Federal Register / Vol. 77, No. 72 / Friday, April 13, 2012 / Proposed Rules 22247 

brought to the center, no compensation 

will be awarded for the loss or damage 

of such property. 

Signed at Washington, DC, this 4th of April 

2012. 

M. Patricia Smith, 

Solicitor of Labor, U.S. Department of Labor. 

[FR Doc. 2012–8735 Filed 4–12–12; 8:45 am] 

BILLING CODE 4510–23–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 558 

[Docket No. FDA–2010–N–0155] 

Veterinary Feed Directive; Draft Text 

for Proposed Regulation 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification; draft text for 

proposed regulation. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of draft text for a proposed 

regulation intended to improve the 

efficiency of FDA’s Veterinary Feed 

Directive (VFD) program. The Agency is 

making this draft text for a proposal 

available because of the complex 

scientific and regulatory issues 

involved, and because of the potential 

impact that changes to the VFD 

regulations may have on stakeholders. 

The Agency invites the public to submit 

comments with questions and concerns 

about the draft text for a proposed 

regulation. 

DATES: Submit either electronic or 

written comments by July 12, 2012. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2010–N– 

0155, by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

Docket No. FDA–2010–N–0155 for this 

rulemaking. All comments received may 

be posted without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Sharon Benz, Center for Veterinary 

Medicine (HFV–220), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–453–6864, 

email: Sharon.Benz@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This document is related to two other 

documents published elsewhere in this 

issue of the Federal Register, wherein 

FDA is announcing: (1) The availability 

of a guidance document entitled ‘‘The 

Judicious Use of Medically Important 

Antimicrobial Drugs in Food-Producing 

Animals’’ (GFI #209) and (2) the 

availability of a draft guidance 

document 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). 

In the Federal Register of March 29, 

2010 (75 FR 15387), FDA published an 

advance notice of proposed rulemaking 

(ANPRM) with a 90-day comment 

period requesting comments on all 

aspects of the VFD regulations. FDA 

published a subsequent document in the 

Federal Register of June 28, 2010 (75 FR 

36588), extending the ANPRM comment 

period for an additional 60 days. 

While FDA encouraged comments on 

all aspects of the VFD regulations, the 

Agency requested input specifically on 

whether efficiency improvements need 

to be made to the current VFD 

regulations. The Agency received 

considerable comments from 

stakeholders suggesting that efficiency 

improvements are needed for the VFD 

regulations. FDA reviewed comments to 

the docket and, based on its review of 

those comments, developed draft text of 

regulatory language intended to 

implement specified changes to the 

existing regulations in part 558 (21 CFR 

part 558). 

Comments to the docket confirmed 

that this is a very complex issue that 

potentially affects many different 

stakeholder interests. Having carefully 

considered the comments and other 

relevant information, the Agency has 

prepared draft text for revisions to the 

existing regulatory language in part 558. 

Because stakeholders’ interests are 

varied, striking the proper regulatory 

balance between sufficient veterinary 

oversight for VFD drugs and increased 

efficiency of the VFD process is a 

challenging proposition. Given the 

number and the nature of the comments 

received, and given the considerable 

impact proposed revisions potentially 

could have on stakeholders, FDA 

believes it is appropriate, before 

publishing an additional proposed rule, 

to offer stakeholders an opportunity to 

review and comment on our draft text 

of proposed revisions to the codified 

language in part 558. 

For that reason, as provided for in 

§§ 10.40(f)(4) and 10.80(b)(2) (21 CFR 

10.40(f)(4) and 21 CFR 10.80(b)(2)), FDA 

has decided to publish the draft text of 

proposed revisions to the codified 

language that the Agency has developed 

in response to public comments on this 

issue. FDA believes that, by making this 

document available under the 

provisions of §§ 10.40(f)(4) and 

10.80(b)(2) and allowing an additional 

public comment period prior to 

publishing an additional proposed rule 

under the provisions of 21 CFR 10.40(b), 

the Agency will be able to develop a 

more informed proposal. When FDA 

publishes the proposed rule, the Agency 

will provide a detailed discussion of 

proposed changes to existing 

regulations. 

The proposed revisions announced in 

this document were developed in 

conjunction with other initiatives 

designed to transition certain new 

animal drug products containing 

medically important antimicrobial drugs 

from an over-the-counter (OTC) status to 

a status that requires veterinary 

oversight. Specifically, the draft text of 

proposed revisions to part 558 reflect 

principles expressed in FDA’s guidance 

document entitled ‘‘The Judicious Use 

of Medically Important Antimicrobial 

Drugs in Food-Producing Animals’’ (GFI 

#209). Further, this draft text of 

proposed revisions is also consistent 

with the specific recommendations 

described in FDA’s draft guidance 

document entitled ‘‘New Animal Drugs 

and New Animal Drug Combination 

Products Administered in or on 


tkelley on DSK3SPTVN1PROD with PROPOSALS
22248 Federal Register / Vol. 77, No. 72 / Friday, April 13, 2012 / Proposed Rules 

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 notices of availability for GFI 

#209 and draft GFI #213 are both 

published elsewhere in this issue of the 

Federal Register. 

FDA acknowledges that in order to 

facilitate the transition of certain new 

animal drug products from an OTC 

status to a status that requires veterinary 

oversight, existing requirements related 

to the distribution and use of VFD drugs 

must be updated and streamlined. As 

reflected in the draft text of proposed 

revisions to part 558 in this document, 

some of the key changes being 

considered include (1) providing for 

alignment between the criteria for 

appropriate veterinary supervision or 

oversight and those established as part 

of veterinary licensing and practice 

requirements, (2) providing 

veterinarians greater flexibility to 

exercise their professional discretion to 

authorize producer access to 

appropriate VFD drugs, and (3) 

streamlining administrative procedures. 

To facilitate the transition from OTC to 

VFD status, FDA believes it is critically 

important that changes such as these be 

implemented to minimize impacts on 

veterinarians, the animal feed industry, 

and animal producers. 

FDA is requesting comments on the 

draft text of proposed revisions to part 

558 as well as comments on any other 

aspect of the VFD regulations, including 

aspects of the regulations not 

specifically addressed in the draft text 

of the proposal. FDA recognizes that it 

is critically important that the Agency 

work with the veterinary and animal 

producer communities, the end users of 

the affected products, to ensure that 

their concerns are taken into 

consideration as these changes are 

implemented. With this in mind, FDA is 

very interested in receiving comments 

on the practical implications of these 

changes for animal producers, 

particularly those with smaller 

operations in remote locations. The 

Agency is also interested in receiving 

input on how impacts or disruption to 

animal producers could be minimized. 

FDA acknowledges that one issue of 

concern is the ability of producers, 

particularly those with smaller 

operations in remote locations, to have 

adequate access to veterinary services. 

Therefore, as steps are taken to phase in 

the changes discussed in this document, 

FDA recognizes the need to 

concurrently engage key stakeholders on 

this broader issue. Therefore, FDA 

intends to work collaboratively with U. 

S. Department of Agriculture (USDA) to 

engage the veterinary community and 

other stakeholders to explore strategic 

approaches (e.g., new models, pilot 

programs) to address this issue. 

FDA encourages the submission of 

comments on the draft text of this 

proposed regulation so that practical 

implementation concerns are adequately 

considered and addressed. However, 

FDA is also exploring other venues for 

seeking and obtaining input, 

particularly from animal producers, 

such as through listening sessions held 

in various parts of the country. FDA is 

working closely with the USDA to 

identify mechanisms for obtaining this 

critical input. 

The draft text of the proposed 

regulation is provided in this document 

and in the docket (refer to the docket 

number in brackets in the heading of 

this document). The Agency emphasizes 

that the draft text of the proposed 

revisions does not represent final 

Agency action or the Agency’s final 

decision on this regulation. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments on 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 558 

Animal drugs, Animal feeds. 

Accordingly, 21 CFR part 558 is 

proposed to be amended as follows: 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

1. The authority citation for 21 CFR 

part 558 continues to read as follows: 

Authority: 21 U.S.C. 360b, 371. 

2. In § 558.3, republish the 

introductory text of paragraph (b), and 

revise paragraphs (b)(1) and (b)(7) to 

read as follows: 

§ 558.3 Definitions and general 

considerations applicable to this part. 

* * * * * 

(b) The following definitions apply to 

terms used in this part: 

(1) New animal drugs approved for 

use in animal feed are placed in two 

categories as follows: 

(i) Category I—These drugs require no 

withdrawal period at the lowest use 

level in each species for which they are 

approved. 

(ii) Category II—These drugs require a 

withdrawal period at the lowest use 

level for at least one species for which 

they are approved, or are regulated on 

a ‘‘no-residue’’ basis or with a zero 

tolerance because of a carcinogenic 

concern regardless of whether a 

withdrawal period is required. 

* * * * * 

(7) A ‘‘veterinary feed directive’’ is a 

written statement issued by a licensed 

veterinarian in the course of the 

veterinarian’s professional practice that 

orders the use of a VFD drug in or on 

an animal feed. This written statement 

authorizes the client (the owner of the 

animal or animals or other caretaker) to 

obtain and use the VFD drug in or on 

an animal feed to treat the client’s 

animals only in accordance with the 

directions for use approved, 

conditionally approved, or indexed by 

the Food and Drug Administration 

(FDA). 

* * * * * 

3. Revise § 558.6 to read as follows: 

§ 558.6 Veterinary feed directive drugs. 

(a) General requirements related to 

veterinary feed directives (VFD): 

(1) A feed containing a VFD drug (a 

VFD feed) shall be fed to animals only 

by or upon a lawful VFD issued by a 

licensed veterinarian in the course of 

the veterinarian’s professional practice. 

(2) VFDs may not be filled after the 

expiration date on the VFD. 

(3) Use and labeling of a VFD drug in 

feed is limited to the approved, 

conditionally approved, or indexed 

conditions of use. Extralabel use (i.e., 

actual or intended use other than as 

directed on the labeling) is not 

permitted. 

(4) All involved parties (the 

veterinarian, the distributor, and the 

client) must retain a copy of the VFD 

and any other required records for 1 

year. 

(5) All involved parties must make the 

VFD and any other records specified in 

this section available for inspection and 

copying by FDA. 

(6) All labeling and advertising for 

VFD drugs and feeds containing VFD 

drugs must prominently and 

conspicuously display the following 

cautionary statement: ‘‘Caution: Federal 

law restricts medicated feed containing 

this VFD drug to use by or on the order 

of a licensed veterinarian.’’ 

(b) Responsibilities of the veterinarian 

issuing the VFD: 

(1) The veterinarian may only issue a 

VFD for use in animals under his or her 

supervision or oversight in the course of 

his or her professional practice, and in 

compliance with all applicable 


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Federal Register / Vol. 77, No. 72 / Friday, April 13, 2012 / Proposed Rules 22249 

veterinary licensing and practice 

requirements. 

(2) The veterinarian must fully and 

accurately enter the following 

information on the VFD: 

(i) The veterinarian’s name, address, 

and telephone number; 

(ii) The client’s name, telephone 

number, and business or home address; 

(iii) The premises at which the 

animals specified in the VFD are 

located; 

(iv) The date of VFD issuance; 

(v) The expiration date of the VFD. 

This date cannot extend beyond the 

expiration date specified in the 

approval, conditional approval, or index 

listing, if such date is specified. In cases 

where the expiration date is not 

specified in the approval, conditional 

approval, or index listing, the expiration 

date of the VFD cannot exceed 6 months 

after the date of issuance; 

(vi) The name of the animal drug; 

(vii) The species and production class 

of animals to be fed the medicated feed; 

(viii) The approximate number of 

animals to be fed the medicated feed 

prior to the expiration date on the VFD; 

(ix) The indication for which the VFD 

is issued; 

(x) The level of drug in the feed and 

duration of use; 

(xi) The withdrawal time, special 

instructions, and cautionary statements 

necessary for use of the drug in 

conformance with the approval; 

(xii) The number of reorders (refills) 

authorized, if permitted by the drug 

approval, conditional approval, or index 

listing; 

(xiii) The statement: ‘‘Extralabel use 

(i.e., use of this VFD feed in a manner 

other than as directed on the labeling) 

is not permitted’’; and 

(xiv) The veterinarian’s electronic or 

written signature. 

(3) The veterinarian may, at his or her 

discretion, enter the following 

information on the VFD to more 

specifically identify the animals 

authorized to be treated/fed the 

medicated feed: 

(i) A more specific description of the 

location of animals (e.g., by site, pen, 

barn, stall, tank, or other descriptor that 

the veterinarian deems appropriate); 

(ii) The approximate age range of the 

animals; 

(iii) The approximate weight range of 

the animals; and 

(iv) Any other information the 

veterinarian deems appropriate to 

identify the animals specified in the 

VFD. 

(4) The veterinarian must send the 

VFD to the feed distributor via 

hardcopy, fax, or electronically. If in 

hardcopy, the veterinarian may send the 

VFD to the distributor either directly or 

through the client. 

(5) The veterinarian must provide a 

copy of the VFD to the client. 

(6) The veterinarian may not transmit 

a VFD by phone. 

(c) Responsibilities of any person who 

distributes an animal feed containing a 

VFD drug: 

(1) The distributor may only fill a 

VFD if the VFD contains the information 

required in § 558.6(b)(2). 

(2) The distributor may only 

distribute an animal feed containing a 

VFD drug that complies with the terms 

of the VFD. 

(3) A distributor of animal feed 

containing VFD drugs must notify FDA 

at the time it first distributes animal 

feed containing VFD drugs. The 

notification is required one time per 

distributor and must include the 

following information: 

(i) The distributor’s complete name 

and business address; 

(ii) The distributor’s signature or the 

signature of the distributor’s authorized 

agent; and 

(iii) The date the notification was 

signed; 

(4) A distributor must submit the 

notification by letter or facsimile to the 

Food and Drug Administration, Center 

for Veterinary Medicine, Division of 

Animal Feeds (HFV–220), 7519 

Standish Pl., Rockville, MD 20855, prior 

to beginning its first distribution. 

(5) A distributor must notify the 

Center for Veterinary Medicine within 

30 days of any change in ownership, 

business name, or business address. 

(6) A distributor may only distribute 

a VFD feed to another person for further 

distribution if the distributor first 

obtains a written acknowledgment from 

the person to whom the feed is shipped 

stating that that person must not ship or 

move such feed to an animal production 

facility without a VFD, or ship such feed 

to another person for further 

distribution unless that person has 

provided the same written 

acknowledgment to the distributor’s 

immediate supplier. 

Dated: April 5, 2012. 

David Dorsey, 

Acting Associate Commissioner for Policy and 

Planning. 

[FR Doc. 2012–8844 Filed 4–11–12; 11:15 am] 

BILLING CODE 4160–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R06–OAR–2009–0648; FRL–9658–2] 

Approval and Promulgation of 

Implementation Plans; New Mexico; 

Albuquerque/Bernalillo County: 

Infrastructure and Interstate Transport 

Requirements for the 1997 and 2008 

Ozone and the 1997 and 2006 PM2.5

NAAQS 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing to approve 

submittals from the Governor of New 

Mexico to the State Implementation 

Plan (SIP) for the City of Albuquerque/ 

Bernalillo County area, pursuant to the 

Clean Air Act (CAA or the Act) that 

address the infrastructure elements 

specified in the CAA section 110(a)(2), 

necessary to implement, maintain, and 

enforce the 1997 and 2008 8-hour ozone 

and the 1997 and 2006 fine particulate 

matter (PM2.5) national ambient air 

quality standards (NAAQS or 

standards). We are proposing to find 

that the current Albuquerque/Bernalillo 

County SIP meets the following 

infrastructure elements for the 1997 and 

2008 8-hour ozone NAAQS and the 

1997 and 2006 PM2.5 NAAQS: 

110(a)(2)(A), (B), (C), (D)(ii), (E), (F), (G), 

(H), (J), (K), (L), and (M). We are also 

proposing to find that the current 

Albuquerque/Bernalillo County SIP 

meets one of the four provisions of CAA 

section 110(a)(2)(D)(i), which addresses 

the requirement that emissions from 

sources in the area do not interfere with 

measures required in the SIP of any 

other state under part C of the CAA to 

prevent significant deterioration (PSD) 

of air quality, with regard to the 1997 

and 2008 ozone and 1997 and 2006 

PM2.5 NAAQS. EPA is also proposing to 

approve SIP revisions that modify the 

PSD SIP to include nitrogen oxides 

(NOX) as an ozone precursor. For 

purposes of the 1997 and 2006 PM2.5

NAAQS, EPA is proposing to approve 

revisions to the Albuquerque/Bernalillo 

County PSD SIP that identify the PM2.5

precursors and establish significant 

emission rates for said precursors, 

consistent with the federal 

requirements. We are also proposing to 

approve other revisions to the 

Albuquerque/Bernalillo County PSD SIP 

to maintain consistency with the federal 

PSD permitting requirements. In 

addition to these revisions, EPA is 

proposing to approve other revisions to 

the Albuquerque/Bernalillo County SIP 


tkelley on DSK3SPTVN1PROD with PROPOSALS