[Congressional Record Volume 166, Number 211 (Monday, December 14, 2020)]
[Senate]
[Pages S7466-S7468]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                           TEXT OF AMENDMENTS

  SA 2705. Mr. McCONNELL (for Mr. Thune) proposed an amendment to the 
bill S. 2597, to require the National Oceanic and Atmospheric 
Administration to make certain operational models available to the 
public, and for other purposes; as follows:

        Strike all after the enacting clause and insert the 
     following:

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Learning Excellence and Good 
     Examples from New Developers Act of 2020'' or the ``LEGEND 
     Act of 2020''.

     SEC. 2. DEFINITIONS.

       In this Act:
       (1) Administration.--The term ``Administration'' means the 
     National Oceanic and Atmospheric Administration.
       (2) Administrator.--The term ``Administrator'' means the 
     Under Secretary of Commerce for Oceans and Atmosphere and 
     Administrator of the National Oceanic and Atmospheric 
     Administration.
       (3) Earth prediction innovation center.--The term ``Earth 
     Prediction Innovation Center'' means the community global 
     weather research modeling system described in paragraph 
     (5)(E) of section 102(b) of the Weather Research Forecasting 
     and Innovation Act of 2017 (15 U.S.C. 8512(b)), as 
     redesignated by section 4(g).
       (4) Model.--The term ``model'' means any vetted numerical 
     model and associated data assimilation of the Earth's system 
     or its components--
       (A) developed, in whole or in part, by scientists and 
     engineers employed by the Administration; or
       (B) otherwise developed using Federal funds.
       (5) Operational model.--The term ``operational model'' 
     means any model that has an output used by the Administration 
     for operational functions.
       (6) Suitable model.--The term ``suitable model'' means a 
     model that meets the requirements described in paragraph 
     (5)(E)(ii) of section 102(b) of the Weather Research 
     Forecasting and Innovation Act of 2017 (15 U.S.C. 8512(b)), 
     as redesignated by section 4(g), as determined by the 
     Administrator.

     SEC. 3. PURPOSES.

       The purposes of this Act are--
       (1) to support innovation in modeling by allowing 
     interested stakeholders to have easy and complete access to 
     the models used by the Administration, as the Administrator 
     determines appropriate; and
       (2) to use vetted innovations arising from access described 
     in paragraph (1) to improve modeling by the Administration.

     SEC. 4. PLAN AND IMPLEMENTATION OF PLAN TO MAKE CERTAIN 
                   MODELS AND DATA AVAILABLE TO THE PUBLIC.

       (a) In General.--The Administrator shall develop and 
     implement a plan to make available to the public the 
     following:
       (1) Operational models developed by the Administration.
       (2) Models that are not operational models, including 
     experimental and developmental models, as the Administrator 
     determines appropriate.
       (3) Applicable information and documentation for models 
     described in paragraphs (1) and (2).
       (4) Subject to section 7, all data owned by the Federal 
     Government and data that the Administrator has the legal 
     right to redistribute that are associated with models made 
     available to the public pursuant to the plan and used in 
     operational forecasting by the Administration, including--
       (A) relevant metadata;
       (B) data used for operational models used by the 
     Administration as of the date of the enactment of this Act; 
     and
       (C) a description of intended model outputs.
       (b) Accommodations.--In developing and implementing the 
     plan under subsection (a), the Administrator may make such 
     accommodations as the Administrator considers appropriate to 
     ensure that the public release of any model, information, 
     documentation, or data pursuant to the plan under subsection 
     (a) does not jeopardize--
       (1) national security;
       (2) intellectual property or redistribution rights, 
     including under titles 17 and 35, United States Code;
       (3) any trade secret or commercial or financial information 
     subject to section 552(b)(4) of title 5, United States Code;
       (4) any models or data that are otherwise restricted by 
     contract or other written agreement; or
       (5) the mission of the Administration to protect lives and 
     property.
       (c) Priority.--In developing and implementing the plan 
     under subsection (a), the Administrator shall prioritize 
     making available to the public the models described in 
     subsection (a)(1).
       (d) Exclusion of Certain Models.--In developing and 
     implementing the plan under subsection (a), the Administrator 
     may exclude models that the Administrator determines will be 
     retired or superseded in fewer than 5 years after the date of 
     the enactment of this Act.
       (e) Platforms.--In carrying out subsections (a) and (b), 
     the Administrator may

[[Page S7467]]

     use government servers, contracts or agreements with a 
     private vendor, or any other platform consistent with the 
     purpose of this Act.
       (f) Support Program.--The Administrator shall plan for and 
     establish a program to support infrastructure, including 
     telecommunications and technology infrastructure of the 
     Administration and the platforms described in subsection (e), 
     relevant to making operational models and data available to 
     the public pursuant to the plan under subsection (a).
       (g) Technical Correction.--Section 102(b) of the Weather 
     Research Forecasting and Innovation Act of 2017 (15 U.S.C. 
     8512(b)) is amended by redesignating the second paragraph (4) 
     (as added by section 4(a) of the National Integrated Drought 
     Information System Reauthorization Act of 2018 (Public Law 
     115-423; 132 Stat. 5456)) as paragraph (5).

     SEC. 5. REQUIREMENT TO REVIEW MODELS AND LEVERAGE 
                   INNOVATIONS.

       The Administrator shall--
       (1) consistent with the mission of the Earth Prediction 
     Innovation Center, periodically review innovations and 
     improvements made by persons outside the Administration to 
     the operational models made available to the public pursuant 
     to the plan under section 4(a) in order to improve the 
     accuracy and timeliness of forecasts of the Administration; 
     and
       (2) if the Administrator identifies an innovation for a 
     suitable model, develop and implement a plan to use the 
     innovation to improve the model.

     SEC. 6. REPORT ON IMPLEMENTATION.

       (a) In General.--Not later than 2 years after the date of 
     the enactment of this Act, the Administrator shall submit to 
     the appropriate congressional committees a report on the 
     implementation of this Act that includes a description of--
       (1) the implementation of the plan required by section 4;
       (2) the process of the Administration under section 5--
       (A) for engaging with interested stakeholders to learn what 
     innovations those stakeholders have found;
       (B) for reviewing those innovations; and
       (C) for operationalizing innovations to improve suitable 
     models.
       (b) Appropriate Congressional Committees Defined.--In this 
     section, the term ``appropriate congressional committees'' 
     means--
       (1) the Committee on Commerce, Science, and Transportation 
     and the Committee on Appropriations of the Senate; and
       (2) the Committee on Science, Space, and Technology and the 
     Committee on Appropriations of the House of Representatives.

     SEC. 7. PROTECTION OF NATIONAL SECURITY INTERESTS.

       (a) In General.--Notwithstanding any other provision of 
     this Act, the Administrator, in consultation with the 
     Secretary of Defense, as appropriate, may withhold any model 
     or data if the Administrator determines doing so to be 
     necessary to protect the national security interests of the 
     United States.
       (b) Rule of Construction.--Nothing in this Act shall be 
     construed to supersede any other provision of law governing 
     the protection of the national security interests of the 
     United States.
                                 ______
                                 
  SA 2706. Mr. McCONNELL (for Mr. Wicker) proposed an amendment to the 
bill H.R. 4704, to direct the Director of the National Science 
Foundation to support multidisciplinary research on the science of 
suicide, and to advance the knowledge and understanding of issues that 
may be associated with several aspects of suicide including intrinsic 
and extrinsic factors related to areas such as wellbeing, resilience, 
and vulnerability; as follows:

        Strike all after the enacting clause and insert the 
     following:

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Advancing Research to 
     Prevent Suicide Act''.

     SEC. 2. FINDINGS.

       Congress finds the following:
       (1) The rate of Americans dying by suicide is on the rise, 
     increasing 10.7 to 14.0 deaths per 100,000 people from 2001 
     to 2017.
       (2) Suicide is the tenth-leading cause of death among 
     people in the United States and the second-leading cause of 
     death for young people between the ages of 15 and 34.
       (3) The National Science Foundation funds research that is 
     improving our basic understanding of factors with potential 
     relevance to suicide, including potential relevance to 
     prevention and treatment.
       (4) Despite progress in mental health research, current 
     gaps exist in scientific understanding and basic knowledge of 
     human neural, genetic, cognitive, perceptual, behavioral, 
     social, and environmental factors with potential relevance to 
     suicide.

     SEC. 3. NATIONAL SCIENCE FOUNDATION RESEARCH.

       (a) In General.--The Director of the National Science 
     Foundation, in consultation with the Director of the National 
     Institutes of Health and the Director of the National 
     Institute of Mental Health and taking into consideration 
     prioritized research agendas or strategic plans, as 
     appropriate, shall, subject to the availability of 
     appropriations, award grants on a competitive, merit-reviewed 
     basis to institutions of higher education (or consortia of 
     such institutions) to support multidisciplinary, fundamental 
     research with potential relevance to suicide, including 
     potential relevance to prevention and treatment, including, 
     but not limited to--
       (1) basic understanding of human social behavior;
       (2) the neural basis of human cognition;
       (3) basic understanding of cognitive, linguistic, social, 
     cultural, and biological processes related to human 
     development across the lifespan;
       (4) basic understanding of perceptual, motor, and cognitive 
     processes, and their interaction, in typical human behavior; 
     and
       (5) basic understanding of the relevance of drug and 
     alcohol abuse.
       (b) Encouraging Applications From Early Career 
     Researchers.--To promote the development of early career 
     researchers, in awarding funds under subsection (a), the 
     Director of the National Science Foundation shall encourage 
     applications submitted by early career researchers, including 
     doctoral students or postdoctoral researchers.
                                 ______
                                 
  SA 2707. Mr. McCONNELL (for Mr. Alexander) proposed an amendment to 
the bill S. 1636, to amend the Federal Food, Drug, and Cosmetic Act 
with respect to the scope of new chemical exclusivity; as follows:

        Strike all after the enacting clause and insert the 
     following:

     SECTION 1. CLARIFYING THE MEANING OF NEW CHEMICAL ENTITY.

       (a) In General.--Chapter V of the Federal Food, Drug, and 
     Cosmetic Act is amended--
       (1) in section 505 (21 U.S.C. 355)--
       (A) in subsection (c)(3)(E), by striking ``active 
     ingredient (including any ester or salt of the active 
     ingredient)'' each place it appears and inserting ``active 
     moiety (as defined by the Secretary in section 314.3 of title 
     21, Code of Federal Regulations (or any successor 
     regulations))'';
       (B) in subsection (j)(5)(F), by striking ``active 
     ingredient (including any ester or salt of the active 
     ingredient)'' each place it appears and inserting ``active 
     moiety (as defined by the Secretary in section 314.3 of title 
     21, Code of Federal Regulations (or any successor 
     regulations))'';
       (C) in subsection (l)(2)(A)--
       (i) by amending clause (i) to read as follows:
       ``(i) not later than 30 days after the date of approval of 
     such applications--
       ``(I) for a drug, no active moiety (as defined by the 
     Secretary in section 314.3 of title 21, Code of Federal 
     Regulations (or any successor regulations)) of which has been 
     approved in any other application under this section; or
       ``(II) for a biological product, no active ingredient of 
     which has been approved in any other application under 
     section 351 of the Public Health Service Act; and''; and
       (ii) in clause (ii), by inserting ``or biological product'' 
     before the period;
       (D) by amending subsection (s) to read as follows:
       ``(s) Referral to Advisory Committee.--The Secretary 
     shall--
       ``(1) refer a drug or biological product to a Food and Drug 
     Administration advisory committee for review at a meeting of 
     such advisory committee prior to the approval of such drug or 
     biological if it is--
       ``(A) a drug, no active moiety (as defined by the Secretary 
     in section 314.3 of title 21, Code of Federal Regulations (or 
     any successor regulations)) of which has been approved in any 
     other application under this section; or
       ``(B) a biological product, no active ingredient of which 
     has been approved in any other application under section 351 
     of the Public Health Service Act; or
       ``(2) if the Secretary does not refer a drug or biological 
     product described in paragraph (1) to a Food and Drug 
     Administration advisory committee prior to such approval, 
     provide in the action letter on the application for the drug 
     or biological product a summary of the reasons why the 
     Secretary did not refer the drug or biological product to an 
     advisory committee prior to approval.''; and
       (E) in subsection (u)(1), in the matter preceding 
     subparagraph (A)--
       (i) by striking ``active ingredient (including any ester or 
     salt of the active ingredient)'' and inserting ``active 
     moiety (as defined by the Secretary in section 314.3 of title 
     21, Code of Federal Regulations (or any successor 
     regulations))''; and
       (ii) by striking ``same active ingredient'' and inserting 
     ``same active moiety'';
       (2) in section 512(c)(2)(F) (21 U.S.C. 360b(c)(2)(F)), by 
     striking ``active ingredient (including any ester or salt of 
     the active ingredient)'' each place it appears and inserting 
     ``active moiety (as defined by the Secretary in section 314.3 
     of title 21, Code of Federal Regulations (or any successor 
     regulations))'';
       (3) in section 524(a)(4) (21 U.S.C. 360n(a)(4)), by 
     amending subparagraph (C) to read as follows:
       ``(C) is for--
       ``(i) a human drug, no active moiety (as defined by the 
     Secretary in section 314.3 of title 21, Code of Federal 
     Regulations (or any successor regulations)) of which has been 
     approved in any other application under section 505(b)(1); or
       ``(ii) a biological product, no active ingredient of which 
     has been approved in any other application under section 351 
     of the Public Health Service Act.'';

[[Page S7468]]

       (4) in section 529(a)(4) (21 U.S.C. 21 U.S.C. 360ff(a)(4)), 
     by striking subparagraphs (A) and (B) and inserting the 
     following:
       ``(A) is for a drug or biological product that is for the 
     prevention or treatment of a rare pediatric disease;
       ``(B)(i) is for such a drug--
       ``(I) that contains no active moiety (as defined by the 
     Secretary in section 314.3 of title 21, Code of Federal 
     Regulations (or any successor regulations)) that has been 
     previously approved in any other application under subsection 
     (b)(1), (b)(2), or (j) of section 505; and
       ``(II) that is the subject of an application submitted 
     under section 505(b)(1); or
       ``(ii) is for such a biological product--
       ``(I) that contains no active ingredient that has been 
     previously approved in any other application under section 
     351(a) or 351(k) of the Public Health Service Act; and
       ``(II) that is the subject of an application submitted 
     under section 351(a) of the Public Health Service Act;''; and
       (5) in section 565A(a)(4) (21 U.S.C. 360bbb-4a(a)(4)), by 
     amending subparagraph (D) to read as follows:
       ``(D) is for--
       ``(i) a human drug, no active moiety (as defined by the 
     Secretary in section 314.3 of title 21, Code of Federal 
     Regulations (or any successor regulations)) of which has been 
     approved in any other application under section 505(b)(1); or
       ``(ii) a biological product, no active ingredient of which 
     has been approved in any other application under section 351 
     of the Public Health Service Act.''.
       (b) Technical Corrections.--Chapter V of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 351 et seq) is amended--
       (1) in section 505 (21 U.S.C. 355)--
       (A) in subsection (c)(3)(E), by repealing clause (i); and
       (B) in subsection (j)(5)(F), by repealing clause (i); and
       (2) in section 505A(c)(1)(A)(i)(II) (21 U.S.C. 
     355a(c)(1)(A)(i)(II)), by striking ``(c)(3)(D)'' and 
     inserting ``(c)(3)(E)''.

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