[Federal Register: August 25, 2000 (Volume 65, Number 166)]
[Notices]
[Page 51981-51982]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25au00-137]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Notification of Request for Emergency Clearance; Modification of
OMB No. 0925-0001/Exp. 2/01, ``PHS 398 Research and Research Training
Grant Applications and Related Forms''
SUMMARY: In accordance with section 3507(j) of the Paperwork Reduction
Act of 1995, the National Institutes of Health (NIH) hereby publishes
notification of a request for Emergency Clearance for modification of
the information collection related to the National Institutes of Health
Guidelines for Research Using Human Pluripotent Stem Cells, published
elsewhere in today's Federal Register. The currently approved
information collection OMB No. 0925-0001 permits the NIH to request
from applicant institutions information related to application, award,
and continued compliance with the terms of Federal assistance for
research and research-related training. The approval also covers the
information collection authorized in accordance with 42 CFR 52,
specifically the obtaining of ``[o]ther pertinent information the
Secretary may require to evaluate the proposed project.'' (42 CFR
52.4(f))
The final National Institutes of Health Guidelines for Research
Using Pluripotent Stem Cells requires submission of additional
documentation in the form of additional institutional records from a
limited number of institutions to enable an independent panel of non-
Government experts to ascertain institutional compliance with the
Guidelines. Compliance with the requirements of existing law and
regulations is authorized under OMB No. 0925-0418, Exp. 1/01,
``Protection of Human Subjects: Assurance Identification/Certification/
Declaration.''
The present modification relates to the added reporting requirement
of submission of documentation to permit the agency to exercise the
oversight responsibility established under the Guidelines.
This modification is essential to the mission of NIH (42 USC 241
and 282(b)) and is of the highest scientific priority as determined by
both internal review and external review by a panel of scientific and
other experts in the field of stem cell research. After extensive
consultation with the public and a public meeting, the NIH published
proposed National Institutes of Health Guidelines for Research Using
Human Pluripotent Stem Cells in the Federal Register on December 2 ,
1999 (Federal Register, Vol. 64, No. 231, pages 67576-67579). The
comment period was extended to February 22, 2000. (Federal Register,
February 3, 2000, Vol. 65, No. 23, page 539). Following the period of
comment, NIH has proceeded to finalize the Guidelines, which are
published elsewhere in this issue of the Federal Register.
These Guidelines are essential to ensure that NIH-funded research
in this area is conducted in an ethical and legal manner. The NIH has
determined that the oversight process stipulated in the Guidelines will
achieve this objective. The Guidelines will require that institutions
requesting or using NIH funds for research using human pluripotent stem
cells submit additional documentation to the NIH in the form of
institutional records that will permit NIH oversight in accordance with
the Guidelines.
NIH has taken all practicable steps to consult with the scientific
community and the public, through the process described above and
through the careful consideration of all comments received from the
public.
In view of the extensive period of comment and the thorough
consideration of all views, both prior to the publication of the
proposed Guidelines in December 1999 and subsequently, NIH is herewith
requesting that OMB approve the modification of the collection of
information simultaneously with the publication of the Federal Register
[[Page 51982]]
notice and the publication of the Guidelines in the Federal Register.
Proposed Collection
Title: Research and Research Training Grant Applications and
Related Forms PHS-398 and PHS-2590.
Type of Information Collection Request: Revision.
Need and Use of Information Collection: The additional NEW
reporting requirement is needed to ascertain compliance with the
National Institutes of Health Guidelines for Research Using Human
Pluripotent Stem Cells. PHS-398 and PHS-2590 are used to apply for
research project grants, Research Career Awards (RCA), and
Institutional National Research Service Awards (NRSA).
Frequency of Response: On occasion and annually.
Affected Public: Individuals or households; business or other for-
profit; not-for-profit institutions; Federal Government; and State,
local or tribal government.
Type of Respondents: Research institutions.
The annual reporting burden was:
Estimated Number of Respondents: 111,482.
Estimated Number of Responses per Respondent: 1.05.
Average Burden Hours Per Response: 16.34.
Estimated Total Annual Burden Hours Requested: 1,913,166.
The NEW annual reporting burden is as follows:
Estimated Number of Respondents: 111,582.
Estimated Number of Responses per Respondent: 1.05.
Average Burden Hours Per Response: 16.33.
Estimated Total Annual Burden Hours Requested: 1,913,466.
There are no Capital Costs to report. There are no Operating or
Maintenance Costs to report.
FOR FURTHER INFORMATION CONTACT: The Office of Management and Budget,
Office of Information and Regulatory Affairs, New Executive Office
Building, Room 10235, Washington, D.C. 20503, Attention: Desk Officer
for NIH.
Dated: August 17, 2000.
Ruth L. Kirschstein,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 00-21761 Filed 8-23-00; 8:45 am]
BILLING CODE 4140-01-P