Regulatory Agenda, 40052-40073 [2011-15487]

Download as PDF 40052 Federal Register / Vol. 76, No. 130 / Thursday, July 7, 2011 / Unified Agenda 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: ACTION: Office of the Secretary, HHS. Semiannual Regulatory Agenda. The following Agenda presents the results of the statutorily required semi-annual inventory of rulemaking actions currently under development within the U.S. Department of Health and Human Services. We hope that this information will enable interested members of the SUMMARY: public to more effectively participate in the Department’s regulatory activity. FOR FURTHER INFORMATION CONTACT: Dawn L. Smalls, 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 most recent Agenda was published on December 20, 2010. Please note that the actions included in this issue of the Federal Register, as required by the Regulatory Flexibility Act of 1980, relate only to those prospective rulemakings that are likely to have a significant economic impact on a substantial number of small entities. Consistent with Executive Order 13563, the purpose of the Agenda is to encourage more effective public participation in the regulatory process. HHS invites all interested members of the public to comment on the rulemaking actions included in this issuance of the Agenda including comments on whether any of these or related rulemaking actions should be modified, streamlined, expanded, or repealed in order to make the agency’s regulatory program more effective or less burdensome in achieving regulatory objectives. The complete Agenda is accessible online at https:// www.reginfo.gov in an interactive format that offers users enhanced capabilities to obtain information from the Agenda’s database. Dated: April 4, 2011. Dawn L. Smalls, Executive Secretary, Department of Health and Human Services. OFFICE OF THE SECRETARY—COMPLETED ACTIONS Regulation Identifier No. Sequence No. Title 138 .................... Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health Information Technology for Economic and Clinical Health Act. 0991–AB57 OFFICE OF CONSUMER INFORMATION AND INSURANCE OVERSIGHT—COMPLETED ACTIONS Regulation Identifier No. Sequence No. Title 139 .................... Status as a Grandfathered Health Plan Under the Affordable Care Act ........................................................ 0950–AA17 SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION—FINAL RULE STAGE Regulation Identifier No. Sequence No. Title 140 .................... Opioid Drugs in Maintenance or Detoxification Treatment of Opiate Addiction (SECTION 610 REVIEW) ......... 0930–AA14 SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION—LONG-TERM ACTIONS Regulation Identifier No. Sequence No. Title 141 .................... Requirements Governing the Use of Seclusion and Restraint in Certain Nonmedical Community-Based Facilities for Children and Youth. 0930–AA10 wwoods2 on DSK1DXX6B1PROD with PROPOSALS-PART 2 CENTERS FOR DISEASE CONTROL AND PREVENTION—FINAL RULE STAGE Regulation Identifier No. Sequence No. Title 142 .................... 143 .................... Control of Communicable Diseases: Foreign and Possessions ..................................................................... Control of Communicable Diseases: Interstate ............................................................................................... VerDate Mar<15>2010 14:12 Jul 06, 2011 Jkt 223001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 E:\FR\FM\07JYP8.SGM 07JYP8 0920–AA12 0920–AA22 Federal Register / Vol. 76, No. 130 / Thursday, July 7, 2011 / Unified Agenda 40053 CENTERS FOR DISEASE CONTROL AND PREVENTION—COMPLETED ACTIONS Regulation Identifier No. Sequence No. Title 144 .................... Quality Assurance Requirements for Respirators ........................................................................................... 0920–AA04 FOOD AND DRUG ADMINISTRATION—PRERULE STAGE Regulation Identifier No. Sequence No. Title 145 .................... 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). 146 .................... 147 .................... 0910–AG14 0910–AG61 0910–AG62 FOOD AND DRUG ADMINISTRATION—PROPOSED RULE STAGE Sequence No. 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 .................... .................... .................... .................... .................... .................... .................... .................... .................... .................... .................... .................... .................... .................... .................... .................... 164 .................... 165 .................... 166 .................... 167 .................... 168 .................... Regulation Identifier No. Title Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics .................................. Over-the-Counter (OTC) Drug Review—Internal Analgesic Products ............................................................ Over-the-Counter (OTC) Drug Review—Oral Health Care Products .............................................................. Over-the-Counter (OTC) Drug Review—Sunscreen Products ........................................................................ Over-the-Counter (OTC) Drug Review—Weight Control 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 .................................................................................. Pet Food Labeling Requirements .................................................................................................................... Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding Animal Food ....... 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 ........... Unique Device Identification ............................................................................................................................ Produce Safety Regulation .............................................................................................................................. Hazard Analysis and Risk-Based Preventive Controls .................................................................................... ‘‘Tobacco Products’’ Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act. General Hospital and Personal Use Devices: Issuance of Draft Special Controls Guidance for Infusion Pumps. Food Labeling: Nutrition Labeling for Food Sold in Vending Machines .......................................................... Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments. Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products. 0910–AC52 0910–AF36 0910–AF40 0910–AF43 0910–AF45 0910–AF69 0910–AF78 0910–AF87 0910–AG09 0910–AG10 0910–AG12 0910–AG18 0910–AG31 0910–AG35 0910–AG36 0910–AG38 0910–AG54 0910–AG56 0910–AG57 0910–AG59 0910–AG60 FOOD AND DRUG ADMINISTRATION—FINAL RULE STAGE Regulation Identifier No. Title 169 .................... wwoods2 on DSK1DXX6B1PROD with PROPOSALS-PART 2 Sequence No. Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports; and Quality Factors. Over-the-Counter (OTC) Drug Review—Cough/Cold (Bronchodilator) Products ........................................... Over-the-Counter (OTC) Drug Review—Cough/Cold (Combination) Products .............................................. Use of Materials Derived From Cattle in Human Food and Cosmetics .......................................................... Label Requirement for Food That Has Been Refused Admission Into the United States .............................. Cigarette Warning Label Statements ............................................................................................................... 170 171 172 173 174 .................... .................... .................... .................... .................... 0910–AF27 0910–AF32 0910–AF33 0910–AF47 0910–AF61 0910–AG41 FOOD AND DRUG ADMINISTRATION—LONG-TERM ACTIONS Regulation Identifier No. Sequence No. Title 175 .................... 176 .................... Postmarketing Safety Reporting Requirements for Human Drug and Biological Products ............................ Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements. Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements ...................... 177 .................... VerDate Mar<15>2010 14:12 Jul 06, 2011 Jkt 223001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 E:\FR\FM\07JYP8.SGM 07JYP8 0910–AA97 0910–AB88 0910–AC53 40054 Federal Register / Vol. 76, No. 130 / Thursday, July 7, 2011 / Unified Agenda FOOD AND DRUG ADMINISTRATION—LONG-TERM ACTIONS—Continued Regulation Identifier No. Sequence No. Title 178 .................... Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling. Over-the-Counter (OTC) Drug Review—Cough/Cold (Antihistamine) Products ............................................. Over-the-Counter (OTC) Drug Review—External Analgesic Products ........................................................... Over-the-Counter (OTC) Drug Review—Laxative Drug Products ................................................................... 179 .................... 180 .................... 181 .................... 0910–AF11 0910–AF31 0910–AF35 0910–AF38 FOOD AND DRUG ADMINISTRATION—COMPLETED ACTIONS Sequence No. 182 183 184 185 186 187 188 189 190 191 192 193 194 .................... .................... .................... .................... .................... .................... .................... .................... .................... .................... .................... .................... .................... Regulation Identifier No. Title Over-the-Counter (OTC) Drug Review—Cough/Cold (Nasal Decongestant) Products .................................. Over-the-Counter (OTC) Drug Review—Labeling of Drug Products for OTC Human Use ............................ Over-the-Counter (OTC) Drug Review—Ophthalmic Products ....................................................................... Over-the-Counter (OTC) Drug Review—Skin Protectant Products ................................................................. Over-the-Counter (OTC) Drug Review—Vaginal Contraceptive Products ...................................................... Over-the-Counter (OTC) Drug Review—Overindulgence in Food and Drink Products .................................. Over-the-Counter (OTC) Drug Review—Antacid Products ............................................................................. Over-the-Counter (OTC) Drug Review—Skin Bleaching Products ................................................................. Over-the-Counter (OTC) Drug Review—Stimulant Drug Products ................................................................. Over-the-Counter (OTC) Drug Review—Antidiarrheal Drug Products ............................................................ Over-the-Counter (OTC) Drug Review—Urinary Analgesic Drug Products .................................................... Over-the-Counter (OTC) Drug Review—Certain Category II Active Ingredients ............................................ Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail Distribution (SECTION 610 REVIEW). 0910–AF34 0910–AF37 0910–AF39 0910–AF42 0910–AF44 0910–AF51 0910–AF52 0910–AF53 0910–AF56 0910–AF63 0910–AF70 0910–AF95 0910–AG06 CENTERS FOR MEDICARE & MEDICAID SERVICES—PRERULE STAGE Regulation Identifier No. Sequence No. Title 195 .................... Five Year Review of Work Relative Value Units Under the Physician Fee Schedule (CMS–1582–PN) ....... 0938–AQ87 CENTERS FOR MEDICARE & MEDICAID SERVICES—PROPOSED RULE STAGE Regulation Identifier No. Sequence No. Title 196 .................... 197 .................... 198 .................... Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS–3819–P) (SECTION 610 REVIEW) ..... Influenza Vaccination Standard for Certain Medicare Participating Providers and Suppliers (CMS–3213–P) Hospital Conditions of Participation: Requirements for Hospital Inpatient Psychiatric and Rehabilitation Units Excluded From the Prospective Payment System and LTCH Requirements (CMS–3177–P). 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–P). Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System for CY 2012 (CMS–1525–P). Changes to the ESRD Prospective Payment System for CY 2012 & Quality Incentives Program for CY 2013 (CMS–1577–P). Medicaid Program Integrity: Registration of Billing Agents, Clearing Houses, or Other Alternate Payees (CMS–2365–P). Medicaid Eligibility Expansion Under the Affordable Care Act of 2010 (CMS–2349–P) ................................ Payments for Primary Care Services Under the Medicaid Program (CMS–2370–P) ..................................... Medicare and Medicaid Electronic Health Record Incentive Program—Stage 2 (CMS–0044–P) .................. 199 .................... 200 .................... 201 .................... 202 .................... wwoods2 on DSK1DXX6B1PROD with PROPOSALS-PART 2 203 .................... 204 .................... 205 .................... 0938–AG81 0938–AP92 0938–AP97 0938–AQ24 0938–AQ26 0938–AQ27 0938–AQ61 0938–AQ62 0938–AQ63 0938–AQ84 CENTERS FOR MEDICARE & MEDICAID SERVICES—FINAL RULE STAGE Regulation Identifier No. Sequence No. Title 206 .................... Enhanced Federal Funding for Medicaid Eligibility Determination and Enrollment Activities (CMS–2346–F) VerDate Mar<15>2010 14:12 Jul 06, 2011 Jkt 223001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 E:\FR\FM\07JYP8.SGM 07JYP8 0938–AQ53 Federal Register / Vol. 76, No. 130 / Thursday, July 7, 2011 / Unified Agenda 40055 CENTERS FOR MEDICARE & MEDICAID SERVICES—LONG-TERM ACTIONS Regulation Identifier No. Sequence No. Title 207 .................... Requirements for Long-Term Care Facilities: Hospice Services (CMS–3140–F) (SECTION 610 REVIEW) ...... 0938–AP32 CENTERS FOR MEDICARE & MEDICAID SERVICES—COMPLETED ACTIONS Regulation Identifier No. Sequence No. Title 208 .................... Amendment to Payment Policies Under the Physician Fee Schedule and Part B for CY 2011 (CMS– 1503–F2). Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System for CY 2011 (CMS–1504–FC). Section 508 Hospitals—Medicare and Medicaid Extenders Act of 2010 Changes (CMS–1357–N) .............. 209 .................... 210 .................... DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Office of the Secretary (OS) Office of Consumer Information and Insurance Oversight (OCIIO) Completed Actions 138. Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health Information Technology for Economic and Clinical Health Act Legal Authority: Pub. L. 111–5, secs 13400 to 13410 Abstract: The Department of Health and Human Services, Office for Civil Rights, will issue rules to modify the HIPAA Privacy, Security, and Enforcement Rules as necessary to implement the privacy, security, and certain enforcement provisions of subtitle D of the Health Information Technology for Economic and Clinical Health Act (title XIII of the American Recovery and Reinvestment Act of 2009). Timetable: Date FR Cite NPRM .................. NPRM Comment Period End. Merged With 0991–AB80. wwoods2 on DSK1DXX6B1PROD with PROPOSALS-PART 2 Action 07/14/10 09/13/10 Completed Actions 139. Status as a Grandfathered Health Plan Under the Affordable Care Act Legal Authority: Pub. L. 111–148 Abstract: The Affordable Care Act protects the ability of individuals and businesses to keep their current plan while providing important consumer protections. The new regulation also provides stability and flexibility to insurers and businesses that offer health insurance coverage as the nation transitions to a more competitive marketplace. In 2014, businesses and consumers will have more affordable choices through exchanges. This rule would finalize the requirements for group health plans and health insurance coverage in the group and individual markets and respond to any comments as the result of the interim final rule implementing this provision. Timetable: 75 FR 40867 03/02/11 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Andra Wicks, Privacy Specialist, Office of Civil Rights, Department of Health and Human Services, 200 Independence Avenue, SW., Washington, DC 20201, Phone: 202 205–2292, Fax: 202 205–4786, E-mail: andra.wicks@hhs.gov. RIN: 0991–AB57 VerDate Mar<15>2010 14:12 Jul 06, 2011 Jkt 223001 Action Date FR Cite Interim Final Rule Interim Final Rule Effective. Interim Final Rule Comment Period End. Merged With 0938–AQ80. 06/17/10 07/12/10 Fmt 4701 0938–AQ97 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) Final Rule Stage 140. 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 will amend the Federal opioid treatment program regulations. It will 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 .................. NPRM Comment Period End. Final Action ......... 08/16/10 06/19/09 08/18/09 74 FR 29153 12/00/11 02/11/11 Regulatory Flexibility Analysis Required: Yes. Agency Contact: James Mayhew, Director, Division of Market Rules Compliance Office, Department of Health and Human Services, Office of Consumer Information and Insurance Oversight, Mail Stop C2–12016, 7500 Security Boulevard, Baltimore, MD Frm 00005 0938–AP82 21244, Phone: 410 786–9244, E-mail: james.mayhew@cms.hhs.gov. RIN: 0950–AA17 75 FR 34538 PO 00000 0938–AP79 Sfmt 4702 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, E-mail: nicholas.reuter@samhsa.hhs.gov. RIN: 0930–AA14 E:\FR\FM\07JYP8.SGM 07JYP8 40056 Federal Register / Vol. 76, No. 130 / Thursday, July 7, 2011 / Unified Agenda DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) Long-Term Actions 141. Requirements Governing the Use of Seclusion and Restraint in Certain Nonmedical Community-Based Facilities for Children and Youth Legal Authority: Pub. L. 106–310, 42 U.S.C. 290jj to 290jj–2 Abstract: The Secretary is required by statute to publish regulations governing States that license nonmedical, community-based residential facilities for children and youth. The regulation requires States to develop licensing rules and monitoring requirements concerning behavior management practice that will ensure compliance; requires States to develop and implement such licensing rules and implementation requirements within one year; and ensures that States require such facilities to have adequate staff, and that the States provide training for professional staff. Timetable: Action Date NPRM .................. FR Cite To Be Determined Regulatory Flexibility Analysis Required: Yes. Agency Contact: Paolo Del Vecchio, Associate Director for Consumer Affairs, Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Room 13–103, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857, Phone: 301 443–2619, E-mail: paolo.delvecchio@samhsa.hhs.gov. RIN: 0930–AA10 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Disease Control and Prevention (CDC) wwoods2 on DSK1DXX6B1PROD with PROPOSALS-PART 2 Final Rule Stage 142. Control of Communicable Diseases: Foreign and Possessions 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: By statute, the Secretary of Health and Human Services has broad authority to prevent introduction, transmission, and spread of communicable diseases from foreign countries into the United States and from one State or possession into another. Communicable disease VerDate Mar<15>2010 14:12 Jul 06, 2011 Jkt 223001 regulations are divided into two parts: Part 71 pertaining to foreign arrivals and part 70 pertaining to interstate matters. This rule (42 CFR Part 71) will update and improve CDC’s response to both global and domestic disease threats by creating a multi-tiered illness detection and response process thus substantially enhancing the public health system’s ability to slow the introduction, transmission, and spread of communicable disease. The final rule focuses primarily on requirements relating to the reporting of deaths and illnesses onboard aircrafts and ships, 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. Final Action ......... 11/30/05 01/20/06 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. Final Action ......... 11/30/05 01/30/06 70 FR 71892 09/00/11 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Stacy Howard, Health Scientist, Department of Health and Human Services, Centers for Disease Control and Prevention, MS E– 03, 1600 Clifton Road NE., Atlanta, GA 30329, Phone: 404 498–1600, E-mail: showard@cdc.gov. RIN: 0920–AA22 70 FR 71892 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) 09/00/11 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Stacy Howard, Health Scientist, Department of Health and Human Services, Centers for Disease Control and Prevention, MS E– 03, 1600 Clifton Road, NE., Atlanta, GA 30329, Phone: 404 498–1600, E-mail: showard@cdc.gov. RIN: 0920–AA12 143. 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: By statute, the Secretary of Health and Human Services has broad authority to prevent introduction, transmission, and spread of communicable diseases from foreign countries into the United States and from one State or possession into another. Communicable disease regulations are divided into two parts: Part 71 pertaining to foreign arrivals and part 70 pertaining to interstate matters. This rule (42 CFR Part 70) will update and improve CDC’s response to both global and domestic disease threats by creating a multi-tiered illness detection and response process thus substantially enhancing the public health system’s ability to slow the introduction, transmission, and spread of communicable disease. The proposed final rule focuses primarily on requirements relating to the reporting of deaths and illnesses onboard aircrafts, PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 Centers for Disease Control and Prevention (CDC) Completed Actions 144. Quality Assurance Requirements for Respirators Legal Authority: 29 U.S.C. 651 et seq.; 30 U.S.C. 3; 30 U.S.C. 5; 30 U.S.C. 7; 30 U.S.C. 811; 30 U.S.C. 842(h); 30 U.S.C. 844 Abstract: NIOSH plans to modify the Administrative/Quality Assurance sections of 42 CFR part 84, Approval of Respiratory Protective Devices. Areas for potential modification in this module are: (1) Upgrade of quality assurance requirements; (2) ability to use private sector quality auditors and private sector testing laboratories in the approval program; and (3) revised approval label requirements. Timetable: Action Date FR Cite NPRM .................. NPRM Comment Period End. NPRM Comment Period Reopened. NPRM Comment Period Reopened End. NPRM Comment Period Reopening Extended. NPRM Comment Period End. Withdrawn ........... 12/10/08 02/09/09 73 FR 75045 03/04/09 74 FR 9381 04/10/09 05/21/09 74 FR 23815 10/09/09 05/01/11 Regulatory Flexibility Analysis Required: Yes. E:\FR\FM\07JYP8.SGM 07JYP8 Federal Register / Vol. 76, No. 130 / Thursday, July 7, 2011 / Unified Agenda Agency Contact: William E. Newcomb, Physical Scientist, Department of Health and Human Services, Centers for Disease Control and Prevention, PO Box 18070, 626 Cochran Mill Road, Pittsburgh, PA 15236, Phone: 412 386–5200, E-mail: wnewcomb@cdc.gov. RIN: 0920–AA04 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) wwoods2 on DSK1DXX6B1PROD with PROPOSALS-PART 2 Prerule Stage 145. 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 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 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 statues, 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 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 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 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 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 VerDate Mar<15>2010 14:12 Jul 06, 2011 Jkt 223001 CFR 205.3 and 205.50 (as amended in 64 FR 67762 and 67763). FDA received one comment on this review; and FDA notes that portions of the PDMA have been stayed in connection with RxUSA Wholesale, Inc., v. HHS, 467 F. Supp.2d 285 (E.D.N.Y. 2006), aff’d, 2008 U.S. App. LEXIS 14661 (2d Cir. 2008); and that the litigation itself has been administratively closed (with either party having the right to reopen) through June 30, 2011. FDA is certifying that it is not feasible for the agency to complete its review by December 4, 2010, and therefore is extending the completion date by one year. 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, E-mail: pdma610(c)review@fda.hhs.gov. RIN: 0910–AG14 146. • 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 610.40, 610.41, 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 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: PO 00000 Frm 00007 Fmt 4701 Sfmt 4702 40057 (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 06/00/11 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 147. • 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; et seq. Abstract: FDA is undertaking a review of 21 CFR 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 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; E:\FR\FM\07JYP8.SGM 07JYP8 40058 Federal Register / Vol. 76, No. 130 / Thursday, July 7, 2011 / Unified Agenda 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 06/00/11 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 148. Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics Legal Authority: 21 U.S.C. 355; 21 U.S.C. 371; 42 U.S.C. 262 Abstract: The Food and Drug Administration is proposing to amend the regulations governing the format in which clinical study data and bioequivalence data are required to be submitted for new drug applications (NDAs), biological license applications (BLAs), and abbreviated new drug applications (ANDAs). The proposal would revise our regulations to require that data submitted for NDAs, BLAs, and ANDAs, and their supplements and amendments, be provided in an electronic format that FDA can process, review, and archive. Timetable: Date NPRM .................. wwoods2 on DSK1DXX6B1PROD with PROPOSALS-PART 2 Action FR Cite 03/00/12 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Martha Nguyen, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6352, 10903 New Hampshire Avenue, Silver Spring, MD 20993–0002, Phone: 301 796–3471, Fax: 301 847–8440, Email: martha.nguyen@fda.hhs.gov. RIN: 0910–AC52 VerDate Mar<15>2010 14:12 Jul 06, 2011 Jkt 223001 149. 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 products labeled to relieve upset stomach associated with overindulgence in food and drink and to relieve symptoms associated with a hangover. The second action addresses acetaminophen safety. The third action addresses products marketed for children under 2 years old and weightand age-based dosing for children’s products. The fourth action addresses combination products containing the analgesic acetaminophen or aspirin and sodium bicarbonate used as an antacid ingredient. The last document finalizes the internal analgesic products monograph. 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). 12/26/06 71 FR 77314 NPRM (Amendment) (Pediatric). NPRM (Amendment) (Sodium Bicarbonate). NPRM (Overindulgence/Hangover). Final Action (Internal Analgesics). 05/25/07 04/29/09 74 FR 19385 06/30/09 74 FR 31177 11/25/09 74 FR 61512 04/00/12 To Be Determined To Be Determined To Be Determined To Be Determined Regulatory Flexibility Analysis Required: Yes. Agency Contact: Mary Chung, Department of Health and Human Services, Food and Drug PO 00000 Frm 00008 Fmt 4701 Sfmt 4702 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, E-mail: mary.chung@fda.hhs.gov. RIN: 0910–AF36 150. 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). ANPRM Comment Period End. NPRM (Benzocaine). 05/29/03 68 FR 32232 NPRM (Plaque Gingivitis). Final Action ......... 08/27/03 12/00/11 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, E-mail: david.eng@fda.hhs.gov. RIN: 0910–AF40 151. 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 action finalizes E:\FR\FM\07JYP8.SGM 07JYP8 40059 Federal Register / Vol. 76, No. 130 / Thursday, July 7, 2011 / Unified Agenda sunscreen labeling and testing requirements for both ultraviolet B and ultraviolet A radiation protection. The second action addresses other safety and effectiveness issues for OTC sunscreen drug products. The third action addresses active ingredients reviewed under Time and Extent Applications. The fourth action addresses the safety of sunscreen products. The last action addresses combination products containing sunscreen and insect repellent ingredients. Timetable: Action Date FR Cite ANPRM (Sunscreen and Insect Repellent). ANPRM Comment Period End. NPRM (UVA/ UVB). NPRM Comment Period End. Final Action (UVA/ UVB). NPRM (Safety and Effectiveness). NPRM (Time and Extent Applications). ANPRM (Safety) 02/22/07 72 FR 7941 NPRM (Sunscreen and Insect Repellent). 05/23/07 08/27/07 12/26/07 08/00/11 08/00/11 04/00/12 06/00/12 To Be Determined wwoods2 on DSK1DXX6B1PROD with PROPOSALS-PART 2 152. Over-the-Counter (OTC) Drug Review—Weight Control 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 NPRM addresses the use of benzocaine for weight control. The first final action finalizes the 2005 proposed rule for weight control 14:12 Jul 06, 2011 Action Date FR Cite NPRM (Phenylpropanolamine). NPRM Comment Period End. NPRM (Benzocaine). NPRM Comment Period End. 12/22/05 70 FR 75988 Final Action (Phenylpropanolamine). Final Action (Benzocaine). 03/22/06 03/09/11 76 FR 12916 06/07/11 To Be Determined To Be Determined 72 FR 49070 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, E-mail: david.eng@fda.hhs.gov. RIN: 0910–AF43 VerDate Mar<15>2010 products containing phenylpropanolamine. The second final action will finalize the proposed rule for weight control products containing benzocaine. Timetable: Jkt 223001 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, E-mail: david.eng@fda.hhs.gov. RIN: 0910–AF45 153. 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. NPRM (Consumer). 06/17/94 59 FR 31402 NPRM (Food Handlers). NPRM (Testing) .. Final Action (Consumer). PO 00000 Frm 00009 Fmt 4701 12/15/95 01/00/12 To Be Determined To Be Determined To Be Determined Sfmt 4702 Action Final Action (Testing). Final Action (Food Handlers). Final Action (First Aid Antiseptic). Date FR Cite 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, E-mail: david.eng@fda.hhs.gov. RIN: 0910–AF69 154. 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 NPRM .................. NPRM Comment Period End. FR Cite 09/00/11 12/00/11 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, E-mail: thomas.moskal@fda.hhs.gov. RIN: 0910–AF78 E:\FR\FM\07JYP8.SGM 07JYP8 40060 Federal Register / Vol. 76, No. 130 / Thursday, July 7, 2011 / Unified Agenda 155. 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 NPRM .................. FR Cite 11/00/11 wwoods2 on DSK1DXX6B1PROD with PROPOSALS-PART 2 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, E-mail: nancy.pirt@fda.hhs.gov. RIN: 0910–AF87 156. 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: VerDate Mar<15>2010 14:12 Jul 06, 2011 Jkt 223001 Action Date NPRM .................. NPRM Comment Period End. FR Cite 03/00/12 06/00/12 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, E-mail: william.burkholder@fda.hhs.gov. RIN: 0910–AG09 157. Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding Animal Food Legal Authority: 21 U.S.C. 342; 21 U.S.C. 350e; 21 U.S.C. 371; 21 U.S.C. 374; 42 U.S.C. 264; Pub. L. 110–85, sec 1002(a)(2); Pub. L. 111–353 Abstract: The Food and Drug Administration (FDA) is proposing regulations for preventive controls for animal feed ingredients and mixed animal feed to provide greater assurance that marketed animal feed ingredients and mixed feeds intended for all animals, including pets, are safe. This action is being taken as part of the FDA’s Animal Feed Safety System initiative. This action is also being taken to carry out the requirements of the Food and Drug Administration Amendments Act of 2007, under section 1002(a), and the Food Safety Modernization Act of 2010, under section 103. Timetable: Action Date NPRM .................. FR Cite 09/00/11 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Kim Young, Deputy Director, Division of Compliance, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, Room 106 (MPN–4, HFV– 230), 7519 Standish Place, Rockville, MD 20855, Phone: 240 276–9207, E-mail: kim.young@fda.hhs.gov. RIN: 0910–AG10 158. 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 PO 00000 Frm 00010 Fmt 4701 Sfmt 4702 OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action will propose changes to the final monograph to address safety and efficacy issues associated with pediatric cough and cold products. Timetable: Action Date NPRM .................. FR Cite 12/00/11 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, E-mail: mary.chung@fda.hhs.gov. RIN: 0910–AG12 159. 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, 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 10/00/11 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Lisa Dwyer, Senior Advisor for Pharmacy Affairs, Department of Health and Human Services, Food and Drug Administration, Office of Policy, WO 32, Room 4253, 10903 New Hampshire Avenue, Silver Spring, MD 20993, E:\FR\FM\07JYP8.SGM 07JYP8 Federal Register / Vol. 76, No. 130 / Thursday, July 7, 2011 / Unified Agenda Phone: 301 796–4709, E-mail: lisa.dwyer@fda.hhs.gov. RIN: 0910–AG18 160. Unique Device Identification Legal Authority: Not Yet Determined Abstract: The Food and Drug Administration Amendments Act of 2007 (FDAAA), amended the Federal Food, Drug, and Cosmetic Act by adding section 519(f) (21 U.S.C. 360i(f)). This section requires FDA to promulgate regulations establishing a unique identification system for medical devices requiring the label of medical devices to bear a unique identifier, unless FDA specifies an alternative placement or provides for exceptions. The unique identifier must adequately identify the device through distribution and use, and may include information on the lot or serial number. Timetable: Action Date NPRM .................. FR Cite 09/00/11 Regulatory Flexibility Analysis Required: Yes. Agency Contact: John J. Crowley, Senior Advisor for Patient Safety, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, WO 66, Room 2315, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 980–1936, E-mail: jay.crowley@fda.hhs.gov. RIN: 0910–AG31 wwoods2 on DSK1DXX6B1PROD with PROPOSALS-PART 2 161. Produce Safety Regulation Legal Authority: 21 U.S.C. 342; 21 U.S.C. 371; 42 U.S.C. 264; Pub. L. 111– 353 (signed on January 4, 2011) Abstract: The Food Safety Modernization Act requires the Secretary to establish and publish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death. FDA is proposing to promulgate regulations setting enforceable standards for fresh produce safety at the farm and packing house. The purpose of the proposed rule is to reduce the risk of illness associated with contaminated fresh produce. The proposed rule will be based on prevention-oriented public health principles and incorporate what we have learned in the past decade since the agency issued general good VerDate Mar<15>2010 14:12 Jul 06, 2011 Jkt 223001 agricultural practice guidelines entitled ‘‘Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables’’ (GAPs Guide). The proposed rule also will reflect comments received on the agency’s 1998 update of its GAPs guide and its July 2009 draft commodity specific guidances for tomatoes, leafy greens, and melons. Although the proposed rule will be based on recommendations that are included in the GAPs guide, FDA does not intend to make the entire guidance mandatory. FDA’s proposed rule would, however, set out clear standards for implementation of modern preventive controls. The proposed rule also would emphasize the importance of environmental assessments to identify hazards and possible pathways of contamination and provide examples of risk reduction practices recognizing that operators must tailor their preventive controls to particular hazards and conditions affecting their operations. The requirements of the proposed rule would be scale appropriate and commensurate with the relative risks and complexity of individual operations. FDA intends to issue guidance to assist industry in complying with the requirements of the new regulation. Timetable: Action Date NPRM .................. FR Cite 01/00/12 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Samir Assar, Supervisory Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Food Safety, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 301 436–1636, E-mail: samir.assar@fda.hhs.gov. RIN: 0910–AG35 162. Hazard Analysis and Risk-Based Preventive Controls Legal Authority: 21 U.S.C. 342; 21 U.S.C. 371; 42 U.S.C. 264; Pub. L. 111– 353, (signed on January 4, 2011) Abstract: The Food and Drug Administration (FDA) Food Safety Modernization Act (the FSMA) requires the Secretary of Health and Human Services to promulgate regulations to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventive controls; and to define the PO 00000 Frm 00011 Fmt 4701 Sfmt 4702 40061 terms ‘small business’ and ‘very small business.’ The FSMA also requires the Secretary to promulgate regulations with respect to activities that constitute on-farm packing or holding of food that is not grown, raised, or consumed on a farm or another farm under the same ownership and activities that constitute on farm manufacturing or processing of food that is not grown, raised, or consumed on a farm or another farm under the same ownership. FDA is proposing to amend its current good manufacturing practice (CGMP) regulations (21 CFR Part 110) for manufacturing, packing, or holding human food to require food facilities to develop and implement a written food safety plan. This proposed rule would require a food facility to have and implement preventive controls to significantly minimize or prevent the occurrence of hazards that could affect food manufactured, processed, packed, or held by the facility and to provide assurances that such food will not be adulterated under section 402 or misbranded under section 403(w). Timetable: Action Date NPRM .................. FR Cite 10/00/11 Regulatory Flexibility Analysis Required: Yes. Agency Contact: John F. Sheehan, Director, Office of Food Safety, Division of Plant and Dairy Food Safety, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS–315), Office of Food Safety, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 301 436–1488, Fax: 301 436– 2632, E-mail: john.sheehan@fda.hhs.gov. RIN: 0910–AG36 163. ‘‘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 E:\FR\FM\07JYP8.SGM 07JYP8 40062 Federal Register / Vol. 76, No. 130 / Thursday, July 7, 2011 / Unified Agenda 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 FDA’s jurisdiction. The scope of the proposed rule deeming cigars to be subject to FDA’s jurisdiction 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 NPRM .................. FR Cite 10/00/11 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, E-mail: may.nelson@fda.hhs.gov. RIN: 0910–AG38 164. 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 issue 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: wwoods2 on DSK1DXX6B1PROD with PROPOSALS-PART 2 Action Date NPRM .................. NPRM Comment Period End. FR Cite 09/00/11 12/00/11 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, VerDate Mar<15>2010 14:12 Jul 06, 2011 Jkt 223001 Silver Spring, MD 20993, Phone: 301 796–6248, Fax: 301 847–8145, E-mail: nancy.pirt@fda.hhs.gov. RIN: 0910–AG54 165. Food Labeling: Nutrition Labeling for Food Sold in Vending Machines Legal Authority: 21 U.S.C. 343; 21 U.S.C. 371 Abstract: The Food and Drug Administration (FDA) is proposing regulations to establish requirements for nutrition labeling of certain food sold in certain vending machines. FDA is also proposing the terms and conditions for vending machine operators registering to voluntarily be subject to the requirements of section 4205. FDA is taking this action to carry out section 4205 of the Patient Protection and Affordable Care Act (‘‘Affordable Care Act’’ or ‘‘ACA’’), which was signed into law on March 23, 2010. Timetable: Action Date FR Cite NPRM .................. NPRM Comment Period End. 04/06/11 07/05/11 76 FR 19238 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Geraldine A. June, Supervisor, Product Evaluation and Labeling Team, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, (HFS–820), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 301 436–1802, Fax: 301 436–2636, E-mail: geraldine.june@fda.hhs.gov. RIN: 0910–AG56 166. Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments Legal Authority: 21 U.S.C. 343; 21 U.S.C. 371 Abstract: The Food and Drug Administration (FDA) is proposing regulations to establish requirements for nutrition labeling of standard menu items in chain restaurants and similar retail food establishments. FDA is also proposing the terms and conditions for restaurants and similar retail food establishments registering to voluntarily be subject to the requirements of section 4205. FDA is taking this action to carry out section 4205 of the Patient Protection and Affordable Care Act (‘‘Affordable Care Act’’ or ‘‘ACA’’), which was signed into law on March 23, 2010. Timetable: PO 00000 Frm 00012 Fmt 4701 Sfmt 4702 Action Date FR Cite NPRM .................. NPRM Comment Period End. 04/06/11 06/06/11 76 FR 19192 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Geraldine A. June, Supervisor, Product Evaluation and Labeling Team, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, (HFS–820), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 301 436–1802, Fax: 301 436–2636, E-mail: geraldine.june@fda.hhs.gov. RIN: 0910–AG57 167. • 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 01/00/12 04/00/12 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, E-mail: carol.drew@fda.hhs.gov. RIN: 0910–AG59 168. • Further Amendments to General Regulations of the Food and Drug Administration To Incorporate Tobacco Products Legal Authority: Not Yet Determined 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 E:\FR\FM\07JYP8.SGM 07JYP8 Federal Register / Vol. 76, No. 130 / Thursday, July 7, 2011 / Unified Agenda Tobacco Control Act. The proposed rule would 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 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Final Rule Stage 169. Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports; and Quality Factors Legal Authority: 21 U.S.C. 321; 21 U.S.C. 350a; 21 U.S.C. 371 Abstract: The Food and Drug Administration (FDA) is revising its infant formula regulations in 21 CFR parts 106 and 107 to establish requirements for current good manufacturing practices (CGMP), including audits; to establish requirements for quality factors; and to amend FDA’s quality control procedures, notification, and record and reporting requirements for infant formula. FDA is taking this action to improve the protection of infants who consume infant formula products. Timetable: wwoods2 on DSK1DXX6B1PROD with PROPOSALS-PART 2 Action Date FR Cite NPRM .................. NPRM Comment Period End. NPRM Comment Period Reopened. NPRM Comment Period Extended. NPRM Comment Period End. NPRM Comment Period Reopened. NPRM Comment Period End. 07/09/96 12/06/96 61 FR 36154 04/28/03 68 FR 22341 06/27/03 68 FR 38247 VerDate Mar<15>2010 08/26/03 08/01/06 71 FR 43392 09/15/06 14:12 Jul 06, 2011 Jkt 223001 Action Date Final Action ......... FR Cite 11/00/11 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Benson Silverman, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS–850), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 301 436–1459, E-mail: benson.silverman@fda.hhs.gov. RIN: 0910–AF27 170. 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 06/00/11 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, E-mail: mary.chung@fda.hhs.gov. RIN: 0910–AF32 171. Over-the-Counter (OTC) Drug Review—Cough/Cold (Combination) Products Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371 PO 00000 Frm 00013 Fmt 4701 Sfmt 4702 40063 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses cough/ cold drug products containing an oral bronchodilator (ephedrine and its salts) in combination with any expectorant or any oral nasal decongestant. Timetable: Action Date FR Cite NPRM (Amendment). NPRM Comment Period End. Final Action (Technical Amendment). Final Action ......... 07/13/05 70 FR 40232 11/10/05 03/19/07 72 FR 12730 03/00/12 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, E-mail: mary.chung@fda.hhs.gov. RIN: 0910–AF33 172. Use of Materials Derived From Cattle in Human Food and Cosmetics Legal Authority: 21 U.S.C. 342; 21 U.S.C. 361; 21 U.S.C. 371 Abstract: On July 14, 2004, FDA issued an interim final rule (IFR), effective immediately, to prohibit the use of certain cattle material and to address the potential risk of bovine spongiform encephalopathy (BSE) in human food, including dietary supplements, and cosmetics. Prohibited cattle materials under the IFR include specified risk materials, small intestine of all cattle, material from nonambulatory disabled cattle, material from cattle not inspected and passed for human consumption, and mechanically separated (MS) beef. Specified risk materials are the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and older; and the tonsils and distal ileum of the small intestine of all cattle. Prohibited cattle materials do not include tallow that contains no more than 0.15 percent E:\FR\FM\07JYP8.SGM 07JYP8 40064 Federal Register / Vol. 76, No. 130 / Thursday, July 7, 2011 / Unified Agenda hexane-insoluble impurities and tallow derivatives. This action minimizes human exposure to materials that scientific studies have demonstrated are highly likely to contain the BSE agent in cattle infected with the disease. Scientists believe that the human disease variant Creutzfeldt-Jakob disease (vCJD) is likely caused by the consumption of products contaminated with the agent that causes BSE. Timetable: Action Date FR Cite Interim Final Rule Interim Final Rule Effective. Interim Final Rule Comment Period End. Interim Final Rule (Amendments). Interim Final Rule (Amendments) Effective. Interim Final Rule (Amendments) Comment Period End. Interim Final Rule (Amendments). Interim Final Rule (Amendments) Comment Period End. Interim Final Rule (Amendments) Effective. Final Action ......... 07/14/04 07/14/04 69 FR 42256 10/12/04 09/07/05 70 FR 53063 10/07/05 11/07/05 04/17/08 73 FR 20785 07/16/08 07/16/08 09/00/11 wwoods2 on DSK1DXX6B1PROD with PROPOSALS-PART 2 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Amber McCoig, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, (HFS– 316), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 301 436–2131, Fax: 301 436–2644, E-mail: amber.mccoig@fda.hhs.gov. RIN: 0910–AF47 173. 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 VerDate Mar<15>2010 14:12 Jul 06, 2011 Jkt 223001 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 07/00/11 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Daniel Sigelman, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, WO Building 1, Room 4245, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796–4706, E-mail: daniel.sigelman@fda.hhs.gov. RIN: 0910–AF61 174. 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 06/00/11 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 PO 00000 Frm 00014 Fmt 4701 Sfmt 4702 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Long-Term Actions 175. Postmarketing Safety Reporting Requirements for Human Drug and Biological Products Legal Authority: 42 U.S.C. 216; 42 U.S.C. 241; 42 U.S.C. 242a; 42 U.S.C. 262 and 263; 42 U.S.C. 263a to 263n; 42 U.S.C. 264; 42 U.S.C. 300aa; 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. 360b to 360j; 21 U.S.C. 361a; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 375; 21 U.S.C. 379e; 21 U.S.C. 381 Abstract: The final rule would amend the postmarketing expedited and periodic safety reporting regulations for human drugs and biological products to revise certain definitions and reporting formats as recommended by the International Conference on Harmonisation and to define new terms; to add to or revise current reporting requirements; to revise certain reporting time frames; and to propose other revisions to these regulations to enhance the quality of safety reports received by FDA. These revisions were proposed as part of a single rulemaking (68 FR 12406) to clarify and revise both premarketing and postmarketing safety reporting requirements for human drug and biological products. FDA plans to finalize the premarket and postmarket safety reporting requirements in separate final rules. Premarketing safety reporting requirements were finalized in a separate final rule published on September 29, 2010 (75 FR 59961). This final rule applies to postmarketing safety reporting requirements. Timetable: Action Date NPRM ............. NPRM Comment Period Extended. NPRM Comment Period End. NPRM Comment Period Extension End. 03/14/03 06/18/03 Final Action ..... FR Cite 68 FR 12406 07/14/03 10/14/03 To Be Determined Regulatory Flexibility Analysis Required: Yes. Agency Contact: Jane E. Baluss, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room E:\FR\FM\07JYP8.SGM 07JYP8 40065 Federal Register / Vol. 76, No. 130 / Thursday, July 7, 2011 / Unified Agenda 6362, 10903 New Hampshire Avenue, Silver Spring, MD 20993–0002, Phone: 301 796–3469, Fax: 301 847–8440, Email: jane.baluss@fda.hhs.gov. RIN: 0910–AA97 176. Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements Legal Authority: 21 U.S.C. 321; 21 U.S.C. 342; 21 U.S.C. 343; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381; 21 U.S.C. 393; 42 U.S.C. 264 Abstract: The Food and Drug Administration published a final rule in the Federal Register of June 25, 2007 (72 FR 34752), on current good manufacturing practice (CGMP) regulations for dietary supplements. FDA also published an Interim Final Rule in the same Federal Register (72 FR 34959) that provided a procedure for requesting an exemption from the final rule requirement that the manufacturer conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient. This IFR allows for submission to, and review by, FDA of an alternative to the required 100 percent identity testing of components that are dietary ingredients, provided certain conditions are met. This IFR also establishes a requirement for retention of records relating to the FDA’s response to an exemption request. Timetable: 177. Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements Legal Authority: 21 U.S.C. 321; 21 U.S.C. 351 to 21 U.S.C. 353 Abstract: The Food and Drug Administration is amending its current good manufacturing practice regulations and other regulations to clarify and strengthen requirements for the label, color, dedication, and design of medical gas containers and closures. Despite existing regulatory requirements and industry standards for medical gases, there have been repeated incidents in which cryogenic containers of harmful industrial gases have been connected to medical oxygen supply systems in hospitals and nursing homes and subsequently administered to patients. These incidents have resulted in death and serious injury. There have also been several incidents involving highpressure medical gas cylinders that have resulted in death and injuries to patients. These amendments, together with existing regulations, are intended to ensure that the types of incidents that have occurred in the past, as well as other types of foreseeable and potentially deadly medical gas accidents, do not occur in the future. FDA has described a number of proposals in the proposed rule including requiring that gas use outlet connections on portable cryogenic medical gas containers be securely attached to the valve body. Timetable: Action Date FR Cite Action Date FR Cite ANPRM ............... ANPRM Comment Period End. NPRM .................. NPRM Comment Period End. Final Rule ............ Interim Final Rule Interim Final Rule Comment Period End. 02/06/97 06/06/97 62 FR 5700 NPRM .................. NPRM Comment Period End. 04/10/06 07/10/06 68 FR 12157 06/25/07 06/25/07 10/24/07 72 FR 34752 72 FR 34959 Final Action ......... wwoods2 on DSK1DXX6B1PROD with PROPOSALS-PART 2 Action Date FR Cite NPRM .................. NPRM Comment Period End. 05/29/08 08/27/08 73 FR 30831 71 FR 18039 03/13/03 08/11/03 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: To amend the regulations governing the format and content of labeling for human prescription drugs and biological products (21 CFR parts 201.56, 201.57, and 201.80). Under FDA’s current regulations, labeling concerning the use of prescription drugs in pregnancy uses letter categories (A, B, C, D, X) to characterize the risk to the fetus of using the drug in pregnancy. One of the deficiencies of the category system is that drugs may be assigned to the same category when the severity, incidence, and types of risk are quite different. Dissatisfaction with the category system has been expressed by health care providers, medical organizations, experts in the study of birth defects, women’s health researchers, and women of childbearing age. Stakeholders consulted through a public hearing, several focus groups, and several advisory committees have recommended that FDA replace the category system with a concise narrative summarizing a product’s risks to pregnant women and to women of childbearing age. Therefore, the revised format and the information provided in the labeling would make it easier for health care providers to understand the risks and benefits of drug use during pregnancy and lactation. Timetable: To Be Determined Regulatory Flexibility Analysis Required: Yes. Agency Contact: Linda Kahl, Senior Policy Analyst, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS–024), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 301 436–2784, Fax: 301 436–2657, E-mail: linda.kahl@fda.hhs.gov. RIN: 0910–AB88 VerDate Mar<15>2010 14:12 Jul 06, 2011 Jkt 223001 Final Action ......... Final Action ......... To Be Determined Regulatory Flexibility Analysis Required: Yes. Agency Contact: Patrick Raulerson, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6368, 10903 New Hampshire Avenue, Silver Spring, MD 20993–0002, Phone: 301 796–3522, Fax: 301 847–8440, Email: patrick.raulerson@fda.hhs.gov. RIN: 0910–AC53 178. Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 358; 21 U.S.C. 360; 21 U.S.C. 360b; 21 U.S.C. 360gg to PO 00000 Frm 00015 Fmt 4701 Sfmt 4702 To Be Determined Regulatory Flexibility Analysis Required: Yes. Agency Contact: Rachel S. Bressler, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation Research, WO 51, Room 6224, 10903 New Hampshire Avenue, Silver Spring, MD 20993–0002, Phone: 301 796–4288, Fax: 301 847–8440, Email: rachel.bressler@fda.hhs.gov. RIN: 0910–AF11 179. Over-The-Counter (OTC) Drug Review—Cough/Cold (Antihistamine) Products Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371 Abstract: 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 E:\FR\FM\07JYP8.SGM 07JYP8 40066 Federal Register / Vol. 76, No. 130 / Thursday, July 7, 2011 / Unified Agenda (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 antihistamine labeling claims for the common cold. Timetable: Action Date FR Cite Reopening of Administrative Record. Comment Period End. NPRM (Amendment) (Common Cold). 08/25/00 65 FR 51780 11/24/00 08/00/12 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, E-mail: mary.chung@fda.hhs.gov. RIN: 0910–AF31 180. Over-the-Counter (OTC) Drug Review—External 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 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 final action addresses the 2003 proposed rule on patches, plasters, and poultices. The proposed rule will address issues not addressed in previous rulemakings. Timetable: Action Date wwoods2 on DSK1DXX6B1PROD with PROPOSALS-PART 2 Final Action (GRASE dosage forms). NPRM (Amendment). FR Cite 06/00/12 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, VerDate Mar<15>2010 14:12 Jul 06, 2011 Jkt 223001 Silver Spring, MD 20993, Phone: 301 796–2773, Fax: 301 796–9899, E-mail: david.eng@fda.hhs.gov. RIN: 0910–AF35 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) 181. Over-the-Counter (OTC) Drug Review—Laxative Drug Products 182. Over-the-Counter (OTC) Drug Review—Cough/Cold (Nasal Decongestant) 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 phenylpropanolamine. Timetable: 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 first NPRM listed will address the professional labeling for sodium phosphate drug products. The second NPRM listed will address all other professional labeling requirements for laxative drug products. The final action will address laxative drug products. Timetable: Action Date FR Cite Final Action (Granular Psyllium). NPRM (Professional Labeling—Sodium Phosphate). NPRM Comment Period End. 03/29/07 72 FR 14669 NPRM (Professional Labeling). Final Action (Laxative Drug Products). 02/11/11 76 FR 7743 03/14/11 To Be Determined To Be Determined 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, E-mail: mary.chung@fda.hhs.gov. RIN: 0910–AF38 PO 00000 Frm 00016 Fmt 4701 Sfmt 4702 Food and Drug Administration (FDA) Completed Actions Action Date FR Cite NPRM (Amendment) (Sinusitis Claim). NPRM Comment Period End. NPRM (Phenylephrine Bitartrate). NPRM Comment Period End. NPRM (Phenylpropanolamine). NPRM Comment Period End. Final Action (Amendment) (Sinusitis Claim). Final Action (Phenylephrine Bitartrate). Withdrawn ........... 08/02/04 69 FR 46119 11/01/04 11/02/04 69 FR 63482 01/31/05 12/22/05 70 FR 75988 03/22/06 10/31/05 70 FR 58974 08/01/06 71 FR 83358 03/11/11 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, E-mail: mary.chung@fda.hhs.gov. RIN: 0910–AF34 183. Over-the-Counter (OTC) Drug Review—Labeling of Drug Products for OTC Human Use Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 358; 21 U.S.C. 360; 21 U.S.C. 371; 21 UCS 374; 21 U.S.C. 379e Abstract: The OTC drug review establishes conditions under which E:\FR\FM\07JYP8.SGM 07JYP8 Federal Register / Vol. 76, No. 130 / Thursday, July 7, 2011 / Unified Agenda OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses labeling for convenience (small) size OTC drug packages. Timetable: Action Date FR Cite NPRM (Convenience Sizes). NPRM Comment Period End. Withdrawn ........... 12/12/06 71 FR 74474 04/11/07 03/11/11 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, E-mail: mary.chung@fda.hhs.gov. RIN: 0910–AF37 184. Over-the-Counter (OTC) Drug Review—Ophthalmic 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 finalizes the monograph for emergency first aid eyewash drug products. Timetable: wwoods2 on DSK1DXX6B1PROD with PROPOSALS-PART 2 Action Date FR Cite NPRM (Amendment) (Emergency First Aid Eyewashes). NPRM Comment Period End. Withdrawn ........... 02/19/03 68 FR 7917 05/20/03 03/11/11 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 VerDate Mar<15>2010 14:12 Jul 06, 2011 Jkt 223001 796–0260, Fax: 301 796–9899, E-mail: mary.chung@fda.hhs.gov. RIN: 0910–AF39 185. Over-the-Counter (OTC) Drug Review—Skin Protectant 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 identifies safe and effective skin protectant active ingredients to treat and prevent diaper rash. The second action addresses skin protectant products used to treat fever blisters and cold sores. Timetable: Action Date FR Cite Final Action (Technical Amendments). Final Action (Aluminum Acetate) (Technical Amendment). Withdrawn ........... 02/01/08 73 FR 6014 03/06/09 74 FR 9759 03/11/11 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, E-mail: david.eng@fda.hhs.gov. RIN: 0910–AF42 186. Over-the-Counter (OTC) Drug Review—Vaginal Contraceptive 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. 358; 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 proposed rule addresses vaginal contraceptive drug products. Timetable: PO 00000 Frm 00017 Fmt 4701 Sfmt 4702 40067 Action Date FR Cite Final Action (Warnings). Withdrawn ........... 12/19/07 72 FR 71769 03/11/11 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, E-mail: mary.chung@fda.hhs.gov. RIN: 0910–AF44 187. Over-the-Counter (OTC) Drug Review—Overindulgence In Food and Drink 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 products containing bismuth subsalicylate for relief of symptoms of upset stomach due to overindulgence resulting from food and drink. Timetable: Action Date NPRM (Amendment). NPRM Comment Period End. Withdrawn ........... 01/05/05 FR Cite 70 FR 741 04/05/05 03/11/11 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, E-mail: mary.chung@fda.hhs.gov. RIN: 0910–AF51 188. Over-the-Counter (OTC) Drug Review—Antacid 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 E:\FR\FM\07JYP8.SGM 07JYP8 40068 Federal Register / Vol. 76, No. 130 / Thursday, July 7, 2011 / Unified Agenda 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. One action addresses the labeling of products containing sodium bicarbonate as an active ingredient. The other action addresses the use of antacids to relieve upset stomach associated with overindulgence in food and drink. Timetable: Action Date Withdrawn ........... FR Cite 03/11/11 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, E-mail: mary.chung@fda.hhs.gov. RIN: 0910–AF52 189. Over-the-Counter (OTC) Drug Review—Skin Bleaching 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 skin bleaching drug products containing hydroquinone. Timetable: Action Date FR Cite NPRM .................. NPRM Comment Period End. Withdrawn ........... 08/29/06 12/27/06 71 FR 51146 190. Over-the-Counter (OTC) Drug Review—Stimulant 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 use of stimulant active ingredients to relieve symptoms associated with a hangover. Timetable: Action Date Withdrawn ........... 191. Over-the-Counter (OTC) Drug Review—Antidiarrheal 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. These actions address new labeling for antidiarrheal drug products. Timetable: Date Withdrawn ........... wwoods2 on DSK1DXX6B1PROD with PROPOSALS-PART 2 Action 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, E-mail: mary.chung@fda.hhs.gov. RIN: 0910–AF56 Action 14:12 Jul 06, 2011 Jkt 223001 192. Over-the-Counter (OTC) Drug Review—Urinary Analgesic 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 products used for urinary pain relief. Timetable: 03/11/11 FR Cite Date Withdrawn ........... 03/11/11 193. Over-the-Counter (OTC) Drug Review—Certain Category II Active Ingredients 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 Food and Drug Administration (FDA) is proposing that certain ingredients in over-the-counter (OTC) drug products are not generally recognized as safe and effective or are misbranded. FDA issued this proposed rule because we did not receive any data and information on these ingredients in response to our request on December 31, 2003 (68 FR 75585). This rule will finalize the 2008 proposed rule. Timetable: Action 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, E-mail: mary.chung@fda.hhs.gov. PO 00000 Frm 00018 Fmt 4701 Sfmt 4702 FR Cite 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, E-mail: mary.chung@fda.hhs.gov. RIN: 0910–AF70 03/11/11 03/11/11 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, E-mail: david.eng@fda.hhs.gov. RIN: 0910–AF53 VerDate Mar<15>2010 FR Cite RIN: 0910–AF63 Date FR Cite NPRM .................. NPRM Comment Period End. Withdrawn ........... 06/19/08 09/17/08 73 FR 34895 03/11/11 Regulatory Flexibility Analysis Required: Yes. Agency Contact: David Eng, Department of Health and Human Services, Food and Drug Administration, Center for Drug E:\FR\FM\07JYP8.SGM 07JYP8 40069 Federal Register / Vol. 76, No. 130 / Thursday, July 7, 2011 / Unified Agenda Evaluation and Research, WO 22, Room 5487, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796–2773, Fax: 301 796–9899, E-mail: david.eng@fda.hhs.gov. RIN: 0910–AF95 wwoods2 on DSK1DXX6B1PROD with PROPOSALS-PART 2 194. Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail Distribution (Section 610 Review) Legal Authority: 15 U.S.C. 1453 to 1455; 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 342 and 343; 21 U.S.C. 348; 21 U.S.C. 371; 42 U.S.C. 243; 42 U.S.C. 264; 42 U.S.C. 271 Abstract: Section 101.17(h) (21 CFR 101.17(h)) describes requirements for the labeling of the cartons of shell eggs that have not been treated to destroy Salmonella microorganisms. Section 115.50 (21 CFR 115.50) describes requirements for refrigeration of shell eggs held for retail distribution. Section 16.5(a)(4) (21 CFR 16.5(a)(4)) provides that part 16 does not apply to a hearing on an order for relabeling, diversion, or destruction of shell eggs under section 361 of the Public Health Service Act (42 U.S.C. 264) and §§ 101.17(h) and 115.50. FDA amended 21 CFR 101.17(h) on August 20, 2007 (72 FR 46375) to permit the safe handling statement to appear on the inside lid of egg cartons to provide the industry greater flexibility in the placement of the statement, provided the words ‘‘keep refrigerated’’ appear on the principal display panel or information panel. FDA is undertaking a review of 21 CFR 101.17(h), 115.50, and 16.5(a)(4) under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations in §§ 101.17(h), 115.50 and 16.5(a)(4) should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize any significant economic impact 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: VerDate Mar<15>2010 14:12 Jul 06, 2011 Jkt 223001 Action Date Begin Review ...... End Review ......... FR Cite 12/15/09 12/30/10 Centers for Medicare & Medicaid Services (CMS) Regulatory Flexibility Analysis Required: No. Agency Contact: Geraldine A. June, Supervisor, Product Evaluation and Labeling Team, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, (HFS–820), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 301 436–1802, Fax: 301 436–2636, E-mail: geraldine.june@fda.hhs.gov. RIN: 0910–AG06 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Prerule Stage 195. • 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 Notice .................. 06/00/11 FR Cite 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, E-mail: rebecca.cole@cms.hhs.gov. RIN: 0938–AQ87 PO 00000 Frm 00019 Fmt 4701 Sfmt 4702 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage 196. Home Health Agency (HHA) Conditions of Participation (COPS) (CMS–3819–P) (Section 610 Review) Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395x; 42 U.S.C. 1395cc(a); 42 U.S.C. 1395hh; 42 U.S.C. 1395bb Abstract: This proposed rule would revise the existing Conditions of Participation (CoPs) that Home Health Agencies (HHAs) must meet to participate in the Medicare program. The CoPs were last revised in 1989. The new requirements will focus on the actual care delivered to patients by HHAs, reflect an interdisciplinary view of patient care, allow HHAs greater flexibility in meeting quality standards, and eliminate unnecessary procedural requirements. These changes are an integral part of our efforts to achieve broad-based improvements and measurements of the quality of care furnished through federal programs while at the same time reducing procedural burdens on providers. Timetable: Action Date FR Cite NPRM .................. NPRM Comment Period End. Second NPRM .... 03/10/97 06/09/97 62 FR 11005 09/00/11 Regulatory Flexibility Analysis Required: Undetermined. Agency Contact: Danielle Shearer, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Clinical Standards & Quality, Mail Stop S3–02–01, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786– 6617, E-mail: danielle.shearer@cms.hhs.gov. RIN: 0938–AG81 197. Influenza Vaccination Standard for Certain Medicare Participating Providers and Suppliers (CMS–3213–P) Legal Authority: Social Security Act secs 1881, 1861, 1102, 1871 Abstract: This proposed rule would require certain Medicare and Medicaid providers and suppliers to offer all patients an annual influenza vaccination, unless medically contraindicated or unless the patient or patient’s representative or surrogate declined vaccination. This proposed rule is intended to increase the number of patients receiving annual vaccination against seasonal influenza and to E:\FR\FM\07JYP8.SGM 07JYP8 40070 Federal Register / Vol. 76, No. 130 / Thursday, July 7, 2011 / Unified Agenda decrease the morbidity and mortality rate from influenza. This proposed rule would also require certain providers and suppliers to develop policies and procedures that would allow them to offer vaccinations for pandemic influenza in case of a future pandemic influenza event for which a vaccine may be developed. Timetable: Action Date NPRM .................. FR Cite 06/00/11 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Lauren Oviatt, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop S3–02–01, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786–4683, E-mail: lauren.oviatt@cms.hhs.gov. RIN: 0938–AP92 198. Hospital Conditions of Participation: Requirements for Hospital Inpatient Psychiatric and Rehabilitation Units Excluded From the Prospective Payment System and Ltch Requirements (CMS–3177–P) Legal Authority: 42 U.S.C. 1385 X; 42 U.S.C. 1396 d; 42 U.S.C. 1395 hh Abstract: This rule proposes requirements for inpatient psychiatric units and inpatient rehabilitation facilities under the hospital conditions of participation (CoPs). This would allow accrediting organizations to deem these units as part of their hospital accreditation process providing a timely and cost effective survey and certification process under the CoPs. In addition, this rule would propose long term care hospital requirements mandated by the Medicare, Medicaid and SCHIP Extension Act of 2007. Timetable: Date NPRM .................. wwoods2 on DSK1DXX6B1PROD with PROPOSALS-PART 2 Action FR Cite 09/00/11 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Capt. Katherine Berkhousen, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mail Stop S3–02–01, Baltimore, MD 21244, Phone: 410 786– 1154, E-mail: katherine.berkhousen@cms.hhs.gov. Jeannie Miller, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD VerDate Mar<15>2010 14:12 Jul 06, 2011 Jkt 223001 21244, Phone: 410 786–3164, E-mail: jeannie.miller@cms.hhs.gov. RIN: 0938–AP97 199. 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–P) Legal Authority: sec 1886(d) of the Social Security Act; Pub. L. 111–148 Abstract: This annual major proposed rule would revise the Medicare hospital inpatient and long-term care hospital prospective payment systems for operating and capital-related costs. This proposed rule would implement changes arising from our continuing experience with these systems. Timetable: Stop, C5–01–26, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786–7809, E-mail: paula.smith@cms.hhs.gov. RIN: 0938–AQ26 201. Changes to the ESRD Prospective Payment System For Cy 2012 & Quality Incentives Program For CY 2013 (CMS– 1577–P) Legal Authority: Sec 1881 of the Social Security Act Abstract: This major proposed rule would update the bundled payment system for End Stage Renal Disease (ESRD) facilities by January 1, 2012. The rule would also update the Quality Incentives in the ESRD Program. Timetable: Action Action Date NPRM .................. FR Cite Date NPRM .................. FR Cite 06/00/11 06/00/11 Regulatory Flexibility Analysis Required: Yes. Agency Contact: AnKit Patel, Health Insurance Specialist, Division of Acute Care, Department of Health and Human 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, E-mail: ankit.patel@cms.hhs.gov. RIN: 0938–AQ24 200. Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System for CY 2012 (CMS–1525–P) Legal Authority: Social Security Act, sec 1833; Pub. L. 111–148 Abstract: This proposed rule would revise the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. The proposed rule also describes changes to the amounts and factors used to determine payment rates for services. In addition, the rule proposes changes to the Ambulatory Surgical Center Payment System list of services and rates. Timetable: Action Date NPRM .................. FR Cite 07/00/11 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Paula Smith, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail PO 00000 Frm 00020 Fmt 4701 Sfmt 4702 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Janet Samen, Director, Division of Chronic Care Management, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C5–05–27, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786–4533, E-mail: janet.samen@cms.hhs.gov. RIN: 0938–AQ27 202. • Medicaid Program Integrity: Registration Of Billing Agents, Clearing Houses, Or Other Alternate Payees (CMS–2365–P) Legal Authority: 42 U.S.C. 1396a(a)(79) Social Security Act; Pub. L. 111–148, sec 6503 Abstract: This proposed rule would require any agent, clearinghouse, or other alternate payee that submits claims on behalf of a health care provider to register with the State and the Secretary in a form and manner specified by the Secretary. Timetable: Action Date NPRM .................. FR Cite 10/00/11 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Richard 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, E-mail: richard.friedman@cms.hhs.gov. RIN: 0938–AQ61 E:\FR\FM\07JYP8.SGM 07JYP8 40071 Federal Register / Vol. 76, No. 130 / Thursday, July 7, 2011 / Unified Agenda 203. • Medicaid Eligibility Expansion Under the Affordable Care Act of 2010 (CMS–2349–P) Legal Authority: Pub. L. 111–148, secs 1413, 2001, 2002, 2201 Abstract: The Affordable Care Act authorizes a major Medicaid expansion to individuals who are under 65, not pregnant, not receiving Medicare and not eligible for other mandatory eligibility categories. This proposed rule would set forth policies for Medicaid expansion including household income and household composition, coordination with Exchanges, simplifying and streamlining Medicaid eligibility determinations. Timetable: Action Date NPRM .................. FR Cite 06/00/11 wwoods2 on DSK1DXX6B1PROD with PROPOSALS-PART 2 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Sarah DeLone, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop S2–01–16, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786–0615, E-mail: sarah.delone@cms.hhs.gov. RIN: 0938–AQ62 204. • Payments for Primary Care Services Under the Medicaid Program (CMS–2370–P) Legal Authority: Pub. L. 111–152, sec 1202 Abstract: This regulation implements section 1202 of the Health Care and Education Reconciliation Act of 2010, which increases Medicaid payments for certain primary care services provided in 2013 and 2014. The increased payments pertain to services provided by a physician with a specialty designation of family medicine, general internal medicine, and pediatric medicine. States must pay for these services at a rate equal to or greater than the rate paid under Medicare Part B. Rates in Medicaid managed care must be consistent with these minimum payment rates. The FMAP to states for such services will equal 100% for the portion of cost for such primary care services, which is comprised of the difference between the Medicare Part B rate and the amount applicable in the State Plan as of July 1, 2009. Timetable: Action Date NPRM .................. Agency Contact: Cherly Powell, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop S2–01–16, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786–9239, E-mail: cherly.powell@cms.hhs.gov. RIN: 0938–AQ63 205. • 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 NPRM .................. 01/00/12 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, E-mail: elizabeth.holland@cms.hhs.gov. RIN: 0938–AQ84 10/00/11 FR Cite Regulatory Flexibility Analysis Required: Yes. VerDate Mar<15>2010 14:12 Jul 06, 2011 Jkt 223001 FR Cite PO 00000 Frm 00021 Fmt 4701 Sfmt 4702 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Final Rule Stage 206. 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’’. 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 06/00/11 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, E-mail: richard.friedman@cms.hhs.gov. RIN: 0938–AQ53 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Long-Term Actions 207. Requirements for Long-Term Care Facilities: Hospice Services (CMS– 3140–F) (Section 610 Review) Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh Abstract: This rule establishes that in order to participate in the Medicare and Medicaid programs, long-term care facilities must have an agreement with hospice agencies when hospice care is E:\FR\FM\07JYP8.SGM 07JYP8 40072 Federal Register / Vol. 76, No. 130 / Thursday, July 7, 2011 / Unified Agenda provided in a long-term care facility. The rule also contains quality of care requirements. Timetable: Action Action Date FR Cite NPRM .................. NPRM Comment Period End. Final Action ......... 10/22/10 12/21/10 75 FR 65282 10/00/13 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Kadie Thomas, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, Mail Stop S3–02–01, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786–0468, E-mail: kadie.thomas@cms.hhs.gov. Mary Collins, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, Mail Stop S3– 02–01, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786– 3189, E-mail: mary.collins@cms.hhs.gov. RIN: 0938–AP32 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Date FR Cite NPRM .................. NPRM Comment Period End. Final Action ......... 2nd Final Action .. 07/13/10 09/24/10 75 FR 40040 11/29/10 01/10/11 75 FR 73169 76 FR 1366 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Carol Bazell, 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: 410 786–6960, E-mail: carol.bazell@cms.hhs gov. RIN: 0938–AP79 209. Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System For CY 2011 (CMS–1504–FC) Legal Authority: sec 1833 of the Social Security Act; BBA, BA, BIPA, MMA, Pub. L. 111.148 Abstract: This final rule revises the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. The rule also describes changes to the amounts and factors used to determine payment rates for services. In addition, the rule changes the Ambulatory Surgical Center Payment System list of services and rates. Timetable: Action Date FR Cite 208. Amendment to Payment Policies Under the Physician Fee Schedule and Part B for CY 2011 (CMS–1503–F2) NPRM .................. NPRM Comment Period End. Final Action ......... 08/03/10 08/31/10 75 FR 46169 11/24/10 75 FR 71800 Legal Authority: Social Security Act, sec 1102; Social Security Act, sec 1871; Pub. L. 111–148 Abstract: This amends the ‘‘Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2011’’ that appeared in the November 29, 2010, Federal Register. Timetable: Regulatory Flexibility Analysis Required: Yes. Agency Contact: Alberta Dwivedi, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C5–01–26, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786–0763, E-mail: alberta.dwivedi@cms.hhs.gov. wwoods2 on DSK1DXX6B1PROD with PROPOSALS-PART 2 Completed Actions VerDate Mar<15>2010 14:12 Jul 06, 2011 Jkt 223001 PO 00000 Frm 00022 Fmt 4701 Sfmt 9990 RIN: 0938–AP82 210. • Section 508 Hospitals—Medicare and Medicaid Extenders Act of 2010 Changes (CMS–1357–N) Legal Authority: MMEA, Sec 102 Abstract: Section 102 of the Medicare and Medicaid Extenders Act of 2010 extends section 508 of the Medicare Modernization Act of 2003 (MMA) and certain additional special exception hospital reclassifications from October 1, 2010, through September 30, 2011. Effective April 1, 2011, section 102 also requires removing section 508 and special exception hospitals’ wage data from the calculation of the reclassified wage index if doing so raises the reclassified wage index. All hospitals affected by section 102 will be assigned an individual special wage index effective April 1, 2011. If the section 508 or special exception hospital’s wage index applicable for the period beginning on October 1, 2010, and ending on March 31, 2011, is lower than for the period beginning on April 1, 2011, and ending on September 30, 2011, the hospital will be paid an additional amount that reflects the difference between the wage indices. The provision applies to both inpatient and outpatient hospital payments, although the implementation timeframe differs for outpatient hospital payments. Timetable: Action Date FR Cite Notice .................. 04/07/11 76 FR 19365 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Brian Slater, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C4–07–07, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786–5229, E-mail: brian.slater@cms.hhs.gov. RIN: 0938–AQ97 [FR Doc. 2011–15487 Filed 7–6–11; 8:45 am] BILLING CODE 4150–24–P E:\FR\FM\07JYP8.SGM 07JYP8 Vol. 76 Thursday, No. 130 July 7, 2011 Part IX Department of Homeland Security wwoods2 on DSK1DXX6B1PROD with PROPOSALS-PART 2 Semiannual Regulatory Agenda VerDate Mar<15>2010 14:13 Jul 06, 2011 Jkt 223001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\07JYP9.SGM 07JYP9

Agencies

[Federal Register Volume 76, Number 130 (Thursday, July 7, 2011)]
[Unknown Section]
[Pages 40052-40073]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-15487]





[[Page 40051]]



Vol. 76



Thursday,



No. 130



July 7, 2011



Part VIII











Department of Health and Human Services











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











Semiannual Regulatory Agenda



Federal Register / Vol. 76 , No. 130 / Thursday, July 7, 2011 / 

Unified Agenda



[[Page 40052]]





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



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 following Agenda presents the results of the statutorily 

required semi-annual inventory of rulemaking actions currently under 

development within the U.S. Department of Health and Human Services. We 

hope that this information will enable interested members of the public 

to more effectively participate in the Department's regulatory 

activity.



FOR FURTHER INFORMATION CONTACT: Dawn L. Smalls, 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 most recent Agenda was published on December 20, 

2010. Please note that the actions included in this issue of the 

Federal Register, as required by the Regulatory Flexibility Act of 

1980, relate only to those prospective rulemakings that are likely to 

have a significant economic impact on a substantial number of small 

entities.

    Consistent with Executive Order 13563, the purpose of the Agenda is 

to encourage more effective public participation in the regulatory 

process. HHS invites all interested members of the public to comment on 

the rulemaking actions included in this issuance of the Agenda 

including comments on whether any of these or related rulemaking 

actions should be modified, streamlined, expanded, or repealed in order 

to make the agency's regulatory program more effective or less 

burdensome in achieving regulatory objectives. The complete Agenda is 

accessible online at https://www.reginfo.gov in an interactive format 

that offers users enhanced capabilities to obtain information from the 

Agenda's database.



    Dated: April 4, 2011.

Dawn L. Smalls,

Executive Secretary, Department of Health and Human Services.



               Office of the Secretary--Completed Actions

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

                                                           Regulation

       Sequence No.                    Title             Identifier No.

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

138.......................  Modifications to the HIPAA         0991-AB57

                             Privacy, Security, and

                             Enforcement Rules Under

                             the Health Information

                             Technology for Economic

                             and Clinical Health Act.

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





    Office of Consumer Information and Insurance Oversight--Completed

                                 Actions

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

                                                           Regulation

       Sequence No.                    Title             Identifier No.

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

139.......................  Status as a Grandfathered          0950-AA17

                             Health Plan Under the

                             Affordable Care Act.

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





  Substance Abuse and Mental Health Services Administration--Final Rule

                                  Stage

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

                                                           Regulation

       Sequence No.                    Title             Identifier No.

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

140.......................  Opioid Drugs in                    0930-AA14

                             Maintenance or

                             Detoxification Treatment

                             of Opiate Addiction

                             (Section 610 Review).

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





  Substance Abuse and Mental Health Services Administration--Long-Term

                                 Actions

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

                                                           Regulation

       Sequence No.                    Title             Identifier No.

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

141.......................  Requirements Governing the         0930-AA10

                             Use of Seclusion and

                             Restraint in Certain

                             Nonmedical Community-

                             Based Facilities for

                             Children and Youth.

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





      Centers for Disease Control and Prevention--Final Rule Stage

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

                                                           Regulation

       Sequence No.                    Title             Identifier No.

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

142.......................  Control of Communicable            0920-AA12

                             Diseases: Foreign and

                             Possessions.

143.......................  Control of Communicable            0920-AA22

                             Diseases: Interstate.

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





[[Page 40053]]





      Centers for Disease Control and Prevention--Completed Actions

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

                                                           Regulation

       Sequence No.                    Title             Identifier No.

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

144.......................  Quality Assurance                  0920-AA04

                             Requirements for

                             Respirators.

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





               Food and Drug Administration--Prerule Stage

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

                                                           Regulation

       Sequence No.                    Title             Identifier No.

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

145.......................  Prescription Drug                  0910-AG14

                             Marketing Act of 1987;

                             Prescription Drug

                             Amendments of 1992;

                             Policies, Requirements,

                             and Administrative

                             Procedures (Section 610

                             Review).

146.......................  Requirements for Testing           0910-AG61

                             Human Blood Donors for

                             Evidence of Infection Due

                             to Communicable Disease

                             Agents (Section 610

                             Review).

147.......................  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.

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

148.......................  Electronic Submission of           0910-AC52

                             Data From Studies

                             Evaluating Human Drugs

                             and Biologics.

149.......................  Over-the-Counter (OTC)             0910-AF36

                             Drug Review--Internal

                             Analgesic Products.

150.......................  Over-the-Counter (OTC)             0910-AF40

                             Drug Review--Oral Health

                             Care Products.

151.......................  Over-the-Counter (OTC)             0910-AF43

                             Drug Review--Sunscreen

                             Products.

152.......................  Over-the-Counter (OTC)             0910-AF45

                             Drug Review--Weight

                             Control Products.

153.......................  Over-the-Counter (OTC)             0910-AF69

                             Drug Review--Topical

                             Antimicrobial Drug

                             Products.

154.......................  Import Tolerances for              0910-AF78

                             Residues of Unapproved

                             New Animal Drugs in Food.

155.......................  Laser Products; Amendment          0910-AF87

                             to Performance Standard.

156.......................  Pet Food Labeling                  0910-AG09

                             Requirements.

157.......................  Current Good Manufacturing         0910-AG10

                             Practice in

                             Manufacturing,

                             Processing, Packing or

                             Holding Animal Food.

158.......................  Over-the-Counter (OTC)             0910-AG12

                             Drug Review--Pediatric

                             Dosing for Cough/Cold

                             Products.

159.......................  Electronic Distribution of         0910-AG18

                             Content of Labeling for

                             Human Prescription Drug

                             and Biological Products.

160.......................  Unique Device                      0910-AG31

                             Identification.

161.......................  Produce Safety Regulation.         0910-AG35

162.......................  Hazard Analysis and Risk-          0910-AG36

                             Based Preventive Controls.

163.......................  ``Tobacco Products''               0910-AG38

                             Subject to the Federal

                             Food, Drug, and Cosmetic

                             Act, as Amended by the

                             Family Smoking Prevention

                             and Tobacco Control Act.

164.......................  General Hospital and               0910-AG54

                             Personal Use Devices:

                             Issuance of Draft Special

                             Controls Guidance for

                             Infusion Pumps.

165.......................  Food Labeling: Nutrition           0910-AG56

                             Labeling for Food Sold in

                             Vending Machines.

166.......................  Food Labeling: Nutrition           0910-AG57

                             Labeling of Standard Menu

                             Items in Restaurants and

                             Similar Retail Food

                             Establishments.

167.......................  Requirements for the               0910-AG59

                             Testing and Reporting of

                             Tobacco Product

                             Constituents,

                             Ingredients, and

                             Additives.

168.......................  Further Amendments to              0910-AG60

                             General Regulations of

                             the Food and Drug

                             Administration to

                             Incorporate Tobacco

                             Products.

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





             Food and Drug Administration--Final Rule Stage

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

                                                           Regulation

       Sequence No.                    Title             Identifier No.

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

169.......................  Infant Formula: Current            0910-AF27

                             Good Manufacturing

                             Practices; Quality

                             Control Procedures;

                             Notification

                             Requirements; Records and

                             Reports; and Quality

                             Factors.

170.......................  Over-the-Counter (OTC)             0910-AF32

                             Drug Review--Cough/Cold

                             (Bronchodilator) Products.

171.......................  Over-the-Counter (OTC)             0910-AF33

                             Drug Review--Cough/Cold

                             (Combination) Products.

172.......................  Use of Materials Derived           0910-AF47

                             From Cattle in Human Food

                             and Cosmetics.

173.......................  Label Requirement for Food         0910-AF61

                             That Has Been Refused

                             Admission Into the United

                             States.

174.......................  Cigarette Warning Label            0910-AG41

                             Statements.

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





             Food and Drug Administration--Long-Term Actions

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

                                                           Regulation

       Sequence No.                    Title             Identifier No.

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

175.......................  Postmarketing Safety               0910-AA97

                             Reporting Requirements

                             for Human Drug and

                             Biological Products.

176.......................  Current Good Manufacturing         0910-AB88

                             Practice in

                             Manufacturing, Packing,

                             Labeling, or Holding

                             Operations for Dietary

                             Supplements.

177.......................  Medical Gas Containers and         0910-AC53

                             Closures; Current Good

                             Manufacturing Practice

                             Requirements.



[[Page 40054]]



 

178.......................  Content and Format of              0910-AF11

                             Labeling for Human

                             Prescription Drugs and

                             Biologics; Requirements

                             for Pregnancy and

                             Lactation Labeling.

179.......................  Over-the-Counter (OTC)             0910-AF31

                             Drug Review--Cough/Cold

                             (Antihistamine) Products.

180.......................  Over-the-Counter (OTC)             0910-AF35

                             Drug Review--External

                             Analgesic Products.

181.......................  Over-the-Counter (OTC)             0910-AF38

                             Drug Review--Laxative

                             Drug Products.

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





             Food and Drug Administration--Completed Actions

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

                                                           Regulation

       Sequence No.                    Title             Identifier No.

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

182.......................  Over-the-Counter (OTC)             0910-AF34

                             Drug Review--Cough/Cold

                             (Nasal Decongestant)

                             Products.

183.......................  Over-the-Counter (OTC)             0910-AF37

                             Drug Review--Labeling of

                             Drug Products for OTC

                             Human Use.

184.......................  Over-the-Counter (OTC)             0910-AF39

                             Drug Review--Ophthalmic

                             Products.

185.......................  Over-the-Counter (OTC)             0910-AF42

                             Drug Review--Skin

                             Protectant Products.

186.......................  Over-the-Counter (OTC)             0910-AF44

                             Drug Review--Vaginal

                             Contraceptive Products.

187.......................  Over-the-Counter (OTC)             0910-AF51

                             Drug Review--

                             Overindulgence in Food

                             and Drink Products.

188.......................  Over-the-Counter (OTC)             0910-AF52

                             Drug Review--Antacid

                             Products.

189.......................  Over-the-Counter (OTC)             0910-AF53

                             Drug Review--Skin

                             Bleaching Products.

190.......................  Over-the-Counter (OTC)             0910-AF56

                             Drug Review--Stimulant

                             Drug Products.

191.......................  Over-the-Counter (OTC)             0910-AF63

                             Drug Review--

                             Antidiarrheal Drug

                             Products.

192.......................  Over-the-Counter (OTC)             0910-AF70

                             Drug Review--Urinary

                             Analgesic Drug Products.

193.......................  Over-the-Counter (OTC)             0910-AF95

                             Drug Review--Certain

                             Category II Active

                             Ingredients.

194.......................  Food Labeling: Safe                0910-AG06

                             Handling Statements,

                             Labeling of Shell Eggs;

                             Refrigeration of Shell

                             Eggs Held for Retail

                             Distribution (Section 610

                             Review).

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





         Centers for Medicare & Medicaid Services--Prerule Stage

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

                                                           Regulation

       Sequence No.                    Title             Identifier No.

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

195.......................  Five Year Review of Work           0938-AQ87

                             Relative Value Units

                             Under the Physician Fee

                             Schedule (CMS-1582-PN).

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





      Centers for Medicare & Medicaid Services--Proposed Rule Stage

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

                                                           Regulation

       Sequence No.                    Title             Identifier No.

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

196.......................  Home Health Agency (HHA)           0938-AG81

                             Conditions of

                             Participation (CoPs) (CMS-

                             3819-P) (Section 610

                             Review).

197.......................  Influenza Vaccination              0938-AP92

                             Standard for Certain

                             Medicare Participating

                             Providers and Suppliers

                             (CMS-3213-P).

198.......................  Hospital Conditions of             0938-AP97

                             Participation:

                             Requirements for Hospital

                             Inpatient Psychiatric and

                             Rehabilitation Units

                             Excluded From the

                             Prospective Payment

                             System and LTCH

                             Requirements (CMS-3177-P).

199.......................  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-P).

200.......................  Changes to the Hospital            0938-AQ26

                             Outpatient Prospective

                             Payment System and

                             Ambulatory Surgical

                             Center Payment System for

                             CY 2012 (CMS-1525-P).

201.......................  Changes to the ESRD                0938-AQ27

                             Prospective Payment

                             System for CY 2012 &

                             Quality Incentives

                             Program for CY 2013 (CMS-

                             1577-P).

202.......................  Medicaid Program                   0938-AQ61

                             Integrity: Registration

                             of Billing Agents,

                             Clearing Houses, or Other

                             Alternate Payees (CMS-

                             2365-P).

203.......................  Medicaid Eligibility               0938-AQ62

                             Expansion Under the

                             Affordable Care Act of

                             2010 (CMS-2349-P).

204.......................  Payments for Primary Care          0938-AQ63

                             Services Under the

                             Medicaid Program (CMS-

                             2370-P).

205.......................  Medicare and Medicaid              0938-AQ84

                             Electronic Health Record

                             Incentive Program--Stage

                             2 (CMS-0044-P).

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





       Centers for Medicare & Medicaid Services--Final Rule Stage

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

                                                           Regulation

       Sequence No.                    Title             Identifier No.

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

206.......................  Enhanced Federal Funding           0938-AQ53

                             for Medicaid Eligibility

                             Determination and

                             Enrollment Activities

                             (CMS-2346-F).

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





[[Page 40055]]





       Centers for Medicare & Medicaid Services--Long-Term Actions

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

                                                           Regulation

       Sequence No.                    Title             Identifier No.

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

207.......................  Requirements for Long-Term         0938-AP32

                             Care Facilities: Hospice

                             Services (CMS-3140-F)

                             (Section 610 Review).

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





       Centers for Medicare & Medicaid Services--Completed Actions

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

                                                           Regulation

       Sequence No.                    Title             Identifier No.

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

208.......................  Amendment to Payment               0938-AP79

                             Policies Under the

                             Physician Fee Schedule

                             and Part B for CY 2011

                             (CMS-1503-F2).

209.......................  Changes to the Hospital            0938-AP82

                             Outpatient Prospective

                             Payment System and

                             Ambulatory Surgical

                             Center Payment System for

                             CY 2011 (CMS-1504-FC).

210.......................  Section 508 Hospitals--            0938-AQ97

                             Medicare and Medicaid

                             Extenders Act of 2010

                             Changes (CMS-1357-N).

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





DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)



Office of the Secretary (OS)



Completed Actions



138. Modifications to the HIPAA Privacy, Security, and Enforcement 

Rules Under the Health Information Technology for Economic and Clinical 

Health Act



    Legal Authority: Pub. L. 111-5, secs 13400 to 13410

    Abstract: The Department of Health and Human Services, Office for 

Civil Rights, will issue rules to modify the HIPAA Privacy, Security, 

and Enforcement Rules as necessary to implement the privacy, security, 

and certain enforcement provisions of subtitle D of the Health 

Information Technology for Economic and Clinical Health Act (title XIII 

of the American Recovery and Reinvestment Act of 2009).

    Timetable:



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

               Action                    Date            FR Cite

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

NPRM................................   07/14/10  75 FR 40867

NPRM Comment Period End.............   09/13/10  .......................

Merged With 0991-AB80...............   03/02/11  .......................

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



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Andra Wicks, Privacy Specialist, Office of Civil 

Rights, Department of Health and Human Services, 200 Independence 

Avenue, SW., Washington, DC 20201, Phone: 202 205-2292, Fax: 202 205-

4786, E-mail: andra.wicks@hhs.gov.

    RIN: 0991-AB57



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)



Office of Consumer Information and Insurance Oversight (OCIIO)



Completed Actions



139. Status as a Grandfathered Health Plan Under the Affordable Care 

Act



    Legal Authority: Pub. L. 111-148

    Abstract: The Affordable Care Act protects the ability of 

individuals and businesses to keep their current plan while providing 

important consumer protections. The new regulation also provides 

stability and flexibility to insurers and businesses that offer health 

insurance coverage as the nation transitions to a more competitive 

marketplace. In 2014, businesses and consumers will have more 

affordable choices through exchanges. This rule would finalize the 

requirements for group health plans and health insurance coverage in 

the group and individual markets and respond to any comments as the 

result of the interim final rule implementing this provision.

    Timetable:



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

               Action                    Date            FR Cite

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

Interim Final Rule..................   06/17/10  75 FR 34538

Interim Final Rule Effective........   07/12/10  .......................

Interim Final Rule Comment Period      08/16/10  .......................

 End.

Merged With 0938-AQ80...............   02/11/11  .......................

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



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: James Mayhew, Director, Division of Market Rules 

Compliance Office, Department of Health and Human Services, Office of 

Consumer Information and Insurance Oversight, Mail Stop C2-12016, 7500 

Security Boulevard, Baltimore, MD 21244, Phone: 410 786-9244, E-mail: 

james.mayhew@cms.hhs.gov.

    RIN: 0950-AA17



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)



Substance Abuse and Mental Health Services Administration (SAMHSA)



Final Rule Stage



140. 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 will amend the Federal opioid treatment program 

regulations. It will 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........................   12/00/11  .......................

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



    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, E-mail: nicholas.reuter@samhsa.hhs.gov.

    RIN: 0930-AA14





[[Page 40056]]







DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)



Substance Abuse and Mental Health Services Administration (SAMHSA)



Long-Term Actions



141. Requirements Governing the Use of Seclusion and Restraint in 

Certain Nonmedical Community-Based Facilities for Children and Youth



    Legal Authority: Pub. L. 106-310, 42 U.S.C. 290jj to 290jj-2

    Abstract: The Secretary is required by statute to publish 

regulations governing States that license nonmedical, community-based 

residential facilities for children and youth. The regulation requires 

States to develop licensing rules and monitoring requirements 

concerning behavior management practice that will ensure compliance; 

requires States to develop and implement such licensing rules and 

implementation requirements within one year; and ensures that States 

require such facilities to have adequate staff, and that the States 

provide training for professional staff.

    Timetable:



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

               Action                    Date            FR Cite

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

NPRM................................           To Be Determined

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



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Paolo Del Vecchio, Associate Director for Consumer 

Affairs, Department of Health and Human Services, Substance Abuse and 

Mental Health Services Administration, Room 13-103, Parklawn Building, 

5600 Fishers Lane, Rockville, MD 20857, Phone: 301 443-2619, E-mail: 

paolo.delvecchio@samhsa.hhs.gov.

    RIN: 0930-AA10



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)



Centers for Disease Control and Prevention (CDC)



Final Rule Stage



142. Control of Communicable Diseases: Foreign and Possessions



    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: By statute, the Secretary of Health and Human Services 

has broad authority to prevent introduction, transmission, and spread 

of communicable diseases from foreign countries into the United States 

and from one State or possession into another. Communicable disease 

regulations are divided into two parts: Part 71 pertaining to foreign 

arrivals and part 70 pertaining to interstate matters. This rule (42 

CFR Part 71) will update and improve CDC's response to both global and 

domestic disease threats by creating a multi-tiered illness detection 

and response process thus substantially enhancing the public health 

system's ability to slow the introduction, transmission, and spread of 

communicable disease. The final rule focuses primarily on requirements 

relating to the reporting of deaths and illnesses onboard aircrafts and 

ships, 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........................   09/00/11  .......................

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



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Stacy Howard, Health Scientist, Department of 

Health and Human Services, Centers for Disease Control and Prevention, 

MS E-03, 1600 Clifton Road, NE., Atlanta, GA 30329, Phone: 404 498-

1600, E-mail: showard@cdc.gov.

    RIN: 0920-AA12



143. 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: By statute, the Secretary of Health and Human Services 

has broad authority to prevent introduction, transmission, and spread 

of communicable diseases from foreign countries into the United States 

and from one State or possession into another. Communicable disease 

regulations are divided into two parts: Part 71 pertaining to foreign 

arrivals and part 70 pertaining to interstate matters. This rule (42 

CFR Part 70) will update and improve CDC's response to both global and 

domestic disease threats by creating a multi-tiered illness detection 

and response process thus substantially enhancing the public health 

system's ability to slow the introduction, transmission, and spread of 

communicable disease. The proposed final rule focuses primarily on 

requirements relating to the reporting of deaths and illnesses onboard 

aircrafts, 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........................   09/00/11  .......................

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



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Stacy Howard, Health Scientist, Department of 

Health and Human Services, Centers for Disease Control and Prevention, 

MS E-03, 1600 Clifton Road NE., Atlanta, GA 30329, Phone: 404 498-1600, 

E-mail: showard@cdc.gov.

    RIN: 0920-AA22



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)



Centers for Disease Control and Prevention (CDC)



Completed Actions



144. Quality Assurance Requirements for Respirators



    Legal Authority: 29 U.S.C. 651 et seq.; 30 U.S.C. 3; 30 U.S.C. 5; 

30 U.S.C. 7; 30 U.S.C. 811; 30 U.S.C. 842(h); 30 U.S.C. 844

    Abstract: NIOSH plans to modify the Administrative/Quality 

Assurance sections of 42 CFR part 84, Approval of Respiratory 

Protective Devices. Areas for potential modification in this module 

are: (1) Upgrade of quality assurance requirements; (2) ability to use 

private sector quality auditors and private sector testing laboratories 

in the approval program; and (3) revised approval label requirements.

    Timetable:



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

               Action                    Date            FR Cite

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

NPRM................................   12/10/08  73 FR 75045

NPRM Comment Period End.............   02/09/09  .......................

NPRM Comment Period Reopened........   03/04/09  74 FR 9381

NPRM Comment Period Reopened End....   04/10/09  .......................

NPRM Comment Period Reopening          05/21/09  74 FR 23815

 Extended.

NPRM Comment Period End.............   10/09/09  .......................

Withdrawn...........................   05/01/11  .......................

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



    Regulatory Flexibility Analysis Required: Yes.



[[Page 40057]]



    Agency Contact: William E. Newcomb, Physical Scientist, Department 

of Health and Human Services, Centers for Disease Control and 

Prevention, PO Box 18070, 626 Cochran Mill Road, Pittsburgh, PA 15236, 

Phone: 412 386-5200, E-mail: wnewcomb@cdc.gov.

    RIN: 0920-AA04



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)



Food and Drug Administration (FDA)



Prerule Stage



145. 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 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 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 statues, 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 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 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 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 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 205.3 and 205.50 (as amended 

in 64 FR 67762 and 67763).

    FDA received one comment on this review; and FDA notes that 

portions of the PDMA have been stayed in connection with RxUSA 

Wholesale, Inc., v. HHS, 467 F. Supp.2d 285 (E.D.N.Y. 2006), aff'd, 

2008 U.S. App. LEXIS 14661 (2d Cir. 2008); and that the litigation 

itself has been administratively closed (with either party having the 

right to reopen) through June 30, 2011. FDA is certifying that it is 

not feasible for the agency to complete its review by December 4, 2010, 

and therefore is extending the completion date by one year.

    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, E-mail: pdma610(c)review@fda.hhs.gov.

    RIN: 0910-AG14



146.  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 610.40, 610.41, 

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 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..   06/00/11  .......................

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



147.  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; et 

seq.

    Abstract: FDA is undertaking a review of 21 CFR 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 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;



[[Page 40058]]



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........................   06/00/11  .......................

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



148. Electronic Submission of Data From Studies Evaluating Human Drugs 

and Biologics



    Legal Authority: 21 U.S.C. 355; 21 U.S.C. 371; 42 U.S.C. 262

    Abstract: The Food and Drug Administration is proposing to amend 

the regulations governing the format in which clinical study data and 

bioequivalence data are required to be submitted for new drug 

applications (NDAs), biological license applications (BLAs), and 

abbreviated new drug applications (ANDAs). The proposal would revise 

our regulations to require that data submitted for NDAs, BLAs, and 

ANDAs, and their supplements and amendments, be provided in an 

electronic format that FDA can process, review, and archive.

    Timetable:



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

               Action                    Date            FR Cite

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

NPRM................................   03/00/12  .......................

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



    Regulatory Flexibility Analysis Required: Yes.

    Agency Contact: Martha Nguyen, Regulatory Counsel, Department of 

Health and Human Services, Food and Drug Administration, Center for 

Drug Evaluation and Research, WO 51, Room 6352, 10903 New Hampshire 

Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3471, Fax: 301 

847-8440, E-mail: martha.nguyen@fda.hhs.gov.

    RIN: 0910-AC52



149. 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 products labeled to relieve upset stomach associated 

with overindulgence in food and drink and to relieve symptoms 

associated with a hangover. The second action addresses acetaminophen 

safety. The third action addresses products marketed for children under 

2 years old and weight- and age-based dosing for children's products. 

The fourth action addresses combination products containing the 

analgesic acetaminophen or aspirin and sodium bicarbonate used as an 

antacid ingredient. The last document finalizes the internal analgesic 

products monograph.

    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)................   04/00/12  .......................

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

NPRM (Amendment) (Pediatric)........           To Be Determined

NPRM (Amendment) (Sodium                       To Be Determined

 Bicarbonate).

NPRM (Overindulgence/Hangover)......           To Be Determined

Final Action (Internal Analgesics)..           To Be Determined

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



    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, E-mail: 

mary.chung@fda.hhs.gov.

    RIN: 0910-AF36



150. 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)...................   12/00/11

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

NPRM (Plaque Gingivitis)............           To Be Determined

Final Action........................           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, E-mail: david.eng@fda.hhs.gov.

    RIN: 0910-AF40



151. 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 

action finalizes



[[Page 40059]]



sunscreen labeling and testing requirements for both ultraviolet B and 

ultraviolet A radiation protection. The second action addresses other 

safety and effectiveness issues for OTC sunscreen drug products. The 

third action addresses active ingredients reviewed under Time and 

Extent Applications. The fourth action addresses the safety of 

sunscreen products. 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)..............   08/00/11

NPRM (Safety and Effectiveness).....   08/00/11

NPRM (Time and Extent Applications).   04/00/12

ANPRM (Safety)......................   06/00/12

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

NPRM (Sunscreen and Insect                     To Be Determined

 Repellent).

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



    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, E-mail: david.eng@fda.hhs.gov.

    RIN: 0910-AF43



152. Over-the-Counter (OTC) Drug Review--Weight Control 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 NPRM 

addresses the use of benzocaine for weight control. The first final 

action finalizes the 2005 proposed rule for weight control products 

containing phenylpropanolamine. The second final action will finalize 

the proposed rule for weight control products containing benzocaine.

    Timetable:



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

               Action                    Date            FR Cite

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

NPRM (Phenylpropanolamine)..........   12/22/05  70 FR 75988

NPRM Comment Period End.............   03/22/06

NPRM (Benzocaine)...................   03/09/11  76 FR 12916

NPRM Comment Period End.............   06/07/11

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

Final Action (Phenylpropanolamine)..           To Be Determined

Final Action (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, E-mail: david.eng@fda.hhs.gov.

    RIN: 0910-AF45



153. 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

NPRM (Consumer).....................   01/00/12

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

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, E-mail: david.eng@fda.hhs.gov.

    RIN: 0910-AF69



154. 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................................   09/00/11

NPRM Comment Period End.............   12/00/11

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



    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, E-mail: 

thomas.moskal@fda.hhs.gov.

    RIN: 0910-AF78



[[Page 40060]]



155. 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................................   11/00/11

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



    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, E-mail: nancy.pirt@fda.hhs.gov.

    RIN: 0910-AF87



156. 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,

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.