[Federal Register Volume 62, Number 39 (Thursday, February 27, 1997)]
[Notices]
[Pages 8961-8972]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4852]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95P-0110]
The Food and Drug Administration's Development, Issuance, and Use
of Guidance Documents
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is publishing a
document entitled ``Good Guidance Practices'' (GGP's), which sets forth
the agency's policies and procedures for the development, issuance, and
use of guidance documents. Issues relating to FDA's development and
issuance of guidance documents were raised in a citizen petition
submitted by the Indiana Medical Devices Manufacturers Council, Inc.
(IMDMC) (see Docket No. 95P-0110). In an effort to improve its guidance
document procedures, FDA has adopted the GGP's described and included
in this notice.
DATES: Although the agency already has begun to follow the procedures
set forth in the GGP's, the GGP's will not be fully implemented until
FDA's proposal to amend its regulations in part 10 (21 CFR part 10) to
clarify that advisory opinions and guidelines do not bind the agency
(57 FR 47314, October 15, 1992) is finalized and in effect.
FOR FURTHER INFORMATION CONTACT: Margaret M. Dotzel, Office of Policy
(HF-22), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-3360.
SUPPLEMENTARY INFORMATION: The IMDMC 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 response to the petition, FDA agreed to take
steps to improve the agency's guidance document procedures. In the
Federal Register of March 7, 1996 (61 FR 9181), FDA published a notice,
which set forth its proposal on how best to improve its guidance
document procedures and solicited comment on these and additional ideas
for improvement (the March 7 Notice). On April 26, 1996, the agency
held a public meeting to further discuss these issues (the April 26
public meeting). The comment period for the March 7 Notice closed on
June 5, 1996. This notice: (1) Sets forth the agency's position on how
it will proceed in the future with respect to guidance document
development, issuance, and use; and (2) includes the agency's GGP's,
which set forth the agency's policies and procedures for developing,
issuing, and using guidance documents.
I. Definition of Guidance
In the March 7 Notice, FDA provided the following definition for
guidance documents:
[T]he 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 to solely internal FDA procedures, speeches,
journal articles and editorials, media interviews, warning letters,
or other communications or actions taken by individuals at FDA or
directed to individual persons or firms.
A number of the comments submitted in response to the March 7
Notice suggested alternative definitions for ``guidance document.'' One
comment suggested that the term include all internal documents intended
to direct activities of FDA staff. Another suggested that a guidance
document be defined as any document or other communication that in
effect announces a regulatory expectation to a broad audience. And yet
another suggested that a guidance document be defined as any statement
that may substantively impact a regulatory evaluation or determination.
Documents relating to internal procedures, warning letters,
information directed at individuals or individual firms, and speeches,
journal articles, editorials, media interviews, press materials, agency
reports, and general information documents provided to consumers are
not guidance documents. FDA disagrees with suggestions for a definition
of guidance documents that would effectively broaden the scope of the
term ``guidance document'' to include such documents. Definitions such
as ``any document that announces a regulatory expectation,'' ``any
statement that may substantively impact a regulatory evaluation or
determination,'' or ``any agency-issued writing that establishes
methods of compliance'' would include some or all of these excluded
documents. A definition such as ``all internal documents that direct
activities of FDA staff'' would include all documents relating to
internal FDA procedures, even if they have no bearing on the regulated
industry. Accordingly, FDA is rejecting these suggestions.
In the GGP document, attached to this notice, the agency is using
the same basic definition as set forth in the March 7 Notice, with
minor revisions to clarify what is and is not in the universe of
guidance documents. It provides:
The term ``guidance documents'' includes documents prepared for
FDA staff, applicants/sponsors, and the public that (1) relate to
the processing, content, and evaluation/approval of submissions; (2)
relate to the design, production, manufacturing, and testing of
regulated products; (3) describe the agency's policy and regulatory
approach to an issue; or (4) establish inspection and enforcement
policies and procedures. ``Guidance documents'' do not include
documents relating to internal FDA procedures, agency reports,
general information documents provided to consumers, speeches,
journal articles and editorials, media interviews, press materials,
warning letters, or other communications directed to individual
persons or firms.
Despite the agency's reluctance to broaden the definition of
guidance, the agency is sensitive to the concern expressed during the
April 26 public meeting and in the comments that too narrow a
definition might permit agency employees to use documents or
communications such as speeches, editorials, or journal articles to
announce regulatory expectations without following the GGP's discussed
herein. Although FDA employees should be able to respond to questions
about how an established policy applies
[[Page 8962]]
to a specific situation or to questions about areas that lack
established policy, the agency should not use these other means of
communication to release guidance. The GGP's explicitly state that when
the agency is first communicating new or different regulatory
expectations not readily apparent from the applicable statute or
regulations to a broad public audience, the GGP's and officially-
designated guidance document procedures should be followed. As part of
the agency's effort to monitor the use of guidance documents (see
section III. of this document), the agency will spot check its staff to
ensure that ``unofficial'' guidance documents or other means (such as
speeches) are not being used to first transmit to a broad public
audience new or different regulatory expectations that are not readily
apparent from the applicable statute or regulations.
II. Nomenclature
In the March 7 Notice, FDA suggested that a standardized
nomenclature for guidance might help the public better understand the
nature and legal effect of guidance documents and might help to
eliminate any confusion regarding which documents are guidance. Both
the discussion at the April 26 public meeting and comments submitted to
the docket indicated overwhelming support for a standardized
nomenclature for guidance documents. Nevertheless, some comments
cautioned the agency not to elevate form over substance. Moreover,
there was no real consensus on what the standardized nomenclature
should be.
Some comments suggested that the nomenclature be based on the
intended use of the guidance, (e.g., compliance guidance versus 510(k)
review guidance); others suggested that it be based on the intended
user (e.g., guidance for industry versus guidance for reviewers). A
number of comments suggested that FDA differentiate guidance documents
on the basis of their type or function (e.g., educational,
interpretive, and descriptive or premarket review, compliance/
enforcement, and educational). Some comments even suggested that the
distinction be drawn on the basis of what procedure is used to develop
the guidance.
Specific suggestions included calling all guidance either
``guidance documents'' or ``compliance policy guides'' or calling all
guidance either ``guidelines'' or ``recommendations.'' A number of
comments suggested using an umbrella term (such as guidance or
guideline) together with additional identifying information, such as
the Center producing the document, the intended users, and the
industrial, regulatory, or professional activities to which the
document applies.
After considering these comments and the universe of guidance
documents, the agency has decided that all guidance documents should
include the following: (1) The umbrella term ``guidance;'' (2)
information that identifies the Center or Office producing the
document; and (3) the regulatory activity to which the document applies
and/or the intended users of the document. The agency anticipates that,
in practice, the majority of guidance documents will be called
``compliance guidance,'' ``guidance for industry,'' or ``guidance for
FDA reviewers/staff.'' The agency believes that this approach
incorporates a number of the suggestions made during the April 26
public meeting and in the comments and ensures that guidance document
nomenclature is uniform and informative (i.e., by identifying the
producing Center or Office and the regulatory activity to which and/or
the persons to whom the document applies).
One comment suggested that, as an additional means of ensuring
uniformity and clarity, FDA should use a consistent format with headed
paper for all guidance documents. Given the diversity of guidance
documents and the subjects that they address, the agency believes that
it would be difficult to use a consistent format. The agency believes,
however, that the benefit that might be achieved from a consistent
format could be achieved, more easily, by using a standardized cover
sheet for all guidance. Therefore, the GGP's include a standardized
cover sheet that should be used as a model for all future guidance
documents.
Existing Guidance. In response to the agency's request for comment
on what to do with existing guidance documents if a standardized
nomenclature is adopted, most comments suggested that FDA update the
nomenclature as documents are revised. In the meantime, it was
suggested that the agency create an interim method of cross-referencing
the older documents with the new nomenclature. One comment suggested
that the agency agree to undertake the review and revision of all
existing guidance within some specified period of time. Specifically,
the comment suggested a ``managed review'' approach pursuant to which
the agency would set progressive goals, with a defined percentage of
the documents to be reviewed for nomenclature changes within a
specified period of time (e.g., 25 percent per year for 4 years).
FDA agrees with the majority of comments, which suggested that the
best approach would be to update the nomenclature of existing guidance
documents as they are revised. In the meantime, when the agency
publishes its comprehensive list of guidance (see section V. of this
document), it will list guidance documents under the issuing Center or
Office and, where possible, will separate guidance documents by their
intended users and/or the regulatory activities to which they apply.
The agency will not undertake a ``managed review'' of all existing
guidance documents pursuant to which the agency would review a defined
percentage of documents for nomenclature changes within a specified
period of time. While the agency agrees that guidance documents should
be reviewed and updated as appropriate, the agency does not agree that
the expenditure of resources for what may be mere name changes is
warranted, particularly when those resources could be applied more
productively to the development of new guidance documents. Over the
past year, the Centers and Offices have been taking stock of their
guidance documents and have been identifying obsolete guidance
documents as well as those needing updates or revisions. Moreover, as
set forth in section IV. of this document, the agency is providing the
public an opportunity to identify guidance documents that need to be
reviewed/updated. Thus, the agency believes that it is taking steps to
ensure that any necessary updates and revisions to guidance documents
will be made.
III. Effect of Guidance Documents
The March 7 Notice described the legal effect of guidance
documents. Specifically, it stated that a guidance document is not
binding on the agency or the public; rather, it represents the agency's
current thinking on a certain subject. Most of the participants at the
April 26 public meeting and the comments to the March 7 Notice agreed
that guidance documents should not be binding. There was significant
support for including a statement of the nonbinding effect of guidance
on each guidance document and for education (particularly of FDA
employees) regarding the legal effect of guidance. A number of comments
suggested that the agency monitor FDA employees to ensure that they are
not applying guidance as binding.
Nonbinding effect of guidance. Although most comments agreed with
the agency's position that guidance should not be binding on the
public, a
[[Page 8963]]
number did argue that FDA should be required to follow its own guidance
(i.e., should not be able to require more than is stated in guidance
documents). One comment argued that FDA's position about the nonbinding
nature of guidance is inconsistent with its own part 10 regulations.
The only binding requirements are those set forth in the statute
and FDA's regulations. Under the Administrative Procedure Act
(Sec. l0.40(d)), in order to bind the public, FDA must (with limited
exceptions) follow the notice and comment rulemaking process. Moreover,
the principle that guidance documents are binding on FDA is
inconsistent with Community Nutrition Institute v. Young, 818 F.2d 943
(D.C. Cir. 1987), which calls into question FDA's procedures for
issuing advisory opinions and guidelines that purport to bind the
agency and thereby constrain the agency's discretion. In fact,
consistent with the D.C. Circuit's decision in CNI, FDA proposed to
revise its part 10 regulations to clarify that advisory opinions and
guidelines do not bind the agency (57 FR 47314). The agency expects to
publish that final rule shortly.\1\ The GGP's will not be fully
implemented until that final rule is in effect.
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\1\ One comment asked FDA to retain Sec. 10.45(d) (21 CFR
10.45(d)) and establish that the agency regards guidance documents
as final agency action. FDA believes that this issue is more
appropriately addressed in the final rule pertaining to the
revisions to the part 10 regulations.
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Although guidance documents cannot legally bind FDA or the public,
the agency recognizes the value of guidance documents in providing
consistency and predictability. A company wants assurance that if it
chooses to follow a guidance document, FDA generally will find it to be
in compliance with the statute and regulations. Moreover, FDA issues
guidance to its staff so that they will apply the statute and
regulations in a consistent manner. With these principles in mind,
FDA's decisionmakers will take steps to ensure that their staff do not
deviate from guidance documents without appropriate justification and
without first obtaining concurrence from a supervisor. This practice
will provide assurance to companies that choose to follow a guidance,
yet will not legally bind the agency or its decisionmakers to a
guidance document.
The statement of nonbinding effect. In the March 7, 1996 Federal
Register Notice, FDA proposed to include language such as the following
in each guidance document:
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 * * *.
A number of comments suggested changes to the proposed statement.
Some of the recommended changes reflect the comments' position that
guidance is binding. Others apparently seek to clarify that approaches
other than those set forth in the guidance are permitted if the
applicable statutory or regulatory requirements are met. Finally, a
number of the comments opined that the statement alone would not ensure
the public a real opportunity to rely on alternate methods to comply
with the statute and regulations.
As set forth above, FDA disagrees with the concept that guidance
documents are binding. In response to the comments regarding
flexibility in complying the statute and regulations, FDA is changing
the statement to read:
This guidance document represents the agency's current thinking
on * * *. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statute, regulations, or both.
In addition, as part of GGP's, the agency is providing an opportunity
for discussion regarding alternate methods of complying with the
applicable statute and regulations.
Absence of Mandatory Language. Because guidance documents are not
binding, the GGP's provide that mandatory words such as ``shall,''
``must,'' ``require'' and ``requirement'' should not be used unless
they are being used to describe or discuss a statutory or regulatory
requirement. The GGP's further provide that, prior to issuance, all new
guidance documents should be reviewed to ensure that mandatory language
has not been used.
Education. In the March 7 Notice, FDA recognized the importance of
educating both agency employees and the public regarding the nonbinding
nature of guidance. Comments to the March 7 Notice agreed that
education is an important step in assuring that guidance is not applied
as a binding requirement. The comments suggested that FDA's GGP's
include a section that describes the legal effect of guidance.
As part of its GGP's, FDA will provide all current and new FDA
employees involved in the development, issuance, or application of
guidance documents a copy of the GGP's, which include a section that
describes the legal effect of guidance. FDA will direct these employees
to review the GGP's and will provide additional training that
describes, in more detail, how to develop and use guidance documents.
For purposes of educating the public, the comments suggested
education through mailings and public service announcements in trade
journals and newsletters. FDA agrees that it is important to take
advantage of opportunities to educate the public about the legal effect
of guidance. The GGP's and the statement of the nonbinding effect of
guidance that will be included in all future guidance documents and on
the list of guidance documents (see section V. of this document) should
help to educate the public about the legal effect of guidance. In
addition, as part of the GGP's, FDA is encouraging its employees to
state and explain the effect of guidance when speaking in public about
guidance documents. The agency believes that public education efforts
will be most effective if targeted to specific discussions of guidance
documents.
Monitoring. A number of the participants at the April 26 public
meeting and a number of the comments to the March 7 Notice suggested
that FDA monitor and evaluate the agency's performance in not applying
guidance as binding. The agency agrees that it is important to monitor
the agency's use of guidance. Therefore, as a part of GGP's, the
Centers and Offices will monitor the development and issuance of
guidance documents to ensure that GGP's are being followed. In
addition, they will spot-check the use of guidance documents to ensure
that they are not being applied as binding requirements and the use of
documents and communications that are not defined as guidance, such as
warning letters and speeches, to ensure that they are not being used to
initially express new regulatory expectations to a broad public
audience.
Three years after the GGP's have been implemented, the agency will
convene a working group to review whether they have improved the
agency's development and use of guidance documents. The working group
will determine whether the GGP's are ensuring: (1) Appropriate public
participation in the development of guidance, (2) that guidance
documents are readily available to the public, and (3) that guidance
documents are not being applied as binding requirements. The working
group will review the results of the Center and Office monitoring
efforts as well as the number and results of appeals relating to
guidance documents.
IV. Development/Public Input
In the March 7 Notice, FDA committed to implementing an agency-wide
practice of soliciting or accepting
[[Page 8964]]
public input in connection with the development of guidance documents.
FDA sought comment on a proposed three-tiered system, which encompassed
a different approach to public comment for each of the three tiers. For
the proposed 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 the proposed Tier 2 documents, FDA would
notify the public after it issues the guidance and solicit comment at
that time. For the proposed 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.
FDA suggested that whether a guidance would be in Tier 1, 2, or 3
would depend on a number of factors. For example, Tier 1 guidance might
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 might be guidance that
merely states FDA's current practices or does not represent a
significant or controversial change; Tier 3 guidance might be guidance
directed largely to FDA's own staff and that has a limited effect on
the public.
In the March 7 Notice, the agency opined that an approach such as
the three-tiered one would allow it to make public input genuinely
meaningful. The agency did not (and does not) want to make a commitment
to extensive public participation in the development of large numbers
of guidance documents and then find itself unable to issue needed
guidance promptly.
Most of the speakers at the April 26 public meeting and many of the
comments to the March 7 Notice did not support the agency's proposed
three-tiered approach. The major criticisms were that it is too
complicated, would not provide sufficient public participation, and
would not sufficiently focus on public participation before a decision
to issue guidance is made and before a proposed guidance is drafted.
Some comments suggested changes to the tiers; others suggested
completely different approaches.
Specific Criticism of the Proposed Three-Tiered Approach. A number
of the comments on the March 7 Notice opined that FDA's proposed three-
tiered approach would be too complex. Many thought that the proposed
approach would make the classification itself a separate burden on the
agency. Moreover, some thought that the agency's determination of
``significance'' would be problematic. For example, what might appear
insignificant to the agency could be significant to the public.
Many of the comments stated that the three-tiered approach would
not provide adequate public participation--particularly with respect to
Tier 3. In addition, a number of comments criticized FDA's approach for
focusing too much on revision of guidance that has already been
drafted. These comments noted the importance of allowing participation
at the earliest stages of the development process.
One comment opined that because guidance documents are used to
explain interpretations of existing requirements, there is no need for
an opportunity to comment. Rather, users should be encouraged to
provide informal feedback at any time. If all of the public's comments
are negative, FDA should consider rewriting the guidance.
Finally, one comment noted that FDA should not use the term
``tier'' because it will lead to confusion with the current ``tier''
system for device section 510(k) submissions.
Suggested Alternatives to the Three-Tiered Approach. Many of the
comments agreed with a tiered approach, but suggested different ways of
deciding which documents fall into each tier. A number suggested
distinguishing between ``educational documents,'' ``interpretive
documents,'' and ``descriptive documents.'' Some suggested
distinguishing between ``significant public interest documents,''
``general public interest documents,'' and ``FDA interest only
documents.'' Others suggested looking at whether the documents: (1)
Represent a significant change in policy, a complex issue, or are new
and have wide applicability; (2) involve no significant or
controversial changes; or (3) affect only FDA staff and have no effect
on the public. A number of comments thought it important for FDA to
look at the impact the guidance document has on the industry.
A comparable number of comments disagreed with a tiered approach.
For example, one comment suggested that any agency statement having the
potential for compliance or enforcement consequences must be subject to
notice and comment rulemaking. Product specific guidance (e.g.,
bioequivalence protocols or biopharmaceutical guidance) alone could be
excepted, provided the guidance is binding on FDA and industry unless a
clearly demonstrated public health safety issue arises.
Some comments suggested that all guidance be available for comment
before issuance through publication in the Federal Register (although
an abbreviated procedure could be employed). Under this approach, a
reasonable amount of time, at least 60 days, would be allowed for
submission of comments.
One comment suggested that advanced public comment always be
required except when it would not be in the public interest to wait for
advanced public comment. The latter guidance documents would undergo
comment after issuance.
Several comments recommended that the agency try processes other
than soliciting comment from the public after a guidance document has
been drafted. For example, some suggested that the agency employ a
negotiated guidance development process, patterned after negotiated
rulemaking. Another comment recommended creation of an internal task
force to evaluate the agency's management procedures for ensuring
consistency in the application of statutes and regulations, identifying
interpretations of how to apply the statutes and regulations, and
determining when the interpretations should be formed into guidance
documents. Another recommended creation of a joint agency-industry
committee to coordinate the development, promulgation, issuance, and
overall management of guidance documents.
At least one comment suggested that FDA experiment with different
models to determine how best to solicit public input in the long run.
In response to the agency's request for comment on how to treat the
comments that are submitted for guidance documents, some suggested that
all comments be available for public review; others said that it is
inappropriate for the general public to have access to comments by
named individuals regarding certain issues. Several comments indicated
that comments need not be in the public docket. Rather, it would be
sufficient to have them sent to the Center or Office issuing the
guidance. Most of the comments agreed that it was important that the
agency commit that all comments received will be considered, and not
just filed.
FDA's Approach. FDA disagrees with many of the suggested
alternatives because they fail to recognize that the agency does not
have unlimited resources to dedicate to the development of guidance
documents.
[[Page 8965]]
As set forth in the March 7 Notice, if FDA commits to a development
process that is akin to rulemaking, it will not be able to issue many
guidance documents. Moreover, what guidance documents could be issued,
could not be issued promptly.
FDA disagrees with other suggested alternatives because they appear
to be even more complex than FDA's proposed three-tiered approach. For
example, under one approach FDA would have to determine whether a
document is ``educational,'' ``interpretive,'' or ``descriptive''
before deciding what type of public participation should go into the
development process. There is overlap between these different types of
guidance documents and would likely be disagreement over the
appropriate categorization of a guidance document. Under another
suggested approach, FDA would have to look at whether a guidance is of
``significant public interest,'' ``general public interest,'' or ``FDA
only interest.'' The latter would require very subjective
determinations. Moreover, it is doubtful that many guidance documents
would fall outside of the category of ``significant public interest.''
Nevertheless, FDA agrees with some of the criticisms to its
proposed three-tiered approach and believes that many of the comments
were constructive. As set forth below, FDA is revising its proposed
approach to public input to: (1) Simplify it; (2) increase public
participation; and (3) ensure that public participation will be at the
earliest stages of the process. Moreover, FDA will not use the term
``tier'' in differentiating the degree of public participation.
As part of its GGP's, FDA will adopt a two-level approach. Level 1
documents generally will include guidances directed primarily to
applicants/sponsors or other members of the regulated industry that set
forth first interpretations of statutory or regulatory requirements,
changes in interpretation or policy that are of more than a minor
nature, unusually complex scientific issues, and highly controversial
issues. Level 2 guidance documents will include all other guidances.
For Level 1 guidance, the agency will solicit public input prior to
implementation, unless: (1) There are public health reasons for
immediate implementation; (2) there is a new statutory requirement,
executive order, or court order that requires immediate implementation
and guidance is needed to help effect such implementation; or (3) the
guidance is presenting a less burdensome policy that is consistent with
the public health. In the latter situations, the agency will solicit
public input upon issuance/implementation. When the agency determines
that even greater public participation is warranted, for example when
there are highly controversial or unusually complex new scientific
issues, the agency may hold a public workshop to discuss a draft
guidance document. In these situations, the agency may also present a
draft of the guidance document to an advisory panel.
In an effort to help ensure that public participation will occur at
the earliest stages of the guidance development process, the agency is
implementing policies pursuant to which the public will have an
opportunity to suggest areas for guidance development or revision and
to suggest drafts of guidance documents for adoption by the agency.
(See ``Proposing New Guidance,'' below.) Through these processes, the
agency often will solicit input prior to its decision to issue a
guidance and/or prior to the development of a draft.
In addition, FDA may solicit or accept early input on the need for
new or revised guidance or assistance on the development of particular
guidance documents from individual nongovernmental groups such as
consumer groups, trade associations, patient groups, and public
interest groups. The agency may participate in meetings with these
various parties to obtain each party's views on priorities for
developing guidance documents. The agency may also hold meetings and
workshops to obtain input from each interested party on the development
or revision of guidance documents in a particular FDA subject area.
Comments submitted for Level 1 documents will be submitted to the
public docket and will be available to the public for review. The
agency will review all comments, but in issuing a final guidance, need
not specifically address every comment. The agency will make changes to
a guidance document in response to comments as appropriate.
For Level 2 guidance, the agency will provide an opportunity for
public comment upon issuance. Unless otherwise indicated, the guidance
will be implemented upon issuance. The agency will make changes to
Level 2 guidance if comments indicate that such changes are
appropriate. Comments submitted for Level 2 guidance documents will be
sent directly to the issuing Center or Office. Each guidance will
identify the Center or Office to which such comments should be sent.
The Center or Office will review all comments and will make changes to
the guidance in response to such comments, as appropriate.
For all guidance documents--Levels 1 and 2--comments will be
accepted at any time. Guidance will be revised in response to comments,
as appropriate. These comments will be submitted to the issuing Center
or Office identified in the guidance document.
Public Notification of Proposed/New Guidance Documents. In the
March 7 Notice, the agency solicited comment regarding what approach
would best ensure that the public is kept apprised of new guidance
document developments. Comments responding to the question regarding
how best to notify the public and solicit input on proposed or new
guidance suggested a variety of vehicles including the Federal
Register, the world wide web (WWW), the trade press, trade
associations/organizations, public workshops, and grassroots meetings.
In an effort to ensure that notice is provided both electronically
and by hard copy, the agency will be providing notice both in the
Federal Register and on the FDA WWW home page. FDA has established a
home page on the WWW at ``http://www.fda.gov''. Each of the Centers and
the Office of Regulatory Affairs also have established home pages,
which are linked to the FDA home page. These Center and Office home
pages can be accessed directly or by going through the FDA home page.
Guidance document notices and/or drafts will be posted on the FDA home
page or will be accessible from there.
The availability of all new guidance documents, both Levels 1 and
2, will be posted on the appropriate FDA WWW home page as each guidance
is issued. Notices of availability of Level 1 guidance documents will
appear in the Federal Register when each new guidance is issued. If
several new Level 1 guidance documents are being issued at the same
time, a single Federal Register notice may be issued for all of those
new documents. The agency will issue Federal Register notices of all
new Level 2 guidance documents on a quarterly basis.
Proposing New Guidance. A number of comments on the March 7 Notice
suggested that it is more important for the agency to ensure adequate
public participation in the process that leads to the development of a
guidance document than in the process following the agency's
development of a draft guidance. These comments urged the agency to
provide a mechanism for the public to recommend subjects for new
guidance or drafts of proposed new
[[Page 8966]]
guidance documents. One comment suggested utilizing a ``Guidance
Proposal Policy'' pursuant to which FDA employees or the public would
propose topics for guidance and the proposals would be reviewed and
approved/not approved by FDA management. Another comment suggested that
a central location, such as a guidance document calendar, be designated
for industry to propose new guidance development and to learn of new
development activities. One comment suggested that the Centers and
Offices solicit comments about the need for guidance through a Federal
Register notice. Finally, one suggested that possible topics for
development of guidance be published in the agency's annual regulatory
agenda.
The agency agrees that it is important to provide for the public's
involvement in the process that leads to the development of a draft
guidance document. As part of its GGP's, therefore, the agency is
instituting procedures for involving the public in decisions to develop
or revise guidance documents and prioritize the development and
revision of guidance documents. The agency will accomplish this in two
ways. First, as a part of its GGP's, the agency will, on a semiannual
basis, publish (in the Federal Register and on the FDA WWW home page),
possible topics for guidance document development during the next year.
At that time, FDA will solicit input from the public regarding these
and additional ideas for new guidance documents or guidance document
revisions or priorities. The purpose of publishing this ``guidance
document agenda'' is to encourage the public to participate in the
process that leads to the development of guidance documents. The agency
will not be bound by the list of possible topics--i.e., it will not be
required to issue every guidance document on the list and it will not
be precluded from issuing guidance documents that are not included on
the list.
The second way that the agency will involve the public in decisions
to develop, revise, or prioritize guidance documents will be to
include, as part of its GGP's, a ``Guidance Proposal Policy.'' The
``Guidance Proposal Policy'' will provide the public an opportunity to
propose topics for new or revised guidance or to propose draft guidance
documents. The guidance proposal policy not only provides the public a
meaningful opportunity to participate in the prioritization and
development of guidance documents, it also allows the agency to take
advantage of outside expertise and resources.
Review and Revision of Guidance Documents. A number of comments to
the March 7 Notice suggested that the agency establish periodic review
of guidance documents at predetermined intervals and create mechanisms
for the public and agency personnel to suggest earlier review. Several
comments suggested that a policy should be adopted whereby if a
guidance document cannot be reviewed and revised within a reasonable
time (e.g., 3 years), it should be deemed obsolete. At least one
comment objected to the sunset concept.
FDA agrees that it would be valuable to periodically review and,
where appropriate, revise all guidance documents. As a practical
matter, guidance documents are regularly used by FDA and thereby
undergo an informal review process. The agency's current workload will
not permit it to commit to formal strict review/revision deadlines
without diverting resources from other tasks. The agency does not think
it is in the public's best interest for guidance documents that have
not been reviewed or revised within some certain period of time to be
deemed obsolete. The result would be to eliminate many current,
valuable guidance documents. The agency believes that the guidance
proposal policy will help to keep the agency apprised of potentially
outdated guidance documents. Thus, as part of its GGP's, the agency is
recommending review of existing guidance regularly and when appropriate
(e.g., when there are significant changes in the statute or
regulations), but it is not adopting a policy whereby certain guidance
documents automatically are deemed obsolete with the mere passage of
time.
Other Quality Control Measures. A number of the comments suggested
additional quality control measures to help improve the quality of
guidance. For example, one suggested that the agency adopt a uniform
sign-off policy whereby each guidance document has concurrence at least
at the level of an Office director. Others suggested that FDA employ
other standard elements such as clearly marking superseded and
superseding documents, identifying the underlying statutory and
regulatory requirements, including a glossary of terminology, cross-
referencing other relevant agency publications, and incorporating the
following information: Relevant dates (issuance, effective,
implementation, review, withdrawal, expiration), status (under
development, draft, final), tier, revision history, superseded/
superseding documents, available appeals mechanisms, draft number, and
a summary/description of the document.
FDA agrees that many of the above standard elements would help to
ensure uniformity throughout the agency and to make the documents more
useful to the public. The agency thinks that it is important to include
the issuance date of a guidance, its status (e.g., draft), and, where
applicable, the date of the document's last revisions. When a guidance
document supersedes another document, it also is important to identify
the document that the new guidance is superseding. In addition,
superseded documents that remain available for historical purposes
should be stamped or otherwise identified as superseded.
Finally, as part of GGP's, the agency is implementing a uniform
sign-off policy that directs that, at a minimum, all Level 1 guidance
documents receive the sign-off of an Office Director and Level 2
guidance receive the sign-off of a Division Director. The Office of the
Chief Counsel (OCC) will review and sign off on Level 1 guidance
documents that set forth new legal interpretations and any other
guidance documents that the Office Directors (or other issuing
officials) determine should have (OCC) review. The Office of Policy
(OP) will review and sign off on Level 1 guidance documents that
constitute significant changes in agency policy and any other guidance
documents that the Office Directors (or other issuing officials)
determine should have OP review.
V. Dissemination/Availability to Public
In the March 7 Notice, FDA solicited comment on how best to provide
the public access to guidance documents. FDA's Centers and Offices
currently use a variety of mechanisms to make guidance documents
available to the public. Nevertheless, many of the comments stated that
there is room for improvement in FDA's current access programs.
Guidance Document Lists. In the March 7 Notice, the agency
expressed its intent to ensure that all current guidance documents are
included on a list and that the public is aware that the list exists.
FDA solicited comment on how best to make the list available--
electronically, on the established FAX information systems, or in the
Federal Register.
Most comments were in favor of one centralized system (with the
individual Centers and Offices keeping copies as well); most agreed
that the centralized system must include one electronic method and one
hard copy method; some urged use of the Federal Register
[[Page 8967]]
because it is available electronically and by hard copy.
As part of its GGP's, FDA will make a comprehensive list of all
guidance documents available on the FDA WWW home page and in the
Federal Register. The WWW list will be updated continuously. The
Federal Register list will be published annually and updated quarterly.
The quarterly update will list all new guidance documents issued during
that quarter and all guidance documents that have been withdrawn during
that quarter. The list will include the name of each guidance document,
the guidance's issuance/revision dates, and information on how to
obtain copies of all of the guidance documents included on the list.
The list will be organized by Center and Office and should group
guidance documents by their intended users or the regulatory activities
to which they apply.
Guidance Documents. In the March 7 Notice, the agency sought
comment on the agency's current systems for providing access to the
actual guidance documents. Specifically, the agency asked whether the
current systems provide adequate access, whether it would be feasible
to rely principally on the FAX systems and electronic methods--such as
the WWW--or whether hard copies are necessary.
Comments submitted to the docket suggested that improvements could
be made to FDA's current access systems. For example, some comments
suggested that there were difficulties in using the FAX-ON-DEMAND
systems. Others complained that the current systems were not kept up to
date.
The Centers and Offices each will retain responsibility for
maintaining a comprehensive, current set of their guidance documents
and making those guidance documents available to the public. All
guidance documents made available by the Centers and Offices should be
included on the comprehensive list. To the extent feasible, guidance
documents will be made available electronically (e.g., on the WWW). The
Centers and Offices will make all guidance documents available in hard
copy upon request.
VI. Appeals
In the March 7 Notice, FDA emphasized the importance of an
effective appeals mechanism to ensure that there will be full and fair
reconsideration and review of how guidance documents are being applied.
The agency expressed its belief that an effective appeals process would
protect against guidance documents being applied as binding
requirements.
Comments submitted to the docket and presentations at the April 26
public meeting indicated that the issue of appeals may not be an
appropriate way to address this issue. According to these comments, if
the agency involves the public in the development of guidance and takes
steps to ensure that its employees do not apply guidance as binding
requirements, there would be fewer appeals relating to guidance
documents. Nevertheless, a number of comments stated that the public is
not sufficiently aware of the agency's current appeals processes and/or
that the agency's current appeals processes are not adequate.
The agency agrees that improving the development and use of
guidance documents should limit the need for appeals. Nevertheless, the
agency believes that an effective appeals mechanism is needed for those
times when someone believes the GGP's may not have been followed or the
GGP's fail to achieve their purpose. The agency has appeals mechanisms
in place. However, there is a lack of knowledge regarding their
existence and a lack of clarity about how they work--both of which
likely contribute to the criticism that they are inadequate.
Accordingly, the agency is including, in its GGP's, a section that
describes the appeals mechanisms relating to guidance.
As a general matter, a person with a dispute involving a guidance
document can appeal a decision by going up the Center and Office chains
of command, which are described in the GGP's. The Office of the Chief
Mediator and Ombudsman (the Ombudsman) may be asked to become involved
if the matter is not resolved by going up the chain of command, little
progress is being made going up the chain of command, or a person does
not know where to begin an appeal. The GGP's provide information
regarding the Office of the Ombudsman and provide Center- and Office-
specific information regarding telephone and/or mail contacts for
questions on appeals.
The text of the GGP's document is set forth below.
Dated: February 18, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
Good Guidance Practices
I. Purpose
This ``Good Guidance Practices'' (GGP's) document sets forth
FDA's general policies and procedures for developing, issuing, and
using guidance documents. The purpose of this document is to help
ensure that agency guidance documents are developed with adequate
public participation, that guidance documents are readily available
to the public, and that guidance documents are not applied as
binding requirements. The agency wants to ensure uniformity in the
development, issuance, and use of guidance documents.\1\
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\1\ This document represents the agency's current practices for
developing, issuing, and using guidance documents. It does not
create or confer any rights for or on any person and does not
operate to bind FDA or the public. Individual FDA Centers or Offices
may have additional/more detailed procedures to implement the
general principles set forth herein.
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II. Definition
The purposes of guidance documents are to: (1) Provide
assistance to the regulated industry by clarifying requirements that
have been imposed by Congress or issued in regulations by FDA and by
explaining how industry may comply with those statutory and
regulatory requirements and (2) provide specific review and
enforcement approaches to help ensure that FDA's employees implement
the agency's mandate in an effective, fair, and consistent manner.
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.
The term ``guidance documents'' includes documents prepared for
FDA staff, applicants/sponsors, and the public that: (1) Relate to
the processing, content, and evaluation/approval of submissions; (2)
relate to the design, production, manufacturing, and testing of
regulated products; (3) describe the agency's policy and regulatory
approach to an issue; or (4) establish inspection and enforcement
policies and procedures. ``Guidance documents'' do not include
documents relating to internal FDA procedures, agency reports,
general information documents provided to consumers, speeches,
journal articles and editorials, media interviews, press materials,
warning letters, or other communications directed to individual
persons or firms.
III. Legal Effect of Guidance Documents
Guidance documents do not themselves establish legally
enforceable rights or responsibilities and are not legally binding
on the public or the agency. Rather, they explain how the agency
believes the statutes and regulations apply to certain regulated
activities. However, because a guidance document represents the
agency's current thinking on the subject addressed in the document,
FDA's decisionmakers will take steps to ensure that their staff do
not deviate from the guidance document without appropriate
justification and appropriate supervisory concurrence.
Alternative methods that comply with the relevant statute or
regulations are acceptable. If a regulated company or person wishes
or chooses to use an approach other than that set forth in a
guidance document, FDA will, upon request, discuss with that company
or person alternative methods of complying with the applicable
statutes and regulations.
[[Page 8968]]
FDA encourages industry to discuss alternative approaches with the
agency before implementing them to avoid unnecessary or wasteful
expenditures of resources.
IV. Application of GGP'S
FDA staff involved in the development, issuance, and application
of guidance documents are expected to adhere to these GGP's.
Documents and other means of communication excluded from the
definition of guidance should not be used to initially communicate
new or different regulatory expectations not readily apparent from
the applicable statute or regulations to a broad public audience.
Whenever such regulatory expectations are first communicated to a
broad public audience, these GGP's should be followed. This does not
limit the agency's ability to respond to questions as to how an
established policy applies to a specific situation or to questions
about areas that may lack established policy. However, such
questions may signal the need to develop guidance in that area.
V. Procedures for Developing Guidance Documents
FDA has adopted a two-level approach to the development of
guidance documents. The procedures for developing a guidance
document will depend on whether that guidance document is a ``Level
1'' guidance or a ``Level 2'' guidance. Level 1 guidance documents
generally include guidances directed primarily to applicants/
sponsors or other members of the regulated industry that set forth
first interpretations of statutory or regulatory requirements,
changes in interpretation or policy that are of more than a minor
nature, unusually complex scientific issues, or highly controversial
issues. Level 2 guidance documents include all other guidance
documents.
Development of Level 1 Guidance Documents. For Level 1 guidance
documents, the agency will solicit public input prior to
implementation, unless: (1) There are public health reasons for
immediate implementation; (2) there is a new statutory requirement,
executive order, or court order that requires immediate
implementation and guidance is needed to help effect such
implementation; or (3) the guidance is presenting a less burdensome
policy that is consistent with public health. In the latter
situations, the agency will solicit public input upon issuance/
implementation.
For Level 1 guidance, the agency will, at a minimum, solicit
public input by (1) issuing a notice of availability of a draft of
the guidance in the Federal Register and indicating its availability
on the appropriate FDA world wide web (WWW) home page \2\, and (2)
posting the draft on the appropriate FDA WWW home page or making the
draft otherwise available. The notice of availability will provide
information regarding how to obtain a copy of the draft guidance;
hard copies of the draft will be available upon request. The agency
may use one Federal Register notice of availability to solicit
public input on several different draft guidance documents. For
Level 1 guidance documents, the agency also may hold a public
workshop to discuss a draft and/or present a draft to an advisory
panel when, for example, there are highly controversial or unusually
complex new scientific issues.
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\2\ FDA has established a home page on the WWW at ``http://
www.fda.gov''. Each of the Centers and the Office of Regulatory
Affairs also have established home pages, which are linked to the
FDA home page. These Center- or Office-specific home pages can be
accessed directly or through the FDA home page. Guidance document
notices and/or drafts will be posted on the FDA home page or will be
accessible from there.
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Because the agency recognizes that it is important to solicit
input prior to its decision to issue a guidance and also, perhaps,
during the development of a draft of a Level 1 guidance, the agency
is implementing various practices to obtain input at the earliest
stages of Level 1 guidance document development. For example, these
GGP's provide that the public will have an opportunity to comment on
and suggest areas for guidance development or revision and to submit
draft guidances for possible adoption by the agency. (See the
``Guidance Document Agenda'' and ``Guidance Proposal Policy'' set
forth below.)
In addition, FDA may solicit or accept early input on the need
for new or revised guidance or assistance in the development of
particular guidance documents from individual nongovernmental groups
such as consumer groups, trade associations, patient groups, and
public interest groups. The agency may participate in meetings with
these various parties to obtain each party's views on priorities for
developing guidance documents. The agency may also hold meetings and
workshops to obtain input from each interested party on the
development or revision of guidance documents in a particular FDA
subject area.
Comments submitted on draft Level 1 guidance documents will be
submitted to the docket identified in the Federal Register notice
and on the appropriate FDA WWW home page. All comments will be
available to the public for review. The agency will review all
comments, but in issuing the guidance, need not specifically address
every comment. The agency will make changes to the guidance document
in response to comments, as appropriate.
Development of Level 2 Guidance Documents. For Level 2
guidance, the agency will provide an opportunity for public comment
upon issuance. Unless otherwise indicated, the guidance will be
implemented upon issuance.\3\ The availability of new Level 2
guidance documents should be posted on the appropriate FDA WWW home
page as each guidance is issued. Each quarter, the agency will
publish a list in the Federal Register of all new Level 2 guidance
documents.
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\3\ The agency may, at the discretion of the issuing Office,
solicit comment before implementing a Level 2 guidance document.
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Comments submitted for Level 2 guidance documents will be sent
directly to the issuing Center or Office. Each guidance will
identify the Center or Office to which such comments should be sent.
The Center or Office will review all comments. The agency will make
changes to the guidance in response to comments, as appropriate.
Comments on Guidance Documents In Use. For all guidance
documents--Levels 1 and 2--comments will be accepted at any time.
Comments on the guidance documents in use should be submitted to the
issuing Center or Office identified in the guidance. Guidance will
be revised in response to such comments, as appropriate.
Sign-off Policy. All drafts of Level 1 guidance documents that
are being made available for public comment will receive the sign-
off of at least an Office Director in a Center or the Office of
Regulatory Affairs equivalent. All final versions of Level 1
guidance documents will receive the sign-off of at least an Office
Director in a Center or the Office of Regulatory Affairs equivalent.
The Office of the Chief Counsel (OCC) will review and sign off on
Level 1 guidance documents that set forth new legal interpretations
and any other guidance documents that the Office Directors (or other
issuing officials) determine should have OCC review. The Office of
Policy (OP) will review and sign off on Level 1 guidance documents
that constitute significant changes in agency policy and any other
guidance documents that the Office Directors (or other issuing
officials) determine should have OP review. All Level 2 guidance
documents will receive the sign-off of an official at the Division
Director level or higher. The agency employees with sign-off
authority should ensure that these GGP's have been followed whenever
a guidance document is issued. If GGP's were not followed, the
person with sign-off authority should withdraw the guidance document
and reissue it in accordance with GGP's.
Guidance Document Agenda. On a semiannual basis, the agency will
publish in the Federal Register and on the FDA WWW home page
possible topics for guidance document development or revision during
the next year. At that time, the agency will specifically solicit
input from the public regarding these and additional ideas for new
guidance documents or guidance document revisions or priorities. The
agency is not bound by the list of possible topics--i.e., it is not
required to issue every guidance document on the list and it is not
precluded from issuing guidance documents that are not included on
the list.
``Guidance Proposal Policy.'' If a member of the public wishes
to propose one or more topics for new guidance or guidance revisions
or to propose one or more draft guidance documents for adoption by
FDA, that person should submit the proposal to the Centers or
Offices with responsibility for overseeing the regulatory activity
to which the guidance document would apply. The submission should
include a statement regarding why new or revised guidance is
necessary.
If the Center or Office agrees that the proposed topic should be
covered by a guidance document, it will develop a guidance document
in accordance with these GGP's. If the Office or Center agrees that
a guidance document should be updated/revised, it will develop a
revision in accordance with these GGP's. If the submitter
[[Page 8969]]
has proposed a draft of the guidance document that the agency agrees
can form the basis for a guidance document, the agency will follow
the GGP's for issuing and implementing a guidance document based on
that proposed draft.
Review and Revision of Guidance Documents. The agency intends
to review existing guidance documents on a regular basis. As part of
the ``Guidance Proposal Policy,'' members of the public may request
review or revision of a particular guidance document on the basis
that it is no longer current. Such requests should be accompanied by
an explanation of why the guidance is out of date and how it should
be revised. The agency will review such requests to determine if the
guidance document at issue needs to be updated/revised. The Agency
will, when appropriate, update or revise that guidance document in
accordance with these GGP's. In addition, when significant changes
are made to the statute or regulations, the agency will, on its own
initiative, review and, as appropriate, revise guidance documents
relating to that changed statute or regulation.
VI. Standard Elements
Nomenclature. All guidance documents will include: (1) The
umbrella term ``guidance,'' (2) information that identifies the
Center or Office producing the document, and (3) the regulatory
activity to which and/or the persons to whom the document applies.
In practice, the majority of guidance documents issued in the future
will be called ``compliance guidance,'' ``guidance for industry,''
or ``guidance for FDA reviewers/staff.''
Statement of Nonbinding Effect. All guidance documents will
include language such as the following:
This guidance document represents the agency's current thinking
on * * *. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statute, regulations, or both.
Absence of Mandatory Language. Because guidance documents are
not binding, mandatory words such as ``shall,'' ``must,''
``require'' and ``requirement'' are inappropriate unless they are
being used to describe or discuss a statutory or regulatory
requirement. Before a new guidance is issued, it should be reviewed
to ensure that mandatory language has not been used.
Other Standard Elements. Each guidance document will include the
dates of issuance and latest revision. Documents that are being made
available for comment should include a ``draft'' notation. When a
guidance supersedes another guidance document, the new guidance
document will identify the document that it is superseding.
Superseded documents that remain available for historical purposes
should be stamped or otherwise identified as superseded. All
guidance documents should include a cover sheet that is modeled
after the samples attached to this document.
The agency will update existing guidance documents (to include
these standard elements) as they are revised.
VII. FDA Implementation of GGP's
Education. All current and new FDA employees involved in the
development, issuance, or application of guidance documents will be
provided a copy of and directed to review the agency's GGP's. The
Centers and Offices will conduct additional training of employees
involved in the development and use of guidance documents that will
describe in more detail how to develop and use guidance documents
under these GGP's. This training will emphasize the principles set
forth in section III., above, regarding the legal effect of guidance
documents.
The agency also will educate the public about the legal effect
of guidance. These GGP's and the statement of the nonbinding effect
of guidance that will be included in every future guidance document
and on the comprehensive list of guidance documents (discussed in
section VIII. below) should help to educate the public about the
legal effect of guidance. FDA staff should take the opportunity to
state and explain the legal effect of guidance when speaking to the
public about guidance documents.
Monitoring. FDA will monitor agency employees' use of guidance
documents. As part of this process, the Centers and Offices will
monitor the development and issuance of guidance documents to ensure
that these GGP's are being followed. In addition, they will spot-
check the use of guidance documents to ensure that they are not
being applied as binding requirements. Finally, the Centers and
Offices will spot-check the use of documents and communications that
are not defined as guidance, such as warning letters and speeches,
to ensure that these documents are not being used to initially
express a new regulatory expectation to a broad public audience.
Three years after these GGP's have been implemented, the agency
will convene a working group to review whether these GGP's have been
successful in achieving the agency's goal in issuing them. The
working group will determine whether the GGP's are ensuring: (1)
Appropriate public participation in the development of guidance, (2)
that guidance documents are readily available to the public, and (3)
that guidance documents are not being applied as binding
requirements. The working group will review the results of the
Center and Office monitoring efforts as well as the number and
results of appeals relating to the development and/or use of
guidance documents.
VIII. Dissemination/Availability to Public
Lists of Guidance Documents. A comprehensive list of all current
guidance documents will be maintained on the FDA WWW home page. New
guidance documents should be added to the list within 30 days of
issuance. The agency will publish the comprehensive list in the
Federal Register annually. Each quarter, the agency will publish a
Federal Register notice that lists all guidance documents that were
issued during that quarter and all guidance documents that have been
withdrawn.
The guidance document lists will include the name of each
guidance document, the document's issuance/revision dates, and
information on how to obtain copies of the document. The lists will
be organized by Center and Office and should group guidance
documents by their intended users and/or the regulatory activities
to which they apply. The list also will include (properly
identified) draft documents being made available for public comment.
Guidance Documents. The Centers and Offices each will retain
responsibility for maintaining a comprehensive set of their guidance
documents and making those guidance documents available to the
public. All guidance documents made available by a Center or Office
should be included on the comprehensive list. To the extent
feasible, guidance documents will be made available electronically
(e.g., on the WWW). The Centers and Offices will make all guidance
documents available in hard copy, upon request.
IX. Appeals
These GGP's should improve the agency's development and use of
guidance documents. Nevertheless, an effective appeals mechanism is
needed for those times when the GGP's may not have been followed or
the GGP's fail to achieve their purpose. FDA intends to provide an
opportunity for appeal to a person who believes that GGP's were not
followed in issuing a particular guidance document or who believes
that a guidance document has been treated as a binding requirement.
As a general matter, a person with a dispute involving a
guidance document should begin with the supervisor of the person
issuing or applying the guidance document. If the issue cannot be
resolved at that level, the matter should be brought to the next
level. This process would continue on up the chain of command.\4\ If
a matter is unresolved at the level of the Center Director, or if
little progress is being made going through the chain of command,
the Office of the Chief Mediator and Ombudsman (the Ombudsman) may
be asked to become involved.\5\ The Office of the Ombudsman can be
reached at 301-827-3390.
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\4\ This general agency-wide process for appealing decisions is
described in FDA's regulations (21 CFR 10.75).
\5\ The Ombudsman reports directly to and acts on behalf of the
FDA Commissioner in investigating and resolving issues and problems
that affect products under FDA's jurisdiction. The office was
created to investigate industry complaints about FDA's regulatory
processes, identify deficiencies in those processes, respond to
problems affecting a product under FDA's jurisdiction, and ensure
that FDA policy is fairly and evenly applied throughout the agency.
The Ombudsman also mediates disputes or issues between FDA and the
regulated industry that have not been resolved through other means.
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The chains of command for such appeals generally are as follows:
Center for Drug Evaluation and Research (CDER)
-Reviewer/Project Manager
-Branch Chief/Team Leader/Supervisory Project Manager
-Division Director
-Office Director
[[Page 8970]]
-Deputy Center Director
-Center Director
In addition, CDER has its own Ombudsman in the Office of the
Center Director (301-594-5443) to help assist with appeals and
dispute resolution. Additional information about this office can be
found on the CDER home page at ``http://www.fda.gov/cder''.
Center for Biologics Evaluation and Research (CBER)
-Reviewer/Consumer Safety Officer
-Branch Chief/Laboratory Chief
-Division Director
-Office Director
-Associate Director
-Deputy Center Director
-Center Director
In addition, CBER has its own Ombudsman in the Office of the
Center Director (301-827-0379) who handles appeals and dispute
resolution.
Center for Veterinary Medicine (CVM)
-Reviewer
-Division Director
-Office Director
-Deputy Center Director
-Center Director
In addition, CVM has procedures in place to handle appeals of
written decisions on issues involving science or policy. These
procedures, which may apply to certain guidance document appeals,
are outlined in a staff manual guide (#1240.3130). For additional
assistance regarding the appeals process in CVM, persons can contact
the Associate Director for Policy at 301-827-0139.
Center for Devices and Radiological Health (CDRH)
-Reviewer/Consumer Safety Officer
-Branch Chief/Team Leader
-Division Director
-Office Director
-Deputy Center Director
-Center Director
Questions related to the CDRH appeals process may be answered by
the Division of Small Manufacturer's Assistance at 800-638-2041 or
301-443-6597. Questions may also be faxed to 301-443-8818.
Center for Food Safety and Applied Nutrition (CFSAN)
-Reviewer/Consumer Safety Officer
-Division Director
-Office Director
-Deputy Center Director
-Center Director
In CFSAN, the Industry Activities staff at 202-205-5251 is the
contact point for appeals and will direct inquiries relating to
appeals of guidance documents to the appropriate CFSAN office.
Office of Regulatory Affairs (ORA)
-Field Investigator/Field Inspector
-Supervisor/Team Leader
-Branch Chief
-District Director
-Regional Director
The Regional Directors report to the Associate Commissioner for
Regulatory Affairs.
In addition, FDA's District Offices and resident posts
nationwide have a variety of small business representatives, public
affairs specialists, and others who can respond to questions from
outside the agency regarding appeals. A listing of FDA's offices is
found in the blue pages of local telephone directories and on FDA's
home page at ``http://www.fda.gov''. Questions related to an appeal
of guidance documents in ORA may be answered by the Division of
Compliance Policy, which can be reached at 301-827-0420.
If it is unclear which Center or Office produced a guidance
document or a person does not know where to begin an appeal, the
Office of the Ombudsman handles jurisdictional questions and is
available to refer those outside the agency to the appropriate
place.
In summary, appeals regarding guidance documents can be made
either by going up the chain of command, using specific Center or
Office procedures, or going directly to the Office of the Ombudsman.
BILLING CODE 4160-01-F
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[GRAPHIC] [TIFF OMITTED] TN27FE97.010
[FR Doc. 97-4852 Filed 2-25-97; 8:45 am]
BILLING CODE 4160-01-C
