[House Report 117-551]
[From the U.S. Government Publishing Office]


117th Congress}                                            { Report

  2d Session  }        HOUSE OF REPRESENTATIVES	           { 117-551   

======================================================================
 
       VA INFRASTRUCTURE POWERS EXCEPTIONAL RESEARCH ACT OF 2021

                                _______
                                

 November 14, 2022.--Committed to the Committee of the Whole House on 
            the State of the Union and ordered to be printed

                                _______
                                

  Mr. Takano, from the Committee on Veterans' Affairs, submitted the 
                               following

                              R E P O R T

                        [To accompany H.R. 5721]

    The Committee on Veterans' Affairs, to whom was referred 
the bill (H.R. 5721) to amend title 38, United States Code, to 
improve research conducted within the Department of Veterans 
Affairs, and for other purposes, having considered the same, 
reports favorably thereon without amendment and recommends that 
the bill do pass.

                                CONTENTS

                                                                   Page
Amendment........................................................     1
Purpose and Summary..............................................     2
Background and Need for Legislation..............................     2
Hearings.........................................................     2
Subcommittee Consideration.......................................     3
Committee Consideration..........................................     3
Committee Votes..................................................     3
Section-by-Section Description...................................     3
Congressional Budget Office Cost Estimate........................     4
Committee Oversight Findings.....................................     4
Constitutional Authority Statement...............................     4
Earmark Statement................................................     4
Federal Mandates Statement.......................................     4
Advisory Committee Statement.....................................     5
Performance Goals................................................     5
Supplemental, Additional, Dissenting, and Minority Views.........     5
Applicability to Legislative Branch..............................     5
Statement on Duplication of Federal Programs.....................     5
Ramseyer Submission..............................................     5

                               Amendment

    No amendment was introduced or considered.

                          Purpose and Summary

    To amend title 38, United States Code, to improve research 
conducted within VA by authorizing the Office of Research and 
Development (ORD) in statute, removing burdensome paperwork 
requirements, expanding scientist hiring and compensation 
flexibility, studying the issue of dedicated research time, 
fixing a technical issue related to VA's Institutional Review 
Boards, and increasing transaction authority for the 
Department.

                  Background and Need for Legislation

    VA's research program is unique in focusing solely on 
health issues that affect veterans. Its intramural status 
requires that principal investigators on VA research projects 
be VA employee scientists, but ORD also partners with 
universities, other federal agencies, nonprofit organizations, 
and industry through additional funding mechanisms to further 
the program's impact on veterans. ORD has an impressive track 
record of discovery that ends up benefiting not only veterans, 
but also non-veterans in areas as far-ranging as post-traumatic 
stress disorder (PTSD), chronic pain, traumatic brain injuries 
(TBI), and cancer. It is remarkably well-positioned to conduct 
and translate research quickly (``from bench to bedside'') 
because it is housed within the largest integrated health care 
system in the United States, with a huge potential research 
population from which to draw and an electronic health record 
system useful for data collection and analysis.
    To more efficiently and effectively support its research 
mission, VA needs new legal authorities in the areas of 
researcher hiring and compensation, intergovernmental personnel 
waivers, paperwork reduction, and use of Institutional Review 
Boards. The Committee also authorized ORD in statute in this 
legislation to ensure that its existence and work continue to 
be supported.

                                Hearings

    On July 14, 2021, the Subcommittee on Health conducted a 
legislative hearing on various bills introduced during the 
116th Congress, including a draft legislation of H.R. 5721. The 
following witnesses testified: The Honorable Mark Takano, U.S. 
House of Representatives, 41st Congressional District of 
California; The Honorable Chris Pappas, U.S. House of 
Representatives, 1st Congressional District of California; The 
Honorable Conor Lamb, U.S. House of Representatives, 17th 
Congressional District of Pennsylvania; The Honorable Jason 
Crow, U.S. House of Representatives, 6th Congressional District 
of Colorado; The Honorable Lauren Underwood, U.S. House of 
Representatives, 14th Congressional District of Illinois. The 
Honorable Gregory F. Murphy, U.S. House of Representatives, 3rd 
Congressional District of North Carolina; Mr. David Perry, 
Chief Officer, Workforce Management and Consulting, Veterans 
Health Administration, U.S. Department of Veterans Affairs; Mr. 
Mike Fisher, MSW, Chief Officer, Readjustment Counseling 
Service, Veterans Health Administration, U.S. Department of 
Veterans Affairs; Mr. Marquis Barefield, Assistant National 
Legislative Director, Disabled American Veterans; Mr. Andy 
Blevins, Operations and Policy Director, Minority Veterans of 
America; Ms. Tammy Barlet, Deputy Director, National 
Legislative Service, Veterans of Foreign Wars.

                       Subcommittee Consideration

    H.R. 5721 was considered before the Subcommittee on Health 
during the above-mentioned legislative hearing on July 14, 
2021.

                        Committee Consideration

    On November 4, 2021, the full Committee met in an open 
session, a quorum being present, to consider H.R. 5721. The 
Committee ordered that H.R. 5721, as introduced, be ordered 
favorably reported to the House of Representatives.

                            Committee Votes

    In compliance with clause 3(b) of rule XIII of the Rules of 
the House of Representatives, there were no recorded votes 
taken on amendments or in connection with ordering H.R. 5721, 
as introduced, reported to the House. A motion by Ranking 
Member Bost of Illinois to report H.R. 5721, as introduced, 
favorably to the House of Representatives was adopted by voice 
vote.

                     Section-by-Section Description

    Sec. 1. Short title. This Act may be cited as the ``VA 
Infrastructure Powers Exceptional Research Act of 2021'' or the 
``VIPER Act of 2021''.
    Sec. 2. Inapplicability of Paperwork Reduction Act. This 
section mandates that the Paperwork Reduction Act shall not 
apply to VA research activities. The requirements of the 
Paperwork Reduction Act have proven extremely burdensome for VA 
researchers, and VA's scientific activities should be made 
exempt in line with how research activities at other agencies 
(including the National Institutes of Health) have already been 
made exempt.
    Sec. 3. Research and development. This section authorizes 
VA's existing Office of Research and Development in statute. It 
also allows the Secretary to waive the limit on the period and 
number of intergovernmental personnel performing research 
duties at VA (current limits are of shorter duration than 
frequently necessary for optimally conducting research, 
particularly longitudinal research). This section also fixes a 
current problem with how VA researchers may be paid for 
conducting research outside of their VA hours, as long as 
certain criteria are met (e.g. the scientist is a VA researcher 
and the outside research is approved by VA).
    Sec. 4. Expansion of hiring authorities for certain classes 
of research occupations. This section allows VA to hire for 
categories of employees not already authorized: 
``statisticians, economists, informaticists, [and] data 
scientists . . .'' These are critical positions for VA's 
intramural research program.
    Sec. 5. Other transaction authority. This section allows 
the VA Secretary more options for entering into agreements with 
other entities for the purpose of research, if VA's current 
mechanisms (procurement contract, grant agreement, or 
cooperative agreement) are deemed inappropriate.
    Sec. 6. Authorizing a Career Development Award grant 
program for medical research at R3 research institutions. This 
section authorizes VA to offer a Career Development Award (CDA) 
for scientists at ``R3'' academic institutions (those without 
tier 1 research programs that already receive the largest 
percentage of federal scientific grant funding). This would 
parallel VA's existing CDA for scientists at historically Black 
colleges and universities, to further expand the scientific 
workforce pipeline for VA.
    Sec. 7. Comptroller General study on dedicated research 
time for certain personnel of the Department of Veterans 
Affairs. This mandates a GAO study of how VA provides its 
clinician-scientists with dedicated time for research (a common 
promise when these employees are hired) and what the effects of 
current policies are on recruitment, retention, and research 
productivity.
    Sec. 8. Clerical amendment. VA requested this section as a 
technical fix to the provision setting up new VA authorities 
for Institutional Review Boards in the Commander John Scott 
Hannon Veterans Mental Health Care Improvement Act of 2020.

               Congressional Budget Office Cost Estimate

    Pursuant to clause 3(c)(2) of House rule XIII and section 
308(a) of the Congressional Budget Act of 1974, and pursuant to 
clause (3)(c)(3) of House rule XIII and section 402 of the 
Congressional budget Act of 1974, the Committee has requested 
but not received from the Director of Congressional Budget 
Office a budgetary analysis and a cost estimate of this bill.

                      Committee Oversight Findings

    In compliance with clause 3(c)(1) of rule XIII and clause 
(2)(b)(1) of rule X of the Rules of the House of 
Representatives, the Committee's oversight findings and 
recommendations are reflected in the descriptive portions of 
this report.

                   Constitutional Authority Statement

    Pursuant to Article I, section 8 of the United States 
Constitution, H.R. 5721, as amended is authorized by Congress' 
power to ``provide for the common Defense and general Welfare 
of the United States.''

                           Earmark Statement

    H.R. 5721, as amended does not contain any Congressional 
earmarks, limited tax benefits, or limited tariff benefits as 
defined in clause 9 of rule XXI of the Rules of the House of 
Representatives.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates regarding H.R. 5721, as introduced, prepared by the 
Director of the Congressional Budget Office pursuant to section 
423 of the Unfunded Mandates Reform Act. https://
link.springer.com/article/10.1007/s10611-020-09911-4

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act would be created by H.R. 
5721, as amended.

                           Performance Goals

    In accordance with clause 3(c)(4) of rule XIII of the Rules 
of the House of Representatives, the Committee's performance 
goals and objectives include assessing whether the new 
authorities granted to VA result in increased hiring and 
retention of researchers, less burdensome research reporting 
processes, improved use of VA Institutional Review Boards, and 
recommendations to dedicate research time for clinician-
scientists.

        Supplemental, Additional, Dissenting, and Minority Views

    There were no supplemental views filed with this report.

                  Applicability to Legislative Branch

    The Committee finds that H.R. 5721, as introduced, does not 
relate to the terms and condition of employment or access to 
public services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

              Statement on Duplication of Federal Programs

    Pursuant to clause 3(c)(5) of rule XIII of the Rules of the 
House of Representatives, the Committee finds that no provision 
of H.R. 5721, as amended establishes or reauthorizes a program 
of the Federal Government known to be duplicative of another 
Federal program, a program that was included in any report from 
the Government Accountability Office to Congress pursuant to 
section 21 of Public Law 111-139, or a program related to a 
program identified in the most recent Catalog of Federal 
Domestic Assistance.

                          Ramseyer Submission


         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italics, and existing law in which no 
change is proposed is shown in roman):

                      TITLE 38, UNITED STATES CODE



           *       *       *       *       *       *       *
PART I--GENERAL PROVISIONS

           *       *       *       *       *       *       *


                           CHAPTER 1--GENERAL

Sec.
101. Definitions.
     * * * * * * *
120. Inapplicability of Paperwork Reduction Act.

           *       *       *       *       *       *       *


Sec. 120. Inapplicability of Paperwork Reduction Act

  Subchapter I of chapter 35 of title 44, United States Code 
(commonly known as the ``Paperwork Reduction Act'') shall not 
apply to research activities of the Department, including 
activities under subchapter V of chapter 73.

           *       *       *       *       *       *       *


PART V--BOARDS, ADMINISTRATIONS, AND SERVICES

           *       *       *       *       *       *       *


 CHAPTER 73--VETERANS HEALTH ADMINISTRATION--ORGANIZATION AND FUNCTIONS

                       SUBCHAPTER I--ORGANIZATION

Sec.
7301. Functions of Veterans Health Administration: in general.
     * * * * * * *

                 Subchapter V--Research and Development

7381. Office of Research and Development.
7382. Research personnel.

           *       *       *       *       *       *       *


                 SUBCHAPTER V--RESEARCH AND DEVELOPMENT

Sec. 7381. Office of Research and Development

  (a) Office of Research and Development.--There is in the 
Veterans Health Administration an Office of Research and 
Development (in this section referred to as the ``Office'').
  (b) Purposes.--The function of the Office is to serve 
veterans through a full spectrum of research (including pre-
clinical, clinical, and health systems science), technology 
transfer, and application.
  (c) Chief Research and Development Officer.--The head of the 
Office is the Chief Research and Development Officer.
  (d) Organization and Personnel.--The Office shall be 
organized in such manner, and its personnel shall perform such 
duties and have such titles, as the Secretary may prescribe.

Sec. 7382. Research personnel

  (a) Waiver of Intergovernmental Personnel Act Mobility 
Program Limits.--The Secretary may waive the limit on the 
period and number of assignments required under section 3372(a) 
of title 5 with respect to an individual who performs research 
for the Department under the mobility program under subchapter 
VI of chapter 33 of such title (commonly referred to as the 
``Intergovernmental Personnel Act Mobility Program'').
  (b) Outside Earned Income for Research for the Department.--
(1) Compensation from a nonprofit corporation established under 
subchapter IV of this chapter, or a university affiliated with 
the Department, may be paid, without regard to section 209 of 
title 18, to an employee described in paragraph (2), for 
research conducted pursuant to section 7303 of this title if--
          (A) the research has been approved in accordance with 
        procedures prescribed by the Under Secretary for 
        Health;
          (B) the employee conducts research under the 
        supervision of personnel of the Department; and
          (C) the Secretary agreed to the terms of such 
        compensation in writing.
  (2) An employee described in this subsection is an employee 
who has an appointment within the Department, whether with or 
without compensation, and without regard to the source of such 
compensation.

           *       *       *       *       *       *       *


CHAPTER 74--VETERANS HEALTH ADMINISTRATION--PERSONNEL

           *       *       *       *       *       *       *


                       SUBCHAPTER I--APPOINTMENTS

Sec. 7401. Appointments in Veterans Health Administration

  There may be appointed by the Secretary such personnel as the 
Secretary may find necessary for the health care of veterans 
(in addition to those in the Office of the Under Secretary for 
Health appointed under section 7306 of this title), as follows:
          (1) Physicians, dentists, podiatrists, chiropractors, 
        optometrists, registered nurses, physician assistants, 
        and expanded-function dental auxiliaries.
          (2) Scientific and professional personnel, such as 
        microbiologists, chemists, and biostatisticians.
          (3) Audiologists, licensed hearing aid specialists, 
        speech pathologists, and audiologist-speech 
        pathologists, biomedical engineers, certified or 
        registered respiratory therapists, dietitians, licensed 
        physical therapists, licensed practical or vocational 
        nurses, nurse assistants, medical instrument 
        technicians, medical records administrators or 
        specialists, medical records technicians, medical 
        technologists, dental hygienists, dental assistants, 
        nuclear medicine technologists, occupational 
        therapists, occupational therapy assistants, 
        kinesiotherapists, orthotist-prosthetists, pharmacists, 
        pharmacy technicians, physical therapy assistants, 
        prosthetic representatives, psychologists, diagnostic 
        radiologic technologists, therapeutic radiologic 
        technologists, social workers, marriage and family 
        therapists, licensed professional mental health 
        counselors, blind rehabilitation specialists, blind 
        rehabilitation outpatient specialists, statisticians, 
        economists, informaticists, data scientists, and and 
        such other classes of health care occupations as the 
        Secretary considers necessary for the recruitment and 
        retention needs of the Department subject to the 
        following requirements:
                  (A) Such other classes of health care 
                occupations--
                          (i) are not occupations relating to 
                        administrative, clerical, or physical 
                        plant maintenance and protective 
                        services;
                          (ii) would otherwise receive basic 
                        pay in accordance with the General 
                        Schedule under section 5332 of title 5;
                          (iii) provide, as determined by the 
                        Secretary, direct patient care services 
                        or services incident to direct patient 
                        services; and
                          (iv) would not otherwise be available 
                        to provide medical care or treatment 
                        for veterans.
                  (B) Not later than 45 days before the 
                Secretary appoints any personnel for a class of 
                health care occupations that is not 
                specifically listed in this paragraph, the 
                Secretary shall submit to the Committee on 
                Veterans' Affairs of the Senate, the Committee 
                on Veterans' Affairs of the House of 
                Representatives, and the Office of Management 
                and Budget notice of such appointment.
                  (C) Before submitting notice under 
                subparagraph (B), the Secretary shall solicit 
                comments from any labor organization 
                representing employees in such class and 
                include such comments in such notice.
          (4) Directors of medical centers and directors of 
        Veterans Integrated Service Networks with demonstrated 
        ability in the medical profession, in health care 
        administration, or in health care fiscal management.

           *       *       *       *       *       *       *

                              ----------                              


COMMANDER JOHN SCOTT HANNON VETERANS MENTAL HEALTH CARE IMPROVEMENT ACT 
                                OF 2019



           *       *       *       *       *       *       *
TITLE VII--OTHER MATTERS

           *       *       *       *       *       *       *


SEC. 704. USE BY DEPARTMENT OF VETERANS AFFAIRS OF COMMERCIAL 
                    INSTITUTIONAL REVIEW BOARDS IN SPONSORED [RESEARCH] 
                     CLINICAL TRIALS.

  (a) In General.--Not later than 90 days after the date of the 
enactment of this Act, the Secretary of Veterans Affairs shall 
complete all necessary policy revisions within the directive of 
the Veterans Health Administration numbered 1200.05 and titled 
``Requirements for the Protection of Human Subjects in 
Research'', to allow sponsored clinical [research] clinical of 
the Department of Veterans Affairs to use [accredited] 
commercial institutional review boards to review research 
proposal protocols of the Department.
  (b) Identification of Review Boards.--Not later than 90 days 
after the completion of the policy revisions under subsection 
(a), the Secretary shall--
          (1) [identify accredited] designate commercial 
        institutional review boards for use in connection with 
        sponsored clinical [research] trials of the Department; 
        and
          (2) establish a process to modify existing approvals 
        in the event that a commercial institutional review 
        board loses [its accreditation] such designation during 
        an ongoing clinical trial.
  (c) Report.--
          (1) In general.--Not later than 90 days after the 
        completion of the policy revisions under subsection 
        (a), and annually thereafter, the Secretary shall 
        submit to the Committee on Veterans' Affairs of the 
        Senate and the Committee on Veterans' Affairs of the 
        House of Representatives a report on all approvals of 
        commercial institutional review boards and central 
        Federal agency institutional review boards used by the 
        Department[, including central institutional review 
        boards and commercial institutional review boards] in 
        clinical investigations (as that term is defined in 
        section 50.3 of title 21, Code of Federal Regulations, 
        or successor regulation).
          (2) Elements.--The report required by paragraph (1) 
        shall include, at a minimum, the following:
                  (A) The name of each clinical trial with 
                respect to which the use of [an] such 
                institutional review board has been approved.
                  (B) The commercial or central Federal agency 
                institutional review board [or institutional 
                review boards] or boards used in the approval 
                process for each clinical trial.
                  (C) The amount of time between submission (as 
                determined by the Secretary) and approval.

           *       *       *       *       *       *       *


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