Regulatory Agenda, 7946-7958 [2012-1647]

Download as PDF 7946 Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Unified Agenda DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary summarized information about forthcoming regulatory actions for public review. FOR FURTHER INFORMATION CONTACT: Jennifer M. Cannistra, Executive Secretary, Department of Health and Human Services, Washington, DC 20201. 21 CFR Ch. I 42 CFR Chs. I–V The information provided in the Agenda presents a forecast of the rulemaking Regulatory Agenda activities that the Department of Health and Human Services (HHS) expects to AGENCY: Office of the Secretary, HHS. undertake in the foreseeable future. ACTION: Semiannual regulatory agenda. Rulemakings are grouped according to SUMMARY: The Regulatory Flexibility Act pre-rulemaking actions, proposed rules, of 1980 and Executive Order (EO) 12866 final rules, long-term actions, and rulemaking actions completed since the require the semiannual issuance of an spring 2011 Agenda was published. inventory of rulemaking actions under Please note that the rulemaking development throughout the abstracts included in this paper issue of Department with a view to offering 45 CFR Subtitle A; Subtitle B, Chs. II, III, and XIII SUPPLEMENTARY INFORMATION: the Federal Register relate strictly to those prospective rulemakings that are likely to have a significant economic impact on a substantial number of small entities, as required by the Regulatory Flexibility Act of 1980. Also available in this issue of the Federal Register is the Department’s submission to the Fiscal Year 2011 Regulatory Plan, required under Executive Order 12866. The complete Regulatory Agenda of the Department is accessible online at www.reginfo.gov in an interactive format that offers users enhanced capabilities to obtain information from the Agenda’s database. The purpose of the Agenda is to encourage more effective public participation in the regulatory process. Jennifer M. Cannistra, Executive Secretary to the Department. SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION—FINAL RULE STAGE Regulation Identifier No. Sequence No. Title 321 .................... Opioid Drugs in Maintenance or Detoxification Treatment of Opiate Addiction (Section 610 Review) ........ 0930–AA14 CENTERS FOR DISEASE CONTROL AND PREVENTION—PROPOSED RULE STAGE Regulation Identifier No. Sequence No. Title 322 .................... Establishment of Minimum Standards for Birth Certificates ............................................................................ 0920–AA46 CENTERS FOR DISEASE CONTROL AND PREVENTION—LONG-TERM ACTIONS Regulation Identifier No. Sequence No. Title 323 .................... 324 .................... Control of Communicable Diseases: Foreign .................................................................................................. Control of Communicable Diseases: Interstate ............................................................................................... 0920–AA12 0920–AA22 FOOD AND DRUG ADMINISTRATION—PRERULE STAGE Regulation Identifier No. Sequence No. Title 325 .................... 326 .................... Over-the-Counter (OTC) Drug Review—Sunscreen Products ........................................................................ Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures (Section 610 Review). Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents (Section 610 Review). General Requirements for Blood, Blood Components, and Blood Derivatives; Donor Notification (Section 610 Review). 327 .................... 328 .................... 0910–AF43 0910–AG14 0910–AG61 0910–AG62 erowe on DSK2VPTVN1PROD with PROPOSALS2 FOOD AND DRUG ADMINISTRATION—PROPOSED RULE STAGE Regulation Identifier No. Sequence No. Title 329 .................... Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics (Reg Plan Seq No. 33). Over-the-Counter (OTC) Drug Review-Internal Analgesic Products ............................................................... Over-the-Counter (OTC) Drug Review-Topical Antimicrobial Drug Products ................................................. Import Tolerances for Residues of Unapproved New Animal Drugs in Food ................................................. Laser Products; Amendment to Performance Standard .................................................................................. 330 331 332 333 .................... .................... .................... .................... VerDate Mar<15>2010 15:15 Feb 10, 2012 Jkt 226001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 E:\FR\FM\13FEP8.SGM 13FEP8 0910–AC52 0910–AF36 0910–AF69 0910–AF78 0910–AF87 Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Unified Agenda 7947 FOOD AND DRUG ADMINISTRATION—PROPOSED RULE STAGE—Continued Regulation Identifier No. Sequence No. Title 334 .................... Current Good Manufacturing Practice and Hazard Analysis and Risk-Benefit Preventive Controls for Food for Animals (Reg Plan Seq No. 34). Over-the-Counter (OTC) Drug Review-Pediatric Dosing for Cough/Cold Products ........................................ Electronic Distribution of Content of Labeling for Human Prescription Drug and Biological Products ........... Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals—Second Phase. Unique Device Identification (Reg Plan Seq No. 35) ..................................................................................... Produce Safety Regulation (Reg Plan Seq No. 36) ....................................................................................... Hazard Analysis and Risk-Based Preventive Controls (Reg Plan Seq No. 37) ............................................ ‘‘Tobacco Products’’ Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act. Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices ......................... 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. 335 .................... 336 .................... 337 .................... 338 339 340 341 .................... .................... .................... .................... 342 .................... 343 .................... 344 .................... 345 .................... 0910–AG10 0910–AG12 0910–AG18 0910–AG20 0910–AG31 0910–AG35 0910–AG36 0910–AG38 0910–AG48 0910–AG54 0910–AG59 0910–AG70 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 346 .................... Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports; and Quality Factors (Reg Plan Seq No. 40). Label Requirement for Food That Has Been Refused Admission Into the United States .............................. Food Labeling: Nutrition Labeling for Food Sold in Vending Machines (Reg Plan Seq No. 43) ................... Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments (Reg Plan Seq No. 44). 347 .................... 348 .................... 349 .................... 0910–AF27 0910–AF61 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 Sequence No. 350 351 352 353 .................... .................... .................... .................... 354 .................... 355 .................... Regulation Identifier No. Title Food Labeling; Revision of the Nutrition and Supplement Facts Labels ........................................................ Over-the-Counter (OTC) Drug Review-Oral Health Care Products ................................................................ Pet Food Labeling Requirements .................................................................................................................... Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products. Food Labeling: Hard Candies and Breath Mints ............................................................................................. Food Labeling; Serving Sizes; Reference Amounts for Candies .................................................................... 0910–AF22 0910–AF40 0910–AG09 0910–AG60 0910–AG82 0910–AG83 FOOD AND DRUG ADMINISTRATION—COMPLETED ACTIONS Regulation Identifier No. Sequence No. Title 356 .................... 357 .................... 358 .................... Over-the-Counter (OTC) Drug Review—Cough/Cold (Bronchodilator) Products ........................................... Over-the-Counter (OTC) Drug Review—Poison Treatment Drug Products .................................................... Cigarette Warning Label Statements ............................................................................................................... 0910–AF32 0910–AF68 0910–AG41 CENTERS FOR MEDICARE & MEDICAID SERVICES—PROPOSED RULE STAGE Regulation Identifier No. erowe on DSK2VPTVN1PROD with PROPOSALS2 Sequence No. Title 359 .................... 360 .................... 361 .................... Covered Outpatient Drugs (CMS–2345–P) (Section 610 Review) ................................................................ Medicare and Medicaid Electronic Health Record Incentive Program—Stage 2 (CMS–0044–P) .................. Medicare and Medicaid Programs: Reform of Hospital and Critical Access Hospital Conditions of Participation (CMS–3244–P) (Reg Plan Seq No. 45). Proposed Changes to Hospital OPPS and CY 2013 Payment Rates; ASC Payment System and CY 2013 Payment Rates (CMS–1589–P) (Section 610 Review) (Reg Plan Seq No. 47). Revisions to Payment Policies Under the Physician Fee Schedule and Part B for CY 2013 (CMS–1590– P) (Section 610 Review) (Reg Plan Seq No. 48). 362 .................... 363 .................... VerDate Mar<15>2010 15:15 Feb 10, 2012 Jkt 226001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 E:\FR\FM\13FEP8.SGM 13FEP8 0938–AQ41 0938–AQ84 0938–AQ89 0938–AR10 0938–AR11 7948 Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Unified Agenda CENTERS FOR MEDICARE & MEDICAID SERVICES—PROPOSED RULE STAGE—Continued Regulation Identifier No. Sequence No. Title 364 .................... Changes to the Hospital Inpatient and Long-Term Care Prospective Payment System for FY 2013 (CMS– 1588–P) (Section 610 Review) (Reg Plan Seq No. 49). Transparency Reports and Reporting of Physician Ownership of Investment Interests (CMS–5060–F) ....... 365 .................... 0938–AR12 0938–AR33 References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register. CENTERS FOR MEDICARE & MEDICAID SERVICES—COMPLETED ACTIONS Regulation Identifier No. Sequence No. Title 366 .................... Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and FY 2012 Rates and to the Long-Term Care Hospital PPS and FY 2012 Rates (CMS–1518–F) (Completion of a Section 610 Review). Revisions to Payment Policies Under the Physician Fee Schedule and Part B for CY 2012 (CMS–1524– FC) (Completion of a Section 610 Review). Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System for CY 2012 (CMS–1525–F) (Completion of a Section 610 Review). Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2012; Required Disclosures of Ownership (CMS–1351–F) (Completion of a Section 610 Review). Home Health Prospective Payment System Refinements and Rate Update for CY 2012 (CMS–1353–F) (Section 610 Review). Enhanced Federal Funding for Medicaid Eligibility Determination and Enrollment Activities (CMS–2346–F) Five Year Review of Work Relative Value Units Under the Physician Fee Schedule (CMS–1582–PN) ....... 367 .................... 368 .................... 369 .................... 370 .................... 371 .................... 372 .................... 2716, Email: nicholas.reuter@samhsa. hhs.gov. RIN: 0930–AA14 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) Final Rule Stage 321. Opioid Drugs in Maintenance or Detoxification Treatment of Opiate Addiction (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. 300xx–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. Timetable: DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Disease Control and Prevention (CDC) Proposed Rule Stage 322. • Establishment of Minimum Standards for Birth Certificates Legal Authority: 42 U.S.C. 264 Abstract: Section 7211 of the Intelligence Reform and Terrorism Prevention Act (IRTPA) mandates that HHS establish, by regulation, minimum standards to improve the security of birth certificates for use by Federal agencies for official purposes. Timetable: DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Disease Control and Prevention (CDC) Long-Term Actions 323. Control of Communicable Diseases: Foreign Legal Authority: 42 U.S.C. 243; 42 U.S.C. 264 and 265; 42 U.S.C. 267 and 268; 42 U.S.C. 270 and 271 Abstract: The final rule focuses primarily on requirements relating to the reporting of deaths and illnesses onboard aircrafts and ships traveling from foreign countries into the United States, and the collection of specific traveler contact information for the purpose of CDC contacting travelers in the event of an exposure to a communicable disease. Timetable: 11/30/05 01/20/06 70 FR 71892 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 Final Action ......... NPRM .................. NPRM Comment Period End. Final Action ......... erowe on DSK2VPTVN1PROD with PROPOSALS2 0938–AQ53 0938–AQ87 NPRM .................. NPRM Comment Period End. Date 06/19/09 08/18/09 74 FR 29153 NPRM .................. 09/00/12 Jkt 226001 0938–AQ30 FR Cite Action 15:15 Feb 10, 2012 0938–AQ29 FR Cite FR Cite VerDate Mar<15>2010 0938–AQ26 Date Date Regulatory Flexibility Analysis Required: No. Agency Contact: Nicholas Reuter, 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– 0938–AQ25 Action Action 02/00/12 0938–AQ24 PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 To Be Determined Regulatory Flexibility Analysis Required: Yes. Agency Contact: Ashley Marrone, Public Health Analyst, Department of Health and Human Services, Centers for Disease Control and Prevention, MS– E03, 1600 Clifton Road NE., Atlanta, GA 30329, Phone: 404 498–1600, Email: amarrone@cdc.gov. E:\FR\FM\13FEP8.SGM 13FEP8 Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Unified Agenda RIN: 0920–AA12 Action 324. Control of Communicable Diseases: Interstate Legal Authority: 28 U.S.C. 198; 28 U.S.C. 231; 25 U.S.C. 1661; 42 U.S.C. 243; 42 U.S.C. 248 and 249; 42 U.S.C. 264; 42 U.S.C. 266 to 268; 42 U.S.C. 270 to 272; 42 U.S.C. 2001 Abstract: This rule focuses primarily on requirements relating to the reporting of deaths and illnesses onboard aircrafts traveling domestically, and the collection of specific traveler contact information for the purpose of CDC contacting travelers in the event of an exposure to a communicable disease. Timetable: Action Date FR Cite NPRM .................. NPRM Comment Period End. 11/30/05 01/30/06 70 FR 71892 Final Action ......... To Be Determined Regulatory Flexibility Analysis Required: Yes. Agency Contact: Ashley Marrone, Public Health Analyst, Department of Health and Human Services, Centers for Disease Control and Prevention, MS– E03, 1600 Clifton Road NE., Atlanta, GA 30329, Phone: 404 498–1600, Email: amarrone@cdc.gov. RIN: 0920–AA22 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Prerule Stage erowe on DSK2VPTVN1PROD with PROPOSALS2 325. Over-the-Counter (OTC) Drug Review—Sunscreen Products Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first of the future actions will address the safety of sunscreen active ingredients. The second of the future actions will address active ingredients reviewed under time and extent applications. The last action addresses combination products containing sunscreen and insect repellent ingredients. Timetable: 15:15 Feb 10, 2012 Jkt 226001 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 06/00/12 08/00/12 Regulatory Flexibility Analysis Required: Yes. Agency Contact: David Eng, 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 326. Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures (Section 610 Review) Food and Drug Administration (FDA) VerDate Mar<15>2010 Date Legal Authority: 21 U.S.C. 331; 21 U.S.C. 333; 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 353; 21 U.S.C. 360; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381 Abstract: Pursuant to section 610 of the Regulatory Flexibility Act, FDA is currently undertaking a review of regulations promulgated under the Prescription Drug Marketing Act (PDMA) including those contained in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763). The purpose of this review is to determine whether the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on a substantial number of small entities. FDA solicited comments on the following: (1) The continued need for PO 00000 Frm 00005 Fmt 4701 Sfmt 4702 7949 the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763); (2) the nature of complaints or comments received from the public concerning the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763); (3) the complexity of the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763); (4) the extent to which the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) overlap, duplicate, or conflict with other Federal rules, and to the extent feasible, with State and local governmental rules, and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763). Last year, FDA extended the completion date by one year due to the RxUSA Wholesale, Inc., v. HHS case. Since then, the case has ended and FDA proposed to withdraw section 203.50(a). Therefore, FDA will complete the review by December 2011. Timetable: Action Date Begin Review of Current Regulation. End Review of Current Regulation. FR Cite 11/24/08 12/00/11 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 327. Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents (Section 610 Review) Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 360c and 360d; 21 U.S.C. 360h and 360i; 21 U.S.C. 371 and 372; 21 U.S.C. 374; 21 U.S.C. 381; 42 U.S.C. 216; 42 U.S.C. 262 to 264; 42 U.S.C. 263; 42 U.S.C. 263a; 42 U.S.C. 264 Abstract: FDA is undertaking a review of 21 CFR sections 610.40, 610.41, E:\FR\FM\13FEP8.SGM 13FEP8 7950 Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Unified Agenda 610.42, 610.44, 640.67, 640.70 (as amended in 66 FR 31146) under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations in 21 CFR sections 610.40, 610.41, 610.42, 610.44, 640.67, 640.70 (as amended in 66 FR 31146) should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on a substantial number of small entities. FDA will consider, and is soliciting comments on, the following: (1) The continued need for the rule; (2) the nature of complaints or comments received concerning the rule from the public; (3) the complexity of the rule; (4) the extent to which the rule overlaps, duplicates, or conflicts with other Federal rules, and, to the extent feasible, with State and local governmental rules; and (5) the length of time since the rule has been evaluated or the degree to which technology, economic conditions, or other factors have changed in the area affected by the rule. Timetable: Action Date Begin Review of Current Regulation. End Review of Current Regulation. FR Cite 06/01/11 12/00/11 erowe on DSK2VPTVN1PROD with PROPOSALS2 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Melissa Reisman, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Suite 200N (HFM–17), 1401 Rockville Pike, Rockville, MD 20852, Phone: 301 827–6210. RIN: 0910–AG61 328. General Requirements for Blood, Blood Components, and Blood Derivatives; Donor Notification (Section 610 Review) Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 and 352; 21 U.S.C. 355; 21 U.S.C. 360 and 360j; 21 U.S.C. 371; 21 U.S.C. 374; 42 U.S.C. 216; 42 U.S.C. 262; 42 U.S.C. 263a; 42 U.S.C. 264; * * * Abstract: FDA is undertaking a review of 21 CFR sections 606.100(b), 606.160(b) and 630.6 (as amended in 66 FR 31165) under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations in 21 CFR sections 606.100(b), 606.160(b) and 630.6 (as amended in 66 FR 31165) should be VerDate Mar<15>2010 15:15 Feb 10, 2012 Jkt 226001 continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on a substantial number of small entities. FDA will consider, and is soliciting comments on, the following: (1) The continued need for the rule; (2) the nature of complaints or comments received concerning the rule from the public; (3) the complexity of the rule; (4) the extent to which the rule overlaps, duplicates, or conflicts with other Federal rules, and, to the extent feasible, with State and local governmental rules; and (5) the length of time since the rule has been evaluated or the degree to which technology, economic conditions, or other factors have changed in the area affected by the rule. Timetable: Action Date Begin Review ...... End Review ......... FR Cite 06/01/11 12/00/11 Regulatory Flexibility Analysis Required: No. Agency Contact: Melissa Reisman, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Suite 200N (HFM–17), 1401 Rockville Pike, Rockville, MD 20852, Phone: 301 827–6210. RIN: 0910–AG62 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Proposed Rule Stage 329. Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics Regulatory Plan: This entry is Seq. No. 33 in part II of this issue of the Federal Register. RIN: 0910–AC52 330. 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 PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 marketed. The first action addresses 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 (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 06/00/12 12/00/12 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Mary Chung, 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 331. 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 products. The second action addresses testing requirements. Timetable: Action Date FR Cite NPRM (Healthcare). Comment Period End. 06/17/94 59 FR 31402 E:\FR\FM\13FEP8.SGM 13FEP8 12/15/95 Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Unified Agenda Action Date NPRM (Consumer). FR Cite 04/00/12 NPRM (Food Handlers). NPRM (Testing) .. Final Action (Consumer). Final Action (Testing). Final Action (Food Handlers). Final Action (First Aid Antiseptic). To Be Determined 333. Laser Products; Amendment to Performance Standard To Be Determined To Be Determined 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. The proposal would adopt portions of an IEC standard to achieve greater harmonization and reflect current science. In addition, the proposal would include an alternative mechanism for providing certification and identification, address novelty laser products, and clarify the military exemption for laser products. Timetable: To Be Determined To Be Determined To Be Determined Regulatory Flexibility Analysis Required: Yes. Agency Contact: David Eng, 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 332. Import Tolerances for Residues of Unapproved New Animal Drugs in Food Legal Authority: 21 U.S.C. 342; 21 U.S.C. 360b(a)(6); 21 U.S.C. 371 Abstract: The Food and Drug Administration (FDA) plans to publish a proposed rule related to the implementation of the import tolerances provision of the Animal Drug Availability Act of 1996 (ADAA). The ADAA authorizes FDA to establish tolerances for unapproved new animal drugs where edible portions of animals imported into the United States may contain residues of such drugs (import tolerances). It is unlawful to import animal-derived food that bears or contains residues of a new animal drug that is not approved in the United States, unless FDA has established an import tolerance for that new animal drug and the residue of the new animal drug in the animal-derived food does not exceed that tolerance. Timetable: Action Date erowe on DSK2VPTVN1PROD with PROPOSALS2 NPRM .................. NPRM Comment Period End. FR Cite 03/00/12 06/00/12 15:15 Feb 10, 2012 Action Date NPRM .................. FR Cite 01/00/12 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 334. Current Good Manufacturing Practice and Hazard Analysis and RiskBenefit Preventive Controls for Food for Animals Regulatory Plan: This entry is Seq. No. 34 in part II of this issue of the Federal Register. RIN: 0910–AG10 335. Over-the-Counter (OTC) Drug Review—Pediatric Dosing for Cough/ Cold Products Regulatory Flexibility Analysis Required: Yes. Agency Contact: Thomas Moskal, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, Room 101, (MPN– 4, HFV–232), 7519 Standish Place, VerDate Mar<15>2010 Rockville, MD 20855, Phone: 240 276– 9242, Fax: 240 276–9241, Email: thomas.moskal@fda.hhs.gov. RIN: 0910–AF78 Jkt 226001 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 PO 00000 Frm 00007 Fmt 4701 Sfmt 4702 7951 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 07/00/12 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Mary Chung, 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 336. Electronic Distribution of Content of Labeling for Human Prescription Drug and 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 exception, 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 .................. FR Cite 12/00/11 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 Building 32, Room 4249, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796–9301, Email: megan.clark@fda.hhs.gov. RIN: 0910–AG18 E:\FR\FM\13FEP8.SGM 13FEP8 7952 Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Unified Agenda 337. Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals—Second Phase Legal Authority: 21 U.S.C. 321; 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 355; 21 U.S.C. 360b; 21 U.S.C. 371; 21 U.S.C. 374; 42 U.S.C. 262; 42 U.S.C. 264 Abstract: The Food and Drug Administration (FDA) periodically reassesses and revises the cGMP regulations to accommodate advances in technology and other scientific knowledge that further safeguard the drug manufacturing process and the public health. In August 2002, FDA announced the Pharmaceutical cGMPs for the 21st Century Initiative. As part of the Initiative, FDA created a cGMP Harmonization Analysis Working Group to analyze related cGMP requirements in the United States and internationally. The cGMP working group compared 21 CFR parts 210 and 211 with the cGMPs of the European Union, as well as other FDA regulations (such as the Quality Systems Regulation in 21 CFR part 820) to identify differences and consider the value of supplementing or changing the current regulations. Based on the cGMP Working Group’s analysis, FDA decided to take an incremental approach to modifying 21 CFR parts 210 and 211. In September of 2008, FDA published a final rule revising the cGMP regulations primarily in the areas of aseptic processing, use of asbestos filters, and verification of operations by a second individual; this final rule represented the culmination of the first increment of modifications to the cGMP regulations. The proposed rule identified on this Unified Agenda would begin the second increment of modifications to the cGMP regulations. Timetable: Action Date NPRM .................. FR Cite RIN: 0910–AG31 339. Produce Safety Regulation Regulatory Plan: This entry is Seq. No. 36 in part II of this issue of the Federal Register. RIN: 0910–AG35 340. Hazard Analysis and Risk-Based Preventive Controls Regulatory Plan: This entry is Seq. No. 37 in part II of this issue of the Federal Register. RIN: 0910–AG36 341. ‘‘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 FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. Section 901 of 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’’ found at section 201(rr) of the FD&C Act to be subject to Chapter IX of the FD&C Act and would clarify additional restrictions under the FD&C Act. The scope of the proposed rule deeming cigars that was previously included in the Unified Agenda is being broadened to encompass products that meet the statutory definition of ‘‘tobacco product.’’ Timetable: 03/00/12 erowe on DSK2VPTVN1PROD with PROPOSALS2 Action Regulatory Flexibility Analysis Required: Yes. Agency Contact: S. Mitchell Weitzman, Regulatory Counsel, Office of Regulatory Policy, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6318, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796–3511, Fax: 301 847–8440, Email: smitchell.weitzman@fda.hhs.gov. RIN: 0910–AG20 338. Unique Device Identification Regulatory Plan: This entry is Seq. No. 35 in part II of this issue of the Federal Register. VerDate Mar<15>2010 15:15 Feb 10, 2012 Jkt 226001 Date NPRM .................. FR Cite 12/00/11 Regulatory Flexibility Analysis Required: Yes. Agency Contact: May Nelson, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 9200 Corporate Boulevard, Rockville, MD 20850, Phone: 877 287–1373, Fax: 240 276–3904, Email: may.nelson@fda.hhs.gov. RIN: 0910–AG38 342. Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices Legal Authority: Not Yet Determined. PO 00000 Frm 00008 Fmt 4701 Sfmt 4702 Abstract: The Food and Drug Administration (FDA) is proposing to amend its regulations on acceptance of data from clinical studies conducted in support of a premarket approval application, humanitarian device exemption application, an investigational device exemption application, or a premarket notification submission for a medical device. Timetable: Action Date NPRM .................. FR Cite 04/00/12 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Sheila Anne Brown, Policy Analyst, Investigational Device Exemptions Staff, Department of Health and Human Services, Food and Drug Administration, WO 66, Room 1651, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796– 6563, Fax: 301 847–8120, Email: sheila.brown@fda.hhs.gov. RIN: 0910–AG48 343. 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: Since 2003, FDA has seen a dramatic increase in the number of device recalls, as well as an increase in the number of death and serious injury reports submitted regarding infusion pumps. An analysis of the reports reveals that a majority of the recalls and failures were caused by user error and/ or device design flaw. As a result of these incidents, FDA is proposing to change the classification of infusion pumps from class II (performance standards) to class II (special controls). Along with the proposed rule, FDA plans to announce a draft special controls guidance document that, when final, will be a special control for infusion pumps. The agency believes that establishing these special controls for infusion pumps is necessary to provide reasonable assurance of the safety and effectiveness of these devices. Timetable: Action Date NPRM .................. NPRM Comment Period End. FR Cite 05/00/12 08/00/12 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Nancy Pirt, Regulatory Counsel, Department of Health and Human Services, Food and E:\FR\FM\13FEP8.SGM 13FEP8 Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Unified Agenda 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 344. Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives Legal Authority: Pub. L. 111–31, The Family Smoking Prevention and Tobacco Control Act, sec 101(b) Abstract: Section 915 of the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act, requires FDA 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 NPRM .................. NPRM Comment Period End. FR Cite 08/00/12 10/00/12 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Carol Drew, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Rm 240 H, 9200 Corporate Boulevard, Rockville, MD 20850, Phone: 877 287–1373, Fax: 240 276–3904, Email: carol.drew@fda.hhs.gov. RIN: 0910–AG59 345. 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: erowe on DSK2VPTVN1PROD with PROPOSALS2 Action Date NPRM .................. 03/00/12 15:15 Feb 10, 2012 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Final Rule Stage 346. Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports; and Quality Factors Regulatory Plan: This entry is Seq. No. 40 in part II of this issue of the Federal Register. RIN: 0910–AF27 347. Label Requirement for Food That Has Been Refused Admission Into the United States Legal Authority: 15 U.S.C. 1453 to 1455; 21 U.S.C. 321; 21 U.S.C. 342 and 343; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381; 42 U.S.C. 216; 42 U.S.C. 264 Abstract: The final rule will require owners or consignees to label imported food that is refused entry into the United States. The label will read, ‘‘UNITED STATES: REFUSED ENTRY.’’ The proposal describes the label’s characteristics (such as its size) and processes for verifying that the label has been affixed properly. We are taking this action to prevent the introduction of unsafe food into the United States, to facilitate the examination of imported food, and to implement section 308 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107–188). Timetable: Action Date FR Cite NPRM .................. NPRM Comment Period End. Final Action ......... 09/18/08 12/02/08 73 FR 54106 FR Cite 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 VerDate Mar<15>2010 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, 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 Jkt 226001 06/00/12 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Daniel Sigelman, Regulatory Counsel, Department of PO 00000 Frm 00009 Fmt 4701 Sfmt 4702 7953 Health and Human Services, Food and Drug Administration, WO Building 32, Room 4254, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796–4706, Email: daniel.sigelman@fda.hhs.gov. RIN: 0910–AF61 348. Food Labeling: Nutrition Labeling for Food Sold in Vending Machines Regulatory Plan: This entry is Seq. No. 43 in part II of this issue of the Federal Register. RIN: 0910–AG56 349. Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments Regulatory Plan: This entry is Seq. No. 44 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 350. 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: In the Federal Register of July 11, 2003 (68 FR 41507), FDA published an ANPRM (the 2003 ANPRM) to solicit information and data on trans fat labeling and claims made about trans fats. Comments received to the 2003 ANPRM that pertain to the labeling of trans fat will be addressed in this proposed rule. In addition, the Agency published an ANPRM on the prominence of calories on the food label on April 4, 2005 (the 2005 ANPRM) (70 FR 17008), and an ANPRM on the revision of reference values and mandatory nutrients on November 2, 2007 (the 2007 ANPRM) (72 FR 62149). The Agency also intends to address the comments received to the 2005 and 2007 ANPRM’s in this proposed rule. FDA is proposing to amend labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the label to assist consumers in maintaining healthy dietary practices. Mandatory nutrition labeling of food was first required in 1993. Much of the information found on the Nutrition Facts label has not been updated since that time. 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. Among the changes proposed, the Agency intends to: (1) Provide updated E:\FR\FM\13FEP8.SGM 13FEP8 7954 Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Unified Agenda Daily Reference values (DRVs) and Reference Daily Intake values (RDIs) that are based on the latest scientific evidence from consensus reports, such as the Institute of Medicine Dietary Reference Intakes; (2) provide DRVs and RDIs, as well as requirements for foods purported to be for children under 4 years of age and pregnant or lactating women; and (3) make changes to the mandatory declaration of specific nutrients. The Agency is also considering revisions to the format and appearance of the Nutrition Facts label and the Supplement Facts label, including the prominence of calories on the label. Timetable: Action 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 12/00/12 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 erowe on DSK2VPTVN1PROD with PROPOSALS2 351. Over-the-Counter (OTC) Drug Review—Oral Health Care Products Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360 to 360a; 21 U.S.C. 371 to 371a Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The NPRM and final action will address oral health care products used to reduce or prevent dental plaque and gingivitis. Timetable: Action Date ANPRM (Plaque Gingivitis). VerDate Mar<15>2010 FR Cite 05/29/03 68 FR 32232 15:15 Feb 10, 2012 Jkt 226001 Action Date ANPRM Comment Period End. 08/27/03 NPRM (Benzocaine). FR Cite To Be Determined Regulatory Flexibility Analysis Required: Yes. Agency Contact: David Eng, 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–AF40 352. Pet Food Labeling Requirements Legal Authority: 21 U.S.C. 343; 21 U.S.C. 371; Pub. L. 110–85, sec 1002(a)(3) Abstract: The President signed into law the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 27, 2007 (Pub. L. 110–85). Title X of the FDAAA includes several provisions pertaining to food safety, including the safety of pet food. Section 1002(a)(3) of the new law directs FDA to issue new regulations to establish updated standards for the labeling of pet food that include nutritional and ingredient information. This same provision of the law also directs that, in developing these new regulations, FDA consult with the Association of American Feed Control Officials and other relevant stakeholder groups, including veterinary medical associations, animal health organizations, and pet food manufacturers. Timetable: Action Date NPRM .................. FR Cite To Be Determined Regulatory Flexibility Analysis Required: Yes. Agency Contact: William Burkholder, Veterinary Medical Officer, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, Room 2642 (MPN–4, HFV–228), 7519 Standish Place, Rockville, MD 20855, Phone: 240 453–6865, Email: william.burkholder@fda.hhs.gov. RIN: 0910–AG09 PO 00000 Frm 00010 Fmt 4701 Sfmt 4702 353. Further Amendments to General Regulation of the Food and Drug Administration To Incorporate Tobacco Products Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 333; 21 U.S.C. 371; 21 U.S.C. 381; 21 U.S.C. 387; 21 U.S.C. 387a; 21 U.S.C. 387c; 21 U.S.C. 387f; 21 U.S.C. 387k; 15 U.S.C. 1333; 15 U.S.C. 4402 Abstract: The Food and Drug Administration is seeking to amend certain of its general regulations to include tobacco products, where appropriate, in light of FDA’s authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act. The final rule will cover revisions to the document reporting requirements and definition of ‘‘product.’’ Timetable: Action Date FR Cite NPRM .................. NPRM Comment Period End. 04/14/11 06/13/11 76 FR 20901 Final Action ......... To Be Determined Regulatory Flexibility Analysis Required: Yes. Agency Contact: Gerie Voss, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 9200 Corporate Boulevard, Rockville, MD 20850, Phone: 877 287–1373,Fax: 240 276–4193, Email: gerie.voss@fda.hhs.gov. RIN: 0910–AG60 354. • 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: The Food and Drug Administration is proposing to amend certain provisions of its serving size regulations to change the label serving size for breath mints to one unit. This action is in response to an advanced notice of proposed rulemaking published in 2005, in which FDA requested comment on whether to amend certain provisions of its nutrition labeling regulations concerning serving size and a 1997 proposed rule entitled Food Labeling: Hard Candies and Breath Mints (62 FR 67775). Timetable: Action Date FR Cite NPRM .................. NPRM Comment Period End. ANPRM ............... ANPRM Comment Period End. 12/30/97 03/16/98 62 FR 67775 04/05/05 06/20/05 70 FR 17010 E:\FR\FM\13FEP8.SGM 13FEP8 7955 Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Unified Agenda Action Date NPRM .................. FR Cite 12/00/12 Food and Drug Administration (FDA) 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 355. • 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: The Food and Drug Administration is proposing to amend certain provisions of its serving size regulations to provide updated Reference Amounts Customarily Consumed for candies. This action is in response to an advance notice of proposed rulemaking published in 2005, in which FDA requested comment on whether to amend certain provisions of its nutrition labeling regulations concerning serving size and a 1998 proposed rule entitled ‘‘Food Labeling: Reference Amounts for Candies’’ (63 FR 1078). Timetable: Date FR Cite NPRM .................. NPRM Comment Period End. ANPRM ............... ANPRM Comment Period End. NPRM .................. erowe on DSK2VPTVN1PROD with PROPOSALS2 Action 01/08/98 02/09/98 63 FR 1078 04/05/05 06/20/05 70 FR 17010 12/00/12 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 VerDate Mar<15>2010 15:15 Feb 10, 2012 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Jkt 226001 marketed. This action addresses the ingredient ipecac syrup. Timetable: Completed Actions Action 356. Over-the-Counter (OTC) Drug Review—Cough/Cold (Bronchodilator) Products Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses labeling for single ingredient bronchodilator products. Timetable: Action Date FR Cite NPRM (Amendment—Ephedrine Single Ingredient). NPRM Comment Period End. Final Action (Technical Amendment). Final Action (Amendment— Single Ingredient Labeling). 07/13/05 70 FR 40237 11/10/05 11/30/07 72 FR 67639 07/26/11 76 FR 44475 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Mary Chung, 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–AF32 357. Over-the-Counter (OTC) Drug Review—Poison Treatment 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 PO 00000 Frm 00011 Fmt 4701 Sfmt 4702 Date Withdrawn ........... FR Cite 09/08/11 Regulatory Flexibility Analysis Required: Yes. Agency Contact: David Eng, 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–AF68 358. Cigarette Warning Label Statements Legal Authority: Pub. L. 111–31, The Family Smoking Prevention and Tobacco Control Act, sec 201 Abstract: Section 4 of the FCLAA, as amended by section 201 of the Tobacco Control Act, requires FDA to issue regulations that require color graphics depicting the negative health consequences of smoking to accompany required warning statements on cigarette packages and advertisements. FDA also may adjust the type size, text and format of the required label statements on product packaging and advertising if FDA determines that it is appropriate so that both the graphics and the accompanying label statements are clear, conspicuous, legible and appear within the specified area. Timetable: Action Date FR Cite NPRM .................. NPRM Comment Period End. Final Action ......... 11/12/10 01/11/11 75 FR 69524 06/22/11 76 FR 36628 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Gerie Voss, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 9200 Corporate Boulevard, Rockville, MD 20850, Phone: 877 287–1373, Fax: 240 276–4193, Email: gerie.voss@fda.hhs.gov. RIN: 0910–AG41 E:\FR\FM\13FEP8.SGM 13FEP8 7956 Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Unified Agenda DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Timetable: Centers for Medicare & Medicaid Services (CMS) Action Date NPRM .................. 02/00/12 Proposed Rule Stage 359. Covered Outpatient Drugs (CMS– 2345–P) (Section 610 Review) Legal Authority: Pub. L. 111–48, secs 2501 and 2503 Abstract: This proposed rule would revise requirements pertaining to Medicaid reimbursement for covered outpatient drugs to implement provisions of the Affordable Care Act. This proposed rule would also revise other requirements related to covered outpatient drugs, including key aspects of Medicaid coverage, payment, and the drug rebate program. Timetable: Action Date NPRM .................. FR Cite 01/00/12 erowe on DSK2VPTVN1PROD with PROPOSALS2 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 360. Medicare and Medicaid Electronic Health Record Incentive Program— Stage 2 (CMS–0044–P) Legal Authority: Pub. L. 111–5 secs 4101, 4102, and 4202 Abstract: The final rule for the Medicare and Medicaid EHR Incentive Programs, which was published in the Federal Register on July 28, 2010, specifies that CMS will expand on the criteria for meaningful use established for Stage 1 to advance the use of certified EHR technology by eligible professionals (EPs), eligible hospitals and critical access hospitals (CAHs). This proposed rule would establish the requirements for Stage 2. As stated in the July 28 final rule, ‘‘Our goals for the Stage 2 meaningful use criteria, consistent with other provisions of Medicare and Medicaid law, expand upon the Stage 1 criteria to encourage the use of health IT for continuous quality improvement at the point of care and the exchange of information in the most structured format possible, such as the electronic transmission of orders entered using computerized provider order entry (CPOE) and the electronic transmission of diagnostic test results.’’ VerDate Mar<15>2010 15:15 Feb 10, 2012 Jkt 226001 FR Cite 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 361. Medicare and Medicaid Programs: Reform of Hospital and Critical Access Hospital Conditions of Participation (CMS–3244–P) Regulatory Plan: This entry is Seq. No. 45 in part II of this issue of the Federal Register. RIN: 0938–AQ89 362. • Proposed Changes to Hospital OPPS and CY 2013 Payment Rates; ASC Payment System and CY 2013 Payment Rates (CMS–1589–P) (Section 610 Review) Regulatory Plan: This entry is Seq. No. 47 in part II of this issue of the Federal Register. RIN: 0938–AR10 363. • Revisions to Payment Policies Under the Physician Fee Schedule and Part B for CY 2013 (CMS–1590–P) (Section 610 Review) Regulatory Plan: This entry is Seq. No. 48 in part II of this issue of the Federal Register. RIN: 0938–AR11 364. • Changes to the Hospital Inpatient and Long-Term Care Prospective Payment System for FY 2013 (CMS–1588–P) (Section 610 Review) Regulatory Plan: This entry is Seq. No. 49 in part II of this issue of the Federal Register. RIN: 0938–AR12 365. • 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 report annually to the Secretary certain payments or transfers of value provided to physicians or teaching hospitals (‘‘covered recipients’’). In PO 00000 Frm 00012 Fmt 4701 Sfmt 4702 addition, applicable manufacturers and applicable group purchasing organizations (GPOs) are required to report annually certain physician ownership or investment interests. The Secretary is required to publish applicable manufacturers’ and applicable GPOs’ submitted payment and ownership information on a public Web site. Timetable: Action 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 Blvd., 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 366. Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and FY 2012 Rates and to the Long-Term Care Hospital PPS and FY 2012 Rates (CMS– 1518–F) (Completion of a Section 610 Review) Legal Authority: sec 1886(d) of the Social Security Act; Pub. L. 111–148 secs 3004, 3025 Abstract: This rule revises the Medicare hospital inpatient and longterm 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. Final Action ......... 05/05/11 06/20/11 76 FR 25788 08/18/11 76 FR 51476 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Ankit Patel, Health Insurance Specialist, Division of Acute Care, Department of Health and Human E:\FR\FM\13FEP8.SGM 13FEP8 Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Unified Agenda Services, Centers for Medicare & Medicaid Services, Hospital and Ambulatory Policy Group, Mail Stop, C4–25–11, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786– 4537, Email: ankit.patel@cms.hhs.gov. RIN: 0938–AQ24 367. Revisions to Payment Policies Under the Physician Fee Schedule and Part B for CY 2012 (CMS–1524–FC) (Completion of a Section 610 Review) Legal Authority: Social Security Act, sec 1102; Social Security Act, sec 1871; Pub. L. 111–148 Abstract: This annual 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 .................. NPRM Comment Period End. Final Action ......... Final Action Effective. 07/19/11 08/30/11 76 FR 42772 11/28/11 01/01/12 76 FR 73026 erowe on DSK2VPTVN1PROD with PROPOSALS2 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–AQ25 368. Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System for CY 2012 (CMS–1525–F) (Completion of a Section 610 Review) Legal Authority: Social Security Act, sec 1833; Pub. L. 111–148 sec 6001 Abstract: This 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 proposed rule also describes changes to the amounts and factors used to determine payment rates for services. In addition, the rule finalizes changes to the Ambulatory Surgical Center Payment System list of services and rates. Timetable: Action Date FR Cite Action Date FR Cite Final Action ......... 11/30/11 76 FR 74122 Final Action ......... 08/08/11 76 FR 48486 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Paula Smith, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop, C4–05–13, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786–4709, Email: paula.smith@cms.hhs.gov. RIN: 0938–AQ26 369. Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2012; Required Disclosures of Ownership (CMS–1351–F) (Completion of a Section 610 Review) Legal Authority: Social Security Act, sec 1888(e), Pub. L. 111–148, sec 6101 Abstract: This major rule finalizes two options for updating the payment rates used under the prospective payment system (SNFs), for fiscal year 2012. In this context, it examines recent changes in provider behavior relating to the implementation of the Resource Utilization Groups, version 4 (RUG–IV) case-mix classification system, discusses how such changes may affect the objective of maintaining parity in overall expenditures between RUG–IV and the previous case-mix classification system, and considers a possible recalibration of the case-mix indexes so that they more accurately reflect parity in expenditures. It also includes a discussion of a Non-Therapy Ancillary component and outlier research currently under development within CMS. In addition, this rule discusses the impact of certain provisions of the Affordable Care Act, and new programs and initiatives affecting SNFs. It also implements section 3401(b) of the Affordable Care Act, which requires for fiscal year 2012 and subsequent fiscal years that the SNF market basket percentage change be reduced by the multi-factor productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act. It also implements section 6101 of the Affordable Care Act, which requires Medicare SNFs and Medicaid nursing facilities to disclose certain information to the Secretary and other entities regarding the ownership and organizational structure of their facilities. Timetable: Action Date FR Cite Action Date FR Cite NPRM .................. NPRM Comment Period End. 07/18/11 08/30/11 76 FR 42170 NPRM .................. NPRM Comment Period End. 05/06/11 06/27/11 76 FR 26364 VerDate Mar<15>2010 15:15 Feb 10, 2012 Jkt 226001 7957 PO 00000 Frm 00013 Fmt 4701 Sfmt 4702 Regulatory Flexibility Analysis Required: Yes. Agency Contact: William Ullman, Technical Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers for Medicare Management, Mail Stop C5–06–27, 7500 Security Boulvard, Baltimore, MD 21244, Phone: 410 786– 5667, Fax: 410 786–0765, Email: bill.ullman@cms.hhs.gov. RIN: 0938–AQ29 370. Home Health Prospective Payment System Refinements and Rate Update for CY 2012 (CMS–1353–F) (Section 610 Review) Legal Authority: Social Security Act, secs 1102 and 1871; 42 U.S.C. 1302 and 1395(hh); Social Security Act, sec 1895; 42 U.S.C. 1395(fff), Pub. L. 111–148 secs 3131, 3401, 6407 Abstract: This rule updates the 60-day national episode rate (based on the applicable Home Health Market Basket Update and case-mix adjustment) and would also update the national per-visit rates (used to calculate low utilization payment adjustments (LUPAs) and outlier payments) amounts under the Medicare Prospective Payment System for home health agencies. These changes are applicable to services furnished on or after January 1st. Timetable: Action Date FR Cite NPRM .................. NPRM Comment Period End. Final Action ......... 07/12/11 09/06/11 76 FR 40988 11/04/11 76 FR 68526 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Kelly Horney, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare Management, Mail Stop C5–07–28, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786– 0558, Fax: 410 786–0765, Email: kelly.horney@cms.hhs.gov. RIN: 0938–AQ30 371. Enhanced Federal Funding for Medicaid Eligibility Determination and Enrollment Activities (CMS–2346–F) Legal Authority: Pub. L. 111–148, sec 1413 Abstract: The Affordable Care Act requires States’ residents to apply, enroll, receive determinations, and participate in the State health subsidy programs known as ‘‘the Exchange’’. E:\FR\FM\13FEP8.SGM 13FEP8 7958 Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Unified Agenda The Affordable Care Act requires many changes to State eligibility and enrollment systems and each State is responsible for developing a secure, electronic interface allowing the exchange of data. Existing legacy eligibility systems are not able to implement the numerous requirements. This rule is key to informing States about the higher rates that CMS will provide to help them update or build legacy eligibility systems that meet the ACA requirements. Timetable: Action Date FR Cite NPRM .................. NPRM Comment Period End. Final Action ......... 11/08/10 01/07/11 75 FR 68583 04/19/11 76 FR 21950 erowe on DSK2VPTVN1PROD with PROPOSALS2 Regulatory Flexibility Analysis Required: Yes. VerDate Mar<15>2010 15:15 Feb 10, 2012 Jkt 226001 Agency Contact: Richard H. Friedman, Director, Division of State Systems, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop S3–18–13, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786–4451, Email: richard.friedman@cms.hhs.gov. RIN: 0938–AQ53 will be effective for services furnished beginning January 1, 2012. Timetable: 372. Five-Year Review of Work Relative Value Units Under the Physician Fee Schedule (CMS–1582–PN) Regulatory Flexibility Analysis Required: Yes. Agency Contact: Rebecca Cole, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop: C4–03–06, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786–1589, Email: rebecca.cole@cms.hhs.gov. RIN: 0938–AQ87 Legal Authority: SSA, sec 1848(c)(2)(B)(i) Abstract: This proposed notice sets forth proposed revisions to work relative value units (RVUs) affecting payment for physicians’ services. The Act requires that we review RVUs no less than every five years. The revised values will be finalized in the CY 2012 Physician Fee Schedule final rule and PO 00000 Frm 00014 Fmt 4701 Sfmt 9990 Action Date FR Cite Notice .................. Merged With 0938–AQ25. 06/06/11 07/07/11 76 FR 32410 [FR Doc. 2012–1647 Filed 2–10–12; 8:45 am] BILLING CODE 4150–24–P E:\FR\FM\13FEP8.SGM 13FEP8

Agencies

[Federal Register Volume 77, Number 29 (Monday, February 13, 2012)]
[Unknown Section]
[Pages 7946-7958]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-1647]



[[Page 7945]]

Vol. 77

Monday,

No. 29

February 13, 2012

Part VIII





Department of Health and Human Services





-----------------------------------------------------------------------





Semiannual Regulatory Agenda

Federal Register / Vol. 77 , No. 29 / Monday, February 13, 2012 / 
Unified Agenda

[[Page 7946]]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

21 CFR Ch. I

42 CFR Chs. I-V

45 CFR Subtitle A; Subtitle B, Chs. II, III, and XIII


Regulatory Agenda

AGENCY: Office of the Secretary, HHS.

ACTION: Semiannual regulatory agenda.

-----------------------------------------------------------------------

SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order 
(EO) 12866 require the semiannual issuance of an inventory of 
rulemaking actions under development throughout the Department with a 
view to offering summarized information about forthcoming regulatory 
actions for public review.

FOR FURTHER INFORMATION CONTACT: Jennifer M. Cannistra, Executive 
Secretary, Department of Health and Human Services, Washington, DC 
20201.

SUPPLEMENTARY INFORMATION:  The information provided in the Agenda 
presents a forecast of the rulemaking activities that the Department of 
Health and Human Services (HHS) expects to undertake in the foreseeable 
future.
    Rulemakings are grouped according to pre-rulemaking actions, 
proposed rules, final rules, long-term actions, and rulemaking actions 
completed since the spring 2011 Agenda was published.
    Please note that the rulemaking abstracts included in this paper 
issue of the Federal Register relate strictly to those prospective 
rulemakings that are likely to have a significant economic impact on a 
substantial number of small entities, as required by the Regulatory 
Flexibility Act of 1980. Also available in this issue of the Federal 
Register is the Department's submission to the Fiscal Year 2011 
Regulatory Plan, required under Executive Order 12866.
    The complete Regulatory Agenda of the Department is accessible 
online at www.reginfo.gov in an interactive format that offers users 
enhanced capabilities to obtain information from the Agenda's database. 
The purpose of the Agenda is to encourage more effective public 
participation in the regulatory process.

Jennifer M. Cannistra,
Executive Secretary to the Department.

  Substance Abuse and Mental Health Services Administration--Final Rule
                                  Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
321.......................  Opioid Drugs in                    0930-AA14
                             Maintenance or
                             Detoxification Treatment
                             of Opiate Addiction
                             (Section 610 Review).
------------------------------------------------------------------------


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


      Centers for Disease Control and Prevention--Long-Term Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
323.......................  Control of Communicable            0920-AA12
                             Diseases: Foreign.
324.......................  Control of Communicable            0920-AA22
                             Diseases: Interstate.
------------------------------------------------------------------------


               Food and Drug Administration--Prerule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
325.......................  Over-the-Counter (OTC)             0910-AF43
                             Drug Review--Sunscreen
                             Products.
326.......................  Prescription Drug                  0910-AG14
                             Marketing Act of 1987;
                             Prescription Drug
                             Amendments of 1992;
                             Policies, Requirements,
                             and Administrative
                             Procedures (Section 610
                             Review).
327.......................  Requirements for Testing           0910-AG61
                             Human Blood Donors for
                             Evidence of Infection Due
                             to Communicable Disease
                             Agents (Section 610
                             Review).
328.......................  General Requirements for           0910-AG62
                             Blood, Blood Components,
                             and Blood Derivatives;
                             Donor Notification
                             (Section 610 Review).
------------------------------------------------------------------------


            Food and Drug Administration--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
329.......................  Electronic Submission of           0910-AC52
                             Data From Studies
                             Evaluating Human Drugs
                             and Biologics (Reg Plan
                             Seq No. 33).
330.......................  Over-the-Counter (OTC)             0910-AF36
                             Drug Review-Internal
                             Analgesic Products.
331.......................  Over-the-Counter (OTC)             0910-AF69
                             Drug Review-Topical
                             Antimicrobial Drug
                             Products.
332.......................  Import Tolerances for              0910-AF78
                             Residues of Unapproved
                             New Animal Drugs in Food.
333.......................  Laser Products; Amendment          0910-AF87
                             to Performance Standard.

[[Page 7947]]

 
334.......................  Current Good Manufacturing         0910-AG10
                             Practice and Hazard
                             Analysis and Risk-Benefit
                             Preventive Controls for
                             Food for Animals (Reg
                             Plan Seq No. 34).
335.......................  Over-the-Counter (OTC)             0910-AG12
                             Drug Review-Pediatric
                             Dosing for Cough/Cold
                             Products.
336.......................  Electronic Distribution of         0910-AG18
                             Content of Labeling for
                             Human Prescription Drug
                             and Biological Products.
337.......................  Amendment to the Current           0910-AG20
                             Good Manufacturing
                             Practice Regulations for
                             Finished Pharmaceuticals--
                             Second Phase.
338.......................  Unique Device                      0910-AG31
                             Identification (Reg Plan
                             Seq No. 35).
339.......................  Produce Safety Regulation          0910-AG35
                             (Reg Plan Seq No. 36).
340.......................  Hazard Analysis and Risk-          0910-AG36
                             Based Preventive Controls
                             (Reg Plan Seq No. 37).
341.......................  ``Tobacco Products''               0910-AG38
                             Subject to the Federal
                             Food, Drug, and Cosmetic
                             Act, as Amended by the
                             Family Smoking Prevention
                             and Tobacco Control Act.
342.......................  Human Subject Protection;          0910-AG48
                             Acceptance of Data From
                             Clinical Studies for
                             Medical Devices.
343.......................  General Hospital and               0910-AG54
                             Personal Use Devices:
                             Issuance of Draft Special
                             Controls Guidance for
                             Infusion Pumps.
344.......................  Requirements for the               0910-AG59
                             Testing and Reporting of
                             Tobacco Product
                             Constituents,
                             Ingredients, and
                             Additives.
345.......................  Amendments to the Current          0910-AG70
                             Good Manufacturing
                             Practice Regulations for
                             Finished Pharmaceuticals--
                             Components.
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
346.......................  Infant Formula: Current            0910-AF27
                             Good Manufacturing
                             Practices; Quality
                             Control Procedures;
                             Notification
                             Requirements; Records and
                             Reports; and Quality
                             Factors (Reg Plan Seq No.
                             40).
347.......................  Label Requirement for Food         0910-AF61
                             That Has Been Refused
                             Admission Into the United
                             States.
348.......................  Food Labeling: Nutrition           0910-AG56
                             Labeling for Food Sold in
                             Vending Machines (Reg
                             Plan Seq No. 43).
349.......................  Food Labeling: Nutrition           0910-AG57
                             Labeling of Standard Menu
                             Items in Restaurants and
                             Similar Retail Food
                             Establishments (Reg Plan
                             Seq No. 44).
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
350.......................  Food Labeling; Revision of         0910-AF22
                             the Nutrition and
                             Supplement Facts Labels.
351.......................  Over-the-Counter (OTC)             0910-AF40
                             Drug Review-Oral Health
                             Care Products.
352.......................  Pet Food Labeling                  0910-AG09
                             Requirements.
353.......................  Further Amendments to              0910-AG60
                             General Regulations of
                             the Food and Drug
                             Administration to
                             Incorporate Tobacco
                             Products.
354.......................  Food Labeling: Hard                0910-AG82
                             Candies and Breath Mints.
355.......................  Food Labeling; Serving             0910-AG83
                             Sizes; Reference Amounts
                             for Candies.
------------------------------------------------------------------------


             Food and Drug Administration--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
356.......................  Over-the-Counter (OTC)             0910-AF32
                             Drug Review--Cough/Cold
                             (Bronchodilator) Products.
357.......................  Over-the-Counter (OTC)             0910-AF68
                             Drug Review--Poison
                             Treatment Drug Products.
358.......................  Cigarette Warning Label            0910-AG41
                             Statements.
------------------------------------------------------------------------


      Centers for Medicare & Medicaid Services--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
359.......................  Covered Outpatient Drugs           0938-AQ41
                             (CMS-2345-P) (Section 610
                             Review).
360.......................  Medicare and Medicaid              0938-AQ84
                             Electronic Health Record
                             Incentive Program--Stage
                             2 (CMS-0044-P).
361.......................  Medicare and Medicaid              0938-AQ89
                             Programs: Reform of
                             Hospital and Critical
                             Access Hospital
                             Conditions of
                             Participation (CMS-3244-
                             P) (Reg Plan Seq No. 45).
362.......................  Proposed Changes to                0938-AR10
                             Hospital OPPS and CY 2013
                             Payment Rates; ASC
                             Payment System and CY
                             2013 Payment Rates (CMS-
                             1589-P) (Section 610
                             Review) (Reg Plan Seq No.
                             47).
363.......................  Revisions to Payment               0938-AR11
                             Policies Under the
                             Physician Fee Schedule
                             and Part B for CY 2013
                             (CMS-1590-P) (Section 610
                             Review) (Reg Plan Seq No.
                             48).

[[Page 7948]]

 
364.......................  Changes to the Hospital            0938-AR12
                             Inpatient and Long-Term
                             Care Prospective Payment
                             System for FY 2013 (CMS-
                             1588-P) (Section 610
                             Review) (Reg Plan Seq No.
                             49).
365.......................  Transparency Reports and           0938-AR33
                             Reporting of Physician
                             Ownership of Investment
                             Interests (CMS-5060-F).
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.


       Centers for Medicare & Medicaid Services--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
366.......................  Proposed Changes to the            0938-AQ24
                             Hospital Inpatient
                             Prospective Payment
                             Systems for Acute Care
                             Hospitals and FY 2012
                             Rates and to the Long-
                             Term Care Hospital PPS
                             and FY 2012 Rates (CMS-
                             1518-F) (Completion of a
                             Section 610 Review).
367.......................  Revisions to Payment               0938-AQ25
                             Policies Under the
                             Physician Fee Schedule
                             and Part B for CY 2012
                             (CMS-1524-FC) (Completion
                             of a Section 610 Review).
368.......................  Changes to the Hospital            0938-AQ26
                             Outpatient Prospective
                             Payment System and
                             Ambulatory Surgical
                             Center Payment System for
                             CY 2012 (CMS-1525-F)
                             (Completion of a Section
                             610 Review).
369.......................  Prospective Payment System         0938-AQ29
                             and Consolidated Billing
                             for Skilled Nursing
                             Facilities for FY 2012;
                             Required Disclosures of
                             Ownership (CMS-1351-F)
                             (Completion of a Section
                             610 Review).
370.......................  Home Health Prospective            0938-AQ30
                             Payment System
                             Refinements and Rate
                             Update for CY 2012 (CMS-
                             1353-F) (Section 610
                             Review).
371.......................  Enhanced Federal Funding           0938-AQ53
                             for Medicaid Eligibility
                             Determination and
                             Enrollment Activities
                             (CMS-2346-F).
372.......................  Five Year Review of Work           0938-AQ87
                             Relative Value Units
                             Under the Physician Fee
                             Schedule (CMS-1582-PN).
------------------------------------------------------------------------


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Substance Abuse and Mental Health Services Administration (SAMHSA)

Final Rule Stage

321. Opioid Drugs in Maintenance or Detoxification Treatment of Opiate 
Addiction (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. 300xx-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.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/19/09  74 FR 29153
NPRM Comment Period End.............   08/18/09
Final Action........................   02/00/12
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: No.
    Agency Contact: Nicholas Reuter, 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

322.  Establishment of Minimum Standards for Birth Certificates

    Legal Authority: 42 U.S.C. 264
    Abstract: Section 7211 of the Intelligence Reform and Terrorism 
Prevention Act (IRTPA) mandates that HHS establish, by regulation, 
minimum standards to improve the security of birth certificates for use 
by Federal agencies for official purposes.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   09/00/12
------------------------------------------------------------------------

    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)

Centers for Disease Control and Prevention (CDC)

Long-Term Actions

323. Control of Communicable Diseases: Foreign

    Legal Authority: 42 U.S.C. 243; 42 U.S.C. 264 and 265; 42 U.S.C. 
267 and 268; 42 U.S.C. 270 and 271
    Abstract: The final rule focuses primarily on requirements relating 
to the reporting of deaths and illnesses onboard aircrafts and ships 
traveling from foreign countries into the United States, and the 
collection of specific traveler contact information for the purpose of 
CDC contacting travelers in the event of an exposure to a communicable 
disease.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   11/30/05  70 FR 71892
NPRM Comment Period End.............   01/20/06
                                     -----------------------------------
Final Action........................           To Be Determined
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Ashley Marrone, Public Health Analyst, Department 
of Health and Human Services, Centers for Disease Control and 
Prevention, MS-E03, 1600 Clifton Road NE., Atlanta, GA 30329, Phone: 
404 498-1600, Email: amarrone@cdc.gov.

[[Page 7949]]

    RIN: 0920-AA12

324. Control of Communicable Diseases: Interstate

    Legal Authority: 28 U.S.C. 198; 28 U.S.C. 231; 25 U.S.C. 1661; 42 
U.S.C. 243; 42 U.S.C. 248 and 249; 42 U.S.C. 264; 42 U.S.C. 266 to 268; 
42 U.S.C. 270 to 272; 42 U.S.C. 2001
    Abstract: This rule focuses primarily on requirements relating to 
the reporting of deaths and illnesses onboard aircrafts traveling 
domestically, and the collection of specific traveler contact 
information for the purpose of CDC contacting travelers in the event of 
an exposure to a communicable disease.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   11/30/05  70 FR 71892
NPRM Comment Period End.............   01/30/06
                                     -----------------------------------
Final Action........................           To Be Determined
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Ashley Marrone, Public Health Analyst, Department 
of Health and Human Services, Centers for Disease Control and 
Prevention, MS-E03, 1600 Clifton Road NE., Atlanta, GA 30329, Phone: 
404 498-1600, Email: amarrone@cdc.gov.
    RIN: 0920-AA22

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Prerule Stage

325. Over-the-Counter (OTC) Drug Review--Sunscreen Products

    Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
    Abstract: The OTC drug review establishes conditions under which 
OTC drugs are considered generally recognized as safe and effective and 
not misbranded. After a final monograph (i.e., final rule) is issued, 
only OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. The first of 
the future actions will address the safety of sunscreen active 
ingredients. The second of the future actions will address active 
ingredients reviewed under time and extent applications. The last 
action addresses combination products containing sunscreen and insect 
repellent ingredients.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
ANPRM (Sunscreen and Insect            02/22/07  72 FR 7941
 Repellent).
ANPRM Comment Period End............   05/23/07  .......................
NPRM (UVA/UVB)......................   08/27/07  72 FR 49070
NPRM Comment Period End.............   12/26/07  .......................
Final Action (UVA/UVB)..............   06/17/11  76 FR 35620
NPRM (Effectiveness)................   06/17/11  76 FR 35672
NPRM (Effectiveness) Comment Period    09/15/11  .......................
 End.
ANPRM (Dosage Forms)................   06/17/11  76 FR 35669
ANPRM (Dosage Forms) Comment Period    09/15/11  .......................
 End.
ANPRM (Safety)......................   06/00/12  .......................
NPRM (Time and Extent Applications).   08/00/12  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: David Eng, 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

326. 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; 21 
U.S.C. 352; 21 U.S.C. 353; 21 U.S.C. 360; 21 U.S.C. 371; 21 U.S.C. 374; 
21 U.S.C. 381
    Abstract: Pursuant to section 610 of the Regulatory Flexibility 
Act, FDA is currently undertaking a review of regulations promulgated 
under the Prescription Drug Marketing Act (PDMA) including those 
contained in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as 
amended in 64 FR 67762 and 67763). The purpose of this review is to 
determine whether the regulations in 21 CFR part 203 and 21 CFR 
sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) should 
be continued without change, or whether they should be amended or 
rescinded, consistent with the stated objectives of applicable 
statutes, to minimize adverse impacts on a substantial number of small 
entities. FDA solicited comments on the following: (1) The continued 
need for the regulations in 21 CFR part 203 and 21 CFR sections 205.3 
and 205.50 (as amended in 64 FR 67762 and 67763); (2) the nature of 
complaints or comments received from the public concerning the 
regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as 
amended in 64 FR 67762 and 67763); (3) the complexity of the 
regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as 
amended in 64 FR 67762 and 67763); (4) the extent to which the 
regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as 
amended in 64 FR 67762 and 67763) overlap, duplicate, or conflict with 
other Federal rules, and to the extent feasible, with State and local 
governmental rules, and (5) the degree to which technology, economic 
conditions, or other factors have changed in the area affected by the 
regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as 
amended in 64 FR 67762 and 67763).
    Last year, FDA extended the completion date by one year due to the 
RxUSA Wholesale, Inc., v. HHS case. Since then, the case has ended and 
FDA proposed to withdraw section 203.50(a). Therefore, FDA will 
complete the review by December 2011.
    Timetable:

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

    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

327. Requirements for Testing Human Blood Donors for Evidence of 
Infection Due to Communicable Disease Agents (Section 610 Review)

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 to 
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 360c and 360d; 21 U.S.C. 
360h and 360i; 21 U.S.C. 371 and 372; 21 U.S.C. 374; 21 U.S.C. 381; 42 
U.S.C. 216; 42 U.S.C. 262 to 264; 42 U.S.C. 263; 42 U.S.C. 263a; 42 
U.S.C. 264
    Abstract: FDA is undertaking a review of 21 CFR sections 610.40, 
610.41,

[[Page 7950]]

610.42, 610.44, 640.67, 640.70 (as amended in 66 FR 31146) under 
section 610 of the Regulatory Flexibility Act. The purpose of this 
review is to determine whether the regulations in 21 CFR sections 
610.40, 610.41, 610.42, 610.44, 640.67, 640.70 (as amended in 66 FR 
31146) should be continued without change, or whether they should be 
amended or rescinded, consistent with the stated objectives of 
applicable statutes, to minimize adverse impacts on a substantial 
number of small entities. FDA will consider, and is soliciting comments 
on, the following: (1) The continued need for the rule; (2) the nature 
of complaints or comments received concerning the rule from the public; 
(3) the complexity of the rule; (4) the extent to which the rule 
overlaps, duplicates, or conflicts with other Federal rules, and, to 
the extent feasible, with State and local governmental rules; and (5) 
the length of time since the rule has been evaluated or the degree to 
which technology, economic conditions, or other factors have changed in 
the area affected by the rule.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Begin Review of Current Regulation..   06/01/11  .......................
End Review of Current Regulation....   12/00/11  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Melissa Reisman, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Biologics Evaluation and Research, Suite 200N (HFM-17), 1401 Rockville 
Pike, Rockville, MD 20852, Phone: 301 827-6210.
    RIN: 0910-AG61

328. General Requirements for Blood, Blood Components, and Blood 
Derivatives; Donor Notification (Section 610 Review)

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 and 
352; 21 U.S.C. 355; 21 U.S.C. 360 and 360j; 21 U.S.C. 371; 21 U.S.C. 
374; 42 U.S.C. 216; 42 U.S.C. 262; 42 U.S.C. 263a; 42 U.S.C. 264; * * *
    Abstract: FDA is undertaking a review of 21 CFR sections 
606.100(b), 606.160(b) and 630.6 (as amended in 66 FR 31165) under 
section 610 of the Regulatory Flexibility Act. The purpose of this 
review is to determine whether the regulations in 21 CFR sections 
606.100(b), 606.160(b) and 630.6 (as amended in 66 FR 31165) should be 
continued without change, or whether they should be amended or 
rescinded, consistent with the stated objectives of applicable 
statutes, to minimize adverse impacts on a substantial number of small 
entities. FDA will consider, and is soliciting comments on, the 
following: (1) The continued need for the rule; (2) the nature of 
complaints or comments received concerning the rule from the public; 
(3) the complexity of the rule; (4) the extent to which the rule 
overlaps, duplicates, or conflicts with other Federal rules, and, to 
the extent feasible, with State and local governmental rules; and (5) 
the length of time since the rule has been evaluated or the degree to 
which technology, economic conditions, or other factors have changed in 
the area affected by the rule.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Begin Review........................   06/01/11  .......................
End Review..........................   12/00/11  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: No.
    Agency Contact: Melissa Reisman, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Biologics Evaluation and Research, Suite 200N (HFM-17), 1401 Rockville 
Pike, Rockville, MD 20852, Phone: 301 827-6210.
    RIN: 0910-AG62

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Proposed Rule Stage

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

    Regulatory Plan: This entry is Seq. No. 33 in part II of this issue 
of the Federal Register.
    RIN: 0910-AC52

330. Over-the-Counter (OTC) Drug Review--Internal Analgesic Products

    Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371; 21 U.S.C. 374; 21 
U.S.C. 379e
    Abstract: The OTC drug review establishes conditions under which 
OTC drugs are considered generally recognized as safe and effective and 
not misbranded. After a final monograph (i.e., final rule) is issued, 
only OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. The first 
action addresses acetaminophen safety. The second action addresses 
products marketed for children under 2 years old and weight- and age-
based dosing for children's products.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM (Amendment) (Required Warnings    12/26/06  71 FR 77314
 and Other Labeling).
NPRM Comment Period End.............   05/25/07  .......................
Final Action (Required Warnings and    04/29/09  74 FR 19385
 Other Labeling).
Final Action (Correction)...........   06/30/09  74 FR 31177
Final Action (Technical Amendment)..   11/25/09  74 FR 61512
NPRM (Acetaminophen)................   06/00/12  .......................
NPRM (Amendment) (Pediatric)........   12/00/12  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Mary Chung, 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

331. 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 products. The second action addresses testing 
requirements.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM (Healthcare)...................   06/17/94  59 FR 31402
Comment Period End..................   12/15/95  .......................

[[Page 7951]]

 
NPRM (Consumer).....................   04/00/12  .......................
                                     -----------------------------------
NPRM (Food Handlers)................           To Be Determined
NPRM (Testing)......................           To Be Determined
Final Action (Consumer).............           To Be Determined
Final Action (Testing)..............           To Be Determined
Final Action (Food Handlers)........           To Be Determined
Final Action (First Aid Antiseptic).           To Be Determined
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: David Eng, 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

332. Import Tolerances for Residues of Unapproved New Animal Drugs in 
Food

    Legal Authority: 21 U.S.C. 342; 21 U.S.C. 360b(a)(6); 21 U.S.C. 371
    Abstract: The Food and Drug Administration (FDA) plans to publish a 
proposed rule related to the implementation of the import tolerances 
provision of the Animal Drug Availability Act of 1996 (ADAA). The ADAA 
authorizes FDA to establish tolerances for unapproved new animal drugs 
where edible portions of animals imported into the United States may 
contain residues of such drugs (import tolerances). It is unlawful to 
import animal-derived food that bears or contains residues of a new 
animal drug that is not approved in the United States, unless FDA has 
established an import tolerance for that new animal drug and the 
residue of the new animal drug in the animal-derived food does not 
exceed that tolerance.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   03/00/12  .......................
NPRM Comment Period End.............   06/00/12  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Thomas Moskal, Consumer Safety Officer, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Veterinary Medicine, Room 101, (MPN-4, HFV-232), 7519 Standish Place, 
Rockville, MD 20855, Phone: 240 276-9242, Fax: 240 276-9241, Email: 
thomas.moskal@fda.hhs.gov.
    RIN: 0910-AF78

333. 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. The proposal would adopt portions of an IEC 
standard to achieve greater harmonization and reflect current science. 
In addition, the proposal would include an alternative mechanism for 
providing certification and identification, address novelty laser 
products, and clarify the military exemption for laser products.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   01/00/12  .......................
------------------------------------------------------------------------

    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

334. Current Good Manufacturing Practice and Hazard Analysis and Risk-
Benefit Preventive Controls for Food for Animals

    Regulatory Plan: This entry is Seq. No. 34 in part II of this issue 
of the Federal Register.
    RIN: 0910-AG10

335. 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................................   07/00/12  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Mary Chung, 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

336. Electronic Distribution of Content of Labeling for Human 
Prescription Drug and 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 exception, 
in lieu of paper, which is currently used. These inserts contain 
prescribing information intended for healthcare practitioners. This 
would ensure that the information accompanying the product is the most 
up-to-date information regarding important safety and efficacy issues 
about these products.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/00/11  .......................
------------------------------------------------------------------------

    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 Building 32, Room 4249, 10903 New Hampshire Avenue, Silver 
Spring, MD 20993, Phone: 301 796-9301, Email: megan.clark@fda.hhs.gov.
    RIN: 0910-AG18

[[Page 7952]]

337. Amendment to the Current Good Manufacturing Practice Regulations 
for Finished Pharmaceuticals--Second Phase

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 351; 21 U.S.C. 352; 21 
U.S.C. 355; 21 U.S.C. 360b; 21 U.S.C. 371; 21 U.S.C. 374; 42 U.S.C. 
262; 42 U.S.C. 264
    Abstract: The Food and Drug Administration (FDA) periodically 
reassesses and revises the cGMP regulations to accommodate advances in 
technology and other scientific knowledge that further safeguard the 
drug manufacturing process and the public health. In August 2002, FDA 
announced the Pharmaceutical cGMPs for the 21st Century Initiative. As 
part of the Initiative, FDA created a cGMP Harmonization Analysis 
Working Group to analyze related cGMP requirements in the United States 
and internationally. The cGMP working group compared 21 CFR parts 210 
and 211 with the cGMPs of the European Union, as well as other FDA 
regulations (such as the Quality Systems Regulation in 21 CFR part 820) 
to identify differences and consider the value of supplementing or 
changing the current regulations. Based on the cGMP Working Group's 
analysis, FDA decided to take an incremental approach to modifying 21 
CFR parts 210 and 211. In September of 2008, FDA published a final rule 
revising the cGMP regulations primarily in the areas of aseptic 
processing, use of asbestos filters, and verification of operations by 
a second individual; this final rule represented the culmination of the 
first increment of modifications to the cGMP regulations. The proposed 
rule identified on this Unified Agenda would begin the second increment 
of modifications to the cGMP regulations.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   03/00/12  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: S. Mitchell Weitzman, Regulatory Counsel, Office of 
Regulatory Policy, Department of Health and Human Services, Food and 
Drug Administration, Center for Drug Evaluation and Research, WO 51, 
Room 6318, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 
301 796-3511, Fax: 301 847-8440, Email: smitchell.weitzman@fda.hhs.gov.
    RIN: 0910-AG20

338. Unique Device Identification

    Regulatory Plan: This entry is Seq. No. 35 in part II of this issue 
of the Federal Register.
    RIN: 0910-AG31

339. Produce Safety Regulation

    Regulatory Plan: This entry is Seq. No. 36 in part II of this issue 
of the Federal Register.
    RIN: 0910-AG35

340. Hazard Analysis and Risk-Based Preventive Controls

    Regulatory Plan: This entry is Seq. No. 37 in part II of this issue 
of the Federal Register.
    RIN: 0910-AG36

341. ``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 FDA authority to regulate cigarettes, 
cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. 
Section 901 of 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'' found at section 201(rr) of the FD&C Act to be 
subject to Chapter IX of the FD&C Act and would clarify additional 
restrictions under the FD&C Act. The scope of the proposed rule deeming 
cigars that was previously included in the Unified Agenda is being 
broadened to encompass products that meet the statutory definition of 
``tobacco product.''
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/00/11  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: May Nelson, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, 9200 Corporate 
Boulevard, Rockville, MD 20850, Phone: 877 287-1373, Fax: 240 276-3904, 
Email: may.nelson@fda.hhs.gov.
    RIN: 0910-AG38

342. Human Subject Protection; Acceptance of Data From Clinical Studies 
for Medical Devices

    Legal Authority: Not Yet Determined.
    Abstract: The Food and Drug Administration (FDA) is proposing to 
amend its regulations on acceptance of data from clinical studies 
conducted in support of a premarket approval application, humanitarian 
device exemption application, an investigational device exemption 
application, or a premarket notification submission for a medical 
device.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/00/12  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Sheila Anne Brown, Policy Analyst, Investigational 
Device Exemptions Staff, Department of Health and Human Services, Food 
and Drug Administration, WO 66, Room 1651, 10903 New Hampshire Avenue, 
Silver Spring, MD 20993, Phone: 301 796-6563, Fax: 301 847-8120, Email: 
sheila.brown@fda.hhs.gov.
    RIN: 0910-AG48

343. 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: Since 2003, FDA has seen a dramatic increase in the 
number of device recalls, as well as an increase in the number of death 
and serious injury reports submitted regarding infusion pumps. An 
analysis of the reports reveals that a majority of the recalls and 
failures were caused by user error and/or device design flaw. As a 
result of these incidents, FDA is proposing to change the 
classification of infusion pumps from class II (performance standards) 
to class II (special controls). Along with the proposed rule, FDA plans 
to announce a draft special controls guidance document that, when 
final, will be a special control for infusion pumps. The agency 
believes that establishing these special controls for infusion pumps is 
necessary to provide reasonable assurance of the safety and 
effectiveness of these devices.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   05/00/12  .......................
NPRM Comment Period End.............   08/00/12  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Nancy Pirt, Regulatory Counsel, Department of 
Health and Human Services, Food and

[[Page 7953]]

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

344. Requirements for the Testing and Reporting of Tobacco Product 
Constituents, Ingredients, and Additives

    Legal Authority: Pub. L. 111-31, The Family Smoking Prevention and 
Tobacco Control Act, sec 101(b)
    Abstract: Section 915 of the Federal Food, Drug, and Cosmetic Act, 
as amended by the Family Smoking Prevention and Tobacco Control Act, 
requires FDA 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................................   08/00/12  .......................
NPRM Comment Period End.............   10/00/12  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Carol Drew, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Rm 240 H, 9200 
Corporate Boulevard, Rockville, MD 20850, Phone: 877 287-1373, Fax: 240 
276-3904, Email: carol.drew@fda.hhs.gov.
    RIN: 0910-AG59

345. 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................................   03/00/12  .......................
------------------------------------------------------------------------

    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, 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Final Rule Stage

346. Infant Formula: Current Good Manufacturing Practices; Quality 
Control Procedures; Notification Requirements; Records and Reports; and 
Quality Factors

    Regulatory Plan: This entry is Seq. No. 40 in part II of this issue 
of the Federal Register.
    RIN: 0910-AF27

347. Label Requirement for Food That Has Been Refused Admission Into 
the United States

    Legal Authority: 15 U.S.C. 1453 to 1455; 21 U.S.C. 321; 21 U.S.C. 
342 and 343; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381; 42 U.S.C. 
216; 42 U.S.C. 264
    Abstract: The final rule will require owners or consignees to label 
imported food that is refused entry into the United States. The label 
will read, ``UNITED STATES: REFUSED ENTRY.'' The proposal describes the 
label's characteristics (such as its size) and processes for verifying 
that the label has been affixed properly. We are taking this action to 
prevent the introduction of unsafe food into the United States, to 
facilitate the examination of imported food, and to implement section 
308 of the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188).
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   09/18/08  73 FR 54106
NPRM Comment Period End.............   12/02/08  .......................
Final Action........................   06/00/12  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Daniel Sigelman, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, WO Building 
32, Room 4254, 10903 New Hampshire Avenue, Silver Spring, MD 20993, 
Phone: 301 796-4706, Email: daniel.sigelman@fda.hhs.gov.
    RIN: 0910-AF61

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

    Regulatory Plan: This entry is Seq. No. 43 in part II of this issue 
of the Federal Register.
    RIN: 0910-AG56

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

    Regulatory Plan: This entry is Seq. No. 44 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

350. 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: In the Federal Register of July 11, 2003 (68 FR 41507), 
FDA published an ANPRM (the 2003 ANPRM) to solicit information and data 
on trans fat labeling and claims made about trans fats. Comments 
received to the 2003 ANPRM that pertain to the labeling of trans fat 
will be addressed in this proposed rule. In addition, the Agency 
published an ANPRM on the prominence of calories on the food label on 
April 4, 2005 (the 2005 ANPRM) (70 FR 17008), and an ANPRM on the 
revision of reference values and mandatory nutrients on November 2, 
2007 (the 2007 ANPRM) (72 FR 62149). The Agency also intends to address 
the comments received to the 2005 and 2007 ANPRM's in this proposed 
rule.
    FDA is proposing to amend labeling regulations for conventional 
foods and dietary supplements to provide updated nutrition information 
on the label to assist consumers in maintaining healthy dietary 
practices. Mandatory nutrition labeling of food was first required in 
1993. Much of the information found on the Nutrition Facts label has 
not been updated since that time. 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.
    Among the changes proposed, the Agency intends to: (1) Provide 
updated

[[Page 7954]]

Daily Reference values (DRVs) and Reference Daily Intake values (RDIs) 
that are based on the latest scientific evidence from consensus 
reports, such as the Institute of Medicine Dietary Reference Intakes; 
(2) provide DRVs and RDIs, as well as requirements for foods purported 
to be for children under 4 years of age and pregnant or lactating 
women; and (3) make changes to the mandatory declaration of specific 
nutrients. The Agency is also considering revisions to the format and 
appearance of the Nutrition Facts label and the Supplement Facts label, 
including the prominence of calories on 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................................   12/00/12  .......................
------------------------------------------------------------------------

    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

351. Over-the-Counter (OTC) Drug Review--Oral Health Care Products

    Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 
353; 21 U.S.C. 355; 21 U.S.C. 360 to 360a; 21 U.S.C. 371 to 371a
    Abstract: The OTC drug review establishes conditions under which 
OTC drugs are considered generally recognized as safe and effective and 
not misbranded. After a final monograph (i.e., final rule) is issued, 
only OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. The NPRM and 
final action will address oral health care products used to reduce or 
prevent dental plaque and gingivitis.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
ANPRM (Plaque Gingivitis)...........   05/29/03  68 FR 32232
ANPRM Comment Period End............   08/27/03  .......................
                                     -----------------------------------
NPRM (Benzocaine)...................           To Be Determined
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: David Eng, 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-AF40

352. Pet Food Labeling Requirements

    Legal Authority: 21 U.S.C. 343; 21 U.S.C. 371; Pub. L. 110-85, sec 
1002(a)(3)
    Abstract: The President signed into law the Food and Drug 
Administration Amendments Act of 2007 (FDAAA) on September 27, 2007 
(Pub. L. 110-85). Title X of the FDAAA includes several provisions 
pertaining to food safety, including the safety of pet food. Section 
1002(a)(3) of the new law directs FDA to issue new regulations to 
establish updated standards for the labeling of pet food that include 
nutritional and ingredient information. This same provision of the law 
also directs that, in developing these new regulations, FDA consult 
with the Association of American Feed Control Officials and other 
relevant stakeholder groups, including veterinary medical associations, 
animal health organizations, and pet food manufacturers.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................           To Be Determined
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: William Burkholder, Veterinary Medical Officer, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Veterinary Medicine, Room 2642 (MPN-4, HFV-228), 7519 
Standish Place, Rockville, MD 20855, Phone: 240 453-6865, Email: 
william.burkholder@fda.hhs.gov.
    RIN: 0910-AG09

353. Further Amendments to General Regulation of the Food and Drug 
Administration To Incorporate Tobacco Products

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 333; 21 
U.S.C. 371; 21 U.S.C. 381; 21 U.S.C. 387; 21 U.S.C. 387a; 21 U.S.C. 
387c; 21 U.S.C. 387f; 21 U.S.C. 387k; 15 U.S.C. 1333; 15 U.S.C. 4402
    Abstract: The Food and Drug Administration is seeking to amend 
certain of its general regulations to include tobacco products, where 
appropriate, in light of FDA's authority to regulate these products 
under the Family Smoking Prevention and Tobacco Control Act. The final 
rule will cover revisions to the document reporting requirements and 
definition of ``product.''
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/14/11  76 FR 20901
NPRM Comment Period End.............   06/13/11  .......................
                                     -----------------------------------
Final Action........................           To Be Determined
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Gerie Voss, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, 9200 Corporate 
Boulevard, Rockville, MD 20850, Phone: 877 287-1373,Fax: 240 276-4193, 
Email: gerie.voss@fda.hhs.gov.
    RIN: 0910-AG60

354.  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: The Food and Drug Administration is proposing to amend 
certain provisions of its serving size regulations to change the label 
serving size for breath mints to one unit. This action is in response 
to an advanced notice of proposed rulemaking published in 2005, in 
which FDA requested comment on whether to amend certain provisions of 
its nutrition labeling regulations concerning serving size and a 1997 
proposed rule entitled Food Labeling: Hard Candies and Breath Mints (62 
FR 67775).
    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  .......................

[[Page 7955]]

 
NPRM................................   12/00/12  .......................
------------------------------------------------------------------------

    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

355.  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: The Food and Drug Administration is proposing to amend 
certain provisions of its serving size regulations to provide updated 
Reference Amounts Customarily Consumed for candies. This action is in 
response to an advance notice of proposed rulemaking published in 2005, 
in which FDA requested comment on whether to amend certain provisions 
of its nutrition labeling regulations concerning serving size and a 
1998 proposed rule entitled ``Food Labeling: Reference Amounts for 
Candies'' (63 FR 1078).
    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................................   12/00/12  .......................
------------------------------------------------------------------------

    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)

Completed Actions

356. Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) 
Products

    Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
    Abstract: The OTC drug review establishes conditions under which 
OTC drugs are considered generally recognized as safe and effective and 
not misbranded. After a final monograph (i.e., final rule) is issued, 
only OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. This action 
addresses labeling for single ingredient bronchodilator products.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM (Amendment--Ephedrine Single      07/13/05  70 FR 40237
 Ingredient).
NPRM Comment Period End.............   11/10/05  .......................
Final Action (Technical Amendment)..   11/30/07  72 FR 67639
Final Action (Amendment--Single        07/26/11  76 FR 44475
 Ingredient Labeling).
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Mary Chung, 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-AF32

357. Over-the-Counter (OTC) Drug Review--Poison Treatment Drug Products

    Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
    Abstract: The OTC drug review establishes conditions under which 
OTC drugs are considered generally recognized as safe and effective and 
not misbranded. After a final monograph (i.e., final rule) is issued, 
only OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. This action 
addresses the ingredient ipecac syrup.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Withdrawn...........................   09/08/11  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: David Eng, 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-AF68

358. Cigarette Warning Label Statements

    Legal Authority: Pub. L. 111-31, The Family Smoking Prevention and 
Tobacco Control Act, sec 201
    Abstract: Section 4 of the FCLAA, as amended by section 201 of the 
Tobacco Control Act, requires FDA to issue regulations that require 
color graphics depicting the negative health consequences of smoking to 
accompany required warning statements on cigarette packages and 
advertisements. FDA also may adjust the type size, text and format of 
the required label statements on product packaging and advertising if 
FDA determines that it is appropriate so that both the graphics and the 
accompanying label statements are clear, conspicuous, legible and 
appear within the specified area.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   11/12/10  75 FR 69524
NPRM Comment Period End.............   01/11/11  .......................
Final Action........................   06/22/11  76 FR 36628
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Gerie Voss, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, 9200 Corporate 
Boulevard, Rockville, MD 20850, Phone: 877 287-1373, Fax: 240 276-4193, 
Email: gerie.voss@fda.hhs.gov.
    RIN: 0910-AG41


[[Page 7956]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Proposed Rule Stage

359. Covered Outpatient Drugs (CMS-2345-P) (Section 610 Review)

    Legal Authority: Pub. L. 111-48, secs 2501 and 2503
    Abstract: This proposed rule would revise requirements pertaining 
to Medicaid reimbursement for covered outpatient drugs to implement 
provisions of the Affordable Care Act. This proposed rule would also 
revise 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................................   01/00/12  .......................
------------------------------------------------------------------------

    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

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

    Legal Authority: Pub. L. 111-5 secs 4101, 4102, and 4202
    Abstract: The final rule for the Medicare and Medicaid EHR 
Incentive Programs, which was published in the Federal Register on July 
28, 2010, specifies that CMS will expand on the criteria for meaningful 
use established for Stage 1 to advance the use of certified EHR 
technology by eligible professionals (EPs), eligible hospitals and 
critical access hospitals (CAHs). This proposed rule would establish 
the requirements for Stage 2. As stated in the July 28 final rule, 
``Our goals for the Stage 2 meaningful use criteria, consistent with 
other provisions of Medicare and Medicaid law, expand upon the Stage 1 
criteria to encourage the use of health IT for continuous quality 
improvement at the point of care and the exchange of information in the 
most structured format possible, such as the electronic transmission of 
orders entered using computerized provider order entry (CPOE) and the 
electronic transmission of diagnostic test results.''
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   02/00/12  .......................
------------------------------------------------------------------------

    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

361. Medicare and Medicaid Programs: Reform of Hospital and Critical 
Access Hospital Conditions of Participation (CMS-3244-P)

    Regulatory Plan: This entry is Seq. No. 45 in part II of this issue 
of the Federal Register.
    RIN: 0938-AQ89

362.  Proposed Changes to Hospital OPPS and CY 2013 Payment 
Rates; ASC Payment System and CY 2013 Payment Rates (CMS-1589-P) 
(Section 610 Review)

    Regulatory Plan: This entry is Seq. No. 47 in part II of this issue 
of the Federal Register.
    RIN: 0938-AR10

363.  Revisions to Payment Policies Under the Physician Fee 
Schedule and Part B for CY 2013 (CMS-1590-P) (Section 610 Review)

    Regulatory Plan: This entry is Seq. No. 48 in part II of this issue 
of the Federal Register.
    RIN: 0938-AR11

364.  Changes to the Hospital Inpatient and Long-Term Care 
Prospective Payment System for FY 2013 (CMS-1588-P) (Section 610 
Review)

    Regulatory Plan: This entry is Seq. No. 49 in part II of this issue 
of the Federal Register.
    RIN: 0938-AR12

365.  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 report annually 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 report 
annually certain physician ownership or investment interests. The 
Secretary is required to publish applicable manufacturers' and 
applicable GPOs' submitted payment and ownership information on a 
public Web site.
    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 Blvd., 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

366. Proposed Changes to the Hospital Inpatient Prospective Payment 
Systems for Acute Care Hospitals and FY 2012 Rates and to the Long-Term 
Care Hospital PPS and FY 2012 Rates (CMS-1518-F) (Completion of a 
Section 610 Review)

    Legal Authority: sec 1886(d) of the Social Security Act; Pub. L. 
111-148 secs 3004, 3025
    Abstract: This 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................................   05/05/11  76 FR 25788
NPRM Comment Period End.............   06/20/11  .......................
Final Action........................   08/18/11  76 FR 51476
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Ankit Patel, Health Insurance Specialist, Division 
of Acute Care, Department of Health and Human

[[Page 7957]]

Services, Centers for Medicare & Medicaid Services, Hospital and 
Ambulatory Policy Group, Mail Stop, C4-25-11, 7500 Security Boulevard, 
Baltimore, MD 21244, Phone: 410 786-4537, Email: 
ankit.patel@cms.hhs.gov.
    RIN: 0938-AQ24

367. Revisions to Payment Policies Under the Physician Fee Schedule and 
Part B for CY 2012 (CMS-1524-FC) (Completion of a Section 610 Review)

    Legal Authority: Social Security Act, sec 1102; Social Security 
Act, sec 1871; Pub. L. 111-148
    Abstract: This annual 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................................   07/19/11  76 FR 42772
NPRM Comment Period End.............   08/30/11  .......................
Final Action........................   11/28/11  76 FR 73026
Final Action Effective..............   01/01/12  .......................
------------------------------------------------------------------------

    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-AQ25

368. Changes to the Hospital Outpatient Prospective Payment System and 
Ambulatory Surgical Center Payment System for CY 2012 (CMS-1525-F) 
(Completion of a Section 610 Review)

    Legal Authority: Social Security Act, sec 1833; Pub. L. 111-148 sec 
6001
    Abstract: This 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 proposed rule also describes changes to the amounts 
and factors used to determine payment rates for services. In addition, 
the rule finalizes changes to the Ambulatory Surgical Center Payment 
System list of services and rates.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/18/11  76 FR 42170
NPRM Comment Period End.............   08/30/11  .......................
Final Action........................   11/30/11  76 FR 74122
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Paula Smith, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Mail Stop, C4-05-13, 7500 Security Boulevard, 
Baltimore, MD 21244, Phone: 410 786-4709, Email: 
paula.smith@cms.hhs.gov.
    RIN: 0938-AQ26

369. Prospective Payment System and Consolidated Billing for Skilled 
Nursing Facilities for FY 2012; Required Disclosures of Ownership (CMS-
1351-F) (Completion of a Section 610 Review)

    Legal Authority: Social Security Act, sec 1888(e), Pub. L. 111-148, 
sec 6101
    Abstract: This major rule finalizes two options for updating the 
payment rates used under the prospective payment system (SNFs), for 
fiscal year 2012. In this context, it examines recent changes in 
provider behavior relating to the implementation of the Resource 
Utilization Groups, version 4 (RUG-IV) case-mix classification system, 
discusses how such changes may affect the objective of maintaining 
parity in overall expenditures between RUG-IV and the previous case-mix 
classification system, and considers a possible recalibration of the 
case-mix indexes so that they more accurately reflect parity in 
expenditures. It also includes a discussion of a Non-Therapy Ancillary 
component and outlier research currently under development within CMS. 
In addition, this rule discusses the impact of certain provisions of 
the Affordable Care Act, and new programs and initiatives affecting 
SNFs. It also implements section 3401(b) of the Affordable Care Act, 
which requires for fiscal year 2012 and subsequent fiscal years that 
the SNF market basket percentage change be reduced by the multi-factor 
productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of 
the Act. It also implements section 6101 of the Affordable Care Act, 
which requires Medicare SNFs and Medicaid nursing facilities to 
disclose certain information to the Secretary and other entities 
regarding the ownership and organizational structure of their 
facilities.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   05/06/11  76 FR 26364
NPRM Comment Period End.............   06/27/11  .......................
Final Action........................   08/08/11  76 FR 48486
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: William Ullman, Technical Advisor, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Centers for Medicare Management, Mail Stop C5-06-27, 7500 Security 
Boulvard, Baltimore, MD 21244, Phone: 410 786-5667, Fax: 410 786-0765, 
Email: bill.ullman@cms.hhs.gov.
    RIN: 0938-AQ29

370. Home Health Prospective Payment System Refinements and Rate Update 
for CY 2012 (CMS-1353-F) (Section 610 Review)

    Legal Authority: Social Security Act, secs 1102 and 1871; 42 U.S.C. 
1302 and 1395(hh); Social Security Act, sec 1895; 42 U.S.C. 1395(fff), 
Pub. L. 111-148 secs 3131, 3401, 6407
    Abstract: This rule updates the 60-day national episode rate (based 
on the applicable Home Health Market Basket Update and case-mix 
adjustment) and would also update the national per-visit rates (used to 
calculate low utilization payment adjustments (LUPAs) and outlier 
payments) amounts under the Medicare Prospective Payment System for 
home health agencies. These changes are applicable to services 
furnished on or after January 1st.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/12/11  76 FR 40988
NPRM Comment Period End.............   09/06/11  .......................
Final Action........................   11/04/11  76 FR 68526
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Kelly Horney, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare Management, Mail Stop C5-07-28, 
7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-0558, Fax: 
410 786-0765, Email: kelly.horney@cms.hhs.gov.
    RIN: 0938-AQ30

371. Enhanced Federal Funding for Medicaid Eligibility Determination 
and Enrollment Activities (CMS-2346-F)

    Legal Authority: Pub. L. 111-148, sec 1413
    Abstract: The Affordable Care Act requires States' residents to 
apply, enroll, receive determinations, and participate in the State 
health subsidy programs known as ``the Exchange''.

[[Page 7958]]

The Affordable Care Act requires many changes to State eligibility and 
enrollment systems and each State is responsible for developing a 
secure, electronic interface allowing the exchange of data. Existing 
legacy eligibility systems are not able to implement the numerous 
requirements. This rule is key to informing States about the higher 
rates that CMS will provide to help them update or build legacy 
eligibility systems that meet the ACA requirements.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   11/08/10  75 FR 68583
NPRM Comment Period End.............   01/07/11  .......................
Final Action........................   04/19/11  76 FR 21950
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Richard H. Friedman, Director, Division of State 
Systems, Department of Health and Human Services, Centers for Medicare 
& Medicaid Services, Mail Stop S3-18-13, 7500 Security Boulevard, 
Baltimore, MD 21244, Phone: 410 786-4451, Email: 
richard.friedman@cms.hhs.gov.
    RIN: 0938-AQ53

372. Five-Year Review of Work Relative Value Units Under the Physician 
Fee Schedule (CMS-1582-PN)

    Legal Authority: SSA, sec 1848(c)(2)(B)(i)
    Abstract: This proposed notice sets forth proposed revisions to 
work relative value units (RVUs) affecting payment for physicians' 
services. The Act requires that we review RVUs no less than every five 
years. The revised values will be finalized in the CY 2012 Physician 
Fee Schedule final rule and will be effective for services furnished 
beginning January 1, 2012.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Notice..............................   06/06/11  76 FR 32410
Merged With 0938-AQ25...............   07/07/11  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Rebecca Cole, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Mail Stop: C4-03-06, 7500 Security Boulevard, 
Baltimore, MD 21244, Phone: 410 786-1589, Email: 
rebecca.cole@cms.hhs.gov.
    RIN: 0938-AQ87

[FR Doc. 2012-1647 Filed 2-10-12; 8:45 am]
BILLING CODE 4150-24-P

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