77012 Federal Register / Vol. 79, No. 246 / Tuesday, December 23, 2014 / Notices 

Blended Seafood Products, which 

provides guidance for our staff on 

labeling requirements for processed and 

blended seafood products made 

primarily with fish protein. The CPG 

has been revised for clarity and format, 

including the addition of Regulatory 

Action Guidance and Specimen Charges 

sections. The CPG contains information 

that may be useful to the regulated 

industry and to the public. 

II. Comments 

Interested persons may submit either 

written comments regarding the 

guidance to the Division of Dockets 

Management (see ADDRESSES) or 

electronic comments regarding the 

guidance to http://www.regulations.gov. 

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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either http:// 

www.fda.gov/ICECI/ 

ComplianceManuals/ 

CompliancePolicyGuidanceManual/ 

default.htm or http:// 

www.regulations.gov. Use the FDA Web 

site listed in the previous sentence to 

find the most current version of the 

guidance. 

Dated: December 18, 2014. 

Melinda K. Plaisir, 

Associate Commissioner for Regulatory 

Affairs, Office of Regulatory Affairs. 

[FR Doc. 2014–30015 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–2014–D–1696] 

Minimal Manipulation of Human Cells, 

Tissues, and Cellular- and TissueBased Products; Draft Guidance for 

Industry and Food and Drug 

Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft document entitled 

‘‘Minimal Manipulation of Human 

Cells, Tissues, and Cellular- and TissueBased Products; Draft Guidance for 

Industry and Food and Drug 

Administration Staff.’’ The draft 

guidance document provides human 

cells, tissues, and cellular- and tissuebased product (HCT/P) manufacturers, 

healthcare providers, and FDA staff 

with recommendations for meeting the 

criterion of ‘‘minimal manipulation’’ as 

it applies to HCT/Ps. The draft 

guidance, when finalized, is intended to 

supersede the document entitled 

‘‘Guidance for Industry and FDA Staff: 

Minimal Manipulation of Structural 

Tissue Jurisdictional Update’’ dated 

September 2006. This draft guidance is 

not final nor is it in effect at this time. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by February 23, 

2015. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002, or to the 

Office of the Center Director, Guidance 

and Policy Development, Center for 

Devices and Radiological Health 

(CDRH), Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 5431, Silver Spring, MD 20993– 

0002, or you may send an email request 

to the Office of Combination Products 

(OCP) at combination@fda.gov. If you 

are submitting a written request, send 

one self-addressed adhesive label to 

assist the office in processing your 

requests. The draft guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–7800. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

Submit electronic comments on the 

draft guidance to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Melissa Segal, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911, or Angela Krueger, Office of 

Device Evaluation, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1666, Silver Spring, 

MD 20993–0002, 301–796–6380, or 

Leigh Hayes, Office of Combination 

Products, Office of the Commissioner, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 32, Hub 

5129, Silver Spring, MD 20993–0002, 

301–796–8938. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft document entitled ‘‘Minimal 

Manipulation of Human Cells, Tissues, 

and Cellular- and Tissue-Based 

Products; Draft Guidance for Industry 

and Food and Drug Administration 

Staff.’’ The draft guidance document 

provides HCT/P manufacturers, 

healthcare providers, and FDA staff 

with recommendations for meeting the 

21 CFR 1271.10(a)(1) criterion of 

minimal manipulation. The draft 

guidance, when finalized, is intended to 

supersede the document entitled 

‘‘Guidance for Industry and FDA Staff: 

Minimal Manipulation of Structural 

Tissue Jurisdictional Update’’ dated 

September 2006. Note that FDA intends 

to publish a separate draft guidance 

document on the criterion described in 

§ 1271.10(a)(2), the HCT/P is intended 

for homologous use only as reflected by 

the labeling, advertising, or other 

indications of the manufacturer’s 

objective intent. 

HCT/Ps are defined in § 1271.3(d) as 

articles containing or consisting of 

human cells or tissues that are intended 

for implantation, transplantation, 

infusion, or transfer into a human 

recipient. FDA has implemented a riskbased approach to the regulation of 

HCT/Ps. Under the authority of section 

361 of the Public Health Service (PHS) 

Act (42 U.S.C. 264), FDA established 

regulations for all HCT/Ps to prevent the 

introduction, transmission, and spread 

of communicable diseases. These 

regulations can be found in part 1271. 

HCT/Ps are regulated solely under 

section 361 of the PHS Act and part 

1271, if they meet all of the following 

criteria (21 CFR 1271.10(a)): 

• The HCT/P is minimally 

manipulated; 

• The HCT/P is intended for 

homologous use only, as reflected by the 

labeling, advertising, or other 

indications of the manufacturer’s 

objective intent; 

• The manufacture of the HCT/P does 

not involve the combination of the cells 

or tissues with another article, except 

for water, crystalloids, or a sterilizing, 

preserving, or storage agent, provided 

that the addition of water, crystalloids, 

or the sterilizing, preserving, or storage 

mstockstill on DSK4VPTVN1PROD with NOTICES

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