14022 Federal Register / Vol. 77, No. 46 / Thursday, March 8, 2012 / Notices 

OMB has now approved the information 

collection and has assigned OMB 

control number 0910–0626. The 

approval expires on February 28, 2015. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http:// 

www.reginfo.gov/public/do/PRAMain. 

Dated: March 2, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–5632 Filed 3–7–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0112] 

Guidance for Industry on Chemistry, 

Manufacturing, and Controls 

Information—Fermentation-Derived 

Intermediates, Drug Substances, and 

Related Drug Products for Veterinary 

Medicinal Use; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

#216 entitled ‘‘Chemistry, 

Manufacturing, and Controls (CMC) 

Information—Fermentation-Derived 

Intermediates, Drug Substances, and 

Related Drug Products for Veterinary 

Medicinal Use.’’ 

The purpose of this document is to 

provide recommendations on what 

documentation to submit to support the 

CMC information for fermentationderived intermediates, drug substances, 

and related drug products for veterinary 

medicinal use. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Communications Staff (HFV–12), Center 

for Veterinary Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

Submit electronic comments on the 

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: 

Michael J. Popek, Center for Veterinary 

Medicine (HFV–144), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8269, 

email: michael.popek@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of March 14, 

2011 (76 FR 13629), FDA published the 

notice of availability for a draft guidance 

entitled ‘‘Chemistry, Manufacturing, 

and Controls (CMC) Information— 

Fermentation-Derived Intermediates, 

Drug Substances, and Related Drug 

Products for Veterinary Medicinal Use’’ 

giving interested persons until May 30, 

2011, to comment on the draft guidance. 

FDA received one comment on the draft 

guidance. No substantive changes were 

made in finalizing this guidance 

document. 

The guidance announced in this 

notice finalizes the draft guidance dated 

March 14, 2012. 

II. Significance of Guidance 

This level 1 guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance will represent the 

Agency’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 

requirements of the applicable statutes 

and regulations. 

III. Paperwork Reduction Act of 1995 

This 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 

this guidance have been approved under 

OMB control number 0910–0032. 

IV. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. 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. 

V. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either 

http://www.fda.gov/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/default.htm or 

http://www.regulations.gov. 

Dated: March 5, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–5629 Filed 3–7–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0091] 

Guidance for Industry: Testing for 

Salmonella Species in Human Foods 

and Direct-Human-Contact Animal 

Foods; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the availability of a 

guidance entitled ‘‘Guidance for 

Industry: Testing for Salmonella Species 

in Human Foods and Direct-HumanContact Animal Foods.’’ The document 

provides guidance to firms that 

manufacture, process, pack, or hold 

human foods or direct-human-contact 

animal foods intended for distribution 

to consumers, institutions, or food 

processors. This guidance does not 

apply to egg producers and other 

persons who are covered by FDA’s final 

rule ‘‘Prevention of Salmonella 

Enteritidis in Shell Eggs During 

Production, Storage, and 

Transportation.’’ The guidance 

addresses testing procedures for 

Salmonella species (spp.) in human 

foods (except shell eggs) and directhuman-contact animal foods, and the 

interpretation of test results, when the 

presence of Salmonella spp. in the food 

may render the food injurious to human 

health. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Office of Food Safety, Center for Food 

Safety and Applied Nutrition, (HFS– 

317), 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 


wreier-aviles on DSK5TPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 46 / Thursday, March 8, 2012 / Notices 14023 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. 

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. 

FOR FURTHER INFORMATION CONTACT: 

Michael E. Kashtock, Center for Food 

Safety and Applied Nutrition (HFS– 

317), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740, 240–402–2022. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of March 23, 

2011 (76 FR 16425), FDA made 

available a draft guidance entitled 

‘‘Testing for Salmonella Species in 

Human Foods and Direct-HumanContact Animal Foods’’ and gave 

interested parties an opportunity to 

submit comments by June 21, 2011. The 

Agency reviewed and evaluated these 

comments and has modified the 

guidance where appropriate. 

This guidance is intended for firms 

that manufacture, process, pack, or hold 

human foods or direct-human-contact 

animal foods intended for distribution 

to consumers, institutions, or food 

processors. The guidance does not apply 

to egg producers and other persons who 

are covered by FDA’s final rule 

‘‘Prevention of Salmonella Enteritidis in 

Shell Eggs During Production, Storage, 

and Transportation’’ (21 CFR part 118; 

the shell egg final rule). The guidance 

addresses testing procedures for 

Salmonella spp. in human foods (except 

shell eggs) and direct-human-contact 

animal foods, and the interpretation of 

test results, when the presence of 

Salmonella spp. in the food may render 

the food injurious to human health. 

FDA issued separate guidances in 

December 2011 and July 2011, 

respectively, entitled ‘‘Guidance for 

Industry: Prevention of Salmonella 

Enteritidis in Shell Eggs During 

Production, Storage and 

Transportation,’’ which provides 

guidance to egg producers on how to 

comply with certain provisions 

contained in the shell egg final rule, 

including provisions for environmental 

and egg testing for Salmonella 

Enteritidis; and ‘‘Draft Guidance for 

Industry: Questions and Answers 

Regarding the Final Rule, Prevention of 

Salmonella Enteritidis in Shell Eggs 

During Production, Storage, and 

Transportation,’’ which responds to 

questions FDA has received on the shell 

egg final rule since its publication and 

includes guidance on environmental 

and egg testing for Salmonella 

Enteritidis. 

II. Significance of Guidance 

The final guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on testing for 

Salmonella spp. in human foods and 

direct-human-contact animal foods. 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. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding the guidance. 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

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

http://www.regulations.gov. Always 

access an FDA document using the FDA 

Web site listed previously to find the 

most current version of the guidance. 

Dated: March 5, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–5628 Filed 3–7–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Alcohol Abuse 

and Alcoholism; Amended Notice of 

Meeting 

Notice is hereby given of a change in 

the meeting of the National Institute on 

Alcohol Abuse and Alcoholism Special 

Emphasis Panel, March 28, 2012, 4 p.m. 

to March 29, 2012, 8 p.m., Legacy Hotel 

and Meeting Center, 1775 Rockville 

Pike, Rockville, MD, 20852 which was 

published in the Federal Register on 

January 17, 2012, 77 FR 2304. 

This meeting will now be held at 5635 

Fishers Lane, Rockville MD 20852. The 

meeting is closed to the public. 

Dated: March 1, 2012. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy 

[FR Doc. 2012–5683 Filed 3–7–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Alcohol Abuse 

and Alcoholism; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Alcohol Abuse and Alcoholism Special 

Emphasis Panel; NIAAA Member Conflict 

application reviews—Biosciences. 

Date: March 26, 2012. 

Time: 1 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: NIAAA/NIH, 5635 Fishers Lane, 

Rockville, MD 20852, (Telephone Conference 

Call). 

Contact Person: Ranga Srinivas, Ph.D., 

Chief, Extramural Project Review Branch 

EPRB, NIAAA, National Institutes of Health, 

5365 Fishers Lane, Room 2085, Rockville, 

MD 20852, (301) 451–2067, 

srinivar@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.271, Alcohol Research 

Career Development Awards for Scientists 

and Clinicians; 93.272, Alcohol National 

Research Service Awards for Research 

Training; 93.273, Alcohol Research Programs; 

93.891, Alcohol Research Center Grants; 

93.701, ARRA Related Biomedical Research 

and Research Support Awards, National 

Institutes of Health, HHS) 

Dated: March 1, 2012. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–5680 Filed 3–7–12; 8:45 am] 

BILLING CODE 4140–01–P 


wreier-aviles on DSK5TPTVN1PROD with NOTICES