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Direct Final Rule Procedures

Guidance for FDA and Industry - Direct Final Rule
Procedures

U.S. Department of Health and Human
Services
Food and Drug Administration
Office of Policy

November 21, 1997

Comments and suggestions regarding this document
should be submitted to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Requests and
comments are to be identified with the docket number found in brackets in the
heading of the notice of availability that published in the FEDERAL REGISTER.
For questions regarding this document, contact the Office of Policy (HF-11),
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
301-827-3360.

I. Summary

This guidance will explain when and how the Food and Drug Administration
(FDA) will employ direct final rulemaking. FDA believes that direct final
rulemaking will expedite the issuance of routine or otherwise noncontroversial
rules.

II. FDA's Direct Final Rulemaking Procedures

This guidance adopts many aspects of the former Administrative Conference of
the United States' (1964 to 1995) recommendations concerning direct final
rulemaking. FDA may use the direct final rule process when the agency does not
anticipate receiving any significant adverse comment, or when a rule may qualify
for exemption from notice-and-comment rulemaking. FDA will publish in the notice
of direct final rulemaking the full text of the rule and the statement of basis
and purpose, including all the material that would be required in the preamble
to a final rule. FDA will also publish a companion proposed rule in the same
issue of the Federal Register. That proposed rule will serve the purpose of
issuing a proposed rule under usual notice-and-comment procedures in the event
the direct final rule is withdrawn because the agency receives any significant
adverse comment.

FDA ordinarily will allow at least 75 days for comment on the direct final
rule after it is published in the Federal Register. If the agency receives any
significant adverse comment, the agency will publish a notice of significant
adverse comment and withdraw the direct final rule within 30 days after the
comment period ends. In that circumstance, any comments received will be
considered comments on the proposed rule and will be considered in developing a
final rule using the usual APA notice-and-comment procedures. If the agency
receives no significant adverse comment during the specified comment period, the
direct final rule will go into effect no later than 60 days after the comment
period ends. The agency will publish a document confirming the effective date
within 30 days after the comment period ends, which ordinarily will state that
the direct final rule will go into effect 30 days after the confirmation notice
is published. This means that a direct final rule that receives no significant
adverse comment will go into effect no later than 135 days after its publication
in the Federal Register.

FDA will adopt ACUS's definition of significant adverse comment. Thus,
significant adverse comment is defined 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.
In determining whether a significant adverse comment is sufficient to terminate
a direct final rulemaking, FDA will consider whether the comment raises an issue
serious enough to warrant a substantive response in a notice-and-comment
process. FDA notes that comments that are frivolous, insubstantial, or outside
the scope of the rule would not be considered adverse under this procedure. A
comment recommending a rule change in addition to the rule would not be
considered a significant adverse comment, unless the comment states why the rule
would be ineffective without the additional change. In addition, if a
significant adverse comment applies to part of a rule and that part can be
severed from the remainder of the rule (e.g., where a rule deletes several
unrelated regulations), FDA may adopt as final those parts of the rule that are
not the subject of a significant adverse comment.

As discussed previously, FDA will only use direct final rulemaking procedures
when the agency expects that there will be no significant adverse comment. For
example, FDA will consider direct final rulemaking for minor, substantive
changes to regulations; incorporation by reference of the latest edition of
technical or industry standards; extensions of compliance dates, direct
incorporations of mandates from new legislation; and other non controversial
rules where FDA determines that use of direct final rulemaking is in the public
interest and that the rule is unlikely to result in any significant adverse
comment.

III. Significance of Guidance

The agency has adopted Good Guidance Practices (GGP's), which set forth the
agency's policies and procedures for the development, issuance, and use of
guidance documents (62 FR 8961, February 27, 1997). This guidance is issued as
Level 1 guidance consistent with GGP's. The agency will not solicit public input
prior to implementation because the guidance presents a less burdensome policy
that is consistent with the public health. This guidance represents the agency's
current thinking on direct final rules. It does not operate to create or confer
any right sfor 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, regulation, or both.

IV. Request for Comments

Interested persons may, at any time, submit written comments on this guidance
to the Dockets Management Branch (address above). Such comments will be
considered when determining whether to amend the current guidance. Two copies of
any comments are to be submitted, except that individuals may submit one
copy.

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