[Unified Agenda of Federal Regulatory and Deregulatory Actions]
[Department of Health and Human Services Semiannual Regulatory Agenda]
[From the U.S. Government Printing Office, www.gpo.gov]


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Part VIII





Department of Health and Human Services





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Semiannual Regulatory Agenda

[[Page 22490]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)                          


  



_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

21 CFR Ch. I

42 CFR Chs. I-V

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

Regulatory Agenda

AGENCY: Office of the Secretary, HHS

ACTION: Semiannual Regulatory Agenda

_______________________________________________________________________

SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order 
12866 require the following inventory of the rulemaking actions under 
development by the Department. The purpose is to encourage public 
participation in the regulatory process by providing, at as early a 
stage as possible, summarized information about regulatory actions 
under consideration. Members of the public wishing to communicate to 
the Department their views on the potential rulemakings outlined below 
are invited to do so.

FOR FURTHER INFORMATION CONTACT: Ann C. Agnew, Executive Secretary, 
Department of Health and Human Services, Washington, DC 20201.

SUPPLEMENTARY INFORMATION:  The capsulized information provided below 
presents for public scrutiny a forecast of the rulemaking activities 
that the Department expects to undertake over the foreseeable future. 
We focus primarily on those areas of work expected to result in 
publication of Notices of Proposed Rulemaking or Final Rules within the 
next 12 months.

     We welcome the views of all concerned with regard to these 
planned rulemakings. Comments may be directed to the Agency 
officials cited in each of the summaries, or, if early attention at 
the Secretary's level is seen as required, comments should be sent 
to: Ann C. Agnew, Executive Secretary to the Department, Room 603H, 
200 Independence Avenue SW., Washington, DC 20201.

Dated: March 27, 2007.

 Ann C. Agnew,

Executive Secretary to the Department.

                                  Office of the Secretary--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
774         Revisions to Regulations Addressing the OIG's Authority To Impose Civil Money             0991-AB03
            Penalties and Assessments.............................................................
----------------------------------------------------------------------------------------------------------------


                                    Office of the Secretary--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
775         Shared Risk Exception to the Safe Harbor Provisions...................................    0991-AA91
776         Safe Harbor for Waiver of Beneficiary Co-insurance and Deductible Amounts for a           0991-AB16
            Medicare SELECT Policy................................................................
777         Clarification of Terms and Application of Program Exclusion Authority for Submitting      0991-AB23
            Claims Containing Excessive Charges...................................................
778         Medicare and State Health Care Programs: Fraud and Abuse; Safe Harbor for Federally       0991-AB38
            Qualified Health Centers Under the Anti-Kickback Statute..............................
----------------------------------------------------------------------------------------------------------------


                                   Office of the Secretary--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
779         Revisions to the Waiver Provisions of the Office of Inspector General's (OIG)             0991-AB33
            Exclusion Authorities.................................................................
----------------------------------------------------------------------------------------------------------------


                                   Office of the Secretary--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
780         Debt Collection.......................................................................    0991-AB18
781         Salary Offset.........................................................................    0991-AB19
----------------------------------------------------------------------------------------------------------------


[[Page 22491]]


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


                   Substance Abuse and Mental Health Services Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
783         Mandatory Guidelines for the Federal Workplace Drug Testing Program...................    0930-AA12
----------------------------------------------------------------------------------------------------------------


                            Centers for Disease Control and Prevention--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
784         Foreign Quarantine Regulations, Proposed Revision of HHS/CDC Animal Importation           0920-AA14
            Regulations...........................................................................
785         Amendments to Powered Air-Purifying Respirator Requirements for Approval of               0920-AA16
            Respiratory Protection Devices........................................................
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                         Centers for Disease Control and Prevention--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
786         Amendments to Quality Assurance and Administrative Provision for Approval of              0920-AA04
            Respiratory Protective Devices........................................................
787         Amendments to Self-Contained Breathing Apparatus Requirements for Approval of             0920-AA10
            Respiratory Protective Devices........................................................
788         Amendments to Requirements for Coal Mine Dust Personal Sampler Units..................    0920-AA18
789         Medical Examination of Aliens.........................................................    0920-AA20
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                          Centers for Disease Control and Prevention--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
790         Control of Communicable Diseases, Interstate and Foreign Quarantine...................    0920-AA12
791         Procedures for Designating Classes of Employees as Members of the Special Exposure        0920-AA13
            Cohort Under the Energy Employees Occupational Illness Compensation Program Act of
            2000; Amendments......................................................................
792         Interstate Shipment of Etiologic Agents...............................................    0920-AA19
----------------------------------------------------------------------------------------------------------------


                          Centers for Disease Control and Prevention--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
793         Amendments to Performance Requirements for Chemical, Biological, Radiological, and        0920-AA17
            Nuclear (CBRN) Approval of Respiratory Protection Devices.............................
----------------------------------------------------------------------------------------------------------------


                                   Food and Drug Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
794         Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality           0910-AF71
            Systems Regulations (Section 610 Review)..............................................

[[Page 22492]]

 
795         Package Size Limitation for Sodium Phosphates Oral Solution and Warning and Direction     0910-AF73
            Statements for Oral and Rectal Sodium Phosphates for Over-the-Counter Laxative Use
            (Section 610 Review)..................................................................
796         Over-the-Counter Drug Products Containing Analgesic/Antipyretic Active Ingredients for    0910-AF74
            Internal Use: Required Alcohol Warning (Section 610 Review)...........................
797         Status of Certain Additional Over-the-Counter Drug Category II and III Active             0910-AF75
            Ingredients (Section 610 Review)......................................................
798         Medical Devices: Classification/Reclassification; Restricted Devices; Analyte Specific    0910-AF76
            Reagents (Section 610 Review).........................................................
799         Amended Economic Impact Analysis of Final Rule on User Labeling on Natural Rubber-        0910-AF77
            Containing Medical Device (Section 610 Review)........................................
800         Financial Disclosure by Clinical Investigators (Section 610 Review)...................    0910-AF79
801         Beverages: Bottled Water (Section 610 Review).........................................    0910-AF80
802         Food Labeling; Nutrient Content Claims: Definition for ``High Potency'' and Definition    0910-AF83
            of ``Antioxidant'' for Use in Nutrient Content Claims for Dietary Supplements and
            Conventional Foods (Section 610 Review)...............................................
----------------------------------------------------------------------------------------------------------------


                                Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
803         Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure            0910-AC30
            Regulators for Use With Medical Oxygen and Separate Classification of Oxygen
            Conserving Devices....................................................................
804         Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics.......    0910-AC52
805         Reporting Information Regarding Falsification of Data.................................    0910-AC59
806         Content and Format of Labeling for Human Prescription Drugs and Biologics;                0910-AF11
            Requirements for Pregnancy and Lactation Labeling.....................................
807         Blood Initiative--Requirements for Human Blood and Blood Components Intended for          0910-AF25
            Transfusion or for Further Manufacturing Use..........................................
808         Over-the-Counter (OTC) Drug Review--Internal Analgesic Products.......................    0910-AF36
809         Over-the-Counter (OTC) Drug Review--Sunscreen Products................................    0910-AF43
810         Over-the-Counter (OTC) Drug Review--Weight Control Products...........................    0910-AF45
811         Over-the-Counter (OTC) Drug Review--Stimulant Drug Products...........................    0910-AF56
812         Label Requirement for Food That Has Been Refused Admission Into the United States.....    0910-AF61
813         Over-the-Counter Antidiarrheal Drug Products..........................................    0910-AF63
814         Over-the-Counter (OTC) Drug Review--Poison Treatment Drug Products....................    0910-AF68
815         Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products...............    0910-AF69
816         Import Tolerances for Unapproved New Animal Drugs.....................................    0910-AF78
817         Current Good Manufacturing Practice for Combination Products..........................    0910-AF81
818         Postmarket Safety Reporting for Combination Products..................................    0910-AF82
819         Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma    0910-AF84
820         Revision of the Requirements for Live Vaccine Processing..............................    0910-AF85
821         Medical Device Reporting; Electronic Submission Requirements..........................    0910-AF86
822         Laser Products; Amendment to Performance Standard.....................................    0910-AF87
823         Electronic Registration and Listing for Devices.......................................    0910-AF88
824         Regulations on Fixed-Combination Drug Products........................................    0910-AF89
825         Use of Ozone-Depleting Substances; Removal of Essential Use Designations [Epinephrine]    0910-AF92
826         Use of Ozone-Depleting Substances; Removal of Essential Use Designations [Flunisolide,    0910-AF93
            Triamcinolone, Metaproterenol, Pirbuterol, Albuterol and Ipratropium in Combination,
            Cromolyn, and Nedocromil].............................................................
827         Status of Certain Additional Over-the-Counter Drug Category II Active Ingredients.....    0910-AF95
828         Postmarketing Safety Reports for Human Drug and Biological Products: Electronic           0910-AF96
            Submission Requirements...............................................................
829         Proposed Revisions to 21 CFR Parts 314 and 320 To Implement Portions of Title XI of       0910-AF97
            the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and Other
            Changes...............................................................................
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[[Page 22493]]


                                 Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
830         Foreign and Domestic Establishment Registration and Listing Requirements for Human        0910-AA49
            Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and
            Animal Drugs..........................................................................
831         Safety Reporting Requirements for Human Drug and Biological Products..................    0910-AA97
832         Applications for FDA Approval To Market a New Drug; Complete Response Letter;             0910-AB34
            Amendments to Unapproved Applications.................................................
833         CGMPs for Blood and Blood Components: Notification of Consignees and Transfusion          0910-AB76
            Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV
            Infection (Lookback)..................................................................
834         Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary         0910-AB88
            Ingredients and Dietary Supplements...................................................
835         Additional Safeguards for Children in Clinical Investigations.........................    0910-AC07
836         Prevention of Salmonella Enteritidis in Shell Eggs....................................    0910-AC14
837         Institutional Review Boards: Registration Requirements................................    0910-AC17
838         Exception From General Requirements for Informed Consent; Request for Comments and        0910-AC25
            Information...........................................................................
839         Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements.    0910-AC53
840         Positron Emission Tomography Drugs; Current Good Manufacturing Practices..............    0910-AC55
841         Charging for Investigational Drugs....................................................    0910-AF13
842         Expanded Access to Investigational Drugs for Treatment Use............................    0910-AF14
843         Human Subject Protection; Foreign Clinical Studies Not Conducted Under an                 0910-AF15
            Investigational New Drug Application..................................................
844         Distribution of Blood Derivatives by Registered Blood Establishments That Qualify as      0910-AF16
            Health Care Entities; PDMA of 1987; PDA of 1992; Policies, Requirements, and
            Administrative Procedures.............................................................
845         Blood Initiative--Revisions to Labeling Requirements for Blood and Blood Components,      0910-AF26
            Including Source Plasma; and Technical Amendment......................................
846         Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures;         0910-AF27
            Notification Requirements; Records and Reports........................................
847         Infant Formula Quality Factors........................................................    0910-AF28
848         Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) Products.................    0910-AF33
849         Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products..........    0910-AF34
850         Over-the-Counter (OTC) Drug Review--External Analgesic Products.......................    0910-AF35
851         Over-the-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use.......    0910-AF37
852         Over-the-Counter (OTC) Drug Review--Laxative Drug Products............................    0910-AF38
853         Over-the-Counter (OTC) Drug Review--Skin Protectant Products..........................    0910-AF42
854         Over-the-Counter (OTC) Drug Review--Vaginal Contraceptive Products....................    0910-AF44
855         Substances Prohibited From Use in Animal Food or Feed To Prevent the Transmission of      0910-AF46
            Bovine Spongiform Encephalopathy......................................................
856         Over-the-Counter (OTC) Drug Review--Overindulgence in Food and Drink Products.........    0910-AF51
857         Over-the-Counter (OTC) Drug Review--Antacid Products..................................    0910-AF52
858         Over-the-Counter (OTC) Drug Review--Skin Bleaching Products...........................    0910-AF53
859         Designation of New Animal Drugs for Minor Uses or Minor Species.......................    0910-AF60
860         Index of Legally Marketed Unapproved New Animal Drugs for Minor Species...............    0910-AF67
861         Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic    0910-AF90
            National Stockpile....................................................................
862         Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and         0910-AF98
            Testing, and Related Labeling.........................................................
863         Over-the-Counter (OTC) Drug Review--Acne Drug Products Containing Benzoyl Peroxide....    0910-AG00
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
864         Requirements for Submission of In Vivo Bioequivalence Data............................    0910-AC23
865         Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs.............    0910-AC35
866         Prior Notice of Imported Food Under the Public Health Security and Bioterrorism           0910-AC41
            Preparedness and Response Act of 2002.................................................
867         Food Labeling: Trans Fatty Acids in Nutrition Labeling: Consumer Research To Consider     0910-AC50
            Nutrient Content and Health Claims and Possible Footnote or Disclosure Statements.....
868         Food Standards: General Principles and Food Standards Modernization...................    0910-AC54

[[Page 22494]]

 
869         Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding     0910-AF08
            of Drugs; Revision of Certain Labeling Controls.......................................
870         Health Claims.........................................................................    0910-AF09
871         Cochineal Extract and Carmine Label Declaration.......................................    0910-AF12
872         Obstetrical and Gynecological Devices; Designation of Special Control for Condoms and     0910-AF21
            Condoms With Spermicidal Lubricant....................................................
873         Food Labeling; Prominence of Calories.................................................    0910-AF22
874         Food Labeling; Serving Sizes of Products That Can Reasonably Be Consumed at One Eating    0910-AF23
            Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for
            Recommending Smaller Portion Sizes....................................................
875         Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products...............    0910-AF31
876         Over-the-Counter (OTC) Drug Review--Ophthalmic Products...............................    0910-AF39
877         Over-the-Counter (OTC) Drug Review--Oral Health Care Products.........................    0910-AF40
878         Use of Materials Derived From Cattle in Human Food and Cosmetics......................    0910-AF47
879         Use of Materials Derived From Cattle in Medical Products Intended for Use in Humans       0910-AF54
            and Drugs Intended for Use in Ruminants...............................................
880         Over-the-Counter (OTC) Drug Review--Urinary Analgesic Drug Products...................    0910-AF70
881         Food Labeling; Serving Sizes; Reference Amount for Baking Powder, Baking Soda, and        0910-AF99
            Pectin (Section 610 Review)...........................................................
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
882         Chronic Wasting Disease: Control of Food Products and Cosmetics Derived From Exposed      0910-AC21
            Animal Populations....................................................................
883         Medical Devices; Patient Examination and Surgeons' Gloves; Test Procedures and            0910-AC32
            Acceptance Criteria...................................................................
884         Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products..............    0910-AF32
885         Over-the-Counter (OTC) Drug Review--Dandruff, Seborrheic Dermatitis, and Psoriasis        0910-AF49
            Products..............................................................................
886         Supplements and Other Changes to Approved New Animal Drug Applications................    0910-AF59
887         Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation.....    0910-AF65
888         Over-the-Counter (OTC) Drug Review--Multiple Drug Products............................    0910-AG01
----------------------------------------------------------------------------------------------------------------


                        Health Resources and Services Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
889         Designation of Medically Underserved Populations and Health Professional Shortage         0906-AA44
            Areas.................................................................................
----------------------------------------------------------------------------------------------------------------


                         Health Resources and Services Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
890         National Practitioner Data Bank for Adverse Information on Physicians and Other Health    0906-AA57
            Care Practitioners: Reporting Adverse and Negative Actions............................
891         Requirements Establishing a Limitation on Administrative Expenses; Ryan White CARE Act    0906-AA65
            Title IV Grants for Coordinated Services and Access to Research.......................
892         National Vaccine Injury Compensation Program: Calculation of Average Cost of a Health     0906-AA68
            Insurance Policy......................................................................
----------------------------------------------------------------------------------------------------------------


[[Page 22495]]


                         Health Resources and Services Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
893         National Practitioner Data Bank for Adverse Information on Physicians and Other Health    0906-AA41
            Care Practitioners: Medical Malpractice Payments Reporting Requirements...............
894         Operation of the Organ Procurement and Transplantation Network (OPTN).................    0906-AA63
----------------------------------------------------------------------------------------------------------------


                         Health Resources and Services Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
895         Intestines Added to the Definition of Organs Covered by the Rules Governing the           0906-AA62
            Operation of the Organ Procurement and Transplantation Network (OPTN).................
896         Healthy Tomorrow's Partnership for Children (HTPC) Program............................    0906-AA70
----------------------------------------------------------------------------------------------------------------


                                     Indian Health Service--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
897         Section 506--Limitation on Charges for Services Furnished by Medicare-Participating       0917-AA07
            Inpatient Hospital to Indians.........................................................
----------------------------------------------------------------------------------------------------------------


                         Agency for Healthcare Research and Quality--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
898         Patient Safety and Quality Improvement Act of 2005 Rules..............................    0919-AA01
----------------------------------------------------------------------------------------------------------------


                               National Institutes of Health--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
899         Grants for Research Projects..........................................................    0925-AA42
900         National Institutes of Health Loan Repayment Programs.................................    0925-AA43
901         National Library of Medicine Training Grants..........................................    0925-AA44
902         Minority Biomedical Research Support Program..........................................    0925-AA45
903         National Institute of Environmental Health Sciences Hazardous Substances Basic            0925-AA46
            Research and Training Grants..........................................................
904         Endowment Program.....................................................................    0925-AA47
905         Undergraduate Scholarship Program Regarding Professions Needed by the National            0925-AA48
            Institutes of Health..................................................................
906         NIH Training Grants...................................................................    0925-AA49
907         NIH Center Grants.....................................................................    0925-AA50
----------------------------------------------------------------------------------------------------------------


                                 National Institutes of Health--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
908         Standards for a National Chimpanzee Sanctuary System..................................    0925-AA31
----------------------------------------------------------------------------------------------------------------


[[Page 22496]]


                                National Institutes of Health--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
909         NIH Construction Grant................................................................    0925-AA51
----------------------------------------------------------------------------------------------------------------


                              Office of Public Health and Science--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
910         Human Subjects Protection Regulations: Institutional Review Boards Registration           0940-AA06
            Requirements..........................................................................
----------------------------------------------------------------------------------------------------------------


                             Office of Public Health and Science--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
911         Public Health Service Standards for the Protection of Research Misconduct                 0940-AA01
            Whistleblowers........................................................................
912         Human Subjects Protection Regulations: Training and Ed. Requirements for Institutional    0940-AA08
            Officials, Institutional Review Board Members and Staff, Human Protections
            Administrators, and Investigators.....................................................
913         Human Subjects Protection Regulations: Additional Protections for Adult Individuals       0940-AA11
            With Impaired Decisionmaking Capacity.................................................
----------------------------------------------------------------------------------------------------------------


                          Centers for Medicare & Medicaid Services--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
914         Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610     0938-AG81
            Review)...............................................................................
915         Appeals of CMS or Contractor Determinations When a Provider or Supplier Fails To Meet     0938-AI49
            the Requirements for Medicare Billing (CMS-6003-P2)...................................
916         Rural Health Clinics: Amendments to Participation Requirements and Payment Provisions     0938-AJ17
            and Establishment of a Quality Assessment and Improvement Program (CMS-1910-P2).......
917         Use of Restraints and Seclusion in Medicare and Medicaid Participating Facilities That    0938-AL26
            Provide Inpatient or Residential Care (CMS-2130-P)....................................
918         Revisions to Conditions for Coverage for Ambulatory Surgical Centers (CMS-3887-P).....    0938-AL80
919         Modifications to Electronic Transactions and Code Sets (CMS-0009-P)...................    0938-AM50
920         Revisions to HIPAA Code Sets (CMS-0013-P).............................................    0938-AN25
921         National Plan and Provider Enumeration System (NPPES) Data Dissemination (CMS-6060-NC)    0938-AN71
922         Changes to the Disclosure of Information Requirements for Quality Improvement             0938-AN73
            Organizations (CMS-3156-P)............................................................
923         Payments for Service Provided Without Charge (CMS-2489-P).............................    0938-AO07
924         Medical Improvement Eligibility Group and Definition of Work (CMS-2143-P).............    0938-AO10
925         Outpatient Hospital Services and Rural Health Clinic Services Amendment (CMS-2213-P)..    0938-AO17
926         Redistribution of Unexpended State Children's Health Insurance Program (SCHIP) Funds      0938-AO28
            From the Appropriation for Fiscal Year 2004 (CMS-2241-NC).............................
927         Home Health Prospective Payment System Refinements and Rate Update for Calendar Year      0938-AO32
            2008 (CMS-1541-P).....................................................................
928         Gynecological Cytology Proficiency Testing Requirements for Laboratories, Individuals,    0938-AO34
            and Proficiency Testing Program Approvals (CMS-2252-P)................................
929         State Option To Establish Non-Emergency Medical Transportation Program (CMS-2234-P)...    0938-AO45
930         Premiums and Cost Sharing (CMS-2244-P)................................................    0938-AO47
931         State Flexibility for Medicaid Benefit Packages (CMS-2232-P)..........................    0938-AO48
932         Self-Directed Personal Assistance Services State Plan Option (CMS-2229-P).............    0938-AO52
933         Home and Community-Based Services (HCBS) State Plan Option (CMS-2249-P)...............    0938-AO53
934         Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2008 (CMS-      0938-AO63
            1551-P)...............................................................................
935         Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities--      0938-AO64
            Update for FY 2008 (CMS-1545-P).......................................................
936         Revisions to Payment Policies Under the Physician Fee Schedule and Other Changes to       0938-AO65
            Payment Under Part B for CY 2008 (CMS-1385-P).........................................
937         Standards for E-Prescribing Under Medicare Part D (CMS-0016-P)........................    0938-AO66

[[Page 22497]]

 
938         Exemption of Privacy Act Disclosure of Certain Investigative Materials (CMS-0029-P)...    0938-AO69
939         Changes to the Hospital Inpatient Prospective Payment Systems and FY 2008 Rates (CMS-     0938-AO70
            1533-P)...............................................................................
940         Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical     0938-AO71
            Center Payment System Calendar Year 2008 Payment Rates (CMS-1392-P)...................
941         Hospice Wage Index for FY 2008 (CMS-1539-P)...........................................    0938-AO72
942         Policy and Technical Changes to the Medicare Prescription Drug Benefit (CMS-4130-P)...    0938-AO74
943         Special Enrollment Period and Medicare Premium Changes (CMS-4129-P)...................    0938-AO77
944         Revisions to the Medicare Advantage and Part D Prescription Drug Contract                 0938-AO78
            Determinations, Appeals, and Intermediate Sanctions Processes (CMS-4124-P)............
945         Rehabilitation Services: State Plan Option (CMS-2261-P)...............................    0938-AO81
946         Waiver of Disapproval of Nurse Aide Training Program in Certain Cases and Nurse Aide      0938-AO82
            Petition for Removal of Information for Singular Finding of Neglect (CMS-2266-P)......
947         Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics,          0938-AO84
            Orthotics, and Supplies (DMEPOS) (CMS-6006-P).........................................
948         Children of State Employees: Premium Assistance (CMS-2148-P)..........................    0938-AO86
949         Application of Certain Part 405 Appeals Provisions to the Part 423 Medicare               0938-AO87
            Prescription Drug Appeals Process (CMS-4127-P)........................................
950         Limitation on Contractor Liability (CMS-2264-P).......................................    0938-AO88
951         Health Insurance Reform: Remote Security Standards (CMS-0020-P).......................    0938-AO89
952         Establishing Additional Provider and Supplier Requirements for Enrollment Standards       0938-AO90
            and Related Issues (CMS-6036-P).......................................................
953         Emergency Preparedness Requirements for Medicare Participating Providers and Suppliers    0938-AO91
            (CMS-3178-P)..........................................................................
954         Inpatient Psychiatric Facility Prospective Payment System--Update for Rate Year           0938-AO92
            Beginning July 1, 2008 (RY 2009) (CMS-1401-P).........................................
955         Prospective Payment System for Long-Term Care Hospitals RY 2009: Annual Payment Rate      0938-AO94
            Updates (CMS-1393-P)..................................................................
----------------------------------------------------------------------------------------------------------------


                           Centers for Medicare & Medicaid Services--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
956         End Stage Renal Disease (ESRD) Conditions for Coverage (CMS-3818-F) (Section 610          0938-AG82
            Review)...............................................................................
957         Hospital Conditions of Participation: Laboratory Services (CMS-3014-IFC) (Section 610     0938-AJ29
            Review)...............................................................................
958         Use of Restraints and Seclusion in Residential Treatment Facilities Providing             0938-AJ96
            Inpatient Psychiatric Services to Individuals Under Age 21 (CMS-2065-F)...............
959         Physicians' Referrals to Health Care Entities With Which They Have Financial              0938-AK67
            Relationships (CMS-1810-RCN)..........................................................
960         Provider Reimbursement Determinations and Appeals (CMS-1727-F)........................    0938-AL54
961         Revisions to the Appeals Process for Initial Claim Determinations (CMS-4064-F)........    0938-AM73
962         Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals Procedures    0938-AM98
            (CMS-6146-F)..........................................................................
963         Enhanced DSH Treatment for Certain Hospitals (CMS-2198-F).............................    0938-AN09
964         Competitive Acquisition for Certain Durable Medical Equipment (DME), Prosthetics,         0938-AN14
            Orthotics, and Supplies (CMS-1270-F)..................................................
965         Medicaid Prescription Drugs--Average Manufacturer Price (CMS-2238-F)..................    0938-AO20
966         Prospective Payment System for Long-Term Care Hospitals RY 2008: Annual Payment Rate      0938-AO30
            Updates and Policy Changes(CMS-1529-F)................................................
967         Inpatient Psychiatric Facility Prospective Payment System--Update for Rate Year 2008      0938-AO40
            (CMS-1479-N)..........................................................................
968         Group Health Plans and Health Insurance Issues Under the Newborns and Mothers Health      0938-AO43
            Protection Act (CMS-4116-F)...........................................................
969         High Risk Pools (CMS-2260-IFC)........................................................    0938-AO46
970         Targeted Case Management (CMS-2237-IFC)...............................................    0938-AO50
971         Citizenship Documentation Requirements (CMS-2257-F)...................................    0938-AO51
972         Cost Limits for Governmentally-Operated Providers (CMS-2258-F) (Section 610 Review)...    0938-AO57
973         Inpatient Hospital Deductible and Hospital and Extended Care Services Co-insurance        0938-AO61
            Amounts for CY 2008 (CMS-8032-N)......................................................
974         Part A Premiums for CY 2008 for the Uninsured Aged and for Certain Disabled               0938-AO62
            Individuals Who Have Exhausted Other Entitlement (CMS-8031-N).........................
975         Part B Monthly Actuarial Rates and Premium Rates Beginning January 1, 2008 (CMS-8033-     0938-AO68
            N)....................................................................................

[[Page 22498]]

 
976         Revised Payment System for Services Furnished in Ambulatory Surgical Centers (ASCs)       0938-AO73
            Effective January 1, 2008 (CMS-1517-F)................................................
977         Fiscal Year 2008 SCHIP Allotments (CMS-2262-N)........................................    0938-AO76
978         Health Care-Related Tax Revisions (CMS-2275-P)........................................    0938-AO80
979         Extending Sunset Date for the Interim Final Regulation on Mental Health Parity (CMS-      0938-AO83
            4094-F5)..............................................................................
980         Fee Schedule for Payment of Ambulance Services--Update for CY 2008 (CMS-1552-N).......    0938-AO85
----------------------------------------------------------------------------------------------------------------


                           Centers for Medicare & Medicaid Services--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
981         Hospice Care Conditions of Participation (CMS-3844-F) (Section 610 Review)............    0938-AH27
982         Electronic Claims Attachments Standards (CMS-0050-F)..................................    0938-AK62
983         Health Coverage Portability: Tolling Certain Time Periods and Interactions With Family    0938-AL88
            and Medical Leave Act (CMS-2158-F)....................................................
984         Prior Determination Process for Certain Items and Services (CMS-6024-F)...............    0938-AN10
985         Medicare Secondary Payer Amendments (CMS-6272-F)......................................    0938-AN27
986         Termination of Non-Random Prepayment Review (CMS-6022-F)..............................    0938-AN31
987         Limitation on Recoupment of Provider and Supplier Overpayments (CMS-6025-F)...........    0938-AN42
988         Medicare Part B Competitive Acquisition of Outpatient Drugs and Biologicals (CMS-1325-    0938-AN58
            F)....................................................................................
989         Medicare Integrity Program, Fiscal Intermediary and Carrier Functions, and Conflict of    0938-AN72
            Interest Requirements (CMS-6030-F)....................................................
990         Payment Error Rate Measurement (PERM) Program (CMS-6026-F)............................    0938-AN77
991         Fire Safety Requirements for Long-Term Care Facilities: Sprinkler Systems (CMS-3191-F)    0938-AN79
992         Use of Repayment Plans (CMS-6032-F)...................................................    0938-AO27
993         Identification of Backward Compatible Version of Adopted Standard for E-Prescribing       0938-AO42
            and the Medicare Prescription Drug Program (Version 8.1) (CMS-0018-F).................
994         Prohibition of Mid-Year Benefit Enhancements for Medicare Advantage Organizations         0938-AO54
            Offering Plans in Calendar Year 2007 and Subsequent Calendar Years (CMS-4121-F).......
995         Medicare Part D Data (CMS-4119-F).....................................................    0938-AO58
----------------------------------------------------------------------------------------------------------------


                           Centers for Medicare & Medicaid Services--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
996         Hospital Conditions of Participation: Requirements for Approval and Reapproval of         0938-AH17
            Transplant Centers To Perform Organ Transplants (CMS-3835-F)..........................
997         Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-P).............    0938-AM87
998         Hospital Conditions of Participation: Requirements for History and Physical               0938-AM88
            Examinations; Authentication of Verbal Orders; Securing Medications; and Post-
            Anesthesia Evaluations (CMS-3122-F)...................................................
999         Nondiscrimination in Health Coverage in the Group Market (CMS-4081-F).................    0938-AN29
1000        Hospital Conditions of Participation: Patients' Rights (CMS-3018-F)...................    0938-AN30
1001        Program for All-Inclusive Care for the Elderly (PACE): Program Revisions (CMS-1201-F).    0938-AN83
1002        Medicare Graduate Medical Education Affiliation Provisions for Teaching Hospitals in      0938-AO35
            Certain Emergency Situations (CMS-1531-F2)............................................
1003        Notification Procedures for Hospital Discharges (CMS-4105-F)..........................    0938-AO41
----------------------------------------------------------------------------------------------------------------


                          Administration for Children and Families--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1004        Developmental Disabilities and Bill of Rights Act.....................................    0970-AC07
1005        Care and Placement of Unaccompanied Alien Children....................................    0970-AC20

[[Page 22499]]

 
1006        Adoption and Foster Care Analysis and Reporting System................................    0970-AC23
1007        Privatizing Functions.................................................................    0970-AC25
1008        Limitation on Use of Funds Made Available To Monitor and Combat Trafficking in Persons    0970-AC28
1009        Child Care and Development Fund Error Rate Reporting..................................    0970-AC29
1010        Abstinence Education..................................................................    0970-AC30
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1011        Safeguarding Child Support and Expanded Federal Parent Locator Services (FPLS)            0970-AC01
            Information...........................................................................
1012        Cost Allocation Methodology Applicable to the Temporary Assistance for Needy Families     0970-AC15
            Program...............................................................................
1013        Child Care and Development Fund State Match Provisions................................    0970-AC18
1014        Chafee National Youth in Transition Database..........................................    0970-AC21
1015        Medical Support.......................................................................    0970-AC22
1016        Child Support Provisions of the Deficit Reduction Act.................................    0970-AC24
1017        TANF Work Provisions of the Deficit Reduction Act.....................................    0970-AC27
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1018        Head Start Transportation.............................................................    0970-AC26
----------------------------------------------------------------------------------------------------------------

_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




774. REVISIONS TO REGULATIONS ADDRESSING THE OIG'S AUTHORITY TO IMPOSE 
CIVIL MONEY PENALTIES AND ASSESSMENTS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1320a-7a; 42 USC 1395mm; 42 USC 1395w-27; 42 
USC 1396b; 42 USC 1396u-2

CFR Citation: 42 CFR 1003

Legal Deadline: None

Abstract: This proposed rule would revise part 1003, addressing the 
Office of Inspector General's authority to propose the imposition of 
civil money penalties and assessments by reorganizing and simplifying 
existing regulatory text and eliminating obsolete references contained 
in the current regulations. Among the proposed revisions, this rule 
would establish separate subparts within part 1003 for various 
categories of violations; modify the current definition for the term 
``claim''; date various references to managed care organization 
authorities; and clarify the application of section 1140 of the Social 
Security Act with respect to the misuse of certain Departmental 
symbols, emblems, or names through Internet and e-mail communications.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/07
NPRM Comment Period End         12/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Joel Jay Schaer, Regulations Officer, Department of 
Health and Human Services, Office of the Secretary, Office of Inspector 
General, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089

RIN: 0991-AB03

[[Page 22500]]

_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




775. SHARED RISK EXCEPTION TO THE SAFE HARBOR PROVISIONS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 1320a-7b; 42 USC 1395hh; PL 104-
191, sec 216(b)

CFR Citation: 42 CFR 1001

Legal Deadline: Final, Statutory, January 1, 1997.

Abstract: This final rule establishes a new statutory exception for 
risk-sharing arrangements under the Federal health care programs' anti-
kickback provisions. The rule sets forth an exception from liability 
for remuneration between an eligible organization and an individual or 
entity providing items or services in accordance with a written 
agreement between these parties. The rule allows remuneration between 
an organization and an individual or entity if a written agreement 
places the individual or entity at ``substantial financial risk'' for 
the cost or utilization of the items or services that the individual or 
entity is obligated to provide.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           05/23/97                    62 FR 28410
ANPRM Comment Period End        06/09/97
Interim Final Rule              11/19/99                    64 FR 63504
Final Action                    10/00/07

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Joel Jay Schaer, Regulations Officer, Department of 
Health and Human Services, Office of the Secretary, Office of Inspector 
General, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089

Related RIN: Related to 0991-AB06
RIN: 0991-AA91
_______________________________________________________________________




776. SAFE HARBOR FOR WAIVER OF BENEFICIARY CO-INSURANCE AND DEDUCTIBLE 
AMOUNTS FOR A MEDICARE SELECT POLICY

Priority: Substantive, Nonsignificant

Legal Authority: PL 100-93, sec 14(a)

CFR Citation: 42 CFR 1001

Legal Deadline: None

Abstract: This final rule will expand the existing safe harbor for 
certain waivers of beneficiary coinsurance and deductible amounts to 
benefit the policyholders of Medicare SELECT supplemental insurance. 
Specifically, the amended safe harbor will protect waivers of 
coinsurance and deductible amounts under part A or part B of the 
Medicare program owed by beneficiaries covered by a Medicare SELECT 
policy issued in accordance with section 1882(t)(1) of the Social 
Security Act, if the waiver is in accordance with a price reduction 
agreement covering such policyholders between the Medicare SELECT 
issuer and the provider or supplier offering the waiver.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/25/02                    67 FR 60202
NPRM Comment Period End         10/25/02
Final Action                    10/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Joel Jay Schaer, Regulations Officer, Department of 
Health and Human Services, Office of the Secretary, Office of Inspector 
General, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089

RIN: 0991-AB16
_______________________________________________________________________




777. CLARIFICATION OF TERMS AND APPLICATION OF PROGRAM EXCLUSION 
AUTHORITY FOR SUBMITTING CLAIMS CONTAINING EXCESSIVE CHARGES

Priority: Substantive, Nonsignificant

Legal Authority: Social Security Act, sec 112B(6); Social Security Act, 
sec 112B(6)(A)

CFR Citation: 42 CFR 1001

Legal Deadline: None

Abstract: This rule would amend the Office of Inspector General's 
exclusion regulations at 42 CFR part 1001.701, addressing excessive 
claims by including definitions for the terms ``substantially in 
excess'' and ``usual charges,'' and by clarifying the ``good cause'' 
exception set forth in this section.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/15/03                    68 FR 53939
NPRM Comment Period End         11/14/03
Final Action                    10/00/07

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Joel Jay Schaer, Regulations Officer, Department of 
Health and Human Services, Office of the Secretary, Office of Inspector 
General, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089

RIN: 0991-AB23
_______________________________________________________________________




778. MEDICARE AND STATE HEALTH CARE PROGRAMS: FRAUD AND ABUSE; SAFE 
HARBOR FOR FEDERALLY QUALIFIED HEALTH CENTERS UNDER THE ANTI-KICKBACK 
STATUTE

Priority: Other Significant

Legal Authority: PL 100-93, sec 14(a); PL 108-173, sec 431

CFR Citation: 42 CFR 1001

Legal Deadline: Final, Statutory, December 8, 2004.

Abstract: This rule will set forth standards for the new anti-kickback 
safe harbor addressing remuneration between federally qualified health 
centers and certain providers where significant community benefit 
exists.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              07/01/05                    70 FR 38081
Interim Final Rule Comment 
Period End                      08/01/05
Final Action                    09/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Joel Jay Schaer, Regulations Officer, Department of 
Health and Human Services, Office of the Secretary, Office of Inspector 
General, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089

Related RIN: Related to 0991-AB06, Related to 0991-AA91
RIN: 0991-AB38

[[Page 22501]]

_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




779. REVISIONS TO THE WAIVER PROVISIONS OF THE OFFICE OF INSPECTOR 
GENERAL'S (OIG) EXCLUSION AUTHORITIES

Priority: Substantive, Nonsignificant

Legal Authority: PL 108-173, sec 949; PL 105-33, sec 4331; Social 
Security Act, sec 1128(c)(3)(b)

CFR Citation: 42 CFR 1001

Legal Deadline: None

Abstract: In accordance with section 949 of the Medicare Prescription 
Drug Improvement and Modernization Act of 2003, this rule would revise 
the OIG's exclusion authority to permit any Federal health care program 
to request a waiver of an OIG exclusion imposed under sections 
1128(a)(1), 1128(a)(3), or 1128(a)(4) of the Social Security Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal

Agency Contact: Joel Jay Schaer, Regulations Officer, Department of 
Health and Human Services, Office of the Secretary, Office of Inspector 
General, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089

RIN: 0991-AB33
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Office of the Secretary (OS)



_______________________________________________________________________




780. DEBT COLLECTION

Priority: Other Significant

CFR Citation: 45 CFR 30

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/08/07                    72 FR 10404

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jeffrey S. Davis
Phone: 202 619-0150

RIN: 0991-AB18
_______________________________________________________________________




781. SALARY OFFSET

Priority: Other Significant

CFR Citation: 5 CFR 550; 45 CFR 33

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/08/07                    72 FR 10419

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jeffrey S. Davis
Phone: 202 619-0150

RIN: 0991-AB19
_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




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

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: PL 106-310, 42 USC 290jj to 290jj-2

CFR Citation: Not Yet Determined

Legal Deadline: NPRM, Statutory, April 2001.

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                            07/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Paolo Del Vecchio, Department of Health and Human 
Services, Substance Abuse and Mental Health Services Administration, 
Room 13-103, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 443-2619

RIN: 0930-AA10

[[Page 22502]]

_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




783. MANDATORY GUIDELINES FOR THE FEDERAL WORKPLACE DRUG TESTING PROGRAM

Priority: Other Significant

Legal Authority: PL 100-71; 5 USC 7301

CFR Citation: None

Legal Deadline: NPRM, Statutory, December 2003.

Abstract: HHS is proposing to establish scientific and technical 
guidelines for the testing of hair, sweat, and oral fluid specimens in 
addition to urine specimens; scientific and technical guidelines for 
using on-site tests to test urine and oral fluids at the collection 
site; requirements for the certification of instrumented initial test 
facilities; and added standards for collectors, on-site testers, and 
medical review officers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          04/13/04                    69 FR 19673
Final Action                    07/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal

Agency Contact: Joseph Denis Faha, Director, DLEA, SAMHSA, Department 
of Health and Human Services, Substance Abuse and Mental Health 
Services Administration, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 443-7017
Fax: 301 443-1450
Email: [email protected]

RIN: 0930-AA12
_______________________________________________________________________


Department of Health and Human Services (HHS)             Prerule Stage


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




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

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 71

Legal Deadline: None

Abstract: The Centers for Disease Control and Prevention (CDC) is 
issuing this Advance Notice of Proposed Rulemaking (ANPRM) to begin the 
process of revising the regulations for importation of dogs, cats, and 
other animals into the United States (42 CFR parts 71.51 and 71.56).
The input received from stakeholders via the ANPRM will guide CDC in 
drafting a rule proposal with the aim of improving CDC's ability to 
prevent importation of communicable diseases. The scope of this ANPRM 
does not include the nonhuman primate regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           12/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Jennifer Brooks, Department of Health and Human 
Services, Centers for Disease Control and Prevention, National Center 
for Infectious Diseases (NE E-03), 1600 Clifton Road NE., Atlanta, GA 
30333
Phone: 404 639-7048

RIN: 0920-AA14
_______________________________________________________________________




785. AMENDMENTS TO POWERED AIR-PURIFYING RESPIRATOR REQUIREMENTS FOR 
APPROVAL OF RESPIRATORY PROTECTION DEVICES

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority: 28 USC 651; 30 USC 3; 30 USC 7; 30 USC 11; 30 USC 842; 
30 USC 844

CFR Citation: 42 CFR 84

Legal Deadline: None

Abstract: NIOSH plans to modify sections of 42 CFR part 84 concerning 
performance testing and other specifications for the certification of 
powered air-purifying respirators. These respirators are used in a 
variety of workplace applications, including emergency response 
activities.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           03/00/08

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Frank Palya, Department of Health and Human Services, 
Centers for Disease Control and Prevention, 626 Cochran Mill Road, 
Pittsburgh, PA 15236
Phone: 412 386-5200
Fax: 412 386-4089
Email: [email protected]

Bill Hoffman, Department of Health and Human Services, Centers for 
Disease Control and Prevention, 626 Cochran Mill Road, Pittsburgh, PA 
15236
Phone: 412 386-5200
Fax: 412 386-4089
Email: [email protected]

RIN: 0920-AA16

[[Page 22503]]

_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




786. AMENDMENTS TO QUALITY ASSURANCE AND ADMINISTRATIVE PROVISION FOR 
APPROVAL OF RESPIRATORY PROTECTIVE DEVICES

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 29 USC 651 et seq; 30 USC 3; 30 USC 5; 30 USC 7; 30 
USC 811; 30 USC 842(h); 30 USC 844

CFR Citation: 42 CFR 84

Legal Deadline: None

Abstract: NIOSH plans to modify the Administrative/Quality Assurance 
sections of 42 CFR part 84, Approval of Respiratory Protective Devices. 
Areas for potential modification in this module are: 1) Upgrade of 
quality assurance requirements; 2) ability to use private sector 
quality auditors and private sector testing laboratories in the 
approval program; 3) revised approval label requirements; 4) updated 
and restructured fee schedule; and 5) fee retention in the respirator 
program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/07

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

Agency Contact: Bill Hoffman, Department of Health and Human Services, 
Centers for Disease Control and Prevention, 626 Cochran Mill Road, 
Pittsburgh, PA 15236
Phone: 412 386-5200
Fax: 412 386-4089
Email: [email protected]

RIN: 0920-AA04
_______________________________________________________________________




787. AMENDMENTS TO SELF-CONTAINED BREATHING APPARATUS REQUIREMENTS FOR 
APPROVAL OF RESPIRATORY PROTECTIVE DEVICES

Priority: Other Significant

Legal Authority: 29 USC 651 et seq; 30 USC 3; 30 USC 5; 30 USC 7; 30 
USC 811; 30 USC 842; 30 USC 844

CFR Citation: 42 CFR 84

Legal Deadline: None

Abstract: NIOSH plans to modify sections of 42 CFR part 84 concerning 
performance testing and other specifications for the certification of 
closed-circuit, self-contained breathing apparatus. These respiratory 
protective devices are used in emergencies for the protection of miners 
and workers in other industries.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/07

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

Agency Contact: Tim Rehak, Department of Health and Human Services, 
Centers for Disease Control and Prevention, 626 Cochran Mill Road, 
Pittsburgh, PA 15236
Phone: 412 386-5200
Fax: 412 386-4089
Email: [email protected]

RIN: 0920-AA10
_______________________________________________________________________




788. AMENDMENTS TO REQUIREMENTS FOR COAL MINE DUST PERSONAL SAMPLER 
UNITS

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: NIOSH and MSHA jointly plan to modify 30 CFR part 74, which 
provides requirements for the approval by NIOSH and MSHA of coal mine 
dust personal sampler units that are worn by miners to determine the 
concentrations of respirable dust in coal mine atmospheres. The 
existing requirements are design-specific for a particular monitoring 
technology that has been available since the 1970s. The amendments 
would establish requirements that would promote the development and 
govern the testing and approval of new coal mine dust sampler designs 
and technology for use in coal mines.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/07

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: John Breslin, Director, Science, Pittsburgh Research 
Laboratory, Department of Health and Human Services, Centers for 
Disease Control and Prevention, 626 Cochrans Mill Road, Pittsburgh, PA 
15236
Phone: 412 386-6873

RIN: 0920-AA18
_______________________________________________________________________




789. [bull] MEDICAL EXAMINATION OF ALIENS

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 34

Legal Deadline: None

Abstract: CDC is changing the definition of ``communicable disease of 
public health significance'' in 42 CFR part 34.2(b). We are taking this 
action to afford CDC the maximum flexibility it needs to identify and 
respond to newly emerging and reemerging diseases. The existing 
definition is outdated, and immediate changes are urgently needed to 
improve the U.S. Government's ability to prevent the importation of 
infectious diseases that are currently causing severe illness and death 
in regions of the world where large numbers of U.S.-bound immigrants 
and refugees reside. Annually, approximately 500,000 immigrants and 
refugees enter the United States to reside permanently. The majority 
arrive from Asia, Africa, and Central and South America, regions with 
recently reported outbreaks of emerging infectious diseases.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Jennifer Brooks, Department of Health and Human 
Services, Centers for Disease Control and Prevention, National Center 
for Infectious Diseases (NE E-03), 1600 Clifton Road NE., Atlanta, GA 
30333
Phone: 404 639-7048

RIN: 0920-AA20

[[Page 22504]]

_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




790. CONTROL OF COMMUNICABLE DISEASES, INTERSTATE AND FOREIGN QUARANTINE

Priority: Economically Significant. Major under 5 USC 801.

Unfunded Mandates: This action may affect the private sector under PL 
104-4.

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 70 to 71

Legal Deadline: None

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. The Secretary has delegated the 
authority to prevent the introduction of diseases from foreign 
countries to the Director, CDC. CDC maintains quarantine stations at 
eight major airports with quarantine inspectors 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, and Severe 
Acute Respiratory Syndrome (SARS) and influenza caused by novel or 
reemergent influenza virus 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                    07/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Ram Koppaka M.D., Ph.D, Department of Health and Human 
Services, Centers for Disease Control and Prevention, MS-E-03, 1600 
Clifton Road, Atlanta, GA 30333
Phone: 404 498-2308

RIN: 0920-AA12
_______________________________________________________________________




791. PROCEDURES FOR DESIGNATING CLASSES OF EMPLOYEES AS MEMBERS OF THE 
SPECIAL EXPOSURE COHORT UNDER THE ENERGY EMPLOYEES OCCUPATIONAL ILLNESS 
COMPENSATION PROGRAM ACT OF 2000; AMENDMENTS

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: None

Legal Deadline: None

Abstract: HHS is amending its procedures to consider designating 
classes of employees to be added to the Special Exposure Cohort under 
the Energy Employees Occupational Illness Compensation Program Act of 
2000 (``EEOICPA''), 42 U.S.C. sections 7384 to 7385. HHS must change 
these procedures to implement amendments to EEOICPA enacted on October 
28, 2004, as part of the Ronald W. Reagan National Defense 
Authorization Act for Fiscal Year 2005, Public Law No. 108-375 
(codified as amended in scattered sections of 42 U.S.C.).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              12/22/05                    70 FR 75949
Interim Final Rule Comment 
Period End                      02/21/06
Final Action                    07/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Larry Elliott, Director, Office of Compensation 
Analysis and Support, Department of Health and Human Services, Centers 
for Disease Control and Prevention, MS C-46, 4676 Columbia Parkway, 
Cincinnati, OH 45226
Phone: 513 533-6825

RIN: 0920-AA13
_______________________________________________________________________




792. INTERSTATE SHIPMENT OF ETIOLOGIC AGENTS

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 72

Legal Deadline: None

Abstract: HHS/CDC proposes to rescind part 72 of title 42, Code of 
Federal Regulations, which governs the interstate shipment of etiologic 
agents, because the U.S. Department of Transportation (DOT) already has 
in effect a more comprehensive set of regulations applicable to the 
transport in commerce of infectious substances. DOT harmonizes its 
transport requirements with international standards adopted by the 
United Nations (UN) Committee of Experts on the Transport of Dangerous 
Goods for the classification, packaging, and transport of infectious 
substances. Rescinding the rule will eliminate duplication of the more 
current DOT regulations that cover intrastate and international, as 
well as interstate, transport. HHS/CDC replaced those sections of part 
72 that deal with select biological agents and toxins with a new set of 
regulations found in part 73 of title 42. HHS/CDC anticipates that 
rescission of part 72 will alleviate confusion and reduce the 
regulatory burden with no adverse impact on public health and safety.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/02/07                       72 FR 92
Interim Final Rule              07/00/07

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Janet K. Nicholson, Associate Director, Lab Science, 
Department of Health and Human Services, Centers for Disease Control 
and Prevention, Room 5131, Clifton Building 16, Atlanta, GA 30329-4018
Phone: 404 639-3945

RIN: 0920-AA19

[[Page 22505]]

_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




793. AMENDMENTS TO PERFORMANCE REQUIREMENTS FOR CHEMICAL, BIOLOGICAL, 
RADIOLOGICAL, AND NUCLEAR (CBRN) APPROVAL OF RESPIRATORY PROTECTION 
DEVICES

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 29 USC 651; 30 USC 3; 30 USC 5; 30 USC 7; 30 USC 11; 
30 USC 842l; 30 USC 844

CFR Citation: 42 CFR 84

Legal Deadline: None

Abstract: NIOSH plans to modify sections of 42 CFR part 84 concerning 
performance testing and other specifications for the certification of 
closed-circuit, self-contained breathing apparatus; supplied air 
respirators; and combination (supplied air and air purifying capable) 
respirators against CBRN respiratory hazards. These respirators are 
used in emergency response situations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           03/00/09

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Bill Hoffman, Department of Health and Human Services, 
Centers for Disease Control and Prevention, 626 Cochran Mill Road, 
Pittsburgh, PA 15236
Phone: 412 386-5200
Fax: 412 386-4089
Email: [email protected]

RIN: 0920-AA17
_______________________________________________________________________


Department of Health and Human Services (HHS)             Prerule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________




794. MEDICAL DEVICES; CURRENT GOOD MANUFACTURING PRACTICE (CGMP) FINAL 
RULE; QUALITY SYSTEMS REGULATIONS (SECTION 610 REVIEW)

Priority: Routine and Frequent

Legal Authority: 5 USC 610

CFR Citation: 21 CFR 808; 21 CFR 812; 21 CFR 820

Legal Deadline: None

Abstract: FDA is initiating a review under section 610 of the 
Regulatory Flexibility Act for the regulations in part 820. The purpose 
of this review is to determine if any of the regulations in part 820 
should be continued without change, or should be amended or rescinded, 
to minimize adverse economic impacts on small entities. FDA will 
consider and is soliciting comments on the following: 1) The continued 
need for a regulation in part 820; 2) the nature of complaints or 
comments received concerning a regulation in part 820; 3) the 
complexity of a regulation in part 820; 4) the extent to which a 
regulation in part 820 overlaps, duplicates, or conflicts with other 
Federal, State, or local government rules; and 5) the degree to which 
technology, economic conditions, or other factors have changed in the 
area affected by a regulation in part 820.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review of Current 
Regulation                      04/00/07
End Review                      12/00/07

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Myrna Hanna, Regulations Staff, Department of Health 
and Human Services, Food and Drug Administration, Center for Devices 
and Radiological Health (HFZ-215), PI50 RM150F, 1350 Piccard Drive, 
Rockville, MD 20850
Phone: 240 276-2347
Fax: 240 276-2352
Email: [email protected]

RIN: 0910-AF71
_______________________________________________________________________




795. PACKAGE SIZE LIMITATION FOR SODIUM PHOSPHATES ORAL SOLUTION AND 
WARNING AND DIRECTION STATEMENTS FOR ORAL AND RECTAL SODIUM PHOSPHATES 
FOR OVER-THE-COUNTER LAXATIVE USE (SECTION 610 REVIEW)

Priority: Routine and Frequent. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 5 USC 610

CFR Citation: 21 CFR 201.307

Legal Deadline: None

Abstract: Section 201.307 (21 CFR sec. 201.307) describes a final rule 
to limit the container size for sodium phosphates oral solution 
(dibasic sodium phosphate/monobasic sodium phosphate oral solution) to 
not greater than 90 milliliters (mL) (3 ounces (oz)) when used as an 
over-the-counter (OTC) laxative drug product. FDA limited the container 
size due to reports of deaths associated with an overdosage of sodium 
phosphates when packaged in a larger size container and a larger-than-
intended dose was ingested inadvertently. In addition, this final rule 
required warning and direction statements to inform consumers that 
exceeding the recommended dose of oral and rectal sodium phosphates 
products in a 24-hour period could be harmful.
FDA is initiating a review under section 610 of the Regulatory 
Flexibility Act for the regulation in section 201.307. The purpose of 
this review is to determine whether the regulation in section 201.307 
should be continued without change, or whether it should be further 
amended or rescinded, consistent with the stated objectives of 
applicable statutes, to minimize adverse impacts on a substantial 
number of small entities. FDA will consider, and is soliciting comments 
on the following: (1) The continued need for the regulation in section 
201.307; (2) the nature of the complaints or comments received 
concerning the regulation in section 201.307; (3) the complexity of the 
regulation in section 201.307; (4) the extent to which the regulation 
in section 201.307 overlaps, duplicates, or conflicts with other 
Federal, State, or governmental rules; and (5) the degree to which 
technology, economic conditions, or other factors have changed for the 
products still subject to the package size and labeling regulation in 
section 201.307.
The section 610 review will be carried out along with a regulatory 
review

[[Page 22506]]

under section 5 of Executive Order 12866, which calls for agencies to 
periodically review existing regulations to determine whether any 
should be modified or eliminated so as to make the Agency's regulatory 
program more effective in achieving its goals, less burdensome, or in 
greater alignment with the President's priorities and the principles 
set forth in the Executive order.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review of Current 
Regulation                      12/01/06
End Review                      12/00/07

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Walter Jefferson 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: [email protected]

RIN: 0910-AF73
_______________________________________________________________________




796. OVER-THE-COUNTER DRUG PRODUCTS CONTAINING ANALGESIC/ANTIPYRETIC 
ACTIVE INGREDIENTS FOR INTERNAL USE: REQUIRED ALCOHOL WARNING (SECTION 
610 REVIEW)

Priority: Routine and Frequent. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 5 USC 610

CFR Citation: 21 CFR 201.322

Legal Deadline: None

Abstract: Section 201.322 describes a regulation that requires an 
alcohol warning for all over-the-counter (OTC) drug products, labeled 
for adult use, containing internal analgesic/antipyretic active 
ingredients. The required warning statements advise consumers with a 
history of heavy alcohol use to consult a physician for advice about 
the use of OTC internal analgesic/antipyretic drug products. FDA issued 
the final rule after considering comments on the Agency's proposed 
regulation for OTC internal analgesic, antipyretic, and antirheumatic 
drug products: A proposed regulation to establish an alcohol warning, 
recommendations from its Nonprescription Drugs Advisory Committee 
(NDAC) and Arthritis Drugs Advisory Committee (ADAC), and data 
submitted to the agency.
FDA is initiating a review under section 610 of the Regulatory 
Flexibility Act for the regulation in section 201.322. The purpose of 
this review is to determine whether the regulation in section 201.322 
should be continued without change, or whether it should be further 
amended or rescinded, consistent with the stated objectives of 
applicable statutes, to minimize adverse impacts on a substantial 
number of small entities. FDA proposed to remove section 201.322 in the 
Federal Register on December 26, 2006, (71 FR 77314). FDA will consider 
the comments received in response to that proposal and, in addition, is 
soliciting comments on the following: (1) The continued need for the 
regulation in section 201.322; (2) the nature of the complaints or 
comments received concerning the regulation in section 201.322; (3) the 
complexity of the regulation in section 201.322; (4) the extent to 
which the regulation in section 201.322 overlaps, duplicates, or 
conflicts with other Federal, State, or governmental rules; and (5) the 
degree to which technology, economic conditions, or other factors have 
changed for the products still subject to the labeling regulation in 
section 201.322.
The section 610 review will be carried out along with a regulatory 
review under section 5 of Executive Order 12866, which calls for 
agencies to periodically review existing regulations to determine 
whether any should be modified or eliminated so as to make the Agency's 
regulatory program more effective in achieving its goals, less 
burdensome, or in greater alignment with the President's priorities and 
the principles set forth in the Executive order.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review of Current 
Regulation                      12/01/06
End Review                      12/00/07

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Walter Jefferson 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: [email protected]

RIN: 0910-AF74
_______________________________________________________________________




797. STATUS OF CERTAIN ADDITIONAL OVER-THE-COUNTER DRUG CATEGORY II AND 
III ACTIVE INGREDIENTS (SECTION 610 REVIEW)

Priority: Routine and Frequent. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 5 USC 610

CFR Citation: 21 CFR 310.545

Legal Deadline: None

Abstract: Section 310.545 (21 CFR part 310.545) codifies a final rule 
that was issued stating certain first aid antiseptic, vaginal 
contraceptive, and antimicrobial diaper rash ingredients in over-the-
counter (OTC) drug products are not generally recognized as safe and 
effective and are misbranded. This rule took into consideration the 
reports and recommendations of various OTC drug advisory review panels 
and public comment on proposed Agency regulations. Based on the absence 
of substantive comments in opposition to the Agency's proposed 
nonmonograph status for various ingredients, as well as the failure of 
interested parties to submit new data or information to FDA, the Agency 
determined that the presence of the subject ingredients in an OTC drug 
product would result in that product not being generally recognized as 
safe and effective and would result in misbranding.
FDA is initiating a review under section 610 of the Regulatory 
Flexibility Act for the regulation in section 310.545. The purpose of 
this review is to determine whether the regulation in section 310.545 
should be continued without change, or whether it should

[[Page 22507]]

be further amended or rescinded, consistent with the stated objectives 
of applicable statutes, to minimize adverse impacts on a substantial 
number of small entities. FDA will consider, and is soliciting comments 
on the following: (1) The continued need for the regulation in section 
310.545; (2) the nature of the complaints or comments received 
concerning the regulation in section 310.545; (3) the complexity of the 
regulations in section 310.545; (4) the extent to which the regulation 
in section 310.545 overlaps, duplicates, or conflicts with other 
Federal, State, or governmental rules; and (5) the degree to which 
technology, economic conditions, or other factors have changed for the 
products still subject to the regulation in section 310.545.
The section 610 review will be carried out along with a regulatory 
review under section 5 of Executive Order 12866, which calls for 
agencies to periodically review existing regulations to determine 
whether any should be modified or eliminated so as to make the Agency's 
regulatory program more effective in achieving its goals, less 
burdensome, or in greater alignment with the President's priorities and 
the principles set forth in the Executive order.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review of Current 
Regulation                      12/01/06
End Review                      12/00/07

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Walter Jefferson 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: [email protected]

RIN: 0910-AF75
_______________________________________________________________________




798. MEDICAL DEVICES: CLASSIFICATION/RECLASSIFICATION; RESTRICTED 
DEVICES; ANALYTE SPECIFIC REAGENTS (SECTION 610 REVIEW)

Priority: Other Significant

Legal Authority: 21 USC 351; 21 USC 352; 21 USC 360j

CFR Citation: 21 CFR 809.10; 21 CFR 809.30

Legal Deadline: None

Abstract: FDA is initiating a review under section 610 of the 
Regulatory Flexibility Act for two regulations in part 809. The purpose 
of this review is to determine if 21 CFR part 809.10 and 809.30 should 
be continued without change, or should be amended or rescinded, to 
minimize adverse economic impact on small entities. FDA is soliciting 
and will consider comments on the following: 1) The continued need for 
21 CFR part 809.10 and 809.30; 2) the nature of complaints or comments 
received concerning 21 CFR part 809.10 and 809.30; 3) the complexity of 
21 CFR part 809.10 and 809.30; 4) the extent to which 21 CFR part 
809.10 and 809.30 overlap, duplicate, or conflict with other Federal, 
State, or local government rules; and 5) the degree to which 
technology, economic conditions, or other factors have changed in the 
area affected by 21 CFR part 809.10 and 809.30.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review of Current 
Regulation                      04/00/07
End Review                      11/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Myrna Hanna, Regulations Staff, Department of Health 
and Human Services, Food and Drug Administration, Center for Devices 
and Radiological Health (HFZ-215), PI50 RM150F, 1350 Piccard Drive, 
Rockville, MD 20850
Phone: 240 276-2347
Fax: 240 276-2352
Email: [email protected]

RIN: 0910-AF76
_______________________________________________________________________




799. AMENDED ECONOMIC IMPACT ANALYSIS OF FINAL RULE ON USER LABELING ON 
NATURAL RUBBER-CONTAINING MEDICAL DEVICE (SECTION 610 REVIEW)

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
357; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC 374

CFR Citation: 21 CFR 801.437

Legal Deadline: Other, Statutory, September 30, 2007, Planned section 
610 review.

Abstract: FDA is initiating a review of the regulations in part 801 
under section 610 of the Regulatory Flexibility Act. The purpose of 
this review is to determine, consistent with stated objectives and 
applicable statutes, whether the regulations in part 801 should be 
continued without change, amended, or rescinded in order 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 regulation; 2) the nature of 
complaints or comments received concerning the regulation; 3) the 
complexity of the regulation; 4) the extent to which a regulation in 
part 801 overlaps, duplicates, or conflicts with other Federal rules, 
and to the extent feasible, with State and local government rules; and 
5) the degree to which technology, economic conditions, or other 
factors have changed in the area affected by the regulation.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/30/97                    62 FR 51021
Final Action Effective          09/30/98
End Review of Current Regulation12/00/07

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Myrna Hanna, Regulations Staff, Department of Health 
and Human Services, Food and Drug Administration, Center for Devices 
and Radiological Health (HFZ-215), PI50 RM150F, 1350 Piccard Drive, 
Rockville, MD 20850
Phone: 240 276-2347
Fax: 240 276-2352

[[Page 22508]]

Email: [email protected]

RIN: 0910-AF77
_______________________________________________________________________




800. FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS (SECTION 610 REVIEW)

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
353; 21 USC 355; 21 USC 360; 21 USC 360c to 360j; 21 USC 371; 21 USC 
372; 21 USC 373; 21 USC 374; 21 USC 375; 21 USC 376; 21 USC 379; 42 USC 
262

CFR Citation: 21 CFR 54

Legal Deadline: Other, Statutory, February 2, 2006, Planned section 610 
review.

Abstract: FDA is undertaking a review of 21 CFR part 54, under section 
610 of the Regulatory Flexibility Act. The purpose of this review is to 
determine whether the regulations in part 54 should be continued 
without change, or whether they should be amended or rescinded, 
consistent with the stated objectives of applicable statues, to 
minimize adverse impacts on a substantial number of small entities. FDA 
will consider, and is soliciting comments on the following: (1) The 
continued need for the regulations in part 54; (2) the nature of 
complaints or comments received concerning the regulations in part 54; 
(3) the complexity of the regulations in part 54, (4) the extent to 
which the regulations in part 54 overlap, duplicate, or conflict with 
other Federal, State, or governmental rules; and (5) the degree to 
which technology, economic conditions, or other factors have changed in 
the area affected by the regulations in part 54.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review of Current 
Regulation                      12/01/06
End Review                      12/00/07

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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, Suite 1101 (HFD-7), 5515 
Security Lane, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

Stephen M. Ripley, Team Leader, Department of Health and Human 
Services, Food and Drug Administration, Center for Biologics Evaluation 
and Research, Suite 200N (HFM-17), 1401 Rockville Pike, Rockville, MD 
20852-1448
Phone: 301 827-6210
Fax: 301 827-9434

Elisa D. Harvey, Director, Office of Device Evaluation, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Devices and Radiological Health, Corp Room 130F (HFZ-215), 1350 Piccard 
Drive, Rockville, MD 20850
Phone: 301 594-1190
Fax: 301 594-3076
Email: [email protected]

RIN: 0910-AF79
_______________________________________________________________________




801. BEVERAGES: BOTTLED WATER (SECTION 610 REVIEW)

Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321; 21 USC 341; 21 USC 343; 21 USC 343-1; 21 
USC 348; 21 USC 349; 21 USC 371; 21 USC 379e

CFR Citation: 21 CFR 165.110

Legal Deadline: Other, Statutory, November 13, 2005, Planned section 
610 review.

Abstract: Section 165.110 (21 CFR part 165.110) describes requirements 
for identity and quality standards for bottled water. FDA is 
undertaking a review of section 165.110 under section 610 of the 
Regulatory Flexibility Act. The purpose of this review is to determine 
whether the regulations in section 165.110 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 regulations in section 165.110; (2) the 
nature of complaints or comments received concerning the regulations in 
section 165.110; (3) the complexity of the regulations; (4) the extent 
to which the regulations in section 165.110 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 section 165.110.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review                    03/01/07
End Review                      12/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Richard A. Williams, Director, Division of Social 
Sciences, ORP, CFSAN, Department of Health and Human Services, Food and 
Drug Administration, Center for Food Safety and Applied Nutrition (HFS-
725), 5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-1989
Fax: 301 436-2626
Email: [email protected]

RIN: 0910-AF80
_______________________________________________________________________




802. FOOD LABELING; NUTRIENT CONTENT CLAIMS: DEFINITION FOR ``HIGH 
POTENCY'' AND DEFINITION OF ``ANTIOXIDANT'' FOR USE IN NUTRIENT CONTENT 
CLAIMS FOR DIETARY SUPPLEMENTS AND CONVENTIONAL FOODS (SECTION 610 
REVIEW)

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 15 USC 1453; 15 USC 1454; 15 USC 1455; 21 USC 321; 21 
USC 331; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 371

CFR Citation: 21 CFR 101.54; 21 CFR 101.60

Legal Deadline: Other, Statutory, September 23, 2007, Deadline for 
610(c) review.

Abstract: Section 101.54 (21 CFR part 101.54) describes the 
requirements for when the terms ``high potency'' and ``antioxidant'' 
may be used on the label or in the labeling of foods, including dietary 
supplements. Section 101.60 (21 CFR part 101.60) describes the 
requirements for when the terms ``low

[[Page 22509]]

calorie'' or ``reduced calorie'' may be used on the label or in the 
labeling of such foods. FDA is undertaking a review of sections 101.54 
and 101.60 under section 610 of the Regulatory Flexibility Act. The 
purpose of this review is to determine whether the regulations 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 regulations in 
sections 101.54 and 101.60; (2) the nature of complaints or comments 
received concerning the regulations; (3) the complexity of the 
regulations; (4) the extent to which the regulations in sections 101.54 
and 101.60 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 101.54 
and 101.60.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review                    12/01/06
End Review                      09/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Federal, Local, State, Tribal

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Richard A. Williams, Director, Division of Social 
Sciences, ORP, CFSAN, Department of Health and Human Services, Food and 
Drug Administration, Center for Food Safety and Applied Nutrition (HFS-
725), 5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-1989
Fax: 301 436-2626
Email: [email protected]

RIN: 0910-AF83
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




803. MEDICAL DEVICES; ANESTHESIOLOGY DEVICES; PROPOSED RECLASSIFICATION 
OF PRESSURE REGULATORS FOR USE WITH MEDICAL OXYGEN AND SEPARATE 
CLASSIFICATION OF OXYGEN CONSERVING DEVICES

Priority: Routine and Frequent

Legal Authority: 21 USC 351; 21 USC 360; 21 USC 360(c); 21 USC 360e; 21 
USC 360j; 21 USC 371

CFR Citation: 21 CFR 868.2700; 21 CFR 868.2750; 21 CFR 868.5905; 21 CFR 
5910

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is proposing to 
reclassify pressure regulators for use with medical oxygen from class I 
to class II, establish a separate classification for oxygen conserving 
devices, and establish a special control for these devices to address 
problems of fire and explosion associated with use of these devices. 
The special control would be a guidance document that includes 
standardized testing, performance, and labeling guidance for industry. 
Devices that meet the standard identified in the special controls 
guidance document would be exempt from the premarket notification 
requirements of the Federal Food, Drug, and Cosmetic Act (the Act). The 
agency believes it is taking a least burdensome approach for industry. 
The requirements of the proposed rule would be phased-in to minimize 
the cost of complying with the special control. FDA seeks to reclassify 
these devices under section 513(e)(1) of the act (21 U.S.C. 
360c(e)(1)).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/27/07                     72 FR 8643
NPRM Comment Period End         05/29/07
Final Action                    01/00/09

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Myrna Hanna, Regulations Staff, Department of Health 
and Human Services, Food and Drug Administration, Center for Devices 
and Radiological Health (HFZ-215), PI50 RM150F, 1350 Piccard Drive, 
Rockville, MD 20850
Phone: 240 276-2347
Fax: 240 276-2352
Email: [email protected]

RIN: 0910-AC30
_______________________________________________________________________




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

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 21 USC 355; 21 USC 371; 42 USC 262

CFR Citation: 21 CFR 314.50; 21 CFR 601.12; 21 CFR 314.94; 21 CFR 
314.96

Legal Deadline: None

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                            11/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Martha Nguyen, Regulatory Counsel, Department of

[[Page 22510]]

Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, Office of Regulatory Policy, Suite 1101 
(HFD-7), 5515 Security Lane, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AC52
_______________________________________________________________________




805. REPORTING INFORMATION REGARDING FALSIFICATION OF DATA

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321; 21 USC 341 to 343; 21 USC 348; 21 USC 349; 
21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360b; 21 USC 360c; 21 USC 
360e; 21 USC 360i to 360k; 21 USC 361; 21 USC 371; 21 USC 379e; 42 USC 
262

CFR Citation: 21 CFR 16.1; 21 CFR 58.11; 21 CFR 58.12; 21 CFR 71.1; 21 
CFR 101.69; 21 CFR 101.70; 21 CFR 170.101; 21 CFR 171.1; 21 CFR 190.6; 
21 CFR 312.56; 21 CFR 511.1; 21 CFR 571.1; 21 CFR 812.46

Legal Deadline: None

Abstract: The proposed rule would require sponsors to promptly report 
any information indicating that any person has or may have engaged in 
the falsification of data in the course of proposing, designing, 
performing, recording, supervising, or reviewing research, or in 
reporting research results.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Brian L. Pendleton, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, Suite 1101 (HFD-7), 5515 Security Lane, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

Related RIN: Previously reported as 0910-AC02
RIN: 0910-AC59
_______________________________________________________________________




806. CONTENT AND FORMAT OF LABELING FOR HUMAN PRESCRIPTION DRUGS AND 
BIOLOGICS; REQUIREMENTS FOR PREGNANCY AND LACTATION LABELING

Priority: Other Significant

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

CFR Citation: 21 CFR 201.56; 21 CFR 201.57; 21 CFR 201.80

Legal Deadline: None

Abstract: To amend the regulations governing the format and content of 
labeling for human prescription drugs and biological products (21 CFR 
part 201.56, 201.57, and 201.80).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Christine F. Rogers, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, Suite 1101, 5515 Security Lane, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AF11
_______________________________________________________________________




807. BLOOD INITIATIVE--REQUIREMENTS FOR HUMAN BLOOD AND BLOOD COMPONENTS 
INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURING USE

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 
21 USC 360; 21 USC 360c to 360e; 21 USC 360h to 360j; 21 USC 360l; 21 
USC 371; 21 USC 372; 21 USC 374; 21 USC 381; 21 USC 383; 42 USC 216; 42 
USC 243; 42 USC 262; 42 USC 263; 42 USC 263a; 42 USC 264; 42 USC 271

CFR Citation: 21 CFR 606; 21 CFR 610; 21 CFR 630; 21 CFR 640; 21 CFR 
660; 21 CFR 820; 21 CFR 1270

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is proposing to amend 
the biologics regulations, particularly those related to blood donor 
eligibility, by removing, revising, or updating specific regulations 
applicable to blood, blood components, source plasma, and source 
leukocytes to be more consistent with current practices and to remove 
unnecessary or outdated requirements. This action is based on FDA's 
comprehensive review of the biologics regulations. It is also based on 
reports by the U.S. House of Representatives Committee on Government 
Reform and Oversight Subcommittee on House Resources and 
Intergovernmental Relations, the General Accounting Office, and the 
Institute of Medicine, and on public comments. These actions are 
intended to help ensure the continued safety of the Nation's blood 
supply.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Brenda Friend, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Center for Biologics 
Evaluation and Research, Suite 200N (HFM-17), 1410 Rockville Pike, 
Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 827-9434

Related RIN: Split from 0910-AB26
RIN: 0910-AF25
_______________________________________________________________________




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

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360a; 21 USC 371a; 21 USC 331; 21 USC 360; 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

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

[[Page 22511]]

Legal Deadline: None

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 labeling intended to better inform consumers of potential 
risks associated with these products. 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 bicarbonate used as an antacid ingredient. The fourth action 
addresses products labeled to relieve upset stomach associated with 
overindulgence in food and drink and to relieve symptoms associated 
with a hangover. The Stevens Johnson and Cardiovascular Warnings 
documents address new proposed product warnings.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment) (Required 
Warnings and Other Labeling)    12/26/06                    71 FR 77314
NPRM Comment Period End         05/25/07
NPRM (Amendment) 
(Overindulgence/ Hangover)      10/00/07
NPRM (Amendment) (Pediatric)    12/00/07
NPRM (Amendment) (Combinations 
with Sodium Bicarbonate)        12/00/07
NPRM (Amendment) (Safety)       12/00/07
Final Action (Internal 
Analgesics)                     06/00/08

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research (HFD-560), 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

Related RIN: Split from 0910-AA01
RIN: 0910-AF36
_______________________________________________________________________




809. OVER-THE-COUNTER (OTC) DRUG REVIEW--SUNSCREEN PRODUCTS

Priority: Other Significant

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

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 sunscreen formulation, labeling, and testing requirements for 
both ultraviolet B (UVB) and ultraviolet A (UVA) radiation protection, 
and the other 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
NPRM (Sunscreen and Insect 
Repellent)                      04/00/07
NPRM (UVA/UVB)                  04/00/07
ANPRM Comment Period End        05/23/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research (HFD-560), 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

Related RIN: Split from 0910-AA01
RIN: 0910-AF43
_______________________________________________________________________




810. OVER-THE-COUNTER (OTC) DRUG REVIEW--WEIGHT CONTROL PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

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 phenyl propanolamine, and the other action 
addresses the ingredient benzocaine.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Phenyl propanolamine)     12/22/05                    70 FR 75988
NPRM (Benzocaine)               12/00/07
Final Action (Phenyl 
propanolamine)                  12/00/08

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human

[[Page 22512]]

Services, Food and Drug Administration, Center for Drug Evaluation and 
Research (HFD-560), 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

Related RIN: Split from 0910-AA01
RIN: 0910-AF45
_______________________________________________________________________




811. OVER-THE-COUNTER (OTC) DRUG REVIEW--STIMULANT DRUG PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 371a

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. This action 
addresses the use of stimulant active ingredients to relieve symptoms 
associated with a hangover.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment) (Hangover)     10/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research (HFD-560), 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

RIN: 0910-AF56
_______________________________________________________________________




812. LABEL REQUIREMENT FOR FOOD THAT HAS BEEN REFUSED ADMISSION INTO THE 
UNITED STATES

Priority: Other Significant

Legal Authority: 15 USC 1453 to 1455 ; 21 USC 321; 21 USC 342; 21 USC 
343; 21 USC 371; 21 USC 374; 21 USC 381; 42 USC 216; 42 USC 264

CFR Citation: 21 CFR 1.98

Legal Deadline: None

Abstract: The proposed rule would require owners or consignees to label 
imported food that is refused entry into the United States. The label 
would read, ``UNITED STATES: REFUSED ENTRY.'' The proposal would 
describe the label's characteristics (such as its size) and processes 
for verifying that the label has been affixed properly. We are taking 
this action to prevent the introduction of unsafe food into the United 
States, to facilitate the examination of imported food, and to 
implement section 308 of the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L. 
107-188).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/08

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Office of 
Policy and Planning (HF-23), Room 14C-17, 5600 Fishers Lane, Rockville, 
MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AF61
_______________________________________________________________________




813. OVER-THE-COUNTER ANTIDIARRHEAL DRUG PRODUCTS

Priority: Routine and Frequent. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 371a

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

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 antidiarrheal drug ingredients.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Walter Jefferson 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: [email protected]

Related RIN: Related to 0910-AC82
RIN: 0910-AF63
_______________________________________________________________________




814. OVER-THE-COUNTER (OTC) DRUG REVIEW--POISON TREATMENT DRUG PRODUCTS

Priority: Routine and Frequent. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally

[[Page 22513]]

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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (IPECAC)                   12/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Walter Jefferson 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: [email protected]

RIN: 0910-AF68
_______________________________________________________________________




815. OVER-THE-COUNTER (OTC) DRUG REVIEW--TOPICAL ANTIMICROBIAL DRUG 
PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

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 the consumer health care, food handlers, and health care 
antiseptic products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Food Handlers)            12/00/07
Final Action                    12/00/08

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Walter Jefferson 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: [email protected]

RIN: 0910-AF69
_______________________________________________________________________




816. IMPORT TOLERANCES FOR UNAPPROVED NEW ANIMAL DRUGS

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 360b(a)(6); 21 USC 371

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: FDA plans to publish a proposed rule and a direct final rule 
related to the implementation of the import tolerances provision of the 
Animal Drug Availability Act of 1996 (ADAA). The ADAA authorizes FDA to 
establish drug residue tolerances (import tolerances) for imported food 
products of animal origin for drugs that are used in other countries, 
but that are unapproved new animal drugs in the United States. Food 
products of animal origin that are in compliance with the import 
tolerances will not be considered adulterated under the Federal Food, 
Drug, and Cosmetic Act (the Act) and may be imported into the United 
States.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/07
Direct Final Rule               08/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: George Kenneth Haibel, Veterinary Medical Officer, 
Department of Health and Human Services, Food and Drug Administration, 
Rm. 169 (MPN-4, HFV-6), 7519 Standish Place, Rockville, MD 20855
Phone: 240 276-9019
Fax: 240 276-9101
Email: [email protected]

RIN: 0910-AF78
_______________________________________________________________________




817. CURRENT GOOD MANUFACTURING PRACTICE FOR COMBINATION PRODUCTS

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
353; 21 USC 355; 21 USC 360; 21 USC 360c to 360f; 21 USC 360h to 360j; 
21 USC 360l; 21 USC 360hh to 360ss; 21 USC 360aaa to 360bbb; 21 USC 
371a; 21 USC 372 to 374; 21 USC 379e; 21 USC 381; 21 USC 394; 42 USC 
216; 42 USC 262; 42 USC 263a; 42 USC 264; 42 USC 271

CFR Citation: 21 CFR 4, subchapter A

Legal Deadline: None

Abstract: The proposed rule would clarify and streamline the current 
good manufacturing practice (cGMP) requirements for combination 
products (combinations of a drug, device, and/or biological product). 
The proposed rule would provide a flexible, quality management 
regulatory framework that recognizes that, in most instances, for 
combination products, a properly implemented quality system program 
under one set of medical product cGMP regulations will meet the 
requirements of another set (e.g., application of cGMPs for finished 
pharmaceuticals in 21 CFR parts 210 and 211 will generally meet the 
requirements of the device quality system regulations in 21 CFR part 
820). It would allow manufacturers the flexibility to select either the 
cGMP or quality system regulation to apply for the manufacture of their 
combination product, provided that their system incorporates select, 
key provisions from the regulations pertaining to the other part of 
their combination product. It would avoid the necessity to fully 
implement both sets of cGMP regulations when manufacturing combination 
products. The proposed rule is intended to

[[Page 22514]]

ensure consistency and appropriateness in the regulation of combination 
products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: James S. Cohen, Senior Counsel, Department of Health 
and Human Services, Food and Drug Administration, Office of Combination 
Products, Suite 200 (HFG-3), 15800 Crabbs Branch Way, Rockville, MD 
20855
Phone: 301 427-1934
Fax: 301 427-1935
Email: [email protected]

RIN: 0910-AF81
_______________________________________________________________________




818. POSTMARKET SAFETY REPORTING FOR COMBINATION PRODUCTS

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
353; 21 USC 355; 21 USC 360; 21 USC 360c to 360f; 21 USC 360h to 360j; 
21 USC 360l; 21 USC 360hh to 360ss; 21 USC 360aaa to 360bbb; 21 USC 
371a; 21 USC 372 to 374; 21 USC 379e; 21 USC 381; 21 USC 394; 42 USC 
216; 42 USC 262; 42 USC 263a; 42 USC 264; 42 USC 271

CFR Citation: 21 CFR 4, subchapter B

Legal Deadline: None

Abstract: The proposed rule would clarify the postmarket safety 
reporting requirements for combination products (combinations of a 
drug, device, and/or biological product). The proposed rule would 
provide a framework for the reporting of adverse events for combination 
products. The proposed rule would clarify the circumstances in which 
following one set of postmarket safety reporting regulations generally 
would meet the requirements of another set, and the circumstances in 
which these requirements would be supplemented with specific reporting 
provisions applicable to the other constituent part of the combination 
product. The regulation would ensure the consistency and 
appropriateness of postmarket safety reporting for combination products 
while avoiding the need for duplicative reporting requirements.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Leigh Hayes, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Office of Combination 
Products, Suite 200 (HFG-3), 15800 Crabbs Branch Way, Rockville, MD 
20855
Phone: 301 427-1934
Fax: 301 427-1935
Email: [email protected]

RIN: 0910-AF82
_______________________________________________________________________




819. REVISIONS TO THE REQUIREMENTS APPLICABLE TO BLOOD, BLOOD 
COMPONENTS, AND SOURCE PLASMA

Priority: Routine and Frequent

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
353; 21 USC 355; 21 USC 360; 21 USC 360c; 21 USC 360d; 21 USC 360h; 21 
USC 360i; 21 USC 360j; 21 USC 371; 21 USC 372; 21 USC 374; 21 USC 381; 
21 USC 393; 42 USC 216; 42 USC 262; 42 USC 263; 42 USC 263a; 42 USC 
264; 42 USC 271

CFR Citation: 21 CFR 606.3; 21 CFR 607.65; 21 CFR 610.53; 21 CFR 640.4; 
21 CFR 640.21; 21 CFR 640.22; 21 CFR 640.24; 21 CFR 640.25; 21 CFR 
640.30; 21 CFR 640.32; 21 CFR 640.34; 21 CFR 640.64

Legal Deadline: None

Abstract: FDA is issuing this rulemaking to amend the biologics 
regulations by removing, revising, or updating specific regulations 
applicable to blood, blood components, and Source Plasma to be more 
consistent with current practices in the blood industry and to remove 
unnecessary or outdated requirements. Some examples of the amendments 
include revisions to the dating period for Platelets, Red Blood Cells 
Deglycerolized, and Red Blood Cells Frozen; storage temperatures for 
blood; and pooling and pH level of Platelets. FDA is also removing two 
obsolete provisions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM--Companion to Direct Final 
Rule                            06/00/07
Direct Final Rule               06/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Stephen M. Ripley, Team Leader, Department of Health 
and Human Services, Food and Drug Administration, Center for Biologics 
Evaluation and Research, Suite 200N (HFM-17), 1401 Rockville Pike, 
Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 827-9434

RIN: 0910-AF84
_______________________________________________________________________




820. REVISION OF THE REQUIREMENTS FOR LIVE VACCINE PROCESSING

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 
21 USC 360i; 21 USC 371; 21 USC 374; 42 USC 216; 42 USC 262; 42 USC 
263; 42 USC 263a; 42 USC 264; 42 USC 300aa-25

CFR Citation: 21 CFR 600.11

Legal Deadline: None

Abstract: This rulemaking is being issued to provide options to the 
existing requirement for processing live vaccines. FDA is amending the 
regulations due to advances in facility, system, and equipment design, 
and in sterilization technologies that will allow live vaccine 
processing to be performed in multiproduct manufacturing areas. We are 
amending this regulation to permit manufacturers greater flexibility in 
the use of their buildings and equipment for processing live vaccines 
when appropriate controls exist and have been demonstrated to be 
effective in preventing cross contamination of other products and 
areas. We are taking this action as part of our continuing effort to 
reduce the burden of unnecessary regulations on industry and to revise 
outdated regulations without diminishing public health protection.

[[Page 22515]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM--Companion to Direct Final 
Rule                            08/00/07
Direct Final Rule               08/00/07

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Nathaniel L. Geary, Consumer Safety Officer, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Biologics Evaluation and Research (HFM-17), 1401 Rockville Pike, 
Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 827-9434
Email: [email protected]

RIN: 0910-AF85
_______________________________________________________________________




821. MEDICAL DEVICE REPORTING; ELECTRONIC SUBMISSION REQUIREMENTS

Priority: Other Significant

Legal Authority: 21 USC 352; 21 USC 360; 21 USC 360i; 21 USC 360j; 21 
USC 371; 21 USC 374

CFR Citation: 21 CFR 803

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is proposing to amend 
its postmarket medical device reporting regulations to require that 
reports submitted to the Agency by persons subject to mandatory 
reporting requirements be transmitted electronically in a form that FDA 
can process, review, and archive. FDA is taking this action to improve 
the Agency's systems for collecting and analyzing postmarketing safety 
reports. The proposed change would help the Agency to more quickly 
review safety reports and identify emerging public health issues.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Myrna Hanna, Regulations Staff, Department of Health 
and Human Services, Food and Drug Administration, Center for Devices 
and Radiological Health (HFZ-215), PI50 RM150F, 1350 Piccard Drive, 
Rockville, MD 20850
Phone: 240 276-2347
Fax: 240 276-2352
Email: [email protected]

RIN: 0910-AF86
_______________________________________________________________________




822. LASER PRODUCTS; AMENDMENT TO PERFORMANCE STANDARD

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 360hh-ss

CFR Citation: 21 CFR 1010; 21 CFR 1040

Legal Deadline: None

Abstract: FDA is proposing to amend the performance standard for laser 
products to achieve closer harmonization between the current standard 
and the International Electrotechnical Commission (IEC) standard for 
laser products and medical laser products. The proposed amendment is 
intended to update FDA's performance standard to reflect advancements 
in technology. The proposal would adopt portions of an IEC standard (to 
achieve harmonization and reflect current science), include an 
alternative mechanism for providing certification and identification, 
address novelty laser products, and clarify the military exemption for 
laser products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/08

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

Agency Contact: Myrna Hanna, Regulations Staff, Department of Health 
and Human Services, Food and Drug Administration, Center for Devices 
and Radiological Health (HFZ-215), PI50 RM150F, 1350 Piccard Drive, 
Rockville, MD 20850
Phone: 240 276-2347
Fax: 240 276-2352
Email: [email protected]

RIN: 0910-AF87
_______________________________________________________________________




823. ELECTRONIC REGISTRATION AND LISTING FOR DEVICES

Priority: Other Significant

Legal Authority: PL 107-188, sec 321; 21 USC 360(p)

CFR Citation: 21 CFR 807

Legal Deadline: None

Abstract: FDA is proposing to amend the medical device establishment 
registration and listing requirements under 21 CFR part 807 to reflect 
the new requirements in section 321 of the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002 (BT Act) and section 
510(p) of the Federal Food, Drug, and Cosmetic Act, which was added by 
section 207 of the Medical Device User Fee and Modernization Act of 
2002 (MDUFMA). This proposed rule would require domestic and foreign 
device establishments to submit registration and listing data 
electronically via the Internet using FDA's Unified Registration and 
Listing System. This proposed rule would convert the registration and 
listing process to a paperless process. For those companies that do not 
have access to the web, FDA would offer an avenue by which they can 
register, list, and update information with a paper submission.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Myrna Hanna, Regulations Staff, Department of Health 
and Human Services, Food and Drug Administration, Center for Devices 
and Radiological Health (HFZ-215), PI50 RM150F, 1350 Piccard Drive, 
Rockville, MD 20850
Phone: 240 276-2347
Fax: 240 276-2352
Email: [email protected]

RIN: 0910-AF88
_______________________________________________________________________




824. REGULATIONS ON FIXED-COMBINATION DRUG PRODUCTS

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 
371

CFR Citation: 21 CFR 300.50

Legal Deadline: None

Abstract: The proposed rule would amend FDA regulations on fixed-
combination prescription and OTC

[[Page 22516]]

drugs. The current regulations require, among other things, that the 
sponsor of a fixed-combination drug demonstrate that each of the 
components makes a contribution to the drug's claimed effects. The 
proposed rule would create a single set of regulations for prescription 
and OTC combination drugs and codify existing policy on what kinds of 
studies are needed to show that the combination drug requirements are 
met, and it would clarify application of FDA's combination policy to 
certain natural source drugs and certain synthetic drugs. The 
regulation would also establish circumstances under which the agency 
might waive the combination drug requirements for a particular drug. 
The proposed rule will also address the issue of co-packaging.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Brian L. Pendleton, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, Suite 1101 (HFD-7), 5515 Security Lane, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AF89
_______________________________________________________________________




825. USE OF OZONE-DEPLETING SUBSTANCES; REMOVAL OF ESSENTIAL USE 
DESIGNATIONS [EPINEPHRINE]

Priority: Economically Significant. Major under 5 USC 801.

Unfunded Mandates: This action may affect the private sector under PL 
104-4.

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 335; 21 USC 342; 21 USC 
346a; 21 USC 348; 21 USC 355; 42 USC 7671 et seq

CFR Citation: 21 CFR 1.25 (Revision); 40 CFR 82.4; 40 CFR 82.64; 40 CFR 
82.66

Legal Deadline: None

Abstract: Medical products using chlorofluorocarbons (CFCs) and other 
ozone-depleting substances may only be legally marketed if they are 
listed in 21 CFR part 2.125 as ``essential uses.'' This proposed rule 
would remove the essential use designations after a specified date for 
metered-dose inhalers (MDIs) containing epinephrine. Under the 
provisions of this proposed rule these MDIs would have to be removed 
from the market. This proposed rule is consistent with obligations 
under the Clean Air Act and the Montreal Protocol on Substances That 
Deplete the Ozone Layer.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Martha Nguyen, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Center for Drug 
Evaluation and Research, Office of Regulatory Policy, Suite 1101 (HFD-
7), 5515 Security Lane, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AF92
_______________________________________________________________________




826. USE OF OZONE-DEPLETING SUBSTANCES; REMOVAL OF ESSENTIAL USE 
DESIGNATIONS [FLUNISOLIDE, TRIAMCINOLONE, METAPROTERENOL, PIRBUTEROL, 
ALBUTEROL AND IPRATROPIUM IN COMBINATION, CROMOLYN, AND NEDOCROMIL]

Priority: Economically Significant. Major under 5 USC 801.

Unfunded Mandates: This action may affect the private sector under PL 
104-4.

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 335; 21 USC 342; 21 USC 
346a; 21 USC 348; 21 USC 355; 42 USC 7671 et seq

CFR Citation: 21 CFR 1.25 (Revision); 40 CFR 82.4; 40 CFR 82.64; 40 CFR 
82.66

Legal Deadline: None

Abstract: Medical products using chlorofluorocarbons (CFCs) and other 
ozone-depleting substances may only be legally marketed if they are 
listed in 21 CFR part 2.125 as ``essential uses.'' This proposed rule 
would remove the essential use designations after a specified date for 
metered-dose inhalers (MDIs) containing flunisolide, triamcinolone, 
metaproterenol, pirbuterol, albuterol and ipratropium in combination, 
cromolyn, and nedocromil. Under the provisions of this proposed rule 
these MDIs would have to be removed from the market. This proposed rule 
is consistent with obligations under the Clean Air Act and the Montreal 
Protocol on Substances That Deplete the Ozone Layer.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/07

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Martha Nguyen, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Center for Drug 
Evaluation and Research, Office of Regulatory Policy, Suite 1101 (HFD-
7), 5515 Security Lane, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AF93
_______________________________________________________________________




827. [bull] STATUS OF CERTAIN ADDITIONAL OVER-THE-COUNTER DRUG CATEGORY 
II ACTIVE INGREDIENTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 371a

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

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.

[[Page 22517]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Walter Jefferson 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: [email protected]

RIN: 0910-AF95
_______________________________________________________________________




828. [bull] POSTMARKETING SAFETY REPORTS FOR HUMAN DRUG AND BIOLOGICAL 
PRODUCTS: ELECTRONIC SUBMISSION REQUIREMENTS

Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 
21 USC 355a; 21 USC 356; 21 USC 356a; 21 USC 356b; 21 USC 360; 21 USC 
371; 21 USC 374; 21 USC 375

CFR Citation: 21 CFR 310.305; 21 CFR 314.80; 21 CFR 314.98; 21 CFR 
600.80; 21 CFR 600.81

Legal Deadline: None

Abstract: The proposed rule would amend FDA's postmarketing safety 
reporting regulations for human drug and biological products (21 CFR 
part 310.305, 314.80, 314.98, 600.80, and 600.81) to require that 
safety reports submitted to the Agency by persons subject to mandatory 
reporting requirements be transmitted electronically in a form that FDA 
can process, review, and archive. FDA is taking this action to improve 
the Agency's systems for collecting and analyzing postmarketing safety 
reports. The proposed rule creates a requirement for manufacturers to 
submit postmarketing safety reports electronically in a compatible 
format using either direct submission or a web-based form. The rule 
will allow the Agency to review safety reports more quickly, and to 
identify emerging safety problems, and disseminate safety information 
more rapidly in support of FDA's public health mission. The proposed 
amendments would be a key element in harmonizing FDA's postmarketing 
safety reporting regulations with international and ICH standards for 
the electronic submission of safety information.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           11/05/98                    63 FR 59746
ANPRM Comment Period End        02/03/99
NPRM                            11/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Marguerita B. Sims, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, Office of Regulatory Policy, Suite 1101, 
(HFD-007), 5515 Security Lane, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AF96
_______________________________________________________________________




829. [bull] PROPOSED REVISIONS TO 21 CFR PARTS 314 AND 320 TO IMPLEMENT 
PORTIONS OF TITLE XI OF THE MEDICARE PRESCRIPTION DRUG, IMPROVEMENT, AND 
MODERNIZATION ACT OF 2003 AND OTHER CHANGES

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: PL 108-173, title XI; 21 USC 355; 21 USC 371

CFR Citation: 21 CFR 314.3; 21 CFR 314.50; 21 CFR 314.52; 21 CFR 
314.53; 21 CFR 314.60; 21 CFR 314.70; 21 CFR 314.94; 21 CFR 314.95; 21 
CFR 314.96; 21 CFR 314.97; 21 CFR 314.101; 21 CFR 314.105; 21 CFR 
314.107; 21 CFR 314.108; 21 CFR 320.1; 21 CFR 320.23

Legal Deadline: None

Abstract: Title XI of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (Public Law 108-173) (MMA) amended provisions 
of the Federal Food, Drug, and Cosmetic Act (the act) that govern the 
approval of new drug applications (NDAs) described by section 505(b)(2) 
of the act (505(b)(2) applications) and abbreviated new drug 
applications (ANDAs) described by section 505(j) of the act. This 
proposed rule would implement portions of Title XI of the MMA. These 
provisions are those: 1) That require applicants to notify drug 
sponsors who have patents listed in the FDA' Orange Book of the 
application; 2) that apply to the period of delay (a 30-month stay) 
before approval of certain applications; 3) that control the submission 
of amendments and supplements to certain applications, and, 4) define 
the types of bioavailability and bioequivalence data that can be used 
to support these applications. This proposed rule also would amend 
certain regulations regarding 505(b)(2) applications and ANDAs to 
facilitate compliance with and efficient enforcement of the Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/08

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Janice L. Weiner, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, Office of Regulatory Policy, Suite 1101 
(HFD-007), 5515 Security Lane, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AF97

[[Page 22518]]

_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




830. FOREIGN AND DOMESTIC ESTABLISHMENT REGISTRATION AND LISTING 
REQUIREMENTS FOR HUMAN DRUGS, INCLUDING DRUGS THAT ARE REGULATED UNDER A 
BIOLOGICS LICENSE APPLICATION, AND ANIMAL DRUGS

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
355; 21 USC 360; 21 USC 360b; 21 USC 371; 21 USC 374; 42 USC 262; 42 
USC 264; 42 USC 271

CFR Citation: 21 CFR 20; 21 CFR 201; 21 CFR 207; 21 CFR 314; 21 CFR 
330; 21 CFR 514; 21 CFR 515; 21 CFR 601; 21 CFR 607; 21 CFR 610; 21 CFR 
1271

Legal Deadline: None

Abstract: The rule will reorganize, consolidate, clarify, and modify 
current regulations at 21 CFR part 207 concerning who must register 
establishments and list human drugs, certain biological drugs, and 
animal drugs. These regulations contain information on when, how, and 
where to register drug establishments and list drugs, and what 
information must be submitted for initial registration and listing and 
for changes to registration and listing. The rule will require that 
this information be submitted via the Internet into the FDA 
registration and listing database, instead of the current requirement 
to submit the information to FDA on paper forms. The rule will also 
require that the NDC number appear on certain drug labels. In addition, 
FDA will assign the NDC number to newly listed drugs and take other 
steps to minimize the use of inaccurate NDC numbers on drug labels.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/29/06                    71 FR 51276
NPRM Comment Period End         02/26/07                     72 FR 5944
Final Action                    03/00/08

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

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, Suite 1101 (HFD-7), 5515 
Security Lane, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AA49
_______________________________________________________________________




831. SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND BIOLOGICAL 
PRODUCTS

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 216; 42 USC 241; 42 USC 242a; 42 USC 262; 42 
USC 263; 42 USC 263a to 263-n; 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

CFR Citation: 21 CFR 310; 21 CFR 312; 21 CFR 314; 21 CFR 320; 21 CFR 
600; 21 CFR 601; 21 CFR 606

Legal Deadline: None

Abstract: This regulation is 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 other revisions 
to these regulations to enhance the quality of safety reports received 
by FDA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/14/03                    68 FR 12406
NPRM Comment Period Extended    06/18/03
NPRM Comment Period End         07/14/03
NPRM Comment Period Extension 
End                             10/14/03
Comment Review End              04/00/07
Final Action                    03/00/08

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: Carol Drew, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Center for Drug 
Evaluation and Research, Suite 1101 (HFD-7), 5515 Security Lane, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA97
_______________________________________________________________________




832. APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG; COMPLETE 
RESPONSE LETTER; AMENDMENTS TO UNAPPROVED APPLICATIONS

Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 
21 USC 371; 21 USC 374; 21 USC 379e

CFR Citation: 21 CFR 312; 21 CFR 314

Legal Deadline: None

Abstract: The rule would amend the regulations on marketing approval of 
new drugs to discontinue the use of approvable and not approvable 
letters when taking action on a marketing application and instead use 
complete response letters. The rule would also amend the regulations on 
extension of the review clock because of amendments to applications.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/20/04                    69 FR 43357
Final Action                    10/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Brian L. Pendleton, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, Suite 1101 (HFD-7), 5515 Security Lane, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AB34

[[Page 22519]]

_______________________________________________________________________




833. CGMPS FOR BLOOD AND BLOOD COMPONENTS: NOTIFICATION OF CONSIGNEES 
AND TRANSFUSION RECIPIENTS RECEIVING BLOOD AND BLOOD COMPONENTS AT 
INCREASED RISK OF TRANSMITTING HCV INFECTION (LOOKBACK)

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 
21 USC 360; 21 USC 360c; 21 USC 360d; 21 USC 360h to 360j; 21 USC 371; 
21 USC 374; 42 USC 216; 42 USC 262; 42 USC 263 to 263a; 42 USC 264; 21 
USC 372; 21 USC 381

CFR Citation: 21 CFR 606; 21 CFR 610

Legal Deadline: None

Abstract: This rulemaking is one of a number of actions being taken to 
amend the biologics regulations to remove, revise, or update the 
regulations applicable to blood, blood components, and blood 
derivatives. These actions are based on FDA's comprehensive review of 
the biologics regulations and on reports by the U.S. House of 
Representatives Committee on Government Reform and Oversight, 
Subcommittee on House Resources and Intergovernmental Relations, the 
General Accounting Office, and the Institute of Medicine, as well as on 
public comments. In this rulemaking, FDA will amend the biologics 
regulations to require that blood establishments prepare and follow 
written procedures for appropriate action when it is determined that 
blood and blood components pose an increased risk for transmitting 
hepatitis C virus (HCV) infection because they have been collected from 
a donor who, at a later date, tested reactive for evidence of HCV. The 
HIV lookback regulations will be amended for consistency.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/16/00                    65 FR 69377
NPRM Comment Period End         02/14/01
Final Action                    06/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Stephen M. Ripley, Team Leader, Department of Health 
and Human Services, Food and Drug Administration, Center for Biologics 
Evaluation and Research, Suite 200N (HFM-17), 1401 Rockville Pike, 
Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 827-9434

Related RIN: Related to 0910-AB26
RIN: 0910-AB76
_______________________________________________________________________




834. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR 
HOLDING DIETARY INGREDIENTS AND DIETARY SUPPLEMENTS

Priority: Economically Significant. Major under 5 USC 801.

Unfunded Mandates: This action may affect the private sector under PL 
104-4.

Legal Authority: 21 USC 321; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 
371; 21 USC 374; 21 USC 381; 21 USC 393; 42 USC 264

CFR Citation: 21 CFR 111

Legal Deadline: None

Abstract: The Food and Drug Administration proposed in the Federal 
Register of March 13, 2003 (68 FR 12158), current good manufacturing 
practice (CGMP) regulations for dietary ingredients and dietary 
supplements. The proposed rule was published to establish the minimum 
CGMPs necessary to ensure that, if firms engage in activities related 
to manufacturing, packaging, or holding dietary ingredients or dietary 
supplements, they do so in a manner that will not adulterate and 
misbrand such dietary ingredients or dietary supplements. FDA also 
proposed to require manufacturers to evaluate the identity, purity, 
quality, strength, and composition of their dietary ingredients and 
dietary supplements. The proposed rule also responds to concerns that 
such regulations are necessary to ensure that consumers are provided 
with dietary supplement products which have not been adulterated as a 
result of manufacturing, packing, or holding; e.g., which have the 
identity and provide the quantity of dietary ingredients declared in 
labeling.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           02/06/97                     62 FR 5700
ANPRM Comment Period End        06/06/97
NPRM                            03/13/03                    68 FR 12157
NPRM Comment Period End         08/11/03
Final Action                    12/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

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: 301 436-1209
Fax: 301 436-2964
Email: [email protected]

RIN: 0910-AB88
_______________________________________________________________________




835. ADDITIONAL SAFEGUARDS FOR CHILDREN IN CLINICAL INVESTIGATIONS

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321; 21 USC 343; 21 USC 346; 21 USC 346a; 21 
USC 348; 21 USC 350a; 21 USC 350b; 21 USC 351 to 353; 21 USC 355; 21 
USC 360; 21 USC 360c to 360f; 21 USC 360h to 360j; 21 USC 371; 21 USC 
379e; 21 USC 381; 41 USC 216; 41 USC 241; 41 USC 262; 41 USC 263b to 
263n

CFR Citation: 21 CFR 50; 21 CFR 56

Legal Deadline: None

Abstract: The final rule will finalize the interim rule that published 
in April 2001, providing additional protections for children involved 
as subjects in clinical investigations of FDA-regulated products, as 
required by the Children's Health Act of 2000.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Rule                    04/24/01                    66 FR 20589
Final Action                    12/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Carol Drew, Regulatory Counsel, Department of Health 
and Human Services, Food and

[[Page 22520]]

Drug Administration, Center for Drug Evaluation and Research, Suite 
1101 (HFD-7), 5515 Security Lane, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AC07
_______________________________________________________________________




836. PREVENTION OF SALMONELLA ENTERITIDIS IN SHELL EGGS

Priority: Economically Significant. Major under 5 USC 801.

Unfunded Mandates: This action may affect the private sector under PL 
104-4.

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;

CFR Citation: 21 CFR 16; 21 CFR 116; 21 CFR 118

Legal Deadline: None

Abstract: 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 by 50 percent by 2005 and eliminate egg-related SE 
illnesses by 2010.
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. This proposal would reduce SE prevalence in the 
egg production environment and consequently in the eggs themselves. 
Most SE contamination of eggs is a result of SE infection in the laying 
hen's reproductive tract, called transovarian contamination. The 
proposed measures are designed to reduce the likelihood of this 
transovarian contamination and include: (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 is one 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
Final Action                    12/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: John Sheehan, Director, Department of Health and Human 
Services, Food and Drug Administration, Division of Dairy and Egg 
Safety (HFS-032), 5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-1488
Fax: 301 436-2632
Email: [email protected]

RIN: 0910-AC14
_______________________________________________________________________




837. INSTITUTIONAL REVIEW BOARDS: REGISTRATION REQUIREMENTS

Priority: Info./Admin./Other

Legal Authority: 21 USC 321; 21 USC 346 to 346a; 21 USC 348; 21 USC 351 
to 353; 21 USC 355; 21 USC 360; 21 USC 360c to 360f; 21 USC 360h to 
360j; 21 USC 371; 21 USC 379e; 21 USC 381; 42 USC 216; 42 USC 241; 42 
USC 262; 42 USC 263b to 263n

CFR Citation: 21 CFR 56.106

Legal Deadline: None

Abstract: The final rule would require institutional review boards 
(IRB) to register with the Department of Health and Human Services. The 
registration information would include the name of the IRB; the name of 
the institution operating the IRB; and names, addresses, phone numbers, 
facsimile (fax) numbers, and electronic mail (e-mail) addresses of the 
senior officer of the institution and IRB chair or contact; the number 
of active protocols involving FDA-regulated products reviewed in the 
previous calendar year; and a description of the types of FDA-regulated 
products reviewed. The final rule would make it easier for FDA to 
inspect IRBs and to convey information to IRBs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/06/04                    69 FR 40556
Final Action                    03/00/08

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Office of 
Policy and

[[Page 22521]]

Planning (HF-23), Room 14C-17, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AC17
_______________________________________________________________________




838. EXCEPTION FROM GENERAL REQUIREMENTS FOR INFORMED CONSENT; REQUEST 
FOR COMMENTS AND INFORMATION

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 343; 21 USC 346; 21 USC 346a; 21 
USC 348; 21 USC 350a; 21 USC 350b; 21 USC 352; 21 USC 353; 21 USC 355; 
21 USC 360; 21 USC 360c to 360f; 21 USC 360h to 360j; 21 USC 371; 21 
USC 379e; 21 USC 381; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 263b 
to 263n

CFR Citation: 21 CFR 50.23

Legal Deadline: None

Abstract: This final rule will add an exception from the general 
requirement for informed consent in certain circumstances involving the 
use of investigational in vitro diagnostic devices to identify 
chemical, biological, radiological, or nuclear agents in a potential 
terrorist event or other public health emergency.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              06/07/06                    71 FR 32827
Final Action                    04/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Catherine Lorraine, Director, Policy Development and 
Coordination Group, Office of Policy and Planning, Department of Health 
and Human Services, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-3360
Fax: 301 594-6777

RIN: 0910-AC25
_______________________________________________________________________




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

Priority: Other Significant

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

CFR Citation: 21 CFR 201.161(a); 21 CFR 211.94; 21 CFR 211.125

Legal Deadline: None

Abstract: The Food and Drug Administration is proposing to amend 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 proposed 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                    01/00/08

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Quynh H. Nguyen, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, Suite 1101 (HFD-7), 5515 Security Lane, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AC53
_______________________________________________________________________




840. POSITRON EMISSION TOMOGRAPHY DRUGS; CURRENT GOOD MANUFACTURING 
PRACTICES

Priority: Other Significant

Legal Authority: PL 105-115, sec 121

CFR Citation: 21 CFR 212

Legal Deadline: Final, Statutory, November 21, 1999.

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 proposed 
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                    08/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: Federal, State

URL For More Information:
www.fda.gov/cder/regulatory/pet

Agency Contact: Brian L. Pendleton, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, Suite 1101 (HFD-7), 5515 Security Lane, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

Related RIN: Previously reported as 0910-AB63
RIN: 0910-AC55
_______________________________________________________________________




841. CHARGING FOR INVESTIGATIONAL DRUGS

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 
21 USC 371; 42 USC 262

CFR Citation: 21 CFR 312.7; 21 CFR 312.8

Legal Deadline: None

Abstract: The rule will amend FDA's investigational new drug regulation

[[Page 22522]]

concerning charging for investigational drugs. The rule will clarify 
the circumstances in which charging for an investigational drug in a 
clinical trial is appropriate, set forth criteria for charging for an 
investigational drug for the different types of treatment uses 
described in the Agency's rule on expanded access to investigational 
drugs for treatment use, and clarify what costs can be recovered for an 
investigational drug. The rule is intended to permit charging for a 
broader range of investigational uses than is explicitly permitted in 
current regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/14/06                    71 FR 75168
NPRM Comment Period End         03/14/07
Final Action                    03/00/08

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Christine F. Rogers, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, Suite 1101, 5515 Security Lane, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AF13
_______________________________________________________________________




842. EXPANDED ACCESS TO INVESTIGATIONAL DRUGS FOR TREATMENT USE

Priority: Other Significant

Legal Authority: 21 USC 355; 21 USC 360bbb; 21 USC 371; 42 USC 262

CFR Citation: 21 CFR 312.42; 21 CFR 312.300; 21 CFR 312.305; 21 CFR 
312.310; 21 CFR 312.315; 21 CFR 312.320

Legal Deadline: None

Abstract: To amend the regulations governing investigational new drugs 
to describe the ways patients may obtain investigational drugs for 
treatment use under expanded access programs. Such use of 
investigational drugs would be available to: (1) Individual patients, 
including in emergencies; (2) intermediate size patient populations; 
and (3) larger populations under a treatment protocol or treatment IND.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/14/06                    71 FR 75147
NPRM Comment Period End         03/14/07
Final Action                    03/00/08

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Organizations

Government Levels Affected: None

Agency Contact: Christine F. Rogers, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, Suite 1101, 5515 Security Lane, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AF14
_______________________________________________________________________




843. HUMAN SUBJECT PROTECTION; FOREIGN CLINICAL STUDIES NOT CONDUCTED 
UNDER AN INVESTIGATIONAL NEW DRUG APPLICATION

Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 21 USC 355(d)(5); 21 USC 355(i); 21 USC 371(a); 42 USC 
262(a)(2)(A); 42 USC 262(a)(2)(B)(i)(l)

CFR Citation: 21 CFR 312.120

Legal Deadline: None

Abstract: This final rule follows a proposed rule, which proposed to 
update the standards for the acceptance of foreign clinical studies not 
conducted under an investigational new drug application (IND) as 
support for an IND or marketing application for a drug or biological 
product. We proposed to replace the requirement in 21 CFR part 312.120 
that non-IND foreign clinical studies be conducted in accordance with 
ethical principles stated in the Declaration of Helsinki or with the 
laws and regulations of the country that is the research site, 
whichever provide greater protection to subjects. We would replace that 
with a requirement that such studies be conducted in accordance with 
good clinical practice (GCP), including review and approval by an 
independent ethics committee. The proposed GCP standard is consistent 
with the standard of the International Conference on Harmonisation of 
Technical Requirements for Registration of Pharmaceuticals for Human 
Use for GCP and is sufficiently flexible to accommodate differences in 
how countries regulate the conduct of clinical research and obtain the 
informed consent of patients.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/10/04                    69 FR 32467
Final Action                    07/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Brian L. Pendleton, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, Suite 1101 (HFD-7), 5515 Security Lane, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AF15
_______________________________________________________________________




844. DISTRIBUTION OF BLOOD DERIVATIVES BY REGISTERED BLOOD 
ESTABLISHMENTS THAT QUALIFY AS HEALTH CARE ENTITIES; PDMA OF 1987; PDA 
OF 1992; POLICIES, REQUIREMENTS, AND ADMINISTRATIVE PROCEDURES

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 351 to 353; 21 USC 371; 21 USC 374

CFR Citation: 21 CFR 203.3(q); 21 CFR 203.22(h); 21 CFR 205.3(h)

Legal Deadline: None

Abstract: FDA is amending certain limited provisions of the 
implementing regulations of the Prescription Drug Marketing Act (PDMA) 
of 1987, as modified by the Prescription Drug Amendments (PDA) of 1992 
and the FDA Modernization Act of 1997. Certain provisions of that final 
rule that published on December 3, 1999 (64 FR 67720), would not allow 
registered blood establishments or hemophilia treatment centers that 
provide health care services to concurrently distribute drugs, 
including blood derivatives. The effective date of those provisions of 
that rule is delayed until December 1, 2008,

[[Page 22523]]

as published on November 13, 2006 (71 FR 66108)--final rule; the 
applicability date was delayed in order to consider comments on the 
proposed rule published in the Federal Register February 1, 2006 (71 FR 
5200). FDA is amending the final rule to allow registered blood 
establishments that provide health care services related to their 
activities as blood establishments and certain hemophilia treatment 
centers to also distribute certain products, including blood 
derivatives.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/01/06                     71 FR 5200
NPRM Comment Period End         05/02/06
Delay of Applicability          11/13/06                    71 FR 66108
Final Action                    03/00/08

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Kathleen E. Swisher, Supervisory Regulatory Counsel, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Biologics Evaluation and Research, Suite 200N (HFM-17), 1401 
Rockville Pike, Rockville, MD 20852
Phone: 301 827-6210
Fax: 301 827-9434

RIN: 0910-AF16
_______________________________________________________________________




845. BLOOD INITIATIVE--REVISIONS TO LABELING REQUIREMENTS FOR BLOOD AND 
BLOOD COMPONENTS, INCLUDING SOURCE PLASMA; AND TECHNICAL AMENDMENT

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 
21 USC 360; 21 USC 360d; 21 USC 360h to 360j; 21 USC 371; 21 USC 374; 
21 USC 381; 42 USC 216; 42 USC 262; 42 USC 263; 42 USC 263a; 42 USC 264

CFR Citation: 21 CFR 606; 21 CFR 610; 21 CFR 640

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is amending the 
regulations regarding container labels and instruction circulars for 
certain human blood and blood components, including Source Plasma, to 
be more consistent with current practices and to remove unnecessary or 
outdated requirements. This action is based on FDA's comprehensive 
review of the biologics regulations. It is also based on reports by the 
U.S. House of Representatives Committee on Government Reform and 
Oversight Subcommittee on House Resources and Intergovernmental 
Relations, the General Accounting Office, and the Institute of 
Medicine, as well as on public comments. This action is intended to 
help ensure the continued safety of the blood supply and to help ensure 
consistency in container labeling.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/30/03                    68 FR 44678
NPRM Comment Period End         10/28/03
Final Action                    10/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Brenda Friend, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Center for Biologics 
Evaluation and Research, Suite 200N (HFM-17), 1410 Rockville Pike, 
Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 827-9434

Related RIN: Split from 0910-AB26
RIN: 0910-AF26
_______________________________________________________________________




846. INFANT FORMULA: CURRENT GOOD MANUFACTURING PRACTICES; QUALITY 
CONTROL PROCEDURES; NOTIFICATION REQUIREMENTS; RECORDS AND REPORTS

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 350a; 21 USC 371;

CFR Citation: 21 CFR 106; 21 CFR 107

Legal Deadline: None

Abstract: The Agency published a proposed rule on July 9, 1996, that 
would establish current good manufacturing practice regulations, 
quality control procedures, quality factors, notification requirements, 
and records and reports for the production of infant formula. This 
proposal was issued in response to the 1986 Amendments to the Infant 
Formula Act of 1980. On April 28, 2003, FDA reopened the comment period 
to update comments on the proposal. The comment period was extended on 
June 27, 2003, to end on August 26, 2003. On August 1, 2006, FDA 
reopened the comment period on selected topics. The comment period 
closed on September 15, 2006.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/09/96                    61 FR 36154
NPRM Comment Period End         12/06/96
NPRM Comment Period Reopened    04/28/03                    68 FR 22341
NPRM Comment Period Extended    06/27/03                    68 FR 38247
NPRM Comment Period End         08/26/03
NPRM Comment Period Reopened    08/01/06                    71 FR 43392
NPRM Comment Period End         09/15/06
Final Action                    02/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Benson Silverman, 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: 301 436-1459
Email: [email protected]

Related RIN: Split from 0910-AA04
RIN: 0910-AF27
_______________________________________________________________________




847. INFANT FORMULA QUALITY FACTORS

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 350a; 21 USC 371;

CFR Citation: 21 CFR 106; 21 CFR 107

Legal Deadline: None

Abstract: The Agency published a proposed rule on July 9, 1996, that 
would establish current good manufacturing practice regulations, 
quality control procedures, quality factors, notification requirements, 
and records and reports for the production of infant formula. This 
proposal was issued in response to the 1986 amendments to the Infant 
Formula Act of 1980. On April 28, 2003, FDA reopened the comment period 
to update comments on the proposal. The

[[Page 22524]]

comment period was extended on June 27, 2003, to end on August 26, 
2003. The comment period was reopened on August 1, 2006, to end on 
September 15, 2006.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/09/96                    61 FR 36154
NPRM Comment Period End         12/06/96
NPRM Comment Period Reopened    04/28/03                    68 FR 22341
NPRM Comment Period Extended    06/27/03                    68 FR 38247
NPRM Comment Period End         08/26/03
NPRM Comment Period Reopened    08/01/06                    71 FR 43392
NPRM Comment Period End         09/15/06
Final Action                    02/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Benson Silverman, 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: 301 436-1459
Email: [email protected]

Related RIN: Split from 0910-AA04
RIN: 0910-AF28
_______________________________________________________________________




848. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (COMBINATION) 
PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

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 combination products containing an oral bronchodilator.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment)                07/13/05                    70 FR 40232
Final Action (Technical 
Amendment)                      04/00/07
Final Action                    06/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research (HFD-560), 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

Related RIN: Split from 0910-AA01
RIN: 0910-AF33
_______________________________________________________________________




849. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (NASAL DECONGESTANT) 
PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

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 phenylephrine bitartrate, and the other action 
addresses the ingredient phenyl propanolamine.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment) (Sinusitis 
Claim)                          08/02/04                    69 FR 46119
NPRM (Phenylephrine Bitartrate) 11/02/04                    69 FR 63482
NPRM (Phenyl propanolamine)     12/22/05                    70 FR 75988
Final Action (Amendment) 
(Sinusitis Claim)               10/31/05                    70 FR 58974
Final Action (Phenylephrine 
Bitartrate)                     08/01/06                    71 FR 83358
Final Action (Phenyl 
propanolamine)                  12/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research (HFD-560), 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

Related RIN: Split from 0910-AA01
RIN: 0910-AF34
_______________________________________________________________________




850. OVER-THE-COUNTER (OTC) DRUG REVIEW--EXTERNAL ANALGESIC PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

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 external analgesic drug products.

[[Page 22525]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research (HFD-560), 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

Related RIN: Split from 0910-AA01
RIN: 0910-AF35
_______________________________________________________________________




851. OVER-THE-COUNTER (OTC) DRUG REVIEW--LABELING OF DRUG PRODUCTS FOR 
OTC HUMAN USE

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371; 21 USC 358; 21 
USC 360gg to 360ss; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 
USC 262; 42 USC 264

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. This action 
addresses labeling for convenience (small) size OTC drug packages.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Convenience Sizes)        12/12/06                    71 FR 74474
Final Action                    12/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research (HFD-560), 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

Related RIN: Split from 0910-AA01
RIN: 0910-AF37
_______________________________________________________________________




852. OVER-THE-COUNTER (OTC) DRUG REVIEW--LAXATIVE DRUG PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

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 will 
address laxative drug products. The other action will address psyllium 
laxative drug products in a granular dosage form.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Granular Psyllium)03/29/07                    72 FR 14669
Final Action (Laxative Drug 
Products)                       12/00/07
NPRM (Professional Labeling)    06/00/08

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research (HFD-560), 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

Related RIN: Split from 0910-AA01
RIN: 0910-AF38
_______________________________________________________________________




853. OVER-THE-COUNTER (OTC) DRUG REVIEW--SKIN PROTECTANT PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

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 labeling for products formulated and marketed as lip 
protectants. The second action addresses skin protectant products to 
protect and treat fever blisters and cold sores.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Technical 
Amendments)                     12/00/07
Final Action (Fever Blisters/
Cold Sores)                     06/00/07
Final Action (Diaper Rash)      12/00/07
Final Action (Aluminum Acetate) 
(Technical Amendment)           06/00/07

[[Page 22526]]

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research (HFD-560), 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

Related RIN: Split from 0910-AA01
RIN: 0910-AF42
_______________________________________________________________________




854. OVER-THE-COUNTER (OTC) DRUG REVIEW--VAGINAL CONTRACEPTIVE PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360a; 21 USC 371a; 21 USC 331; 21 USC 358; 21 USC 360; 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

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

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 will 
address labeling warning statements for products containing Nonoxynol 
9. The other action addresses vaginal contraceptive drug products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Warnings)         04/00/07
NPRM (Vaginal Contraceptive Drug 
Products)                       12/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research (HFD-560), 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

Related RIN: Split from 0910-AA01
RIN: 0910-AF44
_______________________________________________________________________




855. SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED TO PREVENT 
THE TRANSMISSION OF BOVINE SPONGIFORM ENCEPHALOPATHY

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: 21 USC 321; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 
371

CFR Citation: 21 CFR 589.2001

Legal Deadline: None

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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           07/14/04                    69 FR 42288
ANPRM Comment Period End        08/13/04
NPRM                            10/06/05                    70 FR 58569
NPRM Comment Period End         12/20/05
Final Action                    03/00/08

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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: [email protected]

RIN: 0910-AF46
_______________________________________________________________________




856. OVER-THE-COUNTER (OTC) DRUG REVIEW--OVERINDULGENCE IN FOOD AND 
DRINK PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360; 21 USC 360a; 21 USC 371; 21 USC 371a; 21 USC 331

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

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                      FR Cite

________________________________________________________________________

NPRM (Amendment)                01/05/05                      70 FR 741
Final Action                    12/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research (HFD-560),

[[Page 22527]]

5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

RIN: 0910-AF51
_______________________________________________________________________




857. OVER-THE-COUNTER (OTC) DRUG REVIEW--ANTACID PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360; 21 USC 360a; 21 USC 371; 21 USC 371a; 21 USC 331

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

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                      FR Cite

________________________________________________________________________

Final Action (Overindulgence 
Labeling)                       12/00/07
Final Action (Sodium Bicarbonate 
Labeling)                       12/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research (HFD-560), 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

RIN: 0910-AF52
_______________________________________________________________________




858. OVER-THE-COUNTER (OTC) DRUG REVIEW--SKIN BLEACHING PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360; 21 USC 360a; 21 USC 371; 21 USC 371a; 21 USC 331

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. This action 
addresses skin bleaching drug products containing hydroquinone.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/29/06                    71 FR 51146
NPRM Comment Period End         12/27/06
Final Action                    12/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research (HFD-560), 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

RIN: 0910-AF53
_______________________________________________________________________




859. DESIGNATION OF NEW ANIMAL DRUGS FOR MINOR USES OR MINOR SPECIES

Priority: Other Significant

Legal Authority: 21 USC 360ccc-2

CFR Citation: 21 CFR 516

Legal Deadline: NPRM, Statutory, August 2, 2008.
Final, Statutory, August 2, 2009.

Abstract: The proposed rule was published on September 27, 2005, in 
response to the Minor Use and Minor Species (MUMS) Animal Health Act of 
2004. The rule would implement section 573 of the MUMS Act, which sets 
forth the requirements for drug sponsors requesting MUMS designation 
for proposed new animal drugs. MUMS designation of a new animal drug 
allows drug sponsors to be granted 7 years of exclusive marketing 
rights for these limited demand new animal drugs once the drugs are 
approved or conditionally approved. This regulation would define 
content and format requirements for designation, requests changing 
designation ownership, and annual reporting requirements. This rule 
would also describe the criteria CVM will use for granting or denying 
these requests. Specific sections of the rule are dedicated to 
documentation of MUMS status in a request, granting MUMS designation, 
and revocation of MUMS designation. FDA intends to finalize this 
proposal after reviewing comments received. This is a voluntary program 
for animal drug sponsors. A large number of these drug companies are 
classified as small businesses.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/27/05                    70 FR 56394
NPRM Comment Period End         12/12/05
Final Rule                      08/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Bernadette Dunham, Director, Office of Minor Use and 
Minor Species Animal Drug Development, Department of Health and Human 
Services, Food and Drug Administration, Center for Veterinary Medicine 
(HFV-50, MPN-4), Room 180, 7519 Standish Place, Rockville, MD 20855
Phone: 240 276-9000

[[Page 22528]]

Fax: 240 276-9001
Email: [email protected]

RIN: 0910-AF60
_______________________________________________________________________




860. INDEX OF LEGALLY MARKETED UNAPPROVED NEW ANIMAL DRUGS FOR MINOR 
SPECIES

Priority: Other Significant

Legal Authority: 21 USC 360 ccc-1

CFR Citation: 21 CFR 516

Legal Deadline: NPRM, Statutory, February 2, 2009.
Final, Statutory, August 2, 2010.

Abstract: This rule is being issued in response to the Minor Use and 
Minor Species (MUMS) Animal Health Act of 2004. The rule implements 
section 572 of the MUMS Act, which provides for a public index listing 
of legally marketed unapproved new animal drugs for minor species of 
animals (species other than cattle, horses, swine, chickens, turkeys, 
dogs, and cats). The drugs in this index will only be indicated for use 
in non-food minor species or for use in early non-food life stages to 
food-producing minor species. This rule will, among other things, 
specify the procedures for requesting eligibility for indexing and for 
requesting addition to the index as well as the reporting requirements 
for index holders. This rule will also describe the criteria requestors 
will use for assembling a qualified expert panel to evaluate for FDA 
the target animal safety and effectiveness of a new animal drug 
proposed for indexing.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/22/06                    71 FR 48840
NPRM Comment Period Extended    10/02/06                    71 FR 57892
NPRM Comment Period End         12/20/06
Final Action                    08/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Bernadette Dunham, Director, Office of Minor Use and 
Minor Species Animal Drug Development, Department of Health and Human 
Services, Food and Drug Administration, Center for Veterinary Medicine 
(HFV-50, MPN-4), Room 180, 7519 Standish Place, Rockville, MD 20855
Phone: 240 276-9000
Fax: 240 276-9001
Email: [email protected]

RIN: 0910-AF67
_______________________________________________________________________




861. EXCEPTIONS OR ALTERNATIVES TO LABELING REQUIREMENTS FOR PRODUCTS 
HELD BY THE STRATEGIC NATIONAL STOCKPILE

Priority: Other Significant

Legal Authority: 15 USC 1451 to 1561; 21 USC 321; 21 USC 331; 21 USC 
351 to 353; 21 USC 355 and 356; 21 USC 358; 21 USC 360; 21 USC 371 to 
375; 21 USC 379; 21 USC 381 and 382; 21 USC 393; 42 USC 216; 42 USC 
241; 42 USC 262 to 264; 42 USC 271

CFR Citation: 21 CFR 201; 21 CFR 312; 21 CFR 314; 21 CFR 601; 21 CFR 
610; 21 CFR 801; 21 CFR 807; 21 CFR 809; 21 CFR 812; 21 CFR 814

Legal Deadline: None

Abstract: FDA is issuing regulations to permit FDA Center Directors to 
grant an exception or alternative to certain regulatory labeling 
provisions applicable to human drugs, biological products, or medical 
devices that are or will be included in the Strategic National 
Stockpile (SNS). Under this rule, the appropriate Center Director may 
grant an exception or alternative to such labeling requirements if he 
or she determines that compliance with such requirements could 
adversely affect the safety, effectiveness, or availability of 
specified lots, batches, or other units of human drugs, biological 
products, or medical devices that are or will be included in the SNS. A 
grant of an exception or alternative under these regulations will 
include any safeguards or conditions deemed appropriate by the Center 
Director to ensure that the labeling of such products includes 
information for the safe and effective use of the products given their 
anticipated circumstances of use. This rule will facilitate the safety, 
effectiveness, and availability of appropriate medical countermeasures 
in the event of a public health emergency.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              10/00/07

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Stephen M. Ripley, Team Leader, Department of Health 
and Human Services, Food and Drug Administration, Center for Biologics 
Evaluation and Research, Suite 200N (HFM-17), 1401 Rockville Pike, 
Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 827-9434

RIN: 0910-AF90
_______________________________________________________________________




862. [bull] HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED 
PRODUCTS; DONOR SCREENING AND TESTING, AND RELATED LABELING

Priority: Other Significant

Legal Authority: 42 USC 264

CFR Citation: 21 CFR 1271.55; 21 CFR 1271.80; 21 CFR 1271.90; 21 CFR 
1271.290; 21 CFR 1271.370

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is issuing a final 
rule, after issuing an interim final rule that amended certain 
regulations regarding the screening and testing of donors of human 
cells, tissues, and cellular and tissue-based products (HCT/Ps); and 
related labeling. FDA is taking this action to complete the rulemaking 
initiated with the interim final rule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              05/25/05                    70 FR 29949
Final Action                    12/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Brenda Friend, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Center for Biologics 
Evaluation and Research, Suite 200N (HFM-17), 1410 Rockville Pike, 
Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 827-9434

RIN: 0910-AF98

[[Page 22529]]

_______________________________________________________________________




863. [bull] OVER-THE-COUNTER (OTC) DRUG REVIEW--ACNE DRUG PRODUCTS 
CONTAINING BENZOYL PEROXIDE

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 371a

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Walter Jefferson 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: [email protected]

RIN: 0910-AG00
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




864. REQUIREMENTS FOR SUBMISSION OF IN VIVO BIOEQUIVALENCE DATA

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 
21 USC 355a; 21 USC 356; 21 USC 356a to 356c; 21 USC 371; 21 USC 374; 
21 USC 379

CFR Citation: 21 CFR 314.96(a)(1); 21 CFR 314.94(a)(7); 21 CFR 
320.21(b)(1)

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is proposing to 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. FDA is 
proposing to 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/29/03                    68 FR 61640
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Christine F. Rogers, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, Suite 1101, 5515 Security Lane, 
Rockville, MD 20857
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AC23
_______________________________________________________________________




865. TOLL-FREE NUMBER FOR REPORTING ADVERSE EVENTS ON LABELING FOR HUMAN 
DRUGS

Priority: Other Significant

Legal Authority: 21 USC 355b

CFR Citation: 21 CFR 201; 21 CFR 208; 21 CFR 209

Legal Deadline: Final, Statutory, January 4, 2003.

Abstract: To require the labeling of human drugs approved under section 
505 of the Federal Food, Drug, and Cosmetic Act to include a toll-free 
number for reports of adverse events, and a statement that the number 
is to be used for reporting purposes only and not to receive medical 
advice.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/22/04                    69 FR 21778
NPRM Comment Period End         07/21/04
Final Action                    06/00/08

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Carol Drew, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Center for Drug 
Evaluation and Research, Suite 1101 (HFD-7), 5515 Security Lane, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AC35
_______________________________________________________________________




866. PRIOR NOTICE OF IMPORTED FOOD UNDER THE PUBLIC HEALTH SECURITY AND 
BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002

Priority: Other Significant

Legal Authority: PL 107-188, sec 307

CFR Citation: 21 CFR 1.276 et seq

Legal Deadline: Final, Statutory, December 12, 2003.
The Public Health Security and Bioterrorism Preparedness and Response 
Act of 2002, section 307, directs the Secretary, through FDA, to issue 
final regulations establishing prior notice requirements for all 
imported food by December 12, 2003. If FDA fails to issue final 
regulations by this date,

[[Page 22530]]

the statute is self-executing on this date, and requires FDA to receive 
prior notice of not less than eight hours, nor more than five days 
until final regulations are issued.

Abstract: This rulemaking is one of a number of actions being taken to 
improve FDA's ability to respond to threats of bioterrorism. Section 
801(m) of the Federal Food, Drug, and Cosmetic Act (the act), which was 
added by section 307 of the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 (the Bioterrorism Act), requires 
notification to FDA prior to the entry of imported food. The regulation 
explains the information that the prior notice is required to contain, 
the method of submission of the notice, and the minimum and maximum 
period of advance notice required. Section 307 also states that if FDA 
does not receive prior notice or receives inadequate prior notice, the 
imported food shall be refused admission and held at the port of entry 
until proper notice is provided.
Section 307 authorizes the Secretary, through FDA, to promulgate final 
regulations by December 12, 2003. FDA and the Bureau of Customs and 
Border Protection (CBP) issued an interim final rule (IFR) on October 
10, 2003 (68 FR 58974). The IFR originally provided a 75-day comment 
period to ensure that those that comment on the IFR have the benefit of 
our outreach and educational efforts and have the experience with the 
systems, timeframes, and data elements. We reopened the comment period 
for an additional 90 days in April through July 2004, to allow for 
additional comment on the industry's experience with the prior notice 
system, and comment on the Joint FDA-CBP Plan for Increasing 
Integration and Assessing the Coordination of Prior Notice Timeframes. 
The final rule currently is under development, and it will confirm or 
amend the IFR, as appropriate. This final rule is not expected to have 
a significant impact on a substantial number of small entities.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/03/03                     68 FR 5428
Interim Final Rule              10/10/03                    68 FR 58974
Interim Final Rule Comment 
Period Reopened                 04/14/04                    69 FR 19763
Interim Final Rule Comment 
Period Reopened End             07/13/04
Final Rule                      09/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: May Nelson, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Center for Food 
Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, 
MD 20740
Phone: 301 436-1722
Fax: 301 436-2637
Email: [email protected]

RIN: 0910-AC41
_______________________________________________________________________




867. FOOD LABELING: TRANS FATTY ACIDS IN NUTRITION LABELING: CONSUMER 
RESEARCH TO CONSIDER NUTRIENT CONTENT AND HEALTH CLAIMS AND POSSIBLE 
FOOTNOTE OR DISCLOSURE STATEMENTS

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 343; 21 USC 371

CFR Citation: 21 CFR 101

Legal Deadline: None

Abstract: The Food and Drug Administration issued an advance notice of 
proposed rulemaking on July 11, 2003 (68 FR 41507), to solicit 
information and data that potentially could be used to establish new 
nutrient content claims about trans fatty acids; to establish 
qualifying criteria for trans fat in current nutrient content claims 
for saturated fat and cholesterol, lean and extra lean claims, and 
health claims that contain a message about cholesterol-raising lipids; 
and, in addition, to establish disclosure and disqualifying criteria to 
help consumers make heart-healthy food choices. The Agency also 
requested comments on whether it should consider statements about trans 
fat, either alone or in combination with saturated fat and cholesterol, 
as a footnote in the Nutrition Facts panel or as a disclosure statement 
in conjunction with claims to enhance consumers' understanding about 
such cholesterol-raising lipids and how to use the information to make 
healthy food choices. Information and data obtained from comments and 
from consumer studies that will be conducted by FDA also may be used to 
help draft a proposed rule that would establish criteria for certain 
nutrient content or health claims or require the use of a footnote, or 
other labeling approach, about one or more cholesterol-raising lipids 
in the Nutrition Facts panel to assist consumers in maintaining healthy 
dietary practices.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           07/11/03                    68 FR 41507
ANPRM Comment Period End        10/09/03
ANPRM Comment Period Reopened 
for 45 days                     03/01/04                     69 FR 9559
ANPRM Comment Period Extended 
for Additional 60 days          04/19/04                    69 FR 20838
ANPRM Comment Period End        06/18/04
NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Federal

Agency Contact: Julie Moss, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Food Safety and Applied Nutrition (HFS-830), 5100 Paint Branch Parkway, 
College Park, MD 20740
Phone: 301 436-2373
Fax: 301 436-2639
Email: [email protected]

Related RIN: Related to 0910-AB66
RIN: 0910-AC50
_______________________________________________________________________




868. FOOD STANDARDS: GENERAL PRINCIPLES AND FOOD STANDARDS MODERNIZATION

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 336; 21 USC 341; 21 USC 343; 21 USC 
371

CFR Citation: 21 CFR 130.5

Legal Deadline: None

Abstract: In 1995, the FDA and FSIS reviewed their regulatory 
procedures and requirements for food standards to determine whether any 
were still needed, and if so, which ones should be modified or 
streamlined. To request public comment to assist them in their review 
of the need for food standards,

[[Page 22531]]

both Agencies published advance notices of proposed rulemaking (ANPRMs) 
on food standards in December 1995 (60 FR 47453 and 60 FR 67492). These 
ANPRMs discussed the Agencies' regulations and policy governing food 
standards, the history of food standards, and the possible need to 
revise the food standards. Several comments in response to the ANPRMs 
recommended that the Agencies establish general principles or a 
fundamental philosophy for reviewing food standards and revising them. 
The Agencies agreed with these comments and determined that it would be 
appropriate to develop general principles for reviewing and revising 
food standards regulations. The Agencies also agreed with the comments 
that stated that the Agencies should work in concert to develop 
consistent food standards regulations. FDA and FSIS proposed a set of 
general principles that define how modern food standards should be 
structured (70 FR 29214, May 20, 2005). If this proposed rule is 
adopted, FDA and FSIS will require that a citizen petition for 
establishing, revising, or eliminating a food standard in 21 CFR parts 
130 to 169 and 9 CFR part 319 be submitted in accordance with the 
general principles. Conversely, the Agencies may find deficient a 
petition to establish, revise, or eliminate a food standard that does 
not follow these general principles.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           12/29/95                    60 FR 67492
ANPRM Comment Period End        04/29/96
NPRM                            05/20/05                    70 FR 29214
NPRM Comment Period End         08/18/05
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Undetermined

Agency Contact: Ritu Nalubola, Staff Fellow, Department of Health and 
Human Services, Food and Drug Administration, Center for Food Safety 
and Applied Nutrition, Harvey Wiley Building, 5100 Paint Branch 
Parkway, College Park, MD 20740
Phone: 301 436-2371
Fax: 301 436-2636
Email: [email protected]

Related RIN: Related to 0583-AC72
RIN: 0910-AC54
_______________________________________________________________________




869. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, 
PACKING, OR HOLDING OF DRUGS; REVISION OF CERTAIN LABELING CONTROLS

Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 351

CFR Citation: 21 CFR 211.122

Legal Deadline: None

Abstract: The proposed rule would amend the packaging and labeling 
control provisions of the current good manufacturing practice 
regulations for human and veterinary drug products by limiting the 
application of special control procedures for the use of cut labeling 
to immediate container labels, individual unit cartons, or multiunit 
cartons containing immediate containers that are not packaged in 
individual unit cartons. The proposal would also permit the use of any 
automated technique, including differentiation by labeling size and 
shape, that physically prevents incorrect labeling from being processed 
by labeling and packaging equipment when cut labeling is used.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/29/97                    62 FR 40489
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

Federalism:  Undetermined

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, Suite 1101 (HFD-7), 5515 
Security Lane, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AF08
_______________________________________________________________________




870. HEALTH CLAIMS

Priority: Other Significant

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 343; 21 USC 371

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: On November 25, 2003 (68 FR 66040), FDA issued an advance 
notice of proposed rulemaking (ANPRM) to request comments on 
alternatives for regulating qualified health claims in the labeling of 
conventional human foods and dietary supplements. FDA also solicited 
comments on various other issues related to health claims and on the 
appropriateness and nature of dietary guidance statements on 
conventional food and dietary supplement labels. This ANPRM was 
signaled in the July 11, 2003 (68 FR 41387), notice that announced the 
availability of the final report of the FDA Task Force on the Consumer 
Health Information for Better Nutrition Initiative.
Comments on the regulatory alternatives and additional topics 
identified in the ANPRM will inform FDA decisions about regulation of 
qualified health claims.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           11/25/03                    68 FR 66040
ANPRM Comment Period Extended   01/27/04                     69 FR 3868
ANPRM Comment Period End        02/25/04
NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Julie Moss, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Food Safety and Applied Nutrition (HFS-830), 5100 Paint Branch Parkway, 
College Park, MD 20740
Phone: 301 436-2373
Fax: 301 436-2639
Email: [email protected]

RIN: 0910-AF09

[[Page 22532]]

_______________________________________________________________________




871. COCHINEAL EXTRACT AND CARMINE LABEL DECLARATION

Priority: Other Significant

Legal Authority: 21 USC 379e(b)

CFR Citation: 21 CFR 73.100(d); 21 CFR 73.2087(c); 21 CFR 101.22(k)

Legal Deadline: None

Abstract: The Agency published a proposed rule on January 30, 2006, 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 proposal was issued 
in response to adverse event reports received by FDA and to a citizen 
petition submitted to FDA. The comment period ended on May 1, 2006. FDA 
intends to issue a final rule after reviewing comments.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/30/06                     71 FR 4839
NPRM Comment Period End         05/01/06
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Mical E. Honigfort, Consumer Safety Officer, Department 
of Health and Human Services, Food and Drug Administration, HFS-265, 
5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-1278
Fax: 301 436-2972
Email: [email protected]

RIN: 0910-AF12
_______________________________________________________________________




872. OBSTETRICAL AND GYNECOLOGICAL DEVICES; DESIGNATION OF SPECIAL 
CONTROL FOR CONDOMS AND CONDOMS WITH SPERMICIDAL LUBRICANT

Priority: Other Significant

Legal Authority: 21 USC 360c

CFR Citation: 21 CFR 884.5300; 21 CFR 884.5310

Legal Deadline: None

Abstract: The classification regulations for male 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 compliance with the recommendations in the 
guidance, or with some equivalent means of addressing the identified 
issues, 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 moving forward to meet 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/14/05                    70 FR 69102
NPRM Comment Period End         02/13/06
Final Action                    01/00/09

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Myrna Hanna, Regulations Staff, Department of Health 
and Human Services, Food and Drug Administration, Center for Devices 
and Radiological Health (HFZ-215), PI50 RM150F, 1350 Piccard Drive, 
Rockville, MD 20850
Phone: 240 276-2347
Fax: 240 276-2352
Email: [email protected]

RIN: 0910-AF21
_______________________________________________________________________




873. FOOD LABELING; PROMINENCE OF CALORIES

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 343; 21 USC 371

CFR Citation: 21 CFR 101.9

Legal Deadline: None

Abstract: In response to the Report of the Working Group on Obesity 
(OWG) that FDA issued on March 12, 2004, the Agency issued on April 4, 
2005, an advance notice of proposed rulemaking (ANPRM) in its efforts 
to combat the Nation's obesity problem. The ANPRM requested comments on 
ways to give more prominence to ``calories'' on the food label.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           04/04/05                    70 FR 17008
ANPRM Comment Period End        06/20/05
NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Jill Kevala, Chemist, Department of Health and Human 
Services, Food and Drug Administration, Center for Food Safety and 
Applied Nutrition (HFS-830), 5100 Paint Branch Parkway, College Park, 
MD 20740
Phone: 301 436-1450
Fax: 301 436-2636
Email: [email protected]

RIN: 0910-AF22
_______________________________________________________________________




874. FOOD LABELING; SERVING SIZES OF PRODUCTS THAT CAN REASONABLY BE 
CONSUMED AT ONE EATING OCCASION; UPDATING OF REFERENCE AMOUNTS 
CUSTOMARILY CONSUMED; APPROACHES FOR RECOMMENDING SMALLER PORTION SIZES

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 343; 21 USC 371

CFR Citation: 21 CFR 101.9; 21 CFR 101.12; 21 CFR 101.60(b)

Legal Deadline: None

Abstract: In response to the Report of the Working Group on Obesity 
that FDA issued on March 12, 2004, the Agency issued on April 4, 2005, 
an advance notice of proposed rulemaking (ANPRM) in its efforts to 
combat the Nation's obesity problem. The ANPRM requested comments on 
changes to the Agency's nutrition labeling regulations on serving size 
and comments on allowance of truthful, nonmisleading, and useful 
approaches for promoting consumption of smaller portion sizes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           04/04/05                    70 FR 17010

[[Page 22533]]

ANPRM Comment Period End        06/20/05
NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Mary Brandt, Supervisor Team Leader, Department of 
Health and Human Services, Food and Drug Administration, HFS-840, 5100 
Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-1788
Fax: 301 436-2635
Email: [email protected]

RIN: 0910-AF23
_______________________________________________________________________




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

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360a; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 371

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

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 claims for the common cold.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Amendment) (Common 
Cold)                           06/00/08

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research (HFD-560), 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

Related RIN: Split from 0910-AA01
RIN: 0910-AF31
_______________________________________________________________________




876. OVER-THE-COUNTER (OTC) DRUG REVIEW--OPHTHALMIC PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

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                      FR Cite

________________________________________________________________________

NPRM (Amendment) (Emergency 
First Aid Eyewashes)            12/00/08

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research (HFD-560), 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

Related RIN: Split from 0910-AA01
RIN: 0910-AF39
_______________________________________________________________________




877. OVER-THE-COUNTER (OTC) DRUG REVIEW--ORAL HEALTH CARE PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

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                      FR Cite

________________________________________________________________________

NPRM (Plaque Gingivitis)        06/00/08
Final Action                    06/00/08

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research (HFD-560), 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

Related RIN: Split from 0910-AA01
RIN: 0910-AF40

[[Page 22534]]

_______________________________________________________________________




878. USE OF MATERIALS DERIVED FROM CATTLE IN HUMAN FOOD AND COSMETICS

Priority: Other Significant

Legal Authority: 21 USC 342; 21 USC 361; 21 USC 371

CFR Citation: 21 CFR 189.5; 21 CFR 700.27

Legal Deadline: None

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 hexane-insoluble impurities and tallow derivatives. 
This action minimizes human exposure to materials that scientific 
studies have demonstrated are highly likely to contain the BSE agent in 
cattle infected with the disease. Scientists believe that the human 
disease variant Creutzfeldt-Jakob disease (vCJD) is likely caused by 
the consumption of products contaminated with the agent that causes 
BSE. After reviewing comments received to the interim final rule, FDA 
intends to issue a final rule.
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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              07/14/04                    69 FR 42256
Interim Final Rule Comment 
Period End                      10/12/04
Interim Final Rule (Amendments) 09/07/05                    70 FR 53063
Interim Final Rule (Amendments) 
Comment Period End              11/07/05
Final Action                    04/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Morris E. Potter, Lead Scientist for Epidemiology, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Food Safety and Applied Nutrition, HFS-032, 60 Eighth St., 
NE., Atlanta, GA 30309
Phone: 404 253-1225
Fax: 404-253-1218
Email: [email protected]

RIN: 0910-AF47
_______________________________________________________________________




879. USE OF MATERIALS DERIVED FROM CATTLE IN MEDICAL PRODUCTS INTENDED 
FOR USE IN HUMANS AND DRUGS INTENDED FOR USE IN RUMINANTS

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
355; 21 USC 360b; 21 USC 360f; 21 USC 360i; 21 USC 371; 21 USC 374; 21 
USC 381; 42 USC 262; 42 USC 264; 42 USC 271

CFR Citation: 21 CFR 211.116; 21 CFR 226.60; 21 CFR 300.200; 21 CFR 
500.200; 21 CFR 530; 21 CFR 600.16; 21 CFR 895.102; 21 CFR 1271.465; 21 
CFR 1271.470

Legal Deadline: None

Abstract: The regulation would prohibit the use of certain cattle 
material in the manufacture of medical products for humans and drugs 
for ruminants, and would require recordkeeping for products containing 
or manufactured with cattle materials to enable monitoring and 
enforcement of the prohibitions. The rule would prohibit the same 
cattle material that is prohibited in the previous FDA IFR that applies 
to foods and cosmetics. These include certain high risk tissues (e.g., 
brain, skull, eyes, spinal cord, trigeminal ganglia, parts of the 
vertebral column, and dorsal root ganglia) from cattle 30 months and 
older, tonsils and the distal ileum of cattle of any age, mechanically 
separated beef, material from nonambulatory disabled cattle, and 
material from cattle not inspected and passed for human consumption. 
The prohibitions would apply only to materials derived from animals 
slaughtered after the effective dates of the rules. The prohibitions 
would not apply to tallow that met a specified purity standard. The 
rule would provide criteria for deviations from the requirements based 
on a showing of safety or appropriate benefit-to-risk ratio.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/12/07                     72 FR 1582
NPRM Comment Period End         03/13/07
NPRM Comment Period Reopened    03/30/07
Final Action                    10/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Eric Flamm, Senior Policy Advisor, Office of Policy, 
Department of Health and Human Services, Food and Drug Administration, 
Office of the Commissioner, Room 14C-17, HF-23, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-0591
Fax: 301 827-4774
Email: [email protected]

Related RIN: Merged with 0910-AF55
RIN: 0910-AF54
_______________________________________________________________________




880. OVER-THE-COUNTER (OTC) DRUG REVIEW--URINARY ANALGESIC DRUG PRODUCTS

Priority: Routine and Frequent. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 371a

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

[[Page 22535]]

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)        06/00/08

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Walter Jefferson 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: [email protected]

RIN: 0910-AF70
_______________________________________________________________________




881. [bull] FOOD LABELING; SERVING SIZES; REFERENCE AMOUNT FOR BAKING 
POWDER, BAKING SODA, AND PECTIN (SECTION 610 REVIEW)

Priority: Routine and Frequent

Legal Authority: 15 USC 1453; 15 USC 1454; 15 USC 1455; 21 USC 321; 21 
USC 331; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 371

CFR Citation: 21 CFR 101

Legal Deadline: Other, Statutory, March 16, 2009, Planned section 610 
review.

Abstract: Section 101.9 (21 CFR part 101.9) describes the nutrition 
labeling regulations for the reference amount customarily consumed per 
eating occasion for the food category ``Baking powder, baking soda, 
pectin.'' Section 101.12 (21 CFR part 101.12) includes 1/8 teaspoon 
(tsp) as an additional allowable household measure. FDA is undertaking 
a review of sections 101.9 and 101.12 under section 610 of the 
Regulatory Flexibility Act. The purpose of this review is 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 will consider, and is soliciting 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review                    12/00/08
End Review                      03/00/09

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: David Zorn, Lead Economist, Department of Health and 
Human Services, Food and Drug Administration, HFS-020, 5100 Paint 
Branch Parkway, College Park, MD 20740
Phone: 301 436-1825
Fax: 301 436-2505
Email: [email protected]

RIN: 0910-AF99
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Food and Drug Administration (FDA)



_______________________________________________________________________




882. CHRONIC WASTING DISEASE: CONTROL OF FOOD PRODUCTS AND COSMETICS 
DERIVED FROM EXPOSED ANIMAL POPULATIONS

Priority: Other Significant

CFR Citation: Not Yet Determined

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       03/23/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Rebecca Buckner
Phone: 301 436-1486
Fax: 301 436-2632
Email: [email protected]

RIN: 0910-AC21
_______________________________________________________________________




883. MEDICAL DEVICES; PATIENT EXAMINATION AND SURGEONS' GLOVES; TEST 
PROCEDURES AND ACCEPTANCE CRITERIA

Priority: Routine and Frequent

CFR Citation: 21 CFR 800.20

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/19/06                    71 FR 75865

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Myrna Hanna
Phone: 240 276-2347
Fax: 240 276-2352
Email: [email protected]

RIN: 0910-AC32
_______________________________________________________________________




884. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (BRONCHODILATOR) 
PRODUCTS

Priority: Routine and Frequent

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action (Technical 
Amendment)                      03/19/07                    72 FR 12730

[[Page 22536]]

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

Related RIN: Split from 0910-AA01
RIN: 0910-AF32
_______________________________________________________________________




885. OVER-THE-COUNTER (OTC) DRUG REVIEW--DANDRUFF, SEBORRHEIC 
DERMATITIS, AND PSORIASIS PRODUCTS

Priority: Routine and Frequent

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/06/07                     72 FR 9849

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

RIN: 0910-AF49
_______________________________________________________________________




886. SUPPLEMENTS AND OTHER CHANGES TO APPROVED NEW ANIMAL DRUG 
APPLICATIONS

Priority: Substantive, Nonsignificant

CFR Citation: 21 CFR 25; 21 CFR 500; 21 CFR 514; 21 CFR 558

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/13/06                    71 FR 74766

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Dennis Bensley
Phone: 301 827-6956
Email: [email protected]

RIN: 0910-AF59
_______________________________________________________________________




887. BLOOD VESSELS RECOVERED WITH ORGANS AND INTENDED FOR USE IN ORGAN 
TRANSPLANTATION

Priority: Substantive, Nonsignificant

CFR Citation: 21 CFR 1271; 42 CFR 121

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/12/07                    72 FR 10922

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Denise Sanchez
Phone: 301 827-6210
Fax: 301 827-9434

RIN: 0910-AF65
_______________________________________________________________________




888. [bull] OVER-THE-COUNTER (OTC) DRUG REVIEW--MULTIPLE DRUG PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 371a

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

Abstract: Amendments to the Federal Food, Drug, and Cosmetic Act (the 
act) necessitate several changes to the citations used in Food and Drug 
Administration (FDA) regulations regarding the prescription-exemption 
procedure and the list of new drugs that are exempted from the 
prescription-dispensing requirements. These changes are editorial, 
pertaining only to citations, and do not constitute a change in FDA 
regulation.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action-Technical Amendment03/30/07                    72 FR 15043

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Walter Jefferson 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: [email protected]

RIN: 0910-AG01
_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




889. DESIGNATION OF MEDICALLY UNDERSERVED POPULATIONS AND HEALTH 
PROFESSIONAL SHORTAGE AREAS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 254b; 42 USC 254e

CFR Citation: 42 CFR 5; 42 CFR 51c

Legal Deadline: None

Abstract: This rule would consolidate the process for designating areas 
of health professional shortage and medical underservice that apply in 
several Department programs, and would improve the criteria for 
designating medically underserved populations and Primary Care Health 
Professional Shortage Areas. This notice of proposed rulemaking (NPRM) 
will address issues raised by comments received in a previous NPRM, 
dated September 1, 1998.

[[Page 22537]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/01/98                    63 FR 46538
NPRM                            07/00/07

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Andy Jordan, Chief, Shortage Designation Branch, 
Department of Health and Human Services, Health Resources and Services 
Administration, Room 8C-26, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 594-0197
Email: [email protected]

RIN: 0906-AA44
_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




890. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON 
PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: REPORTING ADVERSE AND 
NEGATIVE ACTIONS

Priority: Other Significant

Legal Authority: 42 USC 1396r-2

CFR Citation: 45 CFR 60

Legal Deadline: None

Abstract: Public Law 100-93 amended section 1921 of the Social Security 
Act to require that each State have in effect a system of reporting 
disciplinary licensure actions taken against all licensed health care 
practitioners and entities. It also requires States to report any 
negative action or finding that a peer review organization, private 
accreditation entity, or a State has concluded against a health care 
practitioner or entity. Section 1921 directs the Secretary to provide 
for maximum appropriate coordination in the implementation of these 
reporting requirements with those of the Health Care Quality 
Improvement Act of 1986 (title IV of Pub. L. 99-660). Section 1921 
requirements will be incorporated into the National Practitioner Data 
Bank.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/21/06                    71 FR 14135
NPRM Comment Period End         05/22/06
Final Action                    07/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Mark S. Pincus, Director, Division of Practitioner Data 
Banks, Department of Health and Human Services, Health Resources and 
Services Administration, Room 8-103, 5600 Fishers Lane, Rockville, MD 
20857
Phone: 301 443-2300

RIN: 0906-AA57
_______________________________________________________________________




891. REQUIREMENTS ESTABLISHING A LIMITATION ON ADMINISTRATIVE EXPENSES; 
RYAN WHITE CARE ACT TITLE IV GRANTS FOR COORDINATED SERVICES AND ACCESS 
TO RESEARCH

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 42 USC 300ff-71

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This rule finalizes the determination to establish a 
limitation on administrative expenses for Ryan White Comprehensive AIDS 
Resources Emergency (CARE) Act title IV Grants for Coordinated Services 
and Access to Research for Women, Infants, Children, and Youth. The 
rule establishes the limitation on administrative expenses as a 
percentage of the grant award, provides guidance on the procedures and 
processes for implementation of the limitation on administrative 
expenses, and clarifies the individual expenses that shall be 
categorized as administrative. The rule specifies the date for 
implementation as grants funded using fiscal year 2005 grant dollars.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/12/03                    68 FR 47923
NPRM Comment Period End         09/11/03
Final Rule                      07/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jose Rafael Morales, Acting Director, Division of 
Community Based Programs, Department of Health and Human Services, 
Health Resources and Services Administration, Room 7A-21, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 443-3650
Email: [email protected]

RIN: 0906-AA65
_______________________________________________________________________




892. NATIONAL VACCINE INJURY COMPENSATION PROGRAM: CALCULATION OF 
AVERAGE COST OF A HEALTH INSURANCE POLICY

Priority: Other Significant

Legal Authority: sec 2115 of the Public Health Service Act, 42 USC, 
300aa-15

CFR Citation: 42 CFR 100, sec 100.2

Legal Deadline: None

Abstract: The Department of Health and Human Services (HHS) is 
proposing to revise the current method for calculating the average cost 
of a health insurance policy, which is an amount deducted from the 
award of compensation in certain cases. According to the final rule 
published on June 24, 1992, which established the current calculation, 
``If, over time, the average cost of health insurance, as calculated by 
the method described above, significantly differs from subsequent HIAA 
survey results or other authoritative sources then available, the 
Secretary of HHS will consider appropriate revisions of this rule.`` 57 
FR 28098 (June 24, 1992). When the latest average monthly cost of an 
individual health insurance policy was calculated based on the current 
methodology, it was significantly different from the Kaiser Family 
Foundation/Health Research and Educational Trust average monthly cost 
of an individual health insurance policy for the same time period. 
Therefore, the Secretary is proposing a new methodology to calculate 
the average cost of a health insurance policy.
Subtitle 2 of title XXI of the Public Health Service Act, as enacted by 
the

[[Page 22538]]

National Childhood Vaccine Injury Act of 1986, as amended, governs the 
National Vaccine Injury Compensation Program (VICP). The VICP, 
administered by the Secretary of Health and Human Services (the 
Secretary) provides that a proceeding for compensation for a vaccine-
related injury or death shall be initiated by service upon the 
Secretary, and the filing of a petition with the United States Court of 
Federal Claims. In some cases, the injured individual may receive 
compensation for future lost earnings, less appropriate taxes and the 
``average cost of a health insurance policy, as determined by the 
Secretary.'' The elements of compensation that may be awarded to a 
successful petitioner are set out in section 2115 of the Public Service 
Act, 42 U.S.C. section 300aa-15. Subsection (a)(3)(B) specifically 
provides for compensation for lost earnings for a person who has 
sustained a vaccine-related injury at age 18 and beyond. The injured 
person would be eligible to receive compensation for loss of earnings, 
after the age of 18, which are calculated on the basis of the average 
gross weekly earnings of workers in the private, non-farm sector, less 
appropriate taxes and the ``average cost of a health insurance policy, 
as determined by the Secretary.'' The wage data are taken from the 
Employment and Earnings survey done by the Department of Labor, Bureau 
of Labor Statistics.
Subsection (a)(3)(A) specifically provides for payment of actual and 
anticipated lost earnings for individuals injured after reaching age 18 
and does not include deductions for taxes and the cost of health 
insurance. This new methodology is expected to result in a more 
accurate reflection of the actual average cost of a health insurance 
policy as compared to the figure reached under the methodology that is 
currently used, which results in a number that is too high. Because the 
amount of compensation for lost wages is reduced by this figure for 
some petitioners receiving compensation under the VICP, such 
petitioners are likely to receive a greater amount of compensation if 
the amendment is adopted.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/09/06                    71 FR 33420
Final Action                    07/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Dr. Geoffrey S. Evans, Acting Director, Division of 
Vaccine Injury Compensation, Department of Health and Human Services, 
Health Resources and Services Administration, Room 11C-26, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 443-6593
Fax: 301 443-8196
Email: [email protected]

RIN: 0906-AA68
_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




893. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON 
PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: MEDICAL MALPRACTICE 
PAYMENTS REPORTING REQUIREMENTS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 11131

CFR Citation: 45 CFR 60.7

Legal Deadline: None

Abstract: This notice of proposed rulemaking (NPRM) proposes to require 
that, in addition to reporting to the National Practitioner Data Bank, 
medical malpractice payments made where physicians or other health care 
practitioners are named in medical malpractice actions or claims, 
judgments, or settlements, payments be reported where they are made for 
the benefit of physicians or other health care practitioners not named 
in the judgments or settlements but who furnished or failed to furnish 
the health care services upon which the actions or claims were based. 
The purpose of this NPRM is to prevent the evasion of the medical 
malpractice payment reporting requirement of the Data Bank through the 
agreement of the parties to a lawsuit to use the corporate health care 
entity to ``shield'' practitioners. It would also require malpractice 
payers, in very limited circumstances, when it is impossible to 
identify the practitioner who furnished or failed to furnish the health 
care services upon which the actions or claims were based, to report 
why the practitioner could not be identified, and to provide the name 
of the corporate health care entity.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/24/98                    63 FR 71255
Second NPRM                      To Be                       Determined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Mark S. Pincus, Director, Division of Practitioner Data 
Banks, Department of Health and Human Services, Health Resources and 
Services Administration, Room 8-103, 5600 Fishers Lane, Rockville, MD 
20857
Phone: 301 443-2300

RIN: 0906-AA41
_______________________________________________________________________




894. OPERATION OF THE ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK 
(OPTN)

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 42 USC 274e, sec 301, 1984; 42 USC 273 to 274d, sec 
371 to 376; 42 USC 1320b-8, sec 1138

CFR Citation: 42 CFR 121

Legal Deadline: None

Abstract: The Department of Health and Human Services (HHS) proposes to 
amend the final rule governing the operation of the OPTN.
This notice of proposed rulemaking provides the legislative and 
regulatory history of the current rule, the factors that persuaded HHS 
of the advisability of amending the final rule governing the operation 
of the OPTN, and the anticipated consequences of this proposal. As 
required rapid changes in response to better understanding of the 
clinical scientific issues have become evident, HHS has determined that 
the current process for approving and enforcing policies must be 
amended.

[[Page 22539]]

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Dr. Hui-Hsing Wong, Medical Officer, Department of 
Health and Human Services, Health Resources and Services 
Administration, Mail Stop 16C-17, 5600 Fishers Lane, Parklawn Building, 
Rockville, MD 20857
Phone: 301 443-8104
Fax: 301 594-6095
Email: [email protected]

RIN: 0906-AA63
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




895. INTESTINES ADDED TO THE DEFINITION OF ORGANS COVERED BY THE RULES 
GOVERNING THE OPERATION OF THE ORGAN PROCUREMENT AND TRANSPLANTATION 
NETWORK (OPTN)

Priority: Other Significant

CFR Citation: 42 CFR 121

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      03/09/07                    72 FR 10616

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Laura St. Martin
Phone: 301 443-4423
Email: [email protected]

RIN: 0906-AA62
_______________________________________________________________________




896. HEALTHY TOMORROW'S PARTNERSHIP FOR CHILDREN (HTPC) PROGRAM

Priority: Other Significant

CFR Citation: 42 CFR 51(a)

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      01/24/07                     72 FR 3079

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jose Belardo
Phone: 301 443-0757
Email: [email protected]

RIN: 0906-AA70
_______________________________________________________________________


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


Indian Health Service (IHS)



_______________________________________________________________________




897. SECTION 506--LIMITATION ON CHARGES FOR SERVICES FURNISHED BY 
MEDICARE-PARTICIPATING INPATIENT HOSPITAL TO INDIANS

Priority: Other Significant

Legal Authority: MMA, sec 506; PL 108-173

CFR Citation: 42 CFR 135, subpart D; 42 CFR 489, subpart B

Legal Deadline: None

Abstract: This provision requires that as a condition of participation 
in the Medicare Program, providers accept payment at rates established 
by the Secretary in regulations as payment in full for services 
provided in an inpatient hospital to American Indians/Alaskan Natives 
(AI/AN) beneficiaries referred or authorized by the Indian Health 
Service, Tribes or Tribal organizations, or Urban Indian Organization 
(I/T/U).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/28/06                    71 FR 25124
NPRM Comment Period End         06/27/06
Final Action                    08/00/07

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Betty Z. Gould, Regulations Officer, Department of 
Health and Human Services, Indian Health Service, Suite 450, 12300 
Twinbrook Parkway, Rockville, MD 20852
Phone: 301 443-1116
Email: [email protected]

RIN: 0917-AA07
_______________________________________________________________________


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


Agency for Healthcare Research and Quality (AHRQ)



_______________________________________________________________________




898. [bull] PATIENT SAFETY AND QUALITY IMPROVEMENT ACT OF 2005 RULES

Priority: Economically Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 42 USO 299b-12 to 299b-26; PL 109-41

CFR Citation: 42 CFR 3

Legal Deadline: None

Abstract: The proposed rules to implement the Patient Safety and 
Quality Improvement Act of 2005 establish a framework in which 
hospitals, doctors, and other health care providers may voluntarily 
contract with Patient Safety Organizations (PSOs) to report and analyze 
health care errors. Providers contract with PSOs for expertise in the 
collection of patient safety event reports and analysis of the cause of 
adverse events. The proposed rules outline the requirements that 
entities must meet and certify to the Secretary for acceptance as a 
PSO. The

[[Page 22540]]

proposed rules establish legal boundaries of privilege and 
confidentiality within which reporting and analysis occurs, and sets 
forth procedures for the imposition of civil money penalties for the 
knowing or reckless disclosure of patient safety work product.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: William Munier, Department of Health and Human 
Services, Agency for Healthcare Research and Quality, 540 Gaither Road, 
Rockville, MD 20850
Phone: 301 427-1219
Fax: 301 443-0251
Email: [email protected]

RIN: 0919-AA01
_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




899. GRANTS FOR RESEARCH PROJECTS

Priority: Other Significant

Legal Authority: 42 USC 216

CFR Citation: 42 CFR 52

Legal Deadline: None

Abstract: NIH proposes to amend the regulations governing grants for 
research projects by revising the definition of Principal Investigator 
to mean one or more individuals designated by the grantee in the grant 
application and approved by the Secretary, who is or are responsible 
for the scientific and technical direction of the project, rather than 
limiting the role of principal investigator to one single individual 
when that more accurately reflects the management needs of a research 
project.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA42
_______________________________________________________________________




900. NATIONAL INSTITUTES OF HEALTH LOAN REPAYMENT PROGRAMS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 288-5a; 42 USC 287c-33; 42 USC 288-
6; 42 USC 288-1; 42 USC 288-3; 42 USC 288-5; 42 USC 288-5a; 42 USC 288-
6

CFR Citation: 42 CFR 68

Legal Deadline: None

Abstract: NIH proposes to issue a single set of regulations to govern 
all of its loan repayment (LRP) authorities. This action will include 
rescinding the current regulations at 42 CFR part 68a and at 42 CFR 
part 68c replaced by the new consolidated set of LRP regulations. This 
action will also include withdrawing the previously announced planned 
actions concerning NIH LRP authorities.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA43
_______________________________________________________________________




901. NATIONAL LIBRARY OF MEDICINE TRAINING GRANTS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 286b-3

CFR Citation: 42 CFR 64

Legal Deadline: None

Abstract: NIH proposes to amend the regulations governing National 
Library of Medicine training grants by revising the definition of 
Project Director to mean one or more individuals designated by the 
grantee in the grant application, and approved by the Secretary, who is 
or are responsible for the scientific and technical direction of the 
project, rather than limiting the role of the project director to one 
single individual when that more accurately reflects the management 
needs of a research project.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA44

[[Page 22541]]

_______________________________________________________________________




902. MINORITY BIOMEDICAL RESEARCH SUPPORT PROGRAM

Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 42 USC 216; 42 USC 241(a)(3)

CFR Citation: 42 CFR 52c

Legal Deadline: None

Abstract: NIH proposes to amend the regulations governing Minority 
Biomedical Research Support Program grants by revising the definition 
of Program Director to mean one or more individuals designated by the 
grant application, and approved by the Secretary, who is or are 
responsible for the scientific and technical direction of the program, 
rather than limiting the role of the program director to one single 
individual when that more accurately reflects the management needs of a 
research program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA45
_______________________________________________________________________




903. NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES HAZARDOUS 
SUBSTANCES BASIC RESEARCH AND TRAINING GRANTS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 9660(a)

CFR Citation: 42 CFR 65a

Legal Deadline: None

Abstract: NIH proposes to amend the regulations governing National 
Institute of Environmental Health Sciences Hazardous Substances Basic 
Research and Training grants by revising the definition of Program 
Director to mean one or more individuals designated by the grantee in 
the grant application, and approved by the Secretary, who is or are 
responsible for the scientific and technical direction of the project, 
rather than limiting the role of the program director to one single 
individual when that more accurately reflects the management needs of a 
research project.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA46
_______________________________________________________________________




904. ENDOWMENT PROGRAM

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 287c-31

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: The Director of the National Center for Minority Health and 
Disparities Research is authorized under section 485E(h)(1) of the 
Public Health Service Act to carry out a program to facilitate minority 
health disparities research and other health disparities research by 
providing for research endowments at centers of excellence under 
section 736 (Public Health Service Act). NIH plans to issue 
implementing regulations to govern these research endowments.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA47
_______________________________________________________________________




905. UNDERGRADUATE SCHOLARSHIP PROGRAM REGARDING PROFESSIONS NEEDED BY 
THE NATIONAL INSTITUTES OF HEALTH

Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 42 USC 216; 42 USC 288-4

CFR Citation: 42 CFR 68b

Legal Deadline: None

Abstract: Section 487D of the Public Health Service Act, as added by 
NIH Revitalization Act of 1993, creates a program offering scholarships 
to individuals from disadvantaged backgrounds who are enrolled as full-
time students at accredited institutions pursuing academic programs 
appropriate for careers in professions needed by NIH. For each year of 
scholarship support, the recipient agrees to service (employment) after 
graduation, at NIH, for one year. Additionally, the individual agrees 
to at least 10 consecutive weeks of service (employment) at NIH during 
which the individual is attending the educational institution and 
receiving the NIH scholarship. The proposed new regulations will govern 
this program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA48
_______________________________________________________________________




906. NIH TRAINING GRANTS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 285q-1; 42 USC 287c-32

[[Page 22542]]

CFR Citation: 42 CFR 63a

Legal Deadline: None

Abstract: NIH plans to amend the Agency's existing training grants 
regulations to (1) reflect their applicability to the training 
authorities set forth in PHS's ACT sections 464W and 485F, (2) reflect 
their applicability to the National Center on Minority Health and 
Health Disparities (NCMHD) and Fogarty International Center (FIC) 
Minority Health and Health Disparities International Research Training 
(MHIRT) awards, and (3) revise the definition of program director to 
mean one or more individuals named by the grantee in the grant 
application, and approved by the Secretary, who is responsible for the 
management and conduct of the training program, rather than limiting 
the role of program director to a single individual when that more 
accurately reflects the management needs of a training program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA49
_______________________________________________________________________




907. NIH CENTER GRANTS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 287c-21h; 42 USC 241

CFR Citation: 42 CFR 57a

Legal Deadline: None

Abstract: NIH plans to amend the Agency's existing center grant 
regulations by revising section 52a.1 to reflect the applicability of 
the regulations to (1) the program of research centers on complementary 
and alternative medicine administered by the National Center for 
Complementary and Alternative Medicine (NCCAM) and (2) the regional 
centers of excellence for biodefense and emerging infectious diseases 
research administered by the National Institute of Allergy and 
Infectious Diseases (NIAID).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA50
_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




908. STANDARDS FOR A NATIONAL CHIMPANZEE SANCTUARY SYSTEM

Priority: Other Significant

Legal Authority: 42 USC 287a-3a

CFR Citation: 42 CFR 9

Legal Deadline: NPRM, Statutory, June 18, 2001.

Abstract: NIH proposes to establish standards for operating a national 
chimpanzee sanctuary system to provide for the retirement of federally-
owned or supported chimpanzees no longer needed for research.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/11/05                     70 FR 1843
Final Action                    08/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA31
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


National Institutes of Health (NIH)



_______________________________________________________________________




909. NIH CONSTRUCTION GRANT

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 52b

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       04/02/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA51

[[Page 22543]]

_______________________________________________________________________


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


Office of Public Health and Science (OPHS)



_______________________________________________________________________




910. HUMAN SUBJECTS PROTECTION REGULATIONS: INSTITUTIONAL REVIEW BOARDS 
REGISTRATION REQUIREMENTS

Priority: Substantive, Nonsignificant

Legal Authority: 5 USC 301; 42 USC 289

CFR Citation: 45 CFR 46

Legal Deadline: None

Abstract: This notice of proposed rulemaking proposes to add subpart F 
to Department of Health and Human Services (HHS) regulations for 
protection of human subjects, 45 CFR part 46, to require registration 
of institutional review boards (IRBs) with HHS. The registration 
information would include contact information, approximate numbers of 
active protocols involving research conducted or supported by HHS, 
accreditation status, IRB membership, and staffing for the IRB. The 
proposed registration requirements will make it easier for the Office 
for Human Research Protections (OHRP) to convey information to IRBs, 
and will support the current IRB registration operated by OHRP. Under 
the current OHRP IRB registration system, the submission of certain 
registration information is required by human subjects protection 
regulations, and certain other information may be submitted 
voluntarily. This proposed information collection was submitted to the 
Office of Management and Budget under the Paperwork Reduction Act. 
Under the proposed rule, all registration information will be required, 
making the IRB registration system uniform with IRB registration 
requirements of the Food and Drug Administration (FDA), and creating a 
single, HHS IRB Registration system. FDA simultaneously published a 
proposed rule regarding FDA IRB registration requirements.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/04/04                    69 FR 40584
NPRM Comment Period End         10/04/04
Final Action                    03/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Irene Stith-Coleman Ph.D, Department of Health and 
Human Services, Office of Public Health and Science, The Tower 
Building, 1101 Wootten Parkway, Rockville, MD 20852
Phone: 240 453-6900
Fax: 301 402-2071
Email: [email protected]

RIN: 0940-AA06
_______________________________________________________________________


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


Office of Public Health and Science (OPHS)



_______________________________________________________________________




911. PUBLIC HEALTH SERVICE STANDARDS FOR THE PROTECTION OF RESEARCH 
MISCONDUCT WHISTLEBLOWERS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 241; 42 USC 289b

CFR Citation: 42 CFR 94

Legal Deadline: None

Abstract: To implement section 493(e) of the Public Health Service Act 
(added by sec 163 of the National Institutes of Health Revitalization 
Act of 1993, Pub. L. 103-43), the Department is proposing to add a new 
part 94 to title 42 of the Code of Federal Regulations. Under this 
proposed regulation, covered institutions must follow certain 
requirements for preventing and responding to occurrences of 
retaliation against whistleblowers. The purpose of this part is to 
protect: 1) Persons who make a good faith allegation that a covered 
institution or member thereof engaged in, or failed to respond 
adequately to an allegation of research misconduct; and 2) persons who 
cooperate in good faith with an investigation of research misconduct.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/28/00                    65 FR 70830
NPRM Comment Period End         01/29/01
Final Action                    06/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Chris Pascal, Director, Office of Research Integrity, 
Department of Health and Human Services, Office of Public Health and 
Science, 1101 Wootten Parkway, Rockville, MD 20852
Phone: 240 453-8200
Fax: 301 443-5351

Related RIN: Related to 0940-AA04
RIN: 0940-AA01
_______________________________________________________________________




912. HUMAN SUBJECTS PROTECTION REGULATIONS: TRAINING AND ED. 
REQUIREMENTS FOR INSTITUTIONAL OFFICIALS, INSTITUTIONAL REVIEW BOARD 
MEMBERS AND STAFF, HUMAN PROTECTIONS ADMINISTRATORS, AND INVESTIGATORS

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 5 USC 301; 42 USC 289

CFR Citation: 45 CFR 46

Legal Deadline: None

Abstract: Through this advance notice of proposed rulemaking (ANPRM), 
the Office for Human Research Protections (OHRP), Office of Public 
Health and Science, Department of Health and Human Services is seeking 
comment on whether it is necessary to require institutions engaged in 
human subjects research covered by Federalwide Assurance filed with 
OHRP to ensure that institutional officials and institutional review 
board (IRB) chairpersons, and members, IRB staff, investigators, and 
other personnel involved in the conduct or oversight of human subjects 
research receive appropriate training and education about relevant 
human subjects protection requirements.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                            To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Elyse Summers, Department of Health and Human Services, 
Office of Public Health and

[[Page 22544]]

Science, The Tower Building, 1101 Wootten Parking, Rockville, MD 20852
Phone: 240 453-6900
Email: [email protected]

RIN: 0940-AA08
_______________________________________________________________________




913. HUMAN SUBJECTS PROTECTION REGULATIONS: ADDITIONAL PROTECTIONS FOR 
ADULT INDIVIDUALS WITH IMPAIRED DECISIONMAKING CAPACITY

Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 5 USC 301; 42 USC 289

CFR Citation: 45 CFR 46

Legal Deadline: None

Abstract: Through this advance notice of proposed rulemaking (ANPRM), 
the Office for Human Research Protections (OHRP), Office of Public 
Health and Science, and the Food and Drug Administration (FDA) of the 
Department of Health and Human Services (HHS) are seeking comment on 
whether it is necessary to develop additional safeguards to help 
protect adult individuals with impaired decisionmaking capacity who are 
potential subjects in research, and if so, suggestions for appropriate 
safeguards. This ANPRM stems from the recommendation of an HHS working 
group, generated in response to the report published by the National 
Bioethics Advisory Commission entitled ``Research Involving Persons 
with Mental Disorders That May Affect Decisionmaking Capacity'' 
(December 1998), and from subsequent recommendations by the National 
Human Research Protections Advisory Committee.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                            To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Julie A. Kaneshiro, Department of Health and Human 
Services, Office of Public Health and Science, The Tower Building, 
Suite 200, 1101 Wootton Parkway, Rockville, MD 20852
Phone: 240 452-6900
Fax: 301 402-2071
Email: [email protected]

RIN: 0940-AA11
_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




914. HOME HEALTH AGENCY (HHA) CONDITIONS OF PARTICIPATION (COPS) (CMS-
3819-P) (SECTION 610 REVIEW)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395x; 42 USC 1395cc(a); 42 USC 
1395hh; 42 USC 1395bb

CFR Citation: 42 CFR 409, 42 CFR 418, 42 CFR 484

Legal Deadline: None

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                      FR Cite

________________________________________________________________________

NPRM                            03/10/97                    62 FR 11005
NPRM Comment Period End         06/09/97
Second NPRM                     11/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Commander Mercedes Benitez-McCrary, Health Insurance 
Specialist, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Clinical Standards Group, Mailstop S3-05-
14, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5716
Email: [email protected]

RIN: 0938-AG81
_______________________________________________________________________




915. APPEALS OF CMS OR CONTRACTOR DETERMINATIONS WHEN A PROVIDER OR 
SUPPLIER FAILS TO MEET THE REQUIREMENTS FOR MEDICARE BILLING (CMS-6003-
P2)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395u(b)(3)(C); 42 USC 1395ff(b) 
and 1395hh

CFR Citation: 42 CFR 405.874; 42 CFR 424.525; 42 CFR 424.535; 42 CFR 
424.545; 42 CFR 498.1; 42 CFR 498.2; 42 CFR 498.5; 42 CFR 498.22; 42 
CFR 498.40; 42 CFR 498.44; 42 CFR 498.56; 42 CFR 498.78; 42 CFR 498.79; 
42 CFR 498.86; 42 CFR 498.88; 42 CFR 405.802; 42 CFR 424.510;

Legal Deadline: None

Abstract: This proposed rule would extend appeal rights to all 
suppliers whose enrollment applications for Medicare billing privileges 
are disallowed by a carrier or whose Medicare billing privileges are 
revoked, except for those suppliers covered under other existing 
appeals provisions of our regulations. In addition, certain appeal 
provisions are revised to correspond with the existing appeal 
provisions in those other sections of our regulations. The rule would 
also extend appeal rights to all suppliers not covered by existing 
regulations to ensure they have a full and fair opportunity to be 
heard. This rule would incorporate provisions from section 936 of the 
Medicare Modernization Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/25/99                    64 FR 57431
Second NPRM                     03/02/07                     72 FR 9479

[[Page 22545]]

Second NPRM Comment Period End  05/02/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: August Nemec, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Office of Financial Management, Program Integrity Group, Mailstop C3-
02-16, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0612
Email: [email protected]

RIN: 0938-AI49
_______________________________________________________________________




916. RURAL HEALTH CLINICS: AMENDMENTS TO PARTICIPATION REQUIREMENTS AND 
PAYMENT PROVISIONS AND ESTABLISHMENT OF A QUALITY ASSESSMENT AND 
IMPROVEMENT PROGRAM (CMS-1910-P2)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh; Deficit Reduction Act of 
2005 (PL 109-171), sec 6083

CFR Citation: 42 CFR 405; 42 CFR 491

Legal Deadline: None

Abstract: This rule proposes to amend the Medicare certification and 
payment requirements for rural health clinics (RHCs), as required by 
section 4205 of the Balanced Budget Act of 1997. It proposes to change 
the definition of a qualifying rural shortage area in which a Medicare 
RHC must be located; establish criteria for identifying RHCs essential 
to delivery of primary care services that we can continue to approve as 
Medicare RHCs in areas no longer designated as medically underserved; 
and limit nonphysician practitioner staffing requirements. This rule 
proposes to impose payment limits on provider-based RHCs and prohibit 
the use of RHC space, professional staff, equipment, and other RHC 
resources by another Medicare entity. The rule also proposes to require 
RHCs to establish a quality assessment and performance improvement 
program. In light of the fact that section 902 of MMA of 2003 requires 
the Secretary to issue regulations within 3 years, CMS is republishing 
the provisions of the final RHC rule as a proposed rule to provide the 
public with an opportunity to formally comment on the new policies 
established under the December 24, 2003, rule. In addition, we are 
proposing new policy revisions to the RHC and FQHC program to improve 
and strengthen this rural safety net benefit which addresses section 
5114 of the DRA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/24/03                    68 FR 74792
Interim Final Rule              09/22/06                    71 FR 55341
Interim Final Rule Comment 
Period End                      11/21/06
Second NPRM                     08/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: John Warren, Centers for Medicare Management,, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Ambulatory Services, Mailstop C4-01-15, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3633
Email: [email protected]

RIN: 0938-AJ17
_______________________________________________________________________




917. USE OF RESTRAINTS AND SECLUSION IN MEDICARE AND MEDICAID 
PARTICIPATING FACILITIES THAT PROVIDE INPATIENT OR RESIDENTIAL CARE 
(CMS-2130-P)

Priority: Other Significant

Legal Authority: PL 106-554, (BIPA 2000 of the Children's Health Act)

CFR Citation: 45 CFR 101; 42 CFR 418; 42 CFR 482; 42 CFR 483; 42 CFR 
485

Legal Deadline: None

Abstract: This proposed rule would implement provisions of the 
Children's Health Act of 2000 (CHA) related to the use of restraints or 
seclusion for individuals receiving services in health care facilities 
that receive Federal funding. The rule would establish common 
terminology and basic expectations for the use of restraints and 
seclusion for health care facilities that furnish inpatient or 
residential care and receive Medicare or Medicaid funding.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/07

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Carla McGregor, Technical Director, Survey and 
Certification Group, Department of Health and Human Services, Centers 
for Medicare & Medicaid Services, Center for Medicaid State Operations, 
Mailstop S2-12-25, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0663
Email: [email protected]

RIN: 0938-AL26
_______________________________________________________________________




918. REVISIONS TO CONDITIONS FOR COVERAGE FOR AMBULATORY SURGICAL 
CENTERS (CMS-3887-P)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: sec 1102 and 1871 of the Social Security Act

CFR Citation: 42 CFR 416

Legal Deadline: None

Abstract: This proposed rule would revise the ambulatory surgical 
center conditions for coverage to reflect current innovations in 
healthcare delivery, quality assessment, and performance improvement. 
The focus would be to improve outcomes of health care and satisfaction 
for Medicare beneficiaries, while streamlining structural and 
procedural requirements when possible.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: State

Agency Contact: Joan Brooks, 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: 410 786-5526

[[Page 22546]]

Email: [email protected]

Commander Jacqueline Morgan, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Clinical Standards and Group, Mailstop S3-02-01, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4282
Email: [email protected]

RIN: 0938-AL80
_______________________________________________________________________




919. MODIFICATIONS TO ELECTRONIC TRANSACTIONS AND CODE SETS (CMS-0009-P)

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority: sec 1171 to 1179 of the Social Security Act; Deficit 
Reduction Act of 2005, PL 109-171, sec 6035

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This proposed rule would adopt new versions of the X12 suite 
of HIPAA Transactions and allow the industry to use the most up-to-date 
versions of the HIPAA transactions for claims and remittance advice.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/07

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: Federal, Local, State, Tribal

Federalism:  This action may have federalism implications as defined in 
EO 13132.

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, Mail Stop 
S2-24-18, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0273
Email: [email protected]

RIN: 0938-AM50
_______________________________________________________________________




920. REVISIONS TO HIPAA CODE SETS (CMS-0013-P)

Priority: Economically Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

Legal Authority: PL 104-191

CFR Citation: 45 CFR 162

Legal Deadline: None

Abstract: This proposed rule would revise 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                      FR Cite

________________________________________________________________________

NPRM                            08/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: Federal, Local, State, Tribal

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Energy Effects:  Statement of Energy Effects planned as required by 
Executive Order 13211.

Agency Contact: Gladys Wheeler, Health Insurance Specialist, Office of 
E-Health Standards and Services, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, Mailstop S2-26-17, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0273
Email: [email protected]

RIN: 0938-AN25
_______________________________________________________________________




921. NATIONAL PLAN AND PROVIDER ENUMERATION SYSTEM (NPPES) DATA 
DISSEMINATION (CMS-6060-NC)

Priority: Other Significant

Legal Authority: HIPAA of 1996, secs 1171 to 1179 of the Social 
Security Act (42 USC 1329d to 1320d-8); NPI final rule (01/23/2004); 
NPS System of Records (07/28/1998)

CFR Citation: 45 CFR 163

Legal Deadline: None

Abstract: The National Provider Identifier final rule, published 
January 23, 2004, stated that CMS would publish a follow-up notice to 
describe the data dissemination processes and any applicable charges 
for data. This notice with comment period describes the data that would 
be available from the National Plan and Provider Enumeration System 
(NPPES), in compliance with the provisions of the Privacy Act, the 
Freedom of Information Act (FOIA), the Electronic Freedom of 
Information Act (FOIA) amendments of 1996, and other applicable 
regulations and authorities, and must be consistent with the National 
Provider System of Records Notice published on July 28, 1998. The 
notice describes the data dissemination strategy, processes, and any 
applicable charges for data.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          05/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Patrica Peyton, Technical Advisor, Department of Health 
and Human Services, Centers for Medicare & Medicaid Services, Office of 
Financial Management, Program Integrity Group, Mailstop C3-02-16, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1812
Email: [email protected]

RIN: 0938-AN71
_______________________________________________________________________




922. CHANGES TO THE DISCLOSURE OF INFORMATION REQUIREMENTS FOR QUALITY 
IMPROVEMENT ORGANIZATIONS (CMS-3156-P)

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: sec 1154 to 1160 of the Social Security Act

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This proposed rule would add a provision to the existing 
Quality Improvement Organization (QIO) confidentiality regulations 
allowing the release of Medicare beneficiary-specific information, with 
patient consent, from the QIO to practitioners and providers in a 
treatment relationship with the beneficiary. This release may only be 
permitted after the beneficiary has

[[Page 22547]]

consented to the release and has been provided notice of the release. 
The new provisions will also permit the release of Medicare 
beneficiary-specific information, with patient consent, from the QIO to 
other QIOs, subcontractors to QIOs, and CMS for educational and quality 
improvement purposes. Additionally, the rule would add provisions for 
the Medicare beneficiary complaint system that is required by the 
statute and administered by the QIOs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Captain Arnold C. Farley, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Office of Clinical Standards and Quality, 
Improvement Group, Mailstop S3-02-01, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-1154
Email: [email protected]

RIN: 0938-AN73
_______________________________________________________________________




923. PAYMENTS FOR SERVICE PROVIDED WITHOUT CHARGE (CMS-2489-P)

Priority: Other Significant

Unfunded Mandates: Undetermined

Legal Authority: None

CFR Citation: 42 CFR 435

Legal Deadline: None

Abstract: The proposed rule would clarify that Federal Financial 
Participation (FFP) is not available to States on behalf of Medicaid 
beneficiaries for Medicaid-covered services provided without charge 
(that is, free care) to individuals receiving the services. Free care 
means a particular service is available without charge to an individual 
who receives the service or to any third party on behalf of the 
individual.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/07

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Governmental Jurisdictions

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Melissa L. Harris, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Disability and Elderly Health Programs Group, 
Mailstop S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3397
Email: [email protected]

RIN: 0938-AO07
_______________________________________________________________________




924. MEDICAL IMPROVEMENT ELIGIBILITY GROUP AND DEFINITION OF WORK (CMS-
2143-P)

Priority: Other Significant

Legal Authority: PL 105-33, sec 4733 Balanced Budget Act of 1997; PL 
106-170, sec 201 Ticket to Work and Work Incentives Improvement Act of 
1999

CFR Citation: 42 CFR 435.238; 42 CFR 436.232

Legal Deadline: None

Abstract: This proposed rule would establish, in regulations, certain 
provisions under the Balanced Budget Act of 1997 and the Ticket to Work 
and Work Incentives Improvement Act of 1999 (TWWIIA). In addition, this 
proposed rule would allow States to provide health services to employed 
individuals with disabilities who lose eligibility for disability 
benefits due to improvement in medical conditions or because their 
income exceeds the income limitations. This proposed rule would also 
provide a definition for ``medically determinable severe impairment'' 
under the TWWIIA. Under this definition, States would determine 
eligibility standards for the Medical Improvement Group authorized 
under the TWWIIA legislation, thereby permitting eligible individuals 
to retain their Medicaid coverage.
Additionally, this proposed rule would give States offering Medicaid 
buy-in programs for employed individuals with disabilities the option 
of applying a minimum work standard to two Medicaid buy-in groups.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Carey Appold, Technical Director, Disabled and Elderly 
Health Programs Group, Div. of Advocacy and Special Issues, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Medicaid and State Operations, Mailstop S2-14-26, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-2117
Fax: 410 786-9004
Email: [email protected]

RIN: 0938-AO10
_______________________________________________________________________




925. OUTPATIENT HOSPITAL SERVICES AND RURAL HEALTH CLINIC SERVICES 
AMENDMENT (CMS-2213-P)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: sec 1102 of the Social Security Act

CFR Citation: 42 CFR 440.20

Legal Deadline: None

Abstract: This rule would amend the definition of outpatient hospital 
services for the Medicaid program. The purpose of this amendment is to 
clarify the scope of services available for Federal financial 
participation (FFP) under the outpatient hospital services benefit 
category.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/07

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Jeremy Silanskis, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicaid and State Operations, Mailstop 
S3-13-15, 7500 Security Boulevard, Baltimore, MD 21244

[[Page 22548]]

Phone: 410 786-1592
Fax: 410 786-8533
Email: [email protected]

RIN: 0938-AO17
_______________________________________________________________________




926. REDISTRIBUTION OF UNEXPENDED STATE CHILDREN'S HEALTH INSURANCE 
PROGRAM (SCHIP) FUNDS FROM THE APPROPRIATION FOR FISCAL YEAR 2004 (CMS-
2241-NC)

Priority: Other Significant

Legal Authority: 42 USC 1397dd(g); 42 USC 1397ee(g); secs 2104(e) and 
(f) of the Social Security Act; National Institutes of Health Reform 
Act of 2006 (PL 109-432), sec 201(b)

CFR Citation: 42 CFR 457.600 to 630

Legal Deadline: None

Abstract: This notice announces the procedure for redistribution of 
States' unexpended FY 2004 allotments that remained at the end of FY 
2004 to those States that fully expended the FY 2004 SCHIP allotment. 
These redistributed allotments will be available through the end of FY 
2007.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice With Comment             06/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Richard Strauss, Technical Director, Finance Systems & 
Budget Group, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Centers for Medicaid and State 
Operations, Mailstop, C5-22-25, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-2019
Email: [email protected]

RIN: 0938-AO28
_______________________________________________________________________




927. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM REFINEMENTS AND RATE UPDATE 
FOR CALENDAR YEAR 2008 (CMS-1541-P)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: Social Security Act, sec 1102 and 1871; (42 USC 1302 
and 1395 (hh))

CFR Citation: 42 CFR 484

Legal Deadline: Final, Statutory, January 1, 2008.

Abstract: This major proposed rule would set forth an update to the 60-
day national episode rates and the national per-visit amounts under the 
Medicare prospective payment system for home health services, effective 
on January 1, 2008. As part of this proposed rule, we are also 
proposing to rebase and revise the home health market basket to ensure 
it continues to adequately reflect the price changes of efficiently 
providing home health services. In addition, we are proposing to revise 
the fixed dollar loss ratio, which is used in the calculation of 
outlier payments. This proposed rule also would set forth the 
refinements to the payment system. In addition, this proposed rule 
would establish new quality of care data collection requirements.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Randy L. Throndset, Technical Advisor, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Mailstop C5-02-03, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0131
Email: [email protected]

RIN: 0938-AO32
_______________________________________________________________________




928. GYNECOLOGICAL CYTOLOGY PROFICIENCY TESTING REQUIREMENTS FOR 
LABORATORIES, INDIVIDUALS, AND PROFICIENCY TESTING PROGRAM APPROVALS 
(CMS-2252-P)

Priority: Other Significant

Legal Authority: 42 USC 263a, Clinical Laboratory Improvement 
Amendments of 1988; 42 USC 1395x, secs 1861s(15) through 1861s(17); of 
the Social Security Act.

CFR Citation: 42 CFR 493

Legal Deadline: None

Abstract: This proposed rule would revise certain proficiency testing 
requirements for clinical laboratories offering cytology services and 
individuals examining gynecological cytology specimens, and CMS-
approval requirements for programs offering proficiency testing for 
gynecologic cytology under the Clinical Laboratory Improvement 
Amendments (CLIA) of 1988 program. Evaluating the competency of each 
individual who examines gynecologic cytology specimens (pap smears) is 
required by Federal law and regulations. Identifying these individuals 
is essential in providing quality patient care.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/07

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Cheryl B. Wiseman, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Mailstop, S2-12-25, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-3340
Email: [email protected]

RIN: 0938-AO34
_______________________________________________________________________




929. STATE OPTION TO ESTABLISH NON-EMERGENCY MEDICAL TRANSPORTATION 
PROGRAM (CMS-2234-P)

Priority: Other Significant

Unfunded Mandates: Undetermined

Legal Authority: Deficit Reduction Act of 2005 (PL 109-171), sec 6083

CFR Citation: Not Yet Determined

Legal Deadline: Final, Statutory, February 8, 2006.

Abstract: Enactment of section 6083 of the Deficit Reduction Act of 
2005 (DRA) amends section 1902(a) of the Social Security Act (the Act) 
by adding a new section 1902(a)(70) that provides States with the 
ability to establish, under the State plan, a non-emergency medical 
transportation (NEMT) brokerage program. Such a program may be managed 
through a contract with a broker(s) as a method of assuring NEMT 
services for beneficiaries who need access to medical care but have no 
other means of transportation. A

[[Page 22549]]

regulation is needed in order to implement this provision of the DRA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Jean Sheil, Director, Family and Children's Health 
Programs Group, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Center for Medicaid State Operations, 
Mailstop S2-01-16, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5647
Fax: 410 786-8534
Email: [email protected]

RIN: 0938-AO45
_______________________________________________________________________




930. PREMIUMS AND COST SHARING (CMS-2244-P)

Priority: Other Significant

Unfunded Mandates: Undetermined

Legal Authority: Deficit Reduction Act of 2005; PL 109-171; secs 6041 
to 6043; Tax Relief and Health Care Act of 2006; PL 109-432, sec 405(a)

CFR Citation: Not Yet Determined

Legal Deadline: Final, Statutory, March 31, 2006, secs 6041 and 6042.
Final, Statutory, January 1, 2007, sec 6043.

Abstract: This rule would incorporate sections 6041, 6042, and 6043 of 
the Deficit Reduction Act of 2005 (DRA), which provide State Medicaid 
agencies with increased flexibility to implement premium and cost 
sharing requirements for certain Medicaid recipients. This authority is 
in addition to the current authority States already had under section 
1916 of the Social Security Act to implement premiums and cost sharing. 
Sections 6041, 6042, and 6043 of the DRA provide States with additional 
State plan flexibility to implement alternative premiums for certain 
recipients and to implement alternative cost sharing for certain 
medical services, particularly non-preferred drugs and non-emergency 
care furnished in a hospital emergency department.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Jean Sheil, Director, Family and Childrens Health 
Programs Group, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Centers for Medicaid State Operations, 
Mailstop S2-01-16, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5647
Fax: 410 786-8534
Email: [email protected]

RIN: 0938-AO47
_______________________________________________________________________




931. STATE FLEXIBILITY FOR MEDICAID BENEFIT PACKAGES (CMS-2232-P)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: Deficit Reduction Act of 2005; sec 6044; sec 1102 of 
the Social Security Act

CFR Citation: 42 CFR 440.300; 440.385

Legal Deadline: Final, Statutory, March 31, 2006.

Abstract: This proposed rule would implement provisions of section 6044 
of the Deficit Reduction Act of 2005, which amends the Social Security 
Act by adding a new section related to the coverage of medical 
assistance under approved State plans. Under this new section, States 
have increased flexibility under an approved State plan to define the 
scope of covered medical assistance by offering coverage of benchmark 
or benchmark-equivalent benefit packages to certain Medicaid 
recipients.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Jean Sheil, Director, Family and Children's Health 
Programs Group, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Center for Medicaid State Operations, 
MailStop S2-01-16, 7500 Security Boulevard, Balitimore, MD 21244
Phone: 410 786-5647
Fax: 410 786-8534
Email: [email protected]

RIN: 0938-AO48
_______________________________________________________________________




932. SELF-DIRECTED PERSONAL ASSISTANCE SERVICES STATE PLAN OPTION (CMS-
2229-P)

Priority: Other Significant

Legal Authority: Deficit Reduction Act of 2005; PL 109-171, sec 6087

CFR Citation: Not Yet Determined

Legal Deadline: Final, Statutory, January 1, 2007.

Abstract: The regulation is in support of the Deficit Reduction Act. 
Section 6087 allows a State to offer self-directed personal assistance 
services as a State plan option and is intended to offer guidance to 
States on implementing the statutory provision.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal, State

Agency Contact: Theresa Pratt, Director, Division of Integrated Health 
Systems, Disabled and Elderly Health Programs Group, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Medicaid State Operations, Mailstop S2-14-26, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-9499
Email: [email protected]

RIN: 0938-AO52
_______________________________________________________________________




933. HOME AND COMMUNITY-BASED SERVICES (HCBS) STATE PLAN OPTION (CMS-
2249-P)

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: Deficit Reduction Act of 2005; PL 109-171, sec 6086

CFR Citation: 42 CFR 431; 42 CFR 440; 42 CFR 441

[[Page 22550]]

Legal Deadline: Final, Statutory, January 1, 2007.

Abstract: This proposed rule would amend the Medicaid regulations to 
define and describe the home and community-based State plan services 
implementing new section 1915(i) of the Social Security Act as added by 
section 6086 of the Deficit Reduction Act of 2005.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Theresa Pratt, Director, Division of Integrated Health 
Systems, Disabled and Elderly Health Programs Group, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Medicaid State Operations, Mailstop S2-14-26, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-9499
Email: [email protected]

RIN: 0938-AO53
_______________________________________________________________________




934. PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT REHABILITATION FACILITIES 
FOR FY 2008 (CMS-1551-P)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: SSA, sec 1886(i); PL 105-33; PL 106-554; PL 106-113

CFR Citation: 42 CFR 412

Legal Deadline: Final, Statutory, August 1, 2007.

Abstract: This proposed rule would update rates for the prospective 
payment system for inpatient rehabilitation facilities for FY 2008.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: William Ullman, Health Insurance Specialist, Centers 
for Medicare Management, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, Chronic Care Policy Group, 
Mailstop C5-07-08, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5667
Email: [email protected]

RIN: 0938-AO63
_______________________________________________________________________




935. PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR SKILLED 
NURSING FACILITIES--UPDATE FOR FY 2008 (CMS-1545-P)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: Social Security Act, sec 1888(e)

CFR Citation: 42 CFR 424

Legal Deadline: Final, Statutory, July 31, 2007.

Abstract: This proposed rule would update the payment rates used under 
the prospective payment system (PPS) for skilled nursing facilities 
(SNFs), for fiscal year (FY) 2008. In addition, this proposed rule 
would revise and rebase the SNF market basket.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: William Ullman, Health Insurance Specialist, Centers 
for Medicare Management, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, Chronic Care Policy Group, 
Mailstop C5-07-08, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5667
Email: [email protected]

RIN: 0938-AO64
_______________________________________________________________________




936. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE AND 
OTHER CHANGES TO PAYMENT UNDER PART B FOR CY 2008 (CMS-1385-P)

Priority: Economically Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

Legal Authority: Social Security Act, sec 1102; Social Security Act, 
sec 1871; Social Security Act, sec 1848;; Tax Relief and Health Care 
Act of 2006 (Pub L 109-432), Sec 101(a), 102, 108, and 110

CFR Citation: 42 CFR 405; 42 CFR 410 to 411; 42 CFR 413 to 414; 42 CFR 
426

Legal Deadline: Final, Statutory, November 1, 2007.

Abstract: This rule would make several changes affecting Medicare Part 
B payment to physicians and other Part B providers and suppliers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Diane S. Milstead, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Centers for Medicaid Management, Mailstop C4-03-06, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3355
Email: [email protected]

RIN: 0938-AO65
_______________________________________________________________________




937. STANDARDS FOR E-PRESCRIBING UNDER MEDICARE PART D (CMS-0016-P)

Priority: Economically Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: This action may affect State, local or tribal 
governments and the private sector.

Legal Authority: 42 USC 1395

CFR Citation: 42 CFR 423

Legal Deadline: Final, Statutory, April 1, 2008.

Abstract: This rule proposes standards for electronic prescribing (e-
prescribing) under Medicare Part D. This rule would require Medicare 
Part D and Medicare Advantage plans to support electronic transmission 
of basic prescription data to and from doctors and pharmacies and to 
adopt final standards for e-prescribing as required by section 101 of 
the MMA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/07

[[Page 22551]]

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Denise Buenning, Senior Advisor, Department of Health 
and Human Services, Centers for Medicare & Medicaid Services, Mailstop 
S2-26-17, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6711
Email: [email protected]

RIN: 0938-AO66
_______________________________________________________________________




938. EXEMPTION OF PRIVACY ACT DISCLOSURE OF CERTAIN INVESTIGATIVE 
MATERIALS (CMS-0029-P)

Priority: Info./Admin./Other

Legal Authority: 5 USC 301; 5 USC 552a

CFR Citation: 45 CFR 5b

Legal Deadline: None

Abstract: Unrestricted disclosure of confidential information in CMS 
files can impede ongoing investigations, invade the personal privacy of 
individuals, reveal the identities of confidential sources, or 
otherwise impair the ability of CMS to conduct investigations. For 
these reasons this rule proposes to exempt the ASPEN Complaint/Incident 
Tracking System (ACTS), Organ Procurement Organizations Systems (OPOS), 
Fraud Investigation Database (FID), and HIPAA Information Tracking 
System (HITS) from the notification, access, correction, and amendment 
provisions of the Privacy Act concerning records compiled for law 
enforcement purposes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Katherine Marie Brewer, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Mailstop N2-04-27, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-7235
Fax: 410 786-5636
Email: [email protected]

RIN: 0938-AO69
_______________________________________________________________________




939. CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEMS AND 
FY 2008 RATES (CMS-1533-P)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: sec 1886(d) of the Social Security Act

CFR Citation: 42 CFR 412; 413; 424; 485; 489

Legal Deadline: NPRM, Statutory, April 1, 2007.
Final, Statutory, August 1, 2007.

Abstract: This rule proposes to revise the Medicare hospital inpatient 
prospective payment systems (IPPS) for operating and capital-related 
costs to implement changes arising from our continuing experience with 
these systems.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: Marc Hartstein, Deputy Director, Department of Health 
and Human Services, Centers for Medicare & Medicaid Services, Mailstop 
C4-25-11, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4548
Email: [email protected]

Related RIN: Related to 0938-AO35
RIN: 0938-AO70
_______________________________________________________________________




940. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND 
AMBULATORY SURGICAL CENTER PAYMENT SYSTEM CALENDAR YEAR 2008 PAYMENT 
RATES (CMS-1392-P)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: BBA; BBRA; BIPA; MMA; DRA of 2005; 1833(i)(2)(D)(iii);

CFR Citation: 42 CFR 410, 42 CFR 416, 42 CFR 419; 42 CFR 421, 42 CFR 
485, 42 CFR 488

Legal Deadline: Final, Statutory, November 1, 2007.

Abstract: This proposed rule would revise the Medicare hospital 
outpatient prospective payment system to implement applicable statutory 
requirements and changes arising from our continuing experience with 
this system 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 and rates. These changes would be applicable to services furnished 
on or after January 1, 2008.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Federal

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Alberta Dwivedi, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Mailstop C3-24-23, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-1850
Email: [email protected]

RIN: 0938-AO71
_______________________________________________________________________




941. HOSPICE WAGE INDEX FOR FY 2008 (CMS-1539-P)

Priority: Other Significant

Legal Authority: 42 USC 1814(i)(1) and 1814(i)(2)

CFR Citation: 42 CFR 418

Legal Deadline: Final, Statutory, October 1, 2007.

Abstract: This rule proposes the annual update to the hospice wage 
index for FY 2008. The wage index is used to reflect local differences 
in wage levels.

[[Page 22552]]

The hospice wage index methodology and values are based on 
recommendations of a negotiated rulemaking advisory committee and were 
originally published on August 8, 1997.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/07

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Terri Deutsch, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Division of Community Post Acute Care, Hospital and Ambulatory Policy 
Group, Mailstop C5-08-18, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-9462
Email: [email protected]

RIN: 0938-AO72
_______________________________________________________________________




942. [bull] POLICY AND TECHNICAL CHANGES TO THE MEDICARE PRESCRIPTION 
DRUG BENEFIT (CMS-4130-P)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1395w 101 through 1395w 152; 42 USC 1302

CFR Citation: 42 CFR 423.50; 42 CFR 423.56; 42 CFR 423.100; 42 CFR 
423.120; 42 CFR 423.293; 42 CFR 423.308; 42 CFR 423.350 42 CFR 423.458; 
42 CFR 423.464; 42 CFR 423.504; 42 CFR 423.505; 42 CFR 423.509; 42 CFR 
423.560; 42 CFR 423.570; 42 CFR 423.584; 42 CFR 423.610; 42 CFR 
423.780; 42 CFR 423.884; 42 CFR 423.902; 42 CFR 423.906; 42 CFR 
423.910;

Legal Deadline: None

Abstract: This proposed rule both clarifies existing policy that is 
outlined in the final rule published in the Federal Register on January 
28, 2005 entitled ``Medicare Program; Medicare Prescription Drug 
Benefit,'' as well as offers several proposed clarifications of policy 
for which we seek public comment. These proposed clarifications address 
our expectations of Part D sponsors in providing adequate access to 
home infusion pharmacies for infused covered Part D drugs and supplies 
associated with the ``inhalation of insulin``; the appropriate drug 
costs Part D sponsors should use as the basis for (1) Calculating 
beneficiary cost sharing, (2) reporting drug costs to CMS for the 
purposes of reconciliation and risk sharing, (3) developing bids 
submitted to CMS, and (4) retiree subsidy provisions related to the 
actuarial equivalence test. This proposed rule also addresses the 
exclusion from the definition of ''a Part D drug`` when used for the 
treatment of sexual or erectile dysfunction, in accordance with an 
October 26, 2005 statutory amendment to the Social Security Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Alissa M. Deboy, Acting Division Director, Center for 
Beneficiary Choices, Department of Health and Human Services, Centers 
for Medicare & Medicaid Services, Drug Plan Policy and Analysis 
Division, Mailstop C1-26-16, 7500 Secruity Boulevard, Balitmore, MD 
21244
Phone: 410 786-6041
Email: [email protected]

Related RIN: Related to 0938-AN08
RIN: 0938-AO74
_______________________________________________________________________




943. SPECIAL ENROLLMENT PERIOD AND MEDICARE PREMIUM CHANGES (CMS-4129-P)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: PL 109-171, sec 5115; PL 108-173, sec 811

CFR Citation: 42 CFR 406 to 408

Legal Deadline: Final, Statutory, January 1, 2007.

Abstract: Section 5115 of the Deficit Reduction Act of 2005 (DRA) 
provides a special enrollment period for Medicare Part B/Part A and 
waiver of late enrollment penalty and for individuals who are serving 
as a volunteer outside the United States through a program that covers 
at least a 12-month period and who have health insurance while 
providing the voluntary service outside of the United States. Section 
811 of the Medicare Prescription Drug Improvement and Modernization Act 
(MMA) of 2003 as amended by section 5111 of the DRA requires an 
additional amount be assessed to the Part B premium of individuals who 
have a modified adjusted gross income that reaches certain levels. The 
effective date for these provisions is January 1, 2007. Since SSA has 
the responsibility for calculating the additional premium amount, SSA 
will explain this statutory requirement in its part of the regulations 
(20 CFR part 418). CMS will include a reference to the SSA regulation 
in its change to 42 CFR part 408.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Sam DellaVecchia, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4481
Email: [email protected]

RIN: 0938-AO77
_______________________________________________________________________




944. REVISIONS TO THE MEDICARE ADVANTAGE AND PART D PRESCRIPTION DRUG 
CONTRACT DETERMINATIONS, APPEALS, AND INTERMEDIATE SANCTIONS PROCESSES 
(CMS-4124-P)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395(hh); 42 USC 1395(w-101) to 
1395(w-152)

CFR Citation: 42 CFR 422, and 42 CFR 423

Legal Deadline: None

Abstract: This proposed rule would clarify and modify the Medicare 
Advantage (MA) program provisions relating to disclosure of 
information, and contract determinations by MA organizations and Part D 
prescription drug plan sponsors. This proposed rule would also revise 
requirements

[[Page 22553]]

concerning the reconsideration of determinations and clarify the 
schedule for MA organizations and Part D plan sponsors to complete 
corrective action plans. In addition, it would clarify the intermediate 
sanction and civil money penalty (CMP) provisions relating to MA 
organizations and Medicare Part D prescription drug plan sponsors.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Christine Perenich, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Mailstop C4-23-07, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-2987
Email: [email protected]

RIN: 0938-AO78
_______________________________________________________________________




945. [bull] REHABILITATION SERVICES: STATE PLAN OPTION (CMS-2261-P)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: sec 1905 (a)(13) of the Social Security Act

CFR Citation: 42 CFR 440.130(d)

Legal Deadline: None

Abstract: This proposed rule would amend the definition of Medicaid 
rehabilitative services in order to provide for important beneficiary 
protections such as a person-centered written rehabilitation plan and 
maintenance of case records. The proposed rule would also ensure the 
fiscal integrity of claimed Medicaid expenditures by clarifying the 
service definition and providing that Medicaid rehabilitative services 
must be coordinated with, but do not include services furnished by, 
other programs that are focused on social or educational development 
goals and are available as part of other services or programs. These 
services and programs include, but are not limited to, foster care, 
child welfare, education, child care, prevocational and vocational 
services, housing, parole and probation, juvenile justice, public 
guardianship, and any other non-Medicaid services from Federal, State, 
or local programs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Linda Peltz, Director, Divison of Integrated Health 
Systems, Department of Health and Human Services, Centers for Medicare 
& Medicaid Services, Disabled and Elderly Health Programs Group, Center 
for Medicaid State Operations, Mailstop S2-14-26, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-3399
Fax: 410 786-3262
Email: [email protected]

RIN: 0938-AO81
_______________________________________________________________________




946. [bull] WAIVER OF DISAPPROVAL OF NURSE AIDE TRAINING PROGRAM IN 
CERTAIN CASES AND NURSE AIDE PETITION FOR REMOVAL OF INFORMATION FOR 
SINGULAR FINDING OF NEGLECT (CMS-2266-P)

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority: sec 932 (c) (2) MMA; secs 1819(g)(1)(D) and 
1919(g)(1)(D) of the Social Security Act

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This proposed rule will permit a waiver or nurse aide 
training disapproval for skilled nursing facilities and nursing 
facilities that are assessed a civil money penalty of at least $5,000 
for noncompliance that is not related to quality of care. The purpose 
of this regulation is to implement the legislative waiver provision 
enacted on December 8, 2003, in section 932(c)(2) of the MMA. The 
ability to make these waiver determinations could allow continued and 
consistent operation of a nursing home's nurse aide training program in 
facilities having non-quality of care deficiencies, which would 
ultimately benefit residents. This rule also codifies statutory 
provisions at sections 1819(g)(1)(D) and 1919(g)(1)(D) of the Social 
Security Act that would permit the State to establish a procedure to 
permit a nurse aide to petition the State to have a singular finding of 
neglect removed from the nurse aide registry if the State determines 
that the employment and personal history of the nurse aide does not 
reflect a pattern of abusive behavior or neglect and the neglect 
involved in the original finding was a singular occurrence.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Patricia Miller, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicaid and State Operations, Mailstop 
S2-19-14, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6780
Fax: 410 786-0194
Email: [email protected]

RIN: 0938-AO82
_______________________________________________________________________




947. [bull] SURETY BOND REQUIREMENT FOR SUPPLIERS OF DURABLE MEDICAL 
EQUIPMENT, PROSTHETICS, ORTHOTICS, AND SUPPLIES (DMEPOS) (CMS-6006-P)

Priority: Other Significant

Unfunded Mandates: Undetermined

Legal Authority: sec 4312(a) of BBA of 1997

CFR Citation: 42 CFR 424.57

Legal Deadline: None

Abstract: This proposed rule would implement 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: August Nemec, Department of Health and Human Services, 
Centers for Medicare &

[[Page 22554]]

Medicaid Services, Mailstop C3-08-07, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-0612
Email: [email protected]

RIN: 0938-AO84
_______________________________________________________________________




948. [bull] CHILDREN OF STATE EMPLOYEES: PREMIUM ASSISTANCE (CMS-2148-P)

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 457.1010; 42 CFR 457.310

Legal Deadline: None

Abstract: This proposed rule would amend Medicaid regulations by 
revising the definition of ``optional targeted low-income child'' to 
exclude children eligible for health benefits coverage under a State 
health benefits plan on the basis of a family member's employment with 
a public agency, children who are inmates of a public institution, and 
children who are patients in an institution for mental diseases. This 
proposed rule also addresses the requirements for SCHIP family coverage 
through premium assistance.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Kathleen Farrell, Director, State Children's Health 
Insurance Program, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Centers of Medicaid State Operations, 
Mailstop S2-01-16, 7500 Security Boulevard, Baltimore, MD 21224
Phone: 410 786-1236
Fax: 410786-5882
Email: [email protected]

RIN: 0938-AO86
_______________________________________________________________________




949. [bull] APPLICATION OF CERTAIN PART 405 APPEALS PROVISIONS TO THE 
PART 423 MEDICARE PRESCRIPTION DRUG APPEALS PROCESS (CMS-4127-P)

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority: sec 1102, 1860D-1 to 1860D-42, and 1871 of the Social 
Security Act (42 U.S.C. 1302, 1395w-101 to 1395w-152, and 1395hh)

CFR Citation: 42 CFR 560 to 638

Legal Deadline: None

Abstract: The voluntary prescription drug benefit program was enacted 
into law by section 101 of title 1 of the Medicare Prescription Drug 
Improvement and Modernization Act of 2003 (MMA). The implementing 
regulations for the Part D program were published in a final rule on 
January 28, 2005, and became effective March 22, 2005. These 
regulations provide that the Medicare Advantage (MA) rules regarding 
appeals and reopenings will apply to the Part D appeals process to the 
extent they are appropriate. The MA regulations in turn apply the fee-
for-service (FFS) appeals regulations (concerning the administrative 
review and hearing processes and representation of parties under titles 
II and XVIII of the Act) to the extent they are appropriate.
Based on this regulatory framework, we noted in the January 28, 2005, 
rule that differences in the appeals procedures for Part D enrollees 
would be addressed in a future Part D rulemaking document. The purpose 
of the proposed rule is to provide additional guidance on the 
differences in appeals procedures for Part D enrollees by proposing 
more detailed regulations governing Part D appeals at the ALJ, MAC, and 
Federal district court levels and reopenings of determinations and 
decisions that follow the Part A and Part B procedures set forth in the 
part 405 rule, as appropriate.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/08

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Anthony Culotta, Director, Medicare Enrollment & 
Appeals Group, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Mailstop C2-12-16, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4661
Email: [email protected]

RIN: 0938-AO87
_______________________________________________________________________




950. [bull] LIMITATION ON CONTRACTOR LIABILITY (CMS-2264-P)

Priority: Other Significant

Legal Authority: Deficit Reduction Act of 2005 (PL 109-171), sec 6034; 
sec 1157 of the Social Security Act

CFR Citation: 42 CFR 45

Legal Deadline: None

Abstract: Section 6034 of the Deficit Reduction Act of 2005 established 
the Medicaid Integrity Program to promote the integrity of the Medicaid 
program by authorizing the Centers for Medicare and Medicaid Services 
(CMS) to enter into contracts with contractors that will (1) Review the 
actions of individuals or entities furnishing items or services 
(whether fee-for-service, risk, or other basis) for which payment may 
be made under an approved State plan and/or any waiver of the plan 
approved under section 1115 of the Social Security Act; (2) audit 
claims for payment of items or services furnished, or administrative 
services furnished, under a State plan; (3) identify overpayment of 
individuals or entities receiving Federal funds; and (4) educate 
providers of services, managed care entities, beneficiaries, and other 
individuals with respect to payment integrity and quality of care. This 
proposed rule would set forth limitations on a contractor's liability 
while performing these services under the Medicaid Integrity Program.
This proposed rule would provide for limitation of a contractor's 
liability for actions taken to carry out a contract under the Medicaid 
Integrity Program. The proposed rule would, to the extent possible, 
employ the same or comparable standards and other substantive and 
procedural provisions as are contained in section 1157 of the Social 
Security Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Barbara Rufo, Director, Division of Medicaid Integrity 
Contracts, Medicaid Integrity Group, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, Mailstop B2-02-24, 
7111 Security Boulevard, Baltimore, MD 21244

[[Page 22555]]

Phone: 410 786-5589
Email: [email protected]

RIN: 0938-AO88
_______________________________________________________________________




951. [bull] HEALTH INSURANCE REFORM: REMOTE SECURITY STANDARDS (CMS-
0020-P)

Priority: Other Significant

Legal Authority: HIPAA

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This proposed rule would further address the existing 
compliance requirements of the HIPAA Security regulations specific to 
covered entities that allow offsite access to, or use of, electronic 
protected health information. The proposed rule is necessitated by 
several recent security incidents related to the use of laptops other 
portable and mobile devices and external handware that store, contain, 
or are used to access electronic protected health information. It is 
intended to provide a more prescriptive set of remote security 
requirements designed to reduce the likelihood of unauthorized uses and 
disclosures of sensitive health information.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/07

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: State

Agency Contact: Michael T. Phillips, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Office of Electronic Health E-Standards & Services, 
Mailstop S2-26-17, 7500 Security Boulevard, Baltimore, MD 21224
Phone: 410 786-6713
Email: [email protected]

RIN: 0938-AO89
_______________________________________________________________________




952. [bull] ESTABLISHING ADDITIONAL PROVIDER AND SUPPLIER REQUIREMENTS 
FOR ENROLLMENT STANDARDS AND RELATED ISSUES (CMS-6036-P)

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: The numbers of providers and suppliers enrolling and 
maintaining enrollment within the Medicare Program are of such a large 
magnitude that CMS must be able to ensure that quality care is given to 
beneficiaries while at the same time guaranteeing the protection of the 
Medicare Trust Fund. This rule proposes new standards to help to 
maintain an acceptable level of care for the beneficiaries without 
adding increased risk of loss to the Medicare Trust Fund.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: August Rudolph Nemec III, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Office of Financial Management, Mailstop C3-07-08, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0612
Fax: 410 786-7259
Email: [email protected]

RIN: 0938-AO90
_______________________________________________________________________




953. [bull] EMERGENCY PREPAREDNESS REQUIREMENTS FOR MEDICARE 
PARTICIPATING PROVIDERS AND SUPPLIERS (CMS-3178-P)

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This rule proposes emergency preparedness requirements for a 
variety of Medicare providers and suppliers who participate in the 
Medicare and Medicaid programs. Medicare beneficiaries rely on health 
care facilities to safely and effectively plan for and execute 
appropriate evacuation procedures during times of disaster.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Monique S. Howard, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Mailstop S3-02 01, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-3869
Email: [email protected]

RIN: 0938-AO91
_______________________________________________________________________




954. [bull] INPATIENT PSYCHIATRIC FACILITY PROSPECTIVE PAYMENT SYSTEM--
UPDATE FOR RATE YEAR BEGINNING JULY 1, 2008 (RY 2009) (CMS-1401-P)

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority: PL 106-113, sec 124 BBRA

CFR Citation: 42 CFR 412

Legal Deadline: Final, Statutory, July 1, 2008.

Abstract: This rule proposes updates to the Inpatient Psychiatric 
Facility Prospective Payment System for RY 2009.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/08

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: Local, State

Federalism:  Undetermined

Agency Contact: Janet Samen, Director, Division of Chronic Care 
Management, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Mailstop C5-05-07, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4533
Email: [email protected]

RIN: 0938-AO92

[[Page 22556]]

_______________________________________________________________________




955. [bull] PROSPECTIVE PAYMENT SYSTEM FOR LONG-TERM CARE HOSPITALS RY 
2009: ANNUAL PAYMENT RATE UPDATES (CMS-1393-P)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: sec 123 PL 106-113; sec 307(b) PL 106-554

CFR Citation: 42 CFR 412

Legal Deadline: Final, Statutory, July 1, 2008.

Abstract: This rule proposes the payment rate update for the rate year 
2009 prospective payment system (PPS) for Medicare long-term care 
hospitals (LTCH) and also presents proposed changes or revisions on 
LTCH PPS policy for public comment.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/08

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Judith Richter, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Mailstop C4-16-07, 7500 Security Boulevard, Baltimore
Phone: 410 786-2590
Email: [email protected]

RIN: 0938-AO94
_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




956. END STAGE RENAL DISEASE (ESRD) CONDITIONS FOR COVERAGE (CMS-3818-F) 
(SECTION 610 REVIEW)

Priority: Other Significant

Legal Authority: 42 USC 1395rr et al

CFR Citation: 42 CFR 405; 42 CFR 410; 42 CFR 413 to 414; 42 CFR 488; 42 
CFR 494

Legal Deadline: Final, Statutory, February 4, 2008, MMA sec. 902.

Abstract: This final rule revises the requirements that end stage renal 
disease (ESRD) facilities must meet to be certified under the Medicare 
program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/04/05                     70 FR 6184
Final Action                    02/00/08

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Teresa Casey, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Clinical Standards Group, S3-02-01, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-7215
Email: [email protected]

RIN: 0938-AG82
_______________________________________________________________________




957. HOSPITAL CONDITIONS OF PARTICIPATION: LABORATORY SERVICES (CMS-
3014-IFC) (SECTION 610 REVIEW)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 482

Legal Deadline: None

Abstract: This interim final rule with comment period requires 
hospitals that transfuse blood and blood components to: Prepare and 
follow written procedures for appropriate action when it is determined 
that blood and blood products the hospital received and transfused are 
at increased risk for transmitting hepatitis C virus (HCV); quarantine 
prior collections from a donor who is at increased risk for 
transmitting HCV infection; notify transfusion recipients, as 
appropriate, of the need for HCV testing and counseling; and maintain 
records for at least 10 years.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/16/00                    65 FR 69416
Interim Final Rule              07/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Mary Collins, 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: 410 786-3189
Email: [email protected]

RIN: 0938-AJ29
_______________________________________________________________________




958. USE OF RESTRAINTS AND SECLUSION IN RESIDENTIAL TREATMENT FACILITIES 
PROVIDING INPATIENT PSYCHIATRIC SERVICES TO INDIVIDUALS UNDER AGE 21 
(CMS-2065-F)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1396d

CFR Citation: 42 CFR 441, 42 CFR 442, and 42 CFR 483

Legal Deadline: None

Abstract: This final rule addresses standards of practice that 
residential treatment facilities providing inpatient psychiatric 
services for individuals under age 21 must meet with regard to the use 
of restraints (including psychoactive drugs) and seclusion.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/22/01                     66 FR 7148
60-Day Delay of Effective Date 
to 05/22/2001                   03/21/01                    66 FR 15800
Interim Final Rule Comment 
Period End                      03/23/01
Interim Final Rule Effective    03/23/01
Interim Final Rule Amendment 
with Clarification              05/22/01                    66 FR 28110
Interim Final Rule Comment 
Period End                      07/23/01
Final Action                    09/00/07

Regulatory Flexibility Analysis Required: No

[[Page 22557]]

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Thomas Shenk, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Division of Benefits and Coverage Policy, Mailstop S2-14-26, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3295
Email: [email protected]

RIN: 0938-AJ96
_______________________________________________________________________




959. PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY HAVE 
FINANCIAL RELATIONSHIPS (CMS-1810-RCN)

Priority: Other Significant

Legal Authority: 42 USC 1877

CFR Citation: 42 CFR 411; 42 CFR 424

Legal Deadline: Final, Statutory, March 26, 2007, MMA sec. 902.

Abstract: This rule finalizes certain statutory provisions that prevent 
payment for services and impose penalties when a physician makes a 
referral to an entity in which that physician has a financial interest, 
unless an exception applies. It also addresses comments received on the 
``Phase II'' Stark regulation published in the Federal Register on 
March 26, 2004.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              03/26/04                    69 FR 16054
Interim Final Rule Comment 
Period End                      06/24/04
Correction Notice               04/06/04                    69 FR 17933
Second Correction Notice        09/24/04                    69 FR 57226
Notice                          03/23/07                    72 FR 13710
Final Action                    03/00/08

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Lisa Ohrin, Deputy Director, Department of Health and 
Human Services, Centers for Medicare & Medicaid Services, Center for 
Medicare Management, Chronic Care Policy Group, Divison of Technical 
Payment Policy, Mailstop C4-25-02, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4565
Email: [email protected]

RIN: 0938-AK67
_______________________________________________________________________




960. PROVIDER REIMBURSEMENT DETERMINATIONS AND APPEALS (CMS-1727-F)

Priority: Substantive, Nonsignificant

Legal Authority: sec 1878 of the Social Security Act

CFR Citation: 42 CFR 405, 413, and 417

Legal Deadline: Final, Statutory, June 25, 2007, MMA sec. 902.

Abstract: This final rule redefines, clarifies, and updates the 
guidelines and procedures for Provider Reimbursement Review Board 
appeals, based on recent court decisions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/25/04                    69 FR 35716
NPRM Comment Period End         08/24/04
Final Action                    06/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Morton Marcus, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Mailstop C4-25-02, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4477
Email: [email protected]

RIN: 0938-AL54
_______________________________________________________________________




961. REVISIONS TO THE APPEALS PROCESS FOR INITIAL CLAIM DETERMINATIONS 
(CMS-4064-F)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: sec 1869 (b) of the Act, as amended by sec 521 of BIPA

CFR Citation: 42 CFR 401 and 405

Legal Deadline: Final, Statutory, March 8, 2008, MMA sec 902.

Abstract: This final rule revises the Medicare appeals process by 
adding five levels of review. It will remove the distinction between 
the processing of initial determinations and appeals under part A and 
part B required by section 521 of Benefits Improvement and Protection 
Act of 2000 (BIPA).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              03/08/05                    70 FR 11419
Second Interim Final Rule       06/30/05                    70 FR 37700
Third Interim Final Rule        08/26/05                    70 FR 50214
Final Action                    03/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal

Agency Contact: Katherine L. Hosna, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Mailstop C2-12-16, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-4993
Email: [email protected]

Related RIN: Related to 0938-AK69
RIN: 0938-AM73
_______________________________________________________________________




962. REVISED CIVIL MONEY PENALTIES, ASSESSMENTS, EXCLUSIONS, AND RELATED 
APPEALS PROCEDURES (CMS-6146-F)

Priority: Substantive, Nonsignificant

Unfunded Mandates: Undetermined

Legal Authority: sec 1128a of the Social Security Act

CFR Citation: 42 CFR 402

Legal Deadline: Final, Statutory, July 23, 2007, MMA sec. 902.

Abstract: This final rule revises the CMS civil money penalty 
authorities. These revisions are intended to add the specific exclusion 
sanction authorities as established in the procedures for imposing 
civil money penalties, assessments, and exclusions for certain 
violations of the Medicare and Medicaid programs. This rule also 
finalizes an August 4, 2005, rule that outlines the process for health 
care providers to follow if they wish CMS to request a waiver of 
exclusion on their behalf.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/23/04                    69 FR 43956
Final Action                    07/00/07

[[Page 22558]]

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Joel Cohen, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Office of Financial Management, Program Integrity Group, Mailstop C3-
02-16, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3349
Email: [email protected]

Related RIN: Related to 0938-AN48
RIN: 0938-AM98
_______________________________________________________________________




963. ENHANCED DSH TREATMENT FOR CERTAIN HOSPITALS (CMS-2198-F)

Priority: Other Significant

Legal Authority: sec 1923(a)(2)(D)of the Social Security Act

CFR Citation: 42 CFR 447; 42 CFR 455

Legal Deadline: Final, Statutory, December 8, 2003, sec. 1001(d) of 
MMA.

Abstract: This rule implements section 1001(d) of the Medicare 
Prescription Drug Improvement and Modernization Act of 2003, which 
requires States to report additional information about their 
disproportionate share hospital (DSH) programs in their annual report. 
This section also requires States to independently audit and submit 
these certified audits annually to the Secretary.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/26/05                    70 FR 50262
Final Action                    11/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: James Frizzera, Director, National Institutional 
Payment Policy, Center for Medicaid and State Operations, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Mailstop S3-13-15, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3263
Email: [email protected]

RIN: 0938-AN09
_______________________________________________________________________




964. COMPETITIVE ACQUISITION FOR CERTAIN DURABLE MEDICAL EQUIPMENT 
(DME), PROSTHETICS, ORTHOTICS, AND SUPPLIES (CMS-1270-F)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: PL 108-173, MMA; Deficit Reduction Act of 2005, PL 
109-171, sec 5101

CFR Citation: 42 CFR 411; 42 CFR 414;

Legal Deadline: Final, Statutory, December 31, 2007.

Abstract: Section 302 of the Medicare Modernization Act establishes DME 
competitive bidding. National competitive bidding will provide a 
program for using market forces to set Medicare payment amounts. This 
will create incentives for suppliers to provide quality items and 
services while at the same time providing Medicare with reasonable 
prices for payment. This rule also incorporates provisions from section 
5105 of the DRA of 2005, which concerns beneficiary ownership of 
certain DMEs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/01/06                    71 FR 25654
Notice                          04/10/07                    72 FR 16794
Final Action                    03/00/08

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: Federal, State

Agency Contact: Ralph Goldberg, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Mailstop C5-08-27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4870
Email: [email protected]

RIN: 0938-AN14
_______________________________________________________________________




965. MEDICAID PRESCRIPTION DRUGS--AVERAGE MANUFACTURER PRICE (CMS-2238-
F)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1396r.8; Deficit Reduction Act of 2005, PL 109-
171, sec 6001 to 6003

CFR Citation: 42 CFR 447.535

Legal Deadline: Final, Statutory, July 1, 2007.

Abstract: This final rule implements sections 6001, 6002, and 6003 of 
the Deficit Reduction Act of 2005. This rule sets the Federal upper 
reimbursement limit (FUL) as 250 percent of the average manufacturer 
price (AMP) for drugs on the FUL list, and will clarify the 
requirements and manner in which AMPs are determined for multiple-
source drugs and other drug payment revisions. This rule also lists the 
physician administered multiple-source drugs that the Secretary 
determines have the highest dollar volume of dispensing in Medicaid and 
will require manufacturers to include authorized generics when they 
report their AMP and best price for covered outpatient drugs to the 
Secretary.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/22/06                    71 FR 77174
NPRM Comment Period End         02/20/07
Final Action                    07/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

Agency Contact: Yolanda Lashawn Reese, Health Insurance Specialist, 
Division of Benefits and Coverage Policy Services, Department of Health 
and Human Services, Centers for Medicare & Medicaid Services, Center 
for Medicaid and State Operations, Mailstop S2-06-15, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-9898
Fax: 410 786-5882
Email: [email protected]

RIN: 0938-AO20
_______________________________________________________________________




966. PROSPECTIVE PAYMENT SYSTEM FOR LONG-TERM CARE HOSPITALS RY 2008: 
ANNUAL PAYMENT RATE UPDATES AND POLICY CHANGES(CMS-1529-F)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: PL 106-113, sec 123 ; PL 106-554, sec 307(b)

CFR Citation: 42 CFR 412

Legal Deadline: Final, Statutory, July 1, 2007.

[[Page 22559]]

Abstract: This rule finalizes the annual payment rate update for the 
Rate Year (RY) 2008 prospective payment system for Medicare long-term 
care hospitals and also presents proposed changes or revisions on LTCH 
PPS policy for public comment.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/01/07                     72 FR 4776
NPRM Comment Period End         03/26/07
Final Action                    05/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Judy Richter, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Centers for Medicare Management, Mail Stop C4-16-07, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-2590
Email: [email protected]

RIN: 0938-AO30
_______________________________________________________________________




967. INPATIENT PSYCHIATRIC FACILITY PROSPECTIVE PAYMENT SYSTEM--UPDATE 
FOR RATE YEAR 2008 (CMS-1479-N)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: PL 106-113, sec 124 BBRA

CFR Citation: 42 CFR 412.400, subpart N

Legal Deadline: Final, Statutory, July 1, 2007.

Abstract: This notice updates the Inpatient Psychiatric Facility 
Prospective Payment System for RY 2008. These changes are applicable 
for discharges occuring on or before July 1, 2007 through June 30, 
2008.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          05/00/07

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: Local, State

Agency Contact: Janet Samen, Director, Division of Technical Payment 
Policy, Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Mailstop C5-05-27, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-4533
Email: [email protected]

RIN: 0938-AO40
_______________________________________________________________________




968. GROUP HEALTH PLANS AND HEALTH INSURANCE ISSUES UNDER THE NEWBORNS 
AND MOTHERS HEALTH PROTECTION ACT (CMS-4116-F)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: 42 USC 300gg to 300gg-63; 300gg-91 to 300gg-92

CFR Citation: 45 CFR 144; 45 CFR 146; 45 CFR 148

Legal Deadline: None

Abstract: This final rule sets forth the post-childbirth 
hospitalization length-of-stay requirements for group health plans and 
health insurance issuers that cover such length of stays.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Adam Shaw, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Beneficiary Choices, Employer & Policy Operations Group, 
Mailstop C5-14-15, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1091
Email: [email protected]

Karen B. Levin, Health Insurance Specialist, Department of Health and 
Human Services, Centers for Medicare & Medicaid Services, Center for 
Beneficiary Choices, Employer & Policy Operations Group, Mailstop C5-
14-15, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5445
Email: [email protected]

Related RIN: Related to 0938-AI17
RIN: 0938-AO43
_______________________________________________________________________




969. HIGH RISK POOLS (CMS-2260-IFC)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: Deficit Reduction Act of 2005; PL 109-171, sec 6202

CFR Citation: Not Yet Determined

Legal Deadline: Final, Statutory, March 31, 2006.

Abstract: Section 6202 of the Deficit Reduction Act of 2005 extends the 
funding and authorizes (HR 4519) and appropriates for FY 2006 $75 
million for grants to help fund existing qualified State high-risk 
pools and $15 million for grants to assist States to create and 
initially fund qualified high-risk pools. The bill also authorizes 
appropriations of $75 million for each year FY 2007 through 2010. The 
section 6202 provision amendment to section 2745 establishes: (1) Seed 
grants to States for the creation and initial operation of a qualified 
high-risk pool for those States that do not have one; (2) grants to 
States to reimburse them for a percentage of losses incurred based on a 
methodology that allocates funding by 40 percent among all States, 30 
percent to States based on their number of uninsured residents, and 30 
percent based on the number of people in State risk pools operating as 
an existing qualified high-risk pool during specified years; and (3) 
bonus grants for supplemental consumer benefits. A regulation is needed 
in order to implement this provision of the DRA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              09/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Jean Sheil, Director, Family and Children's Health 
Programs Group, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Centers for Medicaid Services Operations, 
Mailstop C2-01-16, 7500 Security Boulevard, Baltimore, MD 21244

[[Page 22560]]

Phone: 410 786-5647
Fax: 410 786-8534
Email: [email protected]

RIN: 0938-AO46
_______________________________________________________________________




970. TARGETED CASE MANAGEMENT (CMS-2237-IFC)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: Deficit Reduction Act of 2005; PL 109-171, sec 6052

CFR Citation: 42 CFR 431, 42 CFR 440 to 441

Legal Deadline: Final, Statutory, January 1, 2006.

Abstract: This interim final rule with comment period revises current 
Medicaid regulations to incorporate changes made by section 6052 of the 
Deficit Reduction Act of 2005. In addition, it incorporates provisions 
of the Consolidated Omnibus Budget Reconciliation Act of 1985, the 
Omnibus Budget Reconciliation Act of 1986, the Tax Reform Act of 1986, 
the Omnibus Budget Reconciliation Act of 1987, and the Technical and 
Miscellaneous Revenue Act of 1988, concerning case managment and 
targeted case management services. This interim final rule with comment 
period will provide for optional coverage of case management services 
or targeted case management services furnished according to section 
1905 (a)(19) and section 1915 (g) of the Social Security Act. This 
interim final rule with comment period clarifies the situations in 
which Medicaid will pay for case management activities and also 
clarifies when payment will not be consistent with proper and efficient 
operation of the Medicaid program, and is not available.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Theresa A. Pratt, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Mail Stop S2-14-26, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-5831
Email: [email protected]

RIN: 0938-AO50
_______________________________________________________________________




971. CITIZENSHIP DOCUMENTATION REQUIREMENTS (CMS-2257-F)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: Deficit Reduction Act of 2005 (PL 109-171), sec 6036; 
sec 1102 of Social Security Act; Tax Relief and Health Care Act of 2006 
(PL 109-432,) sec 405(c)

CFR Citation: 42 CFR 435.403; 42 CFR 435.1009; 42 CFR 435.1010; 42 CFR 
435.406 to 435.408; 42 CFR 435.1002; 42 CFR 435.1008; 42 CFR 435.1011; 
42 CFR 436.406; 42 CFR 436.403; 42 CFR 436.407; 42 CFR 436.408; 42 CFR 
436.1004; 42 CFR 436.1005; 42 CFR 440.2; 42 CFR 435.1009; 42 CFR 
435.1010; 42 CFR 440.140; 42 CFR 440.180; 42 CFR 440.185; 42 CFR 
441.13; 42 CFR 457.310; 42 CFR 483.5; 42 CFR 483.20; 42 CFR 483.102; 42 
CFR 483.136;

Legal Deadline: Final, Statutory, July 1, 2006.

Abstract: Enactment of section 6036 of the Deficit Reduction Act of 
2005 (DRA) requires that, effective July 1, 2006, all new applicants 
for Medicaid must, in addition to declaring that they are a citizen or 
national of the United States or an alien in a satisfactory immigration 
status, if claiming to be a citizen or national, submit to the State 
evidence of citizenship. Since 1987, aliens claiming to be in a 
satisfactory immigration status have had to provide evidence of the 
claimed status and have that status verified with the Department of 
Homeland Security (previously the Immigration and Naturalization 
Service). A regulation is needed in order to implement this provision 
of the DRA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule Comment 
Period                          07/12/06                    71 FR 39214
Interim Final Rule Comment 
Period End                      08/11/06
Final Action                    05/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Jean Sheil, Director, Family and Children's Health 
Programs Group, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Centers for Medicaid States Operations, 
Mailstop S2-01-16, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5957
Fax: 410 786-8534
Email: [email protected]

RIN: 0938-AO51
_______________________________________________________________________




972. [bull] COST LIMITS FOR GOVERNMENTALLY-OPERATED PROVIDERS (CMS-2258-
F) (SECTION 610 REVIEW)

Priority: Economically Significant. Major under 5 USC 801.

Unfunded Mandates: This action may affect State, local or tribal 
governments.

Legal Authority: sec 1102 of the Social Security Act (42 U.S.C. 1302)

CFR Citation: 42 CFR 447.321; 42 CFR 433.51; 42 CFR 447.271; 42 CFR 
447.272; 42 CFR 447.34; 42 CFR 457.220; 42 CFR 457.628; 42 CFR 447.206, 
447.207;

Legal Deadline: None

Abstract: The final rule will: (1) clarify that only units of 
government are able to participate in the financing of the non-Federal 
share; (2) establish minimum requirements for documenting cost when 
using a certified public expenditure; (3) limit providers operated by 
units of government to reimbursement that does not exceed the cost of 
providing covered services to eligible Medicaid recipients; and (4) 
establish a new regulatory provision explicitly requiring that provders 
receive and retain the total computable amount of their Medicaid 
payments

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/18/07                     72 FR 2236
NPRM Comment Period End         03/19/07
Final Action                    05/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: Federal, Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

[[Page 22561]]

Agency Contact: Aaron Blight, Technical Director, Department of Health 
and Human Services, Centers for Medicare & Medicaid Services, Center 
for Medicaid State Operations, Mailstop S2-01-16, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-9560
Fax: 410786-1008
Email: [email protected]

RIN: 0938-AO57
_______________________________________________________________________




973. INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED CARE 
SERVICES CO-INSURANCE AMOUNTS FOR CY 2008 (CMS-8032-N)

Priority: Other Significant

Legal Authority: 42 USC 1395e-2 (b)(2), Social Security Act, sec 1813 
(b)(2)

CFR Citation: None

Legal Deadline: Final, Statutory, September 15, 2007.

Abstract: This notice announces the inpatient hospital deductible and 
the hospital and extended care services coinsurance amounts for 
services furnished in calendar year 2008 under Medicare's Hospital 
Insurance program (Medicare Part A). The Medicare statute specifies the 
formulae used to determine these amounts.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Clare McFarland, Deputy Director, Medicare and Medicaid 
Cost Estimates Group, Department of Health and Human Services, Centers 
for Medicare & Medicaid Services, Office of the Actuary, Mailstop N3-
26-00, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6390
Email: [email protected]

RIN: 0938-AO61
_______________________________________________________________________




974. PART A PREMIUMS FOR CY 2008 FOR THE UNINSURED AGED AND FOR CERTAIN 
DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER ENTITLEMENT (CMS-8031-N)

Priority: Other Significant

Legal Authority: 42 USC 1395i-2(d)(2); 42 USC 1395i-2a(d)(2); Social 
Security Act, sec 1818(d)(2); Social Security Act, sec 1818A (d)(2)

CFR Citation: None

Legal Deadline: Final, Statutory, September 30, 2007.

Abstract: This notice announces the hospital insurance premium for 
calendar year 2008 under Medicare's Hospital Insurance program 
(Medicare Part A) for the uninsured aged and for certain disabled 
individuals who have exhausted other entitlement.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Clare McFarland, Deputy Director, Medicare and Medicaid 
Cost Estimates Group, Department of Health and Human Services, Centers 
for Medicare & Medicaid Services, Office of the Actuary, Mailstop N3-
26-00, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6390
Email: [email protected]

RIN: 0938-AO62
_______________________________________________________________________




975. PART B MONTHLY ACTUARIAL RATES AND PREMIUM RATES BEGINNING JANUARY 
1, 2008 (CMS-8033-N)

Priority: Other Significant

Legal Authority: 42 USC 1395; Social Security Act, sec 1839; MMA, sec 
629; MMA, sec 811; DRA, sec 5111

CFR Citation: None

Legal Deadline: Final, Statutory, September 30, 2007.

Abstract: This notice announces the monthly actuarial rates for aged 
(age 65 and over) and disabled (under age 65) enrollees in Part B of 
Medicare for CY 2008. It also announces the monthly Part B premiums and 
the Part B deductible for CY 2008.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Suzanne Codespote, Deputy Director, Medicare and 
Medicaid Cost Estimates Group, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, Office of the Actuary, 
Mailstop N3-26-00, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7737
Email: [email protected]

RIN: 0938-AO68
_______________________________________________________________________




976. REVISED PAYMENT SYSTEM FOR SERVICES FURNISHED IN AMBULATORY 
SURGICAL CENTERS (ASCS) EFFECTIVE JANUARY 1, 2008 (CMS-1517-F)

Priority: Economically Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 1833(i)(2)(D)(iii)

CFR Citation: 42 CFR 416

Legal Deadline: Final, Statutory, January 1, 2008.

Abstract: This rule revises the method by which Medicare sets payment 
rates for ASC facility services and includes illustrative new payment 
rates for ASC services in accordance with that methodology. This rule 
finalizes policies proposed as part of the August 23, 2006, CY 2007 
Outpatient Prospective Payment System rule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

Agency Contact: Joan Sanow, Deputy Director, Division of Outpatient 
Services, Department of Health and Human Services, Centers for Medicare 
& Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244

[[Page 22562]]

Phone: 410 786-7802
Email: [email protected]

Related RIN: Split from 0938-AO15
RIN: 0938-AO73
_______________________________________________________________________




977. FISCAL YEAR 2008 SCHIP ALLOTMENTS (CMS-2262-N)

Priority: Other Significant

Legal Authority: title XXI of the Social Security Act, sec 2104

CFR Citation: Not Yet Determined

Legal Deadline: Final, Statutory, September 30, 2007.

Abstract: This notice sets forth the final State Children's Health 
Insurance Program (SCHIP) allotments of Federal funding available to 
each State, the District of Columbia, and each U.S. Territory and 
Commonwealth for fiscal year 2008.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          08/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Richard Strauss, Technical Director, 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 21244
Phone: 410 786-2019
Fax: 410 786-0025
Email: [email protected]

RIN: 0938-AO76
_______________________________________________________________________




978. [bull] HEALTH CARE-RELATED TAX REVISIONS (CMS-2275-P)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: President's 2007 Budget; PL 109-432, sec 403

CFR Citation: 42 CFR 433.66(1)(3)(i); 42 CFR 433.56(a)(4); 42 CFR 
433.56(a)(8); 42 CFR 433.58; 42 CFR 433.60;

Legal Deadline: None

Abstract: This proposed rule would revise the threshold under the 
indirect guarantee hold harmless arrangement test to reflect the 
provisions of the Tax Relief and Health Care Act of 2006 by providing 
that, when determining whether there is an indirect guarantee under the 
two-prong test for any part of a fiscal year on or after January 1, 
2008, through September 30, 2011, the allowable amount that can be 
collected from a health care-related tax is reduced from 6 to 5.5 
percent of net patient revenues received by the taxpayers. This 
proposed rule would also clarify the standard for determining the 
existence of a hold harmless arrangement under the positive correlation 
test, Medicaid payment test, and the guarantee test (with conforming 
changes to parallel provisions concerning hold harmless arrangements 
with respect to provider-related donations); codify descriptions for 
two classes of health care services permissible under Federal statute 
for purposes of taxes on health care providers; and remove obsolete 
transition period regulatory language.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/23/07                    72 FR 13726
Final Action                    07/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Energy Effects:  Statement of Energy Effects planned as required by 
Executive Order 13211.

Agency Contact: James Frizzera, Director, Division of Reimbursement and 
State Financing, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Center for Medicaid and State Operations, 
Mailstop S3-13-15, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-9535
Fax: 410 786-1008
Email: [email protected]

RIN: 0938-AO80
_______________________________________________________________________




979. [bull] EXTENDING SUNSET DATE FOR THE INTERIM FINAL REGULATION ON 
MENTAL HEALTH PARITY (CMS-4094-F5)

Priority: Routine and Frequent

Legal Authority: sec 2705 of the Public Health Service Act (as amended 
by the Mental Health Parity Act of 1996); sec 115(c) of the Tax Relief 
and Health Care Act of 2006 PL 109-432

CFR Citation: 45 CFR 146.136

Legal Deadline: Final, Statutory, December 31, 2007.

Abstract: In section 115(c) of the Tax Relief and Health Care Act of 
2006, legislation was enacted that extended the PHS Act provisions of 
the Mental Health Parity Act (MHPA) to services furnished through 
December 31, 2007. As a result of this most recently enacted 
legislation, it is now necessary to again publish conforming changes to 
the interim final regulation published June 27, 2003. These changes 
would conform the regulatory sunset date to the new statutory sunset 
date December 31, 2007, and would extend the duration of the increased 
cost exemption to be consistent with the new sunset date. The 
conforming changes would make absolutely no substantive changes to the 
existing regulation.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Local, State

Agency Contact: Adam M. Shaw, Senior Technical Adviser, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1091
Email: [email protected]

Related RIN: Related to 0938-AO36
RIN: 0938-AO83
_______________________________________________________________________




980. [bull] FEE SCHEDULE FOR PAYMENT OF AMBULANCE SERVICES--UPDATE FOR 
CY 2008 (CMS-1552-N)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: sec 1834 (e) of the Social Security Act

CFR Citation: 42 CFR 410

Legal Deadline: Final, Statutory, January 1, 2008.

Abstract: This notice updates the fee schedule for ambulance services 
under the Medicare program, implementing

[[Page 22563]]

section 1834(e) of the Social Security Act (effective January 1, 2008).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: Anne Tayloe, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, Mailstop C4-07-07, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4546
Email: [email protected]

RIN: 0938-AO85
_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




981. HOSPICE CARE CONDITIONS OF PARTICIPATION (CMS-3844-F) (SECTION 610 
REVIEW)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 418

Legal Deadline: Final, Statutory, May 27, 2008, MMA sec. 902.

Abstract: This final rule is a regulatory reform initiative that 
revises existing conditions of participation that hospices must meet to 
participate in the Medicare and Medicaid programs. The requirements 
focus on the actual care delivered to patients and patients' families 
by hospices and the results of that care, reflect an interdisciplinary 
view of patient care, and allow hospices greater flexibility in meeting 
quality standards. These changes are an integral part of our efforts to 
achieve broad-based improvements and measurements of the quality of 
care furnished through Federal programs while at the same time reducing 
procedural burdens on providers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/27/05                    70 FR 30840
Final Action                    05/00/08

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses, Organizations

Government Levels Affected: None

Agency Contact: Mary Rossi-Coajou, 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: 410 786-6051
Email: [email protected]

Danielle Shearer, Health Insurance Specialist, Department of Health and 
Human Services, Centers for Medicare & Medicaid Services, Clinical 
Standards Group, S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6617
Email: [email protected]

RIN: 0938-AH27
_______________________________________________________________________




982. ELECTRONIC CLAIMS ATTACHMENTS STANDARDS (CMS-0050-F)

Priority: Economically Significant. Major under 5 USC 801.

Unfunded Mandates: This action may affect State, local or tribal 
governments.

Legal Authority: 42 USC 1320d-2(a)(2)(B)

CFR Citation: 45 CFR 162

Legal Deadline: Final, Statutory, February 21, 1999.

Abstract: This rule finalizes an electronic standard for health care 
claims attachments. The standard is required by the Health Insurance 
Portability and Accountability Act of 1996. It will be used to transmit 
clinical or administrative data for claims adjudication purposes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/23/05                    70 FR 55989
Final Action                    09/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Federal, Local, State, Tribal

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Lorraine Doo, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, Office of E-Health Standards 
and Services, Mailstop S2-25-17, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-6597
Email: [email protected]

RIN: 0938-AK62
_______________________________________________________________________




983. HEALTH COVERAGE PORTABILITY: TOLLING CERTAIN TIME PERIODS AND 
INTERACTIONS WITH FAMILY AND MEDICAL LEAVE ACT (CMS-2158-F)

Priority: Other Significant

Legal Authority: 42 USC 300gg; PL 104-191

CFR Citation: 45 CFR 146.113; 45 CFR 146.115; 45 CFR 146.117; 45 CFR 
146.120; 45 CFR 146.145

Legal Deadline: None

Abstract: This final rule will clarify certain portability requirements 
for group health plans and issuers of health insurance coverage offered 
in connection with a group health plan. It also implements changes made 
to the Internal Revenue Code, the Employee Retirement Income Security 
Act, and the Public Health Service Act enacted as part of the Health 
Insurance Portability and Accountability Act of 1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/30/04                    69 FR 78800
Final Action                    08/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: Federal, Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

[[Page 22564]]

Agency Contact: Adam Shaw, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Beneficiary Choices, Employer and Policy Operations Group, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1091
Email: [email protected]

Karen Levin, Health Insurance Specialist, Department of Health and 
Human Services, Centers for Medicare & Medicaid Services, Center for 
Beneficiary Choices, Employer and Policy Operations Group, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5445
Email: [email protected]

RIN: 0938-AL88
_______________________________________________________________________




984. PRIOR DETERMINATION PROCESS FOR CERTAIN ITEMS AND SERVICES (CMS-
6024-F)

Priority: Other Significant

Legal Authority: sec 938 of the Medicare Modernization Act of 2003

CFR Citation: 42 CFR 410

Legal Deadline: Final, Statutory, June 8, 2005.

Abstract: Section 938 of the Medicare Modernization Act requires that 
physicians and beneficiaries be able to receive a prior determination 
regarding coverage of certain items and physicians' services beginning 
June 8, 2005. Full knowledge regarding financial liability for these 
services will be available to physicians and beneficiaries before 
expenses are incurred, although prior determination of coverage is not 
required for submission of a claim.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/30/05                    70 FR 51321
Final Action                    08/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Debbie Skinner, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Program Integrity Goup, Office of Financial Management, Mailstop C3-02-
16, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7480
Email: [email protected]

RIN: 0938-AN10
_______________________________________________________________________




985. MEDICARE SECONDARY PAYER AMENDMENTS (CMS-6272-F)

Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: sec 301 of the Medicare Modernization Act of 2003

CFR Citation: 42 CFR 411; 42 CFR 489

Legal Deadline: Final, Statutory, November 27, 2009, MMA sec. 902.

Abstract: This final rule implements amendments to the Medicare 
Secondary Payer (MSP) provisions under title III of the Medicare 
Prescription Drug Improvement and Modernization Act of 2003 (MMA). The 
MMA amendments clarify the MSP provisions regarding the obligations of 
primary plans and primary payers, the nature of the insurance 
arrangements subject to the MSP rules, the circumstances under which 
Medicare may make conditional payments, and the obligations of primary 
payers to reimburse Medicare.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              02/24/06                     71 FR 9466
Final Action                    02/00/09

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Suzanne Ripley, Health Insurance Specialist, Office of 
Financial Management, Department of Health and Human Services, Centers 
for Medicare & Medicaid Services, Mailstop C3-14-16, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-0970
Fax: 410 786-7030
Email: [email protected]

RIN: 0938-AN27
_______________________________________________________________________




986. TERMINATION OF NON-RANDOM PREPAYMENT REVIEW (CMS-6022-F)

Priority: Other Significant

Legal Authority: sec 934 of the MMA

CFR Citation: 42 CFR 421

Legal Deadline: Final, Statutory, October 7, 2008, MMA sec. 902.

Abstract: This rule implements the statutory requirements regarding the 
termination of non-random prepayment review under section 934 of the 
Medicare Prescription Drug Improvement and Modernization Act beginning 
December 8, 2003. This rule provides guidelines for terminating a 
provider of services or supplier from non-random payment review.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/07/05                    70 FR 58649
Final Action                    10/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Daniel Schwartz, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Office of Financial Management, Program Intergrity 
Group, Mailstop C3-02-16, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4197
Email: [email protected]

RIN: 0938-AN31
_______________________________________________________________________




987. LIMITATION ON RECOUPMENT OF PROVIDER AND SUPPLIER OVERPAYMENTS 
(CMS-6025-F)

Priority: Other Significant

Legal Authority: sec 1893 (f) (2) of the Social Security Act added by 
sec 935 of the MMA

CFR Citation: 42 CFR 405

Legal Deadline: Final, Statutory, December 8, 2003.

Abstract: This rule implements one provision of section 935 of the 
Medicare Prescription Drug Improvement and Modernization Act which 
added a new subsection to section 1893 of the Social Security Act. It 
adjusts Medicare's ability to recover an overpayment when the Qualified 
Independent Contractor (QIC) receives a valid appeal from the provider 
or supplier. This rule defines the overpayments to which the limitation 
applies, how the limitation works in concert with the appeals process, 
and the change in Medicare's obligation to pay interest to a provider 
or supplier whose appeal is successful at levels above the QIC.

[[Page 22565]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/22/06                    71 FR 55404
NPRM Comment Period End         11/21/06
Final Action                    09/00/09

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Nancy Braymer, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Mailstop C3-14-21, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4323
Email: [email protected]

RIN: 0938-AN42
_______________________________________________________________________




988. MEDICARE PART B COMPETITIVE ACQUISITION OF OUTPATIENT DRUGS AND 
BIOLOGICALS (CMS-1325-F)

Priority: Other Significant

Legal Authority: MMA of 2003, sec 303(d)

CFR Citation: 42 CFR 414

Legal Deadline: Final, Statutory, July 1, 2006.

Abstract: Section 303(d) of the Medicare Modernization Act requires the 
implementation of a competitive bidding program for Medicare Part B 
drugs not paid on a cost or prospective payment system basis. Beginning 
July 1, 2006, physicians will be given a choice between purchasing 
these drugs and being paid by Medicare under the average sales price 
(ASP) system, or obtaining these drugs from vendors selected in a 
competitive bidding process. If the physician elects to obtain drugs 
from a competitive vendor, the vendor will bill Medicare for the drug.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/04/05                    70 FR 10745
Interim Final Rule              07/06/05                    70 FR 39022
Second Interim Final Rule       09/06/05                    70 FR 52930
Third Interim Final Rule        11/21/05                    70 FR 70478
Fourth Interim Final Rule       08/18/06                    71 FR 47870
Fourth Interim Final Rule 
Comment Period End              10/02/06
Final Action                    07/00/08

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Corinne Axelrod, Health Insurance Specialist, Hospital 
and Ambulatory Policy Group, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, Mailstop C5-14-03, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5620
Email: [email protected]

RIN: 0938-AN58
_______________________________________________________________________




989. MEDICARE INTEGRITY PROGRAM, FISCAL INTERMEDIARY AND CARRIER 
FUNCTIONS, AND CONFLICT OF INTEREST REQUIREMENTS (CMS-6030-F)

Priority: Other Significant

Legal Authority: sec 1124, 1816, 1842, and 1893 of the Social Security 
Act

CFR Citation: 42 CFR 400 and 42 CFR 421

Legal Deadline: Final, Statutory, June 17, 2008, MMA sec. 902.

Abstract: This rule finalizes certain sections of the Medicare 
regulations concerning fiscal intermediaries and carriers and brings 
them into conformity with the Medicare statute. The rule distinguishes 
between those functions that the statute requires to be included in 
agreements with fiscal intermediaries and those that may be included in 
the agreements. It would also provide that some or all of the functions 
may be included in carrier contracts. Currently all these functions are 
mandatory for carrier contracts.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/17/05                    70 FR 35204
Final Action                    06/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Gary D. Williams, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Office of Financial Management, Program Integrity 
Group, Mailstop C3-02-16, 7500 Security Boulevard, Baltimore, MD 21244-
1850
Phone: 410 786-6433
Email: [email protected]

Related RIN: Related to 0938-AI09
RIN: 0938-AN72
_______________________________________________________________________




990. PAYMENT ERROR RATE MEASUREMENT (PERM) PROGRAM (CMS-6026-F)

Priority: Other Significant

Legal Authority: Improper Payment Information Act of 2002

CFR Citation: 42 CFR 431; 42 CFR 457

Legal Deadline: Final, Statutory, October 1, 2005.

Abstract: This rule sets forth the State requirements to provide 
information for purposes of estimating improper payments under Medicaid 
and SCHIP. The Improper Payments Information Act of 2002 (IPIA) 
requires heads of Federal agencies to annually estimate and report to 
Congress these estimates of improper payments for the programs they 
oversee and submit a report on actions the Agency is taking to reduce 
erroneous payments.
This rule also responds to the public comments on the August 28, 2006, 
interim final rule and sets forth State requirements for submitting 
claims and policies to the Federal contractor for purposes of 
conducting fee-for-service and managed care reviews. This rule also 
responds to public comments on the State requirements for conducting 
eligibility reviews and estimating payment error rates due to errors in 
eligibility determinations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/27/04                    69 FR 52620
Interim Final Rule              10/05/05                    70 FR 58260
Second Interim Final Rule       08/28/06                    71 FR 51049
Final Action                    08/00/09

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Janet Reichert, Technical Advisor, Department of Health 
and Human Services, Centers for Medicare & Medicaid Services, Office of 
Financial Management, Program

[[Page 22566]]

Integrity Group, Mailstop C3-02-16, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4580
Email: [email protected]

Related RIN: Related to 0938-AM86
RIN: 0938-AN77
_______________________________________________________________________




991. FIRE SAFETY REQUIREMENTS FOR LONG-TERM CARE FACILITIES: SPRINKLER 
SYSTEMS (CMS-3191-F)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 483

Legal Deadline: None

Abstract: On July 16, 2004, the GAO published a report on Federal fire 
safety standards and procedures in nursing facilities. The GAO report 
cited automatic sprinkler systems in all nursing facilities. On October 
27, 2006, CMS published a proposed rule that would require automatic 
sprinkler systems as the single most effective fire safety device in 
long-term care facilities and recommended that CMS explore requiring 
automatic sprinkler systems in all nursing facilities and request 
public comments on the length of a phase-in period to allow nursing 
facilities to comply with the new requirement. We received numerous 
public comments supporting the proposed rule and suggesting changes to 
it. This rule finalizes the content of the proposed rule and 
incorporates changes suggested by the public.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/27/06                    71 FR 62957
NPRM Comment Period End         12/26/06
Final Action                    10/00/09

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Danielle N. 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: 410 786-6617
Fax: 410 786-8532
Email: [email protected]

RIN: 0938-AN79
_______________________________________________________________________




992. USE OF REPAYMENT PLANS (CMS-6032-F)

Priority: Other Significant

Legal Authority: sec 1893(i)(1) of the Social Security Act as amended 
by sec 935(i)(1) of Medicare Modernization Act (MMA)

CFR Citation: 42 CFR 401.601, 42 CFR 401.607

Legal Deadline: Final, Statutory, December 9, 2003.

Abstract: This rule modifies Medicare regulations to implement a 
provision of the Medicare Prescription Drug Improvement and 
Modernization Act of 2003 pertaining to the use of repayment plans 
(also known as extended repayment schedules). Under this provision, we 
will grant a provider or a supplier an extended repayment schedule 
under certain terms and conditions as defined in the statute. The final 
rule establishes criteria and procedures to apply this requirement and 
to define the concepts of ``hardship`` and ''extreme hardship.``

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/27/06                    71 FR 68519
NPRM Comment Period End         01/26/07
Final Action                    11/00/09

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Thomas A. Noplock, Health Insurance Specialist, 
Division of Medicare Overpayments, Office of Financial Management, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Financial Services Group, Mailstop C3-15-01, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3378
Fax: 410 786-7030
Email: [email protected]

RIN: 0938-AO27
_______________________________________________________________________




993. IDENTIFICATION OF BACKWARD COMPATIBLE VERSION OF ADOPTED STANDARD 
FOR E-PRESCRIBING AND THE MEDICARE PRESCRIPTION DRUG PROGRAM (VERSION 
8.1) (CMS-0018-F)

Priority: Other Significant

Legal Authority: 42 USC 1395

CFR Citation: 42 CFR 423

Legal Deadline: Final, Statutory, June 23, 2009, MMA sec. 902.

Abstract: This final rule identifies version 8.1 of the National 
Council for Prescription Drug Programs (NCPDP) SCRIPT Standard as a 
backward compatible update of the adopted version 5.0. This rule also 
permits the voluntary use of version 8.1 of the NCPDP SCRIPT Standard 
for conducting certain e-prescribing transactions for the electronic 
prescription drug program under title I of the Medicare Prescription 
Drug Improvement and Modernization Act of 2003 (MMA).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              06/23/06                    71 FR 36020
Interim Final Rule Comment 
Period End                      08/22/06
Final Action                    06/00/09

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Gladys C. Wheeler, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Office of Electronic Standards and Services, 
Mailstop S2-16-17, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0273
Email: [email protected]

Related RIN: Related to 0938-AN49
RIN: 0938-AO42
_______________________________________________________________________




994. PROHIBITION OF MID-YEAR BENEFIT ENHANCEMENTS FOR MEDICARE ADVANTAGE 
ORGANIZATIONS OFFERING PLANS IN CALENDAR YEAR 2007 AND SUBSEQUENT 
CALENDAR YEARS (CMS-4121-F)

Priority: Other Significant

Legal Authority: 42 USC 1302, 1395hh

[[Page 22567]]

CFR Citation: 42 CFR 422.2; 42 CFR 422.254

Legal Deadline: None

Abstract: This rule implements new policy to prohibit Medicare 
Advantage (MA) organizations from offering mid-year benefit 
enhancements (MYBEs). The policy is based on our experience during the 
first year of the new Medicare Advantage program and our belief that, 
in order to fully comply with the statute (MMA), we can no longer 
permit MYBEs as these threaten the integrity of the competitive bidding 
process established by the statute.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/01/06                    71 FR 52014
Final Action                    09/00/09

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal

Agency Contact: Christopher McClintick, Health Insurance Specialist, 
Center for Beneficiary Choices, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, Medicare Advantage 
Group, Division of Plan Policy, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-4682
Email: [email protected]

RIN: 0938-AO54
_______________________________________________________________________




995. MEDICARE PART D DATA (CMS-4119-F)

Priority: Other Significant

Legal Authority: sec 1860 D-12 of the Social Security Act

CFR Citation: 42 CFR 423

Legal Deadline: Final, Statutory, October 18, 2009, MMA sec. 902.

Abstract: CMS is required by Congress to conduct a number of part D 
related research demonstration and evaluation studies that require part 
D claims data. We are finalizing a regulation that addresses use of 
part D claims information for other research, analysis, reporting, and 
public health functions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/18/06                    71 FR 61445
NPRM Comment Period End         12/18/06
Final Action                    10/00/09

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Organizations

Government Levels Affected: None

Agency Contact: Alissa M. Deboy, Acting Division Director, Center for 
Beneficiary Choices, Department of Health and Human Services, Centers 
for Medicare & Medicaid Services, Drug Plan Policy and Analysis 
Division, Mailstop C1-26-16, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-6041
Email: [email protected]

RIN: 0938-AO58
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




996. HOSPITAL CONDITIONS OF PARTICIPATION: REQUIREMENTS FOR APPROVAL AND 
REAPPROVAL OF TRANSPLANT CENTERS TO PERFORM ORGAN TRANSPLANTS (CMS-3835-
F)

Priority: Other Significant

CFR Citation: 42 CFR 405; 42 CFR 482; 42 CFR 488; 42 CFR 498

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/30/07                    72 FR 15198

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Eva Fung
Phone: 410 786-7539
Email: [email protected]

RIN: 0938-AH17
_______________________________________________________________________




997. REQUIREMENTS FOR LONG-TERM CARE FACILITIES: HOSPICE SERVICES (CMS-
3140-P)

Priority: Other Significant

CFR Citation: 42 CFR 483

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       01/30/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Anita Panicker
Phone: 410 786-5646
Fax: 410 786-8532
Email: [email protected]

RIN: 0938-AM87
_______________________________________________________________________




998. HOSPITAL CONDITIONS OF PARTICIPATION: REQUIREMENTS FOR HISTORY AND 
PHYSICAL EXAMINATIONS; AUTHENTICATION OF VERBAL ORDERS; SECURING 
MEDICATIONS; AND POST-ANESTHESIA EVALUATIONS (CMS-3122-F)

Priority: Other Significant

CFR Citation: 42 CFR 482

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      11/27/06                    71 FR 68672

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Organizations

Government Levels Affected: None

Agency Contact: Patricia Chmielewski
Phone: 410 786-6899
Email: [email protected]

RIN: 0938-AM88

[[Page 22568]]

_______________________________________________________________________




999. NONDISCRIMINATION IN HEALTH COVERAGE IN THE GROUP MARKET (CMS-4081-
F)

Priority: Other Significant

CFR Citation: 45 CFR 146.121

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/13/06                    71 FR 75014

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: Local, State

Agency Contact: Adam Shaw
Phone: 410 786-1091
Email: [email protected]

Karen Levin
Phone: 410 786-5445
Email: [email protected]

Related RIN: Previously reported as 0938-AK19
RIN: 0938-AN29
_______________________________________________________________________




1000. HOSPITAL CONDITIONS OF PARTICIPATION: PATIENTS' RIGHTS (CMS-3018-
F)

Priority: Other Significant

CFR Citation: 42 CFR 482

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/08/06                    71 FR 71378

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Patricia Chmielewski
Phone: 410 786-6899
Email: [email protected]

RIN: 0938-AN30
_______________________________________________________________________




1001. PROGRAM FOR ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE): PROGRAM 
REVISIONS (CMS-1201-F)

Priority: Other Significant

CFR Citation: 42 CFR 460

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/08/06                    71 FR 71244

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: Federal, Local, State, Tribal

Agency Contact: Janet Harris
Phone: 410 786-3137
Email: [email protected]

Related RIN: Previously reported as 0938-AL59
RIN: 0938-AN83
_______________________________________________________________________




1002. MEDICARE GRADUATE MEDICAL EDUCATION AFFILIATION PROVISIONS FOR 
TEACHING HOSPITALS IN CERTAIN EMERGENCY SITUATIONS (CMS-1531-F2)

Priority: Other Significant

CFR Citation: 42 CFR 413

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       02/05/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Tzvi Hefter
Phone: 410 786-6014
Email: [email protected]

Related RIN: Merged with 0938-AO70
RIN: 0938-AO35
_______________________________________________________________________




1003. NOTIFICATION PROCEDURES FOR HOSPITAL DISCHARGES (CMS-4105-F)

Priority: Other Significant

CFR Citation: 42 CFR 405; 42 CFR 412; 42 CFR 422; 42 CFR 489

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      11/27/06                    71 FR 68708

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Eileen Zerhusen
Phone: 410 786-7803
Email: [email protected]

Related RIN: Merged with 0938-AK48, Merged with 0938-AL67
RIN: 0938-AO41
_______________________________________________________________________


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


Administration for Children and Families (ACF)



_______________________________________________________________________




1004. DEVELOPMENTAL DISABILITIES AND BILL OF RIGHTS ACT

Priority: Substantive, Nonsignificant

Legal Authority: PL 106-402; 42 USC 15001 et seq

CFR Citation: 45 CFR 1385 to 1388

Legal Deadline: Final, Statutory, October 30, 2001.

Abstract: A notice of proposed rulemaking to amend current regulations 
and to implement changes made by the Developmental Disabilities 
Assistance and Bill of Rights Act of 2000.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: Local, State, Tribal

Agency Contact: Elsbeth Wyatt, Program Specialist, Department of Health 
and Human Services, Administration for Children and Families, 370 
L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 690-5841

RIN: 0970-AC07
_______________________________________________________________________




1005. CARE AND PLACEMENT OF UNACCOMPANIED ALIEN CHILDREN

Priority: Other Significant

Legal Authority: 6 USC 279

CFR Citation: 45 CFR 410

Legal Deadline: None

Abstract: This rule concerns the placement of unaccompanied alien

[[Page 22569]]

children in appropriate facilities and homes, the services provided for 
the children while they are in the care of the Office of Refugee 
Resettlement (ORR) and the criteria for release of these children from 
Federal custody to sponsors. The rule also implements ORR's role in 
Flores class-action settlement agreement.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal

Agency Contact: Maureen Dunn, Department of Health and Human Services, 
Administration for Children and Families, 370 L'Enfant Promenade SW., 
Washington, DC 20447
Phone: 202 401-5523
Email: [email protected]

RIN: 0970-AC20
_______________________________________________________________________




1006. ADOPTION AND FOSTER CARE ANALYSIS AND REPORTING SYSTEM

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 679

CFR Citation: 45 CFR 1355

Legal Deadline: None

Abstract: This NPRM amends the Adoption and Foster Care Analysis and 
Reporting System (AFCARS) regulations at 45 CFR part 1355.40 and the 
appendices to part 1355 to modify the requirements for States to 
collect and report data to ACF on children in foster care and in 
subsidized adoption or guardianship arrangements with the State. The 
rule also implements the AFCARS penalty requirements of the Adoption 
Promotion Act of 2003 (Pub. L. 108-145).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Kathleen McHugh, Director, Division of Policy, 
Children's Bureau, ACYF/ACF/HHS, Department of Health and Human 
Services, Administration for Children and Families, 370 L'Enfant 
Promenade SW., Washington, DC 20447
Phone: 202 401-5789
Fax: 202 205-8221
Email: [email protected]

RIN: 0970-AC23
_______________________________________________________________________




1007. PRIVATIZING FUNCTIONS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302

CFR Citation: 45 CFR 1355 to 1356

Legal Deadline: None

Abstract: Proposed rule would address States' ability to delegate 
decisionmaking authority to private agencies performing administration 
functions and the availability of funding for training funds under the 
Foster Care program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State

Agency Contact: Kathleen McHugh, Director, Division of Policy, 
Children's Bureau, ACYF/ACF/HHS, Department of Health and Human 
Services, Administration for Children and Families, 370 L'Enfant 
Promenade SW., Washington, DC 20447
Phone: 202 401-5789
Fax: 202 205-8221
Email: [email protected]

RIN: 0970-AC25
_______________________________________________________________________




1008. LIMITATION ON USE OF FUNDS MADE AVAILABLE TO MONITOR AND COMBAT 
TRAFFICKING IN PERSONS

Priority: Other Significant

Legal Authority: 22 USC chapter 78 Trafficking Victims Protection Act

CFR Citation: 45 CFR 404

Legal Deadline: None

Abstract: This rule will implement provisions of the Trafficking 
Victims Protection Act which prohibit programs from using trafficking 
funds to promote, support, or advocate the legalization or practice of 
prostitution and make organizations ineligible to receive such funds 
that promotes, supports, or advocates the legalization or the practice 
of prostitution if the program operates a program that targets several 
forms of trafficking unless the organization provides services to 
individuals solely after they are no longer engaged in activities that 
resulted from such activities being trafficked.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Kenneth Tota, Chief of Operations--Office of Refugee 
Resettlement, Department of Health and Human Services, Administration 
for Children and Families, 370 L'Enfant Promenade SW., Washington, DC 
20447
Phone: 202 401-4858
Email: [email protected]

RIN: 0970-AC28
_______________________________________________________________________




1009. CHILD CARE AND DEVELOPMENT FUND ERROR RATE REPORTING

Priority: Other Significant

Legal Authority: Improper Payments Information Act (PL 107-300)

CFR Citation: 45 CFR 98

Legal Deadline: None

Abstract: This rule will require States and selected territories to 
employ a case review process every 4 years in calculating a CCDF error 
rate.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/02/07                     72 FR 9491
NPRM Comment Period End         05/01/07
Final Action                    08/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: Local, State, Tribal

Agency Contact: Jeffrey J. Polich, Child Care Program Specialist, 
Department of Health and Human Services, Administration for Children 
and Families, 8th Floor, 1250 Maryland Avenue SW., Washington, DC 20447
Phone: 202 205-8696

[[Page 22570]]

Email: [email protected]

RIN: 0970-AC29
_______________________________________________________________________




1010. ABSTINENCE EDUCATION

Priority: Other Significant

Unfunded Mandates: This action may affect State, local or tribal 
governments and the private sector.

Legal Authority: sec 510 of the Social Security Act

CFR Citation: 45 CFR 1352

Legal Deadline: None

Abstract: This rule will provide guidance on the general requirements 
for abstinence education curricula, clarify the treatment of section 
510(b)(2)(A) through (H), clarify appropriate target age groups for 
title V State Abstinence Education Grants, and clarify appropriate 
application of additional activities used by title V State Abstinence 
Education grantees.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Organizations

Government Levels Affected: State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: David Siegel, Family and Youth Services Bureau, 
Department of Health and Human Services, Administration for Children 
and Families, 8th Floor, 1250 Maryland Avenue SW., Washington, DC 20447
Phone: 202 401-9217
Email: [email protected]

RIN: 0970-AC30
_______________________________________________________________________


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


Administration for Children and Families (ACF)



_______________________________________________________________________




1011. SAFEGUARDING CHILD SUPPORT AND EXPANDED FEDERAL PARENT LOCATOR 
SERVICES (FPLS) INFORMATION

Priority: Other Significant

Legal Authority: 42 USC 652 to 654A; 42 USC 663; 42 USC 1302

CFR Citation: 45 CFR 303.3; 45 CFR 303.21; 45 CFR 303.70

Legal Deadline: None

Abstract: The Personal Responsibility and Work Opportunity 
Reconciliation Act of 1996 made far-reaching amendments to title IV-D 
of the Social Security Act, which governs the child support enforcement 
program. The Balanced Budget Act of 1997, the Adoption and Safe 
Families Act of 1997, and the Child Support Performance and Incentive 
Act of 1998 further amended title IV-D. A significant result of this 
legislation is an expansion in the scope of information available to 
State IV-D child support enforcement agencies. The legislation has 
rendered obsolete or inconsistent several regulations at 45 CFR chapter 
III, Office of Child Support Enforcement, including the regulations on 
the Federal Parent Locator Service, the State Parent Locator Services, 
the offset of Federal payments for purposes of collecting child 
support, and the safeguarding of information. This regulation would 
update various sections in 45 CFR chapter III to reflect the statutory 
changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/14/05                    70 FR 60038
NPRM Comment Period End         12/13/05
Final Action                    06/00/07

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Local, State, Tribal

Agency Contact: Elizabeth C. Matheson, Director, Policy and Planning 
Division, Department of Health and Human Services, Administration for 
Children and Families, Office of Child Support Enforcement, 370 
L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 401-9386
Email: [email protected]

RIN: 0970-AC01
_______________________________________________________________________




1012. COST ALLOCATION METHODOLOGY APPLICABLE TO THE TEMPORARY ASSISTANCE 
FOR NEEDY FAMILIES PROGRAM

Priority: Other Significant

Legal Authority: 42 USC 1302

CFR Citation: 45 CFR 263; 45 CFR 263.14

Legal Deadline: None

Abstract: This proposed rule will require States (including the 
District of Columbia) and territories to use the ``benefiting'' cost 
allocation methodology in allocating the common administrative costs of 
determining eligibility in the Temporary Assistance for Needy Families 
(TANF) program, the Medicaid program, and the Food Stamp programs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/27/06                    71 FR 56440
NPRM Comment Period End         11/27/06
Final Action                    03/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Local, State

Agency Contact: Robert Shelbourne, Deputy Director, Office of Family 
Assistance, Office of Policy, Department of Health and Human Services, 
Administration for Children and Families, 5th Floor East, 370 L'Enfant 
Promenade SW., Washington, DC 20447
Phone: 202 401-5150
Email: [email protected]

RIN: 0970-AC15
_______________________________________________________________________




1013. CHILD CARE AND DEVELOPMENT FUND STATE MATCH PROVISIONS

Priority: Other Significant

Legal Authority: 42 USC 9858C

CFR Citation: 45 CFR 98.16

Legal Deadline: None

Abstract: This rule revises the Child Care and Development Fund (CCDF) 
regulations to permit States to designate multiple public and/or 
private entities

[[Page 22571]]

as eligible to receive private donations that may be certified as child 
care expenditures for purposes of receiving Federal CCDF matching 
funds.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/09/04                    69 FR 64881
Final Action                    05/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Local, State

Agency Contact: Christine Calpin, Associate Director, Child Care--
Office of Family Assistance, Department of Health and Human Services, 
Administration for Children and Families, 8th Floor, 1250 Maryland 
Avenue SW., Washington, DC 20447
Phone: 202 690-6782
Email: [email protected]

RIN: 0970-AC18
_______________________________________________________________________




1014. CHAFEE NATIONAL YOUTH IN TRANSITION DATABASE

Priority: Other Significant

Legal Authority: 42 USC 677

CFR Citation: 45 CFR 1356

Legal Deadline: None

Abstract: This rule would require States to collect and report data on 
youth who are receiving independent living services and the outcomes of 
certain youth who are in foster care or who age-out of foster care.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/14/06                    71 FR 40345
Final Action                    03/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Kathleen McHugh, Director, Division of Policy, 
Children's Bureau, ACYF/ACF/HHS, Department of Health and Human 
Services, Administration for Children and Families, 370 L'Enfant 
Promenade SW., Washington, DC 20447
Phone: 202 401-5789
Fax: 202 205-8221
Email: [email protected]

RIN: 0970-AC21
_______________________________________________________________________




1015. MEDICAL SUPPORT

Priority: Other Significant

Legal Authority: 42 USC 1302

CFR Citation: 45 CFR 302 to 305

Legal Deadline: None

Abstract: These rules would require that all support orders in the IV-D 
program address medical support, redefine reasonable-cost health 
insurance, require health insurance to be accessible, and make 
conforming changes to audit and self-assessment requirements.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/20/06                    71 FR 54965
Final Action                    09/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: Local, State

Agency Contact: Elizabeth C. Matheson, Director, Policy and Planning 
Division, Department of Health and Human Services, Administration for 
Children and Families, Office of Child Support Enforcement, 370 
L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 401-9386
Email: [email protected]

RIN: 0970-AC22
_______________________________________________________________________




1016. CHILD SUPPORT PROVISIONS OF THE DEFICIT REDUCTION ACT

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1302

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: The proposed rule would implement provisions of the Deficit 
Reduction Act of 2005 related to review and adjustment of child support 
orders, Federal financial participation in the program, and fees for 
program services.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/24/07                     72 FR 3093
Final Action                    01/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: Federal, Local, State, Tribal

Agency Contact: Elizabeth C. Matheson, Director, Policy and Planning 
Division, Department of Health and Human Services, Administration for 
Children and Families, Office of Child Support Enforcement, 370 
L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 401-9386
Email: [email protected]

RIN: 0970-AC24
_______________________________________________________________________




1017. TANF WORK PROVISIONS OF THE DEFICIT REDUCTION ACT

Priority: Other Significant

Legal Authority: 42 USC 1302

CFR Citation: 261, et seq

Legal Deadline: Other, Statutory, June 30, 2006, Interim Final Rule.

Abstract: This rule will address new work requirements associated with 
the Deficit Reduction Act of 2005, including what counts as work 
activities, reporting and verifying hours of work, and who should be 
included in the work participation rate.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              06/29/06                    71 FR 37454
Final Action                    12/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State, Tribal

Agency Contact: Robert Shelbourne, Director of Policy, OFA/ACF/HHS, 
Department of Health and Human Services, Administration for Children 
and Families, 901 D Street SW., Washington, DC 20447
Phone: 202 401-5150
Email: [email protected]

RIN: 0970-AC27

[[Page 22572]]

_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Administration for Children and Families (ACF)



_______________________________________________________________________




1018. HEAD START TRANSPORTATION

Priority: Other Significant

CFR Citation: 45 CFR 1310

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/04/06                    71 FR 58533

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Craig Turner
Phone: 202 205-8236
Email: [email protected]

RIN: 0970-AC26
[FR Doc. 07-01618 Filed 04-27-07; 8:45 am]
BILLING CODE 4150-24-S
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