Silvio O. Conte Senior Biomedical Research and Biomedical Product Assessment Service
| Published date | 20 April 2020 |
| Citation | 85 FR 21780 |
| Record Number | 2020-07367 |
| Section | Rules and Regulations |
| Court | Public Health Service |
21780
Federal Register / Vol. 85, No. 76 / Monday, April 20, 2020 / Rules and Regulations
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.’’
(c) * * *
(6) * * *
(xxvii) Placer County Air Pollution
Control District.
(A) Previously approved on
September 22, 1972 in paragraph (c)(6)
of this section and now deleted with
replacement in paragraph
(c)(389)(i)(B)(1) of this section: Article 2,
Section 10 (paragraph (a)).
(B) Previously approved on
September 22, 1972 in paragraph (c)(6)
of this section and now deleted with
replacement in paragraph
(c)(389)(i)(B)(1) of this section for
implementation in the Lake Tahoe Air
Basin: Article 2, Section 10 (paragraph
(b)).
* * * * *
(26) * * *
(xvii) * * *
(H) Previously approved on June 14,
1978 in paragraph (c)(26)(xvii)(A) of this
section and now deleted with
replacement in paragraph
(c)(389)(i)(B)(1) of this section: Rule 403.
* * * * *
(41) * * *
(x) * * *
(K) Previously approved on November
15, 1978 in paragraph (c)(41)(x)(A) of
this section and now deleted with
replacement in paragraph
(c)(389)(i)(B)(1) of this section for
implementation in the Mountain
Counties and Sacramento Valley Air
Basins: Rule 507.
* * * * *
(52) * * *
(xiii) * * *
(H) Previously approved on June 18,
1982 in paragraph (c)(52)(xiii)(D) of this
section and now deleted with
replacement in paragraph
(c)(389)(i)(B)(1) of this section for
implementation in the Mountain
Counties and Sacramento Valley Air
Basins: Rules 501(B) and 502.
* * * * *
(80) * * *
(i) * * *
(H) Previously approved on April 23,
1982 in paragraph (c)(80)(i)(B) of this
section and now deleted with
replacement in paragraph
(c)(389)(i)(B)(1) of this section: Rule 507.
(I) Previously approved on June 18,
1982 in paragraphs (c)(80)(i)(C) of this
section and now deleted with
replacement in paragraph
(c)(389)(i)(B)(1) of this section: Rules
502, 503 and 505.
(J) Previously approved on June 23,
1982 in paragraph (c)(80)(i)(E) of this
section and now deleted with
replacement in paragraph
(c)(389)(i)(B)(1) of this section: Rule 514.
* * * * *
(168) * * *
(i) * * *
(C) * * *
(4) Previously approved on February
3, 1987 in paragraph (c)(168)(i)(C)(1) of
this section and now deleted with
replacement in paragraph
(c)(389)(i)(B)(1) of this section for
implementation in the Mountain
Counties and Sacramento Valley Air
Basins: Rules 505 and 507.
* * * * *
(389) * * *
(i) * * *
(B) Placer County Air Pollution
Control District.
(1) Rule 501, ‘‘General Permit
Requirements,’’ adopted on August 12,
2010.
* * * * *
[FR Doc. 2020–07521 Filed 4–17–20; 8:45 am]
BILLING CODE 6560–50–P
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.
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).
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
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Federal Register / Vol. 85, No. 76 / Monday, April 20, 2020 / Rules and Regulations
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.
■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.
§ 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.
§ 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
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Federal Register / Vol. 85, No. 76 / Monday, April 20, 2020 / Rules and Regulations
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.
§ 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.
§ 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.
§ 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
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Federal Register / Vol. 85, No. 76 / Monday, April 20, 2020 / Rules and Regulations
the Federal Employees Retirement
System.
§ 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.
§ 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).
§ 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.
§ 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]
BILLING CODE P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
44 CFR Part 64
[Docket ID FEMA–2020–0005; Internal
Agency Docket No. FEMA–8625]
Suspension of Community Eligibility
AGENCY
: Federal Emergency
Management Agency, DHS.
ACTION
: Final rule.
SUMMARY
: This rule identifies
communities where the sale of flood
insurance has been authorized under
the National Flood Insurance Program
(NFIP) that are scheduled for
suspension on the effective dates listed
within this rule because of
noncompliance with the floodplain
management requirements of the
program. If the Federal Emergency
Management Agency (FEMA) receives
documentation that the community has
adopted the required floodplain
management measures prior to the
effective suspension date given in this
rule, the suspension will not occur and
a notice of this will be provided by
publication in the Federal Register on a
subsequent date. Also, information
identifying the current participation
status of a community can be obtained
from FEMA’s Community Status Book
(CSB). The CSB is available at https://
www.fema.gov/national-flood-
insurance-program-community-status-
book.
DATES
: Effective Dates: The effective
date of each community’s scheduled
suspension is the third date (‘‘Susp.’’)
listed in the third column of the
following tables.
FOR FURTHER INFORMATION CONTACT
: If
you want to determine whether a
particular community was suspended
on the suspension date or for further
information, contact Adrienne L.
Sheldon, PE, CFM, Federal Insurance
and Mitigation Administration, Federal
Emergency Management Agency, 400 C
Street SW, Washington, DC 20472, (202)
212–3966.
SUPPLEMENTARY INFORMATION
: The NFIP
enables property owners to purchase
Federal flood insurance that is not
otherwise generally available from
private insurers. In return, communities
agree to adopt and administer local
floodplain management measures aimed
at protecting lives and new construction
from future flooding. Section 1315 of
the National Flood Insurance Act of
1968, as amended, 42 U.S.C. 4022,
prohibits the sale of NFIP flood
insurance unless an appropriate public
body adopts adequate floodplain
management measures with effective
enforcement measures. The
communities listed in this document no
longer meet that statutory requirement
for compliance with program
regulations, 44 CFR part 59.
Accordingly, the communities will be
suspended on the effective date in the
third column. As of that date, flood
insurance will no longer be available in
the community. We recognize that some
of these communities may adopt and
submit the required documentation of
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