[Federal Register Volume 62, Number 163 (Friday, August 22, 1997)]
[Notices]
[Pages 44701-44702]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22283]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Office for Protection From Research Risks; Proposed Collection; 
Comment Request; Protection of Human Subjects: Assurance 
Identification/Certification/Declaration

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 for Protection from 
Research Risks (OPRR), 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: 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 no 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

[[Page 44702]]

following points: (1) 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) 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.

FOR FURTHER INFORMATION: 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, NIH, 6100 Executive 
Blvd., Suite 3B01, Rockville, MD 20892-7507, or call non-toll-free 
number (301) 496-7005 x236 or E-mail your request, including your 
address to: .

Comments Due Date

    Comments regarding this information collection are best assured of 
having their full effect if received on or before October 21, 1997.

    Dated: August 14, 1997.
Gary B. Ellis,
Director, OPRR.
[FR Doc. 97-22283 Filed 8-21-97; 8:45 am]
BILLING CODE 4140-01-M