[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]
-----------------------------------------------------------------------
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
