[Federal Register Volume 85, Number 76 (Monday, April 20, 2020)]
[Rules and Regulations]
[Pages 21780-21783]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07367]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

42 CFR Part 24

RIN 0991-AC12


Silvio O. Conte Senior Biomedical Research and Biomedical Product 
Assessment Service

AGENCY: Public Health Service, Assistant Secretary for Administration, 
Office of the Secretary, HHS.

ACTION: Final rule.

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SUMMARY: The U.S. Department of Health and Human Services (HHS) is 
issuing this final rule to amend regulations for the Senior Biomedical 
Research Service, a component of the Public Health Service. These 
amendments are necessary to ensure consistency with amendments made to 
the 21st Century Cures Act to improve scientific expertise and outreach 
within the Service

DATES: The rule is effective on April 20, 2020.

FOR FURTHER INFORMATION CONTACT: Policy and Accountability Division, 
Office of Human Resources, Assistant Secretary for Administration, 
Department of Health and Human Services, Hubert H. Humphrey Building, 
200 Independence Avenue SW, Suite 801, Washington, DC 20201.

SUPPLEMENTARY INFORMATION: The U.S. Department of Health and Human 
Services (HHS) is issuing this final rule to amend regulations under 42 
CFR part 24 for the Senior Biomedical Research Service, a component of 
the Public Health Service. These amendments are necessary to ensure 
consistency with amendments made to section 228 of the Public Health 
Service Act (codified at 42 U.S.C. Sec. 237) by section 3071 of the 
21st Century Cures Act to improve scientific expertise and outreach 
within the Service. HHS is publishing this final rule without 
previously publishing a proposed rule because HHS has determined that 
the rule qualifies for exemption from notice-and-comment rulemaking 
under section 4 of the Administrative Procedure Act, 5 U.S.C. 553 (Pub. 
L. 79-404, enacted June 11, 1946) (APA), both because it is a ``matter 
relating to agency management'' under section 553(a)(2) \1\ and a 
``rule of agency organization, procedure or practice'' under section 
553(b)(3)(A).
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    \1\ Although HHS's predecessor agency, the U.S. Department of 
Health, Education, and Welfare (HEW), waived the APA's exemption to 
the requirement for notice and comment rulemaking for ``public 
property, loans, grants, benefits, or contracts'' in section 
553(a)(2), see ``Public Participation in Rule Making,'' 36 FR 2532 
(Feb. 5, 1971), HEW did not waive the exemption in section 553(a)(2) 
for ``matter[s] relating to agency management or personnel.''
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    The Senior Biomedical Research Service (Service) was originally 
established in the Public Health Service by Section 304 of Public Law 
101-509, adding section 228 to the Public Health Service Act (PHS Act). 
HHS promulgated regulations at 42 CFR part 24 to implement section 228 
of the PHS Act.
    The purpose of the Service is to help recruit and retain 
individuals outstanding in the fields of biomedical research, clinical 
research evaluation, and biomedical product assessment without regard 
to the provisions of Title 5 of the U.S. Code concerning appointments. 
Section 228 of the PHS Act originally limited appointments to the 
Service to up to 500 members who are actively engaged in peerreviewed 
original biomedical research and clinical research evaluation. Section 
3071 of the 21st Century Cures Act, Public Law 114-255 amended section 
228 of the PHS Act, 42 U.S.C. Sec. 237, to revise the requirements of 
the Service. The purpose of those statutory amendments was to further 
enhance the Department's capacity to recruit and retain outstanding and 
qualified scientific and technical experts for the Service. Specific 
statutory changes affect matters such as: (1) Renaming of the Service 
to be called the Senior Biomedical Research and Biomedical Product 
Assessment Service (SBRBPAS); (2) increasing the number of members to 
up to 2,000; (3) extending eligibility requirements for appointments to 
include the field of

[[Page 21781]]

biomedical product assessment, in addition to clinical research 
evaluation, and biomedical product assessment and expanding academic 
qualifications to include a doctoral or master's level degree in 
engineering, bioinformatics, or related or emerging fields, in addition 
to a doctoral-level degree in biomedicine or a related field; (4) 
increasing the maximum pay of members not to exceed the amount of 
annual compensation (excluding expenses) specified in 3 U.S.C. 102 and 
removing the requirement for presidential approval of certain pay 
rates; and (5) terminating the Secretary's discretion to make 
contributions to a retirement system of an institution of higher 
education on a member's behalf. This final rule updates the 
implementing regulations at 42 CFR part 24 to incorporate these 
statutory amendments along with other minor technical changes to 
clarify language of the existing regulations. The regulations may be 
supplemented by HHS personnel instructions.

Collection of Information Requirements

    This final rule does not impose information collection 
requirements, that is, reporting, recordkeeping, or third-party 
disclosure requirements. Consequently, there is no need for review by 
the Office of Management and Budget under the authority of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et seq.).

Regulatory Impact Analysis

    HHS has examined the impact of this rule as required by Executive 
Order 12866 on Regulatory Planning and Review (September 30, 1993), 
Executive Order 13563 on Improving Regulation and Regulatory Review 
(January 18, 2011), the Regulatory Flexibility Act (Pub. L. 96-354, 
enacted September 19, 1980) (RFA), section 1102(b) of the Social 
Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 
(Pub. L. 104-4, enacted March 22, 1995), Executive Order 13132 on 
Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 
804(2)), and Executive Order 13771 on Reducing Regulation and 
Controlling Regulatory Costs. Executive Orders 12866 and 13563 direct 
agencies to assess all costs and benefits of available regulatory 
alternatives and, if regulation is necessary, to select regulatory 
approaches that maximize net benefits (including potential economic, 
environmental, public health and safety effects, distributive impacts, 
and equity). A regulatory impact analysis must be prepared for major 
rules with economically significant effects ($100 million or more in 
any one year).
    This final rule is not ``economically significant'' within the 
meaning of section 3(f)(1) of Executive Order 12866 because it is 
unlikely to have an annual effect of $100 million in any single year. 
In addition, for the reasons noted in this final rule, HHS does not 
believe that this final rule is a major rule under the Congressional 
Review Act.
    The RFA requires agencies to analyze options for regulatory relief 
of small businesses. This rule would not have a significant impact on 
small businesses.
    In addition, section 1102(b) of the Social Security Act requires 
HHS to prepare a regulatory impact analysis if a rule may have a 
significant impact on the operations of a substantial number of small 
rural hospitals. This rule would not have a significant impact on small 
rural hospitals because the amendments contained in this final rule do 
not pertain to hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule that may result in expenditure in any 1 year by state, 
local, or tribal governments, in the aggregate, or by the private 
sector, of $100 million in 1995 dollars, updated annually for 
inflation. In 2018, that threshold is approximately $150 million. HHS 
anticipates this rule would not impact state governments or the private 
sector.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it issues a proposed rule (and subsequent final 
rule) that imposes substantial direct requirement costs on state and 
local governments, preempts state law, or otherwise has federalism 
implications. HHS does not anticipate this rule would impose direct 
requirement costs on state or local governments, preempt state law, or 
otherwise have federalism implications.
    Executive Order 13771 establishes certain requirements that an 
agency must meet when it promulgates new regulations. Pursuant to the 
Executive Order these implementing regulations are designated as 
``exempt.'' They are specifically exempt under the terms of the 
Executive Order because they are administrative in nature, namely 
because they relate to agency organization, management, or personnel 
issues. In this case the regulations implement statutory changes made 
to the authority to hire into the Senior Biomedical Research and 
Biomedical Product Assessment Service.

List of Subjects in 42 CFR part 24

    Administrative practice and procedure, Employment, Public health, 
Scientists, Research.

0
For the reasons set forth in the preamble, the Public Health Service is 
revising part 24 of title 42 of the Code of Federal Regulations to read 
as follows.

PART 24--SENIOR BIOMEDICAL RESEARCH AND BIOMEDICAL PRODUCT 
ASSESSMENT SERVICE

Sec.
24.1 Establishment, number of members, and purpose.
24.2 Allocation.
24.3 Policy board.
24.4 Eligibility.
24.5 Pay and compensation.
24.6 Performance appraisal system.
24.7 Inapplicability of provisions regarding appointments.
24.8 Removal from the Service.
24.9 Reporting.

    Authority: 42 U.S.C. 237; Pub. L. 114-255, div. A, title Ill, 
sec. 3071, Dec. 19, 2016, 130 Stat. 1133; Section 228 of the Public 
Health Service Act; 5 U.S.C. 301.


Sec.  24.1  Establishment, number of members, and purpose.

    (a) There is established in the Public Health Service the Silvio O. 
Conte Senior Biomedical Research and Biomedical Product Assessment 
Service (SBRBPAS or Service) consisting of members the maximum number 
of which is prescribed by law. The purpose of the Service is to recruit 
and retain outstanding and qualified scientific and technical experts 
in the fields of biomedical research, clinical research evaluation, and 
biomedical product assessment.
    (b) The Secretary may not use the authority in paragraph (a) of 
this section to reduce the number of employees serving in any other 
employment system to offset the number of members within the Service.


Sec.  24.2  Allocation.

    (a) The Secretary shall determine the number of SBRBPAS slots to be 
allocated to each participating operating division, taking into account 
the need for such expertise within the operating division.
    (b) The SBRBPAS Policy Board may advise the Secretary regarding 
adjustments to the allocation of slots at any time.
    (c) SBRBPAS appointments shall be made judiciously in supporting 
the recruitment and retention of outstanding and qualified scientific 
and technical experts in the fields of biomedical research, clinical 
research evaluation, and biomedical product assessment.
    (d) The Secretary will ensure that SBRBPAS assignments are used 
primarily in support of high priority

[[Page 21782]]

programs authorized by Congress and which directly support the goals 
and priorities of the Department in the areas of biomedical research, 
clinical research evaluation or biomedical product assessment.


Sec.  24.3  Policy Board.

    The Secretary, or designee, may establish an SBRBPAS Policy Board 
to serve in an advisory capacity, recommending allocation of SBRBPAS 
slots among the participating operating divisions; assessing the 
administration of the SBRBPAS and ensuring consistent application of 
regulations, policies, and procedural guidelines; and recommending to 
the Secretary, or designee, changes to the Service as warranted. 
Membership will include representatives from the Office of the 
Assistant Secretary for Administration and representatives from the 
operating divisions which use the Service. The Secretary, or designee, 
shall determine the number of Board members; select the individual 
members, including the chairperson; and decide the length of service of 
each Board position.


Sec.  24.4  Eligibility.

    (a) No individual may be appointed to the SBRBPAS unless such 
individual:
    (1) Has earned a doctoral level degree in biomedicine or a related 
field, or a doctoral or master's level degree in engineering, 
bioinformatics, or a related or emerging field; and
    (2) Meets the qualification standards prescribed by the Office of 
Personnel Management for appointment to a position at GS-15 of the 
General Schedule.
    (b) Individuals eligible under paragraph (a) of this section shall 
be experts outstanding in the field of biomedical research, clinical 
research evaluation, or biomedical product assessment. The criteria in 
paragraphs (c) through (e) of this section are indicators that the 
individual is considered an expert outstanding in their respective 
field.
    (c) An individual will be considered an expert outstanding in 
biomedical research when the individual is actively engaged in original 
biomedical research, including behavioral research, and whose work in 
this area is considered by recognized experts or peers to be 
outstanding. One or more of the following achievements will indicate 
the individual has been recognized by experts or peers as outstanding:
    (1) Conducted original research that has been published in peer-
reviewed journals of high stature;
    (2) Received major prizes and awards (such as visiting 
professorships and named lectureships) in recognition of original 
contributions to research;
    (3) Received invitations to speak at or to chair major national or 
international meetings or symposia;
    (4) Been elected to membership in professional societies of high 
stature; or
    (5) Meet other criteria demonstrating sufficient rigor or 
accomplishment in a field that is relevant and necessary to the 
accomplishment of the agency's mission.
    (d) An individual will be considered an expert outstanding in 
Clinical Research Evaluation when the individual is actively engaged in 
clinical research evaluation and is considered by recognized experts or 
peers to be outstanding. One or more of the following achievements will 
indicate the individual has been recognized by experts or peers as 
outstanding:
    (1) Significant experience dealing with complex, precedent-setting 
evaluation issues, including those arising during product development, 
that involved significant scientific controversy, had far reaching 
implications for clinical research or resulted in a widespread economic 
effect in the health-care delivery system;
    (2) Taken an active role in the development of significant 
scientific or regulatory guidelines for clinical research evaluation;
    (3) Been the recipient of invitations to speak at or to chair major 
national or international meetings and symposia; or
    (4) Meet other criteria demonstrating sufficient rigor or 
accomplishment in a field that is relevant and necessary to the 
accomplishment of the agency's mission.
    (e) An individual will be considered an expert outstanding in 
biomedical product assessment when an individual is actively engaged in 
the development or assessment of biomedical products and whose work in 
this area is considered by recognized experts or peers to be 
outstanding. One or more of the following achievements will indicate 
the individual has been recognized by experts or peers as outstanding.
    (1) Significant experience dealing with complex, precedent-setting 
evaluation, scientific policies or development issues (e.g., those 
associated with novel biomedical products, novel approaches to 
biomedical product-manufacturing, or use of novel evaluation methods);
    (2) Demonstrated cutting-edge expertise in a scientific or 
technical discipline critical to design, development, manufacturing, 
clinical performance assessment, or other technical aspects of 
effective oversight of biomedical products;
    (3) Played a leadership role in planning and conducting public 
meetings to seek public input and communicate regulatory scientific 
policies;
    (4) Been the recipient of invitations to speak at or to chair major 
national or international meetings and symposia; or
    (5) Meet other criteria demonstrating sufficient rigor or 
accomplishment in an activity or field that is relevant and necessary 
to the accomplishment of the agency's mission.


Sec.  24.5  Pay and compensation.

    The Service is an ungraded system, with a single flexible pay range 
to include all members.
    (a) Pay of SBRBPAS members is determined by the Secretary. A 
member's pay shall not be less than the minimum rate payable for GS-15 
of the General Schedule and shall not exceed the amount of annual 
compensation (excluding expenses) specified in section 102 of title 3 
of the U.S. Code. Although the full pay range will be implemented, pay 
at the higher end of the range will be used only as needed to recognize 
individual scientific value and expertise as is necessary to recruit 
and retain exceptionally well-qualified scientists and technical 
experts.
    (b) The following factors will be used in setting pay for 
individual members:
    (1) Impact of the individual on the field of biomedical research, 
clinical research evaluation, or biomedical product assessment;
    (2) Recognition of the individual by his or her peers in the 
respective field;
    (3) Originality of the individual's ideas or work products;
    (4) Specific clinical or highly technical skills of the individuals 
which are of benefit to the agency and which are in addition to 
requirements of the basic scientific assignment;
    (5) The individual's earnings and monetary benefits; and
    (6) Other relevant factors.
    (c) Annual adjustments to pay rates may be made effective on the 
first day of the first pay period on or after January 1 of each 
calendar year. The rate of such adjustments will be at the discretion 
of the Secretary, or designee, except that the minimum rate payable in 
the SBRBPAS will be increased to the amount of the minimum rate of the 
GS-15 of the General Schedule.
    (d) Other pay adjustments may be made by the Secretary or designee 
on an individual basis.
    (e) New appointees to the SBRBPAS, who are not covered by the Civil 
Service Retirement System, will be covered by

[[Page 21783]]

the Federal Employees Retirement System.


Sec.  24.6  Performance appraisal system.

    The members of the Service shall be subject to a performance 
appraisal system that is designed to encourage excellence in 
performance and shall provide for periodic and systematic assessment of 
the performance of members.


Sec.  24.7  Inapplicability of provisions regarding appointments.

    (a) Appointments to the Service shall be made without regard to the 
provisions of title 5 of the U.S. Code regarding appointments.
    (b) Members of the Service shall not be covered by the following 
provisions of title 5 of the U.S. Code:
    (1) Subchapter I of chapter 35 (relating to retention preference in 
the event of reduction in force);
    (2) Chapter 43 (relating to performance appraisal and performance-
based actions);
    (3) Chapter 51 (relating to classification);
    (4) Subchapter III of chapter 53 (relating to General Schedule pay 
rates); and
    (5) Chapter 75 (relating to adverse actions).


Sec.  24. 8  Removal from the Service.

    (a) A member of the Service may be subject to disciplinary action, 
including removal from the Service, for substandard performance of duty 
as a member of the service, for misconduct, for reasons of national 
security or for other reasons as determined by the Secretary.
    (b) A member for whom disciplinary action is proposed is entitled 
to:
    (1) Written notice of the proposed action and the basis therefor;
    (2) A reasonable opportunity to answer the notice of proposed 
action both orally and in writing;
    (3) The right to be represented by an attorney or other 
representative in making such answer; and
    (4) A written decision on the proposal.
    (c) The decision may be made by an official with delegated 
authority to take such action, but in no case may the official be at a 
level below the head of the Operating Division where the member is 
assigned.
    (d) A member who is separated from the Service involuntarily and 
without cause and who, immediately prior to his appointment to the 
Service, was a career appointee in the civil service or the Senior 
Executive Service, may be appointed to a position in the competitive 
civil service at grade GS-15 of the General Schedule. Such an 
appointment may be made by the Secretary or his/her designee without 
regard to the provisions of title 5, U.S. Code regarding appointments 
in the civil service.
    (e) A member who is separated from the Service involuntarily and 
without cause and who, immediately prior to appointment to the Service, 
was not a career appointee in the civil service or the Senior Executive 
Service may be appointed to a position in the excepted civil service at 
grade GS-15 of the General Schedule for a period not to exceed two 
years.
    (f) There shall be no right to further review of the final decision 
on a disciplinary action. At his/her discretion, the Secretary may 
review an action taken under this section and may reduce, suspend, or 
overrule the action taken.
    (g) A member of the Service may be removed from the Service for 
such other reasons as may be prescribed by the Secretary.


Sec.  24.9  Reporting.

    (a) No later than May 1, 2020, and annually thereafter, each 
participating operating division shall submit to the Secretary a report 
of its implementation of the SBRBPAS authority in accordance with the 
Agency's policy requirements.
    (b) At his or her discretion, the Secretary may use the information 
provided in the report under paragraph (a) of this section to inform 
the work of the Policy Board, including allocation of SBRBPAS slots.

Scott W. Rowell,
Assistant Secretary for Administration.
    Approved: April 2, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2020-07367 Filed 4-17-20; 8:45 am]
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