77014 Federal Register / Vol. 79, No. 246 / Tuesday, December 23, 2014 / Notices 

bottled or otherwise packaged beers 

subject to our jurisdiction. It does not 

create or confer any rights for or on any 

person and does not operate to bind 

FDA or the public. An alternate 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. Paperwork Reduction Act of 1995 

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collection of information in 

this guidance was approved under OMB 

control number 0910–0728. 

III. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). 

It is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either http:// 

www.fda.gov/FoodGuidances or http://

www.regulations.gov. Always access an 

FDA guidance document using FDA’s 

Web site listed previously to find the 

most current version of the guidance. 

V. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday, and are available 

electronically at http://

www.regulations.gov. (FDA has verified 

all the Web site addresses in this 

reference section, but we are not 

responsible for any subsequent changes 

to the Web sites after this document 

publishes in the Federal Register.) 

1. TTB Ruling 2008–3, July 7, 2008, 

available at: http://www.ttb.gov/rulings/

2008–3.pdf. 

2. Memorandum of Understanding 225– 

88–2000 between FDA and Bureau of 

Alcohol, Tobacco and Firearms, available at: 

http://www.fda.gov/AboutFDA/Partnerships

Collaborations/Memorandaof

UnderstandingMOUs/DomesticMOUs/

ucm116370.htm. 

Dated: December 17, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–29988 Filed 12–22–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 30-Day 

Comment Request; NIMH Data 

Repositories Data Submission 

Request; NIMH Data Repositories Data 

Access and Use Certification 

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 October 7, 2014, 

page 60479 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 

Institute of Mental Health (NIMH), 

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. 

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. 

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. 

FOR FURTHER INFORMATION CONTACT: To 

obtain a copy of the data collection 

plans and instruments or request more 

information on the proposed project 

contact: NIMH Project Clearance 

Liaison, Science Policy and Evaluation 

Branch, OSPPC, NIMH, NIH, 

Neuroscience Center, 6001 Executive 

Boulevard, MSC 9667, Rockville Pike, 

Bethesda, MD 20892, or call 301–443– 

4335 or Email your request, including 

your address to: 

nimhprapubliccomments@mail.nih.gov. 

Formal requests for additional plans and 

instruments must be requested in 

writing. 

Proposed Collection 

NIMH Data Repositories (NDR) Data 

Submission Request—Revision 0925– 

0667; the NIMH Data Repositories Data 

Access and Use Certification—National 

Institute of Mental Health (NIMH), 

National Institutes of Health (NIH). 

Need and Use of Information 

Collection: The National Institutes of 

Mental Health (NIMH) Data Repositories 

are a group of Federal data repositories 

based on an informatics platform for 

human-subjects research domains 

related to mental health, initially 

established as the National Database for 

Autism Research (NDAR) to support 

autism-related research. In 2013, NIMH 

received approval from OMB for use of 

the NIMH Data Access Request and Use 

Certification (DUC) Form to meet the 

unique data access needs of all existing 

NIMH data repositories, which at the 

time consisted of NDAR, Pediatric MRI 

(PedsMRI), and the NIMH Clinical 

Research Datasets (NCRD)—OMB# 

0925–0667 (Expiration: 09/30/2016). 

Now in 2014, two new databases have 

been added and integrated into the 

NDAR infrastructure, NDCT and 

RDoCdb. At this time, NIMH is seeking 

OMB approval to add an all-purpose 

NIMH Data Repositories Data 

Submission Request Form and to revise 

the all-purpose NIMH Data Repositories 

Data Access and Use Certification Form. 

As the data repositories have matured, 

and with the introduction of the new 

databases—namely NDCT and 

RDoCdb—the information being 

collected for data submission has 

become more complex, rendering an 

OMB-approved submission form a new 

necessity. 

OMB approval is requested for three 

years. There are no costs to respondents 

other than their time. The total 

estimated annualized burden hours are 

221. 

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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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