62466 Federal Register / Vol. 62, No. 225 / Friday, November 21, 1997 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0439]

Guidance for FDA and Industry: Direct

Final Rule Procedures

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance document

entitled ‘‘Guidance for FDA and

Industry: Direct Final Rule Procedures.’’

This guidance explains when and how

FDA will employ direct final

rulemaking. FDA believes that direct

final rulemaking will expedite the

issuance of routine or otherwise

noncontroversial rules and conserve

limited Government resources for

carrying out the agency’ regulatory

functions.

DATES: Written comments may be

submitted at any time.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857. A copy

of this guidance will be made available

on FDA’s World Wide Web site at

‘‘http://www.fda.gov/ opacom/

morechoices /industry/preguide.htm’’.

FOR FURTHER INFORMATION CONTACT:

Marquita B. Steadman, Office of Policy

(HF–26), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–3480.

SUPPLEMENTARY INFORMATION:

I. Background

In Executive Order 12866,

‘‘Regulatory Planning and Review’’ (58

FR 51735, October 4, 1993), the

President set forth the administration’s

regulatory philosophy and principles.

The Executive Order contemplates an

efficient and effective rulemaking

process, including the conservation of

limited Government resources for

carrying out its regulatory functions.

Furthermore, ‘‘Improving Regulatory

Systems,’’ an Accompanying Report of

the National Performance Review,

recognized the need to streamline the

regulatory process and recommended

the use of ‘‘direct final’’ rulemaking

procedures to reduce needless double

review of noncontroversial rules. Direct

final rulemaking involves agency

publication of a rule in the Federal

Register with a statement that unless

significant adverse comment, as defined

later in this document, is received on

the rule within a specified time period,

the rule will become effective as a final

rule on a particular date. However, if a

significant adverse comment is filed, the

rule is withdrawn, and the agency may

publish the rule as a proposed rule

under the usual notice-and-comment

procedures of the Administrative

Procedure Act (APA).

From 1964 to 1995 the Administrative

Conference of the United States (ACUS),

established by the Administrative

Conference Act (5 U.S.C. 591–596),

studied the efficiency, adequacy, and

fairness of the administrative

procedures used by Federal agencies in

carrying out administrative programs.

When it was in existence, ACUS made

recommendations for improvements to

the agencies, collectively or

individually, and to the President,

Congress, and the Judicial Conference of

the United States (5 U.S.C. 594(1)).

In the Federal Register of August 18,

1995 (60 FR 43108), ACUS issued a

notice adopting five recommendations

at its Fifty-Second Plenary Session held

on June 15 to 18, 1995.

Recommendation 95–4, ‘‘Procedures for

Noncontroversial and Expedited

Rulemaking,’’ endorsed direct final

rulemaking as a procedure that can

expedite rules in appropriate cases (see

60 FR 43108, August 18, 1995). ACUS

found direct final rulemaking

appropriate where a rule is expected to

generate no significant adverse

comment. ACUS defined significant

adverse comment as one where the

comment explains why the rule would

be inappropriate, including challenges

to the rule’s underlying premise or

approach, or would be ineffective or

unacceptable without a change (60 FR

43108 at 43111) . ACUS stated that, in

determining whether a significant

adverse comment is sufficient to

terminate a direct final rulemaking,

agencies should consider whether the

comment raises an issue serious enough

to warrant a substantive response in a

notice-and-comment process (Id.).

ACUS noted that the direct final rule

process allows the agency to issue a rule

without having to go through the review

process twice (i.e., at the proposed and

final rule stages) while at the same time

offering the public the opportunity to

challenge the agency’s view that the rule

has no significant opposition (60 FR

43108 at 43111 and 43112).

ACUS determined that direct final

rulemaking is supported by two

rationales under current law. First, it is

justified by the APA’s ‘‘good cause’’

exemption from notice-and-comment

procedures where they are found to be

‘‘unnecessary.’’ ACUS found that the

agency’s solicitation of public comment

does not undercut this argument, but

rather validates the agency’s initial

determination. Second, ACUS stated

that, alternatively, direct final

rulemaking also complies with the basic

notice-and-comment requirements in

section 553 of the APA. ACUS stated

that the agency provides the requisite

notice and opportunity to comment on

the rule through its Federal Register

notice; the publication requirements are

met, although the information has been

published earlier in the process than

normal; and, the requisite advance

notice of the effective date required by

the APA is provided (60 FR 43108 at

43111).

Because the process protects public

comment and expedites routine

rulemaking, ACUS recommended that

agencies use direct final rulemaking in

all cases where the ‘‘unnecessary’’ prong

of the good cause exemption is

available, unless the agency determines

that the process would not expedite

issuance of such rules (60 FR 43108 at

43111). ACUS further recommended

that agencies explain when and how

they will employ direct final

rulemaking. Such a policy should be

issued as a procedural rule or a policy

statement (Id.).

Provided herein and on FDA’s World

Web site at ‘‘http://www.fda.gov/

opacom/morechoices/ industry/

preguide.htm’’, FDA is making available

a guidance document titled ‘‘Guidance

for FDA and Industry: Direct Final Rule

Procedures.’’ This guidance explains

when and how FDA will employ direct

final rulemaking. FDA believes that

direct final rulemaking will expedite the

issuance of routine or otherwise

noncontroversial rules.

II. Comments

Interested persons may, at any time,

submit written comments to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857. Requests and comments are to be

identified with the docket number

found in brackets in the heading of this

document. Comments may be submitted

at any time and will be used to

determine whether to revise the

guidance further.

Dated: November 12, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

The text of the guidance is set forth

below:

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[FR Doc. 97–30704 Filed 11–20–97; 8:45 am]

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