[Federal Register Volume 62, Number 243 (Thursday, December 18, 1997)]
[Notices]
[Page 66381]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33016]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Office for Protection From Research Risks; Submission for OMB 
Review; Comment Request; Protection of Human Subjects: Assurance 
Identification/Certification Declaration

SUMMARY: Under the provisions of Section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995, the Office for Protection from Research Risks 
(OPRR), the National Institutes of Health (NIH) has submitted to the 
Office of Management and Budget (OMB) a request to review and approve 
the information collection listed below. This proposed information 
collection was previously published in the Federal Register of August 
22, 1997 (62 FR 44701) and allowed 60 days for public comment. No 
public comments were received. The purpose of this notice is to allow 
an additional 30 days for public comment. The National Institutes of 
Health may not conduct or sponsor, and the respondent is not required 
to respond to, an information collection that has been extended, 
revised, or implemented on or after October 1, 1995, unless it displays 
a currently valid OMB control number.

Proposed Collection

    Title: Protection of Human Subjects: Assurance Identification/
Certification/Declaration. Type of Information Collection Request: 
Extension. OMB Control Number: 0925-0418. Expiration Date: 12/31/97. 
Need and Use of Information Collection: The Federal Policy for the 
Protection of Human Subjects was promulgated on June 18, 1991 (56 FR 
28003) and requires applicant and awardee institutions receiving 
Federal funds to initiate procedures to report, disclose, and keep 
required records for the protection of human subjects of research. 
Optional Form 310, Protection of Human Subjects: Assurance 
Identification/Certification/Declaration is necessary for the 
implementation and administration of the reporting and recordkeeping 
requirements set forth in the Federal Policy. Frequency of Response: On 
occasion. Affected Public: Individuals or households; Business or other 
for-profit; Not for-profit institutions; Federal Government; State, 
local or tribal government. Type of Respondents: Researchers. The 
annual reporting burden is as follows: Estimated number of Respondents: 
3,831. Estimated Number of Responses per Respondent: 56.8. Average 
burden hours per response: 0.755; and Estimated total Annual Burden 
Hours Requested: 164,428. The annualized cost to respondents is 
estimated at: $2,096. There are not Capital Costs to report. There are 
no Operating or Maintenance Costs to report.

Request for Comments

    Written comments and/or suggestions from the public and affected 
agencies are invited on one or more of the following points: (1) 
Whether the proposed collection of information will have the proper 
performance of the function of the agency, including whether the 
information will have practical utility; (2) 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) Ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) Ways to 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.

Direct Comments to OMB

    Written comments and/or suggestions regarding the item contained in 
this notice, especially regarding the estimated public burden and 
associated response time, should be directed to the: Office of 
Management and Budget, Office of Regulatory Affairs, New Executive 
Office Building, Room 10235, Washington, D.C. 20503, Attention: Desk 
Officer for NIH. To request more information on the proposed project or 
to obtain a copy of the data collection plans and instruments, contact: 
Michele Russell-Einhorn, Director of Regulatory Affairs, Office for 
Protection from Research Risks, 6100 Executive Blvd., Suite 3B-01, 
Rockville, MD. 20892-7507, or call non-toll-free-number (301) 435-5649 
or E-mail your request, including your address 
to:<[email protected]>.

Comments Due Date

    Comments regarding this information collection are best assured of 
having their full effect if received within 30 days of the date of this 
publication.

    Dated: December 10, 1997.
Gary B. Ellis,
Director, OPRR.
[FR Doc. 97-33016 Filed 12-17-97; 8:45 am]
BILLING CODE 4140-01-M