[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \2\ FDA has established a home page on the WWW at ``<a href="http://
www.fda.gov">http://
www.fda.gov</a>''. 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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \3\ The agency may, at the discretion of the issuing Office, 
solicit comment before implementing a Level 2 guidance document.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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

[[Page 8971]]

[GRAPHIC] [TIFF OMITTED] TN27FE97.009


[[Page 8972]]


[GRAPHIC] [TIFF OMITTED] TN27FE97.010

[FR Doc. 97-4852 Filed 2-25-97; 8:45 am]
BILLING CODE 4160-01-C