U.S. Code » Title 5 » Part PART I— THE AGENCIES GENERALLY › Chapter CHAPTER 6— THE ANALYSIS OF REGULATORY FUNCTIONS

5 U.S.C. § 604

Final regulatory flexibility analysis

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(a) When an agency promulgates a final rule under section 553 of this title, after being required by that section or any other law to publish a general notice of proposed rulemaking, or promulgates a final interpretative rule involving the internal revenue laws of the United States as described in section 603(a), the agency shall prepare a final regulatory flexibility analysis. Each final regulatory flexibility analysis shall contain—(1) a statement of the need for, and objectives of, the rule;(2) a statement of the significant issues raised by the public comments in response to the initial regulatory flexibility analysis, a statement of the assessment of the agency of such issues, and a statement of any changes made in the proposed rule as a result of such comments;(3) the response of the agency to any comments filed by the Chief Counsel for Advocacy of the Small Business Administration in response to the proposed rule, and a detailed statement of any change made to the proposed rule in the final rule as a result of the comments;(4) a description of and an estimate of the number of small entities to which the rule will apply or an explanation of why no such estimate is available;(5) a description of the projected reporting, recordkeeping and other compliance requirements of the rule, including an estimate of the classes of small entities which will be subject to the requirement and the type of professional skills necessary for preparation of the report or record;(6) 11 So in original. Two pars. (6) have been enacted. a description of the steps the agency has taken to minimize the significant economic impact on small entities consistent with the stated objectives of applicable statutes, including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in the final rule and why each one of the other significant alternatives to the rule considered by the agency which affect the impact on small entities was rejected; and(6) 1 for a covered agency, as defined in section 609(d)(2), a description of the steps the agency has taken to minimize any additional cost of credit for small entities.(b) The agency shall make copies of the final regulatory flexibility analysis available to members of the public and shall publish in the Federal Register such analysis or a summary thereof.(Added Pub. L. 96–354, § 3(a), Sept. 19, 1980, 94 Stat. 1167; amended Pub. L. 104–121, title II, § 241(b), Mar. 29, 1996, 110 Stat. 864; Pub. L. 111–203, title X, § 1100G(c), July 21, 2010, 124 Stat. 2113; Pub. L. 111–240, title I, § 1601, Sept. 27, 2010, 124 Stat. 2551.)Editorial NotesAmendments

2010—Subsec. (a)(1). Pub. L. 111–240, § 1601(1), struck out “succinct” before “statement”.

Subsec. (a)(2). Pub. L. 111–240, § 1601(2), substituted “statement” for “summary” before “of the significant issues” and “of the assessment”.

Subsec. (a)(3), (4). Pub. L. 111–240, § 1601(3), (4), added par. (3) and redesignated former par. (3) as (4). Former par. (4) redesignated (5).

Subsec. (a)(5). Pub. L. 111–240, § 1601(3), redesignated par. (4) as (5). Former par. (5), relating to description of steps taken to minimize the significant economic impact on small entities, redesignated (6).

Pub. L. 111–203, § 1100G(c)(1), which directed amendment of par. (4) by striking “and” at the end, was executed to par. (5) to reflect the probable intent of Congress and the intervening redesignation of par. (4) as (5) by Pub. L. 111–240, § 1601(3). See above.

Subsec. (a)(6). Pub. L. 111–240, § 1601(3), redesignated par. (5), relating to description of steps taken to minimize the significant economic impact on small entities, as (6).

Pub. L. 111–203, § 1100G(c)(3), added par. (6) relating to description of steps taken to minimize any additional cost of credit for small entities.

Pub. L. 111–203, § 1100G(c)(2), which directed amendment of par. (5) by substituting “; and” for period at end, was executed to par. (6), relating to description of steps taken to minimize the significant economic impact on small entities, to reflect the probable intent of Congress and the intervening redesignation of par. (5) as (6) by Pub. L. 111–240, § 1601(3). See above.

1996—Subsec. (a). Pub. L. 104–121, § 241(b)(1), amended subsec. (a) generally. Prior to amendment, subsec. (a) read as follows: “When an agency promulgates a final rule under section 553 of this title, after being required by that section or any other law to publish a general notice of proposed rulemaking, the agency shall prepare a final regulatory flexibility analysis. Each final regulatory flexibility analysis shall contain—

“(1) a succinct statement of the need for, and the objectives of, the rule;

“(2) a summary of the issues raised by the public comments in response to the initial regulatory flexibility analysis, a summary of the assessment of the agency of such issues, and a statement of any changes made in the proposed rule as a result of such comments; and

“(3) a description of each of the significant alternatives to the rule consistent with the stated objectives of applicable statutes and designed to minimize any significant economic impact of the rule on small entities which was considered by the agency, and a statement of the reasons why each one of such alternatives was rejected.”

Subsec. (b). Pub. L. 104–121, § 241(b)(2), substituted “such analysis or a summary thereof.” for “at the time of publication of the final rule under section 553 of this title a statement describing how the public may obtain such copies.”

Statutory Notes and Related SubsidiariesEffective Date of 2010 Amendment

Amendment by Pub. L. 111–203 effective on the designated transfer date, see section 1100H of Pub. L. 111–203, set out as a note under section 552a of this title.

Effective Date of 1996 Amendment

Amendment by Pub. L. 104–121 effective on expiration of 90 days after Mar. 29, 1996, but inapplicable to interpretative rules for which a notice of proposed rulemaking was published prior to Mar. 29, 1996, see section 245 of Pub. L. 104–121, set out as a note under section 601 of this title.

Effective Date

Section effective Jan. 1, 1981, except that the requirements of this section applicable only to rules for which a notice of proposed rulemaking was issued on or after Jan. 1, 1981, see section 4 of Pub. L. 96–354, set out as a note under section 601 of this title.

Notes of Decisions
Cited in 91 cases (10 in the last 5 years), 1949–2026 · leading case: National Association for Fixed Annuities v. United States Department of Labor
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National Association for Fixed Annuities v. United States Department of Labor (2016) dcd · cites it 10× “, and the Regulatory Flexibility Act (“RFA”), 5 U.S.C. § 604 et seq., challenging three final rules promulgated by the Department of Labor on April 8, 2016.”
Zero Zone, Inc. v. United States Department of Energy (2016) ca7 · cites it 4× “” 5 U.S.C. § 604 (a). Accordingly, DOE included such an analysis in its final rule.”
Associated Fisheries of Maine, Inc. v. Daley (1997) ca1 · cites it 5× “at 864-66 (codified as amended at 5 U.S.C. §§ 604 (a), 611(a)(1) (Supp.1997)).”
Nicopure Labs, LLC v. Food and Drug Administration (2017) dcd · cites it 5× “2009), citing 5 U.S.C. § 604 . As the Court of Appeals has explained: Such an analysis must meet certain statutory requirements.”
United States Telecom Ass'n v. Federal Communications Commission (2016) cadc · cites it 2× “See 5 U.S.C. § 604 (a). We lack jurisdiction to entertain this argument.”
Council For Urological Interes v. Sylvia Mathews Burwell (2015) cadc · cites it 4× “5 U.S.C. § 604 (a)(6). This process is aimed at “assur[ing] that such proposals are given serious consideration.”
American Health Care Ass'n v. Burwell (2016) msnd · cites it 2× “” 5 U.S.C. § 604 (a)(6). The agency may omit this analysis if “the head of the agency certifies that the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities.”
North Carolina Fisheries Ass'n, Inc. v. Gutierrez (2007) dcd · cites it 2× “” 5 U.S.C. § 604 (a)(5). The RFA authorizes judicial review of an agency’s compliance with many but not all of the statutory requirements.”
National Telephone Cooperative Ass'n v. Federal Communications Commission (2009) cadc · cites it 2× “See 5 U.S.C. § 604 . The FCC responded that the Order in question was exempt from the Act because it constituted an interpretive rule.”
Alfa International Seafood, Inc. v. Pritzker (2017) dcd · cites it 3× “*35 In conjunction with publishing the Proposed Rule, the Department prepared both a draft Regulatory Impact Review, in compliance with Executive Order 12866, and an initial Regulatory Flexibility Analysis, as required under the -Regulatory Flexibility Act, 5 U.S.C. § 604 . Id.…”
NATIONAL ASS'N OF PSYCHIATRIC HEALTH SYSTEM v. Shalala (2000) dcd · cites it 6× “The agency must also perform a final regulatory flexibility analysis (“FRFA”) in its final rule, 5 U.S.C. § 604 (a), unless it again makes the requisite certification.”
National Ass'n of Mortgage Brokers v. Board of Governors of the Federal Reserve System (2011) dcd · cites it 3× “5 U.S.C. § 604 (a) (prior to Sept. 27, 2010 amendment).”
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— 5 U.S.C. § 604(a)(6) — 1 case
Nicopure Labs, LLC v. Food and Drug Administration (2017) dcd “2009), citing 5 U.S.C. § 604 . As the Court of Appeals has explained: Such an analysis must meet certain statutory requirements.”
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