Federal Register / Vol. 79, No. 246 / Tuesday, December 23, 2014 / Notices 77013 

agent does not raise new clinical safety 

concerns with respect to the HCT/P; and 

• Either: 

Æ The HCT/P does not have a 

systemic effect and is not dependent 

upon the metabolic activity of living 

cells for its primary function, or 

Æ The HCT/P has a systemic effect or 

is dependent upon the metabolic 

activity of living cells for its primary 

function, and is for the following uses: 

D Autologous, 

D Allogeneic, in a first-degree or 

second-degree blood relative, or 

D Reproductive. 

If an HCT/P does not meet all of the 

criteria set out under § 1271.10(a), the 

HCT/P will be regulated as a drug, 

device, and/or biological product under 

the Federal Food, Drug, and Cosmetic 

Act, and/or section 351 of the PHS Act 

(42 U.S.C. 262). 

The draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent FDA’s current thinking on this 

topic. It does not create or confer any 

rights for or on any person and does not 

operate to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the requirement 

of the applicable statutes and 

regulations. 

II. Paperwork Reduction Act of 1995 

The draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information 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 collections 

of information in part 1271 have been 

approved under OMB control number 

0910–0543. 

III. Comments 

The draft guidance is being 

distributed for comment purposes only 

and is not intended for implementation 

at this time. 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may obtain the draft guidance at either 

http://www.fda.gov/

BiologicsBloodVaccines/

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm, or http://www.fda.gov/

MedicalDevices/DeviceRegulationand

Guidance/GuidanceDocuments/

default.htm, or http://www.fda.gov/

CombinationProducts/

GuidanceRegulatoryInformation/

default.htm, or http://

www.regulations.gov. Persons unable to 

download an electronic copy of the draft 

guidance entitled ‘‘Minimal 

Manipulation of Human Cells, Tissues, 

and Cellular- and Tissue-Based 

Products; Draft Guidance for Industry 

and FDA Staff’’ may send an email 

request to CDRH-guidance@fda.hhs.gov 

to receive an electronic copy of the 

document. 

Dated: December 17, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–30011 Filed 12–22–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0268] 

Labeling of Certain Beers Subject to 

the Labeling Jurisdiction of the Food 

and Drug Administration: Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled 

‘‘Labeling of Certain Beers Subject to the 

Labeling Jurisdiction of the Food and 

Drug Administration.’’ The document 

provides guidance to industry on how to 

label bottled or otherwise packaged 

beers that are subject to FDA’s labeling 

laws and regulations. This guidance is 

being issued in light of the ruling by the 

Alcohol and Tobacco Tax and Trade 

Bureau (TTB) (formerly the Bureau of 

Alcohol, Tobacco, and Firearms) (TTB 

Ruling 2008–3, dated July 7, 2008) 

clarifying that certain beers do not meet 

the definition of a ‘‘malt beverage’’ 

under the Federal Alcohol 

Administration Act (FAA Act). Because 

these beers are not subject to the 

labeling provisions of the FAA Act, they 

are subject to the labeling provisions of 

the Federal Food, Drug, and Cosmetic 

Act and the Fair Packaging and Labeling 

Act. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit electronic 

comments on the guidance to http://

www.regulations.gov. Submit written 

comments on the guidance to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. Submit written requests for 

single copies of the guidance to the 

Office of Nutrition, Labeling and Dietary 

Supplements, Center for Food Safety 

and Applied Nutrition (HFS–820), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740. 

Send two self-addressed adhesive labels 

to assist that office in processing your 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance. 

FOR FURTHER INFORMATION CONTACT: 

Loretta A. Carey, Center for Food Safety 

and Applied Nutrition (HFS–820), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

240–402–2371. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of August 17, 

2009 (74 FR 41438), we announced the 

availability of a draft guidance entitled 

‘‘Guidance for Industry; Labeling of 

Certain Beers Subject to the Labeling 

Jurisdiction of the Food and Drug 

Administration; Availability; Agency 

Information Collection Activities; 

Proposed Collection; Comment 

Request’’ and gave interested parties an 

opportunity to submit comments on the 

draft guidance at any time and 

comments on the proposed collection of 

information by October 16, 2009. We 

received one comment which we 

reviewed and evaluated. On our own 

initiative, we added a reference to the 

nutrition labeling requirements for 

certain beers and other alcohol 

beverages served in restaurants or 

similar retail food establishments, under 

FDA’s final rule for menu labeling 

which appeared in the Federal Register 

on December 1, 2014 (79 FR 71156). We 

also clarified that the guidance pertains 

to bottled or otherwise packaged beers 

subject to our jurisdiction. We are 

issuing the guidance with no 

substantive changes. 

The final guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents our current 

thinking on the labeling of certain 

mstockstill on DSK4VPTVN1PROD with NOTICES

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. 

mstockstill on DSK4VPTVN1PROD with NOTICES