Senior Biomedical Research Service

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

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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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