[Federal Register Volume 79, Number 146 (Wednesday, July 30, 2014)]
[Notices]
[Page 44185]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-17952]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment Request; The NIH/NCATS 
GRDR\SM\ Program; Global Rare Diseases Patient Registry Data Repository 
(GRDR)

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 National Center for Advancing 
Translational Sciences (NCATS), 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.
    Written comments and/or suggestions from the public and affected 
agencies are invited on one or more of the 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.
    To Submit Comments and For Further Information: To obtain a copy of 
the data collection plans and instuments, submit comments in writing, 
or request more information on the proposed project, contact Yaffa 
Rubinstein, Ph.D., Office of Rare Diseases Research (ORDR), National 
Center for Advancing Translational Sciences (NCATS), National 
Institutes of Health (NIH), 6701 Democracy Boulevard, Room 1004, 
Bethesda, Maryland 20892, or call non-toll free number (301) 402-4338, 
or Email your request including your address to 
[email protected]. Formal requests for additional plans and 
instuments must be requested in writing.
    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.
    Proposed Collection: The NIH/NCATS GRDR\SM\ Program, 0925-NEW GRDR, 
National Center for Advancing Translational Sciences (NCATS), National 
Institutes of Health (NIH).
    Need and Use of Information Collection: The NIH created the GRDR 
program https://grdr.ncats.nih.gov an informatics system and central 
data repository, housed at the NCATS/NIH Center to support and 
accelerate research in the cause, diagnosis, and treatment of rare 
diseases. The GRDR program collects a wide range of data types, 
including phenotypic, clinical, and genomic, as well as medical images, 
derived from individuals who participate in rare disease patient 
registries, regardless of the source of funding. The GRDR program 
provides the infrastructure to store, search across, retrieve, and 
analyze these varied types of data. This valuable information will help 
NIH understand and evaluate the use of repositories/datasets in the 
research community. The GRDR program will support: (1) Mapping data to 
standards; (2) increased visibility for participating registries; (3) 
opportunity for cross-disease research; (4) better and faster RD 
clinical research.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 100.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
           Form name                 Type of         Number of     responses per   per response    Total annual
                                   respondent       respondents     respondent      (in hours)      burden hour
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Request for access............  Individuals.....            1000               1            5/60              83
Request to submit.............  Individuals.....             100               1           10/60              17
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    Dated: July 17, 2014.
Pamela McInnes,
Deputy Director, NCATS, NIH.
[FR Doc. 2014-17952 Filed 7-29-14; 8:45 am]
BILLING CODE 4140-01-P