[Federal Register Volume 79, Number 246 (Tuesday, December 23, 2014)]
[Notices]
[Page 77015]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-29640]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request; The NIH/NCATS 
GRDR\SM\ Program: Global Rare Diseases Patient Registry Data Repository 
(GRDR)

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Institutes of Health (NIH) has 
submitted to the Office of Management and Budget (OMB) a request for 
review and approval of the information collection listed below. This 
proposed information collection was previously published in the Federal 
Register on July 30, 2014, page 44185 and allowed 60-days for public 
comment. No public comments were received. The purpose of this notice 
is to allow an additional 30 days for public comment. The National 
Center for Advancing Translational Sciences (NCATS), National 
Institutes of Health, may not conduct or sponsor, and the respondent is 
not required to respond to, an information collection that has been 
extended, revised, or implemented on or after October 1, 1995, unless 
it displays a currently valid OMB control number.

DATES: Comment Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 30-days 
of the date of this publication.

ADDRESSES: Direct Comments to OMB: Written comments and/or suggestions 
regarding the item(s) contained in this notice, especially regarding 
the estimated public burden and associated response time, should be 
directed to the: Office of Management and Budget, Office of Regulatory 
Affairs, <a href="/cdn-cgi/l/email-protection#541b1d06150b272136393d27273d3b3a143b39367a313b247a333b22"><span class="__cf_email__" data-cfemail="91ded8c3d0cee2e4f3fcf8e2e2f8feffd1fefcf3bff4fee1bff6fee7">[email protected]</span></a> or by fax to 202-395-6974, 
Attention: NIH Desk Officer.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments, submit comments in writing, or 
request more information on the proposed project contact: Dr. Yaffa 
Rubinstein, Director of Patient Resources for Clinical and 
Translational Research at the Office of Rare Diseases Research (ORDR), 
NCATS, NIH, Suite 1004, 6701 Democracy Boulevard, Bethesda, MD 20892-
4874, or call non-toll-free number (301) 402-4338 or Email your 
request, including your address to: <a href="/cdn-cgi/l/email-protection#136a727575723d6166717a7d6067767a7d537d7a7b3d747c65"><span class="__cf_email__" data-cfemail="cbb2aaadadaae5b9bea9a2a5b8bfaea2a58ba5a2a3e5aca4bd">[email protected]</span></a>. Formal 
requests for additional plans and instruments must be requested in 
writing.

SUPPLEMENTARY INFORMATION: Proposed Collection: NIH/NCATS GRDR\SM\ 
Program: Global Rare Diseases Patient Registry Data (GRDR), The 
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 and clinical information, 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 rare 
disease 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 133.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
           Form name                 Type of         Number of     responses per   per response    Total annual
                                   respondent       respondents     respondent      (in hours)      burden hour
----------------------------------------------------------------------------------------------------------------
Request for Open..............  Individuals.....            2000               1            1/60              33
Request for Controlled........  Individuals.....            1000               1            5/60              83
Request to Submit.............  Individuals.....             100               1           10/60              17
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    Dated: December 9, 2014.
Pamela McInnes,
Deputy Director, NCATS, NIH.
[FR Doc. 2014-29640 Filed 12-22-14; 8:45 am]
BILLING CODE 4140-01-P


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