Regulatory Agenda, 1574-1585 [2012-31671]

Download as PDF 1574 Federal Register / Vol. 78, No. 5 / Tuesday, January 8, 2013 / Unified Agenda The Department of Health and Human Services (HHS) is the Federal Office of the Secretary Government’s principal agency for protecting the health of all Americans 21 CFR Ch. I and providing essential human services, especially for those who are least able 25 CFR Ch. V to help themselves. The mission of HHS is to enhance the health and well-being 42 CFR Chs. I, II, III, IV and V of Americans by providing for effective health and human services and by 45 CFR Subtitle A; Subtitle B, Chs. II, fostering sound, sustained advances in III, and XIII the sciences underlying medicine, public health, and social services. This Regulatory Agenda agenda presents the rulemaking activities that the Department expects to AGENCY: Office of the Secretary, HHS. undertake in the foreseeable future to ACTION: Semiannual Regulatory Agenda. advance this mission. The agenda SUMMARY: The Regulatory Flexibility Act furthers several Departmental goals, including strengthening health care; of 1980 and Executive Order 12866 require the Department semiannually to advancing scientific knowledge and issue an inventory of rulemaking actions innovation; advancing the health, safety, and well-being of the American people; under development to provide the increasing efficiency, transparency, and public a summary of forthcoming regulatory actions. This information will accountability of HHS programs; and strengthening the Nation’s health and help the public more effectively human services infrastructure and participate in the Department’s workforce. regulatory activity, and the Department welcomes comments on any aspect of The purpose of the agenda is to this agenda. encourage more effective public participation in the regulatory process. FOR FURTHER INFORMATION CONTACT: HHS is currently furthering this goal by Jennifer M. Cannistra, Executive engaging in a Department-wide effort to Secretary, Department of Health and identify ways to make the rulemaking Human Services, Washington, DC process more accessible to the general 20201. SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND HUMAN SERVICES 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 continuing to update its main regulatory Web site to highlight useful information for the public, such as HHS rules currently open for public comment, and actively encouraging meaningful public participation in retrospective review and rulemaking through education and outreach. 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 www.reginfo.gov in an interactive format that offers users enhanced capabilities to obtain information from the agenda’s database. Dated: August 30, 2012. Jennifer M. Cannistra, Executive Secretary to the Department. SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION—COMPLETED ACTIONS Regulation Identifier No. Sequence No. Title 265 .................... Opioid Drugs in Maintenance or Detoxification Treatment of Opiate Addiction (Completion of a Section 610 Review). 0930–AA14 CENTERS FOR DISEASE CONTROL AND PREVENTION—PROPOSED RULE STAGE Regulation Identifier No. Sequence No. Title 266 .................... Establishment of Minimum Standards for Birth Certificates ............................................................................ 0920–AA46 FOOD AND DRUG ADMINISTRATION—PRERULE STAGE Regulation Identifier No. Sequence No, Title 267 .................... Over-the-Counter (OTC) Drug Review—Sunscreen Products ........................................................................ 0910–AF43 FOOD AND DRUG ADMINISTRATION—PROPOSED RULE STAGE Regulation Identifier No. mstockstill on DSK4VPTVN1PROD with Sequence No. Title 268 .................... 269 .................... Food Labeling; Revision of the Nutrition and Supplement Facts Labels ........................................................ Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed in One Eating Occasion; Dual Column Labeling; and Modifying the Reference Amounts Customarily Consumed. Over-the-Counter (OTC) Drug Review—Cough/Cold (Antihistamine) Products ............................................. Over-the-Counter (OTC) Drug Review—Internal Analgesic Products ............................................................ Over-the-Counter (OTC) Drug Review—Topical Antimicrobial Drug Products ............................................... 270 .................... 271 .................... 272 .................... VerDate Mar<15>2010 19:43 Jan 07, 2013 Jkt 229001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP8.SGM 08JAP8 0910–AF22 0910–AF23 0910–AF31 0910–AF36 0910–AF69 Federal Register / Vol. 78, No. 5 / Tuesday, January 8, 2013 / Unified Agenda 1575 FOOD AND DRUG ADMINISTRATION—PROPOSED RULE STAGE—Continued Regulation Identifier No. Sequence No. Title 273 .................... 274 .................... Laser Products; Amendment to Performance Standard .................................................................................. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (Reg Plan Seq No. 33). Over-the-Counter (OTC) Drug Review—Pediatric Dosing for Cough/Cold Products ..................................... Electronic Distribution of Prescribing Information for Human Drugs Including Biological Products ............... Produce Safety Regulation (Reg Plan Seq No. 34) ....................................................................................... Hazard Analysis and Risk-Based Preventive Controls (Reg Plan Seq No. 35) ............................................ ‘‘Tobacco Products’’ Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act. General Hospital and Personal Use Devices: Issuance of Draft Special Controls Guidance for Infusion Pumps. Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals— Components. Use of Symbols in Labeling ............................................................................................................................. Requirements for the Submission of Data Needed to Calculate User Fees for Manufacturers and Importers of Tobacco Products. Food Labeling: Hard Candies and Breath Mints ............................................................................................. Food Labeling: Serving Sizes; Reference Amounts for Candies .................................................................... 275 276 277 278 279 .................... .................... .................... .................... .................... 280 .................... 281 .................... 282 .................... 283 .................... 284 .................... 285 .................... 286 .................... 0910–AF87 0910–AG10 0910–AG12 0910–AG18 0910–AG35 0910–AG36 0910–AG38 0910–AG54 0910–AG59 0910–AG70 0910–AG74 0910–AG81 0910–AG82 0910–AG83 References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register. FOOD AND DRUG ADMINISTRATION—FINAL RULE STAGE Regulation Identifier No. Sequence No. Title 287 .................... Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports; and Quality Factors. Over-the-Counter (OTC) Drug Review—Cough/Cold (Combination) Products .............................................. Unique Device Identification (Reg Plan Seq No. 39) ..................................................................................... Food Labeling: Nutrition Labeling for Food Sold in Vending Machines (Reg Plan Seq No. 40) ................... Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments (Reg Plan Seq No. 41). 288 289 290 291 .................... .................... .................... .................... 0910–AF27 0910–AF33 0910–AG31 0910–AG56 0910–AG57 References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register. FOOD AND DRUG ADMINISTRATION—LONG-TERM ACTIONS Regulation Identifier No. Sequence No. Title 292 .................... 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—COMPLETED ACTIONS Regulation Identifier No. Sequence No. Title 293 .................... Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics .................................. 0910–AC52 CENTERS FOR MEDICARE & MEDICAID SERVICES—PROPOSED RULE STAGE Regulation Identifier No. Sequence No. Title 294 .................... Emergency Preparedness Requirements for Medicare Participating Providers and Suppliers (CMS–3178– P) (Section 610 Review). Changes to the Hospital Inpatient and Long-Term Care Prospective Payment System for FY 2014 (CMS– 1599–P) (Reg Plan Seq No. 45). Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System for CY 2014 (CMS–1601–P) (Reg Plan Seq No. 46). Revisions to Payment Policies Under the Physician Fee Schedule and Medicare Part B for CY 2014 (CMS–1600–P) (Reg Plan Seq No. 47). Prospective Payment System for Federally Qualified Health Centers (FQHCs) (CMS–1443–P) (Section 610 Review) (Reg Plan Seq No. 48). 295 .................... mstockstill on DSK4VPTVN1PROD with 296 .................... 297 .................... 298 .................... References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register. VerDate Mar<15>2010 19:43 Jan 07, 2013 Jkt 229001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP8.SGM 08JAP8 0938–AO91 0938–AR53 0938–AR54 0938–AR56 0938–AR62 1576 Federal Register / Vol. 78, No. 5 / Tuesday, January 8, 2013 / Unified Agenda CENTERS FOR MEDICARE & MEDICAID SERVICES—FINAL RULE STAGE Regulation Identifier No. Sequence No. Title 299 .................... Covered Outpatient Drugs (CMS–2345–F) (Section 610 Review) ................................................................ 0938–AQ41 CENTERS FOR MEDICARE & MEDICAID SERVICES—LONG-TERM ACTIONS Regulation Identifier No. Sequence No. Title 300 .................... Transparency Reports and Reporting of Physician Ownership of Investment Interests (CMS–5060–F) ....... 0938–AR33 CENTERS FOR MEDICARE & MEDICAID SERVICES—COMPLETED ACTIONS Regulation Identifier No. Sequence No. Title 301 .................... Administrative Simplification: Standard Unique Identifier for Health Plans and ICD–10 Compliance Date Delay (CMS–0040–F) (Completion of a Section 610 Review). Medicare and Medicaid Electronic Health Record Incentive Program—Stage 2 (CMS–0044–F) .................. Proposed Changes to Hospital OPPS and CY 2013 Payment Rates; ASC Payment System and CY 2013 Payment Rates (CMS–1589–FC) (Completion of a Section 610 Review). Revisions to Payment Policies Under the Physician Fee Schedule and Part B for CY 2013 (CMS–1590– FC) (Completion of a Section 610 Review). Changes to the Hospital Inpatient and Long-Term Care Prospective Payment Systems for FY 2013 (CMS–1588–F) (Completion of a Section 610 Review). Home Health Prospective Payment System Rate for CY 2013 (CMS–1358–F) (Completion of a Section 610 Review). 302 .................... 303 .................... 304 .................... 305 .................... 306 .................... DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Action NPRM Comment Period End. Final Action ......... Substance Abuse and Mental Health Services Administration (SAMHSA) Completed Actions mstockstill on DSK4VPTVN1PROD with 265. Opioid Drugs in Maintenance or Detoxification Treatment of Opiate Addiction (Completion of a Section 610 Review) Legal Authority: 21 U.S.C. 823 (9); 42 U.S.C. 257a; 42 U.S.C. 290aa(d); 42 U.S.C. 290dd–2; 42 U.S.C. 300x–23; 42 U.S.C. 300x–27(a); 42 U.S.C. 300y–11 Abstract: This rule would amend the Federal opioid treatment program regulations. It would modify the dispensing requirements for buprenorphine and buprenorphine combination products that are approved by the Food and Drug Administration (FDA) for opioid dependence and used in federally certified and registered opioid treatment programs. In particular, this rule would allow opioid treatment programs more flexibility in dispensing take-home supplies of buprenorphine after the assessment and documentation of patients’ responsibility and stability to receive opioid addiction treatment medication. Timetable: Action Date FR Cite NPRM .................. 06/19/09 74 FR 29153 VerDate Mar<15>2010 19:43 Jan 07, 2013 Jkt 229001 Date 08/18/09 12/06/12 FR Cite Regulatory Flexibility Analysis Required: No. Agency Contact: Nicholas Reuter, Supervising Public Health Advisor, Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Suite 2–1063, One Choke Cherry Road, Rockville, MD 20857 Phone: 240 276– 2716, Email: nicholas.reuter@samhsa.hhs.gov. RIN: 0930–AA14 Date NPRM .................. 77 FR 72752 Action 0938–AQ13 0938–AQ84 0938–AR10 0938–AR11 0938–AR12 0938–AR18 FR Cite 03/00/13 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Charles Rothwell, Director, Division of Vital Statistics, Department of Health and Human Services, Centers for Disease Control and Prevention, 3311 Toledo Road, Room 7311, M, Hyattsville, MD 20782, Phone: 301 458–4555. RIN: 0920–AA46 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Disease Control and Prevention (CDC) Proposed Rule Stage 266. Establishment of Minimum Standards for Birth Certificates Legal Authority: 42 U.S.C. 264 Abstract: This proposed rule establishes minimum standards to improve security related to the use of birth certificates by Federal agencies for official purposes. Timetable: PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 Prerule Stage 267. 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 E:\FR\FM\08JAP8.SGM 08JAP8 Federal Register / Vol. 78, No. 5 / Tuesday, January 8, 2013 / Unified Agenda will address the safety of sunscreen active ingredients. The second of the future actions will address active ingredients reviewed under time and extent applications. Timetable: Action Action Date FR Cite ANPRM (Sunscreen and Insect Repellent). ANPRM Comment Period End. NPRM (UVA/ UVB). NPRM Comment Period End. Final Action (UVA/ UVB). NPRM (Effectiveness). NPRM (Effectiveness) Comment Period End. ANPRM (Dosage Forms). ANPRM (Dosage Forms) Comment Period End. ANPRM (Safety) NPRM (Time and Extent Applications). 02/22/07 72 FR 7941 05/23/07 08/27/07 72 FR 49070 12/26/07 06/17/11 76 FR 35620 06/17/11 76 FR 35672 09/15/11 06/17/11 76 FR 35669 09/15/11 07/00/13 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–AF43 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Date FR Cite ANPRM ............... ANPRM Comment Period End. ANPRM ............... ANPRM Comment Period End. ANPRM ............... ANPRM Comment Period End. NPRM .................. 07/11/03 10/09/03 68 FR 41507 04/04/05 06/20/05 70 FR 17008 11/02/07 01/31/08 72 FR 62149 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 269. Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed in One Eating Occasion; Dual Column Labeling; and Modifying the 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: Proposed Rule Stage Action mstockstill on DSK4VPTVN1PROD with 268. 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: VerDate Mar<15>2010 19:43 Jan 07, 2013 02/00/13 Jkt 229001 Date FR Cite ANPRM ............... ANPRM Comment Period End. NPRM .................. 04/04/05 06/20/05 70 FR 17010 02/00/13 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. PO 00000 Frm 00005 Fmt 4701 Sfmt 4702 1577 RIN: 0910–AF23 270. 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). The objectives of the RCC monograph alignment working group are to conduct a pilot program to develop aligned monograph elements for a selected overthe-counter (OTC) drug category (e.g., aligned directions, warnings, indications, and conditions of use) and subsequently, develop recommendations to determine the feasibility of an ongoing mechanism for alignment in review and adoption of these OTC drug monograph elements. Timetable: Action Date FR Cite Reopening of Administrative Record. Comment Period End. NPRM (Amendment) (Common Cold). 08/25/00 65 FR 51780 11/24/00 06/00/13 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Mary Chung, Regulatory Health Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796–0260, Fax: 301 796–9899, Email: mary.chung@fda.hhs.gov. RIN: 0910–AF31 271. 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 E:\FR\FM\08JAP8.SGM 08JAP8 1578 Federal Register / Vol. 78, No. 5 / Tuesday, January 8, 2013 / Unified Agenda acetaminophen safety. The second action addresses products marketed for children under 2 years old and weightand age-based dosing for children’s products. Timetable: Action Date FR Cite NPRM (Amendment) (Required Warnings and Other Labeling). NPRM Comment Period End. Final Action (Required Warnings and Other Labeling). Final Action (Correction). Final Action (Technical Amendment). NPRM (Amendment) (Acetaminophen). NPRM (Amendment) (Pediatric). 12/26/06 71 FR 77314 05/25/07 04/29/09 74 FR 19385 06/30/09 74 FR 31177 11/25/09 74 FR 61512 08/00/13 12/00/13 mstockstill on DSK4VPTVN1PROD with 272. 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. The first action addresses consumer hand wash products. The second action addresses consumer leave-on antiseptic products. Timetable: Action Date FR Cite NPRM (Healthcare). Comment Period End. 06/17/94 59 FR 31402 12/15/95 19:43 Jan 07, 2013 Date NPRM (Consumer Hand Wash Products). NPRM (Consumer Leave-on Products). FR Cite 02/00/13 07/00/13 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 273. Laser Products; Amendment to Performance Standard Regulatory Flexibility Analysis Required: Yes. Agency Contact: Mary Chung, Regulatory Health Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796–0260, Fax: 301 796–9899, Email: mary.chung@fda.hhs.gov. RIN: 0910–AF36 VerDate Mar<15>2010 Action Jkt 229001 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 NPRM .................. FR Cite 12/00/12 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 274. Current Good Manufacturing Practice, Hazard Analysis, and RiskBased Preventive Controls for Food for Animals Regulatory Plan: This entry is Seq. No. 33 in part II of this issue of the Federal Register. RIN: 0910–AG10 PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 275. 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 NPRM .................. FR Cite 06/00/13 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Mary Chung, Regulatory Health Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796–0260, Fax: 301 796–9899, Email: mary.chung@fda.hhs.gov. RIN: 0910–AG12 276. Electronic Distribution of Prescribing Information for Human 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 NPRM .................. 06/00/13 E:\FR\FM\08JAP8.SGM 08JAP8 FR Cite Federal Register / Vol. 78, No. 5 / Tuesday, January 8, 2013 / Unified Agenda Regulatory Flexibility Analysis Required: Yes. Agency Contact: Megan Clark-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.clark@fda.hhs.gov. RIN: 0910–AG18 277. Produce Safety Regulation Regulatory Plan: This entry is Seq. No. 34 in part II of this issue of the Federal Register. RIN: 0910–AG35 Regulatory Plan: This entry is Seq. No. 35 in part II of this issue of the Federal Register. RIN: 0910–AG36 279. ‘‘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: NPRM .................. mstockstill on DSK4VPTVN1PROD with Date 04/00/13 FR Cite 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 VerDate Mar<15>2010 19:43 Jan 07, 2013 Jkt 229001 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 278. Hazard Analysis and Risk-Based Preventive Controls Action 280. General Hospital and Personal Use Devices: Issuance of Draft Special Controls Guidance for Infusion Pumps Date NPRM .................. 03/00/13 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: Date NPRM .................. NPRM Comment Period End. 04/00/13 06/00/13 FR Cite 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. PO 00000 Frm 00007 Fmt 4701 Sfmt 4702 282. 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. 371; 21 U.S.C. 374; 42 U.S.C. 262; 42 U.S.C. 264 Abstract: This rule proposes to amend regulations regarding the control over components used in manufacturing finished pharmaceuticals. Timetable: Action Date NPRM .................. 281. Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives Action RIN: 0910–AG59 FR Cite 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 1579 FR Cite 05/00/13 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 283. Use of 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 proposed rule is to implement section 502(c) of the FD&C Act and to revise 21 CFR 801.15 (prominence of required label statements) using the authority under section 514(c) of the FD&C Act to allow for the inclusion of certain standardized symbols recognized by FDA for use on the labeling of medical devices. If this proposed rule is finalized, certain symbols in compliance with International Standards Organization (ISO) Standard 15223 may be used in medical device labeling with explanatory text or symbols glossary with accompanying labeling, as may other standardized symbols in the future when adopted by a national or international standards development organization and if recognized by FDA guidance or other regulatory action. E:\FR\FM\08JAP8.SGM 08JAP8 1580 Federal Register / Vol. 78, No. 5 / Tuesday, January 8, 2013 / Unified Agenda Timetable: Action Action Date NPRM .................. FR Cite 04/00/13 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 284. 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; PL111–31 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 NPRM .................. 02/00/13 NPRM Comment Period End. ANPRM ............... ANPRM Comment Period End. NPRM .................. 03/16/98 285. Food Labeling: 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 mint. FDA is taking this action in response to comments received on an advance notice of proposed rulemaking published in 2005. Timetable: Action Date 12/30/97 286. 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. Timetable: Action Date FR Cite NPRM .................. NPRM Comment Period End. ANPRM ............... ANPRM Comment Period End. NPRM .................. 01/08/98 02/09/98 63 FR 1078 04/05/05 06/20/05 70 FR 17010 02/00/13 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Mark Kantor, Nutritionist, Department of Health and Human Services, Food and Drug Administration, 5100 Paint Branch Parkway, HFS–830, College Park, MD 20740, Phone: 240 402–1450, Fax: 301 436–1191, Email: mark.kantor@fda.hhs.gov. RIN: 0910–AG83 19:43 Jan 07, 2013 Jkt 229001 PO 00000 Final Rule Stage 287. 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 .................. NPRM Comment Period End. NPRM Comment Period Reopened. NPRM Comment Period Extended. NPRM Comment Period End. NPRM Comment Period Reopened. NPRM Comment Period End. Final Rule ............ 07/09/96 12/06/96 61 FR 36154 04/28/03 68 FR 22341 06/27/03 68 FR 38247 08/26/03 08/01/06 71 FR 43392 09/15/06 04/00/13 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 288. 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 62 FR 67775 VerDate Mar<15>2010 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) 70 FR 17010 02/00/13 FR Cite NPRM .................. 04/05/05 06/20/05 FR Cite Regulatory Flexibility Analysis Required: Yes. Agency Contact: Mark Kantor, Nutritionist, Department of Health and Human Services, Food and Drug Administration, 5100 Paint Branch Parkway, HFS–830, College Park, MD 20740, Phone: 240 402–1450, Fax: 301 436–1191, Email: mark.kantor@fda.hhs.gov. RIN: 0910–AG82 FR Cite 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, 9200 Corporate Boulevard, Room 340K, Rockville, MD 20850, Phone: 877 287–1373, Fax: 240 276–3904, Email: annette.marthaler@fda.hhs.gov. RIN: 0910–AG81 mstockstill on DSK4VPTVN1PROD with Date Frm 00008 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP8.SGM 08JAP8 1581 Federal Register / Vol. 78, No. 5 / Tuesday, January 8, 2013 / Unified Agenda 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). NPRM Comment Period End. Final Action (Technical Amendment). Final Action ......... 07/13/05 70 FR 40232 11/10/05 03/19/07 72 FR 12730 03/00/13 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Mary Chung, Regulatory Health Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796–0260, Fax: 301 796–9899, Email: mary.chung@fda.hhs.gov. RIN: 0910–AF33 289. Unique Device Identification Regulatory Plan: This entry is Seq. No. 39 in part II of this issue of the Federal Register. RIN: 0910–AG31 290. Food Labeling: Nutrition Labeling for Food Sold in Vending Machines Regulatory Plan: This entry is Seq. No. 40 in part II of this issue of the Federal Register. RIN: 0910–AG56 mstockstill on DSK4VPTVN1PROD with VerDate Mar<15>2010 19:43 Jan 07, 2013 Jkt 229001 Food and Drug Administration (FDA) Long-Term Actions 292. 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 December 2013. Timetable: (NDAs), biological license applications (BLAs), and abbreviated new drug applications (ANDAs). The proposal would revise our regulations to require that data submitted for NDAs, BLAs, and ANDAs, and their supplements and amendments, be provided in an electronic format that FDA can process, review, and archive. Timetable: Action Date Withdrawn ........... FR Cite 08/01/12 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Martha Nguyen, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6352, 10903 New Hampshire Avenue, Silver Spring, MD 20993–0002, Phone: 301 796–3471, Fax: 301 847–8440, Email: martha.nguyen@fda.hhs.gov. RIN: 0910–AC52 Action Date FR Cite Begin Review of Current Regulation. End Review of Current Regulation. 11/24/08 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) 12/00/13 Centers for Medicare & Medicaid Services (CMS) Proposed Rule Stage 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) 291. Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments Regulatory Plan: This entry is Seq. No. 41 in part II of this issue of the Federal Register. RIN: 0910–AG57 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Completed Actions 294. Emergency Preparedness Requirements for Medicare 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 will ensure providers and suppliers are adequately prepared to meet the needs of patients, residents, clients, and participants during disasters and emergency situations. Timetable: 293. Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics Action Date NPRM .................. 07/00/13 Legal Authority: 21 U.S.C. 355; 21 U.S.C. 371; 42 U.S.C. 262 Abstract: The Food and Drug Administration is proposing to amend the regulations governing the format in which clinical study data and bioequivalence data are required to be submitted for new drug applications 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, Office of PO 00000 Frm 00009 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP8.SGM 08JAP8 FR Cite 1582 Federal Register / Vol. 78, No. 5 / Tuesday, January 8, 2013 / Unified Agenda 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 295. • Changes to the Hospital Inpatient and Long-Term Care Prospective Payment System for FY 2014 (CMS–1599–P) Regulatory Plan: This entry is Seq. No. 45 in part II of this issue of the Federal Register. RIN: 0938–AR53 296. • Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System for CY 2014 (CMS– 1601–P) Action Date FR Cite DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) NPRM .................. NPRM Comment Period End. Final Action ......... 02/02/12 04/02/12 77 FR 5318 Centers for Medicare & Medicaid Services (CMS) 08/00/13 Completed Actions 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 Regulatory Plan: This entry is Seq. No. 46 in part II of this issue of the Federal Register. RIN: 0938–AR54 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) 297. • Revisions to Payment Policies Under the Physician Fee Schedule and Medicare Part B for CY 2014 (CMS– 1600–P) Long-Term Actions Regulatory Plan: This entry is Seq. No. 47 in part II of this issue of the Federal Register. RIN: 0938–AR56 298. • Prospective Payment System for Federally Qualified Health Centers (FQHCS) (CMS–1443–P) (Section 610 Review) Regulatory Plan: This entry is Seq. No. 48 in part II of this issue of the Federal Register. RIN: 0938–AR62 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) mstockstill on DSK4VPTVN1PROD with 299. 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: VerDate Mar<15>2010 19:43 Jan 07, 2013 Jkt 229001 Legal Authority: Pub. L. 111–148, sec 1104 Abstract: This rule implements provisions of the Affordable Care Act of 2010 under Administrative Simplification that establish a unique health plan identifier. This health plan identifier will be used to identify health plans in HIPAA standard transactions. The rule also finalizes a delay to comply with ICD–10. Timetable: Centers for Medicare & Medicaid Services (CMS) 300. 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 Final Rule Stage 301. Administrative Simplification: Standard Unique Identifier for Health Plans and ICD–10 Compliance Date Delay (CMS–0040–F) (Completion of a Section 610 Review) Date FR Cite NPRM .................. NPRM Comment Period End. Final Action ......... 12/19/11 02/17/12 76 FR 78742 12/00/14 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 PO 00000 Frm 00010 Fmt 4701 Sfmt 4702 Action Date FR Cite NPRM .................. NPRM Comment Period End. Final Action ......... 04/17/12 05/17/12 77 FR 22950 09/05/12 77 FR 54664 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Christine Stahlecker, Acting Director, Administrative Simplification Group, Office of E-Health Standards and Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop S2–26–17, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786–6405, Email: christine.stahlecker@cms.hhs.gov. RIN: 0938–AQ13 302. Medicare and Medicaid Electronic Health Record Incentive Program— Stage 2 (CMS–0044–F) Legal Authority: Pub. L. 111–5 secs 4101, 4102, and 4202 Abstract: The final rule expands the criteria for meaningful use established for Stage 1 to advance the use of certified EHR technology by eligible professionals, eligible hospitals and critical access hospitals (CAHs). This rule is economically significant. The rule establishes the requirements for Stage 2, which encourages the use of continuous quality improvement at the point of care, and the exchange of information in the most structured format possible. For example, the electronic transmission of orders entered using computerized provider order entry, and the electronic transmission of diagnostic test results. Timetable: E:\FR\FM\08JAP8.SGM 08JAP8 Federal Register / Vol. 78, No. 5 / Tuesday, January 8, 2013 / Unified Agenda Action Date FR Cite NPRM .................. NPRM Comment Period End. Final Action ......... 03/07/12 05/07/12 77 FR 13698 09/04/12 77 FR 53967 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Elizabeth Holland, Director, Health Initiatives Group/Office of E-Health Standards and Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop S2–26–17, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786–1309, Email: elizabeth.holland@cms.hhs.gov. RIN: 0938–AQ84 303. Proposed Changes to Hospital OPPS and CY 2013 Payment Rates; ASC Payment System and CY 2013 Payment Rates (CMS–1589–FC) (Completion of a Section 610 Review) Legal Authority: Sec 1833 of the Social Security Act Abstract: This final rule revises the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. The rule also describes changes to the amounts and factors used to determine payment rates for services. In addition, the rule implements changes to the Ambulatory Surgical Center Payment System list of services and rates. Timetable: Action Date FR Cite NPRM .................. NPRM Comment Period End. Final Action ......... 07/30/12 09/04/12 77 FR 45061 11/15/12 77 FR 68210 mstockstill on DSK4VPTVN1PROD with 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, 7500 Security Boulevard, C4–03–06, Baltimore, MD 21244, Phone: 410 786– VerDate Mar<15>2010 19:43 Jan 07, 2013 Jkt 229001 4617, Email: marjorie.baldo@cms.hhs.gov. RIN: 0938–AR10 Action Action Date FR Cite NPRM .................. NPRM Comment Period End. Final Action ......... 07/30/12 09/04/12 77 FR 44721 11/16/12 77 FR 68892 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Christina Ritter, Director, Division of Practitioner Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C4–03–06, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786–4636, Email: christina.ritter@cms.hhs.gov. RIN: 0938–AR11 305. Changes to the Hospital Inpatient and Long-Term Care Prospective Payment Systems for FY 2013 (CMS– 1588–F) (Completion of a Section 610 Review) Legal Authority: Sec 1886(d) of the Social Security Act, Pub. L. 111–148, secs 3025, 5506, 3005 Abstract: This annual final rule revises the Medicare hospital inpatient and long-term care hospital prospective payment systems for operating and capital-related costs. This rule implements changes arising from our continuing experience with these systems. Timetable: Action Date FR Cite NPRM .................. NPRM Comment Period End. 05/11/12 06/25/12 77 FR 27870 Frm 00011 Fmt 4701 Date FR Cite Final Action ......... 304. Revisions to Payment Policies Under the Physician Fee Schedule and Part B for CY 2013 (CMS–1590–FC) (Completion of a Section 610 Review) Legal Authority: Social Security Act, secs 1102, 1871, 1848 Abstract: This annual final rule revises payment polices under the physician fee schedule, as well as other policy changes to payment under Part B. These changes are applicable to services furnished on or after January 1. Timetable: PO 00000 08/31/12 77 FR 53257 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: 410 786–5229, Email: brian.slater@cms.hhs.gov. RIN: 0938–AR12 306. Home Health Prospective Payment System Rate for CY 2013 (CMS–1358–F) (Completion of a Section 610 Review) Legal Authority: Social Security Act, secs 1102 and 1871; 42 U.S.C. 1302 and 42 U.S.C. 1395(hh); Social Security Act, sec 1895; 42 U.S.C. 1395(fff) Abstract: This final rule updates the 60-day national episode rate based on the applicable home health market basket update and case-mix adjustment. It also updates the national per-visit rates used to calculate low utilization payment adjustments (LUPAs) and outlier payments under the Medicare prospective payment system for home health agencies. These changes are applicable to services furnished on or after January 1. Timetable: Action Date FR Cite NPRM .................. NPRM Comment Period End. Final Action ......... 07/13/12 09/04/12 77 FR 41547 11/08/12 77 FR 67068 Regulatory Flexibility Analysis Required: No. Agency Contact: Hillary Loeffler, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C5–08–28, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786–0456, Email: hillary.loeffler@cms.hhs.gov. RIN: 0938–AR18 [FR Doc. 2012–31671 Filed 1–7–13; 8:45 am] BILLING CODE 4150–24–P Sfmt 9990 1583 E:\FR\FM\08JAP8.SGM 08JAP8 VerDate Mar 15 2010 04:16 Oct 27, 2011 Jkt 000000 PO 00000 Frm 00001 Fmt 4700 Sfmt 4700 C:\DOCS\BLANK.FR DEV003 Vol. 78 Tuesday, No. 5 January 8, 2013 Part IX Department of Homeland Security mstockstill on DSK4VPTVN1PROD with Semiannual Regulatory Agenda VerDate Mar<15>2010 19:45 Jan 07, 2013 Jkt 229001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\08JAP9.SGM 08JAP9

Agencies

[Federal Register Volume 78, Number 5 (Tuesday, January 8, 2013)]
[Unknown Section]
[Pages 1574-1585]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-31671]



[[Page 1573]]

Vol. 78

Tuesday,

No. 5

January 8, 2013

Part VIII





Department of Health and Human Services





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Semiannual Regulatory Agenda

Federal Register / Vol. 78 , No. 5 / Tuesday, January 8, 2013 / 
Unified Agenda

[[Page 1574]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

21 CFR Ch. I

25 CFR Ch. V

42 CFR Chs. I, II, III, IV and 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. The mission 
of HHS is to enhance the health and well-being of Americans by 
providing for 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 continuing to update its main regulatory 
Web site to highlight useful information for the public, such as HHS 
rules currently open for public comment, and actively encouraging 
meaningful public participation in retrospective review and rulemaking 
through education and outreach.
    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 
www.reginfo.gov in an interactive format that offers users enhanced 
capabilities to obtain information from the agenda's database.

    Dated: August 30, 2012.
Jennifer M. Cannistra,
Executive Secretary to the Department.

  Substance Abuse and Mental Health Services Administration--Completed
                                 Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
265.......................  Opioid Drugs in                    0930-AA14
                             Maintenance or
                             Detoxification Treatment
                             of Opiate Addiction
                             (Completion of a Section
                             610 Review).
------------------------------------------------------------------------


     Centers for Disease Control and Prevention--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
266.......................  Establishment of Minimum           0920-AA46
                             Standards for Birth
                             Certificates.
------------------------------------------------------------------------


               Food and Drug Administration--Prerule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No,                    Title             Identifier No.
------------------------------------------------------------------------
267.......................  Over-the-Counter (OTC)             0910-AF43
                             Drug Review--Sunscreen
                             Products.
------------------------------------------------------------------------


            Food and Drug Administration--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
268.......................  Food Labeling; Revision of         0910-AF22
                             the Nutrition and
                             Supplement Facts Labels.
269.......................  Food Labeling: Serving             0910-AF23
                             Sizes of Foods That Can
                             Reasonably Be Consumed in
                             One Eating Occasion; Dual
                             Column Labeling; and
                             Modifying the Reference
                             Amounts Customarily
                             Consumed.
270.......................  Over-the-Counter (OTC)             0910-AF31
                             Drug Review--Cough/Cold
                             (Antihistamine) Products.
271.......................  Over-the-Counter (OTC)             0910-AF36
                             Drug Review--Internal
                             Analgesic Products.
272.......................  Over-the-Counter (OTC)             0910-AF69
                             Drug Review--Topical
                             Antimicrobial Drug
                             Products.

[[Page 1575]]

 
273.......................  Laser Products; Amendment          0910-AF87
                             to Performance Standard.
274.......................  Current Good Manufacturing         0910-AG10
                             Practice, Hazard
                             Analysis, and Risk-Based
                             Preventive Controls for
                             Food for Animals (Reg
                             Plan Seq No. 33).
275.......................  Over-the-Counter (OTC)             0910-AG12
                             Drug Review--Pediatric
                             Dosing for Cough/Cold
                             Products.
276.......................  Electronic Distribution of         0910-AG18
                             Prescribing Information
                             for Human Drugs Including
                             Biological Products.
277.......................  Produce Safety Regulation          0910-AG35
                             (Reg Plan Seq No. 34).
278.......................  Hazard Analysis and Risk-          0910-AG36
                             Based Preventive Controls
                             (Reg Plan Seq No. 35).
279.......................  ``Tobacco Products''               0910-AG38
                             Subject to the Federal
                             Food, Drug, and Cosmetic
                             Act, as Amended by the
                             Family Smoking Prevention
                             and Tobacco Control Act.
280.......................  General Hospital and               0910-AG54
                             Personal Use Devices:
                             Issuance of Draft Special
                             Controls Guidance for
                             Infusion Pumps.
281.......................  Requirements for the               0910-AG59
                             Testing and Reporting of
                             Tobacco Product
                             Constituents,
                             Ingredients, and
                             Additives.
282.......................  Amendments to the Current          0910-AG70
                             Good Manufacturing
                             Practice Regulations for
                             Finished Pharmaceuticals--
                             Components.
283.......................  Use of Symbols in Labeling         0910-AG74
284.......................  Requirements for the               0910-AG81
                             Submission of Data Needed
                             to Calculate User Fees
                             for Manufacturers and
                             Importers of Tobacco
                             Products.
285.......................  Food Labeling: Hard                0910-AG82
                             Candies and Breath Mints.
286.......................  Food Labeling: Serving             0910-AG83
                             Sizes; Reference Amounts
                             for Candies.
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.


             Food and Drug Administration--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
287.......................  Infant Formula: Current            0910-AF27
                             Good Manufacturing
                             Practices; Quality
                             Control Procedures;
                             Notification
                             Requirements; Records and
                             Reports; and Quality
                             Factors.
288.......................  Over-the-Counter (OTC)             0910-AF33
                             Drug Review--Cough/Cold
                             (Combination) Products.
289.......................  Unique Device                      0910-AG31
                             Identification (Reg Plan
                             Seq No. 39).
290.......................  Food Labeling: Nutrition           0910-AG56
                             Labeling for Food Sold in
                             Vending Machines (Reg
                             Plan Seq No. 40).
291.......................  Food Labeling: Nutrition           0910-AG57
                             Labeling of Standard Menu
                             Items in Restaurants and
                             Similar Retail Food
                             Establishments (Reg Plan
                             Seq No. 41).
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.


             Food and Drug Administration--Long-Term Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
292.......................  Prescription Drug                  0910-AG14
                             Marketing Act of 1987;
                             Prescription Drug
                             Amendments of 1992;
                             Policies, Requirements,
                             and Administrative
                             Procedures (Section 610
                             Review).
------------------------------------------------------------------------


             Food and Drug Administration--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
293.......................  Electronic Submission of           0910-AC52
                             Data From Studies
                             Evaluating Human Drugs
                             and Biologics.
------------------------------------------------------------------------


      Centers for Medicare & Medicaid Services--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
294.......................  Emergency Preparedness             0938-AO91
                             Requirements for Medicare
                             Participating Providers
                             and Suppliers (CMS-3178-
                             P) (Section 610 Review).
295.......................  Changes to the Hospital            0938-AR53
                             Inpatient and Long-Term
                             Care Prospective Payment
                             System for FY 2014 (CMS-
                             1599-P) (Reg Plan Seq No.
                             45).
296.......................  Changes to the Hospital            0938-AR54
                             Outpatient Prospective
                             Payment System and
                             Ambulatory Surgical
                             Center Payment System for
                             CY 2014 (CMS-1601-P) (Reg
                             Plan Seq No. 46).
297.......................  Revisions to Payment               0938-AR56
                             Policies Under the
                             Physician Fee Schedule
                             and Medicare Part B for
                             CY 2014 (CMS-1600-P) (Reg
                             Plan Seq No. 47).
298.......................  Prospective Payment System         0938-AR62
                             for Federally Qualified
                             Health Centers (FQHCs)
                             (CMS-1443-P) (Section 610
                             Review) (Reg Plan Seq No.
                             48).
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.


[[Page 1576]]


       Centers for Medicare & Medicaid Services--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
299.......................  Covered Outpatient Drugs           0938-AQ41
                             (CMS-2345-F) (Section 610
                             Review).
------------------------------------------------------------------------


       Centers for Medicare & Medicaid Services--Long-Term Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
300.......................  Transparency Reports and           0938-AR33
                             Reporting of Physician
                             Ownership of Investment
                             Interests (CMS-5060-F).
------------------------------------------------------------------------


       Centers for Medicare & Medicaid Services--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
301.......................  Administrative                     0938-AQ13
                             Simplification: Standard
                             Unique Identifier for
                             Health Plans and ICD-10
                             Compliance Date Delay
                             (CMS-0040-F) (Completion
                             of a Section 610 Review).
302.......................  Medicare and Medicaid              0938-AQ84
                             Electronic Health Record
                             Incentive Program--Stage
                             2 (CMS-0044-F).
303.......................  Proposed Changes to                0938-AR10
                             Hospital OPPS and CY 2013
                             Payment Rates; ASC
                             Payment System and CY
                             2013 Payment Rates (CMS-
                             1589-FC) (Completion of a
                             Section 610 Review).
304.......................  Revisions to Payment               0938-AR11
                             Policies Under the
                             Physician Fee Schedule
                             and Part B for CY 2013
                             (CMS-1590-FC) (Completion
                             of a Section 610 Review).
305.......................  Changes to the Hospital            0938-AR12
                             Inpatient and Long-Term
                             Care Prospective Payment
                             Systems for FY 2013 (CMS-
                             1588-F) (Completion of a
                             Section 610 Review).
306.......................  Home Health Prospective            0938-AR18
                             Payment System Rate for
                             CY 2013 (CMS-1358-F)
                             (Completion of a Section
                             610 Review).
------------------------------------------------------------------------


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Substance Abuse and Mental Health Services Administration (SAMHSA)

Completed Actions

265. Opioid Drugs in Maintenance or Detoxification Treatment of Opiate 
Addiction (Completion of a Section 610 Review)

    Legal Authority: 21 U.S.C. 823 (9); 42 U.S.C. 257a; 42 U.S.C. 
290aa(d); 42 U.S.C. 290dd-2; 42 U.S.C. 300x-23; 42 U.S.C. 300x-27(a); 
42 U.S.C. 300y-11
    Abstract: This rule would amend the Federal opioid treatment 
program regulations. It would modify the dispensing requirements for 
buprenorphine and buprenorphine combination products that are approved 
by the Food and Drug Administration (FDA) for opioid dependence and 
used in federally certified and registered opioid treatment programs. 
In particular, this rule would allow opioid treatment programs more 
flexibility in dispensing take-home supplies of buprenorphine after the 
assessment and documentation of patients' responsibility and stability 
to receive opioid addiction treatment medication.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/19/09  74 FR 29153
NPRM Comment Period End.............   08/18/09  .......................
Final Action........................   12/06/12  77 FR 72752
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: No.
    Agency Contact: Nicholas Reuter, Supervising Public Health Advisor, 
Department of Health and Human Services, Substance Abuse and Mental 
Health Services Administration, Suite 2-1063, One Choke Cherry Road, 
Rockville, MD 20857 Phone: 240 276-2716, Email: 
nicholas.reuter@samhsa.hhs.gov.
    RIN: 0930-AA14

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Disease Control and Prevention (CDC)

Proposed Rule Stage

266. Establishment of Minimum Standards for Birth Certificates

    Legal Authority: 42 U.S.C. 264
    Abstract: This proposed rule establishes minimum standards to 
improve security related to the use of birth certificates by Federal 
agencies for official purposes.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   03/00/13  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Charles Rothwell, Director, Division of Vital 
Statistics, Department of Health and Human Services, Centers for 
Disease Control and Prevention, 3311 Toledo Road, Room 7311, M, 
Hyattsville, MD 20782, Phone: 301 458-4555.
    RIN: 0920-AA46

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Prerule Stage

267. 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

[[Page 1577]]

will address the safety of sunscreen active ingredients. The second of 
the future actions will address active ingredients reviewed under time 
and extent applications.
    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.
ANPRM (Safety)......................   07/00/13  .......................
NPRM (Time and Extent Applications).   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-AF43

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Proposed Rule Stage

268. 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  .......................
ANPRM...............................   04/04/05  70 FR 17008
ANPRM Comment Period End............   06/20/05  .......................
ANPRM...............................   11/02/07  72 FR 62149
ANPRM Comment Period End............   01/31/08  .......................
NPRM................................   02/00/13  .......................
------------------------------------------------------------------------

    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

269. Food Labeling: Serving Sizes of Foods That Can Reasonably Be 
Consumed in One Eating Occasion; Dual Column Labeling; and Modifying 
the 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................................   02/00/13  .......................
------------------------------------------------------------------------

    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

270. 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). The objectives of 
the RCC monograph alignment working group are to conduct a pilot 
program to develop aligned monograph elements for a selected over-the-
counter (OTC) drug category (e.g., aligned directions, warnings, 
indications, and conditions of use) and subsequently, develop 
recommendations to determine the feasibility of an ongoing mechanism 
for alignment in review and adoption of these 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)......   06/00/13  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Mary Chung, Regulatory Health Project Manager, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Drug Evaluation and Research, WO 22, Room 5488, 10903 New 
Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-0260, Fax: 
301 796-9899, Email: mary.chung@fda.hhs.gov.
    RIN: 0910-AF31

271. 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

[[Page 1578]]

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) (Acetaminophen)....   08/00/13
NPRM (Amendment) (Pediatric)........   12/00/13
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Mary Chung, Regulatory Health Project Manager, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Drug Evaluation and Research, WO 22, Room 5488, 10903 New 
Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-0260, Fax: 
301 796-9899, Email: mary.chung@fda.hhs.gov.
    RIN: 0910-AF36

272. 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. The first 
action addresses consumer hand wash products. The second action 
addresses consumer leave-on 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)..   02/00/13
NPRM (Consumer Leave-on Products)...   07/00/13
------------------------------------------------------------------------

    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

273. Laser Products; Amendment to Performance Standard

    Legal Authority: 21 U.S.C. 360hh to 360ss; 21 U.S.C. 371; 21 U.S.C. 
393
    Abstract: FDA is proposing to amend the 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................................   12/00/12
------------------------------------------------------------------------

    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

274. Current Good Manufacturing Practice, Hazard Analysis, and Risk-
Based Preventive Controls for Food for Animals

    Regulatory Plan: This entry is Seq. No. 33 in part II of this issue 
of the Federal Register.
    RIN: 0910-AG10

275. 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................................   06/00/13
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Mary Chung, Regulatory Health Project Manager, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Drug Evaluation and Research, WO 22, Room 5488, 10903 New 
Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-0260, Fax: 
301 796-9899, Email: mary.chung@fda.hhs.gov.
    RIN: 0910-AG12

276. Electronic Distribution of Prescribing Information for Human 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................................   06/00/13  .......................
------------------------------------------------------------------------


[[Page 1579]]

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Megan Clark-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.clark@fda.hhs.gov.
    RIN: 0910-AG18

277. Produce Safety Regulation

    Regulatory Plan: This entry is Seq. No. 34 in part II of this issue 
of the Federal Register.
    RIN: 0910-AG35

278. Hazard Analysis and Risk-Based Preventive Controls

    Regulatory Plan: This entry is Seq. No. 35 in part II of this issue 
of the Federal Register.
    RIN: 0910-AG36

279. ``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................................   04/00/13  .......................
------------------------------------------------------------------------

    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

280. 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
------------------------------------------------------------------------
NPRM................................   03/00/13  .......................
------------------------------------------------------------------------

    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-AG54

281. 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................................   04/00/13  .......................
NPRM Comment Period End.............   06/00/13  .......................
------------------------------------------------------------------------

    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

282. 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. 371; 21 U.S.C. 374; 42 U.S.C. 
262; 42 U.S.C. 264
    Abstract: This rule proposes to amend regulations regarding the 
control over components used in manufacturing finished pharmaceuticals.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   05/00/13  .......................
------------------------------------------------------------------------

    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

283. Use of 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 proposed rule is to implement section 
502(c) of the FD&C Act and to revise 21 CFR 801.15 (prominence of 
required label statements) using the authority under section 514(c) of 
the FD&C Act to allow for the inclusion of certain standardized symbols 
recognized by FDA for use on the labeling of medical devices. If this 
proposed rule is finalized, certain symbols in compliance with 
International Standards Organization (ISO) Standard 15223 may be used 
in medical device labeling with explanatory text or symbols glossary 
with accompanying labeling, as may other standardized symbols in the 
future when adopted by a national or international standards 
development organization and if recognized by FDA guidance or other 
regulatory action.

[[Page 1580]]

    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/00/13  .......................
------------------------------------------------------------------------

    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

284. 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; PL111-31
    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................................   02/00/13  .......................
------------------------------------------------------------------------

    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, 9200 Corporate Boulevard, Room 340K, 
Rockville, MD 20850, Phone: 877 287-1373, Fax: 240 276-3904, Email: 
annette.marthaler@fda.hhs.gov.
    RIN: 0910-AG81

285. Food Labeling: 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 mint. FDA is taking this action in 
response to 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................................   02/00/13  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Mark Kantor, Nutritionist, Department of Health and 
Human Services, Food and Drug Administration, 5100 Paint Branch 
Parkway, HFS-830, College Park, MD 20740, Phone: 240 402-1450, Fax: 301 
436-1191, Email: mark.kantor@fda.hhs.gov.
    RIN: 0910-AG82

286. 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.
    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  .......................
NPRM................................   02/00/13  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Mark Kantor, Nutritionist, Department of Health and 
Human Services, Food and Drug Administration, 5100 Paint Branch 
Parkway, HFS-830, 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)

Food and Drug Administration (FDA)

Final Rule Stage

287. 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..........................   04/00/13  .......................
------------------------------------------------------------------------

    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

288. 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

[[Page 1581]]

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........................   03/00/13  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Mary Chung, Regulatory Health Project Manager, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Drug Evaluation and Research, WO 22, Room 5488, 10903 New 
Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-0260, Fax: 
301 796-9899, Email: mary.chung@fda.hhs.gov.
    RIN: 0910-AF33

289. Unique Device Identification

    Regulatory Plan: This entry is Seq. No. 39 in part II of this issue 
of the Federal Register.
    RIN: 0910-AG31

290. Food Labeling: Nutrition Labeling for Food Sold in Vending 
Machines

    Regulatory Plan: This entry is Seq. No. 40 in part II of this issue 
of the Federal Register.
    RIN: 0910-AG56

291. Food Labeling: Nutrition Labeling of Standard Menu Items in 
Restaurants and Similar Retail Food Establishments

    Regulatory Plan: This entry is Seq. No. 41 in part II of this issue 
of the Federal Register.
    RIN: 0910-AG57

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Long-Term Actions

292. 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 December 2013.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Begin Review of Current Regulation..   11/24/08  .......................
End Review of Current Regulation....   12/00/13  .......................
------------------------------------------------------------------------

    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)

Completed Actions

293. Electronic Submission of Data From Studies Evaluating Human Drugs 
and Biologics

    Legal Authority: 21 U.S.C. 355; 21 U.S.C. 371; 42 U.S.C. 262
    Abstract: The Food and Drug Administration is proposing to amend 
the regulations governing the format in which clinical study data and 
bioequivalence data are required to be submitted for new drug 
applications (NDAs), biological license applications (BLAs), and 
abbreviated new drug applications (ANDAs). The proposal would revise 
our regulations to require that data submitted for NDAs, BLAs, and 
ANDAs, and their supplements and amendments, be provided in an 
electronic format that FDA can process, review, and archive.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Withdrawn...........................   08/01/12  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Martha Nguyen, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, WO 51, Room 6352, 10903 New Hampshire 
Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3471, Fax: 301 
847-8440, Email: martha.nguyen@fda.hhs.gov.
    RIN: 0910-AC52

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Proposed Rule Stage

294. Emergency Preparedness Requirements for Medicare 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 will 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................................   07/00/13  .......................
------------------------------------------------------------------------

    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, Office of

[[Page 1582]]

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

295.  Changes to the Hospital Inpatient and Long-Term Care 
Prospective Payment System for FY 2014 (CMS-1599-P)

    Regulatory Plan: This entry is Seq. No. 45 in part II of this issue 
of the Federal Register.
    RIN: 0938-AR53

296.  Changes to the Hospital Outpatient Prospective Payment 
System and Ambulatory Surgical Center Payment System for CY 2014 (CMS-
1601-P)

    Regulatory Plan: This entry is Seq. No. 46 in part II of this issue 
of the Federal Register.
    RIN: 0938-AR54

297.  Revisions to Payment Policies Under the Physician Fee 
Schedule and Medicare Part B for CY 2014 (CMS-1600-P)

    Regulatory Plan: This entry is Seq. No. 47 in part II of this issue 
of the Federal Register.
    RIN: 0938-AR56

298.  Prospective Payment System for Federally Qualified Health 
Centers (FQHCS) (CMS-1443-P) (Section 610 Review)

    Regulatory Plan: This entry is Seq. No. 48 in part II of this issue 
of the Federal Register.
    RIN: 0938-AR62

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Final Rule Stage

299. 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........................   08/00/13  .......................
------------------------------------------------------------------------

    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

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Long-Term Actions

300. 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........................   12/00/14  .......................
------------------------------------------------------------------------

    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

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Completed Actions

301. Administrative Simplification: Standard Unique Identifier for 
Health Plans and ICD-10 Compliance Date Delay (CMS-0040-F) (Completion 
of a Section 610 Review)

    Legal Authority: Pub. L. 111-148, sec 1104
    Abstract: This rule implements provisions of the Affordable Care 
Act of 2010 under Administrative Simplification that establish a unique 
health plan identifier. This health plan identifier will be used to 
identify health plans in HIPAA standard transactions. The rule also 
finalizes a delay to comply with ICD-10.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/17/12  77 FR 22950
NPRM Comment Period End.............   05/17/12  .......................
Final Action........................   09/05/12  77 FR 54664
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Christine Stahlecker, Acting Director, 
Administrative Simplification Group, Office of E-Health Standards and 
Services, Department of Health and Human Services, Centers for Medicare 
& Medicaid Services, Mail Stop S2-26-17, 7500 Security Boulevard, 
Baltimore, MD 21244, Phone: 410 786-6405, Email: 
christine.stahlecker@cms.hhs.gov.
    RIN: 0938-AQ13

302. Medicare and Medicaid Electronic Health Record Incentive Program--
Stage 2 (CMS-0044-F)

    Legal Authority: Pub. L. 111-5 secs 4101, 4102, and 4202
    Abstract: The final rule expands the criteria for meaningful use 
established for Stage 1 to advance the use of certified EHR technology 
by eligible professionals, eligible hospitals and critical access 
hospitals (CAHs). This rule is economically significant. The rule 
establishes the requirements for Stage 2, which encourages the use of 
continuous quality improvement at the point of care, and the exchange 
of information in the most structured format possible. For example, the 
electronic transmission of orders entered using computerized provider 
order entry, and the electronic transmission of diagnostic test 
results.
    Timetable:

[[Page 1583]]



------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   03/07/12  77 FR 13698
NPRM Comment Period End.............   05/07/12
Final Action........................   09/04/12  77 FR 53967
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Elizabeth Holland, Director, Health Initiatives 
Group/Office of E-Health Standards and Services, Department of Health 
and Human Services, Centers for Medicare & Medicaid Services, Mail Stop 
S2-26-17, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-
1309, Email: elizabeth.holland@cms.hhs.gov.
    RIN: 0938-AQ84

303. Proposed Changes to Hospital OPPS and CY 2013 Payment Rates; ASC 
Payment System and CY 2013 Payment Rates (CMS-1589-FC) (Completion of a 
Section 610 Review)

    Legal Authority: Sec 1833 of the Social Security Act
    Abstract: This final rule revises the Medicare hospital outpatient 
prospective payment system to implement applicable statutory 
requirements and changes arising from our continuing experience with 
this system. The rule also describes changes to the amounts and factors 
used to determine payment rates for services. In addition, the rule 
implements changes to the Ambulatory Surgical Center Payment System 
list of services and rates.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/30/12  77 FR 45061
NPRM Comment Period End.............   09/04/12
Final Action........................   11/15/12  77 FR 68210
------------------------------------------------------------------------

    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, 7500 Security 
Boulevard, C4-03-06, Baltimore, MD 21244, Phone: 410 786-4617, Email: 
marjorie.baldo@cms.hhs.gov.
    RIN: 0938-AR10

304. Revisions to Payment Policies Under the Physician Fee Schedule and 
Part B for CY 2013 (CMS-1590-FC) (Completion of a Section 610 Review)

    Legal Authority: Social Security Act, secs 1102, 1871, 1848
    Abstract: This annual final rule revises payment polices under the 
physician fee schedule, as well as other policy changes to payment 
under Part B. These changes are applicable to services furnished on or 
after January 1.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/30/12  77 FR 44721
NPRM Comment Period End.............   09/04/12
Final Action........................   11/16/12  77 FR 68892
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Christina Ritter, Director, Division of 
Practitioner Services, Department of Health and Human Services, Centers 
for Medicare & Medicaid Services, Mail Stop C4-03-06, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-4636, Email: 
christina.ritter@cms.hhs.gov.
    RIN: 0938-AR11

305. Changes to the Hospital Inpatient and Long-Term Care Prospective 
Payment Systems for FY 2013 (CMS-1588-F) (Completion of a Section 610 
Review)

    Legal Authority: Sec 1886(d) of the Social Security Act, Pub. L. 
111-148, secs 3025, 5506, 3005
    Abstract: This annual final rule revises the Medicare hospital 
inpatient and long-term care hospital prospective payment systems for 
operating and capital-related costs. This rule implements changes 
arising from our continuing experience with these systems.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   05/11/12  77 FR 27870
NPRM Comment Period End.............   06/25/12
Final Action........................   08/31/12  77 FR 53257
------------------------------------------------------------------------

    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: 410 786-5229, Email: 
brian.slater@cms.hhs.gov.
    RIN: 0938-AR12

306. Home Health Prospective Payment System Rate for CY 2013 (CMS-1358-
F) (Completion of a Section 610 Review)

    Legal Authority: Social Security Act, secs 1102 and 1871; 42 U.S.C. 
1302 and 42 U.S.C. 1395(hh); Social Security Act, sec 1895; 42 U.S.C. 
1395(fff)
    Abstract: This final rule updates the 60-day national episode rate 
based on the applicable home health market basket update and case-mix 
adjustment. It also updates the national per-visit rates used to 
calculate low utilization payment adjustments (LUPAs) and outlier 
payments under the Medicare prospective payment system for home health 
agencies. These changes are applicable to services furnished on or 
after January 1.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/13/12  77 FR 41547
NPRM Comment Period End.............   09/04/12
Final Action........................   11/08/12  77 FR 67068
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: No.
    Agency Contact: Hillary Loeffler, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Mailstop C5-08-28, 7500 Security Boulevard, 
Baltimore, MD 21244, Phone: 410 786-0456, Email: 
hillary.loeffler@cms.hhs.gov.
    RIN: 0938-AR18

[FR Doc. 2012-31671 Filed 1-7-13; 8:45 am]
BILLING CODE 4150-24-P