[Federal Register: August 25, 2000 (Volume 65, Number 166)]
[Page 51981-51982]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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 
    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/
    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 
    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]