96-5344. Guidance Documents; The Food and Drug Administration's Development and Use; Request for Comments  

  • [Federal Register Volume 61, Number 46 (Thursday, March 7, 1996)]
    [Notices]
    [Pages 9181-9185]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 96-5344]
    
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    Food and Drug Administration
    [Docket No. 95P-0110]
    
    
    Guidance Documents; The Food and Drug Administration's 
    Development and Use; Request for Comments
    
    AGENCY: Food and Drug Administration, HHS.
    
    ACTION: Notice; request for comments.
    
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    SUMMARY: The Food and Drug Administration (FDA) is requesting comment 
    on issues relating to the agency's development and use of guidance 
    documents. These issues were raised in a citizen petition submitted by 
    the Indiana Medical Devices Manufacturers Council, Inc. (IMDMC). (See 
    Docket No. 95P-0110). The petition requested that FDA control the 
    initiation, development, and issuance of guidance documents by written 
    procedures that assure the appropriate level of meaningful public 
    participation. In its response to the petition, FDA agreed that public 
    participation generally benefits the guidance document development 
    process. FDA also stated the importance of communicating more clearly 
    to its employees and to the public the nonbinding nature of guidance 
    documents. Therefore, FDA agreed to take steps to improve its guidance 
    document procedures. FDA is seeking an approach that addresses concerns 
    regarding adequate public participation but does not make it 
    impractical for the agency to continue making guidance available in a 
    timely fashion. Some suggestions for improving FDA's guidance document 
    procedures are set forth in this document. FDA is soliciting comment on 
    these suggestions and is soliciting additional recommendations for 
    improving its guidance document procedures. A public meeting on these 
    issues will be held at least 30 days before the end of the comment 
    period. The agency will announce the details of that meeting in a 
    future issue of the Federal Register.
    
    DATES: Written comments by June 5, 1996.
    ADDRESSES: 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: Margaret M. Dotzel, -Office of Policy 
    (HF-23), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
    20857, 301-827-3380.
    
    Supplementary Information:
    
    I. -FDA Guidance Documents
    
        -For purposes of this document, the term ``guidance documents'' 
    means: (1) Documents prepared for FDA review staff and applicants/
    sponsors relating to the processing, content, and evaluation/approval 
    of applications and relating to the design, production, manufacturing, 
    and testing of regulated products; and (2) documents prepared for FDA 
    personnel and/or the public that establish policies intended to achieve 
    consistency in the agency's regulatory approach and establish 
    inspection and enforcement procedures. Guidance documents do not 
    include agency reports, general information provided to consumers, 
    documents relating solely to internal FDA procedures, speeches, journal 
    articles and editorials, media interviews, warning letters, or other 
    communications or actions taken by
    
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    individuals at FDA or directed to individual persons or firms.
        -The purpose of FDA's guidance documents is to provide assistance 
    to the regulated industry by clarifying requirements that have been 
    imposed by Congress or promulgated by FDA and by explaining how 
    industry may comply with those statutory and regulatory requirements. 
    Guidance documents provide industry with the kind of specific detail 
    that often is not included in the relevant statutes and regulations. 
    Certain guidance documents provide information about what the agency 
    considers to be the important characteristics of preclinical and 
    clinical test procedures, manufacturing practices, and scientific 
    protocols. Others explain FDA's views on how one may comply with the 
    relevant statutes and regulations and how one may avoid enforcement 
    actions. Guidance documents do not themselves establish legally 
    enforceable rights or responsibilities. Rather, they explain how the 
    agency believes the statutes and regulations apply to industry 
    activities.
        -Guidance documents also are essential to the efficient 
    administration of FDA's duties. By providing specific review and 
    enforcement approaches, guidance documents help to ensure that FDA's 
    employees implement the agency's mandate in a fair and consistent 
    manner. Thus, when FDA staff are reviewing applications and petitions, 
    they will be looking for the same kinds of supporting evidence from all 
    submitters. Likewise, when field and headquarter enforcement personnel 
    are reviewing companies' activities, they will have guidance in 
    determining which activities comply with the law and which do not. This 
    benefits industry because it helps to ensure a level playing field.
        -As a general matter, guidance documents reduce uncertainty; their 
    absence would disadvantage the industry. Nevertheless, questions have 
    been raised about guidance document use and the process by which 
    guidance documents are developed and issued. Over the past several 
    months, the agency has been reviewing its development, dissemination, 
    and use of guidance documents to determine what steps it can take to 
    make these processes more transparent and consistent throughout the 
    agency. Representatives from FDA recently met with representatives from 
    the IMDMC to discuss ideas for ``good guidance practices.'' Suggestions 
    for good guidance practices are set forth below. FDA is seeking comment 
    on these suggestions and is seeking additional recommendations for good 
    guidance practices.
    
    A. -Nomenclature
    
        -Guidance documents currently are issued under a number of 
    different names (e.g., guidelines, guidance, points to consider, blue 
    book memos, compliance policy guides, etc.). Although a distinction can 
    be drawn between certain types of guidance (e.g., compliance policy 
    guides versus points to consider), there often is overlap in the types 
    of information contained in many such documents (e.g., guidance 
    memoranda and points to consider). The agency is seeking comment 
    regarding whether a more standardized nomenclature would improve the 
    public's understanding of the nature of guidance documents and would 
    help to eliminate any confusion regarding which documents are guidance 
    documents and their legal effect.
        -If a standardized nomenclature is desirable, then the agency would 
    like to hear suggestions regarding a logical classification system. For 
    example, is it appropriate to distinguish guidance based on how it is 
    used (e.g., in the product approval areas versus inspections) or who 
    are the intended users (e.g., FDA reviewers versus FDA inspectors 
    versus the industry)? Also, is there some way to use a subset of the 
    current names for all guidance documents?
        -If a standardized nomenclature is desired, then the agency also is 
    seeking public comment on the best approach to take regarding the 
    nomenclature for existing guidance documents, which currently are 
    identified under a range of names, including those discussed above. 
    There are major resource implications involved in undertaking a 
    complete renaming of existing guidance documents. Well over a thousand 
    such documents exist. The reprinting costs alone would be prohibitively 
    high. Moreover, because both the public and the agency have been using 
    these documents for some time, there may be confusion if names suddenly 
    are changed. One approach would be to gradually change the names of 
    existing guidance documents. FDA could revise the names of these 
    documents as they are substantively updated or revised. In the 
    meantime, FDA's lists of available guidance would identify existing 
    guidance documents by their current names but under the appropriate 
    category (i.e., the newly adopted nomenclature).
    
    B. -Effect of Guidance Documents
    
        A guidance document, though not intended to be a comprehensive 
    treatise, represents the agency's current thinking on a certain 
    subject. A guidance document is not binding on the agency or the 
    public. Such a document cannot itself be the basis for an enforcement 
    action; there must be a violation of a statute or regulation. 
    Similarly, a company affected by a guidance relating to premarket 
    applications may use a method other than that set forth in the guidance 
    if it can show that the alternate method satisfies the requirements of 
    the applicable statute(s) and regulation(s).
        -The agency explicitly states that guidance is not binding in many 
    of its guidance documents. Moreover, when FDA trains its employees, it 
    instructs them that guidance documents are not binding. Nevertheless, 
    some industry representatives say that industry feels bound by guidance 
    documents and that FDA employees have not always been clear about the 
    nature of such documents. Therefore, FDA plans to undertake a 
    communication effort that will focus both on the language in guidance 
    documents and on education of those who use and rely on guidance 
    documents. With respect to guidance document language, the agency will 
    take two steps. First, within each guidance document, FDA will 
    explicitly state the principle that guidance is not binding. The 
    language FDA has developed is:
        -Although this guidance document does not create or confer any 
    rights for or on any person and does not operate to bind FDA or the 
    public, it does represent the agency's current thinking on ----.
    Second, FDA will attempt to ensure that guidance documents use language 
    that clearly conveys their nonbinding nature. Guidance documents should 
    not use compulsory language such as ``shall'' and ``must,'' except when 
    referring to a statutory or regulatory requirement. The agency 
    currently reviews much of its newly issued guidance to ensure that it 
    includes language such as that proposed above and that it excludes 
    mandatory language. FDA plans to adopt internal procedures to ensure 
    that such a review reaches all guidance documents. If it is determined 
    that the agency should change the nomenclature of existing guidance, 
    the agency will make any appropriate language changes to such guidance 
    on the same schedule established for changing their titles. Otherwise, 
    FDA will make any such language changes when the documents are 
    substantively updated or revised. Regardless of when or whether 
    appropriate language changes are made, existing guidance has the same 
    nonbinding effect as newly issued guidance.
    
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        -FDA believes that the language changes discussed above will serve 
    to communicate the nonbinding nature of guidance. FDA also will develop 
    an internal ``good guidance practices'' document that explicitly 
    describes how the agency will use guidance. In addition, FDA will 
    develop materials that accurately describe the legal effect of guidance 
    to be used in internal FDA training programs. FDA believes that all of 
    the internal efforts also should work to educate the public. 
    Nevertheless, FDA would like to receive comments on additional ways to 
    educate the public regarding guidance documents and their legal 
    effect.\1\ 
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        \1\  In the Federal Register of October 15, 1992 (57 FR 47314), 
    FDA proposed to amend Secs. 10.85 and 10.90 (21 CFR 10.85 and 
    10.90), which address advisory opinions and guidelines, to delete 
    the provisions that obligate the agency to follow advisory opinions 
    and guidelines until they are amended or revoked (except in unusual 
    situations involving immediate and significant danger to health). As 
    set forth in the proposed rule, those provisions appear to be 
    inconsistent with the general principle that Federal agencies may 
    not be estopped from enforcing the law (see 57 FR 47314 at 47315). 
    Although FDA has not yet issued a final rule, the agency plans to 
    make final decisions on the 1992 proposal under that rulemaking.
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    C. -Development/Public Input
    
        -The IMDMC petition argued that FDA should institute greater 
    controls over the initiation, development, and issuance of guidance 
    documents to assure the appropriate level of meaningful public 
    participation. Although FDA recognizes the benefits of input from 
    industry, consumer groups, and scientific experts and it increasingly 
    solicits public input during guidance document development, FDA has not 
    always been consistent in these respects. Therefore, the agency wants 
    to implement consistent procedures for public input on its guidance 
    documents.
        -As part of its effort to increase public participation in the 
    guidance document process, FDA intends to develop an agency-wide 
    practice to ensure that all of FDA's Centers and Offices are soliciting 
    or accepting public input in connection with their guidance documents. 
    The level of public input should allow the public opportunity to 
    comment, but not be so extensive or prolonged that the burden and 
    inherent delay make it too difficult for the agency to issue timely 
    guidance. The IMDMC suggested that FDA adopt the Administrative 
    Conference Recommendation 76-5, Interpretive Rules of General 
    Applicability and Statements of General Policy (hereinafter referred to 
    as the Recommendation). It is the agency's current judgment that such 
    an approach is not practical.
        The Recommendation would require FDA to use notice-and-comment 
    rulemaking before promulgation of an ``interpretive rule of general 
    applicability or a statement of policy which is likely to have a 
    substantial impact on the public'' unless it makes a finding that it is 
    ``impracticable, unnecessary, or contrary to the public interest'' to 
    use such procedures (the Recommendation, para. 1). For other 
    interpretive rules or policy statements, FDA would be required to 
    invite the public to submit postpromulgation comments, unless such 
    procedures would serve no public interest or would be so burdensome as 
    to outweigh any foreseeable gain (the Recommendation, para. 2). FDA 
    would be required to respond to such comments within a prescribed 
    period of time.
        -The problems with this approach were articulated by FDA in the 
    Federal Register of April 4, 1991 (56 FR 13757 at 13758), in the 
    preamble to its final rule on amending Sec. 10.40 (21 CFR 10.40). The 
    substantial impact standard suggested by the Recommendation would 
    invite litigation over virtually every agency decision to issue such 
    rules (and statements) without engaging in informal rulemaking. 
    Moreover, the courts have largely rejected that standard for 
    determining whether a rule is subject to informal rulemaking. (See 
    e.g., American Hospital Ass'n. v. Bowen, 834 F.2d 1037 (D.C. Cir. 
    1987); Baylor University Medical Center v. Heckler, 758 F.2d 1052 (5th 
    Cir. 1985); Alcaraz v. Block, 746 F.2d 593 (9th Cir. 1984); Levesque v. 
    Block, 723 F.2d 175 (1st Cir. 1983).) As to the proposed 
    postpromulgation comment period, the approach suggested by the 
    Recommendation would severely limit the agency's discretion and could 
    require FDA to analyze and inevitably respond to comments on many 
    matters of limited public interest. The burden of such requirements 
    would exceed the benefits in most cases. Finally, FDA already has the 
    option of following notice-and-comment rulemaking even where it is not 
    required by the Administrative Procedure Act (Sec. 10.40(d)).
        -FDA must have flexibility as to what type of public input it 
    solicits in connection with the development of guidance. There are 
    certain documents that warrant greater or lesser input -- the amount of 
    public input should be tailored to the type of guidance document the 
    agency is issuing.
        -One option would be to adopt a three-tiered system with each tier 
    encompassing a different approach to public comment. For tier 1 
    documents, FDA would notify the public of its intent to issue a 
    guidance and solicit comment before issuing that guidance. In addition, 
    where appropriate (e.g., when complex scientific issues are raised), 
    FDA might also hold a public meeting or workshop to discuss the 
    guidance or could involve advisory committees in the development 
    process. For tier 2 documents, FDA would notify the public after it 
    issues the guidance and solicit comment at that time. For tier 3 
    documents, FDA would regularly notify the public of new guidance that 
    recently has been issued and would not specifically solicit comment, 
    but would accept comment. The approach to tier 3 documents is 
    consistent with the principle that FDA is receptive to comments on all 
    of its guidance documents--old and new-- at any time. Under current 
    practices, the public may comment on guidance using informal means 
    (e.g., letters or telephone calls) or using the more formal procedures 
    for petitioning or meeting and corresponding with FDA that are set 
    forth in part 10 (21 CFR part 10) of FDA's regulations (see 
    Secs. 10.25, 10.30, and 10.65).
        -Under the three-tiered approach, comments received on the first 
    two tiers of guidance documents would be submitted to a public docket 
    and be available for public review. Comments regarding the third tier 
    would be submitted directly to the Centers or Offices--either to a 
    person or an office that has been identified on the guidance document. 
    Regardless of the document tier, FDA would not be required to respond 
    to each comment but FDA would make changes to the guidance if any 
    comments convince the agency that such changes are appropriate.
        -Whether a guidance is placed into tier 1, 2, or 3 would depend on 
    a number of factors. FDA would like to receive comment on the types of 
    documents that the public believes should be placed into each of the 
    three categories. FDA anticipates that tier 1 guidance would be 
    guidance that represents a significant change, is novel or 
    controversial, or raises complex issues about which FDA would like to 
    have significant public input; tier 2 guidance would be guidance that 
    merely states FDA's current practices or does not represent a 
    significant or controversial change; tier 3 guidance would be guidance 
    directed largely to FDA's own staff and that has a limited effect on 
    the public.
        -The agency believes that an approach such as the three tiers 
    described here would allow it to make public input genuinely 
    meaningful. The agency does not want to make a commitment to extensive 
    public participation in the
    
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    development of large numbers of guidance documents and then find itself 
    unable to fulfill its promise. In other words, FDA does not want to be 
    in a position where it is unable to review comments or able only to 
    perform a cursory review of comments. FDA is soliciting comment on the 
    three-tiered approach. In addition to receiving comment on the types of 
    documents that the public believes should be placed into each of the 
    three tiers, FDA would like to hear whether the public believes that 
    access to comments (i.e., by placing them on the public docket) is an 
    important part of good guidance practices.
        -To make the three-tiered (or any other) approach to public 
    participation meaningful, FDA has to enable the public to know when new 
    guidance is available for comment. FDA would like to receive comment 
    regarding the best way to achieve this. The agency believes that is it 
    inefficient to issue a separate Federal Register document for each 
    guidance. Such an approach has profound resource implications and would 
    likely result in a backlog. FDA would like to receive comment on how or 
    if it should use the Federal Register. FDA also would like to receive 
    comment on alternate ways of notifying the public. For example, would 
    it be sufficient (or perhaps better) if FDA announced the availability 
    of new guidance on the World Wide Web/internet and/or in the trade 
    press? Are there circumstances when it would be more appropriate to 
    directly notify the interested public or trade associations by letter? 
    If the three-tiered system is adopted, notification of the public could 
    vary depending on the tier of the document at issue.
        -Thus far, this document has focused on the issue of soliciting 
    input on guidance that the agency has decided it should issue. Another 
    important part of public input relates to the public telling the agency 
    when it believes guidance is needed and what it believes the agency's 
    priorities should be in directing resources to guidance development. As 
    set forth in this document, the public currently has a number of 
    vehicles for making its views known. Interested persons can use the 
    regulatory procedures for petitioning or meeting and corresponding with 
    FDA (see Secs. 10.25, 10.30, and 10.65). Alternatively, interested 
    persons may simply write or call FDA to communicate the need for 
    guidance. FDA also could use the Federal Register to remind the public 
    that the agency is open to receiving ideas on new areas for guidance. 
    FDA would like to receive comments on appropriate procedures for 
    suggesting areas for guidance.
    
    D. -Dissemination/Availability to Public
    
        Currently, the public can obtain lists of certain guidance 
    documents from at least some of the Centers and Offices. As for the 
    actual documents, the Centers for Drug Evaluation and Research (CDER), 
    Biologics Evaluation and Research (CBER), and Devices and Radiological 
    Health (CDRH) have FAX information systems through which the public can 
    request copies of guidance documents to be sent by telecopy. CDRH also 
    maintains an electronic docket through which subscribers can access 
    their guidance documents. CBER is in the process of implementing a 
    similar program. The Center for Food Safety and Applied Nutrition 
    (CFSAN) and the Center for Veterinary Medicine (CVM) guidance documents 
    are available directly from those Centers. Some CFSAN guidance is 
    available on Prime Connection. CFSAN, CVM, CBER, and CDER are in the 
    process of making their guidance available on the World Wide Web. The 
    Office of Regulatory Affairs (ORA) makes its ``Guide to the inspection 
    of * * *'' series available via a dial-in PC. A large number of FDA 
    guidance documents are available through the National Technical 
    Information Service (NTIS) or from the Government Printing Office. 
    Finally, when new guidance is issued, the Centers and Offices often 
    publish notices in the Federal Register and/or mail copies of the 
    documents to the regulated industry, trade associations, and the 
    interested public.
        -FDA intends to ensure that all current guidance documents are 
    included on a list of guidance documents and that the public is aware 
    that the list or lists exist. One option is to make the list or lists 
    available electronically and on the established FAX information 
    systems. FDA also could annually publish a list of guidance documents 
    in the Federal Register. The electronic lists should be updated as new 
    documents are developed or old documents are revised, but FDA also 
    could update both the electronic and FAX systems at least quarterly.
         As for obtaining the actual documents, FDA is seeking comment on 
    the current systems that are in place (i.e., do the systems provide 
    adequate access to guidance documents?). Moreover, is it feasible to 
    rely principally on the FAX systems and electronic methods--such as the 
    World Wide Web/internet--or are hard copy dockets necessary?\2\  Even 
    without a hard copy docket, the public could request hard copies. 
    Nevertheless, FDA is concerned that significant reliance on electronic 
    methods could leave some parts of the public without adequate access.
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        \2\ In the Federal Register of July 27, 1993 (58 FR 40150), CDRH 
    implemented a 1-year pilot to test two methods of enhancing public 
    access to agency documents--including guidance documents. Two 
    dockets--a public (hard copy) docket and an electronic docket 
    (discussed herein)--were established. Throughout the year, CDRH 
    monitored the number of inquiries received on the two dockets. The 
    hard copy docket received 100 document requests, while the 
    electronic docket received 17,000 inquiries. In the Federal Register 
    of February 7, 1995 (60 FR 7204), CDRH terminated the public (hard 
    copy) docket because of its marginal utilization. The electronic 
    docket was continued. (The CDRH FAX system, which is another means 
    of obtaining hard copies of guidance documents, was not affected by 
    this pilot program.)
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        -Finally, IMDMC has stated that affected parties do not always 
    receive the most current version of guidance and that the public does 
    not know when guidance is out of date. FDA will take steps to ensure 
    that all guidance documents are dated and that superseded guidance is 
    removed both from the lists of guidance and from the access systems. 
    FDA also will explore ways of informing the public when existing 
    guidance becomes obsolete.
    
    E. -Appeals
    
        -An effective appeals process assures the public that there will be 
    full and fair reconsideration and review of how guidance is being 
    applied. Such a process further protects against guidance documents 
    being applied as binding requirements.
        Under the general provisions set forth in part 10 of its 
    regulations, FDA provides a number of vehicles that any person or firm 
    may use to seek an appeal of an agency employee's decision. Pursuant to 
    Sec. 10.75, an interested person may request internal agency review of 
    an agency decision made by anyone other than the Commissioner. Such 
    review ordinarily would be by the employee's supervisor, but may move 
    up the management chain to the Center Director or Commissioner's Office 
    if the issue cannot be resolved, important policy matters are present, 
    or it would be in the public interest. Sections 10.25 and 10.33 permit 
    an interested person to petition the Commissioner to review any 
    administrative action. This would permit a person or firm to petition 
    the agency regarding guidance documents. The regulations also include 
    less formal methods of appeal. For example, pursuant to Sec. 10.65, an 
    interested person may correspond or meet with FDA
    
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    about any matter under FDA's jurisdiction.
        In addition, there are specific provisions and procedures that 
    apply to or are used by the Centers. For example, FDA's new drug 
    regulations provide procedures for dispute resolution regarding new 
    drug applications. These procedures include informal meetings with the 
    division reviewing the application, meetings with an ombudsman, and 
    referrals to advisory committees (see Sec. 314.103 (21 CFR 314.103)). 
    The new drug regulations also provide the sponsor an opportunity for a 
    hearing on the question of whether there are grounds for denying 
    approval of the application (see Sec. 314.110 (21 CFR 314.110)). CBER's 
    review letters (``approvable'' and ``not approvable'') state the 
    sponsor's options for appeal. Specifically, CBER's ``not approvable'' 
    letter informs the sponsor that it may request a meeting with CBER to 
    discuss the steps needed for approval or may request an opportunity for 
    a hearing.
        Finally, persons with concerns about the application of guidance 
    documents may contact the FDA Office of the Chief Mediator and 
    Ombudsman (the Ombudsman's Office). The Ombudsman's Office, which 
    reports directly to the Commissioner, works on resolving issues and 
    conflicts that arise in any FDA component. The Ombudsman's staff is 
    available to discuss options, explain FDA's practices and procedures, 
    and suggest approaches for resolution. When appropriate, the staff of 
    the Ombudsman's Office may contact the FDA staff involved in the issue 
    and mediate a dispute.
        As the above discussion indicates, FDA already has a significant 
    number of appeals mechanisms--all of which can be used by persons 
    dissatisfied with how guidance is being applied. The agency recently 
    established a working group to address the consistency and adequacy of 
    dispute resolution processes across the agency and the effectiveness of 
    education regarding the availability of such processes to industry. FDA 
    is soliciting comment on whether the public is sufficiently aware of 
    the appeals mechanisms that are in place and whether the public 
    believes that the mechanisms are sufficient for appealing decisions 
    relating to guidance documents. If the answer is that the mechanisms in 
    place are not sufficient, FDA would like to hear why they are not and 
    would like to receive suggestions on alternate methods or ways to 
    improve our current procedures.
    
    II. Summary of Issues for Comment
    
        Sections I. A. through I. E. of this document set forth a number of 
    issues about which the agency would like to receive public comment. A 
    summary of those issues is set forth below:
        (1)   FDA is soliciting comment on the value of a standardized 
    nomenclature for guidance documents. If a standardized nomenclature is 
    desirable, FDA is soliciting comment on what that nomenclature should 
    be and the best approach to take regarding the nomenclature of existing 
    guidance.
        (2)   FDA is soliciting comment on how best to communicate to its 
    own staff and to the public the principle that guidance is not binding.
        (3)  FDA is soliciting comment on the proposed three-tiered 
    approach to public input (including comment on how to classify 
    documents as tier 1, 2, or 3) and/or suggestions for alternatives to 
    the three-tiered approach. FDA also wants to hear whether public access 
    to comments should be included as a part of good guidance practices. 
    Finally, FDA is soliciting comment regarding how FDA should notify the 
    public of new guidance and how the public can notify FDA of the need 
    for guidance.
        (4) -FDA is soliciting comment on the adequacy of its current 
    guidance document access programs and suggestions for improving access 
    to guidance documents.
        (5)   FDA is soliciting comment on whether the public is 
    sufficiently aware of current appeals mechanisms and whether the 
    mechanisms are sufficient for appealing decisions relating to guidance 
    documents. If the current processes are not sufficient, FDA would like 
    to hear why they are not and would like to receive suggestions on 
    alternate methods or ways to improve the current procedures.
        Interested persons may, on or before June 5, 1996, submit to the 
    Dockets Management Branch (address above) written comments regarding 
    this document. 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.
    
        Dated: February 29, 1996.
    William B. Schultz,
    Deputy Commissioner for Policy.
    [FR Doc. 96-5344 Filed 3-6-96; 8:45 am]
    BILLING CODE 4160-01-F
    
    

Document Information

Published:
03/07/1996
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice; request for comments.
Document Number:
96-5344
Dates:
Written comments by June 5, 1996.
Pages:
9181-9185 (5 pages)
Docket Numbers:
Docket No. 95P-0110
PDF File:
96-5344.pdf