01-18910. Notification of Request for Emergency Clearance; Modification of OMB Number 0925-0361, “National Institutes of Health Loan Repayment Programs”

SUMMARY:

In accordance with section 3507(j) of the Paperwork Reduction Act of 1995, the National Institutes of Health hereby publishes notification of request for Emergency Clearance for modification of the information collection related to the “Loan Repayment Program for Health Disparities Research” and the “Extramural Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds,” published elsewhere in today's Federal Register. The currently approved information collection, “National Institutes of Health Loan Repayment Programs” (OMB No. 0925-0361), permits the NIH to request from applicants information related to eligibility, qualifications, career interests and recommendations necessary to evaluate their applications for repayment of educational indebtedness in return for agreeing to conduct research as an employee of the National Institutes of Health. Public Law 106-525 amended the Public Health Service Act (42 U.S.C. 288-5) by adding a new section 485G to provide repayment of educational loan indebtedness of qualified health professionals who are not Federal employees and who agree to conduct basic, clinical, or behavioral research directly related to health disparities. Public Law 106-554 amended section 487E of the Public Health Service Act (42 U.S.C. 288-5) to allow expansion of the existing program to provide repayment of educational loan indebtedness of qualified health professionals from disadvantaged backgrounds who are not Federal employees and who agree to conduct clinical research.

To implement these new loan repayment programs, NIH must request additional information from applicants and the institutions that submit applications on their behalf. Specifically, in the case of the Loan Repayment Program for Health Disparities Research, information in the application will also include: (1) A Research Plan—a description of the applicant's proposed role in the research conducted in the extramural laboratory or clinical research setting; (2) A brief statement addressing the applicant's long-range career plan for engaging in research on health disparities; (3) Institutional Assurance of future/current employment/affiliation; (4) Description of Training Environment, including a Training Plan, describing the applicant's mentoring program, the types of training interactions, research methods to be used and scientific techniques to be taught, journal clubs or groups the applicant will join, conferences and seminars to be attended, and a Description of the Advisor's/Supervisor's Research Program, with a description of the current research, listing of research support and a current C.V. with a list of publications.

In regard to the Extramural Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds, applicants are required to submit: (1) A Research Plan—a description of the applicant's proposed clinical research assignment, including the applicant's specific responsibilities and roles in conducting the research; (2) Institutional Assurance of future/current employment/affiliation; (3) Description of Training Environment, including a Training Plan, describing the applicant's mentoring program, the types of training interactions, research methods to be used and scientific techniques to be taught, journal clubs or groups the applicant will join, conferences and seminars to be attended, and a Description of the Advisor/ Supervisor's Research Program, with a description of the current research, listing of research support and a current C.V. with a list of publications.

The present modification relates to the additional reporting requirement of submission of information and documentation to permit the agency to evaluate the eligibility, qualifications, and overall merit of the applications, including, for example, the quality of the mentoring program, the quality of the mentor/supervisor's research program, the proposed training mechanism, and the research methods and scientific techniques to be taught.

The modification is essential to the mission of NIH (42 U.S.C. 241 and 282(b)) and pursuant to the statutory mandates of 42 U.S.C. 287c-33 and 42 U.S.C. 288-5a requiring the NIH to establish loan repayment programs for eligible qualified health professionals, not employed by the Federal Government, who enter into contracts with the Secretary of Health and Human Services (HHS) to engage in minority health disparities research and for qualified health professionals from disadvantaged backgrounds, not employed by the Federal Government, who enter into contracts with the Secretary, HHS, to conduct clinical research.

The United States Congress conducted hearings to establish these expansions of the National Institutes of Health Loan Repayment Programs on the basis of which it determined that these measures are essential to the public welfare. In view of the record established in legislative hearings and congressional deliberations, NIH is herewith requesting that OMB approve the modification of the collection of information simultaneously with the publication of this Federal Register Notice and the publication of the Program Announcements in the Federal Register.

Proposed Collection

Title: National Institutes of Health Loan Repayment Programs. Type of Information Collection Request: REVISION. Need and Use of Information Collection: The additional NEW reporting requirement is needed to permit the agency to evaluate the eligibility, qualifications and overall merit of the applications. Frequency of Response: One-time response to accommodate NEW programs. Affected Public: Individuals or households; Business or other for-profit; Not-for-profit institutions; State, local or tribal Government. Type of Respondents: Loan Repayment Program Applicants; Scientific and Clinical Researchers; Research and Academic Institutions; Lending Organizations and Banks. The annual reporting burden was: Estimated Number of Respondents: 990. Estimated Number of Responses per Respondent: 1. Average Burden Hours Per Response: 1.53. Estimated Total Annual Burden Hours Requested: 1,424. The NEW annual reporting burden is as follows: Estimated Number of Respondents: 1,540. Estimated Number of Responses per Respondent: 1.02. Average Burden Hours Per Response: 1.43. Estimated Total Annual Burden Hours Requested: 2,214. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

NIH is herewith requesting that OMB approve the modification of the collection of information simultaneously with the publication of this Federal Register notice and the publication of the Program Announcements in the Federal Register.

FOR FURTHER INFORMATION CONTACT:

The Office of Management and Budget, Office of Information and Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Stuart Shapiro, Desk Officer for NIH.

Dated: July 13, 2001.

Ruth L. Kirschstein,

Acting Director, NIH.