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[December 13, 2004 (Volume 69, Number 238)]
[Unified Agenda]
 [frwais.access.gpo.gov]
                         

[Page 73120-73129]
 
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

_______________________________________________________________________


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Part VIII





Department of Health and Human Services





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



Semiannual Regulatory Agenda

[[Page 73120]]




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 agenda.

_______________________________________________________________________

SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order 
12866 require this semiannual publication inventorying all 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. Anyone wishing to communicate 
to the Department their views on the potential rulemakings outlined 
below is 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.

    When the Department publishes a proposed rule, information 
about it automatically becomes available to the public at 
www.regulations.gov, the Governmentwide Web site for submission of 
comments on proposed regulations. Citizens may submit comments on 
such proposals by clicking the ``Submit a Comment on this 
Regulation'' link on the Web site, which will open a blank comment 
form containing instructions on how to submit the comment. Comments 
submitted via www.regulations.gov are transmitted to the Department 
daily, and, as legally required, all comments received are reviewed 
and taken into account if a final regulation is developed.

     We welcome the views of all concerned with regard to the 
planned rulemakings referenced below. 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.

     For this edition of the Department of Health and Human 
Services' regulatory agenda, the most significant regulatory 
actions are included in The Regulatory Plan, which appears in part 
II of this issue of the Federal Register. The Regulatory Plan 
entries are listed in the table of contents below and are denoted 
by a bracketed bold reference, which directs the reader to the 
appropriate sequence in part II.

Dated: November 1, 2004.

 Ann C. Agnew,

Executive Secretary to the Department.

                                  Office of the Secretary--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
910         Health Insurance Portability and Accountability Act--Enforcement......................    0991-AB29
----------------------------------------------------------------------------------------------------------------


                                    Office of the Secretary--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
911         Shared Risk Exception to the Safe Harbor Provisions...................................    0991-AA91
912         Amending the Regulations Governing Nondiscrimination on the Basis of Race, Color,         0991-AB10
            National Origin, Handicap, Sex, and Age To Conform to the Civil Rights Restoration Act
            of 1987...............................................................................
913         Safe Harbor for Waiver of Beneficiary Coinsurance and Deductible Amounts for a            0991-AB16
            Medicare SELECT Policy................................................................
914         Clarification of Terms and Application of Program Exclusion Authority for Submitting      0991-AB23
            Claims Containing Excessive Charges...................................................
----------------------------------------------------------------------------------------------------------------


                                   Office of the Secretary--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
915         Revisions to Regulations Addressing the OIG's Authority to Impose Civil Money             0991-AB03
            Penalties and Assessments.............................................................
916         Claims Collection.....................................................................    0991-AB18
917         Salary Offset.........................................................................    0991-AB19
918         Medicare and Federal Health Care Programs: Fraud and Abuse; Revisions to the Waiver       0991-AB33
            Provisions of the OIG's Exclusion Authorities.........................................
----------------------------------------------------------------------------------------------------------------


[[Page 73121]]


                                   Office of the Secretary--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
919         Safe Harbor for Arrangements Involving Federally Qualified Health Centers.............    0991-AB06
920         Technical Revisions to HIPDB Data Collection Activities...............................    0991-AB31
921         Participation in Department of Health and Human Services Programs by Religious            0991-AB34
            Organizations; Providing for Equal Treatment of All Department of Health and Human
            Services Program Participants.........................................................
----------------------------------------------------------------------------------------------------------------


                 Substance Abuse and Mental Health Services Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
922         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
----------------------------------------------------------------------------------------------------------------
923         Mandatory Guidelines for the Federal Workplace Drug Testing Program...................    0930-AA12
----------------------------------------------------------------------------------------------------------------


                         Centers for Disease Control and Prevention--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
924         Amendments to Quality Assurance and Administrative Provision for Approval of              0920-AA04
            Respiratory Protective Devices........................................................
----------------------------------------------------------------------------------------------------------------


                          Centers for Disease Control and Prevention--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
925         Possession, Use, and Transfer of Select Agents and Toxins.............................    0920-AA09
----------------------------------------------------------------------------------------------------------------


                                   Food and Drug Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
926         Food Labeling; Prominence of Calories (Reg Plan Seq No. 41)...........................    0910-AF22
927         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 (Reg Plan Seq No. 42)..............................
928         Over-the-Counter (OTC) Drug Review--Sunscreen Products................................    0910-AF43
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


                                Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
929         Foreign and Domestic Establishment Registration and Listing Requirements for Human        0910-AA49
            Drugs, Certain Biological Drugs, and Animal Drugs (Reg Plan Seq No. 43)...............

[[Page 73122]]


930         Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure            0910-AC30
            Regulators for Use With Medical Oxygen................................................
931         Submission of Standardized Electronic Study Data From Clinical Studies Evaluating         0910-AC52
            Human Drugs and Biologics.............................................................
932         Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements.    0910-AC53
933         Food Standards: General Principles and Food Standards Modernization...................    0910-AC54
934         Positron Emission Tomography Drugs; Current Good Manufacturing Practices..............    0910-AC55
935         Reporting Information Regarding Falsification of Data.................................    0910-AC59
936         Health Claims.........................................................................    0910-AF09
937         Quality Standard Regulation Establishing an Allowable Level for Arsenic in Bottled        0910-AF10
            Water.................................................................................
938         Content and Format of Labeling for Human Prescription Drugs and Biologics;                0910-AF11
            Requirements for Pregnancy and Lactation..............................................
939         Cochineal Extract and Carmine Label Declaration.......................................    0910-AF12
940         Charging for Investigational Drugs....................................................    0910-AF13
941         Treatment Use of Investigational Drugs................................................    0910-AF14
942         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.............................................................
943         Revocation of the Status of Specific Products; Group A Streptococcus..................    0910-AF20
944         Obstetrical and Gynecological Devices; Designation of Special Control for Condoms and     0910-AF21
            Condoms with Spermicidal Lubricant....................................................
945         Blood Initiative--Requirements for Human Blood and Blood Components Intended for          0910-AF25
            Transfusion or for Further Manufacturing Use..........................................
946         Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products..............    0910-AF32
947         Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) Products.................    0910-AF33
948         Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products..........    0910-AF34
949         Over-the-Counter (OTC) Drug Review--Internal Analgesic Products.......................    0910-AF36
950         Over-the-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use.......    0910-AF37
951         Over-the-Counter (OTC) Drug Review--Weight Control Products...........................    0910-AF45
952         Substances Prohibited From Use in Animal Food or Feed (Reg Plan Seq No. 44)...........    0910-AF46
953         Over-the-Counter (OTC) Drug Review--Dandruff, Seborrheic Dermatitis, and Psoriasis        0910-AF49
            Products..............................................................................
954         Over-the-Counter (OTC) Drug Review--Overindulgence in Food and Drink Products.........    0910-AF51
955         Over-the-Counter (OTC) Drug Review--Skin Bleaching Prodcuts...........................    0910-AF53
956         Use of Materials Derived From Cattle In Human and Animal Medical Products (Reg Plan       0910-AF54
            Seq No. 45)...........................................................................
957         Requirements for Human and Animal Medical Products Manufactured From, Processed With,     0910-AF55
            or Otherwise Containing Material From Cattle (Reg Plan Seq No. 46)....................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


                                 Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
958         Investigational New Drugs: Export Requirements for Unapproved New Drug Products.......    0910-AA61
959         Requirements on Content and Format of Labeling for Human Prescription Drugs and           0910-AA94
            Biological Products (Reg Plan Seq No. 47).............................................
960         Safety Reporting Requirements for Human Drug and Biological Products (Reg Plan Seq No.    0910-AA97
            48)...................................................................................
961         Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based        0910-AB28
            Product Establishments; Inspection and Enforcement (Reg Plan Seq No. 49)..............
962         Applications for FDA Approval To Market a New Drug; Complete Response Letter;             0910-AB34
            Amendments To Unapproved Applications.................................................
963         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) (Reg Plan Seq No. 50)............................................
964         Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary         0910-AB88
            Ingredients and Dietary Supplements (Reg Plan Seq No. 51).............................
965         Additional Safeguards for Children in Clinical Investigations of FDA-Regulated            0910-AC07
            Products..............................................................................
966         Prevention of Salmonella Enteritidis in Shell Eggs (Reg Plan Seq No. 52)..............    0910-AC14
967         Institutional Review Boards: Registration Requirements................................    0910-AC17

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