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ua28jn04 873. PRIOR NOTICE OF IMPORTED FOOD UNDER THE PUBLIC HEALTH SECURITY AND...


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[June 28, 2004 (Volume 69, Number 123)]
[Unified Agenda]
 [frwais.access.gpo.gov]
                         

[Page 37428-37437]
 
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

_______________________________________________________________________


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Part VIII





Department of Health and Human Services





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Semiannual Regulatory Agenda

[[Page 37428]]




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 the semiannual publication of an inventory of all 
rulemaking actions under development or review by Federal departments 
and agencies. 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.

     When the Department publishes a regulatory proposal, 
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 
by clicking the Submit a Comment on the Regulation link on this 
site, which will open a blank comment form that includes 
instructions on how to submit the comment and what information must 
be provided for the comment to be considered. Comments submitted 
via www.regulations.gov are transmitted to the Department daily, 
and, as legally required, all comments are reviewed and taken into 
account if a final regulation is developed.

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 
reflects an effort to present 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. (Also included, in several Long-Term 
Action sections, are summaries of actions that we will probably not 
take any earlier than 12 months after publication of this agenda.) 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: June 9, 2004.

 Ann C. Agnew,

Executive Secretary to the Department.

                                  Office of the Secretary--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
813         Safe Harbor for Arrangements Involving Federally Qualified Health Centers.............    0991-AB06
814         Claims Collection.....................................................................    0991-AB18
815         Salary Offset.........................................................................    0991-AB19
816         Medicare and Federal Health Care Programs: Fraud and Abuse; Revisions to the Waiver       0991-AB33
            Provisions of the OIG's Exclusion Authorities.........................................
----------------------------------------------------------------------------------------------------------------


                                    Office of the Secretary--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
817         Shared Risk Exception to the Safe Harbor Provisions...................................    0991-AA91
818         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...............................................................................
819         Safe Harbor for Waiver of Beneficiary Coinsurance and Deductible Amounts for a            0991-AB16
            Medicare SELECT Policy................................................................
820         Clarification of Terms and Application of Program Exclusion Authority for Submitting      0991-AB23
            Claims Containing Excessive Charges...................................................
821         Technical Revisions to HIPDB Data Collection Activities...............................    0991-AB31
----------------------------------------------------------------------------------------------------------------


                                   Office of the Secretary--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
822         Revisions to Regulations Addressing the OIG's Authority to Impose Civil Money             0991-AB03
            Penalties and Assessments.............................................................
823         Health Insurance Portability and Accountability Act--Enforcement......................    0991-AB29
----------------------------------------------------------------------------------------------------------------


[[Page 37429]]


                                   Office of the Secretary--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
824         Tax Refund Offset.....................................................................    0991-AB17
825         Implementation of the Equal Access to Justice Act in Agency Proceedings...............    0991-AB22
826         OIG Civil Money Penalties Under the Medicare Prescription Drug Discount Card Program..    0991-AB30
----------------------------------------------------------------------------------------------------------------


                 Substance Abuse and Mental Health Services Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
827         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
----------------------------------------------------------------------------------------------------------------
828         Mandatory Guidelines for the Federal Workplace Drug Testing Program...................    0930-AA12
----------------------------------------------------------------------------------------------------------------


                  Substance Abuse and Mental Health Services Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
829         Substance Abuse and Mental Health Services Administration (SAMHSA) Charitable Choice..    0930-AA11
830         Mandatory Guidelines for Federal Workplace Drug Testing Programs; Specimen Validity       0930-AA13
            Testing...............................................................................
----------------------------------------------------------------------------------------------------------------


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


                          Centers for Disease Control and Prevention--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
832         Procedures for Designating Classes of Employees as Members of the Special Exposure        0920-AA07
            Cohort Under the Energy Employee Occupational Illness Compensation Act of 2000........
----------------------------------------------------------------------------------------------------------------


                                   Food and Drug Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
833         Safety Reporting Requirements for Human Drug and Biological Products..................    0910-AA97
834         Food Labeling; Prominence of Calories.................................................    0910-AF22
835         Food Labeling; Serving Sizes..........................................................    0910-AF23
836         Over-the-Counter (OTC) Drug Review--Sunscreen Products................................    0910-AF43
----------------------------------------------------------------------------------------------------------------


[[Page 37430]]


                                Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
837         Foreign and Domestic Establishment Registration and Listing Requirements for Drugs and    0910-AA49
            Biologics.............................................................................
838         Applications for FDA Approval To Market a New Drug; Complete Response Letter;             0910-AB34
            Amendments To Unapproved Applications.................................................
839         Prevention of Salmonella Enteritidis in Shell Eggs....................................    0910-AC14
840         Exception From General Requirements for Informed Consent; Request for Comments and        0910-AC25
            Information...........................................................................
841         Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure            0910-AC30
            Regulators for Use With Medical Oxygen................................................
842         Food Standards: General Principles and Food Standards Modernization...................    0910-AC54
843         Positron Emission Tomography Drugs; Current Good Manufacturing Practices..............    0910-AC55
844         Reporting Information Regarding Falsification of Data.................................    0910-AC59
845         Definition of ``Serious Adverse Health Consequences'' Under the Public Health Security    0910-AF06
            and Bioterrorism Preparedness and Response Act of 2002................................
846         Health Claims.........................................................................    0910-AF09
847         Quality Standard Regulation Establishing Allowable Level for Arsenic in Bottled Water.    0910-AF10
848         Content and Format of Labeling for Human Prescription Drugs and Biologics;                0910-AF11
            Requirements for Pregnancy and Lactation..............................................
849         Cochineal Extract and Carmine Label Declaration.......................................    0910-AF12
850         Charging for Investigational Drugs....................................................    0910-AF13
851         Treatment Use of Investigational Drugs................................................    0910-AF14
852         Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992;            0910-AF16
            Policies, Requirements, and Administrative Procedures; Derivatives of Blood...........
853         Use of Ozone-Depleting Substances: Removal of Essential Use Designation; Albuterol....    0910-AF18
854         Revocation of the Status of Specific Products; Group A Streptococcus..................    0910-AF20
855         Latex Condoms: Special Controls.......................................................    0910-AF21
856         Blood Initiative--Regulations for Human Blood and Blood Components Intended for           0910-AF25
            Transfusion or for Further Manufacturing Use..........................................
857         Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products..............    0910-AF32
858         Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) Products.................    0910-AF33
859         Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products..........    0910-AF34
860         Over-the-Counter (OTC) Drug Review--Internal Analgesic Products.......................    0910-AF36
861         Over-the-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use.......    0910-AF37
862         Over-the-Counter (OTC) Drug Review--Weight Control Products...........................    0910-AF45
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
863         Investigational New Drugs: Export Requirements for Unapproved New Drug Products.......    0910-AA61
864         Labeling for Human Prescription Drugs; Revised Format.................................    0910-AA94
865         Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based        0910-AB28
            Product Establishments; Inspection and Enforcement....................................
866         CGMP 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)..................................................................
867         Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary         0910-AB88
            Ingredients and Dietary Supplements...................................................
868         Additional Safeguards for Children in Clinical Investigations of FDA-Regulated            0910-AC07
            Products..............................................................................
869         Medical Devices; Patient Examination and Surgeons' Gloves; Adulteration...............    0910-AC32
870         Amendments to the Performance Standard for Diagnostic X-Ray Systems and Their Major       0910-AC34
            Components............................................................................
871         Establishment and Maintenance of Records Pursuant to the Public Health Security and       0910-AC39
            Bioterrorism Preparedness and Response Act of 2002....................................
872         Registration of Food and Animal Feed Facilities.......................................    0910-AC40
873         Prior Notice of Imported Food Under the Public Health Security and Bioterrorism           0910-AC41
            Preparedness and Response Act of 2002.................................................
874         Presubmission Conferences.............................................................    0910-AC44

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