Federal Register / Vol. 77, No. 72 / Friday, April 13, 2012 / Notices 22327 

State Public Assistance Agencies 

(SPAAs). 

C.F.D.A. Number: 93.647 

Statutory Authority: Privacy Act of 1974, 

as amended by Public Law 100–503. 

SUMMARY: In compliance with the 

Privacy Act of 1974, as amended by 

Public Law 100–503, the Computer 

Matching and Privacy Protection Act of 

1988, ACF is publishing a notice of a 

computer matching program. The 

purpose of this computer match is to 

identify specific individuals who 

receive benefits from the Department of 

Veterans Affairs (VA) and also receive 

payments pursuant to various benefit 

programs administered by both the 

Department of Health and Human 

Services (HHS) and the Department of 

Agriculture. ACF will facilitate this 

program on behalf of SPAAs that 

participate in PARIS for verification of 

continued eligibility for public 

assistance. The match will utilize VA 

and SPAA records. 

DATES: Submit written comments on or 

before May 14, 2012 

ACF will file a report of the subject 

matching program with the Committee 

on Homeland Security and 

Governmental Affairs of the Senate and 

the Committee on Oversight and 

Government Reform of the House of 

Representatives and the Office of 

Information and Regulatory Affairs 

within the Office of Management and 

Budget (OMB). The dates for the 

matching program will be effective as 

indicated in ‘‘E. Inclusive Dates of the 

Matching Program’’ in this notice. 

ADDRESSES: Interested parties may 

comment on this notice by writing to 

the Director, Office of Financial 

Services, Office of Administration, 370 

L’Enfant Promenade SW., Washington, 

DC 20047. All comments received will 

be available for public inspection at this 

address. 

FOR FURTHER INFORMATION CONTACT: 

Director, Office of Financial Services, 

Office of Administration, 370 L’Enfant 

Promenade SW., Washington, DC 20047. 

Telephone: (202) 401–7237. 

SUPPLEMENTARY INFORMATION: The 

Privacy Act of 1974, as amended by 

Public Law 100–503, the Computer 

Matching and Privacy Protection Act of 

1988, (5 U.S.C. 552a), adds certain 

protections for individuals applying for 

and receiving Federal benefits. The law 

regulates the use of computer matching 

by Federal agencies when records in a 

system of records are matched with 

other Federal, State, and local 

government records. 

Federal agencies that provide or 

receive records in computer matching 

programs must: 

1. Negotiate written agreements with 

source agencies; 

2. Provide notification to applicants 

and beneficiaries that their records are 

subject to matching; 

3. Verify match findings before 

reducing, suspending, or terminating an 

individual’s benefits or payments; 

4. Furnish detailed reports to 

Congress and OMB; and 

5. Establish a Data Integrity Board that 

must approve matching agreements. 

This computer matching program 

meets the requirements of Public Law 

100–503. 

Jason Donaldson, 

Deputy Assistant Secretary for 

Administration, ACF. 

Notice of Computer Matching Program 

A. Participating Agencies 

VA and SPAAs. 

B. Purpose of the Match 

To identify specific individuals who 

receive benefits from the VA and also 

receive payments pursuant to HHS and 

Department of Agriculture benefit 

programs, and to verify their continued 

eligibility for such benefits. SPAAs will 

contact affected individuals and seek to 

verify the information resulting from the 

match before initiating any adverse 

actions based on the match results. 

C. Authority for Conducting the Match 

The authority for conducting the 

matching program is contained in 

section 402(a)(6) of the Social Security 

Act [42 U.S.C. 602(a)(6)]. 

D. Records To Be Matched 

VA will disclose information from the 

system of records identified as 

Compensation, Pension, Education, and 

Vocational Rehabilitation and 

Employment Records—VA (58VA21/22/ 

28) published at 74 FR 29275, (June 19, 

2009), last amended at 75 FR 22187, 

(April 27, 2010). VA’s disclosure of 

information for use in this computer 

match is listed as a routine use in this 

system of records. 

VA, as the source agency, will prepare 

electronic files containing the names 

and other personal identifying data of 

eligible veterans receiving benefits. 

These records are matched 

electronically against SPAA files 

consisting of data regarding monthly 

Medicaid, Temporary Assistance for 

Needy Families, general assistance, and 

Supplemental Nutrition Assistance 

Program beneficiaries. 

1. The electronic files provided by the 

SPAAs will contain client names and 

Social Security numbers (SSNs). 

2. The resulting output returned to 

SPAAs will contain personal identifiers, 

including names, SSNs, employers, 

current work or home addresses, etc. 

E. Inclusive Dates of the Matching 

Program 

The effective date of the matching 

agreement and date when matching may 

actually begin shall be at the expiration 

of the 40-day review period for OMB 

and Congress, or 30 days after 

publication of the matching notice in 

the Federal Register, whichever date is 

later. The matching program will be in 

effect for 18 months from the effective 

date, with an option to renew for 12 

additional months, unless one of the 

parties to the agreement advises the 

others by written request to terminate or 

modify the agreement. 

[FR Doc. 2012–8901 Filed 4–12–12; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0889] 

Draft Guidance for Industry on New 

Animal Drugs and New Animal Drug 

Combination Products Administered in 

or on Medicated Feed or Drinking 

Water of Food-Producing Animals: 

Recommendations for Drug Sponsors 

for Voluntarily Aligning Product Use 

Conditions With GFI #209; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry (draft GFI #213) entitled ‘‘New 

Animal Drugs and New Animal Drug 

Combination Products Administered in 

or on Medicated Feed or Drinking Water 

of Food-Producing Animals: 

Recommendations for Drug Sponsors for 

Voluntarily Aligning Product Use 

Conditions With GFI #209.’’ The 

purpose of this document is to provide 

information to sponsors of certain new 

animal drug products who are interested 

in developing revised conditions of use 

for those products consistent with 

FDA’s GFI #209, ‘‘The Judicious Use of 

Medically Important Antimicrobial 

Drugs in Food-Producing Animals’’ and 

to set timelines for stakeholders wishing 

to comply voluntarily with this 

guidance. 


pmangrum on DSK3VPTVN1PROD with NOTICES
22328 Federal Register / Vol. 77, No. 72 / Friday, April 13, 2012 / Notices 

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 July 12, 2012. 

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 request. 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: 

William T. Flynn, Center for Veterinary 

Medicine (HVF–1), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–276–9084, 

william.flynn@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This document is related to two 

documents published elsewhere in this 

issue of the Federal Register, wherein 

FDA is announcing: (1) The availability 

of a final guidance entitled ‘‘The 

Judicious Use of Medically Important 

Antimicrobial Drugs in Food-Producing 

Animals’’ (GFI #209) and (2) the 

availability of a draft proposed 

regulation for veterinary feed directives. 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘New Animal Drugs and New Animal 

Drug Combination Products 

Administered in or on Medicated Feed 

or Drinking Water of Food-Producing 

Animals: Recommendations for Drug 

Sponsors for Voluntarily Aligning 

Product Use Conditions With GFI #209’’ 

(draft GFI #213). The audience for this 

draft guidance is sponsors of approved 

applications for new animal drug 

products containing medically 

important antimicrobial new animal 

drugs for use in or on medicated feed or 

in drinking water of food-producing 

animals. The purpose of this draft 

guidance is to provide sponsors of the 

affected new animal drug products with 

more specific information on how to 

supplement their approved new animal 

drug applications to align with FDA’s 

recommendations in GFI #209. 

Final GFI #209, published elsewhere 

in this edition of the Federal Register, 

discusses FDA’s concerns regarding the 

development of antimicrobial resistance 

in human and animal bacterial 

pathogens when medically important 

antimicrobial drugs are used in foodproducing animals in an injudicious 

manner. GFI #209 recommends that the 

use of medically important 

antimicrobial drugs be limited to uses in 

animals that are considered necessary 

for assuring animal health and include 

veterinary oversight or consultation 

(namely through the use of prescription 

or veterinary feed directive products). 

FDA encourages all sponsors of new 

animal drug products covered by draft 

GFI #213 to participate in the voluntary 

program outlined in the draft guidance. 

FDA believes a voluntary approach, 

conducted in a cooperative and timely 

manner, will be a far faster and less 

burdensome route to achieving the 

common goal of more judicious use of 

medically important antimicrobials in 

animal agriculture. However, FDA also 

believes it is critical to see meaningful 

progress toward reaching this goal. 

Therefore, in order to ensure an orderly, 

equitable, and timely transition, draft 

GFI #213 also includes clear timelines 

for sponsors of affected products 

wishing to revise their approved 

applications. 

II. Significance of Guidance 

This level 1 draft guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft guidance, when 

finalized, 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 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 21 CFR part 514 have 

been approved under OMB control 

numbers 0910–0032 and 0910–0669. 

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 draft guidance at either 

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

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/default.htm or 

http://www.regulations.gov. 

Dated: April 5, 2012. 

David Dorsey, 

Acting Associate Commissioner for Policy and 

Planning. 

[FR Doc. 2012–8845 Filed 4–11–12; 11:15 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0094] 

Guidance for Industry on the Judicious 

Use of Medically Important 

Antimicrobial Drugs in FoodProducing Animals; 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 

(GFI #209) entitled ‘‘The Judicious Use 

of Medically Important Antimicrobial 

Drugs in Food-Producing Animals.’’ 

This guidance is intended to inform the 

public of FDA’s current thinking on the 

use of medically important 

antimicrobial drugs in animal 

agriculture. 

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, 


pmangrum on DSK3VPTVN1PROD with NOTICES