Proposed Collection; Comment Request; Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service (PHS) Funding is Sought

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Proposed Collection; Comment Request; Responsibility of

Applicants for Promoting Objectivity in Research for Which Public

Health Service (PHS) Funding is Sought

SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of

the Paperwork Reduction Act of 1995, for opportunity for public comment

on proposed data collection projects, the Office of the Director (OD),

the National Institutes of Health (NIH) will publish periodic summaries

of proposed projects to be submitted to the Office of Management and

Budget (OMB) for review and approval.

Proposed Collection

Title: Responsibility of Applicants for Promoting Objectivity in

Research for Which Public Health Service (PHS) Funding is Sought: 42

CFR Part 50; 45 CFR Part 94. Type of Information Collection Request:

Extension of OMB No. 0925-0417, expiration date 09/30/98. Need and Use

of Information Collection: This is a request for OMB approval for the

information collection and recordkeeping requirements contained in the

final rule 42 CFR Part 50 and 45 CFR Part 94. The purpose of the

regulations is to protect the objectivity with which PHS-funded

research is conducted. The regulations require disclosure of financial

interests related to PHS-funded research by personnel who have

decision-making responsibilities that could affect the outcome of the

research. Frequency of Response: On occasion. Affected Public:

Individuals or households; Business or other for-profit; Not-for-profit

institutions; State, Local or Tribal Government. Type of Respondents:

Any public or private entity or organization. The annual reporting

burden is as follows: Estimated Number of Respondents: 57,235;

Estimated Number of Responses per Respondent: 10; Average Burden Hours

per Response: 20; and Estimated Total Annual Burden Hours Requested:

171,110. The annualized costs to respondents is estimated at:

$5,068,850. There are no Capital Costs, Operating Costs and/or

Maintenance Costs to report.

Request For Comments

Written comments and/or suggestions from the public and affected

agencies should address one or more of the following points: (1)

Evaluate whether the proposed collection of information is necessary

for the proper performance of the function of the agency, including

whether the information will have practical utility; (2) Evaluate the

accuracy of the agency's estimate of the burden of the proposed

collection of information, including the validity of the methodology

and assumptions used; (3) Enhance the quality, utility, and clarity of

the information to be collected; and (4) Minimize the burden of the

collection of information on those who are to respond, including the

use of appropriate automated, electronic, mechanical, or other

technological collection techniques or other forms of information

technology.

FOR FURTHER INFORMATION CONTACT:

To request more information on the proposed project or to obtain a copy

of the data collection plans and instruments, contact: Thomas F.

McCormack, Ph.D., Assistant Grant's Policy Officer, Office of

Extramural Research, Office of Policy for Extramural Research

Administration, 6701 Rockledge Drive, Bethesda, MD 20892, or call non-

toll-free number (301) 435-0935 or E-mail your request,

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including your address to: [email protected]

Comments Due Date

Comments regarding this information collection are best assured of

having their full effect if received on or before July 8, 1998.

Dated: April 28, 1998.

Geoffrey Grant,

Director, Office of Policy for Extramural Research Administration

[FR Doc. 98-11931 Filed 5-4-98; 8:45 am]

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