Notices. Semiannual Regulatory Agenda

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BILLING CODE 6450-01-P 78 141 Tuesday, July 23, 2013 Unified Agenda Part VIII Department of Health and Human Services Semiannual Regulatory Agenda 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 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, Washington, DC 20201. 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. The purpose of the agenda is to encourage more effective public participation in the regulatory process. HHS is currently furthering this goal by engaging in a Department-wide effort to identify ways to make the rulemaking process more accessible to the general public. This effort is in response to President Obama's January 18, 2011, Executive Order 13563, “Improving Regulation and Regulatory Review,” which requires ongoing retrospective review of current agency regulations and encourages federal agencies to develop balanced regulations through a process that “allows for public participation and an open exchange of ideas.” HHS's efforts include stakeholder outreach and continuing to update its main regulatory Web page ( *http://www.HHS.gov/Regulations* ) with information helpful to the public. For example, to encourage public participation, the Web page includes links to HHS rules currently open for public comment and provides a “regulations toolkit” with background information on regulations, the commenting process, and how the public can provide effective comments. HHS also actively encourages meaningful public participation in retrospective review and rulemaking through education and outreach ( *http://www.HHS.gov/RetrospectiveReview* ). The rulemaking abstracts included in this paper issue of the **Federal Register** only cover, as required by the Regulatory Flexibility Act of 1980, those prospective HHS rulemakings likely to have a significant economic impact on a substantial number of small entities. The Department's complete Regulatory Agenda is accessible online at *http://www.RegInfo.gov.* Dated: April 22, 2013. Jennifer M. Cannistra, Executive Secretary to the Department. Food and Drug Administration—Prerule Stage Sequence No. Title Regulation Identifier No. 1 Over-the-Counter

(OTC)Drug Review—Sunscreen Products 0910-AF43 2 Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures (Section 610 Review) 0910-AG14 Food and Drug Administration—Proposed Rule Stage Sequence No. Title Regulation Identifier No. 3 Food Labeling; Revision of the Nutrition and Supplement Facts Labels 0910-AF22 4 Serving Sizes of Foods That Can Reasonably Be Consumed in One Eating Occasion; Dual Column Labeling; Updating, Modifying and Establishing Certain Reference Amounts Customarily Consumed 0910-AF23 5 Over-the-Counter

(OTC)Drug Review—Cough/Cold (Antihistamine) Products 0910-AF31 6 Over-the-Counter

(OTC)Drug Review—Internal Analgesic Products 0910-AF36 7 Over-the-Counter

(OTC)Drug Review—Topical Antimicrobial Drug Products 0910-AF69 8 Laser Products; Proposed Amendment to Performance Standard 0910-AF87 9 Updated Standards for Labeling of Pet Food 0910-AG09 10 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals 0910-AG10 11 Over-the-Counter

(OTC)Drug Review—Pediatric Dosing for Cough/Cold Products 0910-AG12 12 Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products 0910-AG18 13 Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals—Second Phase 0910-AG20 14 Produce Safety Regulation 0910-AG35 15 Hazard Analysis and Risk-Based Preventive Controls 0910-AG36 16 “Tobacco Products” Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act 0910-AG38 17 Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives 0910-AG59 18 Foreign Supplier Verification Program 0910-AG64 19 Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals—Components 0910-AG70 20 Requirements for the Submission of Data Needed to Calculate User Fees for Manufacturers and Importers of Tobacco Products 0910-AG81 21 Food Labeling: Serving Sizes; Reference Amount and Serving Size Declaration for Hard Candies and Breath Mints 0910-AG82 22 Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products 0910-AG94 23 Veterinary Feed Directive 0910-AG95 24 Format and Content of Reports Intended to Demonstrate Substantial Equivalence 0910-AG96 25 Radiology Devices; Designation of Special Controls for the Computed Tomography X-Ray System 0910-AH03 26 Mammography Quality Standards Act; Regulatory Amendments 0910-AH04 Food and Drug Administration—Final Rule Stage Sequence No. Title Regulation Identifier No. 27 Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling 0910-AF11 28 Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports; and Quality Factors 0910-AF27 29 Over-the-Counter

(OTC)Drug Review—Cough/Cold (Combination) Products 0910-AF33 30 Unique Device Identification 0910-AG31 31 Food Labeling: Calorie Labeling of Articles of Food Sold in Vending Machines 0910-AG56 32 Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments 0910-AG57 33 Use of Certain Symbols in Labeling 0910-AG74 34 Food Labeling; Gluten-Free Labeling of Foods 0910-AG84 Food and Drug Administration—Long-Term Actions Sequence No. Title Regulation Identifier No. 35 Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices 0910-AG48 Food and Drug Administration—Completed Actions Sequence No. Title Regulation Identifier No. 36 Food Labeling: Serving Sizes; Reference Amounts for Candies 0910-AG83 Centers for Medicare & Medicaid Services—Proposed Rule Stage Sequence No. Title Regulation Identifier No. 37 Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers (CMS-3178-P) (Section 610 Review) 0938-AO91 38 Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System for CY 2014 (CMS-1601-P) 0938-AR54 39 Revisions to Payment Policies Under the Physician Fee Schedule and Medicare Part B for CY 2014 (CMS-1600-P) 0938-AR56 40 Prospective Payment System for Federally Qualified Health Centers (FQHCs) (CMS-1443-P) (Section 610 Review) 0938-AR62 Centers for Medicare & Medicaid Services—Final Rule Stage Sequence No. Title Regulation Identifier No. 41 Covered Outpatient Drugs (CMS-2345-F) (Section 610 Review) 0938-AQ41 42 Changes to the Hospital Inpatient and Long-Term Care Prospective Payment System for FY 2014 (CMS-1599-F) 0938-AR53 Centers for Medicare & Medicaid Services—Completed Actions Sequence No. Title Regulation Identifier No. 43 Transparency Reports and Reporting of Physician Ownership of Investment Interests (CMS-5060-F) 0938-AR33 44 Part B Inpatients Billings in Hospitals (CMS-1455-F) 0938-AR73 DEPARTMENT OF HEALTH AND HUMAN SERVICES

(HHS)Food and Drug Administration

(FDA)Prerule Stage 1. 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 Repellent) 02/22/07 72 FR 7941 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 End 09/15/11 ANPRM (Dosage Forms) 06/17/11 76 FR 35669 ANPRM (Dosage Forms) Comment Period End 09/15/11 ANPRM (Safety) 11/00/13 *Regulatory Flexibility Analysis Required:* Yes. *Agency Contact:* David Eng, Regulatory Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5487, 10903 New Hampshire Avenue, Silver Spring, MD 20993, *Phone:* 301 796-2773, *Fax:* 301 796-9899, *Email: david.eng@fda.hhs.gov.* *RIN:* 0910-AF43 2. Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures (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 is currently reviewing regulations promulgated under the Prescription Drug Marketing Act (PDMA). FDA is undertaking this review to determine whether the regulations should be changed or rescinded to minimize adverse impacts on a substantial number of small entities. FDA has extended again the completion date by 1 year and will complete the review by November 2013. *Timetable:* Action Date FR Cite Begin Review of Current Regulation 11/24/08 End Review of Current Regulation 11/00/13 *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 DEPARTMENT OF HEALTH AND HUMAN SERVICES

(HHS)Food and Drug Administration

(FDA)Proposed Rule Stage 3. 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 11/00/13 *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:* 240 402-1450, *Email: blakeley.fitzpatrick@fda.hhs.gov.* *RIN:* 0910-AF22 4. Serving Sizes of Foods That Can Reasonably Be Consumed in One Eating Occasion; Dual Column Labeling; Updating, Modifying and Establishing Certain Reference Amounts Customarily Consumed *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 and providing for dual-column labeling, which would provide nutrition information per serving and per container, for certain containers. *Timetable:* Action Date FR Cite ANPRM 04/04/05 70 FR 17010 ANPRM Comment Period End 06/20/05 NPRM 11/00/13 *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:* 202 402-1450, *Fax:* 301 436-1191, *Email: cherisa.henderson@fda.hhs.gov.* *RIN:* 0910-AF23 5. 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) 11/00/13 *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 6. 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 and Other Labeling) 12/26/06 71 FR 77314 NPRM Comment Period End 05/25/07 Final Action (Required Warnings and Other Labeling) 04/29/09 74 FR 19385 Final Action (Correction) 06/30/09 74 FR 31177 Final Action (Technical Amendment) 11/25/09 74 FR 61512 NPRM (Amendment) (Acetaminophen) 12/00/13 NPRM (Amendment) (Pediatric) 12/00/13 *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 7. Over-the-Counter

(OTC)Drug Review—Topical Antimicrobial Drug Products *Legal Authority:* 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371 *Abstract:* The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses antimicrobial agents in consumer hand wash 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) 09/00/13 *Regulatory Flexibility Analysis Required:* Yes. *Agency Contact:* David Eng, Regulatory Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5487, 10903 New Hampshire Avenue, Silver Spring, MD 20993, *Phone:* 301 796-2773, *Fax:* 301 796-9899, *Email: david.eng@fda.hhs.gov.* *RIN:* 0910-AF69 8. Laser Products; Proposed Amendment to Performance Standard *Legal Authority:* 21 U.S.C. 360hh to 360ss; 21 U.S.C. 371; 21 U.S.C. 393 *Abstract:* FDA is proposing to amend the 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 proposed 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 *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 9. 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 04/00/14 *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 10. Current Good Manufacturing Practice, 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:* FDA is proposing regulations for 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 08/00/13 *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 11. 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 11/00/13 *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-AG12 12. 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 10/00/13 *Regulatory Flexibility Analysis Required:* Yes. *Agency Contact:* Janet Norden, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6324, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, *Phone:* 301 796-2500, *Email: janet.norden@fda.hhs.gov.* *RIN:* 0910-AG18 13. Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals—Second Phase *Legal Authority:* 21 U.S.C. 321; 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 355; 21 U.S.C. 360b; 21 U.S.C. 371; 21 U.S.C. 374; 42 U.S.C. 262; 42 U.S.C. 264 *Abstract:* FDA will revise regulations for “current good manufacturing practice” for oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products. This revision will update and harmonize requirements and improve detection and response to emerging product safety and quality signals. *Timetable:* Action Date FR Cite NPRM 01/00/14 *Regulatory Flexibility Analysis Required:* Yes. *Agency Contact:* Paula Katz, Regulatory Counsel, Office of Compliance, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 4314, 10903 New Hampshire Avenue, Silver Spring, MD 20993, *Phone:* 301 796-6972, *Fax:* 301 847-8742, *Email: paula.katz@fda.hhs.gov.* *RIN:* 0910-AG20 14. 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 Jan. 4, 2011) *Abstract:* FDA is proposing to 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 proposed 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 *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 15. Hazard Analysis and Risk-Based Preventive Controls *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 proposed 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 Extended 04/26/13 78 FR 24691 NPRM Comment Period End 09/16/13 *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 16. “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 product” to be subject to the FD&C Act and would specify additional restrictions. *Timetable:* Action Date FR Cite NPRM 10/00/13 *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 17. 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 12/00/13 *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 18. 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:* FDA is proposing regulations that describe 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 07/00/13 *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 19. Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals—Components *Legal Authority:* 21 U.S.C. 321; 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 355; 21 U.S.C. 360b; 21 U.S.C. 360bbb-7; 21 U.S.C. 371; 21 U.S.C. 374; 42 U.S.C. 262; 42 U.S.C. 264 *Abstract:* FDA will revise regulations for “current good manufacturing practice” with regard to the control over components used in manufacturing finished pharmaceuticals. *Timetable:* Action Date FR Cite NPRM 07/00/13 *Regulatory Flexibility Analysis Required:* Yes. *Agency Contact:* Brian Hasselbalch, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 4364, 10903 New Hampshire Avenue, Silver Spring, MD 20993, *Phone:* 301 796-3279, *Email: brian.hasselbalch@fda.hhs.gov.* Paula Katz, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 1320, 10903 New Hampshire Avenue, Silver Spring, MD 20993, *Phone:* 301 796-6972, *Email: paula.katz@fda.hhs.gov.* *RIN:* 0910-AG70 20. Requirements for the Submission of Data Needed To Calculate User Fees for Manufacturers and Importers of Tobacco Products *Legal Authority:* 21 U.S.C. 371; 21 U.S.C. 387s; Pub. L. 111-31 *Abstract:* FDA is proposing to 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 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 *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 21. Food Labeling: Serving Sizes; Reference Amount and Serving Size Declaration for Hard Candies and Breath Mints *Legal Authority:* 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371 *Abstract:* FDA is proposing to change the nutrition label serving size for breath mints to one unit. FDA is taking this action in response to a citizen petition that requested a serving size for breath mints that more accurately reflects the amount customarily consumed per eating occasion and comments received on an advance notice of proposed rulemaking published in 2005. *Timetable:* Action Date FR Cite NPRM 12/30/97 62 FR 67775 NPRM Comment Period End 03/16/98 ANPRM 04/05/05 70 FR 17010 ANPRM Comment Period End 06/20/05 NPRM 07/00/13 *Regulatory Flexibility Analysis Required:* Yes. *Agency Contact:* Mark Kantor, Nutritionist, Department of Health and Human Services, Food and Drug Administration, HFS-830, 5100 Paint Branch Parkway, College Park, MD 20740, *Phone:* 240 402-1450, *Fax:* 301 436-1191, *Email: mark.kantor@fda.hhs.gov.* *RIN:* 0910-AG82 22. • 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 proposed 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. The proposed rule would describe the process by which information regarding a “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. The proposed rule also would clarify requirements for the NDA holder for the reference listed drug and all ANDA holders to submit conforming labeling revisions after FDA has taken an action on the NDA and/or ANDA holder's CBE labeling supplement. These proposed revisions to FDA's regulations would create parity between NDA holders and ANDA holders with respect to submission of CBE labeling supplements. *Timetable:* Action Date FR Cite NPRM 09/00/13 *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 6304, 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 23. • 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 drugs (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 09/00/13 *Regulatory Flexibility Analysis Required:* Yes. *Agency Contact:* Sharon Benz, 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 24. • 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 06/00/14 *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 25. • Radiology Devices; Designation of Special Controls for the Computed Tomography X-Ray System *Legal Authority:* 21 U.S.C. 360 *Abstract:* The proposed rule would establish special controls for the computed tomography

(CT)x-ray system, a class II device as defined in 21 CFR 892.1750. 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, or, in extremely high doses, radiation poisoning. Therefore, the design of a CT x-ray system needs to 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 special controls, combined with the general controls, to provide reasonable assurance of the safety and effectiveness of a class II CT x-ray system. *Timetable:* Action Date FR Cite NPRM 12/00/13 *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 26. • 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 12/00/13 *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 DEPARTMENT OF HEALTH AND HUMAN SERVICES

(HHS)Food and Drug Administration

(FDA)Final Rule Stage 27. 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 (21 CFR 201.56 and 201.57) 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 01/00/14 *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 28. 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 in 21 CFR parts 106 and 107 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 Final Rule 07/00/13 *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 29. Over-the-Counter

(OTC)Drug Review—Cough/Cold (Combination) 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 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 10/00/13 *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 30. Unique Device Identification *Legal Authority:* 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 360; 21 U.S.C. 360h; 21 U.S.C. 360i; 21 U.S.C. 360j; 21 U.S.C. 360l; 21 U.S.C. 371 *Abstract:* FDA is issuing a final rule establishing a unique device identification system for medical devices. A unique device identification system would allow healthcare professionals and others to rapidly and precisely identify a device and obtain important information concerning the device and would reduce medical errors. *Timetable:* Action Date FR Cite NPRM 07/10/12 77 FR 40735 NPRM Comment Period End 11/07/12 Second NPRM 11/19/12 77 FR 69393 Second NPRM Comment Period End 12/19/13 Final Action 07/00/13 *Regulatory Flexibility Analysis Required:* Yes. *Agency Contact:* John J. Crowley, Senior Advisor for Patient Safety, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, WO 66, Room 2315, 10903 New Hampshire Avenue, Silver Spring, MD 20993, *Phone:* 301 980-1936, *Email: jay.crowley@fda.hhs.gov.* *RIN:* 0910-AG31 31. 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 09/00/13 *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 32. 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 09/00/13 *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 33. Use of Certain Symbols in Labeling *Legal Authority:* sec 502(c) of the Food Drug and Cosmetic Act (FD&C Act), 21 U.S.C. 352(c); sec 514(c) of FD&C Act, 21 U.S.C. 360d(c), enacted by the Food and Drug Modernization Act of 1997 (FDAMA) *Abstract:* The purpose of this rule is to allow for the inclusion of certain stand-alone symbols contained in a standard that FDA recognizes, provided that such symbols are explained in a symbols glossary that contemporaneously accompanies the medical device. *Timetable:* Action Date FR Cite NPRM 04/19/13 78 FR 23508 NPRM Comment Period End 06/18/13 Final Action 04/00/14 *Regulatory Flexibility Analysis Required:* Yes. *Agency Contact:* Mary Follette Story, Human Factors and Accessible Medical Technology Specialist, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Room 2553, 10903 New Hampshire Avenue, Silver Spring, MD 20993, *Phone:* 301 796-1456, *Email: molly.story@fda.hhs.gov.* *RIN:* 0910-AG74 34. Food Labeling; Gluten-Free Labeling of Foods *Legal Authority:* title II of Pub. L. 108-282; 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 342; 21 U.S.C. 343; 21 U.S.C. 348; 21 U.S.C. 371 *Abstract:* FDA is amending its regulations to define the term “gluten-free” for voluntary use in the labeling of foods. FDA is taking this action to assist persons who have celiac disease to more easily identify foods that they can eat while following a “gluten-free” diet. *Timetable:* Action Date FR Cite NPRM 01/23/07 72 FR 2795 NPRM Comment Period End 04/23/07 NPRM Comment Period Reopened 08/03/11 76 FR 46671 NPRM Comment Period Reopened End 10/03/11 Final Action 07/00/13 *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: felicia.billingslea@fda.hhs.gov.* *RIN:* 0910-AG84 DEPARTMENT OF HEALTH AND HUMAN SERVICES

(HHS)Food and Drug Administration

(FDA)Long-Term Actions 35. 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 conducted in support of a premarket approval application, humanitarian device exemption application, an investigational device exemption application, or a premarket notification submission for a medical device. *Timetable:* Action Date FR Cite NPRM 02/25/13 78 FR 12664 NPRM Comment Period End 05/28/13 Final Action 09/00/14 *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 DEPARTMENT OF HEALTH AND HUMAN SERVICES

(HHS)Food and Drug Administration

(FDA)Completed Actions 36. Food Labeling: Serving Sizes; Reference Amounts for Candies *Legal Authority:* 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371 *Abstract:* FDA is proposing to change its serving size regulations to provide updated Reference Amounts Customarily Consumed for candies. FDA is taking this action in response to comments received on an advance notice of proposed rulemaking published in 2005. This RIN is being withdrawn from the Unified Agenda and merged with RIN 0910-AG82. *Timetable:* Action Date FR Cite NPRM 01/08/98 63 FR 1078 NPRM Comment Period End 02/09/98 ANPRM 04/05/05 70 FR 17010 ANPRM Comment Period End 06/20/05 Withdrawn 03/11/13 *Regulatory Flexibility Analysis Required:* Yes. *Agency Contact:* Mark Kantor, Nutritionist, Department of Health and Human Services, Food and Drug Administration, HFS-830, 5100 Paint Branch Parkway, College Park, MD 20740, *Phone:* , 240 402-1450, *Fax:* 301 436-1191, *Email: mark.kantor@fda.hhs.gov.* *RIN:* 0910-AG83 DEPARTMENT OF HEALTH AND HUMAN SERVICES

(HHS)Centers for Medicare & Medicaid Services

(CMS)Proposed Rule Stage 37. Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers (CMS-3178-P) (Section 610 Review) *Legal Authority:* 42 U.S.C. 1821; 42 U.S.C. 1861

(ff)(3)(B)(i)(ii); 42 U.S.C. 1913 (c)(1) et al *Abstract:* This rule proposes 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 would ensure 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 09/00/13 *Regulatory Flexibility Analysis Required:* Yes. *Agency Contact:* Janice Graham, Health Insurance Specialist, Clincal Standards Group, 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: janice.graham@cms.hhs.gov.* *RIN:* 0938-AO91 38. Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System for CY 2014 (CMS-1601-P) *Legal Authority:* sec 1833 of the Social Security Act *Abstract:* This proposed rule would revise the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. The proposed rule also 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 07/00/13 *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-AR54 39. Revisions to Payment Policies Under the Physician Fee Schedule and Medicare Part B for CY 2014 (CMS-1600-P) *Legal Authority:* Social Security Act secs 1102, 1871, 1848 *Abstract:* This 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 be applicable to services furnished on or after January 1 annually. *Timetable:* Action Date FR Cite NPRM 07/00/13 *Regulatory Flexibility Analysis Required:* Yes. *Agency Contact:* Kathy Bryant, Deputy 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 40. Prospective Payment System for Federally Qualified Health Centers (FQHCS) (CMS-1443-P) (Section 610 Review) *Legal Authority:* Pub. L. 111-148, sec 10501 *Abstract:* The Affordable Care Act amends the current Medicare FQHC payment policy by requiring the establishment of a new payment system, effective with cost reporting periods beginning on or after October 1, 2014. This rule proposes the establishment of the new prospective payment system. *Timetable:* Action Date FR Cite NPRM 09/00/13 *Regulatory Flexibility Analysis Required:* Yes. *Agency Contact:* Sarah Harding, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C4-01-26, 7500 Security Boulevard, Windsor Mill, MD 21244, *Phone:* 410 786-4001, *Email: sarah.harding@cms.hhs.gov.* *RIN:* 0938-AR62 DEPARTMENT OF HEALTH AND HUMAN SERVICES

(HHS)Centers for Medicare & Medicaid Services

(CMS)Final Rule Stage 41. 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 01/00/14 *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.* *RIN:* 0938-AQ41 42. Changes to the Hospital Inpatient and Long-Term Care Prospective Payment System for FY 2014 (CMS-1599-F) *Legal Authority:* sec 1886(d) of the Social Security Act *Abstract:* This annual 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 05/10/13 78 FR 27485 NPRM Comment Period End 06/25/13 Final Action 08/00/13 *Regulatory Flexibility Analysis Required:* Yes. *Agency Contact:* Roechel Kujawa, 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:* 410 786-9111, *Email: roechel.kujawa@cms.hhs.gov.* *RIN:* 0938-AR53 DEPARTMENT OF HEALTH AND HUMAN SERVICES

(HHS)Centers for Medicare & Medicaid Services

(CMS)Completed Actions 43. Transparency Reports and Reporting of Physician Ownership of Investment Interests (CMS-5060-F) *Legal Authority:* Pub. L. 111-148, sec 6002 *Abstract:* This final rule requires applicable manufacturers of drugs, devices, biologicals, or medical supplies covered by Medicare, Medicaid, or CHIP to annually report to the Secretary certain payments or transfers of value provided to physicians or teaching hospitals (covered recipients). In addition, applicable manufacturers and applicable group purchasing organizations

(GPOs)are required to annually report certain physician ownership or investment interests. *Timetable:* Action Date FR Cite NPRM 12/19/11 76 FR 78742 NPRM Comment Period End 02/17/12 Final Action 02/08/13 78 FR 9457 *Regulatory Flexibility Analysis Required:* Yes. *Agency Contact:* Niall Brennan, Director, Policy and Data Analysis Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244, *Phone:* 202 690-6627, *Email: niall.brennan@cms.hhs.gov.* *RIN:* 0938-AR33 44. Part B Inpatients Billings in Hospitals (CMS-1455-F) *Legal Authority:* 42 U.S.C. 1302; 42 U.S.C. 1395hh; 42 U.S.C. 1395rr (b)(1) *Abstract:* This final rule revises Medicare Part B billings policies when a Part A claim for a hospital inpatient admission is denied as not medically reasonable and necessary. *Timetable:* Action Date FR Cite NPRM 03/18/13 78 FR 16632 NPRM Comment Period End 05/17/13 Merged With 0938-AR53 04/23/13 *Regulatory Flexibility Analysis Required:* Yes. *Agency Contact:* Twi Jackson, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244, *Phone:* 410 786-1159, *Email: twi.jackson@cms.hhs.gov.* *RIN:* 0938-AR73 [FR Doc. 2013-17060 Filed 7-22-13; 8:45 am]

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