| Page Range | 35016-35029 | |
| FR Document | 2015-14352 |
[Federal Register Volume 80, Number 117 (Thursday, June 18, 2015)] [Unknown Section] [Pages 35016-35029] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-14352] [[Page 35015]] Vol. 80 Thursday, No. 117 June 18, 2015 Part VII Department of Health and Human Services ----------------------------------------------------------------------- Unified Agenda Federal Register / Vol. 80 , No. 117 / Thursday, June 18, 2015 / Unified Agenda [[Page 35016]] ----------------------------------------------------------------------- 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: C'Reda J. Weeden, 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 rulemaking activities that the Department expects to undertake this year to advance this mission. The Agenda furthers several Departmental goals, including strengthening health care; advancing scientific knowledge and innovation; advancing the health, safety, and well-being of the American people; increasing efficiency, transparency, and accountability of HHS programs; and strengthening the nation's health and human services infrastructure and workforce. In the rules outlined for this Agenda, HHS continues its work to build a better, smarter, and stronger health care delivery system. Our aspiration is for patients to receive higher quality of care, for medical information to be easy to understand, and for health care dollars to be spent more wisely. We welcome the opportunity to build a more transparent health care delivery system and strengthen partnerships with patients, physicians, governments, and businesses. We continue our work by helping more people get and keep health insurance coverage and making health care more affordable for working families. In addition, HHS strives to lead in the advancement of scientific knowledge and innovation to enable our nation's scientists and researchers to continue making new and improved vaccines, cures, therapies, and rapid diagnostics. The accompanying regulations promote advancements in science, research, and innovation to attract the best experts to accelerate cures; reduce administrative burdens and duplication; and promote data sharing to protect the health of the American people. HHS has an agency-wide effort to support the Agenda's purpose of encouraging more effective public participation in the regulatory process and promote increase transparency to the public regarding our regulatory activity. 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.Reglnfo.gov. C'Reda J. Weeden, Executive Secretary to the Department. Substance Abuse and Mental Health Services Administration--Completed Actions ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 99........................ SAMHSA User Fees for 0930-AA18 Publications. ------------------------------------------------------------------------ Food and Drug Administration--Proposed Rule Stage ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 100....................... Over-the-Counter (OTC) 0910-AF31 Drug Review--Cough/Cold (Antihistamine) Products. 101....................... Over-the-Counter (OTC) 0910-AF69 Drug Review--Topical Antimicrobial Drug Products. 102....................... Abbreviated New Drug 0910-AF97 Applications and 505(b)(2). 103....................... Updated Standards for 0910-AG09 Labeling of Pet Food. 104....................... Electronic Distribution of 0910-AG18 Prescribing Information for Human Prescription Drugs Including Biological Products. 105....................... Requirements for the 0910-AG59 Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives. 106....................... Format and Content of 0910-AG96 Reports Intended to Demonstrate Substantial Equivalence. 107....................... Food Labeling; Gluten-Free 0910-AH00 Labeling of Fermented, Hydrolyzed, or Distilled Foods. 108....................... Radiology Devices; 0910-AH03 Designation of Special Controls for the Computed Tomography X-Ray System. 109....................... Mammography Quality 0910-AH04 Standards Act; Regulatory Amendments. 110....................... Investigational New Drug 0910-AH07 Application Annual Reporting. 111....................... General and Plastic 0910-AH14 Surgery Devices: Sunlamp Products. 112....................... Requirements for Tobacco 0910-AH22 Product Manufacturing Practice. ------------------------------------------------------------------------ [[Page 35017]] Food and Drug Administration--Final Rule Stage ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier no. ------------------------------------------------------------------------ 113....................... Requirements for Foreign 0910-AA49 and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs. 114....................... Food Labeling; Revision of 0910-AF22 the Nutrition and Supplement Facts Labels. 115....................... 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. 116....................... Laser Products; Amendment 0910-AF87 to Performance Standard. 117....................... Current Good Manufacturing 0910-AG10 Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. 118....................... Standards for the Growing, 0910-AG35 Harvesting, Packing, and Holding of Produce for Human Consumption. 119....................... Current Good Manufacturing 0910-AG36 and Hazard Analysis, and Risk-Based Preventive Controls for Human Food. 120....................... ``Tobacco Products'' 0910-AG38 Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act. 121....................... Human Subject Protection; 0910-AG48 Acceptance of Data From Clinical Investigations for Medical Devices. 122....................... Foreign Supplier 0910-AG64 Verification Program. 123....................... Supplemental Applications 0910-AG94 Proposing Labeling Changes for Approved Drugs and Biological Products. 124....................... Veterinary Feed Directive. 0910-AG95 125....................... Sanitary Transportation of 0910-AG98 Human and Animal Food. ------------------------------------------------------------------------ Food and Drug Administration--Long-Term Actions ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 126....................... Focused Mitigation 0910-AG63 Strategies To Protect Food Against Intentional Adulteration. ------------------------------------------------------------------------ Food and Drug Administration--Completed Actions ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 127....................... Content and Format of 0910-AF11 Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling. 128....................... Food Labeling: Calorie 0910-AG56 Labeling of Articles of Food Sold in Vending Machines. 129....................... Food Labeling: Nutrition 0910-AG57 Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments. ------------------------------------------------------------------------ Centers for Medicare & Medicaid Services--Proposed Rule Stage ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 130....................... Reform of Requirements for 0938-AR61 Long-Term Care Facilities (CMS-3260-P) (Rulemaking Resulting From a Section 610 Review). 131....................... Electronic Health Record 0938-AS26 (EHR) Incentive Programs-- Stage 3 (CMS-3310-F) (Section 610 Review). 132....................... Medicare Clinical 0938-AS33 Diagnostic Laboratory Test Payment System (CMS- 1621-P) (Section 610 Review). 133....................... CY 2016 Revisions to 0938-AS40 Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1631-P). 134....................... 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-F). 135....................... 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- P). 136....................... FY 2016 Inpatient 0938-AS45 Rehabilitation Facility Prospective Payment System (CMS-1624-F) (Section 610 Review). 137....................... Electronic Health Record 0938-AS58 Incentive Program-- Modifications to Meaningful Use in 2015 through 2017 (CMS-3311-F) (Section 610 Review). ------------------------------------------------------------------------ Centers for Medicare & Medicaid Services--Final Rule Stage ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 138....................... Covered Outpatient Drugs 0938-AQ41 (CMS-2345-F) (Section 610 Review). ------------------------------------------------------------------------ [[Page 35018]] Centers for Medicare & Medicaid Services--Long-Term Actions ------------------------------------------------------------------------ Regulation Sequence No. Title identifier No. ------------------------------------------------------------------------ 139....................... Home Health Agency 0938-AG81 Conditions of Participation (CMS-3819- F) (Rulemaking Resulting From a Section 610 Review). 140....................... Emergency Preparedness 0938-AO91 Requirements for Medicare and Medicaid Participating Providers and Suppliers (CMS-3178- F) (Section 610 Review). 141....................... Medicare Shared Savings 0938-AS06 Program; Accountable Care Organizations (CMS-1461- F) (Section 610 Review). 142....................... 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). ------------------------------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) Completed Actions 99. SAMHSA USER FEES FOR PUBLICATIONS Legal Authority: 31 U.S.C. 9701; 31 U.S.C. 1111; E.O. 8284; E.O. 11541; Pub. L. 113-76 Abstract: SAMSHA is proposing to implement a modest cost recovery program to partially offset the high costs of distributing its materials to the public. This user fee would apply only to over-the- limit'' non-governmental orders. An over the limit'' order is defined as an order that exceeds either the average weight value (3.75 lbs) or the average number of copies (8). The non-governmental orders'' do not include: SAMHSA's Recovery Month bulk orders; orders by SAMHSA staff for meetings or conferences; and orders from .gov'' and .mil'' addresses. Therefore, it is assumed that SAMHSA would not charge shipping for orders by other Federal, State, and local government agencies. The proposed rule would implement recent legislation allowing the funds collected as part of a user fee for publications and data requests to be available to SAMHSA until expended. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ Withdrawn........................... 03/19/15 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Brian Altman, Legislative Director, Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, 1 Choke Cherry Road, Rockville, MD 02857, Phone: 240 276-2009, Email: [email protected]. RIN: 0930-AA18 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Proposed Rule Stage 100. 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)...... 09/00/15 ....................... ------------------------------------------------------------------------ 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 101. 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 healthcare antiseptic products. 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 NPRM (Healthcare Antiseptic)........ 05/01/15 80 FR 25166 NPRM Comment Period End............. 10/28/15 ....................... ------------------------------------------------------------------------ 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 102. 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 [[Page 35019]] 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 Extended........ 04/24/15 80 FR 22953 NPRM Comment Period End............. 05/07/15 ....................... NPRM Comment Period Extended End.... 06/08/15 ....................... ------------------------------------------------------------------------ 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, WO 51, Room 6268, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3601, Fax: 301 847-8440, Email: [email protected]. RIN: 0910-AF97 103. 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................................ 09/00/15 ....................... ------------------------------------------------------------------------ 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 104. 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........................ 03/00/16 ....................... ------------------------------------------------------------------------ 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 105. 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................................ 02/00/16 ....................... ------------------------------------------------------------------------ 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 106. 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................................ 11/00/15 ....................... ------------------------------------------------------------------------ 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 107. 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 [[Page 35020]] 20 parts per million (ppm) gluten in the food. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 05/00/15 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Felicia Billingslea, Director, Food Labeling and Standard Staff, Department of Health and Human Services, Food and Drug Administration, Room 4D045, HFS 820, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1803, Fax: 301 436-2636, Email: [email protected]. RIN: 0910-AH00 108. Radiaology 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, when combined with the general controls, would provide reasonable assurance of the safety and effectiveness of a class II CT X-ray system. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 03/00/16 ....................... ------------------------------------------------------------------------ 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 109. 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................................ 10/00/15 ------------------------------------------------------------------------ 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 110. Investigational New Drug Application Annual Reporting Legal Authority: 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................................ 12/00/15 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Peter A. Taschenberger, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, Building 51, Room 6312, Silver Spring, MD 20993, Phone: 301 796-0018, Fax: 301 847-3529, Email: [email protected]. RIN: 0910-AH07 111. 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................................ 05/00/15 ------------------------------------------------------------------------ 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 112.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................................ 02/00/16 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Darin Achilles, Senior 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 [[Page 35021]] DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Final Rule Stage 113. 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 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........................ 10/00/15 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: David Joy, Senior Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, WO 51, Room 6254, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-2242, Email: [email protected]. RIN: 0910-AA49 114. Food Labeling; Revision of the Nutrition and Supplement Facts Labels Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371 Abstract: FDA is amending the labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the label to assist consumers in maintaining healthy dietary practices. This rule will modernize the nutrition information found on the Nutrition Facts label, as well as the format and appearance of the label. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ ANPRM............................... 07/11/03 68 FR 41507 ANPRM Comment Period End............ 10/09/03 Second ANPRM........................ 04/04/05 70 FR 17008 Second ANPRM Comment Period End..... 06/20/05 Third ANPRM......................... 11/02/07 72 FR 62149 Third ANPRM Comment Period End...... 01/31/08 NPRM................................ 03/03/14 79 FR 11879 NPRM Comment Period End............. 06/02/14 Final Action........................ 03/00/16 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Blakeley Fitzpatrick, Interdisciplinary Scientist, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-830), HFS-830, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-5429, Email: [email protected]. RIN: 0910-AF22 115. Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain RACCS Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371; Pub. L. 101-535, sec 2(b)(1)(A) Abstract: FDA is amending its labeling regulations for foods to provide updated Reference Amounts Customarily Consumed (RACCs) for certain food categories. This rule would provide consumers with nutrition information based on the amount of food that is customarily consumed, which would assist consumers in maintaining healthy dietary practices. In addition to updating certain RACCs, FDA is also amending the definition of single-serving containers; amending the label serving size for breath mints; and providing for dual-column labeling, which would provide nutrition information per serving and per container or unit, as applicable, under certain circumstances. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ ANPRM............................... 04/04/05 70 FR 17010 ANPRM Comment Period End............ 06/20/05 NPRM................................ 03/03/14 79 FR 11989 NPRM Comment Period End............. 06/02/14 Final Action........................ 03/00/16 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Cherisa Henderson, Nutritionist, Department of Health and Human Services, Food and Drug Administration, HFS-830, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-5429, Fax: 301 436-1191, Email: [email protected]. RIN: 0910-AF23 116. 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: The regulation will amend the performance standard for laser products to achieve closer harmonization between the current standard and the 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 Final Action........................ 04/00/16 ------------------------------------------------------------------------ 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 117. 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: [[Page 35022]] ------------------------------------------------------------------------ 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.......................... 08/00/15 ------------------------------------------------------------------------ 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 118. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Legal Authority: 21 U.S.C. 342; 21 U.S.C. 350h; 21 U.S.C. 371; 42 U.S.C. 264; Pub. L. 111-353 (signed on January 4, 2011) Abstract: This rule will establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death. The purpose of the rule is to reduce the risk of illness associated with fresh produce. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 01/16/13 78 FR 3503 NPRM Comment Period End............. 05/16/13 NPRM Comment Period Extended........ 04/26/13 78 FR 24692 NPRM Comment Period Extended End.... 09/16/13 NPRM Comment Period Extended........ 08/09/13 78 FR 48637 NPRM Comment Period Extended End.... 11/15/13 Notice of Intent To Prepare an 08/19/13 78 FR 50358 Environmental Impact Statement for the Proposed Rule. Notice of Intent To Prepare 11/15/13 Environmental Impact Statement for the Proposed Rule Comment Period End. NPRM Comment Period Extended........ 11/20/13 78 FR 69605 NPRM Comment Period Extended End.... 11/22/13 Environmental Impact Statement for 03/11/14 79 FR 13593 the Proposed Rule; Comment Period Extended. Environmental Impact Statement for 04/18/14 ....................... the Proposed Rule; Comment Period Extended End. Supplemental NPRM................... 09/29/14 79 FR 58433 Supplemental NPRM Comment Period End 12/15/14 Draft Environmental Impact Statement 01/14/15 80 FR 1852 Draft Environmental Impact Statement 03/13/15 Comment Period End. Final Rule.......................... 10/00/15 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Samir Assar, Supervisory Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Food Safety, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1636, Email: [email protected]. RIN: 0910-AG35 119. 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.......................... 08/00/15 ------------------------------------------------------------------------ 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 120. ``Tobacco Products'' Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act Legal Authority: 21 U.S.C. 301 et seq.; The Federal Food, Drug, and Cosmetic Act; Pub. L. 111-31; The Family Smoking Prevention and Tobacco Control Act Abstract: The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) provides the Food and Drug Administration (FDA) authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Tobacco Control Act, permits FDA to issue regulations deeming other tobacco products to be [[Page 35023]] subject to the FD&C Act. This rule would deem additional products meeting the statutory definition of ``tobacco product'' to be subject to the FD&C Act, and would specify additional restrictions. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 04/25/14 79 FR 23142 NPRM Comment Period End............. 07/09/14 NPRM Comment Period Extended........ 06/24/14 79 FR 35711 NPRM Comment Period End............. 08/08/14 Final Action........................ 06/00/15 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Gerie Voss, Senior Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, Document Control Center, Building 71, Room G335, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 877 287- 1373, Fax: 301 595-1426, Email: [email protected]. 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-AG38 121. 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........................ 12/00/15 ------------------------------------------------------------------------ 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 122. Foreign Supplier Verification Program Legal Authority: 21 U.S.C. 384a; title III, sec 301 of FDA Food Safety Modernization Act; Pub. L. 111-353, establishing sec 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) Abstract: This rule describes what a food importer must do to verify that its foreign suppliers produce food that is as safe as food produced in the United States. FDA is taking this action to improve the safety of food that is imported into the United States. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 07/29/13 78 FR 45729 NPRM Comment Period End............. 11/26/13 NPRM Comment Period Extended........ 11/20/13 78 FR 69602 NPRM Comment Period Extended End.... 01/27/14 Supplemental NPRM................... 09/29/14 79 FR 58573 Supplemental NPRM Comment Period End 12/15/14 Final Rule.......................... 10/00/15 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Brian L. Pendleton, Senior Policy Advisor, Department of Health and Human Services, Food and Drug Administration, Office of Policy, WO 32, Room 4245, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-4614, Fax: 301 847-8616, Email: [email protected]. RIN: 0910-AG64 123. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products 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 applications (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. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 11/13/13 78 FR 67985 NPRM Comment Period Extended........ 12/27/13 78 FR 78796 NPRM Comment Period End............. 01/13/14 NPRM Comment Period Extended End.... 03/13/14 NPRM Comment Period Reopened........ 02/18/15 80 FR 8577 NPRM Comment Period Reopened End.... 04/27/15 Final Rule.......................... 02/00/16 ------------------------------------------------------------------------ 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, WO 51, Room 6268, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3601, Fax: 301 847-8440, Email: [email protected]. RIN: 0910-AG94 124. 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 [[Page 35024]] NPRM Comment Period End............. 03/12/14 Final Rule.......................... 05/00/15 ------------------------------------------------------------------------ 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 125. Sanitary Transportation of Human and Animal Food Legal Authority: 21 U.S.C. 350e; 21 U.S.C. 373; 21 U.S.C. 331; 21 U.S.C. 342; 21 U.S.C. 371; * * * Abstract: This rule would establish requirements for parties including shippers, carriers by motor vehicle or rail vehicle, and receivers engaged in the transportation of food, including food for animals, to use sanitary transportation practices to ensure that food is not transported under conditions that may render the food adulterated. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ ANPRM............................... 04/30/10 75 FR 22713 ANPRM Comment Period End............ 08/30/10 NPRM................................ 02/05/14 79 FR 7005 NPRM Comment Period Extended........ 05/23/14 79 FR 29699 NPRM Comment Period End............. 05/31/14 NPRM Comment Period Extended End.... 07/30/14 Final Rule.......................... 03/00/16 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Michael E. Kashtock, Supervisory Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Food Safety, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-2022, Fax: 301 346-2632, Email: [email protected]. RIN: 0910-AG98 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Long-Term Actions 126. Focused Mitigation Strategies to Protect Food Against Intentional Adulteration Legal Authority: 21 U.S.C. 331; 21 U.S.C. 342; 21 U.S.C. 350g; 21 U.S.C. 350i; 21 U.S.C. 371; 21 U.S.C. 374; Pub. L. 111-353 Abstract: This rule would require domestic and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act to address hazards that may be intentionally introduced by acts of terrorism. These food facilities would be required to identify and implement focused mitigation strategies to significantly minimize or prevent significant vulnerabilities identified at actionable process steps in a food operation. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 12/24/13 78 FR 78014 NPRM Comment Period Extended........ 03/25/14 79 FR 16251 NPRM Comment Period End............. 03/31/14 NPRM Comment Period Extended End.... 06/30/14 Final Rule.......................... 05/00/16 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Jody Menikheim, Supervisory General Health Scientist, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-005), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1864, Fax: 301 436-2633, Email: [email protected]. RIN: 0910-AG63 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Completed Actions 127. Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 358; 21 U.S.C. 360; 21 U.S.C. 360b; 21 U.S.C. 360gg to 360ss; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 379e; 42 U.S.C. 216; 42 U.S.C. 241; 42 U.S.C. 262; 42 U.S.C. 264 Abstract: This final rule will amend the content and format of the ``Pregnancy,'' ``Labor and delivery,'' and ``Nursing mothers'' subsections of the ``Use in Specific Populations'' section of regulations regarding the labeling for human prescription drug and biological products to better communicate risks. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 05/29/08 73 FR 30831 NPRM Comment Period End............. 08/27/08 Final Action........................ 12/04/14 79 FR 72064 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Kathy Schreier, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., WO51, Rm. 6246, Silver Spring, MD 20993, Phone: 301 796-3432, Email: [email protected]. RIN: 0910-AF11 128. Food Labeling: Calorie Labeling of Articles of Food Sold in Vending Machines Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371 Abstract: FDA published a proposed rule to establish requirements for nutrition labeling of certain food items sold in certain vending machines. FDA also proposed the terms and conditions for vending machine operators registering to voluntarily be subject to the requirements. FDA is issuing a final rule, and taking this action to carry out section 4205 of the Patient Protection and Affordable Care Act. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 04/06/11 76 FR 19238 NPRM Comment Period End............. 07/05/11 Final Action........................ 12/01/14 79 FR 71259 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Daniel Reese, Food Technologist, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-820), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-2126, Email: [email protected]. RIN: 0910-AG56 [[Page 35025]] 129. Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371 Abstract: FDA published a proposed rule in the Federal Register to establish requirements for nutrition labeling of standard menu items in chain restaurants and similar retail food establishments. FDA also proposed the terms and conditions for restaurants and similar retail food establishments registering to voluntarily be subject to the Federal requirements. FDA is issuing a final rule, and taking this action to carry out section 4205 of the Patient Protection and Affordable Care Act. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 04/06/11 76 FR 19192 NPRM Comment Period End............. 07/05/11 Final Action........................ 12/01/14 79 FR 71156 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Daniel Reese, Food Technologist, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-820), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-2126, Email: [email protected]. RIN: 0910-AG57 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Proposed Rule Stage 130. Reform of Requirements for Long-Term Care Facilities (CMS-3260-P) (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 proposed rule would revise the requirements that Long-Term Care facilities must meet to participate in the Medicare and Medicaid programs. These proposed 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. These proposals are also an integral part of our 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................................ 06/00/15 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Ronisha Davis, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, Mail Stop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786- 6882, Email: [email protected]. RIN: 0938-AR61 131. Electronic Health Record (EHR) Incentive Programs--Stage 3 (CMS- 3310-F) (Section 610 Review) Legal Authority: Pub. L. 111-5, title IV of Division B Abstract: This final rule specifies the meaningful use criteria that eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must meet in order to qualify for Medicare and/ or Medicaid electronic health record (EHR) incentive payments and avoid downward payment adjustments under Medicare for Stage 3 of the EHR Incentive Programs. This rule also establishes an EHR reporting period for all providers under a calendar year timeline except for providers in the first year of the Medicaid EHR Incentive Program where states may continue to allow an introductory 90-day period; requires the electronic submission of clinical quality measures (CQMs); creates a single set of meaningful use requirements for Stage 3 which will be optional for providers in 2017 and applicable for all providers beginning in 2018; and ensure privacy and security requirements continue to protect patient health information (PHI). Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 03/30/15 80 FR 16732 NPRM Comment Period End............. 05/29/15 Final Action........................ 03/00/18 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Elizabeth S. Holland, Director, Division of HIT Initiatives, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, Mail Stop S2-26-17, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-1309, Email: [email protected]. RIN: 0938-AS26 132. Medicare Clinical Diagnostic Laboratory Test Payment System (CMS- 1621-P) (Section 610 Review) Legal Authority: Pub. L. 113-93, sec 216 Abstract: This proposed rule would require 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................................ 06/00/15 ------------------------------------------------------------------------ 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 133. CY 2016 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1631-P) Legal Authority: Social Security Act, secs 1102, 1871, 1848 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, 2016. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 06/00/15 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: John McInnes, Acting 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 [[Page 35026]] Boulevard, Baltimore, MD 21244, Phone: 410 786-0791, Email: [email protected]. RIN: 0938-AS40 134. Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY 2016 Rates (CMS-1632-F) 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........................ 08/00/15 ------------------------------------------------------------------------ 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 135. CY 2016 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1633-P) Legal Authority: Sec 1833 of the Social Security Act 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................................ 06/00/15 ------------------------------------------------------------------------ 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 136. FY 2016 Inpatient Rehabilitation Facility Prospective Payment System (CMS-1624-F) (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........................ 08/00/15 ------------------------------------------------------------------------ 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 137. Electronic Health Record Incentive Program--Modifications to Meaningful Use in 2015 Through 2017 (CMS-3311-F) (Section 610 Review) Legal Authority: 42 U.S.C. 1302 and 1395hh; Pub. L. 111-5 Abstract: This final rule changes the Medicare and Medicaid Electronic Health Record (EHR) Incentive Program EHR reporting period in 2015 to a 90-day period aligned with the calendar year, and also aligns the reporting period in 2016 with the calendar year. In addition, this rule modifies the patient action measures in the Stage 2 objectives related to patient engagement. Finally, it streamlines the program by removing reporting requirements on measures which have become redundant, duplicative, or topped out through advancements in EHR function and provider performance for Stage 1 and Stage 2 of the Medicare and Medicaid EHR Incentive Programs. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 04/15/15 80 FR 20346 NPRM Comment Period End............. 06/15/15 Final Action........................ 04/00/18 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Elizabeth S. Holland, Director, Division of HIT Initiatives, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, Mail Stop S2-26-17, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-1309, Email: [email protected]. RIN: 0938-AS58 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Final Rule Stage 138. Covered Outpatient Drugs (CMS-2345-F) (Section 610 Review) Legal Authority: Pub. L. 111- 48, secs 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 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........................ 08/00/15 ------------------------------------------------------------------------ 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 [[Page 35027]] DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Long-Term Actions 139. 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 140. 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 141. Medicare Shared Savings Program; Accountable Care Organizations (CMS-1461-F) (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........................ 12/00/17 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Terri Postma, Medical Officer, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C5-15-24, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786- 4169, Email: [email protected]. RIN: 0938-AS06 142. 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 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 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................................ 12/00/16 ------------------------------------------------------------------------ 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 [FR Doc. 2015-14352 Filed 6-17-15; 8:45 am] BILLING CODE 4150-03-P
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Unknown Section | |
| Action | Semiannual Regulatory Agenda. | |
| Contact | C'Reda J. Weeden, Executive Secretary, Department of Health and Human Services, 200 Independence Avenue SW., Washington, DC 20201; (202) 690-5627. | |
| FR Citation | 80 FR 35016 | |
| CFR Citation | 21 Title 21 CFR Chapter I 25 Title 25 CFR Chapter V |