Department of Health and Human Services Semiannual Regulatory Agenda, 21919-21941 [E9-10274]

Download as PDF Monday, May 11, 2009 Part VI Department of Health and Human Services Semiannual Regulatory Agenda VerDate Nov<24>2008 07:57 May 08, 2009 Jkt 217001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\11MYP6.SGM 11MYP6 21920 Federal Register / Vol. 74, No. 89 / Monday, May 11, 2009 / Unified Agenda 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, Chs. II, III, and XIII Unified Agenda of Federal Regulatory and Deregulatory Actions AGENCY: ACTION: Office of the Secretary, HHS. Semiannual regulations agenda. SUMMARY: The Department’s semiannual Agenda of Regulatory and Deregulatory Actions forecasts the rulemaking activities that we expect to undertake over the foreseeable future. We focus primarily on those areas of work anticipated to result in publication of Notices of Proposed Rulemaking or of Final Rules within the next 12 months. (Please note that the abstracts included below relate only to those prospective rulemakings that are likely to have a significant economic impact on a substantial number of small entities; the Regulatory Flexibility Act of 1980 requires dissemination of this information in the paper edition of the Federal Register. The complete HHS Agenda is accessible online at www.reginfo.gov.) FOR FURTHER INFORMATION CONTACT: by e-mail, John.Gallivan@hhs.gov; by fax, (202) 205-2135; by telephone, (202) 2059165. SUPPLEMENTARY INFORMATION: The Regulatory Flexibility Act of 1980 and Executive Order 12866 require semi-annual publication of an inventory outlining all current and projected rulemakings. The purpose of this exercise is to inform the public about regulatory actions under development across the Department, and to provide an opportunity for all concerned with the impact of these actions to participate in their development at an early stage. The regulatory actions capsulized in this Agenda do not necessarily reflect the policy perspectives of the Obama Administration. The statutorily dictated timing of the Agenda caused the Department to initiate preparation of the requisite information before the Department’s policy officials had the opportunity to conduct a full review. This Agenda thus reflects ongoing efforts by HHS to comply with existing statutory obligations, or to effect improvements at the programimplementation level based on experience in administering existing programs. By contrast, the timing of the October 2009 Agenda will, obviously, provide the Department with an opportunity to set out a regulatory agenda that does reflect current policy directions of the Obama Administration. Public commentary is invited. Comments may be directed to the agency officials cited at the conclusion of each entry. If early attention at the Secretary’s level appears needed, comments should be sent to: Ashley Files Flory, Acting Executive Secretary to the Department, Suite 603H, 200 Independence Avenue SW., Washington, DC 20201. Dated: April 3, 2009. Ashley Files Flory, Acting Executive Secretary to the Department. Substance Abuse and Mental Health Services Administration—Proposed Rule Stage Sequence Number Title Regulation Identifier Number 147 Opioid Drugs in Maintenance or Detoxification Treatment of Opiate Addition (Section 610 Review) ....................... 0930–AA14 Substance Abuse and Mental Health Services Administration—Long-Term Actions Regulation Identifier Number Sequence Number Title 148 Requirements Governing the Use of Seclusion and Restraint in Certain Nonmedical Community-Based Facilities for Children and Youth ................................................................................................................................................ 0930–AA10 Centers for Disease Control and Prevention—Proposed Rule Stage Regulation Identifier Number Sequence Number Title 149 150 Foreign Quarantine Regulations, Proposed Revision of HHS/CDC Animal Importation Regulations ......................... Control of Communicable Diseases: Foreign Quarantine Regulations, Proposed Revision of HHS/CDC Nonhuman Primate Regulations .................................................................................................................................................... VerDate Nov<24>2008 07:57 May 08, 2009 Jkt 217001 PO 00000 Frm 00002 Fmt 1254 Sfmt 1254 E:\FR\FM\11MYP6.SGM 11MYP6 0920–AA14 0920–AA23 Federal Register / Vol. 74, No. 89 / Monday, May 11, 2009 / Unified Agenda 21921 HHS Centers for Disease Control and Prevention—Final Rule Stage Sequence Number Title Regulation Identifier Number 151 152 Control of Communicable Diseases Foreign Quarantine ............................................................................................. Control of Communicable Diseases: Interstate Quarantine, Passenger Information ................................................... 0920–AA12 0920–AA27 Centers for Disease Control and Prevention—Long-Term Actions Sequence Number Title Regulation Identifier Number 153 Possession, Use and Transfer of Select Agents and Toxins (Section 610 Review) .................................................. 0920–AA32 Food and Drug Administration—Prerule Stage Regulation Identifier Number Sequence Number Title 154 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) ...................................................................................................... 155 0910–AG06 0910–AG14 Food and Drug Administration—Proposed Rule Stage Regulation Identifier Number Sequence Number Title 156 157 158 159 160 161 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—Laxative Drug Products ............................................................................... Over-The-Counter (OTC) Drug Review—Sunscreen Products .................................................................................... Over-The-Counter (OTC) Drug Review—Weight Control Products ............................................................................. Pediatric Dosing for Cough, Cold, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-The-Counter Human Use; Proposed Amendment of Final Monograph ........................................................................................... 0910–AC52 0910–AF31 0910–AF38 0910–AF43 0910–AF45 0910–AG12 Food and Drug Administration—Final Rule Stage Regulation Identifier Number Sequence Number Title 162 163 164 165 Prevention of Salmonella Enteritidis in Shell Eggs ....................................................................................................... Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements ................................... Positron Emission Tomography Drugs; Current Good Manufacturing Practices ......................................................... Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling ........................................................................................................................................................ Over-The-Counter (OTC) Drug Review—Cough/Cold (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—Internal Analgesic Products ......................................................................... Over-the-Counter (OTC) Drug Review—Skin Protectant Products .............................................................................. Substances Prohibited From Use in Animal Food or Feed To Prevent the Transmission of Bovine Spongiform Encephalopathy ........................................................................................................................................................... Use of Materials Derived From Cattle in Human Food and Cosmetics ....................................................................... Label Requirement for Food That Has Been Refused Admission Into the United States ........................................... Over-The-Counter (OTC) Drug Review—Acne Drug Products Containing Benzoyl Peroxide .................................... 166 167 168 169 170 171 172 173 174 VerDate Nov<24>2008 07:57 May 08, 2009 Jkt 217001 PO 00000 Frm 00003 Fmt 1254 Sfmt 1254 E:\FR\FM\11MYP6.SGM 11MYP6 0910–AC14 0910–AC53 0910–AC55 0910–AF11 0910–AF32 0910–AF33 0910–AF35 0910–AF36 0910–AF42 0910–AF46 0910–AF47 0910–AF61 0910–AG00 21922 Federal Register / Vol. 74, No. 89 / Monday, May 11, 2009 / Unified Agenda HHS Food and Drug Administration—Long-Term Actions Regulation Identifier Number Sequence Number Title 175 176 Postmarketing Safety Reporting Requirements for Human Drug and Biological Products .......................................... Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements ...................................................................................................................................................................... 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—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—Poison Treatment Drug Products ................................................................ Over-The-Counter (OTC) Drug Review—Topical Antimicrobial Drug Products ........................................................... Over-The-Counter (OTC) Drug Review—Urinary Analgesic Drug Products ................................................................ Status of Certain Additional Over-the-Counter Drug Category II Active Ingredients ................................................... Process Controls for Animal Feed Ingredients and Mixed Animal Feed ...................................................................... 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 0910–AA97 0910–AB88 0910–AF34 0910–AF37 0910–AF39 0910–AF40 0910–AF44 0910–AF51 0910–AF52 0910–AF53 0910–AF56 0910–AF63 0910–AF68 0910–AF69 0910–AF70 0910–AF95 0910–AG10 Food and Drug Administration—Completed Actions Regulation Identifier Number Sequence Number Title 192 193 194 Requirements for Submission of In Vivo Bioequivalence Data .................................................................................... Cochineal Extract and Carmine Label Declaration ....................................................................................................... Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex ...................................................................................................................................................................... Food Labeling; Serving Sizes and Nutrition Labeling (Completion of a Section 610 Review) ................................. 195 0910–AC23 0910–AF12 0910–AF21 0910–AF99 Centers for Medicare & Medicaid Services—Proposed Rule Stage Regulation Identifier Number Sequence Number Title 196 197 198 Changes to the Hospital Inpatient and Long-Term Care Prospective Payment System for FY 2010 (CMS-1406-P) Revisions to Payment Policies Under the Physician Fee Schedule For CY 2010 (CMS-1413-P) .............................. Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System for CY 2010 (CMS-1414-P) .................................................................................................................................. Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities—Update for FY 2010 (CMS1410-P) ........................................................................................................................................................................ 199 0938–AP39 0938–AP40 0938–AP41 0938–AP46 Centers for Medicare & Medicaid Services—Long-Term Actions Sequence Number Title Regulation Identifier Number 200 201 202 203 204 Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610 Review) .................... Electronic Claims Attachments Standards (CMS-0050-IFC) ........................................................................................ Home and Community-Based Services (HCBS) State Plan Option (CMS-2249-F) (Section 610 Review) ............... Medicaid Graduate Medical Education (CMS-2279-F) ................................................................................................. Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-P) (Section 610 Review) .................... 0938–AG81 0938–AK62 0938–AO53 0938–AO95 0938–AP32 VerDate Nov<24>2008 07:57 May 08, 2009 Jkt 217001 PO 00000 Frm 00004 Fmt 1254 Sfmt 1254 E:\FR\FM\11MYP6.SGM 11MYP6 21923 Federal Register / Vol. 74, No. 89 / Monday, May 11, 2009 / Unified Agenda HHS Centers for Medicare & Medicaid Services—Completed Actions Regulation Identifier Number Sequence Number Title 205 206 207 Updates to Electronic Transactions (Version 5010) (CMS-0009-F) (Completion of a Section 610 Review) ........... Revisions to HIPAA Code Sets (CMS-0013-F) (Completion of a Section 610 Review) .......................................... Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (CMS-6006-F) (Completion of a Section 610 Review) ......................................................................... Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System for CY 2009 (CMS-1404-F) .................................................................................................................................. Revisions to Payment Policies Under the Physician Fee Schedule for CY 2009 (CMS-1403-FC) ............................. Home Health Prospective Payment System Refinements and Rate Update for CY 2009 (CMS-1555-N) ................. Changes to Long-Term Care Prospective Payment System Based on Specific Provisions in the Medicare, Medicaid, and SCHIP Extension Act of 2007 (CMS-1493-F) ............................................................................................ 208 209 210 211 Department of Health and Human Services (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) 147. OPIOID DRUGS IN MAINTENANCE OR DETOXIFICATION TREATMENT OF OPIATE ADDITION (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 dispensing restrictions under 42 CFR part 8 for the drug substance buprenorphine. This medication is used to treat kersin and other opioid addiction. Timetable: Action NPRM Abstract: This proposed rule, when finalized will modify the regulatory Date FR Cite 09/00/09 149. FOREIGN QUARANTINE REGULATIONS, PROPOSED REVISION OF HHS/CDC ANIMAL IMPORTATION REGULATIONS Jkt 217001 0938–AP33 Regulatory Flexibility Analysis Required: No Agency Contact: Nicholas Reuter, Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, One Choke Cherry Rd, Suite 2–1063, Rockville, MD 20857 Phone: 240 276–2716 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 FR Cite To Be Determined Department of Health and Human Services (HHS) Centers for Disease Control and Prevention (CDC) 07:57 May 08, 2009 0938–AP17 0938–AP18 0938–AP20 RIN: 0930–AA14 148. 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 0938–AO84 Proposed Rule Stage Department of Health and Human Services (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) Legal Authority: Not Yet Determined 0938–AM50 0938–AN25 Proposed Rule Stage Abstract: By statute, the Secretary of Health and Human Services has broad authority to prevent introduction, transmission, and spread of communicable diseases from foreign PO 00000 Frm 00005 Fmt 1254 Sfmt 1254 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 E:\FR\FM\11MYP6.SGM 11MYP6 21924 Federal Register / Vol. 74, No. 89 / Monday, May 11, 2009 / Unified Agenda HHS—CDC Proposed Rule Stage 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 Unite States (42 CFR parts 71, Subpart F). Timetable: Action Date ANPRM Notice Extending ANPRM Comment Period NPRM FR Cite 07/31/07 72 FR 41676 10/01/07 72 FR 55729 12/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Stacy Howard, Department of Health and Human Services, Centers for Disease Control and Prevention, CLFT Building 16, Room 4324, MS E03, Atlanta, GA 30329 Phone: 404 498–1600 RIN: 0920–AA14 150. CONTROL OF COMMUNICABLE DISEASES: FOREIGN QUARANTINE REGULATIONS, PROPOSED REVISION OF HHS/CDC NONHUMAN PRIMATE REGULATIONS Legal Authority: 42 U.S.C. 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 two 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 12/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Stacy Howard, Department of Health and Human Services, Centers for Disease Control and Prevention, CLFT Building 16, Room 4324, MS E03, Atlanta, GA 30329 Phone: 404 498–1600 RIN: 0920–AA23 Department of Health and Human Services (HHS) Centers for Disease Control and Prevention (CDC) 151. 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 VerDate Nov<24>2008 07:57 May 08, 2009 Jkt 217001 FR Cite Final Rule Stage 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 Timetable: Action Date NPRM Final Action FR Cite 11/30/05 70 FR 71892 09/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Stacy Howard, Department of Health and Human Services, Centers for Disease Control and Prevention, CLFT Building 16, Room 4324, MS E03, Atlanta, GA 30329 Phone: 404 498–1600 RIN: 0920–AA12 disease list, which was last updated in April 2005, includes cholera, diphtheria, tuberculosis, plague, smallpox, yellow fever, viral hemorrhagic fevers, severe acute 152. CONTROL OF COMMUNICABLE DISEASES: INTERSTATE QUARANTINE, PASSENGER INFORMATION respiratory syndrome (SARS), and influenza caused by novel or reemergent influenza viruses that are causing, or have the potential to cause a pandemic. 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 PO 00000 Frm 00006 Fmt 1254 Sfmt 1254 E:\FR\FM\11MYP6.SGM 11MYP6 21925 Federal Register / Vol. 74, No. 89 / Monday, May 11, 2009 / Unified Agenda HHS—CDC Final Rule Stage 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. persons, in regard to significant health risks. 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 Action Timetable: Date NPRM Final Action Regulatory Flexibility Analysis Required: Yes Agency Contact: Stacy Howard, Department of Health and Human Services, Centers for Disease Control and Prevention, CLFT Building 16, Room 4324, MS E03, Atlanta, GA 30329 Phone: 404 498–1600 RIN: 0920–AA27 Department of Health and Human Services (HHS) Centers for Disease Control and Prevention (CDC) 153. ∑ POSSESSION, USE AND TRANSFER OF SELECT AGENTS AND TOXINS (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 reuslt 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 Long-Term Actions to treat and prevent andy 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 NPRM 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 VerDate Nov<24>2008 07:57 May 08, 2009 Jkt 217001 To Be Determined 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 Prerule Stage 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) provides that part 16 does not apply to a hearing on an order for relabeling, diversion, or destruction if PO 00000 Frm 00007 Fmt 1254 FR Cite Regulatory Flexibility Analysis Required: No Department of Health and Human Services (HHS) Food and Drug Administration (FDA) 154. FOOD LABELING: SAFE HANDLING STATEMENTS, LABELING OF SHELL EGGS; REFRIGERATION OF SHELL EGGS HELD FOR RETAIL DISTRIBUTION (SECTION 610 REVIEW) FR Cite 11/30/05 70 FR 71892 12/00/09 Sfmt 1254 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, E:\FR\FM\11MYP6.SGM 11MYP6 21926 Federal Register / Vol. 74, No. 89 / Monday, May 11, 2009 / Unified Agenda HHS—FDA Prerule Stage 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 Begin Review End Review Date FR Cite 12/00/09 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 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 155. 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: (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 Begin Review of 11/24/08 Current Regulation End Review of Current 12/00/09 Regulation Regulatory Flexibility Analysis Required: Yes 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, 10903 New Hampshire Avenue, Bldg. 51, Room 6234, Silver Spring, MD 20993–0002 Phone: 301 796–3601 Fax: 301 847–8440 Email: howard.mullerjr@fda.hhs.gov RIN: 0910–AG14 Department of Health and Human Services (HHS) Food and Drug Administration (FDA) 156. 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 VerDate Nov<24>2008 07:57 May 08, 2009 Jkt 217001 Proposed Rule Stage 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. The proposal would also require that FDA periodically issue guidance on the use of standardized data structure, terminology, and code sets (e.g., the Study Data Tabulation Model (SDTM) developed by the Clinical Data Interchange Standards Consortium) to allow for more efficient and comprehensive data review. PO 00000 Frm 00008 Fmt 1254 FR Cite Sfmt 1254 Timetable: Action Date NPRM 09/00/09 FR Cite 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, 10903 New Hampshire Avenue, Bldg. 51, Room 6224, Silver Spring, MD 20993–0002 Phone: 301 796–3471 Fax: 301 847–8440 E:\FR\FM\11MYP6.SGM 11MYP6 21927 Federal Register / Vol. 74, No. 89 / Monday, May 11, 2009 / Unified Agenda HHS—FDA Proposed Rule Stage Email: martha.nguyen@fda.hhs.gov RIN: 0910–AC52 157. 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 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. 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 04/00/10 Regulatory Flexibility Analysis Required: Yes RIN: 0910–AF31 158. 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 07:57 May 08, 2009 Jkt 217001 Timetable: Action Date FR Cite Final Action (Granular 03/29/07 72 FR 14669 Psyllium) Final Action (Laxative To Be Determined Drug Products) NPRM (Professional 09/00/09 Labeling—Sodium Phosphate) NPRM (Professional To Be Determined Labeling) Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD–560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796–0885 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov Timetable: Action Date ANPRM (Sunscreen and Insect Repellent) ANPRM Comment Period End NPRM (UVA/UVB) NPRM Comment Period End NPRM (Time and Extent) 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 09/00/09 09/00/09 To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD–560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796–0885 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF43 RIN: 0910–AF38 Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD–560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796–0885 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov VerDate Nov<24>2008 marketed. The final action will address laxative drug products. 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. 160. OVER–THE–COUNTER (OTC) DRUG REVIEW—WEIGHT CONTROL PRODUCTS 159. 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 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. One action addresses the ingredient phenylpropanolamine, and the other actions address the ingredient benzocaine. 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 is the final action that addresses sunscreen formulation, labeling, and testing requirements for both ultraviolet B and ultraviolet A radiation protection. The third action addresses combination products containing sunscreen and insect repellent ingredients. PO 00000 Frm 00009 Fmt 1254 Sfmt 1254 Timetable: Action Date NPRM (Phenylpropanol amine) NPRM (Benzocaine) Final Action (Phenylpropanol amine) Final Action (Benzocaine) E:\FR\FM\11MYP6.SGM 11MYP6 FR Cite 12/22/05 70 FR 75988 09/00/09 05/00/10 To Be Determined 21928 Federal Register / Vol. 74, No. 89 / Monday, May 11, 2009 / Unified Agenda HHS—FDA Proposed Rule Stage Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD–560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796–0885 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF45 161. PEDIATRIC DOSING FOR COUGH, COLD, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER–THE–COUNTER HUMAN USE; PROPOSED AMENDMENT OF FINAL MONOGRAPH to address safety and efficacy issues associated with pediatric cough and cold products. Legal Authority: 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360 to 360(a); 21 USC 371 to 371(a) 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 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 Timetable: Action Date NPRM 09/00/09 Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD–560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796–0885 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AG12 Department of Health and Human Services (HHS) Food and Drug Administration (FDA) 162. PREVENTION OF SALMONELLA ENTERITIDIS IN SHELL EGGS Legal Authority: 21 USC 321; 21 USC 342; 21 USC 371; 21 USC 381; 21 USC 393; 42 USC 243; 42 USC 264; 42 USC 271; Abstract: Publication of this final rule was an action item in the Food Protection Plan announced by the Department of Health and Human Services (HHS) in November 2007. In July 1999, the Food and Drug Administration (FDA) and the Food Safety Inspection Service (FSIS) committed to developing an action plan to address the presence of Salmonella Enteritidis (SE) in shell eggs and egg products using a farm-to-table approach. FDA and FSIS held a public meeting on August 26, 1999, to obtain stakeholder input on the draft goals, as well as to further develop the objectives and action items for the action plan. The Egg Safety Action Plan was announced on December 11, 1999. The goal of the Action Plan is to reduce egg-related SE illnesses. The Egg Safety Action Plan consists of eight objectives covering all stages of the farm-to-table continuum as well as support functions. On March 30, 2000 (Columbus, OH), April 6, 2000 (Sacramento, CA), and July 31, 2000 (Washington, DC), joint public meetings were held by FDA and FSIS to solicit and discuss information related to the VerDate Nov<24>2008 07:57 May 08, 2009 Jkt 217001 Final Rule Stage implementation of the objectives in the Egg Safety Action Plan. On September 22, 2004, FDA published a proposed rule that would require egg safety measures to prevent the contamination of shell eggs with SE during egg production. The proposal also solicited comment on whether recordkeeping requirements should include a written SE prevention plan and records for compliance with the SE prevention measures, and whether safe egg handling and preparation practices should be mandated for retail establishments that specifically serve a highly susceptible population (e.g., nursing homes, hospitals, day care centers). The proposed egg production SE prevention measures included: (1) Provisions for procurement of chicks and pullets; (2) a biosecurity program; (3) a rodent and pest control program; (4) cleaning and disinfection of poultry houses that have had an environmental or egg test positive for SE; (5) egg testing when an environmental test is positive; and (6) refrigerated storage of eggs held at the farm. Additionally, to verify that the measures have been effective, the rule proposes that producers test the poultry house environment for SE. If the environmental test is positive, eggs from that environment must be tested for SE, and if the egg test is positive, the eggs must be diverted to egg products processing or a treatment PO 00000 Frm 00010 Fmt 1254 FR Cite Sfmt 1254 process that achieves at least a five-log destruction of SE. The proposed rule was a step in a broader farm-to-table egg safety effort that includes FDA’s requirements for safe handling statements on egg cartons, and refrigerated storage of shell eggs at retail, and egg safety education for consumers and retail establishments. The rule had a 90-day comment period, which ended December 21, 2004. To discuss the proposed rule and solicit comments from interested stakeholders, FDA held three public meetings: October 28, 2004, in College Park, MD; November 9, 2004, in Chicago, IL; and November 16, 2004, in Los Angeles, CA. The comment period was reopened until July 25, 2005, to solicit further comment and information on industry practices and programs that prevent SEmonitored chicks from becoming infected by SE during the period of pullet rearing until placement into laying hen houses. Timetable: Action Date NPRM NPRM Comment Period End NPRM Reopened Comment Period End E:\FR\FM\11MYP6.SGM 11MYP6 FR Cite 09/22/04 69 FR 56824 12/21/04 06/09/05 70 FR 24490 21929 Federal Register / Vol. 74, No. 89 / Monday, May 11, 2009 / Unified Agenda HHS—FDA Final Rule Stage Action Date NPRM Extension of Reopened Comment Period End Final Action FR Cite 07/25/05 70 FR 33404 07/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: John F. Sheehan, Director, Department of Health and Human Services, Food and Drug Administration, Division of Plant and Dairy Food Safety (HFS–315), Room 3B–012, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436–2367 Fax: 301 436–2632 Email: john.sheehan@fda.hhs.gov 164. POSITRON EMISSION TOMOGRAPHY DRUGS; CURRENT GOOD MANUFACTURING PRACTICES Legal Authority: PL 105–115, sec 121 163. MEDICAL GAS CONTAINERS AND CLOSURES; CURRENT GOOD MANUFACTURING PRACTICE REQUIREMENTS Legal Authority: 21 USC 321; 21 USC 351 to 21 USC 353 Abstract: The Food and Drug Administration is amending its current good manufacturing practice regulations and other regulations to clarify and strengthen requirements for the label, color, dedication, and design of medical gas containers and closures. Despite existing regulatory requirements and industry standards for medical gases, there have been repeated incidents in which cryogenic containers of harmful industrial gases have been connected to medical oxygen supply systems in hospitals and nursing homes, and subsequently administered to patients. These incidents have resulted in death and serious injury. There have also been several incidents involving highpressure medical gas cylinders that have resulted in death and injuries to patients. These amendments, together with existing regulations, are intended to ensure that the types of incidents that have occurred in the past, as well as other types of foreseeable and potentially deadly medical gas mixups, do not occur in the future. Timetable: Date NPRM NPRM Comment Period End Final Action VerDate Nov<24>2008 FR Cite 04/10/06 71 FR 18039 07/10/06 09/00/09 07:57 May 08, 2009 Jkt 217001 Agency Contact: Quynh H. Nguyen, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Bldg. 51, Room 6370, Silver Spring, MD 20993–0002 Phone: 301 796–3601 Fax: 301 847–8440 Email: quynh.h.nguyen@fda.hhs.gov RIN: 0910–AC53 RIN: 0910–AC14 Action Regulatory Flexibility Analysis Required: Yes 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 would adopt CGMPs that reflect the unique characteristics of PET drugs. Timetable: 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). Timetable: Action Date NPRM NPRM Comment Period End Final Action FR Cite 05/29/08 73 FR 30831 08/27/08 03/00/10 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, 10903 New Hampshire Ave., Bldg. 51, Room 6224, Silver Spring, MD 20993–0002 Phone: 301 796–4288 Fax: 301–847–8440 Email: rachel.bressler@fda.hhs.gov RIN: 0910–AF11 Agency Contact: Michael D. Bernstein, Supervisory Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Regulatory Policy, 10903 New Hampshire Ave., Bldg. 51, Room 6240, Silver Spring, MD 20993–0002 Phone: 301 796–3478 Fax: 301 847–8440 Email: michael.bernstein@fda.hhs.gov 166. 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 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. This action addresses labeling for single ingredient bronchodilator products. Timetable: RIN: 0910–AC55 Action 165. CONTENT AND FORMAT OF LABELING FOR HUMAN PRESCRIPTION DRUGS AND BIOLOGICS; REQUIREMENTS FOR PREGNANCY AND LACTATION LABELING NPRM (Amendment— 07/13/05 70 FR 40237 Ephedrine Single Ingredient) Final Action (Technical 11/30/07 72 FR 63679 Amendment) Final Action 09/00/09 (Amendment— Ephedrine Single Ingredient) Action Date NPRM NPRM Comment Period End Final Action FR Cite 09/20/05 70 FR 55038 12/19/05 08/00/09 Regulatory Flexibility Analysis Required: Yes 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; PO 00000 Frm 00011 Fmt 1254 Sfmt 1254 Date FR Cite Regulatory Flexibility Analysis Required: Yes E:\FR\FM\11MYP6.SGM 11MYP6 21930 Federal Register / Vol. 74, No. 89 / Monday, May 11, 2009 / Unified Agenda HHS—FDA Final Rule Stage Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD–560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796–0885 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF32 167. 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 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 technical amendment revises a paragraph designation in the CFR. The other action finalizes cough/cold combination products containing oral bronchodilators and expectorants. Timetable: Action Date FR Cite NPRM (Amendment) 07/13/05 70 FR 40232 Final Action (Technical 03/19/07 72 FR 12730 Amendment) Final Action 09/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD–560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796–0885 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF33 168. 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 VerDate Nov<24>2008 07:57 May 08, 2009 Jkt 217001 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 12/00/09 To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD–560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796–0885 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF35 169. 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 products marketed for children under 2 years old and weight- and age-based dosing for children’s products. The third action addresses combination products containing the analgesic acetaminophen or aspirin and sodium PO 00000 Frm 00012 Fmt 1254 Sfmt 1254 bicarbonate used as an antacid ingredient. The fourth action addresses other miscellaneous issues relating to internal analgesics. The fifth document finalizes the document regarding the required warnings and other labeling. The last document finalizes the Internal Analgesic Products monograph. Timetable: Action Date NPRM (Amendment) (Required Warnings and Other Labeling) NPRM Comment Period End NPRM (Amendment) (Overindulgence/ Hangover) NPRM (Amendment) (Pediatric) NPRM (Amendment) (Combinations With Sodium Bicarbonate) NPRM (Amendment) (Miscellaneous Issues) Final Action (Required Warnings and Other Labeling) Final Action (Internal Analgesics) FR Cite 12/26/06 71 FR 77314 05/25/07 05/00/10 To Be Determined 05/00/10 05/00/10 05/00/09 To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD–560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796–0885 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF36 170. 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 E:\FR\FM\11MYP6.SGM 11MYP6 21931 Federal Register / Vol. 74, No. 89 / Monday, May 11, 2009 / Unified Agenda HHS—FDA Final Rule Stage skin protectant products used to treat fever blisters and cold sores. The second action addresses astringent active ingredients. The third action identifies safe and effective skin protectant active ingredients to treat and prevent diaper rash. Timetable: Action Date Timetable: Action FR Cite Final Action (Technical 02/01/08 73 FR 6014 Amendments) Final Action (Fever To Be Determined Blisters/Cold Sores) Final Action 03/06/09 74 FR 9759 (Aluminum Acetate) (Technical Amendment) Final Action (Diaper 12/00/09 Rash) Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD–560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796–0885 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF42 171. SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED TO PREVENT THE TRANSMISSION OF BOVINE SPONGIFORM ENCEPHALOPATHY Legal Authority: 21 USC 321; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 371 Abstract: On October 6, 2005, the Food and Drug Administration (FDA) proposed to amend its regulations to prohibit the use of certain cattle origin materials in the food or feed of all animals to help strengthen existing safeguards to prevent the spread of bovine spongiform encephalopathy (BSE) in U.S. cattle. The discovery of a BSE-positive dairy cow in December 2003 has caused FDA to review its policies for prevention of BSE, which resulted in this rulemaking. FDA is correcting the final rule on BSE that appeared in the Federal Register of April 25, 2008 (73 FR 22719-22758). The final rule inadvertently published with incorrect dollar amounts in two separate areas: the summary of economic impacts and the paperwork burden table. VerDate Nov<24>2008 07:57 May 08, 2009 Jkt 217001 Date ANPRM ANPRM Comment Period End NPRM NPRM Comment Period End Final Rule Final Rule–Correction Final Rule Effective FR Cite 07/14/04 69 FR 42288 08/13/04 10/06/05 70 FR 58569 12/20/05 04/25/08 73 FR 22720 10/23/08 73 FR 63072 04/27/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Burt Pritchett, Biologist, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, HFV–222, 7519 Standish Place, MPN–4, Rockville, MD 20855 Phone: 240 453–6860 Fax: 240 453–6882 Email: burt.pritchett@fda.hhs.gov RIN: 0910–AF46 172. USE OF MATERIALS DERIVED FROM CATTLE IN HUMAN FOOD AND COSMETICS Legal Authority: 21 USC 342; 21 USC 361; 21 USC 371 Abstract: On July 14, 2004, FDA issued an interim final rule (IFR), effective immediately, to prohibit the use of certain cattle material and to address the potential risk of bovine spongiform encephalopathy (BSE) in human food, including dietary supplements, and cosmetics. Prohibited cattle materials under the IFR include specified risk materials, small intestine of all cattle, material from nonambulatory disabled cattle, material from cattle not inspected and passed for human consumption, and mechanically separated (MS) beef. Specified risk materials are the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and older; and the tonsils and distal ileum of the small intestine of all cattle. Prohibited cattle materials do not include tallow that contains no more than 0.15 percent 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 PO 00000 Frm 00013 Fmt 1254 Sfmt 1254 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. On September 7, 2005, FDA amended the IFR to permit the use of small intestine in human food and cosmetics if it is effectively removed from the distal ileum. The amendment also clarified that milk and milk products, hides, and tallow derivatives are not prohibited for use in human food and cosmetics. On April 17, 2008, FDA amended the IFR so that FDA may designate a country as not subject to certain BSErelated restrictions relating to prohibited cattle materials applicable to human food and cosmetics. Comments submitted in response to the July 14, 2004 IFR that were not addressed in the September 7, 2005 and April 17, 2008 amendments will be addressed in the final rule. The final rule also will respond to comments submitted following the September 7, 2005 and April 17, 2008 amendments. Timetable: Action 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) Interim Final Rule (Amendments) Comment Period End Interim Final Rule (Amendments) Effective Final Action FR Cite 07/14/04 69 FR 42256 07/14/04 10/12/04 09/07/05 70 FR 53063 10/07/05 11/07/05 04/17/08 73 FR 20785 07/16/08 07/16/08 09/00/09 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, E:\FR\FM\11MYP6.SGM 11MYP6 21932 Federal Register / Vol. 74, No. 89 / Monday, May 11, 2009 / Unified Agenda HHS—FDA Final Rule Stage (HFS–316), 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436–2131 Fax: 301 436–2644 Email: amber.mccoig@fda.hhs.gov (the Bioterrorism Act) (Pub. L. 107188). 21 USC 360 to 360a; 21 USC 371 to 371a 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 will address acne drug products containing benzoyl peroxide. Action Date NPRM NPRM Comment Period End Final Action RIN: 0910–AF47 173. LABEL REQUIREMENT FOR FOOD THAT HAS BEEN REFUSED ADMISSION INTO THE UNITED STATES FR Cite 09/18/08 73 FR 54106 12/02/08 To Be Determined Regulatory Flexibility Analysis Required: Yes 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 Agency Contact: Kevin O. Kwon, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, (HFS–024), Room 1B–032, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436–2780 Fax: 301 436–2637 Email: kevin.kwon@fda.hhs.gov RIN: 0910–AF61 174. 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; Timetable: Action Date Final Action Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD–560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796–0885 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AG00 Department of Health and Human Services (HHS) Food and Drug Administration (FDA) 175. POSTMARKETING SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND BIOLOGICAL PRODUCTS 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 Abstract: These regulations are one component of the Secretary’s initiative to reduce medical errors. The final rule would amend the 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 VerDate Nov<24>2008 07:57 May 08, 2009 Jkt 217001 FR Cite 10/00/09 Long-Term Actions other revisions to these regulations to enhance the quality of safety reports received by FDA. Fax: 301–847–8440 Timetable: 176. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Action 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 10/14/03 To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Meredith S. Francis, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6238, Silver Spring, MD 20993–0002 Phone: 301 796–3476 PO 00000 Frm 00014 Fmt 1254 Sfmt 1254 RIN: 0910–AA97 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. The final rule (the CGMP rule) was published to establish the minimum CGMPs necessary to ensure that, if firms engage in activities related to manufacturing, packaging, labeling, or E:\FR\FM\11MYP6.SGM 11MYP6 21933 Federal Register / Vol. 74, No. 89 / Monday, May 11, 2009 / Unified Agenda HHS—FDA Long-Term Actions holding dietary supplements, they do so in a manner that will ensure the quality of the dietary supplements—i.e., to ensure that the dietary supplement consistently meets the established specifications for identity, purity, strength, and composition, and limits on contaminants, and has been manufactured, packaged, labeled, and held under conditions to prevent adulteration under section 402(a)(1), (a)(2), (a)(3), and (a)(4) of the act. FDA also published an interim final rule (IFR) in the June 25, 2007 Federal Register (72 FR 34959) that sets forth a procedure for requesting an exemption from the requirement in the final rule described above 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: Action Date ANPRM ANPRM Comment Period End NPRM NPRM Comment Period End Final Action 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 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 VerDate Nov<24>2008 07:57 May 08, 2009 Jkt 217001 177. 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 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. This action addresses the ingredient phenylpropanolamine. Timetable: Action Date NPRM (Amendment) (Sinusitis Claim) NPRM (Phenylephrine Bitartrate) NPRM (Phenylpropanol amine) Final Action (Amendment) (Sinusitis Claim) Final Action (Phenylephrine Bitartrate) Final Action (Phenylpropanol amine) FR Cite 08/02/04 69 FR 46119 11/02/04 69 FR 63482 12/22/05 70 FR 75988 Date NPRM (Convenience Sizes) Final Action FR Cite 12/12/06 71 FR 74474 05/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD–560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796–0885 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF37 08/01/06 71 FR 83358 179. OVER–THE–COUNTER (OTC) DRUG REVIEW—OPHTHALMIC PRODUCTS 05/00/10 Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 178. OVER–THE–COUNTER (OTC) DRUG REVIEW—LABELING OF DRUG PRODUCTS FOR OTC HUMAN USE 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 Frm 00015 Timetable: Action 10/31/05 70 FR 58974 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD–560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796–0885 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF34 PO 00000 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. Fmt 1254 Sfmt 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 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 emergency first aid eyewash products. Timetable: Action Date NPRM (Amendment) (Emergency First Aid Eyewashes) NPRM (Amendment) (Emergency First Aid Eyewashes) FR Cite 02/19/03 68 FR 7917 To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and E:\FR\FM\11MYP6.SGM 11MYP6 21934 Federal Register / Vol. 74, No. 89 / Monday, May 11, 2009 / Unified Agenda HHS—FDA Long-Term Actions Human Services, Food and Drug Administration, HFD–560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796–0885 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF39 180. OVER–THE–COUNTER (OTC) DRUG REVIEW—ORAL HEALTH CARE 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. This action will address oral health care products used to reduce or prevent dental plaque and gingivitis. Timetable: Action Date ANPRM (Plaque Gingivitis) ANPRM Comment Period End NPRM (Plaque Gingivitis) Final Action FR Cite 05/29/03 68 FR 32232 Action Date FR Cite Final Action 12/19/07 72 FR 71769 (Warnings) NPRM (Vaginal 05/00/10 Contraceptive Drug Products) Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD–560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796–0885 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF44 To Be Determined To Be Determined 181. 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 to 360a; 21 USC 360gg to 360ss; 21 USC 371 to 371a; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264 07:57 May 08, 2009 Jkt 217001 Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD–560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796–0885 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF51 Timetable: 08/27/03 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD–560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796–0885 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF40 VerDate Nov<24>2008 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. 182. 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) Final Action FR Cite 01/05/05 70 FR 741 05/00/10 Regulatory Flexibility Analysis Required: Yes PO 00000 Frm 00016 Fmt 1254 Sfmt 1254 183. OVER–THE–COUNTER (OTC) DRUG REVIEW—ANTACID 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. One action addresses the labeling of products containing sodium bicarbonate as an active ingredient. The other action addresses the use of antacids to relieve upset stomach associated with overindulgence in food and drink. Timetable: Action Date Final Action (Sodium Bicarbonate Labeling) Final Action (Overindulgence Labeling) FR Cite 05/00/10 05/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD–560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796–0885 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF52 184. OVER–THE–COUNTER (OTC) DRUG REVIEW—SKIN BLEACHING PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; E:\FR\FM\11MYP6.SGM 11MYP6 21935 Federal Register / Vol. 74, No. 89 / Monday, May 11, 2009 / Unified Agenda HHS—FDA Long-Term Actions 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. 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, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD–560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796–0885 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov 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. This action addresses the use of stimulant active ingredients to relieve symptoms associated with a hangover. Timetable: Date VerDate Nov<24>2008 FR Cite 05/00/10 07:57 May 08, 2009 Jkt 217001 Date NPRM (Proposed New Labeling) Final Action (New Labeling) 185. OVER–THE–COUNTER (OTC) DRUG REVIEW—STIMULANT DRUG PRODUCTS NPRM (Amendment) (Hangover) 186. 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 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. These actions address new labeling for antidiarrheal drug products. Timetable: Action RIN: 0910–AF53 Action Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD–560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796–0885 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF56 FR Cite To Be Determined To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD–560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796–0885 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF63 OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses the ingredient ipecac syrup. Timetable: Action Date NPRM (IPECAC) Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD–560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796–0885 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF68 188. 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 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 action addresses food handler products. The second action addresses testing requirements. The final actions listed will address the healthcare, consumer, and first aid antiseptic drug products respectively. Timetable: Action 187. OVER–THE–COUNTER (OTC) DRUG REVIEW—POISON TREATMENT 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 PO 00000 Frm 00017 Fmt 1254 Sfmt 1254 FR Cite 06/00/10 Date NPRM (Healthcare) NPRM (Food Handlers) NPRM (Testing) NPRM (Consumer) Final Action (Healthcare) Final Action (Consumer) E:\FR\FM\11MYP6.SGM 11MYP6 FR Cite 06/17/94 59 FR 31402 To Be Determined To Be Determined To Be Determined To Be Determined To Be Determined 21936 Federal Register / Vol. 74, No. 89 / Monday, May 11, 2009 / Unified Agenda HHS—FDA Long-Term Actions Action Date FR Cite Final Action (First Aid Antiseptic) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD–560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796–0885 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF69 189. 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 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. This action addresses the products used for urinary pain relief. Timetable: Action Date FR Cite NPRM (Urinary Analgesic) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD–560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796–0885 VerDate Nov<24>2008 07:57 May 08, 2009 Jkt 217001 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF70 190. 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 to 360a; 21 USC 371 to 371a 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 is issuing 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 proposed rule is part of FDA’s ongoing review of OTC drug products. Timetable: Action Date NPRM NPRM Comment Period End Final Action FR Cite 06/19/08 73 FR 34895 09/17/08 191. PROCESS CONTROLS FOR ANIMAL FEED INGREDIENTS AND MIXED ANIMAL FEED Legal Authority: 21 USC 342; 21 USC 371; PL 110–85, sec 1002(a)(2) Frm 00018 Fmt 1254 Timetable: Action To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Walter J. Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, HFD–560, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 796–0885 Fax: 301 796–9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910–AF95 PO 00000 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. Sfmt 1254 Date NPRM NPRM Comment Period End FR Cite 04/00/10 07/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Kim Young, Deputy Director, Division of Compliance, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, MPN4, Room 106, HFV–230, 7519 Standish Place, Rockville, MD 20855 Phone: 240 276–9207 Email: kim.young@fda.hhs.gov RIN: 0910–AG10 E:\FR\FM\11MYP6.SGM 11MYP6 Federal Register / Vol. 74, No. 89 / Monday, May 11, 2009 / Unified Agenda Department of Health and Human Services (HHS) Food and Drug Administration (FDA) Reason Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355 to 355a; 21 USC 356; 21 USC 356a to 356c; 21 USC 371; 21 USC 374; 21 USC 379 Abstract: The Food and Drug Administration (FDA) published a proposed regulation on October 29, 2003 (68 FR 61640), that would amend its regulations on submission of bioequivalence (BE) data to require an abbreviated new drug application (ANDA) applicant to submit data from all BE studies the applicant conducts on a drug product formulation submitted for approval. In the past, ANDA applicants have submitted BE studies demonstrating that a generic product meets BE criteria for FDA to approve the ANDA but have not typically submitted additional BE studies conducted on the same drug product formulation. If finalized, this rule would require ANDA applicants to submit information, in either a complete or summary report, from all additional passing and nonpassing BE studies conducted on the same drug product formulation submitted for approval. Completed: Reason Date Final Action FR Cite 01/16/09 74 FR 2849 Regulatory Flexibility Analysis Required: Yes Agency Contact: Jennifer L. Stevens Phone: 301 796–3601 Fax: 301 847–8440 Email: jennifer.stevens@fda.hhs.gov RIN: 0910–AC23 193. COCHINEAL EXTRACT AND CARMINE LABEL DECLARATION Legal Authority: 21 USC 379e(b) Abstract: The Agency published a final rule on January 5, 2009, to require the label declaration of all foods and cosmetics containing the color additives cochineal extract and carmine in order to protect consumers with allergies to these additives. This final rule was issued in response to adverse event reports received by FDA and to a citizen petition submitted to FDA. VerDate Nov<24>2008 07:57 May 08, 2009 Completed Actions Completed: 192. REQUIREMENTS FOR SUBMISSION OF IN VIVO BIOEQUIVALENCE DATA Jkt 217001 Date FR Cite Final Action 01/05/09 74 FR 207 Final Rule—Objection 02/04/09 Period End Final 03/11/09 74 FR 10483 Rule–Confirmation of Effective Date Regulatory Flexibility Analysis Required: Yes Agency Contact: Mical E. Honigfort Phone: 301 436–1278 Fax: 301 436–2972 Email: mical.honigfort@fda.hhs.gov RIN: 0910–AF12 194. OBSTETRICAL AND GYNECOLOGICAL DEVICES; DESIGNATION OF SPECIAL CONTROLS FOR MALE CONDOMS MADE OF NATURAL RUBBER LATEX Legal Authority: 21 USC 360c Abstract: The classification regulation for condoms would be amended to specify a labeling guidance document as a special control for condoms made from natural rubber latex. The new special control guidance document would identify issues presented by these devices, and would provide detailed recommendations for labeling to address these issues. FDA believes that addressing the issues identified in the guidance, either by following the recommendations in the guidance or by some other means that provide equivalent assurances of safety and effectiveness, together with the general controls, will provide a reasonable assurance of the safety and effectiveness of these devices. These labeling recommendations are also consistent with the labeling requirements of 21 CFR part 801. The rule will demonstrate how the Agency is addressing the congressional directive of Public Law 106-554 that FDA review condom labeling to assure that the information regarding the overall effectiveness or lack of effectiveness of condoms in preventing sexually transmitted diseases is medically accurate. Completed: Reason Final Action Date FR Cite 11/10/08 73 FR 66522 Regulatory Flexibility Analysis Required: Yes Agency Contact: Myrna Hanna Phone: 240 276–2347 PO 00000 Frm 00019 21937 Fmt 1254 Sfmt 1254 Fax: 240 276–2352 Email: myrna.hanna@fda.hhs.gov RIN: 0910–AF21 195. FOOD LABELING; SERVING SIZES AND NUTRITION LABELING (COMPLETION OF A 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 Abstract: Section 101.9 (21 CFR 101.9) describes the nutrition labeling requirements for foods. Section 101.12 (21 CFR 101.12) specifies the reference amount customarily consumed per eating occasion for each food category. The reference amount customarily consumed of a food is the basis for the serving size that is declared in the food’s nutrition labeling. Under section 101.9, the serving size must be expressed in a common household measure that is appropriate to the food. The most recent change to sections 101.9 and 101.12 was in 1999, when FDA amended these regulations to reduce the reference amount customarily consumed for baking powder, baking soda, and pectin, and to include 1/8 teaspoon as an allowable unit of household measure for nutrition labeling purposes. FDA has completed a review of sections 101.9 and 101.12 under section 610 of the Regulatory Flexibility Act. The purpose of this review was to determine whether the regulations in sections 101.9 and 101.12 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 solicited comments on the following: (1) The continued need for the regulations in sections 101.9 and 101.12; (2) the nature of complaints or comments received concerning the regulations in sections 101.9 and 101.12; (3) the complexity of the regulations; (4) the extent to which the regulations in sections 101.9 and 101.12 overlap, duplicate, or conflict with other Federal rules, and to the extent feasible, with State or governmental rules; and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulations in sections 101.9 and 101.12. FDA received no comments and concluded that there is a continuing E:\FR\FM\11MYP6.SGM 11MYP6 21938 Federal Register / Vol. 74, No. 89 / Monday, May 11, 2009 / Unified Agenda HHS—FDA Completed Actions need for the nutrition labeling and serving size regulations in sections 101.9 and 101.12 and that these regulations should be retained without change. Timetable: Action Date Begin Review End Review FR Cite 12/12/08 02/10/09 Regulatory Flexibility Analysis Required: No Agency Contact: Mary Brandt, Statistician, Department of Health and Human Services, Food and Drug Administration, Center for Food Safey and Applied Nutrition, 5100 Paint Branch Parkway, ONLDS (HFS–820), College Park, MD 20740 Phone: 301 436–1788 Fax: 301 436–1191 Email: mary.brandt@fda.hhs.gov RIN: 0910–AF99 Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) Proposed Rule Stage 196. CHANGES TO THE HOSPITAL INPATIENT AND LONG–TERM CARE PROSPECTIVE PAYMENT SYSTEM FOR FY 2010 (CMS–1406–P) Legal Authority: Sec 1886(d) of the Social Security Act Abstract: This major rule proposes to revise the Medicare hospital inpatient and Long Term Care prospective payment systems (IPPS) for operating and capital-related costs to implement changes arising from our continuing experience with these systems. Timetable: 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 Blvd, Baltimore, MD 21244 Phone: 410 786–3355 Email: diane.milstead@cms.hhs.gov RIN: 0938–AP40 Action Date NPRM 04/00/09 197. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR CY 2010 (CMS–1413–P) Legal Authority: Social Security Act, sec 1102; Social Security Act, sec 1871 Abstract: This major proposed rule would revise payment polices under the physician fee schedule, as well as other policy changes to payment under Part B. Timetable: 198. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2010 (CMS–1414–P) Legal Authority: BBA; PPRA; BIPA; MMA; MMSEA; MIPPA; DRA; TRHCA Abstract: This major 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 and to implement certain related provisions of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003. 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 1 annually. Timetable: Action Date Action Date NPRM 06/00/09 NPRM 06/00/09 FR Cite Regulatory Flexibility Analysis Required: Yes Agency Contact: Tiffany Swygert, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Div of Acute Care, Hosp and Ambulatory Policy Group, Mailstop C4–25–11, 7500 Security Blvd, Baltimore, MD 21244 Phone: 410 786–4642 Email: tiffany.swygert@cms.hhs.gov RIN: 0938–AP39 VerDate Nov<24>2008 07:57 May 08, 2009 FR Cite Jkt 217001 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 Blvd, Baltimore, MD 21244 Phone: 410 786–0763 Email: alberta.dwivedi@cms.hhs.gov RIN: 0938–AP41 PO 00000 Frm 00020 Fmt 1254 Sfmt 1254 FR Cite 199. PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR SKILLED NURSING FACILITIES—UPDATE FOR FY 2010 (CMS–1410–P) Legal Authority: Social Security Act, sec 1888(e) Abstract: This major rule proposes updates to the payment rates used under the SNF PPS beginning October 1, 2009. Timetable: Action Date NPRM FR Cite 05/00/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: William Ullman, Technical Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers for Medicare Management, Mailstop C5–06–27, 7500 Security Boulvard, Baltimore, MD 21244 Phone: 410 786–5667 Fax: 410 786–0765 Email: bill.ullman@cms.hhs.gov RIN: 0938–AP46 E:\FR\FM\11MYP6.SGM 11MYP6 21939 Federal Register / Vol. 74, No. 89 / Monday, May 11, 2009 / Unified Agenda Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) 200. 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) 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. Timetable: Action Date NPRM NPRM Comment Period End Second NPRM FR Cite 03/10/97 62 FR 11005 06/09/97 To Be Determined 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 Group, Mailstop S3–02–01, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786–5716 Email: danielle.shearer@cms.hhs.gov RIN: 0938–AG81 201. ELECTRONIC CLAIMS ATTACHMENTS STANDARDS (CMS–0050–IFC) 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. 07:57 May 08, 2009 Jkt 217001 Timetable: Action Date NPRM Interim Final Rule FR Cite 09/23/05 70 FR 55989 To Be Determined 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 202. HOME AND COMMUNITY–BASED SERVICES (HCBS) STATE PLAN OPTION (CMS–2249–F) (SECTION 610 REVIEW) Legal Authority: Deficit Reduction Act of 2005; PL 109–171, sec 6086 Abstract: This major rule amends the Medicaid regulations to define and describe the home- and communitybased State plan services implementing the new section 1915(i) of the Social Security Act as added by section 6086 of the Deficit Reduction Act of 2005. Timetable: Action Date NPRM NPRM Comment Period End Final Action FR Cite 04/04/08 73 FR 18676 06/03/08 To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Suzanne Bosstick, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786–1301 Email: suzanne.bosstick@cms.hhs.gov RIN: 0938–AO53 Legal Authority: 42 USC 1320d–2(a)(2)(B) VerDate Nov<24>2008 Long-Term Actions 203. MEDICAID GRADUATE MEDICAL EDUCATION (CMS–2279–F) Legal Authority: title XIX; Social Security Act Abstract: As part of the President’s 2008 Budget, this major rule establishes that States may not include GME as a reimbursable cost or program under PO 00000 Frm 00021 Fmt 1254 Sfmt 1254 their approved Medicaid State Plan. The rule enhances fiscal integrity and improves accountability with respect to payment for medical services in the Medicaid program. Timetable: Action Date NPRM NPRM Comment Period End Final Action FR Cite 05/23/07 72 FR 28930 06/22/07 To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Dianne Heffron, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers for Medicaid State Operations, Mailstop S3–13–15, 7500 Security Boulevard, Baltimore, MD 21224 Phone: 410 786–3247 Fax: 410 786–1008 Email: dianne.heffron@cms.hhs.gov RIN: 0938–AO95 204. REQUIREMENTS FOR LONG–TERM CARE FACILITIES: HOSPICE SERVICES (CMS–3140–P) (SECTION 610 REVIEW) Legal Authority: 42 USC 1302; 42 USC 1395hh Abstract: This proposed rule would establish requirements that long-term care (LTC) facilities must have an agreement with hospice agencies when hospice care is provided in a long-term care facility to participate in the Medicare and Medicaid programs. We are proposing these new requirements to ensure that quality hospice care is provided to eligible residents. Timetable: Action Date FR Cite NPRM To Be Determined 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 RIN: 0938–AP32 E:\FR\FM\11MYP6.SGM 11MYP6 21940 Federal Register / Vol. 74, No. 89 / Monday, May 11, 2009 / Unified Agenda Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) 205. UPDATES TO ELECTRONIC TRANSACTIONS (VERSION 5010) (CMS–0009–F) (COMPLETION OF A SECTION 610 REVIEW) Legal Authority: sec 1171 to 1179 of the Social Security Act; Deficit Reduction Act of 2005, PL 109–171, sec 6035 Abstract: This rule adopts new versions of the X12 suite of HIPAA transactions and allows the industry to use the most up-to-date versions of the HIPAA transactions for claims and remittance advice. The rule will also adopt an updated pharmacy transactions standard for retail pharmacy claims. Timetable: Action Date NPRM NPRM Comment Period End Final Action FR Cite 08/22/08 73 FR 49741 10/21/08 01/16/09 74 FR 3296 Completed Actions Services, Centers for Medicare & Medicaid Services, Mailstop S2–26–17, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786–6711 Email: denise.buenning@cms.hhs.gov RIN: 0938–AN25 207. SURETY BOND REQUIREMENT FOR SUPPLIERS OF DURABLE MEDICAL EQUIPMENT, PROSTHETICS, ORTHOTICS, AND SUPPLIES (DMEPOS) (CMS–6006–F) (COMPLETION OF A SECTION 610 REVIEW) Legal Authority: sec 4312(a) of BBA of 1997 Abstract: This rule implements section 4312(a) of the Balanced Budget Act of 1997, which requires a Medicare supplier of durable medical equipment (DME) to furnish CMS with a surety bond. Regulatory Flexibility Analysis Required: Yes Timetable: Agency Contact: Gladys C. Wheeler, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of E–Health Standards and Services, Mailstop S2–24–18, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786–0273 Email: gladys.wheeler@cms.hhs.gov NPRM NPRM Comment Period End Final Action Action Date FR Cite 08/01/07 72 FR 42001 10/01/07 01/02/09 74 FR 166 Regulatory Flexibility Analysis Required: Yes 206. REVISIONS TO HIPAA CODE SETS (CMS–0013–F) (COMPLETION OF A SECTION 610 REVIEW) Agency Contact: Frank Whelan, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Financial Management, Mailstop C3–02–16, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786–1302 Email: frank.whelan@cms.hhs.gov Legal Authority: PL 104–191 RIN: 0938–AO84 RIN: 0938–AM50 Abstract: This rule revises some of the adopted transaction and code set standards detailed in regulations published by HHS on August 17, 2000, and February 20, 2003. Timetable: Action Date NPRM NPRM Comment Period End Final Action FR Cite 08/22/08 73 FR 49795 10/21/08 01/16/09 74 FR 3328 Regulatory Flexibility Analysis Required: Yes Agency Contact: Denise Buenning, Health Insurance Specialist, Office of E–Health Standards and Services, Department of Health and Human VerDate Nov<24>2008 07:57 May 08, 2009 Jkt 217001 208. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2009 (CMS–1404–F) Legal Authority: BBA; PPRA; BIPA; MMA; 42 USC 1302 et al Abstract: This rule revises the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from continuing experience with this system and to implement certain related provisions of the Medicare Prescription Drug, Improvement, and Modernization PO 00000 Frm 00022 Fmt 1254 Sfmt 1254 Act (MMA) of 2003. In addition, the 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 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 1 annually. Completed: Reason Final Action Date FR Cite 11/18/08 73 FR 68501 Regulatory Flexibility Analysis Required: Yes Agency Contact: Alberta Dwivedi Phone: 410 786–0763 Email: alberta.dwivedi@cms.hhs.gov RIN: 0938–AP17 209. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR CY 2009 (CMS–1403–FC) Legal Authority: Social Security Act, sec 1102; Social Security Act, sec 1871 Abstract: This major rule makes changes affecting Medicare Part B payment to physicians and other Part B suppliers. Completed: Reason Final Action Date FR Cite 11/19/08 73 FR 69725 Regulatory Flexibility Analysis Required: Yes Agency Contact: Diane Milstead Phone: 410 786–3355 Email: diane.milstead@cms.hhs.gov RIN: 0938–AP18 210. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM REFINEMENTS AND RATE UPDATE FOR CY 2009 (CMS–1555–N) Legal Authority: Social Security Act, secs 1102 and 1871; (42 USC 1302 and 1395(hh)); Social Security Act, sec 1895 (42 USC 1395fff) Abstract: Section 1895 of the Act requires that the Home Health PPS be adjusted in a prospective manner specified by the Secretary by the home health increase percentage applicable to the year involved. E:\FR\FM\11MYP6.SGM 11MYP6 21941 Federal Register / Vol. 74, No. 89 / Monday, May 11, 2009 / Unified Agenda HHS—CMS Completed Actions Completed: Reason Date Notice FR Cite 11/03/08 73 FR 65351 Regulatory Flexibility Analysis Required: Yes Agency Contact: Randy Throndset Phone: 410 786–0131 Fax: 410 786–0765 Email: randy.throndset@cms.hhs.gov RIN: 0938–AP20 211. CHANGES TO LONG–TERM CARE PROSPECTIVE PAYMENT SYSTEM BASED ON SPECIFIC PROVISIONS IN THE MEDICARE, MEDICAID, AND SCHIP EXTENSION ACT OF 2007 (CMS–1493–F) Legal Authority: Provisions of sec 114 of PL 110–173 (MMSE Act of 2007); sec 1886(d) of the Social Security Act VerDate Nov<24>2008 07:57 May 08, 2009 Jkt 217001 as amended by sec 114 of PL 110–173 (MMSE Act of 2007) Abstract: This rule implements provisions of the Medicare, Medicaid, and SCHIP Extension Act of 2007 relating to long-term care hospitals. In addition to amending section 1861 of the Act with a new definition of LTCHs, this rule includes provisions that are effective on the date of enactment (December 29, 2007). Specifically, the statute imposes a 3year delay in implementation of certain payment policies that set percentage thresholds for LTCH patients admitted from certain referring hospitals and raises the percentage threshold for those LTCHs unaffected by the 3-year delay. The legislation imposes the same 3-year delay on the implementation of a particular payment adjustment for short-stay patients and also for the possible application of a one-time PO 00000 Frm 00023 Fmt 1254 Sfmt 1254 adjustment to the standard Federal rate. The statute also required a change in the Federal rate for RY 2008, (effective April 1, 2008). Additionally, the statute created a 3-year moratorium on the establishment of new LTCHs and LTCH satellites and on bed expansion in existing LTCHs, subject to significant exceptions. Completed: Reason Withdrawn Date FR Cite 01/29/09 Regulatory Flexibility Analysis Required: Yes Agency Contact: Tzvi Hefter Phone: 410 786–4487 Email: tzvi.hefter@cms.hhs.gov RIN: 0938–AP33 [FR Doc. E9–10274 Filed 05–08–09; 8:45 am] BILLING CODE 4150–24–S E:\FR\FM\11MYP6.SGM 11MYP6

Agencies

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 74, Number 89 (Monday, May 11, 2009)]
[Unknown Section]
[Pages 21919-21941]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-10274]


[[Page 21919]]

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

Part VI





Department of Health and Human Services





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



Semiannual Regulatory Agenda

[[Page 21920]]



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, Chs. II, III, and XIII

Unified Agenda of Federal Regulatory and Deregulatory Actions

AGENCY: Office of the Secretary, HHS.

ACTION: Semiannual regulations agenda.

_______________________________________________________________________

SUMMARY:  The Department's semiannual Agenda of Regulatory and 
Deregulatory Actions forecasts the rulemaking activities that we expect 
to undertake over the foreseeable future. We focus primarily on those 
areas of work anticipated to result in publication of Notices of 
Proposed Rulemaking or of Final Rules within the next 12 months. 
(Please note that the abstracts included below relate only to those 
prospective rulemakings that are likely to have a significant economic 
impact on a substantial number of small entities; the Regulatory 
Flexibility Act of 1980 requires dissemination of this information in 
the paper edition of the Federal Register. The complete HHS Agenda is 
accessible online at www.reginfo.gov.)

FOR FURTHER INFORMATION CONTACT: by e-mail, John.Gallivan@hhs.gov; by 
fax, (202) 205-2135; by telephone, (202) 205-9165.

SUPPLEMENTARY INFORMATION: 

    The Regulatory Flexibility Act of 1980 and Executive Order 
12866 require semi-annual publication of an inventory outlining all 
current and projected rulemakings. The purpose of this exercise is 
to inform the public about regulatory actions under development 
across the Department, and to provide an opportunity for all 
concerned with the impact of these actions to participate in their 
development at an early stage.

    The regulatory actions capsulized in this Agenda do not 
necessarily reflect the policy perspectives of the Obama 
Administration. The statutorily dictated timing of the Agenda 
caused the Department to initiate preparation of the requisite 
information before the Department's policy officials had the 
opportunity to conduct a full review. This Agenda thus reflects 
ongoing efforts by HHS to comply with existing statutory 
obligations, or to effect improvements at the program-
implementation level based on experience in administering existing 
programs. By contrast, the timing of the October 2009 Agenda will, 
obviously, provide the Department with an opportunity to set out a 
regulatory agenda that does reflect current policy directions of 
the Obama Administration.

    Public commentary is invited. Comments may be directed to the 
agency officials cited at the conclusion of each entry. If early 
attention at the Secretary's level appears needed, comments should 
be sent to: Ashley Files Flory, Acting Executive Secretary to the 
Department, Suite 603H, 200 Independence Avenue SW., Washington, DC 
20201.

Dated: April 3, 2009.

 Ashley Files Flory,

Acting Executive Secretary to the Department.

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


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


                         Centers for Disease Control and Prevention--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
149         Foreign Quarantine Regulations, Proposed Revision of HHS/CDC Animal Importation           0920-AA14
            Regulations...........................................................................
150         Control of Communicable Diseases: Foreign Quarantine Regulations, Proposed Revision of    0920-AA23
            HHS/CDC Nonhuman Primate Regulations..................................................
----------------------------------------------------------------------------------------------------------------


[[Page 21921]]


                          Centers for Disease Control and Prevention--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
151         Control of Communicable Diseases Foreign Quarantine...................................    0920-AA12
152         Control of Communicable Diseases: Interstate Quarantine, Passenger Information........    0920-AA27
----------------------------------------------------------------------------------------------------------------


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


                                   Food and Drug Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
154         Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of         0910-AG06
            Shell Eggs Held for Retail Distribution (Section 610 Review)..........................
155         Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992;            0910-AG14
            Policies, Requirements, and Administrative Procedures (Section 610 Review)............
----------------------------------------------------------------------------------------------------------------


                                Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
156         Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics.......    0910-AC52
157         Over-The-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products...............    0910-AF31
158         Over-The-Counter (OTC) Drug Review--Laxative Drug Products............................    0910-AF38
159         Over-The-Counter (OTC) Drug Review--Sunscreen Products................................    0910-AF43
160         Over-The-Counter (OTC) Drug Review--Weight Control Products...........................    0910-AF45
161         Pediatric Dosing for Cough, Cold, Allergy, Bronchodilator, and Antiasthmatic Drug         0910-AG12
            Products for Over-The-Counter Human Use; Proposed Amendment of Final Monograph........
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
162         Prevention of Salmonella Enteritidis in Shell Eggs....................................    0910-AC14
163         Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements.    0910-AC53
164         Positron Emission Tomography Drugs; Current Good Manufacturing Practices..............    0910-AC55
165         Content and Format of Labeling for Human Prescription Drugs and Biologics;                0910-AF11
            Requirements for Pregnancy and Lactation Labeling.....................................
166         Over-The-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products..............    0910-AF32
167         Over-The-Counter (OTC) Drug Review--Cough/Cold (Combination) Products.................    0910-AF33
168         Over-The-Counter (OTC) Drug Review--External Analgesic Products.......................    0910-AF35
169         Over-The-Counter (OTC) Drug Review--Internal Analgesic Products.......................    0910-AF36
170         Over-the-Counter (OTC) Drug Review--Skin Protectant Products..........................    0910-AF42
171         Substances Prohibited From Use in Animal Food or Feed To Prevent the Transmission of      0910-AF46
            Bovine Spongiform Encephalopathy......................................................
172         Use of Materials Derived From Cattle in Human Food and Cosmetics......................    0910-AF47
173         Label Requirement for Food That Has Been Refused Admission Into the United States.....    0910-AF61
174         Over-The-Counter (OTC) Drug Review--Acne Drug Products Containing Benzoyl Peroxide....    0910-AG00
----------------------------------------------------------------------------------------------------------------


[[Page 21922]]


                                 Food and Drug Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
175         Postmarketing Safety Reporting Requirements for Human Drug and Biological Products....    0910-AA97
176         Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding       0910-AB88
            Operations for Dietary Supplements....................................................
177         Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products..........    0910-AF34
178         Over-The-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use.......    0910-AF37
179         Over-The-Counter (OTC) Drug Review--Ophthalmic Products...............................    0910-AF39
180         Over-The-Counter (OTC) Drug Review--Oral Health Care Products.........................    0910-AF40
181         Over-The-Counter (OTC) Drug Review--Vaginal Contraceptive Products....................    0910-AF44
182         Over-The-Counter (OTC) Drug Review--Overindulgence in Food and Drink Products.........    0910-AF51
183         Over-The-Counter (OTC) Drug Review--Antacid Products..................................    0910-AF52
184         Over-The-Counter (OTC) Drug Review--Skin Bleaching Products...........................    0910-AF53
185         Over-the-Counter (OTC) Drug Review--Stimulant Drug Products...........................    0910-AF56
186         Over-The-Counter Antidiarrheal Drug Products..........................................    0910-AF63
187         Over-The-Counter (OTC) Drug Review--Poison Treatment Drug Products....................    0910-AF68
188         Over-The-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products...............    0910-AF69
189         Over-The-Counter (OTC) Drug Review--Urinary Analgesic Drug Products...................    0910-AF70
190         Status of Certain Additional Over-the-Counter Drug Category II Active Ingredients.....    0910-AF95
191         Process Controls for Animal Feed Ingredients and Mixed Animal Feed....................    0910-AG10
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
192         Requirements for Submission of In Vivo Bioequivalence Data............................    0910-AC23
193         Cochineal Extract and Carmine Label Declaration.......................................    0910-AF12
194         Obstetrical and Gynecological Devices; Designation of Special Controls for Male           0910-AF21
            Condoms Made of Natural Rubber Latex..................................................
195         Food Labeling; Serving Sizes and Nutrition Labeling (Completion of a Section 610          0910-AF99
            Review)...............................................................................
----------------------------------------------------------------------------------------------------------------


                          Centers for Medicare & Medicaid Services--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
196         Changes to the Hospital Inpatient and Long-Term Care Prospective Payment System for FY    0938-AP39
            2010 (CMS-1406-P).....................................................................
197         Revisions to Payment Policies Under the Physician Fee Schedule For CY 2010 (CMS-1413-     0938-AP40
            P)....................................................................................
198         Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical     0938-AP41
            Center Payment System for CY 2010 (CMS-1414-P)........................................
199         Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities--      0938-AP46
            Update for FY 2010 (CMS-1410-P).......................................................
----------------------------------------------------------------------------------------------------------------


                           Centers for Medicare & Medicaid Services--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
200         Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610     0938-AG81
            Review)...............................................................................
201         Electronic Claims Attachments Standards (CMS-0050-IFC)................................    0938-AK62
202         Home and Community-Based Services (HCBS) State Plan Option (CMS-2249-F) (Section 610      0938-AO53
            Review)...............................................................................
203         Medicaid Graduate Medical Education (CMS-2279-F)......................................    0938-AO95
204         Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-P) (Section 610    0938-AP32
            Review)...............................................................................
----------------------------------------------------------------------------------------------------------------


[[Page 21923]]


                           Centers for Medicare & Medicaid Services--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
205         Updates to Electronic Transactions (Version 5010) (CMS-0009-F) (Completion of a           0938-AM50
            Section 610 Review)...................................................................
206         Revisions to HIPAA Code Sets (CMS-0013-F) (Completion of a Section 610 Review)........    0938-AN25
207         Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics,          0938-AO84
            Orthotics, and Supplies (DMEPOS) (CMS-6006-F) (Completion of a Section 610 Review)....
208         Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical     0938-AP17
            Center Payment System for CY 2009 (CMS-1404-F)........................................
209         Revisions to Payment Policies Under the Physician Fee Schedule for CY 2009 (CMS-1403-     0938-AP18
            FC)...................................................................................
210         Home Health Prospective Payment System Refinements and Rate Update for CY 2009 (CMS-      0938-AP20
            1555-N)...............................................................................
211         Changes to Long-Term Care Prospective Payment System Based on Specific Provisions in      0938-AP33
            the Medicare, Medicaid, and SCHIP Extension Act of 2007 (CMS-1493-F)..................
----------------------------------------------------------------------------------------------------------------

_______________________________________________________________________


Department of Health and Human Services (HHS)       Proposed Rule Stage


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________



147. OPIOID DRUGS IN MAINTENANCE OR DETOXIFICATION TREATMENT OF OPIATE 
ADDITION (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 proposed rule, when finalized will modify the regulatory 
dispensing restrictions under 42 CFR part 8 for the drug substance 
buprenorphine. This medication is used to treat kersin and other opioid 
addiction.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/09

Regulatory Flexibility Analysis Required: No

Agency Contact: Nicholas Reuter, Department of Health and Human 
Services, Substance Abuse and Mental Health Services Administration, 
One Choke Cherry Rd, Suite 2-1063, 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)



_______________________________________________________________________



148. 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
_______________________________________________________________________


Department of Health and Human Services (HHS)       Proposed Rule Stage


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________



149. FOREIGN QUARANTINE REGULATIONS, PROPOSED REVISION OF HHS/CDC ANIMAL 
IMPORTATION REGULATIONS

Legal Authority: Not Yet Determined

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

[[Page 21924]]

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 Unite States (42 CFR parts 71, Subpart F).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           07/31/07                    72 FR 41676
Notice Extending ANPRM Comment 
Period                          10/01/07                    72 FR 55729
NPRM                            12/00/09

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0920-AA14
_______________________________________________________________________



150. CONTROL OF COMMUNICABLE DISEASES: FOREIGN QUARANTINE REGULATIONS, 
PROPOSED REVISION OF HHS/CDC NONHUMAN PRIMATE REGULATIONS

Legal Authority: 42 U.S.C. 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 two 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                            12/00/09

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0920-AA23
_______________________________________________________________________


Department of Health and Human Services (HHS)          Final Rule Stage


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________



151. 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
Final Action                    09/00/09

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0920-AA12
_______________________________________________________________________



152. 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

[[Page 21925]]

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
Final Action                    12/00/09

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0920-AA27
_______________________________________________________________________


Department of Health and Human Services (HHS)         Long-Term Actions


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________



153.  POSSESSION, USE AND TRANSFER OF SELECT AGENTS 
AND TOXINS (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 
reuslt 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 andy 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                             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
_______________________________________________________________________


Department of Health and Human Services (HHS)             Prerule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________



154. 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) provides that part 16 does not 
apply to a hearing on an order for relabeling, diversion, or 
destruction if 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,

[[Page 21926]]

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                    12/00/09
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
_______________________________________________________________________



155. 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: (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 Regulation12/00/09

Regulatory Flexibility Analysis Required: Yes

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, 10903 New Hampshire Avenue, 
Bldg. 51, Room 6234, Silver Spring, MD 20993-0002
Phone: 301 796-3601
Fax: 301 847-8440
Email: howard.mullerjr@fda.hhs.gov

RIN: 0910-AG14
_______________________________________________________________________


Department of Health and Human Services (HHS)       Proposed Rule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________



156. 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. The 
proposal would also require that FDA periodically issue guidance on the 
use of standardized data structure, terminology, and code sets (e.g., 
the Study Data Tabulation Model (SDTM) developed by the Clinical Data 
Interchange Standards Consortium) to allow for more efficient and 
comprehensive data review.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/09

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, 10903 New Hampshire Avenue, Bldg. 51, Room 
6224, Silver Spring, MD 20993-0002
Phone: 301 796-3471
Fax: 301 847-8440

[[Page 21927]]

Email: martha.nguyen@fda.hhs.gov

RIN: 0910-AC52
_______________________________________________________________________



157. 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 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. 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)  04/00/10

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF31
_______________________________________________________________________



158. 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 final 
action will address laxative drug products. 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Granular Psyllium)03/29/07                    72 FR 14669
Final Action (Laxative Drug 
Products)                        To Be                       Determined
NPRM (Professional Labeling--
Sodium Phosphate)               09/00/09
NPRM (Professional Labeling)     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF38
_______________________________________________________________________



159. 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 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 
action addresses active ingredients reviewed under Time and Extent 
Applications. The second action is the final action that addresses 
sunscreen formulation, labeling, and testing requirements for both 
ultraviolet B and ultraviolet A radiation protection. The third action 
addresses combination products containing sunscreen and insect 
repellent ingredients.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM (Sunscreen and Insect 
Repellent)                      02/22/07                     72 FR 7941
ANPRM Comment Period End        05/23/07
NPRM (UVA/UVB)                  08/27/07                    72 FR 49070
NPRM Comment Period End         12/26/07
NPRM (Time and Extent)          09/00/09
Final Action (UVA/UVB)          09/00/09
NPRM (Sunscreen and Insect 
Repellent)                       To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF43
_______________________________________________________________________



160. 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. One action 
addresses the ingredient phenylpropanolamine, and the other actions 
address the ingredient benzocaine.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Phenylpropanol amine)     12/22/05                    70 FR 75988
NPRM (Benzocaine)               09/00/09
Final Action (Phenylpropanol 
amine)                          05/00/10
Final Action (Benzocaine)        To Be                       Determined

[[Page 21928]]

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF45
_______________________________________________________________________



161. PEDIATRIC DOSING FOR COUGH, COLD, ALLERGY, BRONCHODILATOR, AND 
ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE; PROPOSED 
AMENDMENT OF FINAL MONOGRAPH

Legal Authority: 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360 
to 360(a); 21 USC 371 to 371(a)

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                      FR Cite

________________________________________________________________________

NPRM                            09/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AG12
_______________________________________________________________________


Department of Health and Human Services (HHS)          Final Rule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________



162. PREVENTION OF SALMONELLA ENTERITIDIS IN SHELL EGGS

Legal Authority: 21 USC 321; 21 USC 342; 21 USC 371; 21 USC 381; 21 USC 
393; 42 USC 243; 42 USC 264; 42 USC 271;

Abstract: Publication of this final rule was an action item in the Food 
Protection Plan announced by the Department of Health and Human 
Services (HHS) in November 2007.
In July 1999, the Food and Drug Administration (FDA) and the Food 
Safety Inspection Service (FSIS) committed to developing an action plan 
to address the presence of Salmonella Enteritidis (SE) in shell eggs 
and egg products using a farm-to-table approach. FDA and FSIS held a 
public meeting on August 26, 1999, to obtain stakeholder input on the 
draft goals, as well as to further develop the objectives and action 
items for the action plan. The Egg Safety Action Plan was announced on 
December 11, 1999. The goal of the Action Plan is to reduce egg-related 
SE illnesses. The Egg Safety Action Plan consists of eight objectives 
covering all stages of the farm-to-table continuum as well as support 
functions. On March 30, 2000 (Columbus, OH), April 6, 2000 (Sacramento, 
CA), and July 31, 2000 (Washington, DC), joint public meetings were 
held by FDA and FSIS to solicit and discuss information related to the 
implementation of the objectives in the Egg Safety Action Plan.
On September 22, 2004, FDA published a proposed rule that would require 
egg safety measures to prevent the contamination of shell eggs with SE 
during egg production. The proposal also solicited comment on whether 
recordkeeping requirements should include a written SE prevention plan 
and records for compliance with the SE prevention measures, and whether 
safe egg handling and preparation practices should be mandated for 
retail establishments that specifically serve a highly susceptible 
population (e.g., nursing homes, hospitals, day care centers). The 
proposed egg production SE prevention measures included: (1) Provisions 
for procurement of chicks and pullets; (2) a biosecurity program; (3) a 
rodent and pest control program; (4) cleaning and disinfection of 
poultry houses that have had an environmental or egg test positive for 
SE; (5) egg testing when an environmental test is positive; and (6) 
refrigerated storage of eggs held at the farm. Additionally, to verify 
that the measures have been effective, the rule proposes that producers 
test the poultry house environment for SE. If the environmental test is 
positive, eggs from that environment must be tested for SE, and if the 
egg test is positive, the eggs must be diverted to egg products 
processing or a treatment process that achieves at least a five-log 
destruction of SE.
The proposed rule was a step in a broader farm-to-table egg safety 
effort that includes FDA's requirements for safe handling statements on 
egg cartons, and refrigerated storage of shell eggs at retail, and egg 
safety education for consumers and retail establishments. The rule had 
a 90-day comment period, which ended December 21, 2004. To discuss the 
proposed rule and solicit comments from interested stakeholders, FDA 
held three public meetings: October 28, 2004, in College Park, MD; 
November 9, 2004, in Chicago, IL; and November 16, 2004, in Los 
Angeles, CA. The comment period was reopened until July 25, 2005, to 
solicit further comment and information on industry practices and 
programs that prevent SE-monitored chicks from becoming infected by SE 
during the period of pullet rearing until placement into laying hen 
houses.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/22/04                    69 FR 56824
NPRM Comment Period End         12/21/04
NPRM Reopened Comment Period End06/09/05                    70 FR 24490

[[Page 21929]]

NPRM Extension of Reopened 
Comment Period End              07/25/05                    70 FR 33404
Final Action                    07/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: John F. Sheehan, Director, Department of Health and 
Human Services, Food and Drug Administration, Division of Plant and 
Dairy Food Safety (HFS-315), Room 3B-012, 5100 Paint Branch Parkway, 
College Park, MD 20740
Phone: 301 436-2367
Fax: 301 436-2632
Email: john.sheehan@fda.hhs.gov

RIN: 0910-AC14
_______________________________________________________________________



163. MEDICAL GAS CONTAINERS AND CLOSURES; CURRENT GOOD MANUFACTURING 
PRACTICE REQUIREMENTS

Legal Authority: 21 USC 321; 21 USC 351 to 21 USC 353

Abstract: The Food and Drug Administration is amending its current good 
manufacturing practice regulations and other regulations to clarify and 
strengthen requirements for the label, color, dedication, and design of 
medical gas containers and closures. Despite existing regulatory 
requirements and industry standards for medical gases, there have been 
repeated incidents in which cryogenic containers of harmful industrial 
gases have been connected to medical oxygen supply systems in hospitals 
and nursing homes, and subsequently administered to patients. These 
incidents have resulted in death and serious injury. There have also 
been several incidents involving high-pressure 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 mixups, do not 
occur in the future.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/10/06                    71 FR 18039
NPRM Comment Period End         07/10/06
Final Action                    09/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Quynh H. Nguyen, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, 10903 New Hampshire Avenue, Bldg. 51, 
Room 6370, Silver Spring, MD 20993-0002
Phone: 301 796-3601
Fax: 301 847-8440
Email: quynh.h.nguyen@fda.hhs.gov

RIN: 0910-AC53
_______________________________________________________________________



164. 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 
would adopt CGMPs that reflect the unique characteristics of PET drugs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/20/05                    70 FR 55038
NPRM Comment Period End         12/19/05
Final Action                    08/00/09

Regulatory Flexibility Analysis Required: Yes

Agency Contact: Michael D. Bernstein, Supervisory Regulatory Counsel, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Drug Evaluation and Research, Office of Regulatory Policy, 
10903 New Hampshire Ave., Bldg. 51, Room 6240, Silver Spring, MD 20993-
0002
Phone: 301 796-3478
Fax: 301 847-8440
Email: michael.bernstein@fda.hhs.gov

RIN: 0910-AC55
_______________________________________________________________________



165. 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).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/29/08                    73 FR 30831
NPRM Comment Period End         08/27/08
Final Action                    03/00/10

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, 10903 New Hampshire Ave., Bldg. 51, Room 
6224, Silver Spring, MD 20993-0002
Phone: 301 796-4288
Fax: 301-847-8440
Email: rachel.bressler@fda.hhs.gov

RIN: 0910-AF11
_______________________________________________________________________



166. 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 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. This action 
addresses labeling for single ingredient bronchodilator products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment--Ephedrine 
Single Ingredient)              07/13/05                    70 FR 40237
Final Action (Technical 
Amendment)                      11/30/07                    72 FR 63679
Final Action (Amendment--
Ephedrine Single Ingredient)    09/00/09

Regulatory Flexibility Analysis Required: Yes

[[Page 21930]]

Agency Contact: Walter J. Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, HFD-560, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 796-0885
Fax: 301 796-9899
Email: walter.ellenberg@fda.hhs.gov

RIN: 0910-AF32
_______________________________________________________________________



167. 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 to 360a; 21 USC 371 to 371a

Abstract: The OTC drug review establishes

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