[Federal Register Volume 62, Number 225 (Friday, November 21, 1997)]
[Notices]
[Pages 62466-62470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30704]



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Part IV





Department of Health and Human Services





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Food and Drug Administration



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Guidance for FDA and Industry: Direct Final Rule Procedures; Notice

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

[[Page 62466]]



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.

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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 ``<a href="http://www.fda.gov/opacom/morechoices/
industry/preguide.htm">http://www.fda.gov/opacom/morechoices/
industry/preguide.htm</a>''.

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 ``<a href="http://
www.fda.gov/opacom/morechoices/industry/preguide.htm">http://
www.fda.gov/opacom/morechoices/industry/preguide.htm</a>'', 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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