[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] [[Page 62465]] _______________________________________________________________________ Part IV Department of Health and Human Services _______________________________________________________________________ Food and Drug Administration _______________________________________________________________________ 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. ----------------------------------------------------------------------- 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: BILLING CODE 4160-01-F [[Page 62467]] [GRAPHIC] [TIFF OMITTED] TN21NO97.015 [[Page 62468]] [GRAPHIC] [TIFF OMITTED] TN21NO97.016 [[Page 62469]] [GRAPHIC] [TIFF OMITTED] TN21NO97.017 [[Page 62470]] [GRAPHIC] [TIFF OMITTED] TN21NO97.018 [FR Doc. 97-30704 Filed 11-20-97; 8:45 am] BILLING CODE 4160-01-C