[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.)
---------------------------------------------------------------------------
-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
[[Page 9185]]
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