[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
                                                 ---------------------------------------------------------------
    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
                                                 ---------------------------------------------------------------
    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