80 FR 77960 - Regulatory Agenda
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary Federal Register Volume 80, Issue 240 (December 15, 2015)
Office of the Secretary
Federal Register Volume 80, Issue 240 (December 15, 2015)
| Page Range | 77960-77970 | |
| FR Document | 2015-30620 |
[Federal Register Volume 80, Number 240 (Tuesday, December 15, 2015)] [Unknown Section] [Pages 77960-77970] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-30620] [[Page 77959]] Vol. 80 Tuesday, No. 240 December 15, 2015 Part VIII Department of Health and Human Services ----------------------------------------------------------------------- Semiannual Regulatory Agenda Federal Register / Vol. 80 , No. 240 / Tuesday, December 15, 2015 / Unified Agenda [[Page 77960]] ----------------------------------------------------------------------- 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: Madhura C. Valverde, 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 principal 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 reflects this complex mission through planned rulemakings structured to implement the Department's six arcs for implementation of its strategic plan: Leaving the Department Stronger; Keeping People Healthy and Safe; Reducing the Number of Uninsured and Providing Access to Affordable Quality Care; Leading in Science and Innovation; Delivering High Quality Care and Spending Our Health Care Dollars More Wisely; and Ensuring the Building Blocks for Success at Every Stage of Life. 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 welcomes 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. Madhura C. Valverde, Executive Secretary to the Department. Office for Civil Rights--Proposed Rule Stage ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 244.......................... Nondiscrimination Under 0945-AA02 the Patient Protection and Affordable Care Act. ------------------------------------------------------------------------ Food and Drug Administration--Proposed Rule Stage ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 245.......................... Over-the-Counter (OTC) 0910-AF31 Drug Review--Cough/ Cold (Antihistamine) Products. 246.......................... Over-the-Counter (OTC) 0910-AF69 Drug Review--Topical Antimicrobial Drug Products. 247.......................... Laser Products; 0910-AF87 Amendment to Performance Standard. 248.......................... Updated Standards for 0910-AG09 Labeling of Pet Food. 249.......................... Requirements for the 0910-AG59 Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives. 250.......................... Format and Content of 0910-AG96 Reports Intended to Demonstrate Substantial Equivalence. 251.......................... Food Labeling; Gluten- 0910-AH00 Free Labeling of Fermented, Hydrolyzed, or Distilled Foods. 252.......................... Radiology Devices; 0910-AH03 Designation of Special Controls for the Computed Tomography X- Ray System. 253.......................... Mammography Quality 0910-AH04 Standards Act; Regulatory Amendments. 254.......................... Investigational New 0910-AH07 Drug Application Annual Reporting. 255.......................... General and Plastic 0910-AH14 Surgery Devices: Sunlamp Products. 256.......................... Requirements for 0910-AH22 Tobacco Product Manufacturing Practice. ------------------------------------------------------------------------ Food and Drug Administration--Final Rule Stage ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 257.......................... Requirements for 0910-AA49 Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs. 258.......................... Food Labeling: Revision 0910-AF22 of the Nutrition and Supplement Facts Labels (Reg Plan Seq No. 32). 259.......................... Food Labeling: Serving 0910-AF23 Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain RACCs (Reg Plan Seq No. 33). 260.......................... Abbreviated New Drug 0910-AF97 Applications and 505(b)(2). 261.......................... Electronic Distribution 0910-AG18 of Prescribing Information for Human Prescription Drugs Including Biological Products. [[Page 77961]] 262.......................... Standards for the 0910-AG35 Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Reg Plan Seq No. 34). 263.......................... ``Tobacco Products'' 0910-AG38 Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act (Reg Plan Seq No. 35). 264.......................... Human Subject 0910-AG48 Protection; Acceptance of Data From Clinical Investigations for Medical Devices. 265.......................... Focused Mitigation 0910-AG63 Strategies To Protect Food Against Intentional Adulteration (Reg Plan Seq No. 37). 266.......................... Foreign Supplier 0910-AG64 Verification Program (Reg Plan Seq No. 38). 267.......................... Supplemental 0910-AG94 Applications Proposing Labeling Changes for Approved Drugs and Biological Products (Reg Plan Seq No. 40). 268.......................... Sanitary Transportation 0910-AG98 of Human and Animal Food (Reg Plan Seq No. 41). ------------------------------------------------------------------------ References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register. Food and Drug Administration--Long-Term Actions ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 269.......................... Regulations on Human 0910-AH10 Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. ------------------------------------------------------------------------ Food and Drug Administration--Completed Actions ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 270.......................... Current Good 0910-AG10 Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. 271.......................... Current Good 0910-AG36 Manufacturing and Hazard Analysis, and Risk-Based Preventive Controls for Human Food. 272.......................... Veterinary Feed 0910-AG95 Directive. ------------------------------------------------------------------------ Centers for Medicare & Medicaid Services--Proposed Rule Stage ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 273.......................... Hospital and Critical 0938-AS21 Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care (CMS-3295-P) (Rulemaking Resulting From a Section 610 Review). 274.......................... Medicare Clinical 0938-AS33 Diagnostic Laboratory Test Payment System (CMS-1621-F) (Section 610 Review). 275.......................... Merit-Based Incentive 0938-AS69 Payment System (MIPS) and Alternative Payment Models (APMs) in Medicare Fee-for- Service (CMS-5517-P) (Section 610 Review) (Reg Plan Seq No. 44). 276.......................... Hospital Inpatient 0938-AS77 Prospective Payment System for Acute Care Hospitals and the Long- Term Care Hospital Prospective Payment System and FY 2017 Rates (CMS-1655-P) (Section 610 Review) (Reg Plan Seq No. 45). 277.......................... CY 2017 Home Health 0938-AS80 Prospective Payment System Refinements and Rate Update (CMS-1648- P) (Section 610 Review). 278.......................... CY 2017 Revisions to 0938-AS81 Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1654-P) (Section 610 Review) (Reg Plan Seq No. 46). 279.......................... CY 2017 Hospital 0938-AS82 Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1656-P) (Section 610 Review) (Reg Plan Seq No. 47). ------------------------------------------------------------------------ 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. ------------------------------------------------------------------------ 280.......................... Covered Outpatient 0938-AQ41 Drugs (CMS-2345-F) (Section 610 Review). 281.......................... Reform of Requirements 0938-AR61 for Long-Term Care Facilities (CMS-3260- F) (Rulemaking Resulting From a Section 610 Review). 282.......................... CY 2016 Revisions to 0938-AS40 Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1631-FC) (Section 610 Review). 283.......................... CY 2016 Hospital 0938-AS42 Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1633-FC) (Section 610 Review). 284.......................... Comprehensive Care for 0938-AS64 Joint Replacement (CMS- 5516-F) (Section 610 Review). ------------------------------------------------------------------------ [[Page 77962]] Centers for Medicare & Medicaid Services--Long-Term Actions ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 285.......................... Home Health Agency 0938-AG81 Conditions of Participation (CMS- 3819-F) (Rulemaking Resulting From a Section 610 Review). 286.......................... Emergency Preparedness 0938-AO91 Requirements for Medicare and Medicaid Participating Providers and Suppliers (CMS-3178-F) (Section 610 Review). ------------------------------------------------------------------------ Centers for Medicare & Medicaid Services--Completed Actions ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 287.......................... Medicare Shared Savings 0938-AS06 Program; Accountable Care Organizations (CMS-1461-F) (Completion of a Section 610 Review). 288.......................... Electronic Health 0938-AS26 Record Incentive Program--Stage 3 and Modifications to Meaningful Use in 2015 through 2017 (CMS-3310- F) (Section 610 Review). 289.......................... Hospital Inpatient 0938-AS41 Prospective Payment System for Acute Care Hospitals and the Long- Term Care Hospital Prospective Payment System and FY 2016 Rates (CMS-1632-FC) (Completion of a Section 610 Review). 290.......................... FY 2016 Inpatient 0938-AS45 Rehabilitation Facility Prospective Payment System (CMS- 1624-F) (Completion of a Section 610 Review). 291.......................... CY 2016 Home Health 0938-AS46 Prospective Payment System Refinements and Rate Update (CMS-1625- F) (Section 610 Review). 292.......................... Electronic Health 0938-AS58 Record Incentive Program--Modifications to Meaningful Use in 2015 through 2017 (CMS- 3311-F) (Completion of a Section 610 Review). ------------------------------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Office for Civil Rights (OCR) Proposed Rule Stage 244. Nondiscrimination Under the Patient Protection and Affordable Care Act Legal Authority: 42 U.S.C. 18116 Abstract: This final rule implements prohibitions against discrimination on the basis of race, color, national origin, sex, age, and disability as provided in section 1557 of the Affordable Care Act. Section 1557 provides protection from discrimination in health programs and activities of covered entities. This section also identifies additional forms of Federal financial assistance to which the section will apply. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 09/08/15 80 FR 54172 NPRM Comment Period End............. 11/09/15 ....................... Final Action........................ 06/00/16 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Eileen Hanrahan, Senior Civil Rights Analyst, Department of Health and Human Services, Office for Civil Rights, 200 Independence Avenue SW., Washington, DC 20201, Phone: 202 205-4925, Email: [email protected]. RIN: 0945-AA02 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Proposed Rule Stage 245. Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products 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)...... 03/00/16 ....................... ------------------------------------------------------------------------ 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 246. Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products 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. This action addresses antimicrobial agents in consumer antiseptic hand wash. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM (Healthcare)................... 06/17/94 59 FR 31402 Comment Period End.................. 12/15/95 ....................... NPRM (Consumer Hand Wash Products).. 12/17/13 78 FR 76443 [[Page 77963]] NPRM (Consumer Hand Wash) Comment 06/16/14 ....................... Period End. NPRM (Healthcare Antiseptic)........ 05/01/15 80 FR 25166 NPRM Comment Period End (Healthcare 10/28/15 ....................... Antiseptic). NPRM (Consumer Hand Rub)............ 06/00/16 ....................... Final Rule (Consumer Hand Wash)..... 09/00/16 ....................... ------------------------------------------------------------------------ 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-AF69 247. Laser Products; Amendment to Performance Standard Legal Authority: 21 U.S.C. 360hh to 360ss; 21 U.S.C. 371; 21 U.S.C. 393 Abstract: FDA is proposing to amend the 2013 proposed rule for the performance standard for laser products, which will amend the performance standard for laser products to achieve closer harmonization between the current standard and the recently amended International Electrotechnical Commission (IEC) standard for laser products and medical laser products. The amendment is intended to update FDA's performance standard to reflect advancements in technology. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 06/24/13 78 FR 37723 NPRM Comment Period End............. 09/23/13 ....................... NPRM (Reproposal)................... 07/00/16 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Nancy Pirt, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-6248, Fax: 301 847- 8145, Email: [email protected]. RIN: 0910-AF87 248. Updated Standards for Labeling of Pet Food 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. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 06/00/16 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: William Burkholder, Veterinary Medical Officer, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, MPN-4, Room 2642, HFV-228, 7519 Standish Place, Rockville, MD 20855, Phone: 240 402-5900, Email: [email protected]. RIN: 0910-AG09 249. Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives Legal Authority: 21 U.S.C. 301 et seq.et seq.; 21 U.S.C. 387; The Family Smoking Prevention and Tobacco Control Act Abstract: The Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act, requires the Food and Drug Administration to promulgate regulations that require the testing and reporting of tobacco product constituents, ingredients, and additives, including smoke constituents, that the Agency determines should be tested to protect the public health. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 07/00/16 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Laura Rich, Senior Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, 10903 New Hampshire Avenue, Building 71, G335, Silver Spring, MD 20993, Phone: 877 287-1373, Email: [email protected]. RIN: 0910-AG59 250. Format and Content of Reports Intended to Demonstrate Substantial Equivalence Legal Authority: 21 U.S.C. 387e(j); 21 U.S.C. 387j(a); secs 905(j) and 910(a) of the Federal Food, Drug, and Cosmetic Act Abstract: This regulation would establish the format and content of reports intended to demonstrate substantial equivalence. This regulation also would provide information as to how the Agency will review and act on these submissions. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 07/00/16 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes Agency Contact: Annette L. Marthaler, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, Document Control Center, Building 71, Room G335, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 877 287-1373, Fax: 877 287-1426, Email: [email protected]. RIN: 0910-AG96 251. Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods Legal Authority: sec 206 of the Food Allergen Labeling and Consumer Protection Act; 21 U.S.C. 343(a)(1); 21 U.S.C. 321(n); 21 U.S.C. 371(a) Abstract: This proposed rule would establish requirements concerning compliance for using a ``gluten-free'' labeling claim for those foods for which there is no scientifically valid analytical method available that can reliably detect and accurately quantify the presence of 20 parts per million (ppm) gluten in the food. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 11/00/15 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Carol D'Lima, 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 [[Page 77964]] 402-2371, Fax: 301 436-2636, Email: [email protected]. RIN: 0910-AH00 252. Radiology Devices; Designation of Special Controls for the Computed Tomography X-RAY SYSTEM 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. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 07/00/16 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Erica Blake, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, WO 66, Room 4426, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-6248, Fax: 301 847- 8145, Email: [email protected]. RIN: 0910-AH03 253. Mammography Quality Standards Act; Regulatory Amendments Legal Authority: 21 U.S.C. 360i; 21 U.S.C. 360nn; 21 U.S.C. 374(e); 42 U.S.C. 263b Abstract: FDA is proposing to amend its regulations governing mammography. The amendments would update the regulations issued under the Mammography Quality Standards Act of 1992 (MQSA). FDA is taking this action to address changes in mammography technology and mammography processes, such as breast density reporting, that have occurred since the regulations were published in 1997. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 05/00/16 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Nancy Pirt, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-6248, Fax: 301 847- 8145, Email: [email protected]. RIN: 0910-AH04 254. Investigational New Drug Application Annual Reporting 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: This proposed rule would revise the requirements concerning annual reports submitted to investigational new drug applications (INDs) by replacing the current annual reporting requirement with a requirement that is generally consistent with the format, content, and timing of submission of the development safety update report devised by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 10/00/16 ....................... ------------------------------------------------------------------------ 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 255. General and Plastic Surgery Devices: Sunlamp Products Legal Authority: 21 U.S.C. 360j(e) Abstract: This proposed rule would apply device restrictions to sunlamp products. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 11/00/15 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Paul Gadiock, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Avenue, W0-66, Room 4432, Silver Spring, MD 20993-0002, Phone: 301 796-5736, Fax: 301 847-8145, Email: [email protected]. RIN: 0910-AH14 256. Requirements for Tobacco Product Manufacturing Practice Legal Authority: 21 U.S.C. 371; 21 U.S.C. 387b; 21 U.S.C. 387f Abstract: FDA is proposing requirements that govern the methods used in, and the facilities and controls used for, the pre-production design validation, manufacture, packing, and storage of tobacco products. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ ANPRM............................... 03/19/13 78 FR 16824 ANPRM Comment Period End............ 05/20/13 ....................... NPRM................................ 04/00/16 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Darin Achilles, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335, Silver Spring, MD 20993, Phone: 877 287-1373, Fax: 301 595-1426, Email: [email protected]. RIN: 0910-AH22 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Final Rule Stage 257. Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That are Regulated Under a Biologics License Application, and Animal Drugs Legal Authority: 21 U.S.C. 321 and 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355 to 356c; 21 U.S.C. 360 and 360b; 21 U.S.C. 360c to 360f; 21 U.S.C. 360h to 360j; 21 U.S.C. 371 and 374; 21 U.S.C. 379e and 381; 21 U.S.C. 393; 15 U.S.C. 1451 to 1561; 42 U.S.C. 262 and 264; 42 U.S.C. 271 Abstract: The rule will reorganize, consolidate, clarify, and modify current regulations concerning who must register establishments and list human drugs, including certain biological [[Page 77965]] drugs, and animal drugs. These regulations contain information on when, how, and where to register drug establishments and list drugs, and what information must be submitted. They also address National Drug Codes. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 08/29/06 71 FR 51276 NPRM Comment Period End............. 02/26/07 ....................... Final Action........................ 04/00/16 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: David Joy, Senior 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 6254, Silver Spring, MD 20993, Phone: 301 796-2242, Email: [email protected]. RIN: 0910-AA49 258. Food Labeling: Revision of the Nutrition and Supplement Facts Labels Regulatory Plan: This entry is Seq. No. 32 in part II of this issue of the Federal Register. RIN: 0910-AF22 259. Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain RACCS Regulatory Plan: This entry is Seq. No. 33 in part II of this issue of the Federal Register. RIN: 0910-AF23 260. Abbreviated New Drug Applications and 505(B)(2) Legal Authority: Pub. L. 108-173, title XI; 21 U.S.C. 355; 21 U.S.C. 371 Abstract: This proposed rule would make changes to certain procedures for Abbreviated New Drug Applications and related applications to patent certifications, notice to patent owners and application holders, the availability of a 30-month stay of approval, amendments and supplements, and the types of bioavailability and bioequivalence data that can be used to support these applications. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 02/06/15 80 FR 6802 NPRM Comment Period End............. 05/07/15 ....................... NPRM Comment Period Extended........ 04/24/15 80 FR 22953 NPRM Comment Period Extended End.... 06/08/15 ....................... Final Action........................ 08/00/16 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Janice L. Weiner, Senior 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 6268, Silver Spring, MD 20993-0002, Phone: 301 796- 3601, Fax: 301 847-8440, Email: [email protected]. RIN: 0910-AF97 261. Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products 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. 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 Action........................ 10/00/16 ------------------------------------------------------------------------ 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]. RIN: 0910-AG18 262. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Regulatory Plan: This entry is Seq. No. 34 in part II of this issue of the Federal Register. RIN: 0910-AG35 263. ``Tobacco Products'' Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act Regulatory Plan: This entry is Seq. No. 35 in part II of this issue of the Federal Register. RIN: 0910-AG38 264. Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices 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 will amend FDA's regulations on acceptance of data for medical devices to require that clinical investigations submitted in support of a premarket approval application, humanitarian device exemption application, an investigational device exemption application, or a premarket notification submission be conducted in accordance with good clinical practice if conducted outside the United States. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 02/25/13 78 FR 12664 NPRM Comment Period End............. 05/28/13 Final Action........................ 05/00/16 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Aaliyah K. Eaves, Policy Advisor, Office of the Director, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, WO 66, Room 5422, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-2948, Fax: 301 847-8120, Email: [email protected]. RIN: 0910-AG48 [[Page 77966]] 265. Focused Mitigation Strategies To Protect Food Against Intentional Adulteration Regulatory Plan: This entry is Seq. No. 37 in part II of this issue of the Federal Register. RIN: 0910-AG63 266. Foreign Supplier Verification Program Regulatory Plan: This entry is Seq. No. 38 in part II of this issue of the Federal Register. RIN: 0910-AG64 267. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products Regulatory Plan: This entry is Seq. No. 40 in part II of this issue of the Federal Register. RIN: 0910-AG94 268. Sanitary Transportation of Human and Animal Food Regulatory Plan: This entry is Seq. No. 41 in part II of this issue of the Federal Register. RIN: 0910-AG98 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Long-Term Actions 269. Regulations on Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act Legal Authority: 21 U.S.C. 353a; 21 U.S.C. 353b; 21 U.S.C. 371 Abstract: FDA will propose regulations to define and implement certain statutory conditions under which compounded products may qualify for exemptions from certain requirements. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 12/00/16 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Sarah Rothman, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 5197, Silver Spring, MD 20993, Phone: 301 796-3536, Email: [email protected]. RIN: 0910-AH10 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Completed Actions 270. Current Good Manufacturing Practice and Hazard Analysis and Risk- Based Preventive Controls for Food for Animals Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 342; 21 U.S.C. 350c; 21 U.S.C. 350d note; 21 U.S.C. 350g; 21 U.S.C. 350g note; 21 U.S.C. 371; 21 U.S.C. 374; 42 U.S.C. 264; 42 U.S.C. 243; 42 U.S.C. 271; . . . Abstract: This rule establishes requirements for good manufacturing practice, and requires that certain facilities establish and implement hazard analysis and risk-based preventive controls for animal food, including ingredients and mixed animal feed. This action is intended to provide greater assurance that food for all animals, including pets, is safe. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 10/29/13 78 FR 64736 NPRM Comment Period Extension....... 02/03/14 79 FR 6111 NPRM Comment Period End............. 02/26/14 NPRM Comment Period Extension End... 03/31/14 Supplemental NPRM................... 09/29/14 79 FR 58475 Supplemental NPRM Comment Period End 12/15/14 Final Rule.......................... 09/17/15 80 FR 56169 Final Rule Effective................ 11/16/15 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Jeanette (Jenny) B. Murphy, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, Room 2671 (MPN-4, HFV- 200), 7519 Standish Place, Rockville, MD 20855, Phone: 240 453-6845, Email: [email protected]. RIN: 0910-AG10 271. Current Good Manufacturing and Hazard Analysis, and Risk-Based Preventive Controls for Human Food Legal Authority: 21 U.S.C. 342; 21 U.S.C. 371; 42 U.S.C. 264; Pub. L. 111-353 (signed on Jan. 4, 2011) Abstract: This rule would require a food facility to have and implement preventive controls to significantly minimize or prevent the occurrence of hazards that could affect food manufactured, processed, packed, or held by the facility. This action is intended to prevent or, at a minimum, quickly identify foodborne pathogens before they get into the food supply. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 01/16/13 78 FR 3646 NPRM Comment Period End............. 05/16/13 NPRM Comment Period Extended........ 04/26/13 78 FR 24691 NPRM Comment Period Extended End.... 09/16/13 NPRM Comment Period Extended........ 08/09/13 78 FR 48636 NPRM Comment Period Extended End.... 11/15/13 NPRM Comment Period Extended........ 11/20/13 78 FR 69604 NPRM Comment Period Extended End.... 11/22/13 Supplemental NPRM................... 09/29/14 79 FR 58523 Supplemental NPRM Comment Period End 12/15/14 Final Rule.......................... 09/17/15 80 FR 55907 Final Action Effective.............. 11/16/15 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Jenny Scott, Senior Advisor, Department of Health and Human Services, Food and Drug Administration, Office of Food Safety, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1488, Email: [email protected]. RIN: 0910-AG36 272. Veterinary Feed Directive Legal Authority: 21 U.S.C. 354; 21 U.S.C. 360b; 21 U.S.C. 360ccc; 21 U.S.C. 360ccc-1; 21 U.S.C. 371 Abstract: The Animal Drug Availability Act created a new category of products called veterinary feed directive (VFD) drugs. This rulemaking is intended to provide for the increased efficiency of the VFD program. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ ANPRM............................... 03/29/10 75 FR 15387 ANPRM Comment Period End............ 06/28/10 NPRM................................ 12/12/13 78 FR 75515 NPRM Comment Period End............. 03/12/14 [[Page 77967]] Final Action........................ 06/03/15 80 FR 31708 Final Action (Correction)........... 06/23/15 80 FR 35841 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Sharon Benz, Supervisory Animal Scientist, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, MPN-4, Room 2648, HFV-220, 7519 Standish Place, Rockville, MD 20855, Phone: 240 402-5939, Email: [email protected]. RIN: 0910-AG95 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Proposed Rule Stage 273. Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care (CMS-3295-P) (Rulemaking Resulting From a Section 610 Review) Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh and 1395rr Abstract: This proposed rule would update the requirements that hospitals and Critical Access Hospitals (CAHs) must meet to participate in the Medicare and Medicaid programs. These proposals are intended to conform the requirements to current standards of practice and to support improvements in quality of care, reduce barriers to care, and reduce some issues that may exacerbate workforce shortage concerns. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 02/00/16 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. 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 274. Medicare Clinical Diagnostic Laboratory Test Payment System (CMS- 1621-F) (Section 610 Review) Legal Authority: Pub. L. 113-93, sec 216 Abstract: This final rule requires Medicare payment for clinical laboratory tests to be based on private payor rates beginning January 1, 2017, as required by section 216(a) of the Protecting Access to Medicare Act of 2014. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 10/01/15 80 FR 59385 NPRM Comment Period End............. 11/25/15 Final Action........................ 10/00/18 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Valerie Miller, Deputy Director, Division of Ambulatory Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, Mail Stop C4-01- 26, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4535, Email: [email protected]. Sarah Harding, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C4-01-26, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4535, Email: [email protected]. RIN: 0938-AS33 275.Merit-Based Incentive Payment System (MIPS) and Alternative Payment Models (APMS) in Medicare Fee-for-Service (CMS- 5517-P) (Section 610 Review) Regulatory Plan: This entry is Seq. No. 44 in part II of this issue of the Federal Register. RIN: 0938-AS69 276. Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY 2017 Rates (CMS-1655-P) (Section 610 Review) Regulatory Plan: This entry is Seq. No. 45 in part II of this issue of the Federal Register. RIN: 0938-AS77 277. CY 2017 Home Health Prospective Payment System Refinements and Rate Update (CMS-1648-P) (Section 610 Review) Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh Abstract: This annual proposed rule would update the 60-day national episode rate based on the applicable home health market basket update and case-mix adjustment. It would also update the national per- visit rates used to calculate low utilization payment adjustments (LUPAs) and outlier payments under the Medicare prospective payment system for home health agencies. These changes would apply to services furnished during home health episodes beginning on or after January 1, 2017. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 06/00/16 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Hillary Loeffler, Technical Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C5-07-28, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-0456, Email: [email protected]. RIN: 0938-AS80 278. CY 2017 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1654-P) (Section 610 Review) Regulatory Plan: This entry is Seq. No. 46 in part II of this issue of the Federal Register. RIN: 0938-AS81 279. CY 2017 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1656-P) (Section 610 Review) Regulatory Plan: This entry is Seq. No. 47 in part II of this issue of the Federal Register. RIN: 0938-AS82 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Final Rule Stage 280. Covered Outpatient Drugs (CMS-2345-F) (Section 610 Review) Legal Authority: Pub. L. 111- 48, sec 2501; Pub. L. 111- 48, 2503; Pub. L. 111- 48, 3301(d)(2); Pub. L. 111-152, sec 1206; Pub. L. 111-8, sec 221 Abstract: This final rule revises requirements pertaining to Medicaid [[Page 77968]] reimbursement for covered outpatient drugs to implement provisions of the Affordable Care Act. This rule also revises other requirements related to covered outpatient drugs, including key aspects of Medicaid coverage, payment, and the drug rebate program. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 02/02/12 77 FR 5318 NPRM Comment Period End............. 04/02/12 Final Action........................ 11/00/15 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Wendy Tuttle, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid and State Operations, Mail Stop S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786- 8690, Email: [email protected]. RIN: 0938-AQ41 281. Reform of Requirements for Long-Term Care Facilities (CMS-3260-F) (Rulemaking Resulting From a Section 610 Review) Legal Authority: Pub. L. 111-148, sec 6102; 42 U.S.C. 263a; 42 U.S.C. 1302; 42 U.S.C. 1395hh; 42 U.S.C. 1395rr Abstract: This final rule revises the requirements that long-term care facilities must meet to participate in the Medicare and Medicaid programs. These changes are necessary to reflect the substantial advances that have been made over the past several years in the theory and practice of service delivery and safety. The rule is also an integral part of CMS efforts to achieve broad-based improvements both in the quality of health care furnished through federal programs, and in patient safety, while at the same time reducing procedural burdens on providers. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 07/16/15 80 FR 42167 NPRM Comment Period Extension....... 09/15/15 80 FR 55284 NPRM Comment Period End............. 10/14/15 Final Action........................ 09/00/16 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Ronisha Blackstone, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, MS: S3- 02-01, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786- 6882, Email: [email protected]. RIN: 0938-AR61 282. CY 2016 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1631-FC) (Section 610 Review) Legal Authority: 42 U.S.C. 405(a), 1302, 1395x, 1395y(a), 1395ff, 1395kk, 1395rr and 1395ww(k); 42 U.S.C. 263a; 42 U.S.C. 1395m, 1395hh, and 1395ddd; 42 U.S.C. 1395w-101 through 1395w-152, and 1395nn; . . . 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, 2016. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 07/15/15 80 FR 41686 NPRM Comment Period End............. 09/08/15 Final Action........................ 11/00/15 ------------------------------------------------------------------------ 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-AS40 283. CY 2016 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1633-FC) (Section 610 Review) Legal Authority: 42 U.S.C. 1302, 1395m, 1395hh, and 1395ddd 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 changes the ambulatory surgical center payment system list of services and rates. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 07/08/15 80 FR 39200 NPRM Comment Period End............. 08/31/15 Final Action........................ 11/00/15 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Marjorie Baldo, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C4-03-06, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4617, Email: [email protected]. RIN: 0938-AS42 284. Comprehensive Care for Joint Replacement (CMS-5516-F) (Section 610 Review) Legal Authority: Social Security Act, sec 1115A Abstract: This final rule implements a new Medicare Part A and B payment model under section 1115A of the Social Security Act, called the Comprehensive Care Joint Replacement Model, in which acute care hospitals in certain selected geographic areas receive retrospective bundled payments for episodes of care for lower extremity joint replacement or reattachment of a lower extremity. All related care within 90 days of hospital discharge from the joint replacement procedures would be included in the episode of care. We believe this model furthers our goals in improving the efficiency and quality of care for Medicare beneficiaries for these common medical procedures. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 07/14/15 80 FR 41198 NPRM Comment Period End............. 09/08/15 Final Action........................ 11/00/15 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Gabriel Scott, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare & Medicaid Innovation, MS: WB- 06-05, 7500 Security Blvd., Baltimore, MD 21244, Phone: 410 786-3928, Email: [email protected]. RIN: 0938-AS64 [[Page 77969]] DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Long-Term Actions 285. Home Health Agency Conditions of Participation (CMS-3819-F) (Rulemaking Resulting From a Section 610 Review) Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395x; 42 U.S.C. 1395cc(a); 42 U.S.C. 1395hh; 42 U.S.C. 1395bb Abstract: This final rule revises the existing Conditions of Participation that Home Health Agencies (HHA) must meet to participate in the Medicare program. The new requirements focus on the actual care delivered to patients by HHAs, reflect an interdisciplinary view of patient care, allow HHAs greater flexibility in meeting quality standards, and eliminate unnecessary procedural requirements. These changes are an integral part of our efforts to improve patient safety and achieve broad-based improvements in the quality of care furnished through Federal programs, while at the same time reducing procedural burdens on providers. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 03/10/97 62 FR 11005 NPRM Comment Period End............. 06/09/97 Second NPRM......................... 10/09/14 79 FR 61163 NPRM Comment Period Extended........ 12/01/14 79 FR 71081 Second NPRM Comment Period End...... 01/07/15 Final Action........................ 10/00/17 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: No. Agency Contact: Danielle Shearer, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Clinical Standards & Quality, MS: S3-02- 01, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-6617, Email: [email protected]. RIN: 0938-AG81 286. Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers (CMS-3178-F) (Section 610 Review) Legal Authority: 42 U.S.C. 1821; 42 U.S.C. 1861ff (3)(B)(i)(ii); 42 U.S.C. 1913(c)(1) et al Abstract: This rule finalizes emergency preparedness requirements for Medicare and Medicaid participating providers and suppliers to ensure that they adequately plan for both natural and man-made disasters and coordinate with Federal, State, tribal, regional, and local emergency preparedness systems. This rule ensures providers and suppliers are adequately prepared to meet the needs of patients, residents, clients, and participants during disasters and emergency situations. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 12/27/13 78 FR 79082 NPRM Comment Period Extended........ 02/21/14 79 FR 9872 NPRM Comment Period End............. 03/31/14 Final Action........................ 12/00/16 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Janice Graham, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Clincial Standards and Quality, Mail Stop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244-1850, Phone: 410 786-8020, Email: [email protected]. RIN: 0938-AO91 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Completed Actions 287. Medicare Shared Savings Program; Accountable Care Organizations (CMS-1461-F) (Completion of a Section 610 Review) Legal Authority: Pub. L. 111-148, sec 3022 Abstract: This rule finalizes changes to the Medicare Shared Savings Program (Shared Savings Program), including provisions relating to the payment of Accountable Care Organizations (ACOs) participating in the Shared Savings Program. Under the Shared Savings Program, providers of services and suppliers that participate in an ACO continue to receive traditional Medicare fee for service (FFS) payments under Parts A and B and are eligible for additional payments from the ACO if they meet specified quality and savings requirements. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 12/08/14 79 FR 72760 NPRM Comment Period End............. 02/06/15 Final Action........................ 06/09/15 80 FR 32691 Final Action Effective.............. 08/03/15 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Terri Postma, Medical Officer, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS:C5-15-24, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4169, Email: [email protected]. RIN: 0938-AS06 288. Electronic Health Record Incentive Program--Stage 3 and Modifications to Meaningful Use in 2015 Through 2017 (CMS-3310-F) (Section 610 Review) Legal Authority: Pub. L. 111-5, title IV of Division B Abstract: This final rule specifies the requirements that eligible professionals, eligible hospitals, and critical access hospitals must meet in order to qualify for Medicare and Medicaid electronic health record (EHR) incentive payments and avoid downward payment adjustments under the Medicare EHR Incentive Program. In addition, it changes the Medicare and Medicaid EHR Incentive Programs reporting period in 2015 to a 90-day period aligned with the calendar year. This rule also removes reporting requirements on measures that have become redundant, duplicative, or topped out from the Medicare and Medicaid EHR incentive programs. In addition, this rule establishes the requirements for Stage 3 of the program as optional in 2017 and required for all participants beginning in 2018. The rule continues to encourage the electronic submission of clinical quality measure data, establishes requirements to transition the program to a single stage, and aligns reporting for providers in the Medicare and Medicaid EHR Incentive Programs. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 03/30/15 80 FR 16732 NPRM Comment Period End............. 05/29/15 Final Action........................ 10/16/15 80 FR 62762 Final Action Effective.............. 12/12/15 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Elizabeth S. Holland, Technical Advisor, Department of Health and Human Services, Centers for [[Page 77970]] Medicare & Medicaid Services, Center for Clinical Standards and Quality, MS: S2-26-17, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-1309, Email: [email protected]. RIN: 0938-AS26 289. Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY 2016 Rates (CMS-1632-FC) (Completion of a Section 610 Review) Legal Authority: sec 1886(d) of the Social Security Act 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. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 04/30/15 80 FR 24323 NPRM Comment Period End............. 06/16/15 Final Action and Interim Final Rule. 08/17/15 80 FR 49325 Interim Final Rule Comment Period 09/29/15 End. Final Action Effective.............. 10/01/15 ------------------------------------------------------------------------ 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: C4-01-26, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-6504, Email: [email protected]. RIN: 0938-AS41 290. FY 2016 Inpatient Rehabilitation Facility Prospective Payment System (CMS-1624-F) (Completion of a Section 610 Review) Legal Authority: Social Security Act, sec 1886(j); Pub. L. 106-554; Pub. L. 106-113 Abstract: This annual final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for fiscal year 2016. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 04/27/15 80 FR 23332 NPRM Comment Period End............. 06/22/15 Final Action........................ 08/06/15 80 FR 47035 Final Action Effective.............. 10/01/15 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Gwendolyn Johnson, Health Insurance Specialist, 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: 410 786-6954, Email: [email protected]. RIN: 0938-AS45 291. CY 2016 Home Health Prospective Payment System Refinements and Rate Update (CMS-1625-F) (Section 610 Review) Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395(hh) Abstract: This annual final rule updates the 60-day national episode rate based on the applicable home health market basket update and case-mix adjustment. It also updates the national per-visit rates used to calculate low utilization payment adjustments (LUPAs) and outlier payments under the Medicare prospective payment system for home health agencies. These changes apply to services furnished during home health episodes beginning on or after January 1, 2016. Additionally, this rule will implement a Home Health value-based purchasing model, beginning January 1, 2016, in which all Medicare-Certified Home Health Agencies in selected states will be required to participate. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 07/10/15 80 FR 39840 NPRM Comment Period End............. 09/04/15 Final Action........................ 11/05/15 80 FR 68624 Final Rule Effective................ 01/01/16 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Hillary Loeffler, Technical Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C5-07-28, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-0456, Email: [email protected]. RIN: 0938-AS46 292. Electronic Health Record Incentive Program--Modifications to Meaningful Use in 2015 Through 2017 (CMS-3311-F) (Completion of a Section 610 Review) Legal Authority: 42 U.S.C. 1302 and 1395hh; Pub. L. 111-5 Abstract: This rule would implement changes to the Medicare and Medicaid Electronic Health Record (EHR) Incentive Program EHR reporting requirements. These changes will be finalized in the ``Electronic Health Record Incentive Program--Stage 3 and Modifications to Meaningful Use in 2015 through 2017'' final rule. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 04/15/15 80 FR 20346 NPRM Comment Period End............. 06/15/15 Merged With 0938-AS26............... 07/24/15 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Elizabeth S. Holland, Technical Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, MS: S2-26-17, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-1309, Email: [email protected]. RIN: 0938-AS58 [FR Doc. 2015-30620 Filed 12-14-15; 8:45 am] BILLING CODE 4150-24-P
![77970 Federal Register / Vol. 80, No. 240 / Tuesday, December 15, 2015 / Unified Agenda
Medicare & Medicaid Services, Center Abstract: This annual final rule Action Date FR Cite
for Clinical Standards and Quality, MS: updates the prospective payment rates
S2–26–17, 7500 Security Boulevard, for inpatient rehabilitation facilities Final Action ......... 11/05/15 80 FR 68624
Baltimore, MD 21244, Phone: 410 786– (IRFs) for fiscal year 2016. Final Rule Effec- 01/01/16
1309, Email: elizabeth.holland@ Timetable: tive.
cms.hhs.gov.
RIN: 0938–AS26 Action Date FR Cite Regulatory Flexibility Analysis
Required: Yes.
289. Hospital Inpatient Prospective NPRM .................. 04/27/15 80 FR 23332
Payment System for Acute Care Agency Contact: Hillary Loeffler,
NPRM Comment 06/22/15
Hospitals and the Long-Term Care Period End.
Technical Advisor, Department of
Hospital Prospective Payment System Final Action ......... 08/06/15 80 FR 47035 Health and Human Services, Centers for
and FY 2016 Rates (CMS–1632–FC) Final Action Effec- 10/01/15 Medicare & Medicaid Services, Center
(Completion of a Section 610 Review) tive. for Medicare, MS: C5–07–28, 7500
Security Boulevard, Baltimore, MD
Legal Authority: sec 1886(d) of the Regulatory Flexibility Analysis 21244, Phone: 410 786–0456, Email:
Social Security Act Required: Yes. hillary.loeffler@cms.hhs.gov.
Abstract: This annual final rule
Agency Contact: Gwendolyn Johnson, RIN: 0938–AS46
revises the Medicare hospital inpatient
Health Insurance Specialist, Department
and long-term care hospital prospective 292. Electronic Health Record Incentive
of Health and Human Services, Centers
payment systems for operating and Program—Modifications to Meaningful
for Medicare & Medicaid Services,
capital-related costs. This rule Use in 2015 Through 2017 (CMS–3311–
Center for Medicare, MS: C5–06–27,
implements changes arising from our F) (Completion of a Section 610 Review)
7500 Security Boulevard, Baltimore, MD
continuing experience with these
21244, Phone: 410 786–6954, Email: Legal Authority: 42 U.S.C. 1302 and
systems.
Timetable: gwendolyn.johnson@cms.hhs.gov. 1395hh; Pub. L. 111–5
RIN: 0938–AS45 Abstract: This rule would implement
Action Date FR Cite 291. CY 2016 Home Health Prospective changes to the Medicare and Medicaid
Payment System Refinements and Rate Electronic Health Record (EHR)
NPRM .................. 04/30/15 80 FR 24323 Incentive Program EHR reporting
NPRM Comment 06/16/15 Update (CMS–1625–F) (Section 610
Review) requirements. These changes will be
Period End.
Final Action and 08/17/15 80 FR 49325 finalized in the ‘‘Electronic Health
Legal Authority: 42 U.S.C. 1302; 42 Record Incentive Program—Stage 3 and
Interim Final U.S.C. 1395(hh)
Rule. Modifications to Meaningful Use in
Abstract: This annual final rule 2015 through 2017’’ final rule.
Interim Final Rule 09/29/15
Comment Pe- updates the 60-day national episode rate
Timetable:
riod End. based on the applicable home health
Final Action Effec- 10/01/15 market basket update and case-mix Action Date FR Cite
tive. adjustment. It also updates the national
per-visit rates used to calculate low NPRM .................. 04/15/15 80 FR 20346
Regulatory Flexibility Analysis utilization payment adjustments NPRM Comment 06/15/15
Required: Yes. (LUPAs) and outlier payments under the Period End.
Agency Contact: Donald Thompson, Medicare prospective payment system Merged With 07/24/15
Deputy Director, Division of Acute Care, for home health agencies. These changes 0938–AS26.
Department of Health and Human apply to services furnished during home
Services, Centers for Medicare & health episodes beginning on or after Regulatory Flexibility Analysis
Medicaid Services, Center for Medicare, January 1, 2016. Additionally, this rule Required: Yes.
MS: C4–01–26, 7500 Security will implement a Home Health value- Agency Contact: Elizabeth S. Holland,
Boulevard, Baltimore, MD 21244, based purchasing model, beginning Technical Advisor, Department of
Phone: 410 786–6504, Email: January 1, 2016, in which all Medicare- Health and Human Services, Centers for
donald.thompson@cms.hhs.gov. Certified Home Health Agencies in Medicare & Medicaid Services, Center
RIN: 0938–AS41 selected states will be required to for Clinical Standards and Quality, MS:
290. FY 2016 Inpatient Rehabilitation participate. S2–26–17, 7500 Security Boulevard,
Facility Prospective Payment System Timetable: Baltimore, MD 21244, Phone: 410 786–
(CMS–1624–F) (Completion of a Section 1309, Email: elizabeth.holland@
610 Review) Action Date FR Cite cms.hhs.gov.
Legal Authority: Social Security Act, RIN: 0938–AS58
NPRM .................. 07/10/15 80 FR 39840
sec 1886(j); Pub. L. 106–554; Pub. L. NPRM Comment 09/04/15 [FR Doc. 2015–30620 Filed 12–14–15; 8:45 am]
106–113 Period End. BILLING CODE 4150–24–P
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS
VerDate Sep<11>2014 19:59 Dec 14, 2015 Jkt 238001 PO 00000 Frm 00012 Fmt 4701 Sfmt 9990 E:\FR\FM\15DEP8.SGM 15DEP8](https://thefederalregister.org/doc/80_FR_78200/page/11.svg)
Document Created: 2018-03-02 09:15:07
Document Modified: 2018-03-02 09:15:07
| 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 | Madhura C. Valverde, Executive Secretary, Department of Health and Human Services, 200 Independence Avenue SW., Washington, DC 20201; (202) 690-5627. | |
| FR Citation | 80 FR 77960 | |
| CFR Citation | 21 Title 21 CFR Chapter I 25 Title 25 CFR Chapter V |
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