I 117th CONGRESS 1st Session H. R. 5520 IN THE HOUSE OF REPRESENTATIVES October 8, 2021 Mr. Jacobs of New York introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Public Health Service Act to increase due process and transparency at the National Library of Medicine in listing and delisting journals in MEDLINE (or any other current or successor databases or indices), and for other purposes.

1. Short title This Act may be cited as the Literature Selection Technical Review Committee Reform Act of 2021 . 2. Journal collection of National Library of Medicine Title IV of the Public Health Service Act ( 42 U.S.C. 281 et seq. ) is amended by inserting after section 467 of such Act ( 42 U.S.C. 286a–1 ) the following new section: 468. Journal collection (a) In general In acquiring, preserving, organizing, publishing, and disseminating journals through the National Library of Medicine, including through the Literature Selection Technical Review Committee (or any successor committee) and MEDLINE (or any other current or successor databases or indices), the Secretary shall comply with the requirements of this section. (b) Review metrics and methodologies (1) Specification of objective metric requirement The Secretary shall require the Literature Selection Technical Review Committee (or any successor committee) to evaluate the scientific and editorial character and quality of a journal based only on an objective scoring rubric. (2) Metrics and methodologies used to include and remove journals from collections The Secretary shall specify and make publicly available the objective metrics and methodologies pursuant to which the Library lists and removes journals in the Library’s collections, including— (A) all rubrics and other guidance documents used in carrying out a journal review; (B) the specific metrics used in determining the outcome of a journal review, including those related to a journal’s— (i) scope and coverage; (ii) editorial policies and processes; (iii) scientific and methodological rigor; (iv) production and administration; (v) impact; and (vi) any other issues taken into account in determining the review outcome; and (C) the methodology for determining the outcome of a journal review and for ensuring that the outcome is objective. (3) Initial specification The Secretary shall comply with this subsection beginning not later than 60 days after the date of enactment of this section. (c) Processes for and standards of review The Secretary shall specify and make publicly available the processes for and standards of review of journals, including— (1) the scope of review; (2) a timeline including detailed steps of the review; (3) any other guidelines used to ensure the objectivity of reviews; and (4) the process used to ensure journals selected for reevaluation are provided— (A) notice; (B) a clear description of why the journal was selected for reevaluation; and (C) an opportunity for the journal to address identified concerns prior to formal submission for reevaluation. (d) Ensuring independent advice and expertise Regarding the members of the Literature Selection Technical Review Committee (and any successor committee): (1) Independence The Secretary shall appoint the members without regard to political affiliation or political campaign activity. (2) Process The Secretary shall— (A) not less than annually, solicit nominations for potential members; and (B) before making an appointment— (i) provide a publicly accessible mechanism for interested persons to comment on the potential member; and (ii) take such comments into consideration. (e) Reevaluation process (1) Notification of intent to reevaluate Before selecting a journal for reevaluation for MEDLINE (or any other current or successor databases or indices), the Secretary shall— (A) notify the journal in writing of the Secretary’s intention to refer the journal to the Literature Selection Technical Review Committee (or any successor committee) for review; (B) provide the journal a list of concerns that form the basis for such referral; (C) provide the journal a period of 60 days, beginning on the date of such notification, to respond to the concerns forming the basis for the referral to the Literature Selection Technical Review Committee (or any successor committee) for review; and (D) provide for an independent review process that considers the concerns and the journal’s response and determines whether the concerns were resolved. (2) Concerns not resolved If a journal fails during the 60-day period described in paragraph (1)(C) to resolve to the Secretary’s satisfaction the concerns forming the basis for the referral to the Literature Selection Technical Review Committee (or any successor committee) for review, the Secretary shall— (A) provide a detailed explanation to the journal of the initial concerns and why the journal has not satisfactorily resolved such concerns; (B) provide the journal a reasonable opportunity to meet and discuss such concerns and the explanation required by subparagraph (A); and (C) after providing such explanation and opportunity to meet, issue a determination about whether the journal is to be referred to the Literature Selection Technical Review Committee (or a successor committee) for reevaluation. (3) Right to supplement application A journal selected for reevaluation pursuant to the process described under this subsection shall have the right to supplement its MEDLINE application through the provision of additional information and statements, which shall be presented to the Literature Selection Technical Review Committee (or a successor committee) during its consideration of the journal. (4) Right to be present A journal being reviewed by the Literature Selection Technical Review Committee (or a successor committee) pursuant to a referral under paragraph (2)(C) shall have the right to be present at such review. (5) Right to an explanation; period for appeal (A) In general If, upon review pursuant to this section, the Literature Selection Technical Review Committee (or any successor committee) recommends that a journal be removed from MEDLINE (or any other current or successor databases or indices), and the Secretary agrees with such recommendation and issues a decision to remove the journal, the journal shall have— (i) the right to receive detailed information regarding each reviewer’s objective score, any subsequent Literature Selection Technical Review Committee (or any successor committee) discussion, and a detailed explanation of the decision so the journal may address the concerns raised in subsequent applications; and (ii) a period of 60 days to appeal the Secretary’s decision. (B) No change to status during appeal During the 60-day period under subparagraph (A) and during an appeal under paragraph (6), the Secretary shall not make any change in the journal’s status with MEDLINE (or any other current or successor databases or indices). (6) Appeals (A) In general The Secretary shall establish and make publicly available a standardized process for journals to appeal a decision described in paragraph (5)(A). (B) Meeting Pursuant to the process established under subparagraph (A), the Literature Selection Technical Review Committee (or any successor committee) shall determine, at the Committee’s next meeting that takes place at least 30 days after an appeal is filed, whether to recommend that the Secretary’s decision to remove the journal involved should be reversed. Prior to the Committee making such a determination, the journal shall be afforded an opportunity to— (i) attend such meeting; (ii) present its appeal in person or, if it so chooses, in writing; and (iii) submit supplemental material in support of its appeal, which shall be provided to the Literature Selection Technical Review Committee (or any successor committee) for its review and consideration. (C) Final recommendation After meeting pursuant to subparagraph (B) with respect to a decision to remove a journal, the Literature Selection Technical Review Committee (or any successor committee) shall— (i) make a final recommendation with respect such removal; and (ii) concurrently with the transmission of such final recommendation to the Secretary, notify the journal of such final recommendation. (D) Final decision Not later than 30 days after receiving a final recommendation pursuant to subparagraph (C), the Secretary shall— (i) make a final decision as to whether the journal should be removed from MEDLINE (or any other current or successor databases or indices); and (ii) notify the journal of such decision, including by providing a detailed explanation of such decision. (E) Post-decision period If the Secretary decides pursuant to subparagraph (D) to remove a journal, the Secretary shall— (i) notify the journal in writing and provide the journal a period of 30 days from the date of such notice to inform its authors, subscribers, and other relevant parties that the journal will no longer be listed on MEDLINE; and (ii) refrain from removing the journal until the conclusion of such 30-day period. (F) Right to reapply Any journal that is removed pursuant to this section from MEDLINE (or any other current or successor databases or indices) shall, beginning on the date that is one year after the date of its removal, have the right to reapply, but not more than once each year, to be re-listed in MEDLINE (or any successor databases or indices). (7) Previously delisted journals Any journal that was removed from MEDLINE on or after January 1, 2016, and before the date of enactment of this section, shall be given an opportunity during the 60-day period following such date of enactment to appeal the removal decision. Any such appeal shall be resolved pursuant to the process described in paragraph (6). .