................ 06/00/19 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: No. Agency Contact: CDR Scott Cooper, Senior Technical Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, Mail Stop S3-01-02, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786- 9465, Email: [email protected]. RIN: 0938-AS21 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Completed Actions 260. Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2018 Rates (CMS-1677-F) (Completion of a Section 610 Review) E.O. 13771 Designation: Regulatory. Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh; Pub. L. 114-255; . . . Abstract: We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2018. Some of these changes implement certain statutory provisions contained in the Pathway for Sustainable Growth Rate (SGR) Reform Act of 2013, the Improving Medicare Post-Acute Care Transformation Act of 2014, the Medicare Access and CHIP Reauthorization Act of 2015, the 21st Century Cures Act, and other legislation. We also are making changes relating to the provider-based status of Indian Health Service (IHS) and Tribal facilities and organizations and to the low-volume hospital payment adjustment for hospitals operated by the IHS or a Tribe. In addition, we are providing the market basket update that will apply to the rate- of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits for FY 2018. We are updating the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2018. In addition, we are establishing new requirements or revising existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS-exempt cancer hospitals, LTCHs, and inpatient psychiatric facilities). We also are establishing new requirements or revising existing requirements for eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) participating in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs. We are updating policies relating to the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program. We also are making changes relating to transparency of accrediting organization survey reports and plans of correction of providers and suppliers; electronic signature and electronic submission of the Certification and Settlement Summary page of the Medicare cost reports; and clarification of provider disposal of assets. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 04/28/17 82 FR 19796 NPRM Comment Period End............. 06/13/17 Final Action........................ 08/14/17 82 FR 37990 Final Action Effective.............. 10/01/17 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Donald Thompson, Deputy Director, Division of Acute Care, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C4-08-06, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-6504, Email: [email protected]. RIN: 0938-AS98 261. CY 2018 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B; Medicare Shared Savings Program Requirements; Medicare Diabetes Prevention Program (CMS-1676-F) (Completion of a Section 610 Review) E.O. 13771 Designation: Regulatory. Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh Abstract: This annual final rule revises payment polices under the Medicare physician fee schedule, and makes other policy changes to payment under Medicare Part B. These changes apply to services furnished beginning January 1, 2018. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 07/21/17 82 FR 33950 NPRM Comment Period End............. 09/11/17 Final Action........................ 11/15/17 82 FR 52976 Final Action Effective.............. 01/01/18 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Ryan Howe, Director, Division of Practitioner Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C4-01-15, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-3355, Email: [email protected]. RIN: 0938-AT02 262. CY 2018 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1678-FC) (Completion of a Section 610 Review) E.O. 13771 Designation: Fully or Partially Exempt. Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh; Pub. L. 114-255 Abstract: This annual final rule revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 to implement changes arising from our continuing experience with these systems and certain provisions under the 21st Century Cures Act. In this rule, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this rule 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................................ 07/20/17 82 FR 33558 NPRM Comment Period End............. 09/11/17 Final Action........................ 11/13/17 82 FR 52356 Final Action Effective.............. 01/01/18 ------------------------------------------------------------------------ [[Page 1870]] Regulatory Flexibility Analysis Required: Yes. Agency Contact: Lela Strong, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C4-05-13, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-3213, Email: [email protected]. RIN: 0938-AT03 [FR Doc. 2017-28220 Filed 1-11-18; 8:45 am] BILLING CODE 4150-03-P
![1870 Federal Register / Vol. 83, No. 9 / Friday, January 12, 2018 / Unified Agenda
Regulatory Flexibility Analysis Medicare & Medicaid Services, Center RIN: 0938–AT03
Required: Yes. for Medicare, MS: C4–05–13, 7500 [FR Doc. 2017–28220 Filed 1–11–18; 8:45 am]
Agency Contact: Lela Strong, Health Security Boulevard, Baltimore, MD BILLING CODE 4150–03–P
Insurance Specialist, Department of 21244, Phone: 410 786–3213, Email:
Health and Human Services, Centers for lela.strong@cms.hhs.gov.
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Document Created: 2018-10-26 09:50:31
Document Modified: 2018-10-26 09:50:31
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Unknown Section | |
| Action | Semiannual regulatory agenda. | |
| Contact | Ann C. Agnew, Executive Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201; (202) 690-5627. | |
| FR Citation | 83 FR 1860 | |
| CFR Citation | 21 Title 21 CFR Chapter I 25 Title 25 CFR Chapter V |
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