[Federal Register Volume 61, Number 35 (Wednesday, February 21, 1996)]
[Rules and Regulations]
[Pages 6556-6559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-3739]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

42 CFR Part 24


Senior Biomedical Research Service

AGENCY: Public Health Service (PHS), DHHS.

ACTION: Interim final rule with request for comments.

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SUMMARY: The Secretary of Health and Human Services (DHHS) is issuing 

[[Page 6557]]
interim final regulations implementing section 228 of the Public Health 
Service Act, as amended by section 304 of Public Law 101-509 and 
section 2001 of Public Law 103-43, which establish in the Public Health 
Service a Senior Biomedical Research Service.
    These regulations are being published as an interim final rule with 
request for comment. Although the Administrative Procedure Act does not 
apply to a matter relating to agency management or personnel [5 U.S.C. 
553(a)(2)] and although the Act itself permits publication of a final 
rule without a notice and comment period for rules of agency 
organization or procedure [5 U.S.C. 553(b))], these regulations are 
considered a significant enough change in policy to benefit from public 
comment.

EFFECTIVE DATE: This interim rule is effective February 21, 1996. 
Comments should be received within thirty days from the date of 
publication.

ADDRESSES: Comments may be sent or delivered to Rosemary Taylor, Office 
of the Assistant Secretary for Management and Budget, Office of the 
Secretary, Department of Health and Human Services, Hubert H. Humphrey 
Building, Room 522-A, 200 Independence Ave., S.W., Washington, D.C. 
20201.

FOR FURTHER INFORMATION CONTACT:
Rosemary Taylor at (202) 690-7358, Office of the Assistant Secretary 
for Management and Budget, Office of the Secretary, Department of 
Health and Human Services, Hubert H. Humphrey Building, Room 522-A, 200 
Independence Ave., S.W., Washington, D.C. 20201.

SUPPLEMENTARY INFORMATION: Section 304 of Public Law 101-509 amended 
the Public Health Service Act by adding a new section 228, which 
establishes the Senior Biomedical Research Service (SBRS) in the PHS. 
Section 2001 of Public Law 103-43 amended the Public Health Service Act 
by increasing the number of authorized positions to 500. Members of the 
SBRS are to be appointed by the Secretary without regard to the 
provisions of title 5, U.S. Code, regarding appointment, and are to be 
individuals outstanding in the field of biomedical research or clinical 
research evaluation. Appointments to the SBRS will be only to 
individuals actively engaged in either peer-reviewed original 
biomedical research of clinical research evaluation. These regulations 
establish the basic eligibility criteria, pay rates, performance 
appraisal system, optional retirement system, and procedure for removal 
from the SBRS. These regulations may be supplemented by HHS personnel 
instructions.

Executive Order 12866

    I have examined the impacts of the interim final rule under 
Executive Order 12866. I believe that this interim final rule is 
consistent with the regulatory philosophy and principles identified in 
the Executive Order. In addition, the interim final rule is a 
significant regulatory action as defined by the Executive Order and, 
therefore, is subject to OMB review.

Regulatory Flexibility Act

    I certify that these regulations will not have a significant 
economic impact on a substantial number of small entities because they 
will affect only a small number of federal employees who are members of 
the Senior Biomedical Research Service.

List of Subjects in 42 CFR Part 24

    Government employees, Health professions, Reporting and 
recordkeeping requirements, wages.

    Accordingly, the Department of Health and Human Services is 
amending 42 CFR by adding a new Part 24, reading as follows:

PART 24--SENIOR BIOMEDICAL RESEARCH SERVICE

Sec.
24.1  Establishment.
24.2  Allocation.
24.3  Policy Board.
24.4  Eligibility.
24.5  Peer review.
24.6  Pay and compensation.
24.7  Performance appraisal system.
24.8  Applicability of provisions of Title 5, U.S. Code.
24.9  Removal from the Service.
24.10  Reporting.

    Authority: Section 228(g) of the Public Health Service Act; 5 
U.S.C. 301.


Sec. 24.1  Establishment.

    There is established in the Public Health Service (PHS) a Senior 
Biomedical Research Service (SBRS) consisting of members the maximum 
number of which is prescribed by law.


Sec. 24.2  Allocation.

    (a) The Secretary, within the number authorized in the PHS Act, 
shall determine the number of SBRS slots to be allocated to each 
participating Operating Division.
    (b) The SBRS Policy Board may advise the Secretary to make 
adjustments to the allocation at any time.
    (c) The majority of the SBRS allocation is to be reserved for 
recruitment. The remaining SBRS allocation may be used for the 
retention of current employees.
    (d) SBRS slots will be used judiciously, resulting in SBRS 
appointments only where other senior-level appointing authorities are 
not sufficient to recruit or retain scientific talent.
    (e) The Secretary will ensure that SBRS slots are used in support 
of high priority programs authorized by Congress and which directly 
support the research goals and priorities of the Department.


Sec. 24.3  Policy Board.

    The Secretary or his/her designee shall establish an SBRS Policy 
Board to serve in an advisory capacity, recommending SBRS allocations 
among the participating Operating Divisions, reviewing the operations 
of the SBRS and ensuring consistent application of regulations, 
policies, and procedural guidelines, and recommending changes to the 
Secretary as necessary. Membership, to the extent possible, will 
include SBRS eligibles nominated by their respective Operating 
Divisions, will be weighted in proportion to Operating Divisions' SBRS 
allocations, and will include representation from the Office of the 
Secretary. The Secretary or his/her designee will select the board 
membership and the Chair.


Sec. 24.4  Eligibility.

    To be eligible for appointment to the Service an individual must 
have a doctoral-level degree in biomedicine or a related field and must 
meet the qualification standards prescribed by the U.S. Office of 
Personnel Management for appointment to a position at GS-15 of the 
General Schedule. In addition, the individual must be outstanding in 
the field of biomedical research or clinical research evaluation. 
Appointment to the Service will be made only to individuals actively 
engaged in either biomedical research or clinical research evaluation.
    (a) Outstanding in the field of biomedical research means an 
individual who is actively engaged in peer-reviewed original biomedical 
research and whose work in this area is considered by his or her peers 
to be outstanding. In order to meet the eligibility criteria, an 
individual must have conducted original peer-reviewed biomedical 
research resulting in major accomplishments reflected by a steady and 
current record of highly cited publications in peer-reviewed journals 
of high stature. In addition, the individual should be the recipient of 
major prizes and awards (such as visiting professorships and named 
lectureships) in recognition of original contributions to research. 

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    (b) Outstanding in the field of clinical research evaluation means 
that an individual is actively engaged in clinical research evaluation 
and is considered by his or her peers to be outstanding. In order to 
meet the eligibility criteria, an individual, by force of his or her 
own technical expertise, must be in a position to shape the course of 
drug or device evaluation or exert a similar influence on the PHS 
handling of other agents that may affect the public health. The 
individual would normally have dealt with complex, precedent-setting 
evaluation issues 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. In 
addition, the individual should have been involved in the development 
of scientific or regulatory guidelines for clinical research and been 
the recipient of invitations to speak at or to chair major national or 
international meetings and symposia.


Sec. 24.5  Peer review.

    An individual may not be considered for appointment into the SBRS 
unless his/her qualifications have been reviewed by a PHS peer review 
committee and the committee has recommended appointment to the Service.


Sec. 24.6  Pay and compensation.

    The SBRS is an ungraded system, with a single, flexible pay range 
to include all members.
    (a) Pay of the members of the Service shall be determined by the 
Secretary or his/her designee.
    (b) The pay of a member of the Service shall be not less than the 
minimum rate payable for GS-15 of the General Schedule and shall not 
exceed:
    (1) The rate payable for level I of the Executive Schedule unless a 
higher rate of pay is expressly approved on an individual basis by the 
President, pursuant to 5 U.S.C. 5377(d)(2), or
    (2) The rate payable for level II of the Executive Schedule unless 
a higher rate of pay is expressly approved on an individual basis by 
the Secretary.
    (c) While the full pay range will be used, individual pay at the 
higher end of the range will be used only as needed to recognize 
individual scientific value and as necessary to recruit or retain an 
exceptionally well-qualified scientist.
    (d) The following factors will be used in establishing appropriate 
pay rates for individual members:
    (1) Impact of the individual on the scientific field;
    (2) Recognition of the individual by the scientific community;
    (3) Originality of the individual's ideas/work products;
    (4) Specific ``clinical'' or highly technical skills of the 
individual 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;
    (6) Salary surveys of similar skills in pertinent labor markets; 
and
    (7) Other relevant factors.
    (e) 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 his/her designee, except that the minimum rate 
payable in the SBRS will be increased to the amount of the minimum rate 
of the GS-15 of the General Schedule.
    (f) Other pay adjustments will be made on an individual basis by 
the Secretary or his/her designee.
    (g) Except as provided in paragraph (h) of this section, new 
appointees to the Service, who are not covered by the Civil Service 
Retirement System, will be covered by the Federal Employees Retirement 
System.
    (h) Upon the request of a member who performed service in the 
employ of an institution of higher education immediately prior to his 
appointment as a member of the Service, and retains the right to make 
contributions to the retirement system of such institution, the 
Department of Health and Human Services may contribute an amount not to 
exceed ten percent per annum of the member's basic pay to such 
institution's retirement system on behalf of such member. A member who 
participates in this program shall not be covered by any retirement 
system established for employees of the United States under title 5, 
United States Code.


Sec. 24.7  Performance appraisal system.

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


Sec. 24.8  Applicability of provisions of Title 5, U.S. Code.

    (a) Appointments to the Service shall be made without regard to the 
provisions of title 5, U.S. Code regarding appointments.
    (b) Members of the Service shall not be covered by the following 
provisions of title 5, U.S. Code:
    (1) Subchapter I of Chapter 35 (relating to retention preference in 
the event of reduction in force);
    (2) Chapter 43, Performance Appraisal (and performance-based 
actions);
    (3) Chapter 51 (relating to classification);
    (4) Subchapter III of Chapter 53, The General Schedule; and
    (5) Chapter 75, Adverse Actions.
    (c) Other provisions of Title 5 will be applied as administratively 
determined by the Secretary or his/her designee.


Sec. 24.9  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 

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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. 24.10  Reporting.

    For each quarter of the first year of implementation and annually 
thereafter, participating Operating Divisions shall maintain reports on 
the operation of the SBRS. At a minimum, these reports should include 
the number of appointees, the source of those appointees, their 
earnings immediately prior to appointment, and their SBRS pay at 
appointment.

    Dated: October 10, 1995.
Donna E. Shalala,
Secretary.
[FR Doc. 96-3739 Filed 2-20-96; 8:45 am]
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