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est, at any time without prepayment penalty.

charges, in addition to the regular interest charge, in accordance with 45 CFR part 30.

(b) Failure to make full payment of principal and/or interest when due may result in the Secretary placing the borrower in default of the loan. See $ 23.28(a). 8 23.28 What events constitute default?

The following events will constitute defaults of the loan agreement:

(a) Failure to make full payment of principal and/or interest when due, and continuance of that failure for a period of sixty (60) days, or a lesser period of time if the Secretary determines that more immediate action is necessary in order to protect the interests of the Government.

(b) Failure to perform or observe any of the terms and conditions of the loan agreement and continuance of that failure for a period of sixty (60) days.

(c) The institution of bankruptcy proceedings, either voluntary or involuntary, under any State or Federal statute, which may adversely affect the borrower's ability to comply with the terms and conditions of the agreement or the promissory note.

$ 23.31 May loan payments be post

poned or waived? (a) Whenever health, economic, or other personal problems affect the borrower's ability to make scheduled payments on the loan, the Secretary may allow the borrower an extension of time or allow the borrower to make smaller payments than were previously scheduled; however, interest will continue to accrue at the rate specified in the promissory note until the loan is repaid in full. The loan must be fully repaid within 10 years after it was made.

(b) No waiver, full or partial, of repayment of the loan will be granted; except that the obligation of a borrower to repay a loan shall be cancelled upon the death or total and permanent disability of the borrower, as determined by the Secretary.

(c) In order to make a determination under paragraph (a) or (b) of this section, the Secretary may require supporting medical, financial, or other documentation.

$ 23.29 What happens in the case of a

default? (a) In the event of default, the Secretary may declare the entire amount owed (including principal, accrued interest and any applicable charges) immediately due and payable. Collection of the amount owed will be made in accordance with 45 CFR part 30.

(b) The borrower is not entitled to written notice of any default and the failure to deliver written notice of default in no way affects the Secretary's right to declare the loan in default and take any appropriate action under the loan agreement or the promissory note.

(c) The failure of the Secretary to exercise any remedy available under law or regulation shall in no event be construed as a waiver of his or her right to exercise that remedy if any subsequent or continued default or breach occurs.

$ 23.32 What conditions are imposed

on the use of the loan funds? (a) The borrower must use the total amount of the loan to purchase or lease, or both, equipment and supplies, to hire authorized personnel to assist in providing health services and/or to renovate facilities for use in providing health services in his or her private practice. Equipment and supplies purchased and/or leased, personnel hired and facilities renovated shall be limited to the items requested in the loan application and approved by the Secretary.

(b) The borrower must expend the loan funds within 6 months from the date of the loan or within such other time as the Secretary may approve. Documentation of the expenditure of funds must be furnished to the Secretary upon request.

8 23.30 May the loan be prepaid?

The borrower shall have the option to prepay the balance of any part of the loan, together with accrued inter

$ 23.33 What security must be given for

these loans? The Secretary may require the borrower to pledge to the Secretary a security interest in specified collateral.

$23.34 What other conditions are im

posed? (a) The borrower must sign a loan agreement describing the loan and practice conditions, and a promissory note agreeing to repay the loan plus interest.

(b) The borrower must agree to enter into private full-time clinical practice in a HMSA for the time period specified in the loan agreement.

(c) The borrower must accept assignment, for the time period specified in the loan agreement, under section 1842(b)(3)(B)(ii) of the Social Security Act as full payment for all services for which payment may be made under part B of title XVIII of that Act.

(d) The borrower must enter into an appropriate agreement, for the time period specified in the loan agreement, with the State agency which administers the State plan for medical assistance under title XIX of the Social Security Act to provide services to individuals entitled to medical assistance under the plan.

(e) During the time period specified in the loan agreement, the borrower must provide health services to individuals at the usual and customary rate prevailing in the HMSA in which services are provided; however, services must be provided at no charge or at a nominal charge to those persons unable to pay for these services.

(f) The borrower must keep and preserve all documents, including bills, receipts, checks, and correspondence which affect the operation of the private practice and the expenditure of loan funds for the period of the practice obligation specified in the loan agreement plus 3 years. Accounts will be maintained under one of the accounting principles identified by the Secretary in the loan agreement.

(g) The borrower must provide the Secretary and the Controller General of the United States, or their representatives, access during normal working hours to accounts, documents, and records for the purposes of audit or evaluation; and must permit the Secretary or his or her representative to inspect the private practice at reasonable times during the period of the practice obligation specified in the

loan agreement plus 3 years. All information as to personal facts and circumstances about recipients of services shall be held confidential, and shall not be divulged without the individual's consent except as may be required by law or as may be necessary to provide medical service to the individual or to provide for medical or fiscal audits by the Secretary or his or her designee with appropriate safeguards for confidentiality of records.

(h) For the entire period of loan repayment, the borrower must acquire, maintain, and when requested, must provide the Secretary with copies of policies of insurance on equipment and supplies in amounts adequate to reasonably protect the borrower from risk, including public liability, fire, theft, and worker's compensation.

(i) If the Secretary retains a security interest pursuant to $23.33, the borrower must keep and preserve all documents which affect that security interest for the period of the loan repayment and allow the Secretary or his or her designee access, during normal working hours, to those documents.

(j) The borrower must maintain the loan proceeds in a separate account from his or her other transactions and must agree to draw upon this account and expend the loan proceeds in accordance with $23.32.

(k) The Secretary may impose other conditions which he or she deems appropriate under law or regulation to protect the Government's interests.

$ 23.35 What criteria are used in mak

ing loans? Approval of loan applications will be based on the criteria set forth below:

(a) The need in the HMSA for the applicant's health profession as determined under section 332 of the Act;

(b) The applicant's need for the loan funds; and

(c) The comments from State or local health professional societies on the appropriateness of the applicant's intended private practice; and

(d) The applicant's credit worthiness and projected financial ability to repay the loan.

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.

SOURCE: 61 FR 6557, Feb. 21, 1996, unless otherwise noted.

$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.

Subpart C-Private Startup Loans $ 23.41 What conditions are applicable

to loans under this subpart? The regulations set out in subpart B of this part are fully applicable to loans awarded under section 338C(e)(1) of the Public Health Service Act, except as noted below;

(a) Eligibility. (1) In lieu of $23.23(a), the following applies to loans made under this subpart:

(i) Eligibility for loans is limited to NHSC scholarship recipients who plan to enter private practice and have not begun fulfilling their scholarship service obligation or are currently fulfilling their scholarship service obligation under section 338B of the Act and have completed less than 2 years of this obligation.

(2) In lieu of $23.23(c), the following applies to loans made under this subpart:

(i) NHSC scholarship recipients who have received loans under either this subpart or subpart B of this part are ineligible for loans under this subpart.

(b) Loan amounts. (1) In lieu of $23.24, the following applies to loans made under this subpart:

(i) The Secretary may make loans in the amount of $12,500 if the recipient agrees to practice in accordance with the loan agreement for a period of at least 1 year but less than 2 years or the remaining period of the borrower's NHSC scholarship service obligation, whichever is shorter.

(ii) The Secretary may make loans in the amount of $25,000 if the recipient agrees to practice in accordance with the loan agreement for a period of at least 2 years or the remaining period of the borrower's NHSC scholarship service obligation, whichever is shorter.

(c) Use of funds. (1) In lieu of $23.32(a), the following applies to loans made under this subpart:

(i) The borrower must use the total amount of the loan only to purchase or lease, or both, the equipment and supplies needed for providing health services in his or her private practice. Equipment and supplies purchased and/ or leased shall be limited to the items requested in the loan application and approved by the Secretary. (51 FR 31950, Sept. 8, 1986)

8 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. 8 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,

re

reviewing the operations of the SBRS course of drug or device evaluation or and ensuring consistent application of exert a similar influence on the PHS regulations, policies, and procedural handling of other agents that may afguidelines, and recommending changes fect the public health. The individual to the Secretary as necessary. Member- would normally have dealt with comship, to the extent possible, will in- plex, precedent-setting evaluation clude SBRS eligibles nominated by issues that involved significant scitheir respective Operating Divisions, entific controversy, had far reaching will be weighted in proportion to Oper- implications for clinical research or reating Divisions' SBRS allocations, and sulted in a widespread economic effect will include representation from the in the health-care delivery system. In Office of the Secretary. The Secretary addition, the individual should have or his/her designee will select the board been involved in the development of membership and the Chair.

scientific or regulatory guidelines for

clinical research and been the recipient $24.4 Eligibility.

of invitations to speak at or to chair To be eligible for appointment to the major national or international meetService an individual must have a doc- ings and symposia. toral-level degree in biomedicine or a related field and must meet the quali

8 24.5 Peer review. fication standards prescribed by the An individual may not be considered U.S. Office of Personnel Management

for appointment into the SBRS unless for appointment to a position at GS-15 his/her qualifications have been of the General Schedule. In addition, viewed by a PHS peer review comthe individual must be outstanding in mittee and the committee has recthe field of biomedical research or clin

ommended appointment to the Service. ical research evaluation. Appointment to the Service will be made only to in- $24.6 Pay and compensation. dividuals actively engaged in either

The SBRS is an ungraded system, biomedical research or clinical search evaluation.

with a single, flexible pay range to in

clude all members. (a) Outstanding in the field of biomedical research means an individual

(a) Pay of the members of the Service who is actively engaged in peer-re

shall be determined by the Secretary viewed original biomedical research

or his/her designee. and whose work in this area is consid

(b) The pay of a member of the Serv

ice shall be not less than the minimum ered by his or her peers to be outstanding. In order to meet the eligi

rate payable for GS-15 of the General bility criteria, an individual must have

Schedule and shall not exceed: conducted original peer-reviewed bio

(1) The rate payable for level I of the medical research resulting in major ac

Executive Schedule unless a higher complishments reflected by a steady

rate of pay is expressly approved on an and current record of highly cited pub

individual basis by the President, purlications in peer-reviewed journals of

suant to 5 U.S.C. 5377(d)(2), or high stature. In addition, the indi- (2) The rate payable for level II of the vidual should be the recipient of major Executive Schedule unless a higher prizes and awards (such as visiting pro

rate of pay is expressly approved on an fessorships and named lectureships) in

individual basis by the Secretary. recognition of original contributions to (c) While the full pay range will be research.

used, individual pay at the higher end (b) Outstanding in the field of clin- of the range will be used only as needed ical research evaluation means that an to recognize individual scientific value individual is actively engaged in clin- and as necessary to recruit or retain an ical research evaluation and is consid- exceptionally well-qualified scientist. ered by his or her peers to be out- (d) The following factors will be used standing. In order to meet the eligi- in establishing appropriate pay rates bility criteria, an individual, by force for individual members: of his or her own technical expertise, (1) Impact of the individual on the must be in a position to shape the scientific field;

re

atic appraisal of the performance of the members. $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.

1

(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.

$ 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

$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 system

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