Federal Register / Vol. 62, No. 39 / Thursday, February 27, 1997 / Notices 8961

MATTERS TO BE CONSIDERED:

1. Approval of the minutes of the

February 10, 1997, Board member

meeting.

2. Thrift Savings Plan activity report by

the Executive Director.

3. Briefings by National Finance Center

and Board staff on:

a. National Finance Center;

b. Thrift Savings Plan system

replacement effort;

c. Thrift Savings Plan improvements;

d. Capability maturity model;

e. Software methodology;

f. Project tracking and controls;

g. Service Office enhancements;

h. Local area network; and

i. Thrift Savings Plan costs.

CONTACT PERSON FOR MORE INFORMATION:

Tom Trabucco, Director, Office of

External Affairs (202) 942–1640.

Dated: February 24, 1997.

Roger W. Mehle,

Executive Director, Federal Retirement Thrift

Investment Board.

[FR Doc. 97–5013 Filed 2–25–97; 11:37 am]

BILLING CODE 6760–01–M

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
8962 Federal Register / Vol. 62, No. 39 / Thursday, February 27, 1997 / Notices

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 officiallydesignated 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
Federal Register / Vol. 62, No. 39 / Thursday, February 27, 1997 / Notices 8963

1One comment asked FDA to retain § 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.

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 (§ 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.

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 agencywide practice of soliciting or accepting
8964 Federal Register / Vol. 62, No. 39 / Thursday, February 27, 1997 / Notices

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 threetiered 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 ThreeTiered 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.
Federal Register / Vol. 62, No. 39 / Thursday, February 27, 1997 / Notices 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 threetiered 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
8966 Federal Register / Vol. 62, No. 39 / Thursday, February 27, 1997 / Notices

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
Federal Register / Vol. 62, No. 39 / Thursday, February 27, 1997 / Notices 8967

1This 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.

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

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.
8968 Federal Register / Vol. 62, No. 39 / Thursday, February 27, 1997 / Notices

2FDA has established a home page on the WWW

at ‘‘http://www.fda.gov’’. Each of the Centers and

the Office of Regulatory Affairs also have

established home pages, which are linked to the

FDA home page. These Center- or Office-specific

home pages can be accessed directly or through the

FDA home page. Guidance document notices and/

or drafts will be posted on the FDA home page or

will be accessible from there.

3The agency may, at the discretion of the issuing

Office, solicit comment before implementing a

Level 2 guidance document.

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.

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.

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
Federal Register / Vol. 62, No. 39 / Thursday, February 27, 1997 / Notices 8969

4This general agency-wide process for appealing

decisions is described in FDA’s regulations (21 CFR

10.75).

5The 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.

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.

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
8970 Federal Register / Vol. 62, No. 39 / Thursday, February 27, 1997 / Notices

-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.

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