Semiannual Regulatory Agenda, 34051-34065 [2014-13125]
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[Federal Register Volume 79, Number 114 (Friday, June 13, 2014)] [Unknown Section] [Pages 34051-34065] From the Federal Register Online via the Government Printing Office [www.gpo.gov] [FR Doc No: 2014-13125] [[Page 34051]] Vol. 79 Friday, No. 114 June 13, 2014 Part VIII Department of Health and Human Services ----------------------------------------------------------------------- Semiannual Regulatory Agenda Federal Register / Vol. 79 , No. 114 / Friday, June 13, 2014 / Unified Agenda [[Page 34052]] ----------------------------------------------------------------------- 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 Semiannual Regulatory Agenda AGENCY: Office of the Secretary, HHS. ACTION: Semiannual regulatory agenda. ----------------------------------------------------------------------- SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order 12866 require the Department semiannually to issue an inventory of rulemaking actions under development to provide the public a summary of forthcoming regulatory actions. This information will help the public more effectively participate in the Department's regulatory activity, and the Department welcomes comments on any aspect of this agenda. FOR FURTHER INFORMATION CONTACT: Jennifer M. Cannistra, Executive Secretary, Department of Health and Human Services, 200 Independence Avenue SW., Washington, DC 20201; (202) 690-6827. 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 presents the rulemaking activities that the Department expects to undertake in the foreseeable future 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. HHS has an agency-wide effort to support the Agenda's purpose of encouraging more effective public participation in the regulatory process. The Department's Public Participation Task Force, which was created as part of the HHS Retrospective Review plan in response to Executive Order 13563 (Improving Regulation and Regulatory Review), regularly meets to identify ways to make the rulemaking process more accessible to the general public. For example, to encourage public participation, we regularly update our regulatory Web page (https://www.hhs.gov/regulations), which includes links to HHS rules currently open for public comment, and 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, including through a comment form on the HHS retrospective review Web page (https://www.HHS.gov/RetrospectiveReview). In addition, a cross- agency team at HHS is currently considering how to increase efficiency in rulemaking by organizing public comment on proposed rules. The rulemaking abstracts included in this paper issue of the Federal Register cover, as required by the Regulatory Flexibility Act of 1980, those prospective HHS rulemakings likely to have a significant economic impact on a substantial number of small entities. The Department's complete Regulatory Agenda is accessible online at https://www.reginfo.gov. Dated: February 20, 2014. Jennifer M. Cannistra, Executive Secretary to the Department. Substance Abuse and Mental Health Services Administration--Proposed Rule Stage ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 120....................... SAMHSA User Fees for 0930-AA18 Publications. ------------------------------------------------------------------------ Food and Drug Administration--Proposed Rule Stage ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 121....................... Food Labeling; Revision of 0910-AF22 the Nutrition and Supplement Facts Labels. 122....................... 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. 123....................... Over-the-Counter (OTC) 0910-AF31 Drug Review--Cough/Cold (Antihistamine) Products. 124....................... Over-the-Counter (OTC) 0910-AF36 Drug Review--Internal Analgesic Products. 125....................... Over-the-Counter (OTC) 0910-AF43 Drug Review--Sunscreen Products. 126....................... Over-the-Counter (OTC) 0910-AF69 Drug Review--Topical Antimicrobial Drug Products. 127....................... Abbreviated New Drug 0910-AF97 Applications and 505(b)(2). 128....................... Updated Standards for 0910-AG09 Labeling of Pet Food. 129....................... Current Good Manufacturing 0910-AG10 Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. 130....................... Over-the-Counter (OTC) 0910-AG12 Drug Review--Pediatric Dosing for Cough/Cold Products. 131....................... Electronic Distribution of 0910-AG18 Prescribing Information for Human Prescription Drugs Including Biological Products. 132....................... Produce Safety Regulation. 0910-AG35 133....................... Current Good Manufacturing 0910-AG36 and Hazard Analysis, and Risk-Based Preventive Controls for Human Food. 134....................... ``Tobacco Products'' 0910-AG38 Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act. 135....................... Requirements for the 0910-AG59 Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives. 136....................... Foreign Supplier 0910-AG64 Verification Program. [[Page 34053]] 137....................... Format and Content of 0910-AG96 Reports Intended to Demonstrate Substantial Equivalence. 138....................... Sanitary Transportation of 0910-AG98 Human and Animal Food. 139....................... Radiology Devices; 0910-AH03 Designation of Special Controls for the Computed Tomography X-Ray System. 140....................... Mammography Quality 0910-AH04 Standards Act; Regulatory Amendments. 141....................... Investigational New Drug 0910-AH07 Application Annual Reporting. ------------------------------------------------------------------------ Food and Drug Administration--Final Rule Stage ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 142....................... Content and Format of 0910-AF11 Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling. 143....................... Combinations of 0910-AF33 Bronchodilators With Nasal Decongestants or Expectorants; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the- Counter Human Use. 144....................... Over-the-Counter (OTC) 0910-AF38 Drug Review--Laxative Drug Products. 145....................... Laser Products; Amendment 0910-AF87 to Performance Standard. 146....................... Human Subject Protection; 0910-AG48 Acceptance of Data From Clinical Studies for Medical Devices. 147....................... Food Labeling: Calorie 0910-AG56 Labeling of Articles of Food Sold in Vending Machines. 148....................... Food Labeling: Nutrition 0910-AG57 Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments. 149....................... Requirements for the 0910-AG81 Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products. 150....................... Supplemental Applications 0910-AG94 Proposing Labeling Changes for Approved Drugs and Biological Products. 151....................... Veterinary Feed Directive. 0910-AG95 ------------------------------------------------------------------------ Food and Drug Administration--Long-Term Actions ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 152....................... Infant Formula: Current 0910-AF27 Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports; and Quality Factors. 153....................... Focused Mitigation 0910-AG63 Strategies To Protect Food Against Intentional Adulteration. ------------------------------------------------------------------------ Food and Drug Administration--Completed Actions ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 154....................... Prescription Drug 0910-AG14 Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures (Completion of a Section 610 Review). 155....................... General Hospital and 0910-AG54 Personal Use Devices: Issuance of Draft Special Controls Guidance for Infusion Pumps. 156....................... Food Labeling: Nutrient 0910-AH13 Content Claims; Alpha- Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids. ------------------------------------------------------------------------ Centers for Medicare & Medicaid Services--Proposed Rule Stage ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 157....................... Home Health Agency 0938-AG81 Conditions of Participation (CMS-3819- P) (Rulemaking Resulting From a Section 610 Review). 158....................... Hospital Inpatient 0938-AS11 Prospective Payment System for Acute Care Hospitals and the Long- Term Care Hospital Prospective Payment System and Fiscal Year 2015 Rates (CMS-1607-P) (Section 610 Review). 159....................... CY 2015 Revisions to 0938-AS12 Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1612-P) (Section 610 Review). 160....................... CY 2015 Hospital 0938-AS15 Outpatient Prospective Payment System (PPS) Policy Changes and Payment Rates, and CY 2015 Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1613- P) (Section 610 Review). 161....................... CY 2016 Notice of Benefit 0938-AS19 and Payment Parameters (CMS-9944-P) (Section 610 Review). 162....................... 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). ------------------------------------------------------------------------ [[Page 34054]] Centers for Medicare & Medicaid Services--Final Rule Stage ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 163....................... Covered Outpatient Drugs 0938-AQ41 (CMS-2345-F) (Section 610 Review). 164....................... Prospective Payment System 0938-AR62 for Federally Qualified Health Centers; Changes to Contracting Policies for Rural Health Clinics and CLIA Enforcement Actions for Proficiency Testing Referral (CMS- 1443-FC) (Section 610 Review). 165....................... Adoption of Operating 0938-AS01 Rules for HIPAA Transactions (CMS-0036- IFC). 166....................... Extension of Payment 0938-AS18 Adjustment for Low-Volume Hospitals and the Medicare-Dependent Hospital Program Under the FY 2014 Hospital Inpatient Prospective Payment System (CMS-1599- IFC2) (Section 610 Review). ------------------------------------------------------------------------ Centers for Medicare & Medicaid Services--Long-Term Actions ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 167....................... Emergency Preparedness 0938-AO91 Requirements for Medicare and Medicaid Participating Providers and Suppliers (CMS-3178- F). ------------------------------------------------------------------------ Centers for Medicare & Medicaid Services--Completed Actions ------------------------------------------------------------------------ Regulation Sequence No. Title Identifier No. ------------------------------------------------------------------------ 168....................... CY 2014 Changes to the End- 0938-AR55 Stage Renal Disease (ESRD) Prospective Payment System, ESRD Quality Incentive Program, and Durable Medical Equipment (CMS- 1526-F) (Completion of a Section 610 Review). 169....................... Revisions to Payment 0938-AR56 Policies Under the Physician Fee Schedule and Medicare Part B for CY 2014 (CMS-1600-FC) (Completion of a Section 610 Review). 170....................... CY 2015 Notice of Benefit 0938-AR89 and Payment Parameters (CMS-9954-F) (Completion of a Section 610 Review). ------------------------------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) Proposed Rule Stage 120.SAMHSA User Fees for Publications Legal Authority: 31 U.S.C. 9701; 31 U.S.C. 1111; EO 8284; EO 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 ------------------------------------------------------------------------ NPRM................................ 12/00/14 ------------------------------------------------------------------------ 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: brian.altman@samhsa.gov. RIN: 0930-AA18 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Proposed Rule Stage 121. 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 proposing to amend 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. If finalized, 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 ------------------------------------------------------------------------ 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, [[Page 34055]] Phone: 240 402-5429, Email: staff@fda.hhs.gov">nutritionprogramstaff@fda.hhs.gov. RIN: 0910-AF22 122. 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 Abstract: FDA is proposing to amend its labeling regulations for foods to provide updated Reference Amounts Customarily Consumed (RACCs) for certain food categories. If finalized, 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 considering amending the definition of single-serving containers; amending the definition of serving size for breath mints; and providing for dual-column labeling, which would provide nutrition information per serving and per container or units, 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 ------------------------------------------------------------------------ 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: staff@fda.hhs.gov">nutritionprogramstaff@fda.hhs.gov. RIN: 0910-AF23 123. 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)...... 09/00/14 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Janice Adams-King, Regulatory Health Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3713, Fax: 301 796-9899, Email: janice.adams-king@fda.hhs.gov. RIN: 0910-AF31 124. Over-the-Counter (OTC) Drug Review--Internal Analgesic 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; 21 U.S.C. 374; 21 U.S.C. 379e Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective, and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action addresses acetaminophen safety. The second action addresses products marketed for children under 2 years old and weight- and age-based dosing for children's products. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM (Amendment) (Required Warnings 12/26/06 71 FR 77314 and Other Labeling). NPRM Comment Period End............. 05/25/07 Final Action (Required Warnings and 04/29/09 74 FR 19385 Other Labeling). Final Action (Correction)........... 06/30/09 74 FR 31177 Final Action (Technical Amendment).. 11/25/09 74 FR 61512 NPRM (Amendment) (Pediatric)........ 12/00/14 NPRM (Amendment) (Acetaminophen).... 12/00/14 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Janice Adams-King, Regulatory Health Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3713, Fax: 301 796-9899, Email: janice.adams-king@fda.hhs.gov. RIN: 0910-AF36 125. Over-the-Counter (OTC) Drug Review--Sunscreen 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. The first of the future actions will address the safety of sunscreen active ingredients. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ ANPRM (Sunscreen and Insect 02/22/07 72 FR 7941 Repellent). ANPRM Comment Period End............ 05/23/07 NPRM (UVA/UVB)...................... 08/27/07 72 FR 49070 NPRM Comment Period End............. 12/26/07 Final Action (UVA/UVB).............. 06/17/11 76 FR 35620 NPRM (Effectiveness)................ 06/17/11 76 FR 35672 NPRM (Effectiveness) Comment Period 09/15/11 End. ANPRM (Dosage Forms)................ 06/17/11 76 FR 35669 ANPRM (Dosage Forms) Comment Period 09/15/11 End. Proposed Rule....................... 03/00/15 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Janice Adams-King, Regulatory Health Project Manager, [[Page 34056]] Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3713, Fax: 301 796-9899, Email: janice.adams-king@fda.hhs.gov. RIN: 0910-AF43 126. 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)........ 03/00/15 ------------------------------------------------------------------------ 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: janice.adams-king@fda.hhs.gov. RIN: 0910-AF69 127. 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................................ 05/00/14 ------------------------------------------------------------------------ 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: janice.weiner@fda.hhs.gov. RIN: 0910-AF97 128. 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 useful information about the nutrient content and ingredient composition of pet food products. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 10/00/14 ------------------------------------------------------------------------ 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, Room 2642 (MPN-4, HFV-228), 7519 Standish Place, Rockville, MD 20855, Phone: 240 453-6865, Email: william.burkholder@fda.hhs.gov. RIN: 0910-AG09 129. 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 to require 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 marketed 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................... 07/00/14 Final Rule.......................... 08/00/15 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Kim Young, Deputy Director, Division of Compliance, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, Room 106 (MPN-4, HFV-230), 7519 Standish Place, Rockville, MD 20855, Phone: 240 276-9207, Email: kim.young@fda.hhs.gov. RIN: 0910-AG10 130. Over-the-Counter (OTC) Drug Review--Pediatric Dosing for Cough/ Cold Products Legal Authority: 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective, and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action will propose changes to the final monograph to address safety and efficacy issues associated with pediatric cough and cold products. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 12/00/14 ------------------------------------------------------------------------ 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 [[Page 34057]] 796-3713, Fax: 301 796-9899, Email: janice.adams-king@fda.hhs.gov. RIN: 0910-AG12 131. 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................................ 06/00/14 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Megan Velez, Policy Analyst, Department of Health and Human Services, Food and Drug Administration, Office of Policy, WO 32, Room 4249, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-9301, Email: megan.velez@fda.hhs.gov. RIN: 0910-AG18 132. Produce Safety Regulation 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 Enviromental Impact Statement for the Proposed Rule. Notice of Intent To Prepare 11/15/13 Enviromental 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 11/18/13 78 FR 69006 the Proposed Rule; Comment Period Extended. Environmental Impact Statement for 03/14/14 the Proposed Rule; Comment Period Extended End. Supplemental NPRM................... 07/00/14 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: samir.assar@fda.hhs.gov. RIN: 0910-AG35 133. 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................... 07/00/14 ....................... 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: jenny.scott@fda.hhs.gov. RIN: 0910-AG36 134. ``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 subject to the FD&C Act. This proposed rule would deem products meeting the statutory definition of ``tobacco [[Page 34058]] 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 ....................... Final Action........................ 06/00/15 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: May Nelson, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, 9200 Corporate Boulevard, Rockville, MD 20850, Phone: 877 287-1373, Fax: 240 276-3904, Email: may.nelson@fda.hhs.gov. RIN: 0910-AG38 135. Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives Legal Authority: 21 U.S.C. 301 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................................ 11/00/14 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Carol Drew, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, 9200 Corporate Boulevard, Room 240 H, Rockville, MD 20850, Phone: 877 287-1373, Fax: 240 276-3904, Email: carol.drew@fda.hhs.gov. RIN: 0910-AG59 136. 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................... 07/00/14 ....................... 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: brian.pendleton@fda.hhs.gov. RIN: 0910-AG64 137. 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 and compliance with the FD&C Act (sections 905(j) and 910(a) of the FD&C Act). This regulation also would provide information as to how the Agency will review and act on these submissions. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 02/00/15 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Gerie Voss, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, 9200 Corporate Boulevard, Rockville, MD 20850, Phone: 877 287-1373, Fax: 240 276-4193, Email: gerie.voss@fda.hhs.gov. RIN: 0910-AG96 138. 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 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 End............. 05/31/14 ....................... 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: michael.kashtock@fda.hhs.gov. RIN: 0910-AG98 139. 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, when combined with the general controls, would provide reasonable assurance of the safety and effectiveness of a class II CT X-ray system. [[Page 34059]] Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 12/00/14 ....................... ------------------------------------------------------------------------ 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: erica.blake@fda.hhs.gov. RIN: 0910-AH03 140. 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................................ 12/00/14 ....................... ------------------------------------------------------------------------ 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: nancy.pirt@fda.hhs.gov. RIN: 0910-AH04 141. Investigational New Drug Application Annual Reporting Legal Authority: 21 U.S.C. 355(i); 21 U.S.C. 371(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 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................................ 03/00/15 ....................... ------------------------------------------------------------------------ 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: peter.taschenberger@fda.hhs.gov. RIN: 0910-AH07 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Final Rule Stage 142. 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........................ 07/00/14 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Molly Flannery, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6246, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3543, Email: molly.flannery@fda.hhs.gov. RIN: 0910-AF11 143. Combinations of Bronchodilators With Nasal Decongestants or Expectorants; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective, and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. These actions address cough/cold drug products containing an oral bronchodilator (ephedrine and its salts) in combination with any expectorant or any oral nasal decongestant. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM (Amendment).................... 07/13/05 70 FR 40232 NPRM Comment Period End............. 11/10/05 ....................... Final Action (Technical Amendment).. 03/19/07 72 FR 12730 Final Action (Oral Bronchodilator 12/00/14 ....................... and Oral Nasal Decongestant). Final Action (Oral Bronchodilator 12/00/14 ....................... and Expectorant). ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Janice Adams-King, Regulatory Health Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3713, Fax: 301 796-9899, Email: janice.adams-king@fda.hhs.gov. RIN: 0910-AF33 144. Over-the-Counter (OTC) Drug Review--Laxative 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 to 360a; 21 U.S.C. 371 to 371a 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 [[Page 34060]] monograph, or having an approved new drug application, may be legally marketed. The final rule listed will address the professional labeling for sodium phosphate drug products. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ Final Action (Granular Psyllium).... 03/29/07 72 FR 14669 NPRM (Professional Labeling--Sodium 02/11/11 76 FR 7743 Phosphate). NPRM Comment Period End............. 03/14/11 ....................... Final Action (Professional Labeling-- 12/00/14 ....................... Sodium Phosphate). ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Janice Adams-King, Regulatory Health Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3713, Fax: 301 796-9899, Email: janice.adams-king@fda.hhs.gov. RIN: 0910-AF38 145. 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........................ 12/00/14 ....................... ------------------------------------------------------------------------ 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: nancy.pirt@fda.hhs.gov. RIN: 0910-AF87 146. Human Subject Protection; Acceptance of Data From Clinical Studies 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 from clinical studies for medical devices to require that clinical studies conducted outside the United States 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. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 02/25/13 78 FR 12664 NPRM Comment Period End............. 05/28/13 ....................... Final Action........................ 12/00/14 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Sheila Anne Brown, Policy Analyst, Investigational Device Exemptions Staff, Department of Health and Human Services, Food and Drug Administration, WO 66, Room 1651, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-6563, Fax: 301 847-8120, Email: sheila.brown@fda.hhs.gov. RIN: 0910-AG48 147. 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........................ 06/00/14 ....................... ------------------------------------------------------------------------ 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: daniel.reese@fda.hhs.gov. RIN: 0910-AG56 148. 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........................ 06/00/14 ....................... ------------------------------------------------------------------------ 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: daniel.reese@fda.hhs.gov. RIN: 0910-AG57 149. Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products Legal Authority: 21 U.S.C. 371; 21 U.S.C. 387s; Pub. L. 111-31 Abstract: This rule will require manufacturers and importers of tobacco products to submit certain market share data to FDA. USDA currently collects such data, but its program sunsets at the end of September 2014, and USDA will cease collection of this information. FDA is taking this action so that it may [[Page 34061]] continue to calculate market share percentages needed to compute user fees. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 05/31/13 78 FR 32581 NPRM Comment Period End............. 08/14/13 ....................... Final Action........................ 06/00/14 ....................... ------------------------------------------------------------------------ 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, Room 340K, 9200 Corporate Boulevard, Rockville, MD 20850, Phone: 877 287-1373, Fax: 240 276-3904, Email: annette.marthaler@fda.hhs.gov. RIN: 0910-AG81 150. 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. This rule would describe the process by which information regarding ``changes being effected'' (CBE) labeling supplement submitted by an NDA or ANDA holder would be made publicly available during FDA's review of the labeling change. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 11/13/13 78 FR 67985 NPRM Comment Period End............. 01/13/14 ....................... Final Rule.......................... 12/00/14 ....................... ------------------------------------------------------------------------ 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: janice.weiner@fda.hhs.gov. RIN: 0910-AG94 151. 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) drug. 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 ....................... Final Rule.......................... 04/00/15 ....................... ------------------------------------------------------------------------ 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, 7529 Standish Place, Rockville, MD 20855, Phone: 240 453-6864, Email: sharon.benz@fda.hhs.gov. RIN: 0910-AG95 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Long-Term Actions 152. Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports; and Quality Factors Legal Authority: 21 U.S.C. 321; 21 U.S.C. 342; 21 U.S.C. 350a; 21 U.S.C. 371 Abstract: The Food and Drug Administration (FDA) is revising its infant formula regulations to establish requirements for current good manufacturing practices (CGMP), including audits; to establish requirements for quality factors; and to amend FDA's quality control procedures, notification, and record and reporting requirements for infant formula. FDA is taking this action to improve the protection of infants who consume infant formula products. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 07/09/96 61 FR 36154 NPRM Comment Period End............. 12/06/96 ....................... NPRM Comment Period Reopened........ 04/28/03 68 FR 22341 NPRM Comment Period Extended........ 06/27/03 68 FR 38247 NPRM Comment Period End............. 08/26/03 ....................... NPRM Comment Period Reopened........ 08/01/06 71 FR 43392 NPRM Comment Period End............. 09/15/06 ....................... Interim Final Rule.................. 02/10/14 79 FR 7934 Interim Final Rule Comment Period 03/27/14 ....................... End. Final Rule.......................... 07/00/15 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Benson Silverman, Staff Director, Infant Formula and Medical Foods, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS- 850), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1459, Email: benson.silverman@fda.hhs.gov. RIN: 0910-AF27 153. 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 End............. 03/31/14 ....................... 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 [[Page 34062]] 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: fooddefense@fda.hhs.gov. RIN: 0910-AG63 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Completed Actions 154. Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures (Completion of a Section 610 Review) Legal Authority: 21 U.S.C. 331; 21 U.S.C. 333; 21 U.S.C. 351 to 353; 21 U.S.C. 360; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381 Abstract: FDA has completed their review of the regulations promulgated under the Prescription Drug Marketing Act. The review was done to determine whether the regulations should be changed or rescinded to minimize adverse impacts on a substantial number of small entities. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ Begin Review of Current Regulation.. 11/24/08 ....................... End Review of Current Regulation.... 11/29/13 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Howard Muller, Office of Regulatory Policy, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6234, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3601, Fax: 301 847-8440, Email: pdma610(c)review@fda.hhs.gov. RIN: 0910-AG14 155. General Hospital and Personal Use Devices: Issuance of Draft Special Controls Guidance for Infusion Pumps Legal Authority: 21 U.S.C. 351; 21 U.S.C. 360; 21 U.S.C. 360c; 21 U.S.C. 360e; 21 U.S.C. 360j; 21 U.S.C. 371 Abstract: FDA is proposing to amend the classification of infusion pumps from class II (performance standards) to class II (special controls). FDA is taking this action to provide reasonable assurance of the safety and effectiveness of these devices. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ Withdrawn........................... 04/24/14 ....................... ------------------------------------------------------------------------ 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: nancy.pirt@fda.hhs.gov. RIN: 0910-AG54 156. Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids Legal Authority: 21 U.S.C. 343; 21 U.S.C. 371 Abstract: The final rule addresses the nutrient content claims for docosahexaenoic acid and eicosapentaenoic acid set forth in notifications submitted by (1) Alaska General Seafoods, Ocean Beauty Seafoods Inc., and Trans-Ocean Products Inc. (the seafood processors notification), (2) Martek Biosciences Corp. (the Martek notification), and (3) Ocean Nutrition Canada Ltd. The final rule also addresses the nutrient content claims for alpha-linolenic acid set forth in the seafood processors notification and the Martek notification. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 11/27/07 72 FR 66103 NPRM Comment Period End............. 02/11/08 ....................... Final Action........................ 04/28/14 79 FR 23262 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Vincent De Jesus, Nutritionist, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, (HFS-830), Room 3D-031, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1774, Fax: 301 436-1191, Email: vincent.dejesus@fda.hhs.gov. RIN: 0910-AH13 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Proposed Rule Stage 157. Home Health Agency Conditions of Participation (CMS-3819-P) (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 proposed rule would revise the existing Conditions of Participation that Home Health Agencies must meet to participate in the Medicare program. The new requirements would 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......................... 05/00/14 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: No. Agency Contact: Danielle Shearer, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Clinical Standards & Quality, Mail Stop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-6617, Email: danielle.shearer@cms.hhs.gov. RIN: 0938-AG81 158. Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2015 Rates (CMS-1607-P) (Section 610 Review) Legal Authority: sec 1886(d) of the Social Security Act Abstract: This annual proposed rule would revise the Medicare hospital inpatient and long-term care hospital prospective payment systems for operating and capital-related costs. This proposed rule would implement changes arising from our continuing experience with these systems. [[Page 34063]] Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 05/14/14 79 FR 27977 NPRM Comment Period End............. 06/30/14 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Brian Slater, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C4-07-07, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-6229, Email: brian.slater@cms.hhs.gov. RIN: 0938-AS11 159. CY 2015 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1612-P) (Section 610 Review) Legal Authority: Social Security Act, secs 1102, 1871 and 1848 Abstract: This annual proposed rule would revise payment policies 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, 2015. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 06/00/14 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Kathy Bryant, Director, Division of Practitioner Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C4-01-27, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-3448, Email: kathy.bryant@cms.hhs.gov. RIN: 0938-AS12 160. CY 2015 Hospital Outpatient Prospective Payment System (PPS) Policy Changes and Payment Rates, and CY 2015 Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1613-P) (Section 610 Review) Legal Authority: Sec 1833 of the Social Security Act Abstract: This annual proposed rule would revise the Medicare hospital outpatient prospective payment system (PPS) 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................................ 07/00/14 ....................... ------------------------------------------------------------------------ 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 Management, Mail Stop C4-03-06, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4617, Email: marjorie.baldo@cms.hhs.gov. RIN: 0938-AS15 161. CY 2016 Notice of Benefit and Payment Parameters (CMS- 9944-P) (Section 610 Review) Legal Authority: Pub. L. 111-148, title I Abstract: This proposed rule would establish the CY 2016 payment parameters for the cost-sharing reductions, advance payments of the premium tax credit, reinsurance, and risk adjustment programs as required by the Affordable Care Act. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 11/00/14 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Sharon Arnold, Director, Payment Policy and Financial Management Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Consumer Information & Insurance Oversight, Mail Stop 733H.02, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 301 492-4286, Email: sharon.arnold@cms.hhs.gov. RIN: 0938-AS19 162. 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 revise the requirements that hospitals and CAHs must meet to participate in the Medicare and Medicaid programs. These changes are necessary to reflect substantial advances in healthcare delivery and in patient safety knowledge and practices, and would allow hospitals and CAHs the flexibility to implement innovative patient care practices. The changes are also an integral part of our efforts to achieve broad-based improvements in patient safety and in the quality of health care furnished through Federal programs. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 09/00/14 ....................... ------------------------------------------------------------------------ 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: scott.cooper@cms.hhs.gov. RIN: 0938-AS21 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Final Rule Stage 163. Covered Outpatient Drugs (CMS-2345-F) (Section 610 Review) Legal Authority: Pub. L. 111-48, secs 2501, 2503, 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........................ 06/00/14 ....................... ------------------------------------------------------------------------ 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: wendy.tuttle@cms.hhs.gov. [[Page 34064]] RIN: 0938-AQ41 164. Prospective Payment System for Federally Qualified Health Centers; Changes to Contracting Policies for Rural Health Clinics and CLIA Enforcement Actions for Proficiency Testing Referral (CMS-1443-FC) (Section 610 Review) Legal Authority: Pub. L. 111-148, sec 10501 Abstract: This final rule establishes methodology and payment rates for a prospective payment system (PPS) for Federally qualified health center (FQHC) services under Medicare Part B beginning on October 1, 2014, in compliance with the statutory requirement of the Affordable Care Act. This rule also establishes a policy which would allow rural health clinics (RHCs) to contract with nonphysician practitioners when statutory requirements for employment of nurse practitioners and physician assistants are met, and makes other technical and conforming changes to the RHC and FQHC regulations. Finally, this rule makes changes to the Clinical Laboratory Improvement Amendments (CLIA) regulations regarding enforcement actions for proficiency testing referral. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 09/23/13 78 FR 58386 NPRM Comment Period End............. 11/18/13 ....................... Final Rule.......................... 05/02/14 79 FR 25436 Final Rule With Comment Period End.. 07/01/14 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Corinne Axelrod, Health Insurance Specialist, Hospital and Ambulatory Policy Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C5-14-03, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-5620, Email: corinne.axelrod@cms.hhs.gov. RIN: 0938-AR62 165. Adoption of Operating Rules for HIPAA Transactions (CMS-0036-IFC) Legal Authority: Pub. L. 104-191, sec 1104 Abstract: Under the Affordable Care Act, this interim final rule adopts operating rules for HIPAA transactions for health care claims or equivalent encounter information, enrollment and disenrollment of a health plan, health plan premium payments, and referral certification and authorization. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ Interim Final Rule.................. 03/00/15 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Geanelle Herring, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Administrative Simplification Group, Office of E- Health Standards and Services, Mail Stop S2-26-17, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4466, Email: geanelle.herring@cms.hhs.gov. RIN: 0938-AS01 166. Extension of Payment Adjustment for Low-Volume Hospitals and the Medicare-Dependent Hospital Program Under the FY 2014 Hospital Inpatient Prospective Payment System (CMS-1599-IFC2) (Section 610 Review) Legal Authority: Pub. L. 113-67, secs 1105 and 1106 Abstract: This interim final rule implements changes to the payment adjustment for low-volume hospitals and to the Medicare-dependent hospital program under the hospital inpatient prospective payment systems for FY 2014 (through March 31, 2014) in accordance with sections 1105 and 1106, respectively, of the Pathway for SGR Reform Act of 2013. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ Interim Final Rule.................. 03/18/14 79 FR 15022 Interim Final Rule Comment Period 05/12/14 ....................... End. ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Michele Hudson, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C4-10-07, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-5490, Email: michele.hudson@cms.hhs.gov. RIN: 0938-AS18 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Long-Term Actions 167. Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers (CMS-3178-F) 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 Clinical Standards and Quality, Mail Stop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244-1850, Phone: 410 786-8020, Email: janice.graham@cms.hhs.gov. RIN: 0938-AO91 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Completed Actions 168. CY 2014 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System, ESRD Quality Incentive Program, and Durable Medical Equipment (CMS-1526-F) (Completion of a Section 610 Review) Legal Authority: MIPPA; sec 153(b); Pub. L. 111-148; sec 3401(h); ATRA; sec 632(a) [[Page 34065]] Abstract: This final rule updates the bundled payment system for End Stage Renal Disease (ESRD) facilities by 1/1/13. The rule also updates the Quality Incentives in the ESRD Program. In addition, this rule clarifies the grandfathering provision related to the 3-year minimum lifetime requirement for Durable Medical Equipment (DME). It also provides clarification of the definition of routinely purchased DME. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 07/08/13 78 FR 40835 NPRM Comment Period End............. 08/30/13 ....................... Final Action........................ 12/02/13 78 FR 72156 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Michelle Cruse, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C5-05-27, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-7540, Email: michelle.cruse@cms.hhs.gov. RIN: 0938-AR55 169. Revisions to Payment Policies Under the Physician Fee Schedule and Medicare Part B for CY 2014 (CMS-1600-FC) (Completion of a Section 610 Review) Legal Authority: Social Security Act, secs 1102, 1871, 1848 Abstract: This final rule revises payment polices under the Medicare physician fee schedule, and make other policy changes to payment under Medicare Part B. These changes are applicable to services furnished on or after January 1, annually. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 07/19/13 78 FR 43282 NPRM Comment Period End............. 09/06/13 ....................... Final Action........................ 12/10/13 78 FR 74230 ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Kathy Bryant, Director, Division of Practitioner Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C4-01-27, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-3448, Email: kathy.bryant@cms.hhs.gov. RIN: 0938-AR56 170. CY 2015 Notice of Benefit and Payment Parameters (CMS-9954-F) (Completion of a Section 610 Review) Legal Authority: Pub. L. 111-148 Abstract: This final rule establishes the CY 2015 payment parameters for the cost-sharing reductions, advance premium tax credit, reinsurance, and risk adjustment programs as required by the Affordable Care Act. Timetable: ------------------------------------------------------------------------ Action Date FR Cite ------------------------------------------------------------------------ NPRM................................ 12/02/13 78 FR 72322 NPRM Comment Period End............. 12/26/13 ....................... Final Action........................ 03/11/14 79 FR 13743 Final Action Effective.............. 05/12/14 ....................... ------------------------------------------------------------------------ Regulatory Flexibility Analysis Required: Yes. Agency Contact: Sharon Arnold, Director, Payment Policy and Financial Management Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Consumer Information & Insurance Oversight, Mail Stop 733H.02, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 301 492-4286, Email: sharon.arnold@cms.hhs.gov. RIN: 0938-AR89 [FR Doc. 2014-13125 Filed 6-12-14; 8:45 am] BILLING CODE 4150-24-P
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