Federal Register / Vol. 79, No. 246 / Tuesday, December 23, 2014 / Notices 77015 

ESTIMATED ANNUALIZED BURDEN HOURS

Form 

A. Estimates annual burden hours 

Number of 

respondents 

Frequency of 

response 

Average time 

per response 

(in hours) 

Annual burden 

hour 

NIMH Data Repositories Data Submission Request Form ............................. 40 1 95/60 63 

NIMH Data Repositories Data Access and Use Certification Form ................ 100 1 95/60 158 

Dated: December 15, 2014. 

Keisha Shropshire, 

NIMH Project Clearance Officer, NIMH, NIH. 

[FR Doc. 2014–30057 Filed 12–22–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 30-Day 

Comment Request; The NIH/NCATS 

GRDRSM 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, 

OIRA_submission@omb.eop.gov 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: 

yaffa.rubinstein@nih.gov. Formal 

requests for additional plans and 

instruments must be requested in 

writing. 

SUPPLEMENTARY INFORMATION: Proposed 

Collection: NIH/NCATS GRDRSM

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

Form name Type of respondent Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total annual 

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 

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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