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on the draft guidance by July 12, 2012.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draft guidance to http:// 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a draft guidance for industry entitled 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draft guidance is sponsors of approved 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
Federal Register / Vol. 77, No. 72 / Friday, April 13, 2012 / Notices 22329 

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 draft guidance 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); and (2) the availability of a draft 

proposed regulation for veterinary feed 

directives. 

In the Federal Register of June 29, 

2010 (75 FR 37450), FDA published the 

notice of availability for a draft guidance 

entitled ‘‘The Judicious Use of 

Medically Important Antimicrobial 

Drugs in Food-Producing Animals,’’ 

giving interested persons until August 

30, 2010, to comment on the draft 

guidance. FDA received numerous 

comments on the draft guidance, and 

those comments were considered as the 

guidance was finalized. Minor editorial 

changes were made to improve clarity. 

The Agency was pleased to receive a 

number of comments that were 

generally supportive of the concepts 

outlined in draft GFI #209. However, 

other comments were more critical, 

based largely on the guidance’s lack of 

specificity related to implementation 

issues. FDA decided not to make any 

substantive changes to GFI #209 but 

rather to address specific issues related 

to implementation through issuance of a 

separate draft guidance document, draft 

GFI #213, that would afford additional 

opportunity for public comment. As 

noted earlier, a notice of availability for 

draft GFI #213 is published elsewhere in 

this issue of the Federal Register. 

The guidance announced in this 

notice finalizes the draft guidance dated 

June 28, 2010. 

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 represents the Agency’s 

current thinking on the 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 

FDA concludes that there are no 

collections of information under the 

Paperwork Reduction Act of 1995. 

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: April 5, 2012. 

David Dorsey, 

Acting Associate Commissioner for Policy and 

Planning. 

[FR Doc. 2012–8846 Filed 4–11–12; 11:15 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Recruitment of Sites for Assignment of 

Corps Personnel Obligated Under the 

National Health Service Corps 

Scholarship Program 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: General notice. 

SUMMARY: The Health Resources and 

Services Administration (HRSA) 

announces that the listing of entities, 

and their Health Professional Shortage 

Area (HPSA) scores, that will receive 

priority for the assignment of National 

Health Service Corps (NHSC) 

scholarship recipients (Corps Personnel, 

Corps members) during the period July 

1, 2012, through June 30, 2013, is posted 

on the NHSC Web site at http:// 

datawarehouse.hrsa.gov/HGDWReports/ 

OneClickRptFilter.

aspx?rptName=NHSCApp

SiteList&rptFormat=HTML3.2. This 

searchable database specifies all 

currently approved NHSC service sites, 

by State, and can be utilized to 

determine which entities are eligible to 

receive assignment of Corps members 

who are participating in the NHSC 

Scholarship Program based on the 

threshold HPSA score set forth below. 

Please note that entities on this list may 

or may not have current job 

opportunities for NHSC scholars. 

Furthermore, not all vacancies 

associated with sites on the list 

described below will be for Corps 

members, but could be for NHSC 

Scholarship Program participants 

serving their obligation through the 

Private Practice Option. 

Eligible HPSAs and Entities 

To be eligible to receive assignment of 

Corps personnel, entities must: (1) Have 

a current HPSA designation by the 

Office of Shortage Designation, Bureau 

of Health Professions, HRSA; (2) not 

deny requested health care services, or 

discriminate in the provision of services 

to an individual because the individual 

is unable to pay for the services or 

because payment for the services would 

be made under Medicare, Medicaid, or 

the Children’s Health Insurance 

Program (CHIP); (3) enter into an 

agreement with the State agency that 

administers Medicaid and CHIP, accept 

assignment under Medicare, see all 

patients regardless of their ability to pay 

and post such policy, and use and post 

a discounted fee plan; and (4) be 

determined by the Secretary to have: 

(a) A need and demand for health 

manpower in the area; (b) appropriately 

and efficiently used Corps members 

assigned to the entity in the past; (c) 

general community support for the 

assignment of Corps members; (d) made 

unsuccessful efforts to recruit; (e) a 

reasonable prospect for sound fiscal 

management by the entity with respect 

to Corps members assigned there; and (f) 

demonstrated a willingness to support 

and facilitate mentorship, professional 

development, and training opportunities 

for Corps members. 

Priority in approving applications for 

assignment of Corps members goes to 

sites that (1) provide primary medical 

care, mental health, and/or oral health 

services to a primary medical care, 

mental health, or dental HPSA of 

greatest shortage, respectively; (2) are 

part of a system of care that provides a 

continuum of services, including 

comprehensive primary health care and 

appropriate referrals or arrangements for 

secondary and tertiary care; (3) have a 

documented record of sound fiscal 

management; and (4) will experience a 

negative impact on its capacity to 

provide primary health services if a 


pmangrum on DSK3VPTVN1PROD with NOTICES