, 21781-21804 [2010-8934]

Download as PDF Monday, April 26, 2010 Part VII Department of Health and Human Services erowe on DSK5CLS3C1PROD with PROPOSALS Semiannual Regulatory Agenda VerDate Nov<24>2008 12:23 Apr 23, 2010 Jkt 220001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\26APP7.SGM 26APP7 21782 Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Unified Agenda DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Services (HHS). We hope that this information will enable interested members of the public to more effectively participate in the Department’s regulatory activity. Office of the Secretary 21 CFR Ch. I 42 CFR Chs. I-V 45 CFR Subtitle A; Subtitle B, Chs. II, III, and XIII ACTION: Office of the Secretary, HHS. 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 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. The complete Agenda is accessible online at www.reginfo.gov in an interactive format that offers users enhanced capabilities to obtain information from the Agenda’s database. The information provided in the Agenda presents a forecast of the rulemaking activities that HHS expects to undertake in the foreseeable future. Rulemakings are grouped according to prerulemaking actions, proposed rules, final rules, long-term actions, and rulemaking actions completed since the most recent Agenda was published on December 7, 2009. Please note that the actions included in this issue of the Federal Register, as required by the SUPPLEMENTARY INFORMATION: Regulatory Agenda AGENCY: 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. FOR FURTHER INFORMATION CONTACT: Dawn L. Smalls, Executive Secretary, Department of Health and Human Services, Washington, DC 20201. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: March 10, 2010. Dawn L. Smalls, Executive Secretary, Department of Health and Human Services. Office of the Secretary—Proposed Rule Stage Regulation Identifier Number Sequence Number Title 120 Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health Information Technology for Economic and Clinical Health Act .......................................................................................................................... 0991–AB57 Office of the Secretary—Final Rule Stage Regulation Identifier Number Sequence Number Title 121 Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Rulemaking Resulting From a Section 610 Review) .......................... 0991–AB58 Substance Abuse and Mental Health Services Administration—Final Rule Stage Sequence Number Title Regulation Identifier Number 122 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 Number erowe on DSK5CLS3C1PROD with PROPOSALS Sequence Number Title 123 Requirements Governing the Use of Seclusion and Restraint in Certain Nonmedical Community-Based Facilities for Children and Youth ................................................................................................................................................ VerDate Nov<24>2008 12:23 Apr 23, 2010 Jkt 220001 PO 00000 Frm 00002 Fmt 1254 Sfmt 1254 E:\FR\FM\26APP7.SGM 26APP7 0930–AA10 Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Unified Agenda 21783 HHS Centers for Disease Control and Prevention—Proposed Rule Stage Regulation Identifier Number Sequence Number Title 124 Control of Communicable Diseases: Foreign Quarantine Regulations, Proposed Revision of HHS/CDC Animal Importation Regulations ................................................................................................................................................... Control of Communicable Diseases: Foreign Quarantine Regulations, Nonhuman Primate ....................................... Total Inward Leakage Requirements for Respirators ................................................................................................... 125 126 0920–AA14 0920–AA23 0920–AA33 Centers for Disease Control and Prevention—Final Rule Stage Sequence Number Title Regulation Identifier Number 127 128 Quality Assurance Requirements for Respirators ......................................................................................................... Control of Communicable Diseases: Foreign Quarantine ............................................................................................ 0920–AA04 0920–AA12 Centers for Disease Control and Prevention—Long-Term Actions Sequence Number Title Regulation Identifier Number 129 Possession, Use, and Transfer of Select Agents and Toxins: Chapare Virus (Section 610 Review) ....................... 0920–AA32 Centers for Disease Control and Prevention—Completed Actions Sequence Number Title Regulation Identifier Number 130 Control of Communicable Diseases: Interstate Quarantine, Passenger Information ................................................... 0920–AA27 Food and Drug Administration—Prerule Stage Regulation Identifier Number Sequence Number Title 131 Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail Distribution (Section 610 Review) ................................................................................................................................... Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures (Section 610 Review) ...................................................................................................... Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation (Section 610 Review) ......................... Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents ................................................................................................................................................................. Over-the-Counter Human Drugs; Labeling Requirements (Section 610 Review) ...................................................... 132 133 134 135 0910–AG06 0910–AG14 0910–AG25 0910–AG33 0910–AG34 Food and Drug Administration—Proposed Rule Stage erowe on DSK5CLS3C1PROD with PROPOSALS Sequence Number Title Regulation Identifier Number 136 137 138 139 140 141 142 Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics ............................................... Over-the-Counter (OTC) Drug Review—Cough/Cold (Antihistamine) Products .......................................................... Over-the-Counter (OTC) Drug Review—Internal Analgesic Products .......................................................................... Over-the-Counter (OTC) Drug Review—Laxative Drug Products ................................................................................ Over-the-Counter (OTC) Drug Review—Sunscreen Products ..................................................................................... Over-the-Counter (OTC) Drug Review—Topical Antimicrobial Drug Products ............................................................ Process Controls for Animal Feed Ingredients and Mixed Animal Feed ...................................................................... 0910–AC52 0910–AF31 0910–AF36 0910–AF38 0910–AF43 0910–AF69 0910–AG10 VerDate Nov<24>2008 12:23 Apr 23, 2010 Jkt 220001 PO 00000 Frm 00003 Fmt 1254 Sfmt 1254 E:\FR\FM\26APP7.SGM 26APP7 21784 Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Unified Agenda HHS Food and Drug Administration—Proposed Rule Stage (Continued) Regulation Identifier Number Sequence Number Title 143 Pediatric Dosing for Cough, Cold, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph ........................................................................................... Unique Device Identification .......................................................................................................................................... Produce Safety Regulation ........................................................................................................................................... Modernization of the Current Food Good Manufacturing Practices Regulation ........................................................... Cigars Subject to the Family Smoking Prevention and Tobacco Control Act .............................................................. 144 145 146 147 0910–AG12 0910–AG31 0910–AG35 0910–AG36 0910–AG38 Food and Drug Administration—Final Rule Stage Regulation Identifier Number Sequence Number Title 148 149 150 Postmarketing Safety Reporting Requirements for Human Drug and Biological Products .......................................... Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements ................................... Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling ........................................................................................................................................................ 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 ............................................................ Over-the-Counter (OTC) Drug Review—External Analgesic Products ......................................................................... Over-the-Counter (OTC) Drug Review—Skin Protectant 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 ........................................... 151 152 153 154 155 156 157 0910–AA97 0910–AC53 0910–AF11 0910–AF27 0910–AF32 0910–AF33 0910–AF35 0910–AF42 0910–AF47 0910–AF61 Food and Drug Administration—Long-Term Actions Regulation Identifier Number Sequence Number Title 158 Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements ...................................................................................................................................................................... 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—Oral Health Care Products ........................................................................... Over-the-Counter (OTC) Drug Review—Vaginal Contraceptive Products ................................................................... Over-the-Counter (OTC) Drug Review—Weight Control 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 Antidiarrheal Drug Products ............................................................................................................. Over-the-Counter (OTC) Drug Review—Urinary Analgesic Drug Products ................................................................. Status of Certain Additional Over-the-Counter Drug Category II Active Ingredients ................................................... erowe on DSK5CLS3C1PROD with PROPOSALS 159 160 161 162 163 164 165 166 167 168 169 170 171 0910–AB88 0910–AF34 0910–AF37 0910–AF39 0910–AF40 0910–AF44 0910–AF45 0910–AF51 0910–AF52 0910–AF53 0910–AF56 0910–AF63 0910–AF70 0910–AF95 Food and Drug Administration—Completed Actions Sequence Number Title Regulation Identifier Number 172 173 Positron Emission Tomography Drugs; Current Good Manufacturing Practices ......................................................... Over-the-Counter (OTC) Drug Review—Acne Drug Products Containing Benzoyl Peroxide ...................................... 0910–AC55 0910–AG00 VerDate Nov<24>2008 12:23 Apr 23, 2010 Jkt 220001 PO 00000 Frm 00004 Fmt 1254 Sfmt 1254 E:\FR\FM\26APP7.SGM 26APP7 21785 Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Unified Agenda HHS Centers for Medicare & Medicaid Services—Proposed Rule Stage Regulation Identifier Number Sequence Number Title 174 175 176 Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610 Review) .................... Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-P) (Section 610 Review) .................... Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and FY 2011 Rates and to the Long-Term Care Hospital PPS and RY 2011 Rates (CMS-1498-P) .............................................. Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System for CY 2011 (CMS-1504-P) .................................................................................................................................. Home Health Prospective Payment System Refinements and Rate Update for CY 2011 (CMS-1510-P) .................. Omnibus Influenza Immunization (CMS-3213-P) .......................................................................................................... Proposed Changes to the Hospital Conditions of Participation: Requirements for Hospital Psychiatric and Rehabilitation Units Excluded From the Prospective Payment System (CMS-3177-P) .......................................................... 177 178 179 180 0938–AG81 0938–AP32 0938–AP80 0938–AP82 0938–AP88 0938–AP92 0938–AP97 Centers for Medicare & Medicaid Services—Long-Term Actions Regulation Identifier Number Sequence Number Title 181 Revisions to the Medicare Advantage and Medicare Prescription Drug Benefit Programs for Contract Year 2011 (CMS-4085-F) .............................................................................................................................................................. 0938–AP77 Centers for Medicare & Medicaid Services—Completed Actions Regulation Identifier Number Sequence Number Title 182 183 184 Electronic Claims Attachments Standards (CMS-0050-IFC) ........................................................................................ Revisions to Payment Policies Under the Physician Fee Schedule for CY 2010 (CMS-1413-FC) ............................. Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System for CY 2010 (CMS-1414-FC) ................................................................................................................................ Department of Health and Human Services (HHS) Office of the Secretary (OS) erowe on DSK5CLS3C1PROD with PROPOSALS 120. MODIFICATIONS TO THE HIPAA PRIVACY, SECURITY, AND ENFORCEMENT RULES UNDER THE HEALTH INFORMATION TECHNOLOGY FOR ECONOMIC AND CLINICAL HEALTH ACT Legal Authority: PL 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 VerDate Nov<24>2008 12:23 Apr 23, 2010 Jkt 220001 Timetable: Action Date NPRM 05/00/10 Frm 00005 Fmt 1254 0938–AP41 Proposed Rule Stage 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). PO 00000 0938–AK62 0938–AP40 Sfmt 1254 FR Cite Regulatory Flexibility Analysis Required: Yes Agency Contact: Andra Wicks, Department of Health and Human Services, 200 Independence Avenue SW., Washington, DC 20201 Phone: 202 205–2292 Fax: 202 205–4786 Email: andra.wicks@hhs.gov RIN: 0991–AB57 E:\FR\FM\26APP7.SGM 26APP7 21786 Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Unified Agenda Department of Health and Human Services (HHS) Office of the Secretary (OS) Final Rule Stage specifications, and certification criteria, as required by section 3004(b)(1) of the Public Health Service Act. The certification criteria adopted in this initial set establish the technical capabilities and related standards that certified electronic health record (EHR) technology will need to include in support of the Medicare and Medicaid EHR Incentive Programs. 121. HEALTH INFORMATION TECHNOLOGY: INITIAL SET OF STANDARDS, IMPLEMENTATION SPECIFICATIONS, AND CERTIFICATION CRITERIA FOR ELECTRONIC HEALTH RECORD TECHNOLOGY (RULEMAKING RESULTING FROM A SECTION 610 REVIEW) Legal Authority: 42 USC 300jj–14 Abstract: The Department of Health and Human Services (HHS), Office of the National Coordinator for Health Information Technology, will issue an interim final rule with a request for comments to adopt an initial set of standards, implementation Timetable: Action Date Interim Final Rule Interim Final Rule Comment Period End FR Cite 01/13/10 75 FR 2014 03/15/10 Action Date Interim Final Rule Effective Final Action Final Action Effective Action Abstract: This rule will amend the Federal opioid treatment program regulations. It will modify the dispensing requirements for NPRM NPRM Comment Period End Final Action Agency Contact: Steven Posnack, Policy Analyst, Department of Health and Human Services, Office of the Secretary, Office of the National Coordinator for Health Information Technology, 200 Independence Avenue SW., Washington, DC 20201 Phone: 202 690–7151 Date FR Cite 06/19/09 74 FR 29153 08/18/09 Final Rule Stage 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 RIN: 0930–AA14 09/00/10 erowe on DSK5CLS3C1PROD with PROPOSALS Department of Health and Human Services (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) 123. REQUIREMENTS GOVERNING THE USE OF SECLUSION AND RESTRAINT IN CERTAIN NONMEDICAL COMMUNITY–BASED FACILITIES FOR CHILDREN AND YOUTH Legal Authority: PL 106–310, 42 USC 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 VerDate Nov<24>2008 12:23 Apr 23, 2010 Jkt 220001 05/00/10 06/00/10 RIN: 0991–AB58 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: Legal Authority: 21 USC 823 (9); 42 USC 257a; 42 USC 290aa(d); 42 USC 290dd–2; 42 USC 300xx–23; 42 USC 300x–27(a); 42 USC 300y–11 02/12/10 Regulatory Flexibility Analysis Required: No Department of Health and Human Services (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) 122. OPIOID DRUGS IN MAINTENANCE OR DETOXIFICATION TREATMENT OF OPIATE ADDICTION (SECTION 610 REVIEW) FR Cite Long-Term Actions 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. Regulatory Flexibility Analysis Required: Yes Timetable: RIN: 0930–AA10 Action Date NPRM Agency Contact: Paolo Del Vecchio, 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 To Be Determined PO 00000 Frm 00006 Fmt 1254 Sfmt 1254 FR Cite E:\FR\FM\26APP7.SGM 26APP7 21787 Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Unified Agenda Department of Health and Human Services (HHS) Centers for Disease Control and Prevention (CDC) 124. CONTROL OF COMMUNICABLE DISEASES: FOREIGN QUARANTINE REGULATIONS, PROPOSED REVISION OF HHS/CDC ANIMAL IMPORTATION REGULATIONS Legal Authority: 42 USC 264 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. The Secretary has designated the authority to prevent the introduction of diseases from foreign countries to the Director, Centers for Disease Control and Prevention (CDC). CDC also enforces entry requirements for certain animals, etiologic agents, and vectors deemed to be of public health significance. Currently the regulations restrict the importation of nonhuman primates, dogs, cats, small turtles, etiologic agents, hosts, and vectors, such as bats (42 CFR sections 71.53, 71.51, 71.52, 71.54). In addition, CDC has recently issued a series of emergency orders restricting the importation of African rodents (42 CFR section 71.56) and civets (67 FR 336401). CDC is issuing this Notice of Proposed Rulemaking (NPRM) to revise the regulations for importation of certain animals and vectors into the United States (42 CFR parts 71, subpart F). Timetable: Action Date ANPRM ANPRM Comment Period End Notice Extending ANPRM Comment Period ANPRM Extended Comment Period End NPRM FR Cite 07/31/07 72 FR 41676 10/01/07 10/01/07 72 FR 55729 12/01/07 11/00/10 Regulatory Flexibility Analysis Required: Yes Proposed Rule Stage Agency Contact: Stacy Howard, Department of Health and Human Services, Centers for Disease Control and Prevention, MS E03, CLFT Building 16, Room 4324, Atlanta, GA 30329 Phone: 404 498–1600 Email: showard@cdc.gov RIN: 0920–AA14 125. CONTROL OF COMMUNICABLE DISEASES: FOREIGN QUARANTINE REGULATIONS, NONHUMAN PRIMATE Legal Authority: 42 USC 264 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. The Secretary has delegated the authority to prevent the introduction of diseases from foreign countries to the Director, CDC. CDC also enforces entry requirements for certain animals, etiologic agents, and vectors deemed to be of public health significance. CDC is proposing to amend its regulations related to the importation of live nonhuman primates (NHPs) by extending existing requirements for the importation of cynomolgus, African green, and rhesus monkeys to all NHPs. The agency also is proposing to reduce the frequency at which importers of the three species are required to renew their registrations (from every 180 days to every 2 years). CDC proposes to incorporate existing guidelines into the regulations and add new provisions to address NHPs imported as part of a circus or trained animal act, NHPs imported by zoological societies, the transfer of NHPs from approved laboratories, and non-live imported NHP products. CDC is also proposing that all NHPs be imported only through ports of entry where a CDC quarantine station is located. Timetable: Action Date NPRM 08/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Stacy Howard, Department of Health and Human Services, Centers for Disease Control and Prevention, MS E03, CLFT Building 16, Room 4324, Atlanta, GA 30329 Phone: 404 498–1600 Email: showard@cdc.gov RIN: 0920–AA23 126. TOTAL INWARD LEAKAGE REQUIREMENTS FOR RESPIRATORS Legal Authority: 29 USC 651 et seq; 29 USC 657(g); 30 USC 3; 30 USC 7; 30 USC 811; 30 USC 842(h) and 844 Abstract: The Centers for Disease Control and Prevention (CDC) proposes to establish total inward leakage (TIL) requirements under 42 CFR part 84 for half-mask air-purifying particulate respirators approved by the National Institute for Occupational Safety and Health (NIOSH) of CDC. Timetable: Action Date NPRM NPRM Comment Period End NPRM Comment Period Reopened erowe on DSK5CLS3C1PROD with PROPOSALS Legal Authority: 29 USC 651 et seq; 30 USC 3; 30 USC 5; 30 USC 7; 30 USC 811; 30 USC 842(h); 30 USC 844 VerDate Nov<24>2008 12:23 Apr 23, 2010 Jkt 220001 Frm 00007 Fmt 1254 04/00/10 Agency Contact: William E. Newcomb, Physical Scientist, Department of Health and Human Services, Centers for Disease Control and Prevention, 626 Cochran Mill Road, PO Box 18070, Pittsburgh, PA 15236 Phone: 412 386–5200 RIN: 0920–AA33 Final Rule Stage 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 PO 00000 FR Cite 10/30/09 74 FR 66935 12/29/09 Regulatory Flexibility Analysis Required: Yes Department of Health and Human Services (HHS) Centers for Disease Control and Prevention (CDC) 127. QUALITY ASSURANCE REQUIREMENTS FOR RESPIRATORS FR Cite Sfmt 1254 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. E:\FR\FM\26APP7.SGM 26APP7 21788 Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Unified Agenda HHS—CDC Final Rule Stage Timetable: Action Date NPRM NPRM Comment Period End NPRM Comment Period Reopened NPRM Comment Period Reopened End NPRM Comment Period Reopening Extended NPRM Comment Period End Final Action FR Cite 12/10/08 73 FR 75045 02/09/09 03/04/09 74 FR 9381 04/10/09 05/21/09 74 FR 23815 10/09/09 12/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: William E. Newcomb, Physical Scientist, Department of Health and Human Services, Centers for Disease Control and Prevention, 626 Cochran Mill Road, PO Box 18070, Pittsburgh, PA 15236 Phone: 412 386–5200 RIN: 0920–AA04 128. CONTROL OF COMMUNICABLE DISEASES: FOREIGN QUARANTINE Legal Authority: 42 USC 243; 42 USC 248 and 249 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. Quarantine regulations are divided into two parts: Part 71 dealing with foreign arrivals and part 70 dealing with 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 rule will also modify current Federal regulations governing the apprehension, quarantine isolation, and conditional release of individuals suspected of carrying a quarantinable disease, while respecting individual autonomy. CDC maintains quarantine stations at 20 ports of entry staffed with medical and public health officers who respond to reports of diseases from carriers. According to the statutory scheme, the President determines through Executive Order which diseases may subject individuals to quarantine. The current disease list, which was last updated in April 2005, includes cholera, diphtheria, tuberculosis, plague, smallpox, yellow fever, viral hemorrhagic fevers, severe acute respiratory syndrome (SARS), and influenza caused by novel or reemergent influenza viruses that are causing, or have the potential to cause a pandemic. Timetable: Action Date NPRM NPRM Comment Period End Final Action erowe on DSK5CLS3C1PROD with PROPOSALS Legal Authority: PL 107–188 Abstract: The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 authorizes the HHS Secretary to regulate the possession, use, and transfer of select agents and toxins that have the potential to pose a severe threat to public health and safety. These regulations are set forth at 42 CFR 73. Criteria used to determine whether a select agent or toxin should be included under the provisions of these regulations are based on: 1) The effect on human health as a result of exposure to the agent or toxin, 2) the degree of contagiousness of the agent or toxin, 3) the methods by which the agent or toxin is transferred to humans, 4) the availability and effectiveness of pharmacotherapies and immunizations VerDate Nov<24>2008 12:23 Apr 23, 2010 Jkt 220001 Frm 00008 Fmt 1254 11/00/10 Agency Contact: Stacy Howard, Department of Health and Human Services, Centers for Disease Control and Prevention, MS E03, CLFT Building 16, Room 4324, Atlanta, GA 30329 Phone: 404 498–1600 Email: showard@cdc.gov RIN: 0920–AA12 Long-Term Actions to treat and prevent and illness resulting from infection by the agent or toxin, and 5) any other criteria, including the needs of children and other vulnerable populations that the HHS Secretary considers appropriate. Based on these criteria, we are proposing to amend the list of HHS select agents and toxins by adding Chapare virus to the list. After consulting with subject matter experts from CDC, the National Institutes of Health (NIH), the Food Drug Administration (FDA), the United States Department of Agriculture (USDA) /Animal and Plant Health Inspection Service (APHIS), USDA/Agricultural Research Service (ARS), USDA/CVB (Center for Veterinary Biologics), and the Department of Defense (DOD)/United States Army Medical Research Institute for Infectious Diseases (USAMRIID) and review of relevant published studies, we believe the Chapare virus should be added to the list of HHS select agents PO 00000 11/30/05 70 FR 71892 01/20/06 Regulatory Flexibility Analysis Required: Yes Department of Health and Human Services (HHS) Centers for Disease Control and Prevention (CDC) 129. POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS: CHAPARE VIRUS (SECTION 610 REVIEW) FR Cite Sfmt 1254 and toxins based on our conclusion that the Chapare virus has been phylogenetically identified as a Clade B arenavirus and is closely related to other South American arenaviruses that cause haemorrhagic fever, particularly Sabia virus. Timetable: Action Date NPRM NPRM Comment Period End Final Action FR Cite 08/19/09 74 FR 159 10/19/09 To Be Determined Regulatory Flexibility Analysis Required: No Agency Contact: Robbin Weyant, Department of Health and Human Services, Centers for Disease Control and Prevention, CLFT Building 20, Room 4202, 1600 Clifton Road NE., Atlanta, GA 30333 Phone: 404 718–2000 RIN: 0920–AA32 E:\FR\FM\26APP7.SGM 26APP7 21789 Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Unified Agenda Department of Health and Human Services (HHS) Centers for Disease Control and Prevention (CDC) 130. CONTROL OF COMMUNICABLE DISEASES: INTERSTATE QUARANTINE, PASSENGER INFORMATION Legal Authority: 25 USC 198.231; 25 USC 1661; 42 USC 243; 42 USC 248; 42 USC 249; 42 USC 264; 42 USC 266 to 268; 42 USC 270 to 272; 42 USC 2001 Abstract: By statute, the Secretary of Health and Human Services has broad authority to prevent introduction, transmission, and spread of communicable diseases from one State or possession into another. Quarantine regulations are divided into two parts: Part 71 dealing with foreign arrivals and part 70 dealing with interstate matters. The CDC Director has been delegated the responsibility for carrying out these regulations. The Director’s Completed Actions authority to investigate suspected cases and potential spread of communicable disease among interstate travelers is thus not limited to those known or suspected of having a quarantinable disease, but rather all communicable diseases that may necessitate a public health response. Among the fundamental components of the public health response to the report of a person with a communicable disease is the identification and evaluation of individuals who may have been exposed. This provision, which was proposed section 70.4, would require any airline operating in interstate traffic to solicit and electronically submit certain passenger information to CDC for use in contact tracing when necessary to protect the vital interests of an individual, or other persons, in regard to significant health risks. Timetable: Action Date NPRM NPRM Comment Period End Merged With 0920–AA22 Agency Contact: Stacy Howard, Department of Health and Human Services, Centers for Disease Control and Prevention, MS E03, CLFT Building 16, Room 4324, Atlanta, GA 30329 Phone: 404 498–1600 Email: showard@cdc.gov RIN: 0920–AA27 erowe on DSK5CLS3C1PROD with PROPOSALS VerDate Nov<24>2008 12:23 Apr 23, 2010 Jkt 220001 Prerule Stage sections 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: Action Date Begin Review End Review FR Cite 12/15/09 12/00/10 Regulatory Flexibility Analysis Required: Undetermined 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 PO 00000 Frm 00009 Fmt 1254 02/12/10 Regulatory Flexibility Analysis Required: Yes Department of Health and Human Services (HHS) Food and Drug Administration (FDA) 131. FOOD LABELING: SAFE HANDLING STATEMENTS, LABELING OF SHELL EGGS; REFRIGERATION OF SHELL EGGS HELD FOR RETAIL DISTRIBUTION (SECTION 610 REVIEW) Legal Authority: 15 USC 1453 to 1455; 21 USC 321; 21 USC 331; 21 USC 342 and 343; 21 USC 348; 21 USC 371; 42 USC 243; 42 USC 264; 42 USC 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 sections 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. FDA is undertaking a review of 21 CFR sections 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 FR Cite 11/30/05 70 FR 71892 01/30/06 Sfmt 1254 and Applied Nutrition, (HFS–820), 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436–1802 Fax: 301 436–2636 Email: geraldine.june@fda.hhs.gov RIN: 0910–AG06 132. PRESCRIPTION DRUG MARKETING ACT OF 1987; PRESCRIPTION DRUG AMENDMENTS OF 1992; POLICIES, REQUIREMENTS, AND ADMINISTRATIVE PROCEDURES (SECTION 610 REVIEW) Legal Authority: 21 USC 331; 21 USC 333; 21 USC 351; 21 USC 352; 21 USC 353; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 381 Abstract: FDA is undertaking a review of 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on a substantial number of small entities. FDA will consider, and is soliciting comments on, the following: E:\FR\FM\26APP7.SGM 26APP7 21790 Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Unified Agenda HHS—FDA Prerule Stage (1) The continued need for the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763); (2) the nature of complaints or comments received from the public concerning the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763); (3) the complexity of the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763); (4) the extent to which the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) overlap, duplicate, or conflict with other Federal rules, and to the extent feasible, with State and local governmental rules; and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763). Timetable: Action Date FR Cite Begin Review of 11/24/08 Current Regulation End Review of Current 06/00/10 Regulation erowe on DSK5CLS3C1PROD with PROPOSALS Regulatory Flexibility Analysis Required: Yes Agency Contact: Howard Muller, Office of Regulatory Policy, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6234, 10903 New Hampshire Avenue, Silver Spring, MD 20993–0002 Phone: 301 796–3601 Fax: 301 847–8440 Email: pdma610(c)review@fda.hhs.gov RIN: 0910–AG14 133. STERILITY REQUIREMENT FOR AQUEOUS–BASED DRUG PRODUCTS FOR ORAL INHALATION (SECTION 610 REVIEW) Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21 USC 360e; 21 USC 371; 21 USC 374; 21 USC 375 Abstract: FDA is undertaking a review of 21 CFR 200.51, under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether this regulation on aqueousbased drug products for oral inhalation should be continued without change, or VerDate Nov<24>2008 12:23 Apr 23, 2010 Jkt 220001 whether it 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 will consider, and is soliciting comments on the following: (1) The continued need for 21 CFR 200.51; (2) the nature of complaints or comments received concerning 21 CFR 200.51; (3) the complexity of 21 CFR 200.51; (4) the extent to which the regulation overlaps, duplicates, or conflicts with other Federal, State, or governmental rules; and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by 21 CFR 200.51. Timetable: Action Date Begin Review End Review FR Cite 05/01/09 05/00/10 Regulatory Flexibility Analysis Required: No Agency Contact: Howard P. Muller, Office of Regulatory Policy, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6234, 10903 New Hampshire Avenue, Silver Spring, MD 20993–0002 Phone: 301 796–3601 Fax: 301 847–8440 Email: howard.mullerjr@fda.hhs.gov RIN: 0910–AG25 134. REGULATIONS RESTRICTING THE SALE AND DISTRIBUTION OF CIGARETTES AND SMOKELESS TOBACCO TO PROTECT CHILDREN AND ADOLESCENTS Legal Authority: 21 USC 301 et seq, The Federal Food, Drug, and Cosmetic Act; PL 111–31, Family Smoking Prevention and Tobacco Control Act Abstract: This rule establishes regulations restricting the sale and distribution of cigarettes and smokeless tobacco to children and adolescents, implementing section 102 of the Family Smoking Prevention and Tobacco Control Act (FSPTCA). FSPTCA sections 102 and 6(c)(1) require the Secretary to publish, within 270 days of enactment, a final rule regarding cigarettes and smokeless tobacco. This final rule must be identical, except for several changes identified in section 102(a)(2) of FSPTCA, to part 897 of the regulations promulgated by the Secretary of HHS in the August 28, PO 00000 Frm 00010 Fmt 1254 Sfmt 1254 1996, issue of the Federal Register (61 FR 44396). This final rule prohibits the sale of cigarettes and smokeless tobacco to individuals under the age of 18 and requires manufacturers, distributors, and retailers to comply with certain conditions regarding access to, and promotion of, these products. Among other things, the final rule requires retailers to verify a purchaser’s age by photographic identification. It also prohibits, with limited exception, free samples and prohibits the sale of these products through vending machines and self-service displays except in facilities where individuals under the age of 18 are not present or permitted at any time. The rule also limits the advertising and labeling to which children and adolescents are exposed. The rule accomplishes this by generally restricting advertising to which children and adolescents are exposed to a black-and-white, text-only format. The rule also prohibits the sale or distribution of brand-identified promotional, non-tobacco items such as hats and tee shirts. Furthermore, the rule prohibits sponsorship of sporting and other events, teams, and entries in a brand name of a tobacco product, but permits such sponsorship in a corporate name. FDA will also publish in the same issue of the Federal Register an advance notice of proposed rulemaking requesting comments, data, research, or other information on the regulation of outdoor advertising of cigarettes and smokeless tobacco. Timetable: Action Date ANPRM Final Rule ANPRM Comment Period End Final Rule Effective FR Cite 03/19/10 75 FR 13241 03/19/10 75 FR 13225 05/18/10 06/22/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Annette L. Marthaler, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 9200 Corporate Boulevard, 100K, Rockville, MD 20850 Phone: 877 287–1373 Fax: 240 276–3904 Email: annette.marthaler@fda.hhs.gov RIN: 0910–AG33 E:\FR\FM\26APP7.SGM 26APP7 21791 Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Unified Agenda HHS—FDA Prerule Stage 135. OVER–THE–COUNTER HUMAN DRUGS; LABELING REQUIREMENTS (SECTION 610 REVIEW) Legal Authority: 5 USC 610 Abstract: Part 201.66 (21 CFR section 201.66) established a standardized format for the labeling of OTC drug products that included: (1) Specific headings and subheadings presented in a standardized order, (2) standardized graphical features such as Helvetica type style and the use of ‘‘bullet points’’ to introduce key information, and (3) minimum standards for type size and spacing. FDA issued the final rule to improve labeling after considering comments submitted to the agency following the publication of the proposed regulation in 1997. In 1999, FDA published the final rule and stated that a standardized labeling format would significantly improve readability by familiarizing consumers with the types of information in OTC drug product labeling and the location of that information. In addition, a standardized appearance and standardized content, including various ‘‘user-friendly’’ visual cues, would help consumers locate and read important health and safety information and allow quick and effective product comparisons, thereby helping consumers to select the most appropriate product. FDA is initiating a review under section 610 of the Regulatory Flexibility Act for the regulation in part 201.66. The purpose of this review is to determine whether the regulation in part 201.66 should be continued without change, or whether it should be further 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 regulation in part 201.66; (2) the nature of the complaints or comments received concerning the regulation in part 201.66; (3) the complexity of the regulations in part 201.66; (4) the extent to which the regulations in part 201.66 overlap, duplicate, or conflict with other Federal, State, or governmental rules; and (5) the degree to which technology, economic conditions, or other factors have changed for the products still subject to the labeling standard regulations in part 201. The section 610 review will be carried out along with a regulatory review under section 5 of Executive Order 12866, which calls for agencies to periodically review existing regulations to determine whether any should be modified or eliminated so as to make the agency’s regulatory program more effective in achieving its goals, less burdensome, or in greater alignment with the President’s priorities and the principles set forth in the Executive order. Timetable: Action Date Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, 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: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AG34 Department of Health and Human Services (HHS) Food and Drug Administration (FDA) 136. ELECTRONIC SUBMISSION OF DATA FROM STUDIES EVALUATING HUMAN DRUGS AND BIOLOGICS erowe on DSK5CLS3C1PROD with PROPOSALS Legal Authority: 21 USC 355; 21 USC 371; 42 USC 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 NPRM 10/00/10 VerDate Nov<24>2008 12:23 Apr 23, 2010 FR Cite Jkt 220001 Proposed Rule Stage 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 137. OVER–THE–COUNTER (OTC) DRUG REVIEW—COUGH/COLD (ANTIHISTAMINE) PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally PO 00000 Frm 00011 Fmt 1254 FR Cite Begin Review of 08/03/09 Current Regulation End Review of Current 05/00/10 Regulation Sfmt 1254 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 antihistamine labeling claims for the common cold. Timetable: Action Date Reopening of Administrative Record NPRM (Amendment) (Common Cold) FR Cite 08/25/00 65 FR 51780 03/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug E:\FR\FM\26APP7.SGM 26APP7 21792 Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Unified Agenda HHS—FDA Proposed Rule Stage Evaluation and Research, WO–22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov Action Date NPRM (Amendment) (Sodium Bicarbonate) Final Action (Internal Analgesics) To Be Determined RIN: 0910–AF31 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, 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: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF36 138. OVER–THE–COUNTER (OTC) DRUG REVIEW—INTERNAL ANALGESIC PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 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: erowe on DSK5CLS3C1PROD with PROPOSALS Action Date NPRM (Amendment) (Required Warnings and Other Labeling) NPRM Comment Period End NPRM (Overindulgence/ Hangover) Final Action (Required Warnings and Other Labeling) Final Action (Correction) Final Action (Technical Amendment) NPRM (Acetaminophen) NPRM (Amendment) (Pediatric) VerDate Nov<24>2008 FR Cite 12/26/06 71 FR 77314 FR Cite To Be Determined 139. OVER–THE–COUNTER (OTC) DRUG REVIEW—LAXATIVE DRUG PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360 to 360a; 21 USC 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: 05/25/07 Action To Be Determined 04/29/09 74 FR 19385 06/30/09 74 FR 31177 11/25/09 74 FR 61512 FR Cite Final Action (Granular 03/29/07 72 FR 14669 Psyllium) NPRM (Professional 10/00/10 Labeling—Sodium Phosphate) NPRM (Professional To Be Determined Labeling) Final Action (Laxative To Be Determined Drug Products) Regulatory Flexibility Analysis Required: Yes 03/00/11 To Be Determined 12:23 Apr 23, 2010 Date Jkt 220001 Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, PO 00000 Frm 00012 Fmt 1254 Sfmt 1254 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: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF38 140. OVER–THE–COUNTER (OTC) DRUG REVIEW—SUNSCREEN PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 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 active ingredients reviewed under Time and Extent Applications. The second action addresses other effectiveness issues for OTC sunscreen drug products. The third action finalizes sunscreen formulation, labeling, and testing requirements for both ultraviolet B and ultraviolet A radiation protection. The last action addresses combination products containing sunscreen and insect repellent ingredients. Timetable: Action Date ANPRM (Sunscreen and Insect Repellent) ANPRM Comment Period End NPRM (UVA/UVB) NPRM Comment Period End NPRM (Time and Extent Applications) NPRM (Effectiveness) Final Action (UVA/UVB) NPRM (Sunscreen and Insect Repellent) FR Cite 02/22/07 72 FR 7941 05/23/07 08/27/07 72 FR 49070 12/26/07 07/00/10 10/00/10 10/00/10 To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human E:\FR\FM\26APP7.SGM 26APP7 21793 Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Unified Agenda HHS—FDA Proposed Rule Stage Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO–22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF43 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF69 142. PROCESS CONTROLS FOR ANIMAL FEED INGREDIENTS AND MIXED ANIMAL FEED 141. OVER–THE–COUNTER (OTC) DRUG REVIEW—TOPICAL ANTIMICROBIAL DRUG PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 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 food handler products. The second action addresses testing requirements for healthcare professional products. The third action addresses the safety and effectiveness of consumer products. The final actions listed will address the healthcare, consumer, and first aid antiseptic drug products respectively. Timetable: Action Date erowe on DSK5CLS3C1PROD with PROPOSALS NPRM (Healthcare) NPRM (Food Handlers) NPRM (Testing — Healthcare Professional Products) NPRM (Consumer) Final Action (Healthcare) Final Action (Consumer) Final Action (First Aid Antiseptic) FR Cite 06/17/94 59 FR 31402 To Be Determined To Be Determined Abstract: The Food and Drug Administration (FDA) is proposing regulations for process 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. The proposed process controls will apply to animal feed ingredients and mixed animal feed, including pet food. This action is also being taken to carry out the requirements of the Food and Drug Administration Amendments Act of 2007. Section 1002(a) directs FDA to establish by regulation processing standards for pet food. This same provision of the law also directs that, in developing these new regulations, FDA obtain input from its stakeholders, including the Association of American Feed Control Officials, veterinary medical associations, animal health organizations, and pet food manufacturers. Timetable: Action 03/00/11 To Be Determined Date NPRM NPRM Comment Period End FR Cite 03/00/11 06/00/11 To Be Determined 12:23 Apr 23, 2010 Jkt 220001 Agency Contact: Kim Young, Deputy Director, Division of Compliance, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, Room 106 (MPN–4, HFV–230), 7519 Standish Place, Rockville, MD 20855 Phone: 240 276–9207 Email: kim.young@fda.hhs.gov RIN: 0910–AG10 Frm 00013 Fmt 1254 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a monograph 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 12/00/10 FR Cite Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, 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: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AG12 Legal Authority: Not Yet Determined Regulatory Flexibility Analysis Required: Yes PO 00000 Legal Authority: 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 144. UNIQUE DEVICE IDENTIFICATION To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, 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: 301 796–2090 Fax: 301 796–9899 VerDate Nov<24>2008 Legal Authority: 21 USC 342; 21 USC 350e; 21 USC 371; 21 USC 374; 42 USC 264; PL 110–85, sec 1002(a)(2) 143. PEDIATRIC DOSING FOR COUGH, COLD, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER–THE–COUNTER HUMAN USE; PROPOSED AMENDMENT OF FINAL MONOGRAPH Sfmt 1254 Abstract: The Food and Drug Administration Amendments Act of 2007, amended the Federal Food, Drug, and Cosmetic Act by adding section 519(f) (21 USC 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. E:\FR\FM\26APP7.SGM 26APP7 21794 Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Unified Agenda HHS—FDA Proposed Rule Stage Action Date NPRM FR Cite 12/00/10 erowe on DSK5CLS3C1PROD with PROPOSALS Regulatory Flexibility Analysis Required: Yes Agency Contact: John J. Crowley, Senior Advisor for Patient Safety, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, WO 66, Room 2315, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 980–1936 Email: jay.crowley@fda.hhs.gov RIN: 0910–AG31 145. PRODUCE SAFETY REGULATION Legal Authority: 21 USC 342; 21 USC 371; 42 USC 264 Abstract: The Food and Drug Administration (FDA) has determined that enforceable standards (as opposed to voluntary recommendations) for the production and packing of fresh produce are necessary to ensure best practices are commonly adopted. 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 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 VerDate Nov<24>2008 12:23 Apr 23, 2010 Jkt 220001 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 after the proposed rule is finalized to assist industry in complying with the requirements of the new regulation. Timetable: Regulatory Flexibility Analysis Required: Yes Action Date NPRM Timetable: 12/00/10 147. ∑ CIGARS SUBJECT TO THE FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT FR Cite Regulatory Flexibility Analysis Required: Yes Agency Contact: Samir Assar, 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 Email: samir.assar@fda.hhs.gov RIN: 0910–AG35 146. MODERNIZATION OF THE CURRENT FOOD GOOD MANUFACTURING PRACTICES REGULATION Legal Authority: 21 USC 342; 21 USC 371; 42 USC 264 Abstract: The Food and Drug Administration (FDA) is proposing to amend its current good manufacturing practices (CGMP) regulations (21 CFR part 110) for manufacturing, packing, or holding human food. This proposed rule would require food facilities to address issues such as environmental pathogens, food allergens, mandatory employee training, and sanitation of food contact surfaces. The proposed rule also would require food facilities to develop and implement preventive control systems. FDA is taking this action to better address changes that have occurred in the food industry and protect public health. Timetable: Action Date NPRM 03/00/11 PO 00000 Frm 00014 Fmt 1254 Sfmt 1254 FR Cite Agency Contact: Paul South, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS–317), Office of Food Safety, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436–1640 Email: paul.south@fda.hhs.gov RIN: 0910–AG36 Legal Authority: 21 USC 301 et seq, The Federal Food, Drug, and Cosmetic Act; PL 111–31, The Family Smoking Prevention and Tobacco Control Act Abstract: The Family Smoking Prevention and Tobacco Control Act (the 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, as amended by the Tobacco Control Act, permits FDA to issue regulations deeming other tobacco products to be subject to the Tobacco Control Act. This proposed rule would deem cigars to be subject to the Tobacco Control Act and include provisions to address public health concerns raised by cigars. Timetable: Action Date NPRM FR Cite 06/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: May Nelson, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 877 287–1373 Fax: 240 276–3904 Email: may.nelson@fda.hhs.gov RIN: 0910–AG38 E:\FR\FM\26APP7.SGM 26APP7 Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Unified Agenda Department of Health and Human Services (HHS) Food and Drug Administration (FDA) Final Rule Stage 148. POSTMARKETING SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND BIOLOGICAL PRODUCTS 149. MEDICAL GAS CONTAINERS AND CLOSURES; CURRENT GOOD MANUFACTURING PRACTICE REQUIREMENTS Legal Authority: 42 USC 216; 42 USC 241; 42 USC 242a; 42 USC 262 and 263; 42 USC 263a to 263n; 42 USC 264; 42 USC 300aa; 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360b to 360j; 21 USC 361a; 21 USC 371; 21 USC 374; 21 USC 375; 21 USC 379e; 21 USC 381 Legal Authority: 21 USC 321; 21 USC 351 to 21 USC 353 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. Timetable: Date NPRM NPRM Comment Period Extended NPRM Comment Period End NPRM Comment Period Extension End Final Action FR Cite 03/14/03 68 FR 12406 06/18/03 07/14/03 Action Date NPRM NPRM Comment Period End Final Action 04/10/06 71 FR 18039 07/10/06 03/00/11 Regulatory Flexibility Analysis Required: Yes 11/00/10 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 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 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–AC53 RIN: 0910–AA97 VerDate Nov<24>2008 FR Cite 10/14/03 Regulatory Flexibility Analysis Required: Yes erowe on DSK5CLS3C1PROD with PROPOSALS 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. Timetable: Action 12:23 Apr 23, 2010 Jkt 220001 PO 00000 Frm 00015 Fmt 1254 21795 Sfmt 1254 150. CONTENT AND FORMAT OF LABELING FOR HUMAN PRESCRIPTION DRUGS AND BIOLOGICS; REQUIREMENTS FOR PREGNANCY AND LACTATION LABELING Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 360b; 21 USC 360gg to 360ss; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 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: Action Date NPRM NPRM Comment Period End Final Action FR Cite 05/29/08 73 FR 30831 08/27/08 03/00/11 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 E:\FR\FM\26APP7.SGM 26APP7 21796 Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Unified Agenda HHS—FDA Final Rule Stage Fax: 301 847–8440 Email: rachel.bressler@fda.hhs.gov RIN: 0910–AF11 151. INFANT FORMULA: CURRENT GOOD MANUFACTURING PRACTICES; QUALITY CONTROL PROCEDURES; NOTIFICATION REQUIREMENTS; RECORDS AND REPORTS; AND QUALITY FACTORS Legal Authority: 21 USC 321; 21 USC 350a; 21 USC 371; . . . Abstract: The Food and Drug Administration (FDA) is revising its infant formula regulations in 21 CFR parts 106 and 107 to establish requirements for current good manufacturing practices (CGMP), including audits; to establish requirements for quality factors; and to amend FDA’s quality control procedures, notification, and record and reporting requirements for infant formula. FDA is taking this action to improve the protection of infants who consume infant formula products. Timetable: Action Date NPRM NPRM Comment Period End NPRM Comment Period Reopened NPRM Comment Period Extended NPRM Comment Period End NPRM Comment Period Reopened NPRM Comment Period End Final Action FR Cite 07/09/96 61 FR 36154 12/06/96 04/28/03 68 FR 22341 06/27/03 68 FR 38247 08/26/03 08/01/06 71 FR 43392 09/15/06 10/00/10 erowe on DSK5CLS3C1PROD with PROPOSALS 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 Email: benson.silverman@fda.hhs.gov RIN: 0910–AF27 VerDate Nov<24>2008 12:23 Apr 23, 2010 Jkt 220001 152. OVER–THE–COUNTER (OTC) DRUG REVIEW—COUGH/COLD (BRONCHODILATOR) PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 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 NPRM (Amendment— Ephedrine Single Ingredient) NPRM Comment Period End Final Action (Technical Amendment) Final Action (Amendment— Single Ingredient Labeling) FR Cite 07/13/05 70 FR 40237 11/10/05 11/30/07 72 FR 67639 09/00/10 153. OVER–THE–COUNTER (OTC) DRUG REVIEW—COUGH/COLD (COMBINATION) PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 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 Frm 00016 Fmt 1254 Sfmt 1254 Timetable: Action Date NPRM (Amendment) NPRM Comment Period End Final Action (Technical Amendment) Final Action FR Cite 07/13/05 70 FR 40232 11/10/05 03/19/07 72 FR 12730 03/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, 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: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF33 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, 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: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF32 PO 00000 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. 154. OVER–THE–COUNTER (OTC) DRUG REVIEW—EXTERNAL ANALGESIC PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 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 Final Action (GRASE dosage forms) NPRM (Amendment) FR Cite 12/00/10 To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human E:\FR\FM\26APP7.SGM 26APP7 Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Unified Agenda HHS—FDA Final Rule Stage 156. USE OF MATERIALS DERIVED FROM CATTLE IN HUMAN FOOD AND COSMETICS Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO–22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov Legal Authority: 21 USC 342; 21 USC 361; 21 USC 371 RIN: 0910–AF35 155. OVER–THE–COUNTER (OTC) DRUG REVIEW—SKIN PROTECTANT PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 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 skin protectant products used to treat fever blisters and cold sores. The second action identifies safe and effective skin protectant active ingredients to treat and prevent diaper rash. Timetable: Action Date Final Action (Aluminum Acetate) (Technical Amendment) Final Action (Diaper Rash) Final Action (Technical Amendments) Final Action (Fever Blisters/Cold Sores) FR Cite 03/06/09 74 FR 9759 03/00/11 02/01/08 73 FR 6014 erowe on DSK5CLS3C1PROD with PROPOSALS 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 hexaneinsoluble 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: 03/00/11 Action Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, 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: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF42 VerDate Nov<24>2008 21797 12:23 Apr 23, 2010 Jkt 220001 Date 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) PO 00000 Frm 00017 Fmt 1254 FR Cite 07/14/04 69 FR 42256 07/14/04 10/12/04 09/07/05 70 FR 53063 Date Interim Final Rule (Amendments) Comment Period End Interim Final Rule (Amendments) Effective Final Action 11/07/05 04/17/08 73 FR 20785 FR Cite 07/16/08 07/16/08 10/00/10 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 Email: amber.mccoig@fda.hhs.gov RIN: 0910–AF47 157. LABEL REQUIREMENT FOR FOOD THAT HAS BEEN REFUSED ADMISSION INTO THE UNITED STATES Legal Authority: 15 USC 1453 to 1455; 21 USC 321; 21 USC 342 and 343; 21 USC 371; 21 USC 374; 21 USC 381; 42 USC 216; 42 USC 264 Abstract: The final rule will require owners or consignees to label imported food that is refused entry into the United States. The label will read, ‘‘UNITED STATES: REFUSED ENTRY.’’ The proposal describes the label’s characteristics (such as its size) and processes for verifying that the label has been affixed properly. We are taking this action to prevent the introduction of unsafe food into the United States, to facilitate the examination of imported food, and to implement section 308 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107188). Timetable: Action Date NPRM NPRM Comment Period End Final Action 10/07/05 Sfmt 1254 Action FR Cite 09/18/08 73 FR 54106 12/02/08 03/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: John D. Reilly, Regulatory Counsel, Department of Health and Human Services, Food and E:\FR\FM\26APP7.SGM 26APP7 21798 Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Unified Agenda HHS—FDA Final Rule Stage Drug Administration, Center for Food Safety and Applied Nutrition, CPK 1, Room 1C–015, (HFS–024), 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436–1530 Fax: 301 436–2637 Email: john.reilly@fda.hhs.gov RIN: 0910–AF61 Department of Health and Human Services (HHS) Food and Drug Administration (FDA) 158. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Legal Authority: 21 USC 321; 21 USC 342 and 343; 21 USC 348; 21 USC 371; 21 USC 374; 21 USC 381; 21 USC 393; 42 USC 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: erowe on DSK5CLS3C1PROD with PROPOSALS Action Date ANPRM ANPRM Comment Period End NPRM NPRM Comment Period End Final Rule Interim Final Rule Interim Final Rule Comment Period End Final Action FR Cite 02/06/97 62 FR 5700 06/06/97 03/13/03 68 FR 12157 08/11/03 06/25/07 72 FR 34752 06/25/07 72 FR 34959 10/24/07 To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Linda Kahl, Senior Policy Analyst, Department of Health and Human Services, Food and Drug VerDate Nov<24>2008 12:23 Apr 23, 2010 Jkt 220001 Long-Term Actions 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 Email: linda.kahl@fda.hhs.gov RIN: 0910–AB88 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: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov 159. OVER–THE–COUNTER (OTC) DRUG REVIEW—COUGH/COLD (NASAL DECONGESTANT) PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 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: RIN: 0910–AF34 Action Date 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) Final Action (Phenylpropanolamine) FR Cite 08/02/04 69 FR 46119 Frm 00018 Fmt 1254 Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 371; 21 UCS 374; 21 USC 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. This action addresses labeling for convenience (small) size OTC drug packages. Timetable: 11/01/04 Action 11/02/04 69 FR 63482 12/22/05 70 FR 75988 NPRM (Convenience Sizes) NPRM Comment Period End Final Action 03/22/06 Regulatory Flexibility Analysis Required: Yes 01/31/05 10/31/05 70 FR 58974 08/01/06 71 FR 83358 To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, PO 00000 160. OVER–THE–COUNTER (OTC) DRUG REVIEW—LABELING OF DRUG PRODUCTS FOR OTC HUMAN USE Sfmt 1254 Date FR Cite 12/12/06 71 FR 74474 04/11/07 To Be Determined Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, 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: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF37 E:\FR\FM\26APP7.SGM 26APP7 21799 Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Unified Agenda HHS—FDA Long-Term Actions 161. OVER–THE–COUNTER (OTC) DRUG REVIEW—OPHTHALMIC PRODUCTS used to reduce or prevent dental plaque and gingivitis. Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Action Timetable: 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: Action Date NPRM (Amendment) (Emergency First Aid Eyewashes) Final Action (Amendment) (Emergency First Aid Eyewashes) FR Cite 02/19/03 68 FR 7917 To Be Determined Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, 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: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF39 162. OVER–THE–COUNTER (OTC) DRUG REVIEW—ORAL HEALTH CARE PRODUCTS erowe on DSK5CLS3C1PROD with PROPOSALS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360 to 360a; 21 USC 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 12:23 Apr 23, 2010 FR Cite 05/29/03 68 FR 32232 To Be Determined To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, 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: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov Jkt 220001 163. OVER–THE–COUNTER (OTC) DRUG REVIEW—VAGINAL CONTRACEPTIVE PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 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: Action Date FR Cite Final Action 12/19/07 72 FR 71769 (Warnings) NPRM (Vaginal To Be Determined Contraceptive Drug Products) Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO–22, PO 00000 Frm 00019 Fmt 1254 RIN: 0910–AF44 08/27/03 RIN: 0910–AF40 Regulatory Flexibility Analysis Required: Yes VerDate Nov<24>2008 Date ANPRM (Plaque Gingivitis) ANPRM Comment Period End NPRM (Plaque Gingivitis) Final Action Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov Sfmt 1254 164. OVER–THE–COUNTER (OTC) DRUG REVIEW—WEIGHT CONTROL PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 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 NPRM (Phenylpropanolamine) NPRM Comment Period End NPRM (Benzocaine) Final Action (Phenylpropanolamine) Final Action (Benzocaine) FR Cite 12/22/05 70 FR 75988 03/22/06 To Be Determined To Be Determined To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, 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: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF45 E:\FR\FM\26APP7.SGM 26APP7 21800 Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Unified Agenda HHS—FDA Long-Term Actions 165. OVER–THE–COUNTER (OTC) DRUG REVIEW—OVERINDULGENCE IN FOOD AND DRINK PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 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 Final Action FR Cite 01/05/05 70 FR 741 04/05/05 To Be Determined Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, 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: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF51 166. OVER–THE–COUNTER (OTC) DRUG REVIEW—ANTACID PRODUCTS erowe on DSK5CLS3C1PROD with PROPOSALS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 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. 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 12:23 Apr 23, 2010 Jkt 220001 Timetable: Action Date FR Cite Final Action (Sodium Bicarbonate Labeling) Final Action (Overindulgence Labeling) To Be Determined To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, 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: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF52 Regulatory Flexibility Analysis Required: Yes VerDate Nov<24>2008 associated with overindulgence in food and drink. Phone: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF53 168. OVER–THE–COUNTER (OTC) DRUG REVIEW—STIMULANT DRUG PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 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: 167. OVER–THE–COUNTER (OTC) DRUG REVIEW—SKIN BLEACHING PRODUCTS Action Date NPRM (Amendment) (Hangover) To Be Determined Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Regulatory Flexibility Analysis Required: Yes 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 NPRM NPRM Comment Period End Final Action FR Cite 08/29/06 71 FR 51146 12/27/06 To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, 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 PO 00000 Frm 00020 Fmt 1254 Sfmt 1254 FR Cite Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, 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: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF56 169. OVER–THE–COUNTER ANTIDIARRHEAL DRUG PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 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. E:\FR\FM\26APP7.SGM 26APP7 21801 Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Unified Agenda HHS—FDA Long-Term Actions Timetable: Action Date NPRM (New Labeling) Final Action (New Labeling) To Be Determined To Be Determined FR Cite Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, 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: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF63 170. OVER–THE–COUNTER (OTC) DRUG REVIEW—URINARY ANALGESIC DRUG PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 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: Action Date NPRM (Urinary Analgesic) To Be Determined FR Cite Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, 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: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF70 171. STATUS OF CERTAIN ADDITIONAL OVER–THE–COUNTER DRUG CATEGORY II ACTIVE INGREDIENTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 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 Date NPRM NPRM Comment Period End Final Action erowe on DSK5CLS3C1PROD with PROPOSALS Action Date NPRM NPRM Comment Period End Final Action FR Cite 09/20/05 70 FR 55038 12/19/05 12/10/09 74 FR 65409 Regulatory Flexibility Analysis Required: Yes VerDate Nov<24>2008 12:23 Apr 23, 2010 Jkt 220001 RIN: 0910–AC55 Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, 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: 301 796–2090 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF95 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 address acne drug products containing benzoyl peroxide. Timetable: Action 173. OVER–THE–COUNTER (OTC) DRUG REVIEW—ACNE DRUG PRODUCTS CONTAINING BENZOYL PEROXIDE Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360 to 360a; 21 USC 371 to 371a Abstract: The OTC drug review establishes conditions under which Frm 00021 Fmt 1254 To Be Determined Completed Actions Agency Contact: Reena Raman, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., WO 51, Room 6238, Silver Spring, MD 20993–0002 Phone: 301 796–7577 Fax: 301 847–8440 Email: reena.raman@fda.hhs.gov PO 00000 06/19/08 73 FR 34895 09/17/08 Regulatory Flexibility Analysis Required: Yes Department of Health and Human Services (HHS) Food and Drug Administration (FDA) 172. POSITRON EMISSION TOMOGRAPHY DRUGS; CURRENT GOOD MANUFACTURING PRACTICES Legal Authority: PL 105–115, sec 121 Abstract: Section 121 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) directs FDA to establish requirements for current good manufacturing practices (CGMPs) for positron emission tomography (PET) drugs, a type of radiopharmaceutical. The final rule adopts CGMPs that reflect the unique characteristics of PET drugs. Timetable: FR Cite Sfmt 1254 Date Final Action FR Cite 03/04/10 75 FR 9767 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO–22, E:\FR\FM\26APP7.SGM 26APP7 21802 Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Unified Agenda HHS—FDA Completed Actions Phone: 301 796–2090 Fax: 301 796–9899 Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AG00 Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) 174. HOME HEALTH AGENCY (HHA) CONDITIONS OF PARTICIPATION (COPS) (CMS–3819–P) (SECTION 610 REVIEW) Legal Authority: 42 USC 1302; 42 USC 1395x; 42 USC 1395cc(a); 42 USC 1395hh; 42 USC 1395bb Abstract: This proposed rule would revise the existing Conditions of Participation (CoPs), last set in 1999, that Home Health Agencies (HHAs) must meet to participate in the Medicare program. The requirements 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. Abstract: This proposed rule would establish that in order to participate in the Medicare and Medicaid programs, long-term care (LTC) facilities must have an agreement with hospice agencies when hospice care is provided in a long-term care facility. We are proposing new requirements to ensure that quality hospice care is provided to eligible residents. Action Date NPRM NPRM Comment Period End Second NPRM FR Cite 03/10/97 62 FR 11005 06/09/97 09/00/10 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, Mailstop S3–02–01, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786–6617 Email: danielle.shearer@cms.hhs.gov RIN: 0938–AG81 Action Date NPRM FR Cite 03/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: Trish Brooks, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, Mailstop S3–02–01, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786–4561 Email: trish.brooks@cms.hhs.gov 176. PROPOSED CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEMS FOR ACUTE CARE HOSPITALS AND FY 2011 RATES AND TO THE LONG–TERM CARE HOSPITAL PPS AND RY 2011 RATES (CMS–1498–P) Legal Authority: Sec 1886(d) of the Social Security Act Abstract: This annual proposed rule would revise the Medicare hospital inpatient and long-term care prospective payment systems for operating and capital-related costs to implement changes arising from our continuing experience with these systems. These changes would be applicable to services furnished on or after October 1st. 175. REQUIREMENTS FOR LONG–TERM CARE FACILITIES: HOSPICE SERVICES (CMS–3140–P) (SECTION 610 REVIEW) Timetable: Legal Authority: 42 USC 1302; 42 USC 1395hh Regulatory Flexibility Analysis Required: Yes VerDate Nov<24>2008 12:23 Apr 23, 2010 Jkt 220001 Agency Contact: Tiffany Swygert, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C4–25–11, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786–4642 Email: tiffany.swygert@cms.hhs.gov RIN: 0938–AP80 Timetable: RIN: 0938–AP32 Timetable: erowe on DSK5CLS3C1PROD with PROPOSALS Proposed Rule Stage Action Date NPRM 04/00/10 PO 00000 Frm 00022 Fmt 1254 Sfmt 1254 FR Cite 177. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2011 (CMS–1504–P) Legal Authority: sec 1833 of the Social Security Act Abstract: This annual 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. In addition, the proposed rule describes proposed changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. The rule also proposes changes to the Ambulatory Surgical Center Payment System list of services and rates. These changes would be applicable to services furnished on or after January 1st. Timetable: Action Date NPRM 06/00/10 FR Cite 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 Email: alberta.dwivedi@cms.hhs.gov RIN: 0938–AP82 E:\FR\FM\26APP7.SGM 26APP7 21803 Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Unified Agenda HHS—CMS Proposed Rule Stage 179. ∑ OMNIBUS INFLUENZA IMMUNIZATION (CMS–3213–P) 178. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM REFINEMENTS AND RATE UPDATE FOR CY 2011 (CMS–1510–P) Legal Authority: Social Security Act sec 1881, 1861, 1920, 1102, 1871, 1965 Legal Authority: Social Security Act, secs 1102 and 1871; 42 USC 1302 and 42 USC 1395(hh); Social Security Act, sec 1895 Abstract: This annual proposed rule would update the 60-day national episode rate (based on the applicable Home Health Market Basket Update and case-mix adjustment) and would also update the national per-visit rates (used to calculate low utilization payment adjustments (LUPAs) and outlier payments) amounts under the Medicare Prospective Payment System for home health agencies. These changes would be applicable to services furnished on or after January 1st. Timetable: Action Date NPRM FR Cite 07/00/10 Abstract: This proposed rule would require certain providers to offer all patients or residents an influenza immunization annually. The providers required to do so are hospitals, intermediate care facilities, critical access hospitals, rural health clinics, Federally qualified health centers, ESRD facilities, psychiatric residential treatment facilities, and inpatient rehabilitation facilities. This proposed rule is based on the most recent recommendations from the CDC’s Advisory 3 Committee on Immunization Practices. The goal of this proposed rule is to improve influenza immunization rates for all patients and residents and to address the disparities in immunization rates Legal Authority: 42 USC 1385 X; 42 USC 1396 d; 42 USC 1395 hh Abstract: This proposed rule would transfer the existing process requirements for hospital psychiatric and rehabilitation units that are excluded from prospective payment systems to the hospital conditions of participation (CoPs) part of the Act. 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. Timetable: Timetable: Action Date NPRM Regulatory Flexibility Analysis Required: Yes 180. ∑ PROPOSED CHANGES TO THE HOSPITAL CONDITIONS OF PARTICIPATION: REQUIREMENTS FOR HOSPITAL PSYCHIATRIC AND REHABILITATION UNITS EXCLUDED FROM THE PROSPECTIVE PAYMENT SYSTEM (CMS–3177–P) 09/00/10 Action Date NPRM FR Cite 01/00/11 RIN: 0938–AP88 Regulatory Flexibility Analysis Required: Yes 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 Email: lauren.oviatt@cms.hhs.gov Agency Contact: Scott Cooper, Health Insurnce Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail stop S3–02–01, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786–9465 Email: scott.cooper@cms.hhs.gov RIN: 0938–AP92 Agency Contact: Randy Throndeset, Technical Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers for Medicare Management, Mailstop C5–07–28, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786–0131 Email: randy.throndeset@cms.hhs.gov RIN: 0938–AP97 erowe on DSK5CLS3C1PROD with PROPOSALS Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) 181. REVISIONS TO THE MEDICARE ADVANTAGE AND MEDICARE PRESCRIPTION DRUG BENEFIT PROGRAMS FOR CONTRACT YEAR 2011 (CMS–4085–F) Legal Authority: MMA 2003; MIPPA (title XVIII of the Social Security Act) Abstract: This final rule makes revisions to the regulations governing the Medicare Advantage (MA) program (Part C) and prescription drug benefit program (Part D) based on our continued experience in the administration of the Part C and D programs. The revisions strengthen various program participation and exit VerDate Nov<24>2008 12:23 Apr 23, 2010 FR Cite Jkt 220001 Long-Term Actions requirements; strengthen beneficiary protections; ensure that plan offerings to beneficiaries include meaningful differences; improve plan payment rules and processes; improve data collection for oversight and quality assessment; implement new policy such as a Part D formulary policy; and clarify program policy. Timetable: Action Date NPRM NPRM Comment Period End Final Action PO 00000 Frm 00023 Fmt 1254 FR Cite 10/22/09 74 FR 54634 12/07/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Alissa Deboy, Director, Division of Drug Plan Policy and Quality, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C1–26–26, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786–6041 Email: alissa.deboy@cms.hhs.gov RIN: 0938–AP77 10/00/12 Sfmt 1254 E:\FR\FM\26APP7.SGM 26APP7 21804 Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Unified Agenda Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) 182. ELECTRONIC CLAIMS ATTACHMENTS STANDARDS (CMS–0050–IFC) Legal Authority: 42 USC 1320d–2(a)(2)(B) Abstract: This rule sets forth electronic standards for health care claims attachments. The standards are required by the Health Insurance Portability and Accountability Act of 1996. They will be used to transmit clinical or administrative data for claims adjudication purposes. Timetable: Action Date NPRM NPRM Comment Period End Withdrawn FR Cite 09/23/05 70 FR 55989 11/22/05 01/25/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Elizabeth Holland, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of E–Health Standards and Services, Mailstop S2–26–17, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786–1309 Email: elizabeth.holland@cms.hhs.gov, RIN: 0938–AK62 erowe on DSK5CLS3C1PROD with PROPOSALS 183. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR CY 2010 (CMS–1413–FC) Legal Authority: Social Security Act, sec 1102; Social Security Act, sec 1871 VerDate Nov<24>2008 12:23 Apr 23, 2010 Jkt 220001 Completed Actions Abstract: This annual rule revises payment polices under the physician fee schedule, as well as other policy changes to payment under Part B. Timetable: Action Date NPRM NPRM Comment Period End Final Action FR Cite 07/13/09 74 FR 33520 08/31/09 11/25/09 74 FR 61738 Regulatory Flexibility Analysis Required: Yes Agency Contact: Diane Milstead, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers for Medicaid Mangement, Mailstop C4–03–06, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786–3355 Email: diane.milstead@cms.hhs.gov RIN: 0938–AP40 184. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2010 (CMS–1414–FC) Legal Authority: BBA; BBA; BIPA; MMA; MMSEA; MIPPA; DRA; TRHCA Abstract: This annual rule revises the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system and to implement certain PO 00000 Frm 00024 Fmt 1254 Sfmt 1254 related provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). In addition, the rule describes changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. The rule also changes the Ambulatory Surgical Center Payment System list of services and rates. These changes are applicable to services furnished on or after January 1st. Timetable: Action Date NPRM NPRM Comment Period End Final Action FR Cite 07/20/09 74 FR 35231 08/31/09 11/20/09 74 FR 60315 Regulatory Flexibility Analysis Required: Yes Agency Contact: Alberta Dwivedi, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers for Medicare Management, Mailstop C5–01–26, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786–0763 Email: alberta.dwivedi@cms.hhs.gov RIN: 0938–AP41 [FR Doc. 2010–8934 Filed 04–23–10; 8:45 am] BILLING CODE 4150–24–S E:\FR\FM\26APP7.SGM 26APP7

Agencies

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 75, Number 79 (Monday, April 26, 2010)]
[Unknown Section]
[Pages 21781-21804]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-8934]


[[Page 21781]]

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Part VII





Department of Health and Human Services





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



###Semiannual Regulatory Agenda###

[[Page 21782]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

_______________________________________________________________________

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 
(HHS). 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 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 7, 2009. 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.

    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. The complete Agenda is accessible 
online at www.reginfo.gov in an interactive format that offers 
users enhanced capabilities to obtain information from the Agenda's 
database.

Dated: March 10, 2010.

 Dawn L. Smalls,

Executive Secretary,
Department of Health and Human Services.

                                  Office of the Secretary--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
120         Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health      0991-AB57
            Information Technology for Economic and Clinical Health Act...........................
----------------------------------------------------------------------------------------------------------------


                                    Office of the Secretary--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
121         Health Information Technology: Initial Set of Standards, Implementation                   0991-AB58
            Specifications, and Certification Criteria for Electronic Health Record Technology
            (Rulemaking Resulting From a Section 610 Review)......................................
----------------------------------------------------------------------------------------------------------------


                   Substance Abuse and Mental Health Services Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
122         Opioid Drugs in Maintenance or Detoxification Treatment of Opiate Addiction (Section      0930-AA14
            610 Review)...........................................................................
----------------------------------------------------------------------------------------------------------------


                  Substance Abuse and Mental Health Services Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
123         Requirements Governing the Use of Seclusion and Restraint in Certain Nonmedical           0930-AA10
            Community-Based Facilities for Children and Youth.....................................
----------------------------------------------------------------------------------------------------------------


[[Page 21783]]


                         Centers for Disease Control and Prevention--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
124         Control of Communicable Diseases: Foreign Quarantine Regulations, Proposed Revision of    0920-AA14
            HHS/CDC Animal Importation Regulations................................................
125         Control of Communicable Diseases: Foreign Quarantine Regulations, Nonhuman Primate....    0920-AA23
126         Total Inward Leakage Requirements for Respirators.....................................    0920-AA33
----------------------------------------------------------------------------------------------------------------


                          Centers for Disease Control and Prevention--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
127         Quality Assurance Requirements for Respirators........................................    0920-AA04
128         Control of Communicable Diseases: Foreign Quarantine..................................    0920-AA12
----------------------------------------------------------------------------------------------------------------


                          Centers for Disease Control and Prevention--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
129         Possession, Use, and Transfer of Select Agents and Toxins: Chapare Virus (Section 610     0920-AA32
            Review)...............................................................................
----------------------------------------------------------------------------------------------------------------


                          Centers for Disease Control and Prevention--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
130         Control of Communicable Diseases: Interstate Quarantine, Passenger Information........    0920-AA27
----------------------------------------------------------------------------------------------------------------


                                   Food and Drug Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
131         Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of         0910-AG06
            Shell Eggs Held for Retail Distribution (Section 610 Review)..........................
132         Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992;            0910-AG14
            Policies, Requirements, and Administrative Procedures (Section 610 Review)............
133         Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation (Section 610    0910-AG25
            Review)...............................................................................
134         Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco     0910-AG33
            To Protect Children and Adolescents...................................................
135         Over-the-Counter Human Drugs; Labeling Requirements (Section 610 Review)..............    0910-AG34
----------------------------------------------------------------------------------------------------------------


                                Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
136         Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics.......    0910-AC52
137         Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products...............    0910-AF31
138         Over-the-Counter (OTC) Drug Review--Internal Analgesic Products.......................    0910-AF36
139         Over-the-Counter (OTC) Drug Review--Laxative Drug Products............................    0910-AF38
140         Over-the-Counter (OTC) Drug Review--Sunscreen Products................................    0910-AF43
141         Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products...............    0910-AF69
142         Process Controls for Animal Feed Ingredients and Mixed Animal Feed....................    0910-AG10

[[Page 21784]]

 
143         Pediatric Dosing for Cough, Cold, Allergy, Bronchodilator, and Antiasthmatic Drug         0910-AG12
            Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph........
144         Unique Device Identification..........................................................    0910-AG31
145         Produce Safety Regulation.............................................................    0910-AG35
146         Modernization of the Current Food Good Manufacturing Practices Regulation.............    0910-AG36
147         Cigars Subject to the Family Smoking Prevention and Tobacco Control Act...............    0910-AG38
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
148         Postmarketing Safety Reporting Requirements for Human Drug and Biological Products....    0910-AA97
149         Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements.    0910-AC53
150         Content and Format of Labeling for Human Prescription Drugs and Biologics;                0910-AF11
            Requirements for Pregnancy and Lactation Labeling.....................................
151         Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures;         0910-AF27
            Notification Requirements; Records and Reports; and Quality Factors...................
152         Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products..............    0910-AF32
153         Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) Products.................    0910-AF33
154         Over-the-Counter (OTC) Drug Review--External Analgesic Products.......................    0910-AF35
155         Over-the-Counter (OTC) Drug Review--Skin Protectant Products..........................    0910-AF42
156         Use of Materials Derived From Cattle in Human Food and Cosmetics......................    0910-AF47
157         Label Requirement for Food That Has Been Refused Admission Into the United States.....    0910-AF61
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
158         Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding       0910-AB88
            Operations for Dietary Supplements....................................................
159         Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products..........    0910-AF34
160         Over-the-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use.......    0910-AF37
161         Over-the-Counter (OTC) Drug Review--Ophthalmic Products...............................    0910-AF39
162         Over-the-Counter (OTC) Drug Review--Oral Health Care Products.........................    0910-AF40
163         Over-the-Counter (OTC) Drug Review--Vaginal Contraceptive Products....................    0910-AF44
164         Over-the-Counter (OTC) Drug Review--Weight Control Products...........................    0910-AF45
165         Over-the-Counter (OTC) Drug Review--Overindulgence in Food and Drink Products.........    0910-AF51
166         Over-the-Counter (OTC) Drug Review--Antacid Products..................................    0910-AF52
167         Over-the-Counter (OTC) Drug Review--Skin Bleaching Products...........................    0910-AF53
168         Over-the-Counter (OTC) Drug Review--Stimulant Drug Products...........................    0910-AF56
169         Over-the-Counter Antidiarrheal Drug Products..........................................    0910-AF63
170         Over-the-Counter (OTC) Drug Review--Urinary Analgesic Drug Products...................    0910-AF70
171         Status of Certain Additional Over-the-Counter Drug Category II Active Ingredients.....    0910-AF95
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
172         Positron Emission Tomography Drugs; Current Good Manufacturing Practices..............    0910-AC55
173         Over-the-Counter (OTC) Drug Review--Acne Drug Products Containing Benzoyl Peroxide....    0910-AG00
----------------------------------------------------------------------------------------------------------------


[[Page 21785]]


                          Centers for Medicare & Medicaid Services--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
174         Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610     0938-AG81
            Review)...............................................................................
175         Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-P) (Section 610    0938-AP32
            Review)...............................................................................
176         Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care     0938-AP80
            Hospitals and FY 2011 Rates and to the Long-Term Care Hospital PPS and RY 2011 Rates
            (CMS-1498-P)..........................................................................
177         Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical     0938-AP82
            Center Payment System for CY 2011 (CMS-1504-P)........................................
178         Home Health Prospective Payment System Refinements and Rate Update for CY 2011 (CMS-      0938-AP88
            1510-P)...............................................................................
179         Omnibus Influenza Immunization (CMS-3213-P)...........................................    0938-AP92
180         Proposed Changes to the Hospital Conditions of Participation: Requirements for            0938-AP97
            Hospital Psychiatric and Rehabilitation Units Excluded From the Prospective Payment
            System (CMS-3177-P)...................................................................
----------------------------------------------------------------------------------------------------------------


                           Centers for Medicare & Medicaid Services--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
181         Revisions to the Medicare Advantage and Medicare Prescription Drug Benefit Programs       0938-AP77
            for Contract Year 2011 (CMS-4085-F)...................................................
----------------------------------------------------------------------------------------------------------------


                           Centers for Medicare & Medicaid Services--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
182         Electronic Claims Attachments Standards (CMS-0050-IFC)................................    0938-AK62
183         Revisions to Payment Policies Under the Physician Fee Schedule for CY 2010 (CMS-1413-     0938-AP40
            FC)...................................................................................
184         Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical     0938-AP41
            Center Payment System for CY 2010 (CMS-1414-FC).......................................
----------------------------------------------------------------------------------------------------------------

_______________________________________________________________________
Department of Health and Human Services (HHS)       Proposed Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________

120. MODIFICATIONS TO THE HIPAA PRIVACY, SECURITY, AND ENFORCEMENT RULES 
UNDER THE HEALTH INFORMATION TECHNOLOGY FOR ECONOMIC AND CLINICAL HEALTH 
ACT

Legal Authority: PL 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                            05/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Andra Wicks, Department of Health and Human Services, 
200 Independence Avenue SW., Washington, DC 20201
Phone: 202 205-2292
Fax: 202 205-4786
Email: andra.wicks@hhs.gov

RIN: 0991-AB57

[[Page 21786]]

_______________________________________________________________________
Department of Health and Human Services (HHS)          Final Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________

121. HEALTH INFORMATION TECHNOLOGY: INITIAL SET OF STANDARDS, 
IMPLEMENTATION SPECIFICATIONS, AND CERTIFICATION CRITERIA FOR ELECTRONIC 
HEALTH RECORD TECHNOLOGY (RULEMAKING RESULTING FROM A SECTION 610 
REVIEW)

Legal Authority: 42 USC 300jj-14

Abstract: The Department of Health and Human Services (HHS), Office of 
the National Coordinator for Health Information Technology, will issue 
an interim final rule with a request for comments to adopt an initial 
set of standards, implementation specifications, and certification 
criteria, as required by section 3004(b)(1) of the Public Health 
Service Act. The certification criteria adopted in this initial set 
establish the technical capabilities and related standards that 
certified electronic health record (EHR) technology will need to 
include in support of the Medicare and Medicaid EHR Incentive Programs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/13/10                     75 FR 2014
Interim Final Rule Comment 
Period End                      03/15/10
Interim Final Rule Effective    02/12/10
Final Action                    05/00/10
Final Action Effective          06/00/10

Regulatory Flexibility Analysis Required: No

Agency Contact: Steven Posnack, Policy Analyst, Department of Health 
and Human Services, Office of the Secretary, Office of the National 
Coordinator for Health Information Technology, 200 Independence Avenue 
SW., Washington, DC 20201
Phone: 202 690-7151

RIN: 0991-AB58
_______________________________________________________________________
Department of Health and Human Services (HHS)          Final Rule Stage
Substance Abuse and Mental Health Services Administration (SAMHSA)
_______________________________________________________________________

122. OPIOID DRUGS IN MAINTENANCE OR DETOXIFICATION TREATMENT OF OPIATE 
ADDICTION (SECTION 610 REVIEW)

Legal Authority: 21 USC 823 (9); 42 USC 257a; 42 USC 290aa(d); 42 USC 
290dd-2; 42 USC 300xx-23; 42 USC 300x-27(a); 42 USC 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                    09/00/10

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

RIN: 0930-AA14
_______________________________________________________________________
Department of Health and Human Services (HHS)         Long-Term Actions
Substance Abuse and Mental Health Services Administration (SAMHSA)
_______________________________________________________________________

123. REQUIREMENTS GOVERNING THE USE OF SECLUSION AND RESTRAINT IN 
CERTAIN NONMEDICAL COMMUNITY-BASED FACILITIES FOR CHILDREN AND YOUTH

Legal Authority: PL 106-310, 42 USC 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, 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

RIN: 0930-AA10

[[Page 21787]]

_______________________________________________________________________
Department of Health and Human Services (HHS)       Proposed Rule Stage
Centers for Disease Control and Prevention (CDC)
_______________________________________________________________________

124. CONTROL OF COMMUNICABLE DISEASES: FOREIGN QUARANTINE REGULATIONS, 
PROPOSED REVISION OF HHS/CDC ANIMAL IMPORTATION REGULATIONS

Legal Authority: 42 USC 264

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. The Secretary has designated 
the authority to prevent the introduction of diseases from foreign 
countries to the Director, Centers for Disease Control and Prevention 
(CDC). CDC also enforces entry requirements for certain animals, 
etiologic agents, and vectors deemed to be of public health 
significance. Currently the regulations restrict the importation of 
nonhuman primates, dogs, cats, small turtles, etiologic agents, hosts, 
and vectors, such as bats (42 CFR sections 71.53, 71.51, 71.52, 71.54). 
In addition, CDC has recently issued a series of emergency orders 
restricting the importation of African rodents (42 CFR section 71.56) 
and civets (67 FR 3364-01). CDC is issuing this Notice of Proposed 
Rulemaking (NPRM) to revise the regulations for importation of certain 
animals and vectors into the United States (42 CFR parts 71, subpart 
F).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           07/31/07                    72 FR 41676
ANPRM Comment Period End        10/01/07
Notice Extending ANPRM Comment 
Period                          10/01/07                    72 FR 55729
ANPRM Extended Comment Period 
End                             12/01/07
NPRM                            11/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Stacy Howard, Department of Health and Human Services, 
Centers for Disease Control and Prevention, MS E03, CLFT Building 16, 
Room 4324, Atlanta, GA 30329
Phone: 404 498-1600
Email: showard@cdc.gov

RIN: 0920-AA14
_______________________________________________________________________

125. CONTROL OF COMMUNICABLE DISEASES: FOREIGN QUARANTINE REGULATIONS, 
NONHUMAN PRIMATE

Legal Authority: 42 USC 264

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. The Secretary has delegated 
the authority to prevent the introduction of diseases from foreign 
countries to the Director, CDC. CDC also enforces entry requirements 
for certain animals, etiologic agents, and vectors deemed to be of 
public health significance. CDC is proposing to amend its regulations 
related to the importation of live nonhuman primates (NHPs) by 
extending existing requirements for the importation of cynomolgus, 
African green, and rhesus monkeys to all NHPs. The agency also is 
proposing to reduce the frequency at which importers of the three 
species are required to renew their registrations (from every 180 days 
to every 2 years). CDC proposes to incorporate existing guidelines into 
the regulations and add new provisions to address NHPs imported as part 
of a circus or trained animal act, NHPs imported by zoological 
societies, the transfer of NHPs from approved laboratories, and non-
live imported NHP products. CDC is also proposing that all NHPs be 
imported only through ports of entry where a CDC quarantine station is 
located.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Stacy Howard, Department of Health and Human Services, 
Centers for Disease Control and Prevention, MS E03, CLFT Building 16, 
Room 4324, Atlanta, GA 30329
Phone: 404 498-1600
Email: showard@cdc.gov

RIN: 0920-AA23
_______________________________________________________________________

126. TOTAL INWARD LEAKAGE REQUIREMENTS FOR RESPIRATORS

Legal Authority: 29 USC 651 et seq; 29 USC 657(g); 30 USC 3; 30 USC 7; 
30 USC 811; 30 USC 842(h) and 844

Abstract: The Centers for Disease Control and Prevention (CDC) proposes 
to establish total inward leakage (TIL) requirements under 42 CFR part 
84 for half-mask air-purifying particulate respirators approved by the 
National Institute for Occupational Safety and Health (NIOSH) of CDC.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/30/09                    74 FR 66935
NPRM Comment Period End         12/29/09
NPRM Comment Period Reopened    04/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: William E. Newcomb, Physical Scientist, Department of 
Health and Human Services, Centers for Disease Control and Prevention, 
626 Cochran Mill Road, PO Box 18070, Pittsburgh, PA 15236
Phone: 412 386-5200

RIN: 0920-AA33
_______________________________________________________________________
Department of Health and Human Services (HHS)          Final Rule Stage
Centers for Disease Control and Prevention (CDC)
_______________________________________________________________________

127. QUALITY ASSURANCE REQUIREMENTS FOR RESPIRATORS

Legal Authority: 29 USC 651 et seq; 30 USC 3; 30 USC 5; 30 USC 7; 30 
USC 811; 30 USC 842(h); 30 USC 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.

[[Page 21788]]

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 End04/10/09
NPRM Comment Period Reopening 
Extended                        05/21/09                    74 FR 23815
NPRM Comment Period End         10/09/09
Final Action                    12/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: William E. Newcomb, Physical Scientist, Department of 
Health and Human Services, Centers for Disease Control and Prevention, 
626 Cochran Mill Road, PO Box 18070, Pittsburgh, PA 15236
Phone: 412 386-5200

RIN: 0920-AA04
_______________________________________________________________________

128. CONTROL OF COMMUNICABLE DISEASES: FOREIGN QUARANTINE

Legal Authority: 42 USC 243; 42 USC 248 and 249

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. Quarantine regulations are 
divided into two parts: Part 71 dealing with foreign arrivals and part 
70 dealing with 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 rule will also modify current Federal regulations 
governing the apprehension, quarantine isolation, and conditional 
release of individuals suspected of carrying a quarantinable disease, 
while respecting individual autonomy. CDC maintains quarantine stations 
at 20 ports of entry staffed with medical and public health officers 
who respond to reports of diseases from carriers. According to the 
statutory scheme, the President determines through Executive Order 
which diseases may subject individuals to quarantine. The current 
disease list, which was last updated in April 2005, includes cholera, 
diphtheria, tuberculosis, plague, smallpox, yellow fever, viral 
hemorrhagic fevers, severe acute respiratory syndrome (SARS), and 
influenza caused by novel or reemergent influenza viruses that are 
causing, or have the potential to cause a pandemic.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/30/05                    70 FR 71892
NPRM Comment Period End         01/20/06
Final Action                    11/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Stacy Howard, Department of Health and Human Services, 
Centers for Disease Control and Prevention, MS E03, CLFT Building 16, 
Room 4324, Atlanta, GA 30329
Phone: 404 498-1600
Email: showard@cdc.gov

RIN: 0920-AA12
_______________________________________________________________________
Department of Health and Human Services (HHS)         Long-Term Actions
Centers for Disease Control and Prevention (CDC)
_______________________________________________________________________

129. POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS: CHAPARE 
VIRUS (SECTION 610 REVIEW)

Legal Authority: PL 107-188

Abstract: The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 authorizes the HHS Secretary to regulate the 
possession, use, and transfer of select agents and toxins that have the 
potential to pose a severe threat to public health and safety. These 
regulations are set forth at 42 CFR 73. Criteria used to determine 
whether a select agent or toxin should be included under the provisions 
of these regulations are based on: 1) The effect on human health as a 
result of exposure to the agent or toxin, 2) the degree of 
contagiousness of the agent or toxin, 3) the methods by which the agent 
or toxin is transferred to humans, 4) the availability and 
effectiveness of pharmacotherapies and immunizations to treat and 
prevent and illness resulting from infection by the agent or toxin, and 
5) any other criteria, including the needs of children and other 
vulnerable populations that the HHS Secretary considers appropriate. 
Based on these criteria, we are proposing to amend the list of HHS 
select agents and toxins by adding Chapare virus to the list. After 
consulting with subject matter experts from CDC, the National 
Institutes of Health (NIH), the Food Drug Administration (FDA), the 
United States Department of Agriculture (USDA) /Animal and Plant Health 
Inspection Service (APHIS), USDA/Agricultural Research Service (ARS), 
USDA/CVB (Center for Veterinary Biologics), and the Department of 
Defense (DOD)/United States Army Medical Research Institute for 
Infectious Diseases (USAMRIID) and review of relevant published 
studies, we believe the Chapare virus should be added to the list of 
HHS select agents and toxins based on our conclusion that the Chapare 
virus has been phylogenetically identified as a Clade B arenavirus and 
is closely related to other South American arenaviruses that cause 
haemorrhagic fever, particularly Sabia virus.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/19/09                      74 FR 159
NPRM Comment Period End         10/19/09
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: No

Agency Contact: Robbin Weyant, Department of Health and Human Services, 
Centers for Disease Control and Prevention, CLFT Building 20, Room 
4202, 1600 Clifton Road NE., Atlanta, GA 30333
Phone: 404 718-2000

RIN: 0920-AA32

[[Page 21789]]

_______________________________________________________________________
Department of Health and Human Services (HHS)         Completed Actions
Centers for Disease Control and Prevention (CDC)
_______________________________________________________________________

130. CONTROL OF COMMUNICABLE DISEASES: INTERSTATE QUARANTINE, PASSENGER 
INFORMATION

Legal Authority: 25 USC 198.231; 25 USC 1661; 42 USC 243; 42 USC 248; 
42 USC 249; 42 USC 264; 42 USC 266 to 268; 42 USC 270 to 272; 42 USC 
2001

Abstract: By statute, the Secretary of Health and Human Services has 
broad authority to prevent introduction, transmission, and spread of 
communicable diseases from one State or possession into another. 
Quarantine regulations are divided into two parts: Part 71 dealing with 
foreign arrivals and part 70 dealing with interstate matters. The CDC 
Director has been delegated the responsibility for carrying out these 
regulations. The Director's authority to investigate suspected cases 
and potential spread of communicable disease among interstate travelers 
is thus not limited to those known or suspected of having a 
quarantinable disease, but rather all communicable diseases that may 
necessitate a public health response.
Among the fundamental components of the public health response to the 
report of a person with a communicable disease is the identification 
and evaluation of individuals who may have been exposed. This 
provision, which was proposed section 70.4, would require any airline 
operating in interstate traffic to solicit and electronically submit 
certain passenger information to CDC for use in contact tracing when 
necessary to protect the vital interests of an individual, or other 
persons, in regard to significant health risks.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/30/05                    70 FR 71892
NPRM Comment Period End         01/30/06
Merged With 0920-AA22           02/12/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Stacy Howard, Department of Health and Human Services, 
Centers for Disease Control and Prevention, MS E03, CLFT Building 16, 
Room 4324, Atlanta, GA 30329
Phone: 404 498-1600
Email: showard@cdc.gov

RIN: 0920-AA27
_______________________________________________________________________
Department of Health and Human Services (HHS)             Prerule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________

131. FOOD LABELING: SAFE HANDLING STATEMENTS, LABELING OF SHELL EGGS; 
REFRIGERATION OF SHELL EGGS HELD FOR RETAIL DISTRIBUTION (SECTION 610 
REVIEW)

Legal Authority: 15 USC 1453 to 1455; 21 USC 321; 21 USC 331; 21 USC 
342 and 343; 21 USC 348; 21 USC 371; 42 USC 243; 42 USC 264; 42 USC 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 sections 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. FDA is undertaking a review of 21 CFR sections 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 sections 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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review                    12/15/09
End Review                      12/00/10

Regulatory Flexibility Analysis Required: Undetermined

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
Email: geraldine.june@fda.hhs.gov

RIN: 0910-AG06
_______________________________________________________________________

132. PRESCRIPTION DRUG MARKETING ACT OF 1987; PRESCRIPTION DRUG 
AMENDMENTS OF 1992; POLICIES, REQUIREMENTS, AND ADMINISTRATIVE 
PROCEDURES (SECTION 610 REVIEW)

Legal Authority: 21 USC 331; 21 USC 333; 21 USC 351; 21 USC 352; 21 USC 
353; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 381

Abstract: FDA is undertaking a review of 21 CFR part 203 and 21 CFR 
sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) under 
section 610 of the Regulatory Flexibility Act. The purpose of this 
review is to determine whether the regulations in 21 CFR part 203 and 
21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) 
should be continued without change, or whether they should be amended 
or rescinded, consistent with the stated objectives of applicable 
statutes, to minimize adverse impacts on a substantial number of small 
entities. FDA will consider, and is soliciting comments on, the 
following:

[[Page 21790]]

(1) The continued need for the regulations in 21 CFR part 203 and 21 
CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763); 
(2) the nature of complaints or comments received from the public 
concerning the regulations in 21 CFR part 203 and 21 CFR sections 205.3 
and 205.50 (as amended in 64 FR 67762 and 67763); (3) the complexity of 
the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 
(as amended in 64 FR 67762 and 67763); (4) the extent to which the 
regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as 
amended in 64 FR 67762 and 67763) overlap, duplicate, or conflict with 
other Federal rules, and to the extent feasible, with State and local 
governmental rules; and (5) the degree to which technology, economic 
conditions, or other factors have changed in the area affected by the 
regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as 
amended in 64 FR 67762 and 67763).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review of Current 
Regulation                      11/24/08
End Review of Current Regulation06/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Howard Muller, Office of Regulatory Policy, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, WO 51, Room 6234, 10903 New Hampshire 
Avenue, Silver Spring, MD 20993-0002
Phone: 301 796-3601
Fax: 301 847-8440
Email: pdma610(c)review@fda.hhs.gov

RIN: 0910-AG14
_______________________________________________________________________

133. STERILITY REQUIREMENT FOR AQUEOUS-BASED DRUG PRODUCTS FOR ORAL 
INHALATION (SECTION 610 REVIEW)

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 
21 USC 358; 21 USC 360e; 21 USC 371; 21 USC 374; 21 USC 375

Abstract: FDA is undertaking a review of 21 CFR 200.51, under section 
610 of the Regulatory Flexibility Act. The purpose of this review is to 
determine whether this regulation on aqueous-based drug products for 
oral inhalation should be continued without change, or whether it 
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 will consider, and is soliciting comments 
on the following: (1) The continued need for 21 CFR 200.51; (2) the 
nature of complaints or comments received concerning 21 CFR 200.51; (3) 
the complexity of 21 CFR 200.51; (4) the extent to which the regulation 
overlaps, duplicates, or conflicts with other Federal, State, or 
governmental rules; and (5) the degree to which technology, economic 
conditions, or other factors have changed in the area affected by 21 
CFR 200.51.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review                    05/01/09
End Review                      05/00/10

Regulatory Flexibility Analysis Required: No

Agency Contact: Howard P. Muller, Office of Regulatory Policy, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Drug Evaluation and Research, WO 51, Room 6234, 10903 New 
Hampshire Avenue, Silver Spring, MD 20993-0002
Phone: 301 796-3601
Fax: 301 847-8440
Email: howard.mullerjr@fda.hhs.gov

RIN: 0910-AG25
_______________________________________________________________________

134. REGULATIONS RESTRICTING THE SALE AND DISTRIBUTION OF CIGARETTES AND 
SMOKELESS TOBACCO TO PROTECT CHILDREN AND ADOLESCENTS

Legal Authority: 21 USC 301 et seq, The Federal Food, Drug, and 
Cosmetic Act; PL 111-31, Family Smoking Prevention and Tobacco Control 
Act

Abstract: This rule establishes regulations restricting the sale and 
distribution of cigarettes and smokeless tobacco to children and 
adolescents, implementing section 102 of the Family Smoking Prevention 
and Tobacco Control Act (FSPTCA). FSPTCA sections 102 and 6(c)(1) 
require the Secretary to publish, within 270 days of enactment, a final 
rule regarding cigarettes and smokeless tobacco. This final rule must 
be identical, except for several changes identified in section 
102(a)(2) of FSPTCA, to part 897 of the regulations promulgated by the 
Secretary of HHS in the August 28, 1996, issue of the Federal Register 
(61 FR 44396).
This final rule prohibits the sale of cigarettes and smokeless tobacco 
to individuals under the age of 18 and requires manufacturers, 
distributors, and retailers to comply with certain conditions regarding 
access to, and promotion of, these products. Among other things, the 
final rule requires retailers to verify a purchaser's age by 
photographic identification. It also prohibits, with limited exception, 
free samples and prohibits the sale of these products through vending 
machines and self-service displays except in facilities where 
individuals under the age of 18 are not present or permitted at any 
time. The rule also limits the advertising and labeling to which 
children and adolescents are exposed. The rule accomplishes this by 
generally restricting advertising to which children and adolescents are 
exposed to a black-and-white, text-only format. The rule also prohibits 
the sale or distribution of brand-identified promotional, non-tobacco 
items such as hats and tee shirts. Furthermore, the rule prohibits 
sponsorship of sporting and other events, teams, and entries in a brand 
name of a tobacco product, but permits such sponsorship in a corporate 
name.
FDA will also publish in the same issue of the Federal Register an 
advance notice of proposed rulemaking requesting comments, data, 
research, or other information on the regulation of outdoor advertising 
of cigarettes and smokeless tobacco.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           03/19/10                    75 FR 13241
Final Rule                      03/19/10                    75 FR 13225
ANPRM Comment Period End        05/18/10
Final Rule Effective            06/22/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Annette L. Marthaler, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, 9200 Corporate 
Boulevard, 100K, Rockville, MD 20850
Phone: 877 287-1373
Fax: 240 276-3904
Email: annette.marthaler@fda.hhs.gov

RIN: 0910-AG33

[[Page 21791]]

_______________________________________________________________________

135. OVER-THE-COUNTER HUMAN DRUGS; LABELING REQUIREMENTS (SECTION 610 
REVIEW)

Legal Authority: 5 USC 610

Abstract: Part 201.66 (21 CFR section 201.66) established a 
standardized format for the labeling of OTC drug products that 
included: (1) Specific headings and subheadings presented in a 
standardized order, (2) standardized graphical features such as 
Helvetica type style and the use of ``bullet points'' to introduce key 
information, and (3) minimum standards for type size and spacing. FDA 
issued the final rule to improve labeling after considering comments 
submitted to the agency following the publication of the proposed 
regulation in 1997. In 1999, FDA published the final rule and stated 
that a standardized labeling format would significantly improve 
readability by familiarizing consumers with the types of information in 
OTC drug product labeling and the location of that information. In 
addition, a standardized appearance and standardized content, including 
various ``user-friendly'' visual cues, would help consumers locate and 
read important health and safety information and allow quick and 
effective product comparisons, thereby helping consumers to select the 
most appropriate product.
FDA is initiating a review under section 610 of the Regulatory 
Flexibility Act for the regulation in part 201.66. The purpose of this 
review is to determine whether the regulation in part 201.66 should be 
continued without change, or whether it should be further 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 regulation in part 201.66; 
(2) the nature of the complaints or comments received concerning the 
regulation in part 201.66; (3) the complexity of the regulations in 
part 201.66; (4) the extent to which the regulations in part 201.66 
overlap, duplicate, or conflict with other Federal, State, or 
governmental rules; and (5) the degree to which technology, economic 
conditions, or other factors have changed for the products still 
subject to the labeling standard regulations in part 201.
The section 610 review will be carried out along with a regulatory 
review under section 5 of Executive Order 12866, which calls for 
agencies to periodically review existing regulations to determine 
whether any should be modified or eliminated so as to make the agency's 
regulatory program more effective in achieving its goals, less 
burdensome, or in greater alignment with the President's priorities and 
the principles set forth in the Executive order.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review of Current 
Regulation                      08/03/09
End Review of Current Regulation05/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, 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: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AG34
_______________________________________________________________________
Department of Health and Human Services (HHS)       Proposed Rule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________

136. ELECTRONIC SUBMISSION OF DATA FROM STUDIES EVALUATING HUMAN DRUGS 
AND BIOLOGICS

Legal Authority: 21 USC 355; 21 USC 371; 42 USC 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                            10/00/10

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
_______________________________________________________________________

137. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (ANTIHISTAMINE) 
PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 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 antihistamine labeling claims for the common cold.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Reopening of Administrative 
Record                          08/25/00                    65 FR 51780
NPRM (Amendment) (Common Cold)  03/00/11

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug

[[Page 21792]]

Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue, 
Silver Spring, MD 20993
Phone: 301 796-2090
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF31
_______________________________________________________________________

138. OVER-THE-COUNTER (OTC) DRUG REVIEW--INTERNAL ANALGESIC PRODUCTS

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 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 and Other Labeling)

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