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e-CFR data is current as of June 14, 2021

Amendment


42 CFR--PART 404

View Printed Federal Register page 86 FR 5753 in PDF format.

Amendment(s) published January 19, 2021, in 86 FR 5753

Effective Dates: Mar. 22, 2021

3. Add part 404 to subchapter A to read as follows:

PART 404—REVIEW OF REGULATIONS


Sec.

404.1   Retrospective Review of Existing Regulations

404.2-404.5   [Reserved]


Authority: 5 U.S.C. 301; 5 U.S.C. 610; 31 U.S.C. 9701; 42 U.S.C. 263a; 42 U.S.C. 273; 42 U.S.C. 300e; 42 U.S.C. 300e-5; 42 U.S.C. 300e-9; 42 U.S.C. 405(a), 42 U.S.C. 1302; 42 U.S.C. 1306; 42 U.S.C. 1315a; 42 U.S.C. 1320a-7; 42 U.S.C. 1320a-7j; 42 U.S.C. 1320b-8; 42 U.S.C. 1320b-12; 42 U.S.C. 1395; 42 U.S.C. 1395aa(m); 42 U.S.C. 1395cc; 42 U.S.C. 1395d(d); 42 U.S.C. 1395ddd; 42 U.S.C. 1395eee(f); 42 U.S.C. 1395f(b); 42 U.S.C. 1395ff; 42 U.S.C. 1395g; 42 U.S.C. 1395hh; 42 U.S.C. 1395i; 42 U.S.C. 1395i-3; 42 U.S.C. 1395l(a), (i), (n), and (t); 42 U.S.C. 1395jjj; 42 U.S.C. 1395kk; 42 U.S.C. 1395m; 42 U.S.C. 1395nn; 42 U.S.C. 1395rr; 42 U.S.C. 1395rr(b)(l); 42 U.S.C. 1395tt; 42 U.S.C. 1395w-5; 42 U.S.C. 1395w-101 through 1395w-152; 42 U.S.C. 1395ww; 42 U.S.C. 1395ww(k); 42 U.S.C. 1395x; 1395x(e), the sentence following 1395x(s)(11) through 1395x(s)(16)); 42 U.S.C. 1395x(v); 42 U.S.C. 1395y(a); 42 U.S.C. 1396r; 42 U.S.C. 1396r-8; 42 U.S.C. 1396u-4(f); 44 U.S.C. Chapter 35; Section 1331 of the Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148, 124 Stat. 119), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152, 124 Stat 1029); Pub. L. 112-202 amendments to 42 U.S.C. 263a; sec. 105, Pub. L. 114-10, 129 Stat. 87.

§404.1   Retrospective Review of Existing Regulations.

(a) This section applies to and shall be deemed to amend all regulations issued by the Secretary or his delegates or sub-delegates in this chapter.

(b) For purposes of this section,

(1) Assess shall refer to a determination by the Department, in consultation with other Federal agencies as appropriate, as to whether the Sections issued as part of the same rulemaking (and any amendments or additions that may have been added thereafter) currently have a significant economic impact upon a substantial number of small entities.

(2) Review shall refer to a process conducted by the Department, in consultation with other Federal agencies as appropriate, the purpose of which shall be to determine whether Sections that were issued as part of the same rulemaking (and any amendments or additions that may have been issued thereafter) should be continued without change, or should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize any significant economic impact of the Sections upon a substantial number of small entities.

(3) Section (when capitalized) shall mean a section of the Code of Federal Regulations. For example, 42 CFR 2.13 is a Section, and 42 CFR 2.14 is another Section (see 1 CFR 21.11).

(4) Year of the Section's promulgation shall mean the year the Section first became effective, irrespective of whether it was subsequently amended.

(5) Significant economic impact upon a substantial number of small entities shall have the meaning of that term in section 610 of title 5 of the United States Code.

(c)(1) Unless a Section expires earlier or is rescinded, all Sections issued by the Secretary or his delegates or sub-delegates in this chapter shall expire at the end of:

(i) Five calendar years after the year that this section first becomes effective;

(ii) Ten calendar years after the year of the Section's promulgation; or

(iii) Ten calendar years after the last year in which the Department assessed and (if review of the Section is required pursuant to paragraph (d) of this section) reviewed the Section, whichever is latest.

(2) The last year in which the Department assessed and (if review of the Section is required) reviewed the Section shall be the year during which the findings of the assessment and (if required) the review of a Section are published in the Federal Register pursuant to paragraph (f) of this section.

(3)(i) If, prior to the expiration of a Section under paragraph (c)(1) of this section, the Secretary makes a written determination that the public interest requires continuation of the Section in force beyond the date on which the Section would otherwise expire under paragraph (c)(1), the Secretary may continue the Section in force one time for a period stated in the determination, which shall not exceed one calendar year.

(ii) The Department shall promptly publish in the Federal Register any written determination under paragraph (c)(3)(i) of this section.

(iii) The authority of the Secretary under paragraph (c)(3)(i) of this section is not delegable and may be exercised only by the Secretary or, when the office of the Secretary is vacant or the Secretary has become unable to perform the functions and duties of the office of the Secretary, by the individual acting as Secretary in accordance with the law.

(d) The Department is required to review those rulemakings (and any amendments or additions that may have been added thereafter) that the Department assesses have a significant economic impact upon a substantial number of small entities. In reviewing rulemakings to minimize any significant economic impact on a substantial number of small entities in a manner consistent with the stated objectives of applicable statutes, the Department's review shall consider the following factors:

(1) The continued need for the rulemaking, consideration of which shall include but not be limited to the extent to which the rulemaking defines terms or sets standards used in or otherwise applicable to other Federal rules;

(2) The nature of complaints or comments received concerning the rulemaking from the public;

(3) The complexity of the rulemaking;

(4) The extent to which the rulemaking overlaps, duplicates or conflicts with other Federal rules, and, to the extent feasible, with State and local governmental rules;

(5) The degree to which technology, economic conditions, or other factors have changed in the area affected by the rulemaking since the rulemaking was promulgated or the last time the rulemaking was reviewed by the Department; and

(6) Whether the rulemaking complies with applicable law.

(e) If the review concludes the Section should be amended or rescinded, the Department shall have two years from the date that the findings of the review are published in the Federal Register pursuant to paragraph (f) of this section to amend or rescind the Section. If the Secretary determines that completion of the amendment or rescission is not feasible by the established date, he shall so certify in a statement published in the Federal Register and may extend the completion date by one year at a time, no more than three times, for a total of not more than five years (inclusive of the initial two-year period).

(f) The results of all assessments and reviews conducted in a calendar year, including the full underlying analyses and data used to support the results (subject to any applicable privilege, protections for confidential business information, or explicit legal prohibition on disclosure), shall be published in a single document in the Federal Register during that calendar year. The document shall be organized in a manner that enables both the Department and the public to readily determine which assessments and reviews were conducted during that calendar year. The document shall also specify the year by which the next assessment (and, if required, the next review) of the Section shall be completed.

(g) Paragraph (c) of this section shall not apply to:

(1) Sections that are prescribed by Federal law, such that the Department exercises no discretion as to whether to promulgate the Section and as to what is prescribed by the Section. For Sections described in this paragraph (g)(1) that are adopted after the effective date of this section, the Federal law described in this paragraph (g)(1) shall be cited in the notice of adoption.

(2) Sections whose expiration pursuant to this section would violate any other Federal law.

(3) This section.

(4) Sections that involve a military or foreign affairs function of the United States.

(5) Sections addressed solely to internal agency management or personnel matters.

(6) Sections related solely to Federal Government procurement.

(7) Sections that were issued jointly with other Federal agencies, or that were issued in consultation with other agencies because of a legal requirement to consult with that other agency.

(8) The annual Medicare payment update rules.

(h) When the Department commences the process of performing an assessment or review, it shall state on a Department-managed website the Section(s) whose assessment or review it is commencing. It shall also announce once a month in the Federal Register those new assessments or reviews that it has commenced in the last month. The Department will create a docket on Regulations.gov for each assessment or review that the Department is conducting. The public will be able to submit comments to the dockets of each rulemaking being assessed or reviewed. Each docket shall specify the date by which comments must be received. There shall also be a general docket on Regulations.gov where the public can submit comments requesting that the Department assess or review a Section.

(i) Any provision of this section held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, shall be construed so as to continue to give the maximum effect to the provision permitted by law, unless such holding shall be one of utter invalidity or unenforceability, in which event the provision shall be severable from this section and shall not affect the remainder thereof or the application of the provision to persons not similarly situated or to dissimilar circumstances.

§§404.2-404.5   [Reserved]

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