10662 Federal Register / Vol. 77, No. 36 / Thursday, February 23, 2012 / Rules and Regulations 

relationship between the National 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Accordingly, the 

Agency concludes that the IFR does not 

contain policies that have federalism 

implications as defined in the Executive 

order and, consequently, a federalism 

summary impact statement is not 

required. 

VII. Comments 

The requirements in this IFR will be 

in effect immediately upon publication 

in the Federal Register. FDA invites 

public comment on this IFR and will 

consider modifications to it based on 

comments made during the comment 

period when FDA issues the final rule. 

FDA intends to finalize this IFR 1 year 

from the close of the comment period. 

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. 

List of Subjects in 21 CFR Part 1 

Cosmetics, Drugs, Exports, Food 

labeling, Imports, Labeling, Reporting 

and recordkeeping requirements. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 1 is 

amended as follows: 

PART 1—GENERAL ENFORCEMENT 

REGULATIONS 

■ 1. The authority citation for 21 CFR 

part 1 continues to read as follows: 

Authority: 15 U.S.C. 1453, 1454, 1455; 19 

U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 333, 

334, 335a, 343, 350c, 350d, 352, 355, 360b, 

362, 371, 374, 381, 382, 387, 387a, 393; 42 

U.S.C. 216, 241, 243, 262, 264. 

■ 2. Section 1.361 is revised to read as 

follows: 

§ 1.361 What are the record availability 

requirements? 

When FDA has a reasonable belief 

that an article of food, and any other 

article of food that FDA reasonably 

believes is likely to be affected in a 

similar manner, is adulterated and 

presents a threat of serious adverse 

health consequences or death to humans 

or animals, or when FDA believes that 

there is a reasonable probability that the 

use of or exposure to an article of food, 

and any other article of food that FDA 

reasonably believes is likely to be 

affected in a similar manner, will cause 

serious adverse health consequences or 

death to humans or animals, any records 

and other information accessible to FDA 

under section 414 or 704(a) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 350c and 374(a)) must be 

made readily available for inspection 

and photocopying or other means of 

reproduction. Such records and other 

information must be made available as 

soon as possible, not to exceed 24 hours 

from the time of receipt of the official 

request, from an officer or employee 

duly designated by the Secretary of 

Health and Human Services who 

presents appropriate credentials and a 

written notice. 

Dated: February 17, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4165 Filed 2–22–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 1 

[Docket No. FDA–2011–D–0598] 

Guidance for Industry: Questions and 

Answers Regarding Establishment and 

Maintenance of Records by Persons 

Who Manufacture, Process, Pack, 

Transport, Distribute, Receive, Hold, or 

Import Food (Edition 5) 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of guidance availability. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled 

‘‘Questions and Answers Regarding 

Establishment and Maintenance of 

Records by Persons Who Manufacture, 

Process, Pack, Transport, Distribute, 

Receive, Hold, or Import Food (Edition 

5).’’ This guidance provides updated 

information pertaining to the 

establishment and maintenance of 

records by persons who manufacture, 

process, pack, transport, distribute, 

receive, hold, or import food in the 

United States under the Federal Food, 

Drug, and Cosmetic Act (FD&C Act), as 

amended by the FDA Food Safety and 

Modernization Act (FSMA) of January 4, 

2011. 

DATES: February 23, 2012. 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 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 Outreach and 

Information Center (HFS–009), Center 

for Food Safety and Applied Nutrition, 

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: 

William A. Correll, Jr., Center for Food 

Safety and Applied Nutrition (HFS– 

607), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740, 240–402–1611. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance entitled ‘‘Questions and 

Answers Establishment and 

Maintenance of Records by Persons 

Who Manufacture, Process, Pack, 

Transport, Distribute, Receive, Hold, or 

Import Food (Edition 5),’’ which 

replaces the fourth edition of a guidance 

of the same title issued in September 

2006. The guidance is intended for 

persons who manufacture, process, 

pack, hold, or import human or animal 

foods intended for distribution to 

consumers, institutions, or food 

processors. 

In the Federal Register of December 9, 

2004 (69 FR 71562), FDA published a 

final rule implementing sections 414 

and 704 of FD&C Act (21 U.S.C. 350c 

and 374) as amended by section 306 of 

the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002. The final rule 

requires the establishment and 

maintenance of records by persons who 

manufacture, process, pack, transport, 

distribute, receive, hold, or import food 

in the United States. Such records are to 

allow for the identification of the 

immediate previous sources and the 

immediate subsequent recipients of 

food. FSMA, signed into law on January 

4, 2011 (Pub. L. 111–353), amended 

sections 414 and 704 of the FD&C Act 

by expanding FDA’s access to records 

relating to foods that may cause serious 

adverse health consequences or death to 

humans or animals. In February 2012, 

FDA issued an interim final rule that 

revises § 1.361 (21 CFR 1.361) to reflect 

the FSMA amendments to the FD&C 


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Federal Register / Vol. 77, No. 36 / Thursday, February 23, 2012 / Rules and Regulations 10663 

Act. This guidance document has been 

updated to reflect these changes. 

On September 12, 2005, FDA issued 

the first edition of a guidance entitled 

‘‘Questions and Answers Regarding the 

Establishment and Maintenance of 

Records.’’ This document is the fifth 

edition of that guidance and is updated 

to reflect changes to the FD&C Act made 

by FSMA. This guidance is intended to 

provide individuals in the human and 

animal food industries with an updated 

overview of FDA’s access to records. It 

provides practical information by 

answering common questions that cover 

a range of topics, including who is 

subject to records requirements, the 

scope of records retention and 

availability requirements, and the 

consequences of failing to establish and 

maintain required records or failing to 

make required records available to FDA. 

This guidance is being issued consistent 

with FDA’s good guidance practices 

regulation § 10.115 (21 CFR 10.115) as a 

level 1 guidance. The Agency will 

accept comments, but it is 

implementing this document 

immediately, in accordance with 

§ 10.115(g)(2) because the Agency has 

determined that prior public 

participation is not feasible or 

appropriate. The Agency made this 

determination because this guidance 

simply reflects the statutory changes 

made by section 101 of FSMA to 

sections 414 and 704 of the FD&C Act 

and seeks to remove any confusion that 

might arise due to the existence of a 

guidance document that is inconsistent 

with the FD&C Act and its 

implementing regulations. In addition, 

much of this guidance remains the same 

as the guidance issued in September 

2006. 

This guidance represents the Agency’s 

current thinking on its authority to 

access and copy records. 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 refers to information 

collection provisions 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). We 

conclude that the collection of 

information in § 1.361 is exempt from 

OMB review under 44 U.S.C. 

18(c)(1)(B)(ii) and 5 CFR 1320.4(a)(2) as 

collections of information obtained 

during the conduct of a civil action to 

which the United States or any official 

or Agency thereof is a party, or during 

the conduct of an administrative action, 

investigation, or audit involving an 

Agency against specific individuals or 

entities. The regulations in 5 CFR 

1320.3(c) provide that the exception in 

5 CFR 1320.4(a)(2) applies during the 

entire course of the investigation, audit 

or action, but only after a case file or 

equivalent is opened with respect to a 

particular party. Such a case file would 

be opened as part of the request to 

access records under § 1.361. 

III. 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. 

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 by 

using the Web sites listed previously to 

find the most current version of the 

guidance. 

Dated: February 17, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4167 Filed 2–22–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF VETERANS 

AFFAIRS 

38 CFR Part 59 

RIN 2900–AN77 

Due Date of Initial Application 

Requirements for State Home 

Construction Grants 

AGENCY: Department of Veterans Affairs. 

ACTION: Final rule. 

SUMMARY: This final rule amends the 

Department of Veterans Affairs (VA) 

regulations concerning the calendar date 

by which VA must receive an initial 

application for a State Home 

Construction Grant in order for the 

application to be included on the 

priority list for the award of grants 

during the next fiscal year. We require 

that initial application materials must 

be received by VA no later than April 

15, instead of August 15, of the year 

before the fiscal year in which the 

application would be considered for 

inclusion on the priority list for the 

award of grants. We require certification 

of State matching funds to be submitted 

no later than August 1, instead of 

August 15, in order for the project to be 

placed in priority group 1 of the priority 

list for the next fiscal year. The purpose 

of these changes is to ensure that VA 

has sufficient time to process all 

applications received and timely 

prepare the priority list, so that we can 

accurately notify States that VA intends 

to select and fund particular projects. 

We also make technical revisions to 

conform our regulations to these 

revisions. 

DATES: This final rule is effective March 

26, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Vernon Wilkes, State Veterans Homes 

(10NA5), 1717 H Street NW., 

Washington, DC 20006, (202) 266–4617. 

(This is not a toll-free number.) 

SUPPLEMENTARY INFORMATION: Under 

38 U.S.C. 8131 through 8138, VA is 

authorized to award grants to assist 

States in constructing, remodeling, 

altering, or expanding State home 

facilities that will furnish specified 

types of care to veterans. VA has 

implemented this statutory authority at 

38 CFR part 59. 

Under 38 U.S.C. 8135, States that 

wish to receive assistance for a State 

home construction project (or 

acquisition of an existing facility to be 

used as a State home facility) must 

submit an application that includes 

certain information and documentation 

described in the statute. VA has 

implemented the application 

requirement in current § 59.20(a), which 

requires that applicants seeking 

inclusion on the priority list for grants 

awarded during the next fiscal year 

submit to VA an original and one copy 

of a completed VA Form 10–0388–1 and 

all information, documentation, and 

other forms specified by VA Form 10– 

0388–1. Under current § 59.20(c), VA 

encourages the submission of the 

application by April 15 but considers 

any application submitted before 

August 16 for inclusion on the priority 

list. VA maintains the ‘‘priority list’’ 

pursuant to current 38 CFR 59.50. 

Additionally, under current § 59.70(b), 

VA requires a State to commit funds for 

a project before August 16 in order for 

that project to be eligible for inclusion 

in priority group 1 of the priority list for 

the next fiscal year. 

On March 1, 2011, VA published a 

proposed rule to improve the clarity and 

efficacy of the application process and 


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