[Federal Register Volume 77, Number 194 (Friday, October 5, 2012)]
[Notices]
[Pages 61008-61009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-24623]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Request for Comments Under the Paperwork Reduction Act, Section
3506
AGENCY: National Institutes of Health (NIH), HHS.
ACTION: Request for comments.
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SUMMARY: The National Institutes of Health (NIH), as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public and other Federal agencies to take this opportunity
to comment on proposed and/or continuing information collections, as
required by the Paperwork Reduction Act of 1995, Section 3506.
Proposed Collection: Title: National Institutes of Health
Information Collection Forms to Support Genomic Data Sharing for
Research Purposes; Type of Information Collection Request: New; Need
and Use of Information Collection: The NIH mission is to seek
fundamental knowledge about the nature and behavior of living systems
and the application of that knowledge to enhance health, lengthen life,
and reduce the burdens of illness and disability. The sharing of
research data supports this mission and is essential to facilitate the
translation of research results into knowledge, products, practices,
and procedures that improve human health.
By enabling secondary research questions to be addressed, data
sharing maximizes the public benefit achieved through research
investments. NIH's Policy for Sharing of Data Obtained in NIH Supported
or Conducted Genome-Wide Association Studies (GWAS) was established to
enable the full value of GWAS data to be realized. GWAS data are
maintained in a central data repository, the database of Genotypes and
Phenotypes (dbGaP), which is administered by the National Center for
Biotechnology Information (NCBI), part of the National Library of
Medicine at NIH.
As stipulated in the NIH GWAS policy, all principal investigators
(PIs) who receive NIH funding to conduct genomic research are expected
to register studies with genomic data in dbGaP. The nature of the
genomic, phenotypic, and other associated data generated through large-
scale human genomic studies requires responsible stewardship throughout
research and data sharing activities. Since the data being collected
and shared are from human research participants, the protection of
participant interests is paramount. PIs submitting data to dbGaP must
describe any limitations on sharing the data, as defined in the
informed consent provided by the participants from whom the data were
originally collected. PIs must also provide basic study information
such as the type of data that will be submitted to dbGaP and a
description of the study.
Researchers interested in using dbGaP data for secondary research
must submit a request through dbGaP and be granted permission from the
relevant NIH Data Access Committees to access the data. As part of the
request process, researchers must provide information such as a
description of the proposed research use of the dbGaP datasets, a data
security plan, and a Data Use Certification, in which the researcher
agrees to the terms and conditions for use of the data. NIH has
developed online forms, which will be available through dbGaP, in an
effort to reduce the burden for researchers to complete the study
registration, data submission, and data access processes.
Frequency of Response: As necessary.
Description of Respondents: PIs and senior officials from their
institutions.
Estimate of Burden: The burden associated with this information
collection is calculated in two parts: (1) The burden associated with
registering genomic studies and submitting data to dbGaP and (2) the
burden associated with applying for genomic data in dbGaP. The annual
reporting burden for study registration and data submission is as
follows: Estimated Number of Respondents: 100; Estimated Number of
Responses per Respondent: 1; and Estimated Total Annual Burden Hours
Requested: 63. The annual cost to respondents is estimated at $2,506.
The annual reporting burden for applying for genomic data in dbGaP is
as follows: Estimated Number of Respondents: 1,266; Estimated Number of
Responses per Respondent: 2; and Estimated Total Annual Burden Hours
Requested: 1,583. The annual cost to respondents is estimated at
$63,452. There are no capital, operating, or maintenance costs to the
respondents.
[[Page 61009]]
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Estimated Average
Estimated number of burden per Estimated
Type of respondent number of responses per response (in total annual
respondents respondent hours) burden hours
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Study Registration and Data Submission
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PI.............................................. 50 1 45/60 38
Senior Official................................. 50 1 30/60 25
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Total....................................... 100 .............. .............. 63
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Data Access Request
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PI.............................................. 633 2 45/60 950
Senior Official................................. 633 2 30/60 633
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Total....................................... 1,266 .............. .............. 1,583
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Request For Comments: Written comments and/or suggestions from the
public and affected agencies should address one or more of the
following points: (1) Evaluate 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) Evaluate 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) Enhance the
quality, utility, and clarity of the information to be collected; and
(4) 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 CONTACT: To request additional information on
the proposed information collection, contact: Sarah Carr, Acting
Director, Office of Clinical Research and Bioethics Policy, Office of
Science Policy, NIH, 6705 Rockledge Drive, Suite 750, Bethesda, MD
20892; telephone 301-496-9838; fax 301-496-9839; or email
[email protected], Attention: Ms. Carr.
Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication. Comments should be directed to Ms.
Carr through the contact information above.
Dated: September 28, 2012.
Sarah Carr,
Acting Director, Office of Clinical Research and Bioethics Policy,
Office of Science Policy, NIH.
[FR Doc. 2012-24623 Filed 10-4-12; 8:45 am]
BILLING CODE 4140-01-P