Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Notices 8091 

provided that no person is required to 

supply specific information pertaining 

to the commenter, other than that 

necessary for self-identification, as a 

condition of the Agency’s full 

consideration of the comment. 

Dated: February 5, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–02976 Filed 2–12–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1049] 

Conditional Approval of New Animal 

Drugs; Public Meeting; Request for 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of public meeting; 

request for comments. 

The Food and Drug Administration 

(FDA) is announcing a public meeting to 

explore the use of statutory changes to 

expand the use of conditional approval 

to additional categories of new animal 

drugs. This policy exploration is 

consistent with a stated performance 

goal in the Animal Drug User Fee 

Amendments of 2013 (ADUFA III) goals 

letter. FDA is requesting that you submit 

any comments related to this issue by 

September 30, 2015. 

Date and Time: The public meeting 

will be held on March 16, 2015, from 1 

p.m. until 4 p.m. 

Location: The public meeting will be 

held at the Center for Veterinary 

Medicine, Food and Drug 

Administration, 7519 Standish Pl., 3rd 

Floor, Rockville, MD 20855. Parking is 

free. 

Contact Person: Laura Bradbard, 

Center for Veterinary Medicine, Food 

and Drug Administration, 7519 Standish 

Pl., Rm. 159, Rockville, MD 20855, 240– 

276–9109, FAX: 240–276–9020, email: 

Laura.Bradbard@fda.hhs.gov. 

Registration: Registration is free and 

available on a first-come, first-served 

basis. Persons interested in attending 

this meeting must register by March 10, 

2015. For general questions about the 

meeting, for assistance to register for the 

meeting, to request an opportunity to 

make an oral presentation, or to request 

special accommodations due to a 

disability, contact Laura Bradbard (see 

Contact Person). Please include your 

name, organization, and contact 

information. If you are requesting an 

opportunity to speak, please send a brief 

summary of your comments. Early 

registration for the meeting is 

encouraged due to limited time and 

space. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA considers the timely review of 

the safety and effectiveness of new 

animal drugs to be central to the 

Agency’s mission to protect and 

promote the public health. Before 2004, 

the timeliness and predictability of the 

new animal drug review program was a 

concern. The Animal Drug User Fee Act 

enacted in 2003 (Pub. L. 108–130; 

hereinafter referred to as ‘‘ADUFA I’’), 

authorized FDA to collect user fees for 

5 years—fiscal year (FY) 2004 to FY 

2008—that were to be dedicated to 

expediting the review of new animal 

drug applications according to certain 

performance goals and to expand and 

modernize the new animal drug review 

program. The Agency agreed to meet a 

comprehensive set of performance goals 

established to show significant 

improvement in the timeliness and 

predictability of the new animal drug 

review process. The implementation of 

ADUFA I provided a significant funding 

increase that enabled FDA to increase 

the number of staff dedicated to the new 

animal drug application review process. 

In 2008, before ADUFA I expired, 

Congress passed the Animal Drug User 

Fee Amendments of 2008 (Pub. L. 110– 

316; hereinafter referred to as ‘‘ADUFA 

II’’), which included an extension of 

ADUFA for an additional 5 years—FY 

2009 to FY 2013. ADUFA II 

performance goals were established 

based on ADUFA I FY 2008 review 

timeframes. In addition, FDA provided 

program enhancements to reduce review 

cycles and improve communications 

during reviews. 

In 2013, before ADUFA II expired, 

Congress passed ADUFA III (Pub. L. 

113–14), which was signed by the 

President on June 13, 2013. Like its 

predecessors, ADUFA III includes its 

own comprehensive set of performance 

goals. One such goal, as stated in the 

ADUFA III goals letter, is: Beginning in 

early FY 2014, the Agency agrees to 

explore, in concert with industry, the 

feasibility of pursuing statutory 

revisions, consistent with the Agency’s 

mission to protect and promote the 

public health, that may expand the use 

of conditional approvals to other 

appropriate categories of new animal 

drug applications and develop 

recommendations by September 30, 

2015. 

Currently, the conditional approval 

provisions allow an applicant to market 

a new animal drug intended for a minor 

species or a minor use in a major 

species after the applicant has 

demonstrated that the drug is safe and 

can be manufactured according to 

standards applicable to approval of 

applications under section 512(b)(1) of 

the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 360b(b)(1)). FDA and 

members of regulated industry jointly 

agreed to explore, as part of the 

performance goals outlined in the 

ADUFA III goals letter, statutory 

changes to expand the use of 

conditional approval to other 

appropriate categories of new animal 

drugs. 

This public meeting is intended to 

provide an additional opportunity for 

public comment. The Agency is 

especially interested in receiving 

comments during the meeting on the 

categories of new animal drug 

applications that would be considered 

‘‘appropriate’’ and why; concerns, if 

any, that might arise due to the 

expansion of the Conditional Approval 

process; and the length of marketing 

exclusivity, if any, that should be 

associated with the expansion of the 

Conditional Approval process. 

FDA will consider comments received 

at this meeting as it moves forward with 

this process. 

FDA has already opened public 

docket FDA Docket No. FDA–2014–N– 

1049 to receive comments on the issue 

(79 FR 53430, September 9, 2014). 

Although you can comment on this 

document at any time, to ensure that the 

Agency considers your comment before 

finalizing work on the exploration 

process described in this document, 

submit either electronic or written 

comments by September 30, 2015. 

II. Participation in a Public Meeting 

While oral presentations from specific 

individuals and organizations may be 

limited due to time constraints during 

the public meeting, stakeholders may 

submit electronic or written comments 

discussing any issues of concern to the 

administration record (the docket). All 

relevant data and documentation should 

be submitted with the comments to 

Docket No. FDA–2014–N–1049. Submit 

electronic comments 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. It is only 

necessary to send one set of comments. 

Identify comments with the docket 

number FDA–2014–N–1049. Received 

comments may be seen in the Division 


tkelley on DSK3SPTVN1PROD with NOTICES
8092 Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Notices 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http:// 

www.regulations.gov. 

III. Comments, Transcripts, and 

Recorded Video 

Information and data submitted 

voluntarily to FDA during the public 

meeting will become part of the 

administrative record and will be 

accessible to the public at http:// 

www.regulations.gov. The transcript of 

the proceedings from the public meeting 

will become part of the administrative 

record. Please be advised that as soon as 

a transcript is available, it will be 

accessible at http:// 

www.regulations.gov, Docket No. FDA– 

2014–N–1049, and at FDA’s CVM Web 

site at: http://www.fda.gov/ForIndustry/ 

UserFees/ 

AnimalDrugUserFeeActADUFA/ 

ucm042891.htm. It may also be viewed 

at the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. A transcript 

will also be available in either hardcopy 

or on CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to the Division 

of Freedom of Information (ELEM– 

1029), Food and Drug Administration, 

12420 Parklawn Dr., Element Bldg., 

Rockville, MD 20857. Additionally, 

FDA will be recording the meeting via 

Adobe Connect on March 16, 2015. 

Once the recording has been made 508 

compliant, it will be accessible at FDA’s 

CVM Web site at http://www.fda.gov/ 

ForIndustry/UserFees/ 

AnimalDrugUserFeeActADUFA/ 

ucm042891.htm. 

Dated: February 10, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03004 Filed 2–12–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1050] 

Regulation of Combination Drug 

Medicated Feeds; Public Meeting; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of public meeting; 

request for comments. 

The Food and Drug Administration 

(FDA) is announcing a public meeting to 

explore the feasibility of pursuing 

statutory revisions that may modify the 

current requirement that the use of 

multiple new animal drugs in the same 

medicated feed be subject to an 

approved application. This policy 

exploration is consistent with a stated 

performance goal in the Animal Drug 

User Fee Amendments of 2013 (ADUFA 

III) goals letter. FDA is requesting that 

you submit any comments related to 

this issue by March 31, 2016. 

Date and Time: The public meeting 

will be held on March 16, 2015, from 9 

a.m. until 12 p.m. 

Location: The public meeting will be 

held at the Center for Veterinary 

Medicine, Food and Drug 

Administration, 7519 Standish Pl., 3rd 

Floor, Rockville, MD 20855. Parking is 

free. 

Contact Person: Laura Bradbard, 

Center for Veterinary Medicine, Food 

and Drug Administration, 7519 Standish 

Pl., Rm. 159, Rockville, MD 20855, 240– 

276–9109, FAX: 240–276–9020, email: 

Laura.Bradbard@fda.hhs.gov. 

Registration: Registration is free and 

available on a first-come, first-served 

basis. Persons interested in attending 

this meeting must register by March 10, 

2015. For general questions about the 

meeting, for assistance to register for the 

meeting, to request an opportunity to 

make an oral presentation, or to request 

special accommodations due to a 

disability, contact Laura Bradbard (see 

Contact Person). Please include your 

name, organization, and contact 

information. If you are requesting an 

opportunity to speak, please send a brief 

summary of your comments. Early 

registration for the meeting is 

encouraged due to limited time and 

space. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA considers the timely review of 

the safety and effectiveness of new 

animal drugs to be central to the 

Agency’s mission to protect and 

promote the public health. Before 2004, 

the timeliness and predictability of the 

new animal drug review program was a 

concern. The Animal Drug User Fee Act 

enacted in 2003 (Pub. L. 108–130; 

hereinafter referred to as ‘‘ADUFA I’’), 

authorized FDA to collect user fees for 

5 years—fiscal year (FY) 2004 to FY 

2008—that were to be dedicated to 

expediting the review of new animal 

drug applications (NADAs) according to 

certain performance goals and to expand 

and modernize the new animal drug 

review program. The Agency agreed to 

meet a comprehensive set of 

performance goals established to show 

significant improvement in the 

timeliness and predictability of the new 

animal drug review process. The 

implementation of ADUFA I provided a 

significant funding increase that 

enabled FDA to increase the number of 

staff dedicated to the new animal drug 

application review process. 

In 2008, before ADUFA I expired, 

Congress passed the Animal Drug User 

Fee Amendments of 2008 (Pub. L. 110– 

316; hereinafter referred to as ‘‘ADUFA 

II’’), which included an extension of 

ADUFA for an additional 5 years—FY 

2009 to FY 2013. ADUFA II 

performance goals were established 

based on ADUFA I FY 2008 review 

timeframes. In addition, FDA provided 

program enhancements to reduce review 

cycles and improve communications 

during reviews. 

In 2013, before ADUFA II expired, 

Congress passed ADUFA III (Pub. L. 

113–14), which was signed by the 

President on June 13, 2013. Like its 

predecessors, ADUFA III includes its 

own comprehensive set of performance 

goals. One such goal, as stated in the 

ADUFA III goals letter, is: Beginning in 

early FY 2014, the Agency agrees to 

explore, in concert with affected parties, 

the feasibility of pursuing statutory 

revisions, consistent with the Agency’s 

mission to protect and promote the 

public health, that may modify the 

current requirement that the use of 

multiple new animal drugs in the same 

medicated feed be subject to an 

approved application and develop 

recommendations by September 30, 

2016. 

Currently, the use of multiple new 

animal drugs in the same medicated 

feed (i.e., a combination drug medicated 

feed) requires an approved NADA for 

each new animal drug in the 

combination and a separate approved 

NADA for the combination new animal 

drug itself (21 U.S.C. 360b(d)(4); 21 CFR 

514.4(c)). FDA and members of 

regulated industry jointly agreed to 

explore, as part of the performance goals 

outlined in the ADUFA III goals letter, 

potential changes to the approval 

process for the use of a combination 

drug medicated feed. The intent of this 

exploration is to consider changes 

intended to allow combination drug 

medicated feeds to be made available to 

the end user in the most efficient 

manner possible while protecting and 

promoting the public health. 

This public meeting is intended to 

provide an additional opportunity for 

public comment. Although in the 

ADUFA III performance goals letter FDA 

only agreed to explore the feasibility of 

pursuing statutory changes, the Agency 

also invites comment on potential 

changes to procedures and requirements 


tkelley on DSK3SPTVN1PROD with NOTICES