[Federal Register Volume 61, Number 108 (Tuesday, June 4, 1996)]
[Proposed Rules]
[Pages 28116-28118]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-13980]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 2, 3, 5, 10, 12, 20, 56, and 58

[Docket No. 96N-0163]
RIN 0910-AA69


Reinvention of Administrative Procedures Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: The Food and Drug Administration (FDA) is considering ways to 
further streamline its administrative procedures regulations as a 
result of a page-by-page review of the agency's regulations. This 
regulatory review is part of the administration's ``Reinventing 
Government'' initiative that seeks to streamline Government and to ease 
the burden on regulated industry and consumers. FDA is seeking public 
comment on ways to streamline its administrative procedures 
regulations.

DATES: Written comments by September 3, 1996.


[[Page 28117]]


ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:
    Regarding information concerning the regulations: Philip L. Chao, 
Policy Development and Coordination Staff (HF-23), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3380.
    Regarding general information on FDA's ``reinventing initiative'': 
Lisa M. Helmanis, Regulations Policy Management Staff (HF-26), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-
3480.

SUPPLEMENTARY INFORMATION: On March 4, 1995, President Clinton 
announced plans for reforming the Federal regulatory system as part of 
his ``Reinventing Government'' initiative. In his March 4, 1995, 
directive, the President ordered all Federal agencies to conduct a 
page-by-page review of their regulations and to ``eliminate or revise 
those that are outdated or otherwise in need of reform.'' This notice 
represents FDA's continuing effort to implement the President's plan. 
In previous issues of the Federal Register, FDA proposed revoking or 
revising other regulations; the agency expects to issue additional 
reinvention proposals in the future.
    In this notice, FDA is seeking comments on ways listed in the table 
below in which its administrative regulations could be updated or 
revised in order to streamline the agency's administrative practices 
and procedures.
    The following table contains a section-by-section analysis of the 
regulations that FDA is considering ``reinventing.'' These regulations 
are listed numerically as they appear in the Code of Federal 
Regulations (CFR).

     Section-by-Section Analysis of Regulations Under Consideration     
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                                  Description or                        
          21 CFR Cite                Title of          Explanation of   
                                    Regulation          Reinvention     
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Sec.  1.3.....................  Defines label and  Should the           
                                 labeling.          definitions be      
                                                    amended? There are  
                                                    only two definitions
                                                    (label and labeling)
                                                    involved, but they  
                                                    could be updated to 
                                                    be more consistent  
                                                    with current        
                                                    statutory language. 
Sec.  1.21....................  Describes what     This section provides
                                 constitutes a      general information 
                                 failure to         on failures to      
                                 reveal a           reveal material     
                                 material fact.     facts. Should this  
                                                    section be revised, 
                                                    expanded, or        
                                                    removed?            
Sec.  1.23....................  Describes          This provision could 
                                 procedures for     be rewritten to     
                                 requesting a       remove extraneous   
                                 variance or        material and to     
                                 exemption from     provide better      
                                 required label     instructions on     
                                 statements.        procedures for a    
                                                    variance or         
                                                    exemption.          
Sec.  1.24....................  Lists granted      Because much of the  
                                 label exemptions   text is devoted to  
                                 for foods,         foods, the provision
                                 animal drugs,      could be relocated  
                                 and cosmetics.     to that part of the 
                                                    CFR devoted to      
                                                    foods. Similar moves
                                                    could be made for   
                                                    the paragraphs on   
                                                    animal drugs and    
                                                    cosmetics. Would it 
                                                    be more useful to   
                                                    move these          
                                                    provisions to the   
                                                    corresponding       
                                                    subject areas?      
Sec.  1.90....................  Notice of          This section explains
                                 sampling.          the procedures for  
                                                    notification of     
                                                    sampling of imports.
                                                    Should this section 
                                                    be consolidated with
                                                    Sec.  1.91?         
Sec.  1.91....................  Payment for        This section provides
                                 samples.           that FDA will pay   
                                                    for import samples  
                                                    of nonviolative     
                                                    goods.              
Sec.  2.125...................  Establishes        Should this provision
                                 procedures to      be modified to      
                                 permit the use     reflect current     
                                 of                 requirements under  
                                 chlorofluorocarb   the Clean Air Act   
                                 ons (CFC's) in     and to correspond   
                                 self-pressurized   with the            
                                 containers.        Environmental       
                                                    Protection Agency   
                                                    regulations on CFC  
                                                    use and warning     
                                                    labels?             
Sec.  3.6.....................  States who the     This section should  
                                 product            be amended to       
                                 jurisdiction       reflect the current 
                                 officer is.        information.        
Part 5........................  Delegations of     Some of the          
                                 authority.         delegations of      
                                                    authority refer to  
                                                    offices or titles   
                                                    that no longer exist
                                                    or have changed due 
                                                    to reorganizations. 
                                                    This part should be 
                                                    revised to reflect  
                                                    the most current    
                                                    information. Does it
                                                    remain useful to    
                                                    codify these        
                                                    delegations of      
                                                    authority?          
Part 10 subparts A and B......  Administrative     These regulations    
                                 practices and      govern the practices
                                 procedures.        and procedures for  
                                                    petitions, hearings,
                                                    and other           
                                                    administrative      
                                                    proceedings and     
                                                    activities conducted
                                                    by FDA. Some        
                                                    sections should be  
                                                    revised to provide  
                                                    more flexibility or 
                                                    efficiency. For     
                                                    example, could FDA's
                                                    citizen petitions   
                                                    process be made more
                                                    efficient?          
Part 12.......................  Formal             Should FDA's         
                                 evidentiary        regulations         
                                 public hearing.    governing formal    
                                                    hearings be         
                                                    simplified or       
                                                    clarified?          
Part 20.......................  Public             This part governs    
                                 information.       FDA's communication 
                                                    with the public.    
                                                    Does this part      
                                                    continue to reflect 
                                                    the best way for FDA
                                                    to handle public    
                                                    information? Are    
                                                    there better, more  
                                                    efficient approaches
                                                    that should be      
                                                    embodied in FDA's   
                                                    regulations?        
Sec.  56.104..................  Describes          The first two exempt 
                                 exemptions from    classes are probably
                                 institutional      inapplicable today  
                                 review boards      because they refer  
                                 requirements.      to clinical research
                                                    begun before July   
                                                    27, 1981. Should    
                                                    this section be     
                                                    amended by removing 
                                                    paragraphs (a) and  
                                                    (b)?                
Part 58.......................  Good laboratory    This part describes  
                                 practice           fundamental         
                                 regulations.       principles for      
                                                    laboratories to     
                                                    observe and are     
                                                    intended to ensure  
                                                    the quality and     
                                                    integrity of safety 
                                                    data. Updating to   
                                                    reflect current     
                                                    technology (such as 
                                                    greater use of      
                                                    computers) may be   
                                                    needed.             
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    Interested persons may, on or before, September 3, 1996, submit to 
the Dockets Management Branch (address above) written comments 
regarding this advance notice of proposed rulemaking (ANPRM). Two 
copies of any comments are to be submitted, except that individuals may 
submit one copy. Comments are to be identified with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the office above between 9 a.m. and 4 p.m., Monday 
through Friday.

[[Page 28118]]

    This ANPRM is issued under section 301 et seq. of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and under the authority 
of the Commissioner of Food and Drugs.

    Dated: May 28, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-13980 Filed 6-3-96; 8:45 am]
BILLING CODE 4160-01-F