96-3739. Senior Biomedical Research Service  

  • [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]
    
    
    
    =======================================================================
    -----------------------------------------------------------------------
    
    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.
    
    -----------------------------------------------------------------------
    
    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. 
    
    [[Page 6558]]
    
        (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 
    
    [[Page 6559]]
    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]
    BILLING CODE 4150-04-M
    
    

Document Information

Effective Date:
2/21/1996
Published:
02/21/1996
Department:
Public Health Service
Entry Type:
Rule
Action:
Interim final rule with request for comments.
Document Number:
96-3739
Dates:
This interim rule is effective February 21, 1996. Comments should be received within thirty days from the date of publication.
Pages:
6556-6559 (4 pages)
PDF File:
96-3739.pdf
CFR: (10)
42 CFR 24.1
42 CFR 24.2
42 CFR 24.3
42 CFR 24.4
42 CFR 24.5
More ...