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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10664 Federal Register / Vol. 77, No. 36 / Thursday, February 23, 2012 / Rules and Regulations 

to address certain administrative 

challenges presented by the current 

rules. 76 FR 11187 (Mar. 1, 2011). We 

proposed adopting April 15 as the due 

date for applications, including 

matching funding. We provided a 60- 

day comment period during which we 

received eight comments from State 

departments of veterans affairs and State 

veterans homes and a comment from the 

National Association of State Veterans 

Homes. All of the commenters raised 

similar or identical concerns, which we 

address below. We are grateful for their 

submissions and, after careful 

deliberation, make one change to the 

final rule based on these comments. 

First, several commenters assert that 

they have consistently treated the April 

15 date as a ‘‘preapplication’’ date and 

acknowledge that they complete as 

much of the application as possible on 

or before that date. However, they argue 

that it is impossible to meet an April 15 

deadline for matching funds because the 

fiscal year for most States begins on July 

1, which is after that deadline. To 

address this concern, the final rule 

adopts a separate, later, deadline for the 

official certification of matching funds. 

Under the final rule, the application 

must be received no later than April 15. 

If official certification of the matching 

funds is received on or before August 1, 

the State may be included in priority 

group 1. 

This will allow VA to review the 

submissions and establish each 

application in priority groups 2 through 

7 (which mirror the sub-priorities in 

priority group 1 with the distinction 

that projects in priority group 1 have 

State matching funds while those in 

priority groups 2 through 7 lack these 

resources). When a State is able to 

provide documentation of State 

matching funds, the application will be 

placed in the appropriate position in 

priority group 1. Should a State be 

unable to document matching funds by 

the new August 1 deadline, the project 

will be placed in one of groups 2 

through 7 for the following fiscal year. 

Some commenters argue that the 

burden of filing the application itself, 

not just the matching-funds 

requirement, would be impossible to 

meet before April 15. Previous 

experience is that most States already 

submit preapplication materials on or 

before April 15, as acknowledged by the 

commenters themselves, and thus, we 

do not think that there will be a new 

significant burden. The items required 

on the VA Form 10–0388–1 are 

generally administrative information 

(such as identifier numbers) and the 

schematics of the project. Schematics 

generally require an aerial view of the 

site of the project, a floor plan, and a 

rendering of the exterior of the building. 

Although these may require some 

financial expense, we believe that the 

cost is usually between $6,000 and 

$10,000. In any event, it is never a 

significant expense in relation to the 

cost of the project itself, which is 

usually over $30 million. We do not 

believe that it should be necessary to 

wait for a State legislature to authorize 

the expense or time for producing these 

application materials. 

The commenters challenged VA’s 

need for the additional review time, 

citing the impact of the American 

Recovery and Reinvestment Act of 2009 

(ARRA) on the previous grant cycle 

asserting that it resulted in an 

anomalously high number of 

applications. We acknowledge that the 

ARRA increased the 2010 workload but 

maintain that there is a need for 

additional review time in general, based 

on the uniqueness of each fiscal year, 

the complexity of the projects, and the 

need for extensive detailed and careful 

review of each application. In fact, we 

had begun reassessing the August 15 

due date before Fiscal Year 2010. 

Adoption of the proposed April 15 

application due date, while allowing 

States to submit documentation of 

matching funds by August 1, will allow 

VA to provide due diligence in the 

review and prioritization process, while 

maximizing the States’ opportunity to 

obtain and document matching funds to 

secure a position in priority group 1. 

Several commenters recommended 

delaying publication of the priority list 

rather than altering the due date. We 

appreciate the flexibility recommended 

by these parties but note that release of 

the priority list is determined by the 

time federal budget funds are 

appropriated. Regardless of the ultimate 

date the budget is finalized, VA strives 

to publish the priority list in a timely 

manner and will continue to do so in an 

effort to provide quick, efficient 

distribution of and maximum access to 

available funds. 

The commenters also argue 

administrative inconvenience. However, 

the initial application materials are not 

overly burdensome, and requiring the 

earlier deadlines will help VA ensure 

the timely delivery of funds to worthy 

State projects. Because most 

applications are already received by 

April 15, this date is reasonable, and 

allowing for the August 1 date for the 

certification of matching funds 

addresses the administrative needs of 

the States. 

Finally, commenters objected to VA’s 

rulemaking as being based solely on the 

administrative needs of VA staff, at the 

expense of America’s veterans. VA 

strives diligently to remain veterancentric in all of its programs. 

Clarification of the due date and the 

technical changes proposed in this 

amendment are designed to mirror 

current practice and to facilitate a 

thorough and complete review of grant 

applications prior to funding, in an 

effort to minimize program delays and 

make space in the State homes available 

to our veterans as quickly as possible. 

VA has always initiated review of 

proposals upon receipt, which in most 

cases has been by the April 15 date cited 

in § 59.20. However, VA’s review of 

these grants and their construction 

plans necessitates numerous internal 

concurrences; communications with the 

States for clarification of the application 

materials; development and adoption of 

memorandums of understanding for 

each project; and other significant, timeconsuming, relevant processes. Each 

proposal is unique and may have 

special issues, including terrain, access, 

potential for natural disaster, facility 

measures, varying codes and local 

requirements, etc. VA staff assesses new 

construction as well as renovations to 

facilities of various ages, under an 

assortment of State and national 

construction and safety standards, to 

ascertain that each element of the 

application is thorough, complete, and 

current. Requiring this detailed review 

prior to prioritization and funding 

ensures that the project is ‘‘shovel 

ready’’ when funds become available. 

This, in turn, helps ensure that VA 

funds projects that will be ready, on 

time, for waiting veterans. 

Acknowledging the effort the States 

have historically made to submit 

applications by the April 15 date to 

secure their position on the priority list, 

we believe formal adoption of an April 

15 deadline, with the August 1 date for 

documentation of matching funds for 

placement in priority group 1, will help 

VA and the States and, most 

importantly, serve the needs of veterans 

by improving existing space and making 

new space available for eligible veterans 

at the earliest possible moment. 

Unfunded Mandates 

The Unfunded Mandates Reform Act 

of 1995 requires, at 2 U.S.C. 1532, that 

agencies prepare an assessment of 

anticipated costs and benefits before 

issuing any rule that may result in an 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100 million or more 

(adjusted annually for inflation) in any 

given year. This rule would have no 

such effect on State, local, and tribal 

governments, or on the private sector. 


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Federal Register / Vol. 77, No. 36 / Thursday, February 23, 2012 / Rules and Regulations 10665 

Paperwork Reduction Act 

Although this document contains 

provisions constituting collections of 

information, at 38 CFR 59.20, under the 

provisions of the Paperwork Reduction 

Act (44 U.S.C. 3501 et seq.), no new or 

revised collections of information are 

associated with this rule. The 

information collection requirements for 

§ 59.20 are currently approved by OMB 

and have been assigned OMB control 

number 2900–0661. 

Executive Orders 12866 and 13563 

Executive Orders 12866 and 13563 

direct agencies to assess the costs and 

benefits of available regulatory 

alternatives and, when regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, and other advantages; 

distributive impacts; and equity). 

Executive Order 13563 (Improving 

Regulation and Regulatory Review) 

emphasizes the importance of 

quantifying both costs and benefits, 

reducing costs, harmonizing rules, and 

promoting flexibility. Executive Order 

12866 (Regulatory Planning and 

Review) defines a ‘‘significant 

regulatory action,’’ which requires 

review by the Office of Management and 

Budget (OMB), as ‘‘any regulatory action 

that is likely to result in a rule that may: 

(1) Have an annual effect on the 

economy of $100 million or more or 

adversely affect in a material way the 

economy, a sector of the economy, 

productivity, competition, jobs, the 

environment, public health or safety, or 

State, local, or tribal governments or 

communities; (2) Create a serious 

inconsistency or otherwise interfere 

with an action taken or planned by 

another agency; (3) Materially alter the 

budgetary impact of entitlements, 

grants, user fees, or loan programs or the 

rights and obligations of recipients 

thereof; or (4) Raise novel legal or policy 

issues arising out of legal mandates, the 

President’s priorities, or the principles 

set forth in this Executive Order.’’ 

The economic, interagency, 

budgetary, legal, and policy 

implications of this regulatory action 

have been examined and it has been 

determined to be a significant regulatory 

action under Executive Order 12866 

because it is likely to result in a rule that 

may raise novel legal or policy issues 

arising out of legal mandates, the 

President’s priorities, or the principles 

set forth in the Executive Order. 

Regulatory Flexibility Act 

The Secretary hereby certifies that 

this final rule would not have a 

significant economic impact on a 

substantial number of small entities as 

they are defined in the Regulatory 

Flexibility Act, 5 U.S.C. 601–612. The 

rule affects States and has no impact on 

any small entities. Therefore, pursuant 

to 5 U.S.C. 605(b), this amendment is 

exempt from the initial and final 

regulatory flexibility analysis 

requirements of sections 603 and 604. 

Catalog of Federal Domestic Assistance 

The Catalog of Federal Domestic 

Assistance program numbers and titles 

for this rule are as follows: 64.005, 

Grants to States for Construction of State 

Home Facilities; 64.007, Blind 

Rehabilitation Centers; 64.008, Veterans 

Domiciliary Care; 64.009, Veterans 

Medical Care Benefits; 64.010, Veterans 

Nursing Home Care; 64.014, Veterans 

State Domiciliary Care; 64.015, Veterans 

State Nursing Home Care; 64.018, 

Sharing Specialized Medical Resources; 

64.019, Veterans Rehabilitation Alcohol 

and Drug Dependence; 64.022, Veterans 

Home Based Primary Care; and 64.024, 

VA Homeless Providers Grant and Per 

Diem Program. 

Signing Authority 

The Secretary of Veterans Affairs, or 

designee, approved this document and 

authorized the undersigned to sign and 

submit the document to the Office of the 

Federal Register for publication 

electronically as an official document of 

the Department of Veterans Affairs. John 

R. Gingrich, Chief of Staff, Department 

of Veterans Affairs, approved this 

document on November 14, 2011, for 

publication. 

List of Subjects in 38 CFR Part 59 

Administrative practice and 

procedure; Alcohol abuse; Alcoholism; 

Claims; Day care; Dental health; Drug 

abuse; Government contracts; Grant 

programs—health; Grant programs— 

veterans; Health care; Health facilities; 

Health professions; Health records; 

Homeless; Mental health programs; 

Nursing homes; Philippines, Reporting 

and recordkeeping requirements; 

Veterans. 

Dated: February 17, 2012. 

Robert C. McFetridge, 

Director of Regulation Policy and 

Management, Office of the General Counsel, 

Department of Veterans Affairs. 

For the reasons set forth in the 

preamble, VA amends 38 CFR part 59 as 

follows: 

PART 59—GRANTS TO STATES FOR 

CONSTRUCTION OR ACQUISITION OF 

STATE HOMES 

■ 1. Revise the authority citation for part 

59 to read as follows: 

Authority: 38 U.S.C. 101, 501, 1710, 1742, 

8105, 8131–8137. 

■ 2. Amend § 59.20 by: 

■ a. Revising paragraph (c). 

■ b. Removing ‘‘August’’ from paragraph 

(d) and adding, in its place, ‘‘April’’. 

■ c. Adding an information collection 

approval parenthetical after the 

authority citation at the end of the 

section. 

The revision and addition read as 

follows: 

§ 59.20 Initial application requirements. 

* * * * * 

(c) The items requested under 

paragraph (a) of this section must be 

received by VA no later than April 15 

in order for VA to include the 

application on the priority list for the 

award of grants during the next fiscal 

year. See § 59.50, Priority List. 

* * * * * 

(The Office of Management and Budget 

has approved the information collection 

requirements in this section under 

control number 2900–0661) 

■ 3. Amend § 59.50 by removing 

‘‘August’’ from the introductory text of 

paragraph (a) and adding, in its place, 

‘‘April’’. 

■ 4. Amend § 59.70 by removing 

‘‘August 15’’ from paragraph (b) and 

adding, in its place, ‘‘August 1’’. 

[FR Doc. 2012–4234 Filed 2–22–12; 8:45 am] 

BILLING CODE 8320–01–P 

GENERAL SERVICES 

ADMINISTRATION 

48 CFR Parts 519 and 552 

[GSAR Amendment 2012–02; GSAR Case 

2011–G502; (Change 54) Docket 2012–0003, 

Sequence 1] 

RIN 3090–AJ24 

General Services Administration 

Acquisition Regulation; AcquisitionRelated Thresholds 

AGENCIES: Office of Acquisition Policy, 

General Services Administration (GSA). 

ACTION: Final rule. 

SUMMARY: GSA is issuing a final rule 

amending the General Services 

Administration Acquisition Regulation 

(GSAR) to update the acquisition-related 

thresholds in two GSAR clauses. 

DATES: Effective Date: March 26, 2012. 


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