[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

[[Page 9182]]

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.

[[Page 9183]]

    -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

[[Page 9184]]

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