The Food and Drug Administration's Development, Issuance, and Use of Guidance Documents

Federal RegisterFeb 27, 1997

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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

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

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

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