I 

117TH CONGRESS 

1ST SESSION H. R. 3716 

To require agencies to analyze how certain rules impact children, and for 

other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 4, 2021 

Mrs. CAROLYN B. MALONEY of New York (for herself, Ms. PRESSLEY, Ms. 

NORTON, Mr. RASKIN, Mr. COOPER, and Mr. KHANNA) introduced the 

following bill; which was referred to the Committee on the Judiciary, and 

in addition to the Committee on Oversight and Reform, for a period to 

be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee 

concerned 

A BILL 

To require agencies to analyze how certain rules impact 

children, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Children’s Protection Act of 2021’’. 

6 (b) TABLE OF CONTENTS.—The table of contents for 

7 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Initial regulatory children’s analysis. 


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Sec. 3. Final regulatory children’s analysis. 

Sec. 4. Exception, delay, and preparation of analyses. 

Sec. 5. Procedures for gathering comments. 

Sec. 6. Avoidance of duplicative or unnecessary analyses. 

Sec. 7. Reports. 

Sec. 8. Applicability. 

Sec. 9. Judicial review. 

Sec. 10. Definitions. 

1 SEC. 2. INITIAL REGULATORY CHILDREN’S ANALYSIS. 

2 (a) PUBLICATION AND PUBLIC COMMENT RE3 QUIRED.—Except as provided for in subsections (a) and 

4 (b) of section 4, with respect to any proposed applicable 

5 rule, the head of an agency shall include an initial regu6 latory children’s analysis, or a summary of the analysis, 

7 in the general notice of proposed rulemaking published in 

8 the Federal Register under section 553 of title 5, United 

9 States Code, or other applicable law, and make such anal10 ysis or summary available for public comment. 

11 (b) CONTENTS OF INITIAL ANALYSIS.—Each initial 

12 regulatory children’s analysis required under this section 

13 shall describe the impact of the proposed applicable rule 

14 on children and contain the following: 

15 (1) An estimate of the number of children who 

16 may be directly or indirectly negatively affected by 

17 the proposed rule. 

18 (2) An analysis of how children may be directly 

19 or indirectly negatively affected by the proposed ap20 plicable rule, including with respect to the following: 

21 (A) Physical safety. 


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1 (B) Mental, emotional, and physical health, 

2 including the unique vulnerabilities of children’s 

3 specific stages of development. 

4 (C) Relationship with and attachment to a 

5 parent, legal guardian, sibling, or other ex6 tended family, Tribe, or community member. 

7 (D) Well-being and security, including eco8 nomic security, education, and healthy develop9 ment. 

10 (E) Identity, including race, ethnicity, reli11 gion, gender, gender identity, sexual orienta12 tion, and immigration status. 

13 (3) Data sources and a description of any un14 certainties. 

15 (4) A description of the demographic groups of 

16 children negatively affected. 

17 (5) Any reasonably foreseeable projected in18 crease in negative health or educational outcomes for 

19 children, including reduced access to health insur20 ance, health care, and behavioral health care serv21 ices. 

22 (6) Any significant alternatives to the proposed 

23 applicable rule that could accomplish the stated ob24 jectives of the proposed applicable rule and that 


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1 minimize any negative impacts to children or that 

2 provide greater benefits to children. 

3 (c) REQUIREMENTS BEFORE PUBLICATION OF INI4 TIAL ANALYSIS.—Before the publication of an initial regu5 latory children’s analysis by an agency: 

6 (1) The head of the agency shall convene a re7 view panel for the proposed applicable rule con8 sisting of full-time Federal employees of the office 

9 within the agency responsible for carrying out the 

10 proposed applicable rule, 3 children’s representa11 tives, a board certified pediatrician, a member of the 

12 National Academy of Sciences with expertise in chil13 dren’s health, a licensed early childhood educator, 

14 and 1 career employee from the Office of Informa15 tion and Regulatory Affairs. 

16 (2) The review panel convened pursuant to 

17 paragraph (1) shall review any material related to 

18 the applicable rule that the agency has prepared in 

19 connection with the requirements of this Act, includ20 ing any draft proposed applicable rule, and collect 

21 advice and recommendations of each individual rep22 resentative identified by the agency on issues de23 scribed in subsection (b). 

24 (3) Not later than 60 days after the date on 

25 which an agency convenes a review panel pursuant 


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1 to paragraph (1), the review panel shall submit to 

2 the head of the agency a report on the comments of 

3 the children’s representatives and any findings on 

4 issues described in subsection (b). Such report shall 

5 be made public as part of the rulemaking record. 

6 (4) Where appropriate, the agency shall publish 

7 any modification of the proposed applicable rule, the 

8 initial regulatory children’s analysis, or the decision 

9 on whether an initial regulatory children’s analysis is 

10 required. 

11 (d) WAIVER OF REQUIREMENTS.—In consultation 

12 with the individuals identified in subsection (c)(1), the Ad13 ministrator may waive the requirements of paragraph (2), 

14 (3), or (4) of subsection (c) by including in the rulemaking 

15 record a written finding with reasons therefor that those 

16 requirements would not advance the effective participation 

17 of children’s representatives in the rulemaking process. 

18 For purposes of this subsection, the factors to be consid19 ered in making such a finding are as follows: 

20 (1) In developing a proposed applicable rule, 

21 the extent to which the agency consulted with indi22 viduals representing and advocating for affected chil23 dren with respect to the potential impacts of the ap24 plicable rule and took such concerns into consider25 ation. 


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1 (2) Special circumstances requiring prompt 

2 issuance of the applicable rule. 

3 SEC. 3. FINAL REGULATORY CHILDREN’S ANALYSIS. 

4 (a) PUBLICATION REQUIRED.—Except as provided 

5 for in subsections (a) and (b) of section 4, simultaneously 

6 with the promulgation of a final applicable rule under sec7 tion 553 of title 5, United States Code, or any other appli8 cable statue, the head of the agency shall publish a final 

9 regulatory children’s analysis, or a summary of the anal10 ysis, in the Federal Register. In a case in which only the 

11 summary is published, the head of the agency shall make 

12 the final regulatory children’s analysis available on a pub13 lic website of the agency and include a link to that website 

14 in the summary. 

15 (b) CONTENTS OF FINAL ANALYSIS.—Each final reg16 ulatory children’s analysis required under this section 

17 shall contain the following: 

18 (1) A statement of the significant issues raised 

19 by the public comments in response to the initial 

20 regulatory children’s analysis including the impacts 

21 on children and the regulatory analysis, a statement 

22 of the assessment by the agency of such issues, and 

23 a statement of any changes made to the proposed 

24 applicable rule as a result of such comments. 


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1 (2) An estimate of the number of children who 

2 may be directly or indirectly negatively impacted by 

3 the final applicable rule and the basis of such esti4 mate or a substantiated explanation of why such es5 timate is unavailable. 

6 (3) A description of the demographic groups of 

7 children impacted by the final applicable rule. 

8 (4) A description of the steps the agency has 

9 taken to minimize the negative impact on children, 

10 and to maximize the benefits to children, including 

11 a statement of the factual, policy, and legal reasons 

12 for selecting any alternative adopted in the final ap13 plicable rule and why any other alternative that had 

14 less negative impact on children’s health was not 

15 adopted. 

16 (5) An appendix containing the following: 

17 (A) Any draft of the proposed applicable 

18 rule submitted by the agency to the Office of 

19 Management and Budget for any interagency 

20 review process prior to proposal of any such 

21 rule and each document accompanying any such 

22 draft. 

23 (B) Each written comment to any draft 

24 described in subparagraph (A) by any other 


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1 agency and each written response to such writ2 ten comment by the Administrator. 

3 (C) Each draft of the final applicable rule 

4 submitted for such review process prior to pro5 mulgation and each written comment thereon 

6 and any document accompanying each such 

7 draft and any written response thereto. 

8 SEC. 4. EXCEPTION, DELAY, AND PREPARATION OF ANAL9 YSES. 

10 (a) EXCEPTION.—The requirements of sections 2 and 

11 3 do not apply if the head of an agency— 

12 (1) certifies that an applicable rule will not 

13 have a negative impact on a substantial number of 

14 children; and 

15 (2) publishes such certification in the Federal 

16 Register at the time of publication of general notice 

17 of proposed rulemaking for the applicable rule along 

18 with a statement providing details for the factual 

19 basis for such certification. 

20 (b) DELAYS.— 

21 (1) EMERGENCY.—The head of an agency may 

22 delay the completion of the requirements of section 

23 2 by publishing in the Federal Register, not later 

24 than the date of publication of the final applicable 

25 rule, a written finding that the final applicable rule 


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1 is being promulgated in response to an emergency 

2 that makes timely compliance impracticable. 

3 (2) IMPRACTICABILITY.—The head of an agen4 cy may delay the completion of the requirements of 

5 section 3 for a period of not more than 180 days 

6 after the date of publication in the Federal Register 

7 of a final applicable rule by publishing in the Fed8 eral Register with the final applicable rule, a written 

9 finding that the final applicable rule is being pro10 mulgated in response to an emergency that makes 

11 timely compliance with the provisions of section 3 

12 impracticable. If the agency has not prepared and 

13 published the final regulatory analysis as described 

14 in section 3 within 180 days after the date of publi15 cation of the final applicable rule, such applicable 

16 rule shall lapse and have no effect. 

17 (c) PREPARATION.— 

18 (1) IN GENERAL.—In complying with sections 2 

19 and 3, an agency shall include in any analysis— 

20 (A) a quantifiable or numerical description 

21 of the effects of a proposed and final applicable 

22 rule or alternatives to the proposed and final 

23 applicable rule; and 

24 (B) a qualitative analysis and description 

25 of the effects of a proposed and final applicable 


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1 rule or alternatives to the proposed and final 

2 applicable rule. 

3 (2) SPECIAL ATTENTION TO UNIQUE

4 VULNERABILITIES.—An agency shall consider the 

5 unique vulnerabilities of children, including the 

6 unique behaviors, exposure routes, developing bodies, 

7 and dependence on adults for their care, in pre8 paring the analysis and description described in 

9 paragraph (1). 

10 SEC. 5. PROCEDURES FOR GATHERING COMMENTS. 

11 For any applicable rule, the head of the agency pro12 mulgating the applicable rule shall assure that children’s 

13 representatives have been given an opportunity to partici14 pate in the rulemaking for the applicable rule through rea15 sonable use of techniques, including the following: 

16 (1) The inclusion in an advanced notice of pro17 posed rulemaking, if issued, of a statement that the 

18 proposed applicable rule may have a negative effect 

19 on a substantial number of children. 

20 (2) The issuance of the notice through an easily 

21 accessible publicly available press release or official 

22 statement. 

23 (3) The conduct of an open conference or a 

24 public hearing concerning the applicable rule for 


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1 children’s representatives, including soliciting and 

2 receiving comments through the internet. 

3 SEC. 6. AVOIDANCE OF DUPLICATIVE OR UNNECESSARY 

4 ANALYSES. 

5 (a) IN GENERAL.—An agency may perform the anal6 yses required by sections 2 and 3 in conjunction with any 

7 other required analysis, such as subchapter I of chapter 

8 35 of title 44, United States Code (commonly referred to 

9 as the Paperwork Reduction Act), or Executive Order 

10 12866 (relating to regulatory planning and review). 

11 (b) CONSOLIDATION OF RULES.—In order to avoid 

12 duplicative action, an agency may consider a series of 

13 closely related applicable rules as one rule for the purposes 

14 of sections 2, 3, 4, and 5. 

15 SEC. 7. REPORTS. 

16 (a) OIRA REPORT ON COMPLIANCE.—The Adminis17 trator shall monitor agency compliance with this Act and 

18 not less frequently than annually submit to the President, 

19 the Committee on Homeland Security and Governmental 

20 Affairs of the Senate, and the Committee on Oversight 

21 and Reform of the House of Representatives a report on 

22 such compliance. 

23 (b) AGENCY BIANNUAL SUBMISSION TO OFFICE OF

24 INFORMATION AND REGULATORY AFFAIRS.— 


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1 (1) IN GENERAL.—On a biannual basis, the 

2 head of each agency shall submit to the Adminis3 trator, in such a manner as the Administrator may 

4 reasonably require, a report on the following infor5 mation: 

6 (A) For each rule that the agency expects 

7 to propose or finalize during the following 6- 

8 month period: 

9 (i) A summary of the nature of the 

10 rule and justification for whether or not 

11 the rule will require an initial or final reg12 ulatory children’s analysis, including— 

13 (I) the regulation identifier num14 ber and the docket number for the 

15 rule; and 

16 (II) the objectives of and legal 

17 basis for the issuance of the rule, in18 cluding any statutory or judicial dead19 line and whether the agency plans to 

20 conduct an initial regulatory chil21 dren’s analysis during the rulemaking. 

22 (ii) The stage of the rulemaking as of 

23 the date on which the report is submitted. 

24 (iii) Whether the rule is subject to re25 view under section 3. 


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1 (2) PUBLIC AVAILABILITY.—Not later than 30 

2 days after the date on which the report is submitted 

3 pursuant to paragraph (1), the Administrator shall 

4 make such report publicly available on the internet. 

5 (c) OFFICE OF INFORMATION AND REGULATORY AF6 FAIRS PUBLICATIONS.— 

7 (1) CUMULATIVE ASSESSMENT OF AGENCY

8 RULEMAKING PUBLISHED ANNUALLY.— 

9 (A) PUBLICATION IN THE FEDERAL REG10 ISTER.—Not later than October 1 of each year, 

11 the Administrator shall publish in the Federal 

12 Register, for the previous year a report on the 

13 following: 

14 (i) Each report the Administrator re15 ceived from the head of each agency under 

16 subsection (b)(1). 

17 (ii) The number of rules and a list of 

18 each such rule— 

19 (I) that was proposed by each 

20 agency, including, for each such rule, 

21 an indication of whether the issuing 

22 agency conducted an initial regulatory 

23 children’s analysis of the rule; and 


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1 (II) that was finalized by each 

2 agency, including for each such rule 

3 an indication of whether— 

4 (aa) the issuing agency con5 ducted a final regulatory chil6 dren’s analysis of the rule; 

7 (bb) the agency claimed an 

8 exception from the procedures 

9 under section 4(a); or 

10 (cc) the rule was issued pur11 suant to a statutory mandate or 

12 the rulemaking is committed to 

13 agency discretion by law. 

14 (B) PUBLICATION ON THE INTERNET.— 

15 Not later than October 1 of each year, the Ad16 ministrator shall make publicly available on the 

17 internet the following: 

18 (i) The initial and final regulatory 

19 children’s analysis, if conducted, for each 

20 proposed rule or final rule issued by an 

21 agency for the previous year. 

22 (ii) The docket number and regulation 

23 identifier number for each proposed or 

24 final rule issued by an agency for the pre25 vious year. 


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1 (iii) The number of rules and a list of 

2 each rule reviewed by the Director of the 

3 Office of Management and Budget for the 

4 previous year, and the authority under 

5 which each such review was conducted. 

6 SEC. 8. APPLICABILITY. 

7 This Act shall apply with respect to any proposed ap8 plicable rule within the year before the date of enactment 

9 of this Act that has not been finalized as of the date of 

10 the enactment of this Act and any proposed applicable rule 

11 on or after the date of the enactment of this Act. 

12 SEC. 9. JUDICIAL REVIEW. 

13 In the case of an action brought under chapter 7 of 

14 title 5, United States Code, alleging that the head of an 

15 agency did not comply with the requirement under section 

16 2(a) or that the head of an agency’s determination that 

17 a rule was not an applicable rule was arbitrary, capricious, 

18 an abuse of discretion, or otherwise not in accordance with 

19 law, the reviewing court may not vacate a rule but may 

20 only remand the rule to the agency to comply with such 

21 section or review the determination, as applicable. 

22 SEC. 10. DEFINITIONS. 

23 In this Act: 


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1 (1) ADMINISTRATOR.—The term ‘‘Adminis2 trator’’ means the Administrator of the Office of In3 formation and Regulatory Affairs. 

4 (2) AGENCY.—The term ‘‘agency’’ has the 

5 meaning given that term in section 551 of title 5, 

6 United States Code. 

7 (3) APPLICABLE RULE.—The term ‘‘applicable 

8 rule’’ means a rule that may negatively affect, di9 rectly or indirectly, a substantial number of children. 

10 (4) CHILD.—The term ‘‘child’’ means a human 

11 from the moment immediately after birth up to an 

12 age of 18 years. 

13 (5) CHILDREN’S REPRESENTATIVE.—The term 

14 ‘‘children’s representative’’— 

15 (A) means a nonprofit organization or a 

16 municipal, State, or Federal agency, or Federal 

17 advisory committee that has the mission of pro18 tecting all children’s health and welfare or pro19 viding healthcare services to all children despite 

20 race, ethnicity, socioeconomic class, sexual ori21 entation, or other identification markers; and 

22 (B) does not include any trade association 

23 or for-profit entities. 

24 (6) NONPROFIT ORGANIZATION.—The term 

25 ‘‘nonprofit organization’’ means an organization that 


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1 is described in section 501(c)(3) of the Internal Rev2 enue Code of 1986 and is exempt from taxation 

3 under section 501(a) of such Code. 

4 (7) RULE.—The term ‘‘rule’’ has the meaning 

5 given that term in section 551 of title 5, United 

6 States Code, to which section 553 of title 5, United 

7 States Code, applies. 

8 (8) STATE.—The term ‘‘State’’ means each 

9 State of the United States, the District of Columbia, 

10 each commonwealth, territory, or possession of the 

11 United States, and each federally recognized Indian 

12 Tribe. 

13 (9) SUBSTANTIAL NUMBER OF CHILDREN.— 

14 The term ‘‘substantial number of children’’ means at 

15 least 500 children. 

Æ 


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