80 FR 8091 - Conditional Approval of New Animal Drugs; Public Meeting; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 30 (February 13, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 30 (February 13, 2015)
| Page Range | 8091-8092 | |
| FR Document | 2015-03004 |
[Federal Register Volume 80, Number 30 (Friday, February 13, 2015)] [Notices] [Pages 8091-8092] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-03004] ----------------------------------------------------------------------- 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 [[Page 8092]] 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
![Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Notices 8091
provided that no person is required to opportunity to speak, please send a brief Currently, the conditional approval
supply specific information pertaining summary of your comments. Early provisions allow an applicant to market
to the commenter, other than that registration for the meeting is a new animal drug intended for a minor
necessary for self-identification, as a encouraged due to limited time and species or a minor use in a major
condition of the Agency’s full space. species after the applicant has
consideration of the comment. demonstrated that the drug is safe and
SUPPLEMENTARY INFORMATION: can be manufactured according to
Dated: February 5, 2015.
I. Background standards applicable to approval of
Leslie Kux,
applications under section 512(b)(1) of
Associate Commissioner for Policy. FDA considers the timely review of the Federal Food, Drug, and Cosmetic
[FR Doc. 2015–02976 Filed 2–12–15; 8:45 am] the safety and effectiveness of new Act (21 U.S.C. 360b(b)(1)). FDA and
BILLING CODE 4164–01–P animal drugs to be central to the members of regulated industry jointly
Agency’s mission to protect and agreed to explore, as part of the
promote the public health. Before 2004, performance goals outlined in the
DEPARTMENT OF HEALTH AND the timeliness and predictability of the ADUFA III goals letter, statutory
HUMAN SERVICES new animal drug review program was a changes to expand the use of
concern. The Animal Drug User Fee Act conditional approval to other
Food and Drug Administration enacted in 2003 (Pub. L. 108–130; appropriate categories of new animal
[Docket No. FDA–2014–N–1049] hereinafter referred to as ‘‘ADUFA I’’), drugs.
authorized FDA to collect user fees for This public meeting is intended to
Conditional Approval of New Animal 5 years—fiscal year (FY) 2004 to FY provide an additional opportunity for
Drugs; Public Meeting; Request for 2008—that were to be dedicated to public comment. The Agency is
Comments expediting the review of new animal especially interested in receiving
drug applications according to certain comments during the meeting on the
AGENCY: Food and Drug Administration, categories of new animal drug
performance goals and to expand and
HHS. applications that would be considered
modernize the new animal drug review
ACTION: Notification of public meeting; program. The Agency agreed to meet a ‘‘appropriate’’ and why; concerns, if
request for comments. comprehensive set of performance goals any, that might arise due to the
established to show significant expansion of the Conditional Approval
The Food and Drug Administration process; and the length of marketing
(FDA) is announcing a public meeting to improvement in the timeliness and
predictability of the new animal drug exclusivity, if any, that should be
explore the use of statutory changes to associated with the expansion of the
expand the use of conditional approval review process. The implementation of
ADUFA I provided a significant funding Conditional Approval process.
to additional categories of new animal FDA will consider comments received
drugs. This policy exploration is increase that enabled FDA to increase
the number of staff dedicated to the new at this meeting as it moves forward with
consistent with a stated performance this process.
goal in the Animal Drug User Fee animal drug application review process.
FDA has already opened public
Amendments of 2013 (ADUFA III) goals In 2008, before ADUFA I expired, docket FDA Docket No. FDA–2014–N–
letter. FDA is requesting that you submit Congress passed the Animal Drug User 1049 to receive comments on the issue
any comments related to this issue by Fee Amendments of 2008 (Pub. L. 110– (79 FR 53430, September 9, 2014).
September 30, 2015. 316; hereinafter referred to as ‘‘ADUFA Although you can comment on this
Date and Time: The public meeting II’’), which included an extension of document at any time, to ensure that the
will be held on March 16, 2015, from 1 ADUFA for an additional 5 years—FY Agency considers your comment before
p.m. until 4 p.m. 2009 to FY 2013. ADUFA II finalizing work on the exploration
Location: The public meeting will be performance goals were established process described in this document,
held at the Center for Veterinary based on ADUFA I FY 2008 review submit either electronic or written
Medicine, Food and Drug timeframes. In addition, FDA provided comments by September 30, 2015.
Administration, 7519 Standish Pl., 3rd program enhancements to reduce review
Floor, Rockville, MD 20855. Parking is cycles and improve communications II. Participation in a Public Meeting
free. during reviews. While oral presentations from specific
Contact Person: Laura Bradbard, In 2013, before ADUFA II expired, individuals and organizations may be
Center for Veterinary Medicine, Food Congress passed ADUFA III (Pub. L. limited due to time constraints during
and Drug Administration, 7519 Standish 113–14), which was signed by the the public meeting, stakeholders may
Pl., Rm. 159, Rockville, MD 20855, 240– President on June 13, 2013. Like its submit electronic or written comments
276–9109, FAX: 240–276–9020, email: predecessors, ADUFA III includes its discussing any issues of concern to the
Laura.Bradbard@fda.hhs.gov. own comprehensive set of performance administration record (the docket). All
Registration: Registration is free and goals. One such goal, as stated in the relevant data and documentation should
available on a first-come, first-served ADUFA III goals letter, is: Beginning in be submitted with the comments to
basis. Persons interested in attending early FY 2014, the Agency agrees to Docket No. FDA–2014–N–1049. Submit
this meeting must register by March 10, explore, in concert with industry, the electronic comments to http://
2015. For general questions about the feasibility of pursuing statutory www.regulations.gov. Submit written
meeting, for assistance to register for the revisions, consistent with the Agency’s comments to the Division of Dockets
tkelley on DSK3SPTVN1PROD with NOTICES
meeting, to request an opportunity to mission to protect and promote the Management (HFA–305), Food and Drug
make an oral presentation, or to request public health, that may expand the use Administration, 5630 Fishers Lane, rm.
special accommodations due to a of conditional approvals to other 1061, Rockville, MD 20852. It is only
disability, contact Laura Bradbard (see appropriate categories of new animal necessary to send one set of comments.
Contact Person). Please include your drug applications and develop Identify comments with the docket
name, organization, and contact recommendations by September 30, number FDA–2014–N–1049. Received
information. If you are requesting an 2015. comments may be seen in the Division
VerDate Sep<11>2014 21:56 Feb 12, 2015 Jkt 235001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\13FEN1.SGM 13FEN1](https://thefederalregister.org/doc/80_FR_8121/page/1.svg)
![8092 Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Notices
of Dockets Management between 9 a.m. statutory revisions that may modify the timeliness and predictability of the new
and 4 p.m., Monday through Friday, and current requirement that the use of animal drug review process. The
will be posted to the docket at http:// multiple new animal drugs in the same implementation of ADUFA I provided a
www.regulations.gov. medicated feed be subject to an significant funding increase that
approved application. This policy enabled FDA to increase the number of
III. Comments, Transcripts, and
exploration is consistent with a stated staff dedicated to the new animal drug
Recorded Video
performance goal in the Animal Drug application review process.
Information and data submitted User Fee Amendments of 2013 (ADUFA In 2008, before ADUFA I expired,
voluntarily to FDA during the public III) goals letter. FDA is requesting that Congress passed the Animal Drug User
meeting will become part of the you submit any comments related to Fee Amendments of 2008 (Pub. L. 110–
administrative record and will be this issue by March 31, 2016. 316; hereinafter referred to as ‘‘ADUFA
accessible to the public at http:// Date and Time: The public meeting II’’), which included an extension of
www.regulations.gov. The transcript of will be held on March 16, 2015, from 9 ADUFA for an additional 5 years—FY
the proceedings from the public meeting a.m. until 12 p.m. 2009 to FY 2013. ADUFA II
will become part of the administrative Location: The public meeting will be performance goals were established
record. Please be advised that as soon as held at the Center for Veterinary based on ADUFA I FY 2008 review
a transcript is available, it will be Medicine, Food and Drug timeframes. In addition, FDA provided
accessible at http:// Administration, 7519 Standish Pl., 3rd program enhancements to reduce review
www.regulations.gov, Docket No. FDA– Floor, Rockville, MD 20855. Parking is cycles and improve communications
2014–N–1049, and at FDA’s CVM Web free. during reviews.
site at: http://www.fda.gov/ForIndustry/ Contact Person: Laura Bradbard, In 2013, before ADUFA II expired,
UserFees/ Center for Veterinary Medicine, Food Congress passed ADUFA III (Pub. L.
AnimalDrugUserFeeActADUFA/ and Drug Administration, 7519 Standish 113–14), which was signed by the
ucm042891.htm. It may also be viewed Pl., Rm. 159, Rockville, MD 20855, 240– President on June 13, 2013. Like its
at the Division of Dockets Management 276–9109, FAX: 240–276–9020, email: predecessors, ADUFA III includes its
(HFA–305), Food and Drug Laura.Bradbard@fda.hhs.gov. own comprehensive set of performance
Administration, 5630 Fishers Lane, Rm. Registration: Registration is free and goals. One such goal, as stated in the
1061, Rockville, MD 20852. A transcript available on a first-come, first-served ADUFA III goals letter, is: Beginning in
will also be available in either hardcopy basis. Persons interested in attending early FY 2014, the Agency agrees to
or on CD–ROM, after submission of a this meeting must register by March 10, explore, in concert with affected parties,
Freedom of Information request. Written 2015. For general questions about the the feasibility of pursuing statutory
requests are to be sent to the Division meeting, for assistance to register for the revisions, consistent with the Agency’s
of Freedom of Information (ELEM– meeting, to request an opportunity to mission to protect and promote the
1029), Food and Drug Administration, make an oral presentation, or to request public health, that may modify the
12420 Parklawn Dr., Element Bldg., special accommodations due to a current requirement that the use of
Rockville, MD 20857. Additionally, disability, contact Laura Bradbard (see multiple new animal drugs in the same
FDA will be recording the meeting via Contact Person). Please include your medicated feed be subject to an
Adobe Connect on March 16, 2015. name, organization, and contact approved application and develop
Once the recording has been made 508 information. If you are requesting an recommendations by September 30,
compliant, it will be accessible at FDA’s opportunity to speak, please send a brief 2016.
CVM Web site at http://www.fda.gov/ Currently, the use of multiple new
summary of your comments. Early
ForIndustry/UserFees/ animal drugs in the same medicated
registration for the meeting is
AnimalDrugUserFeeActADUFA/ feed (i.e., a combination drug medicated
encouraged due to limited time and feed) requires an approved NADA for
ucm042891.htm. space.
Dated: February 10, 2015.
each new animal drug in the
SUPPLEMENTARY INFORMATION: combination and a separate approved
Leslie Kux,
NADA for the combination new animal
Associate Commissioner for Policy. I. Background
drug itself (21 U.S.C. 360b(d)(4); 21 CFR
[FR Doc. 2015–03004 Filed 2–12–15; 8:45 am] FDA considers the timely review of 514.4(c)). FDA and members of
BILLING CODE 4164–01–P the safety and effectiveness of new regulated industry jointly agreed to
animal drugs to be central to the explore, as part of the performance goals
Agency’s mission to protect and outlined in the ADUFA III goals letter,
DEPARTMENT OF HEALTH AND promote the public health. Before 2004, potential changes to the approval
HUMAN SERVICES the timeliness and predictability of the process for the use of a combination
new animal drug review program was a drug medicated feed. The intent of this
Food and Drug Administration
concern. The Animal Drug User Fee Act exploration is to consider changes
[Docket No. FDA–2014–N–1050] enacted in 2003 (Pub. L. 108–130; intended to allow combination drug
hereinafter referred to as ‘‘ADUFA I’’), medicated feeds to be made available to
Regulation of Combination Drug authorized FDA to collect user fees for the end user in the most efficient
Medicated Feeds; Public Meeting; 5 years—fiscal year (FY) 2004 to FY manner possible while protecting and
Request for Comments 2008—that were to be dedicated to promoting the public health.
AGENCY: Food and Drug Administration, expediting the review of new animal This public meeting is intended to
tkelley on DSK3SPTVN1PROD with NOTICES
HHS. drug applications (NADAs) according to provide an additional opportunity for
ACTION: Notification of public meeting; certain performance goals and to expand public comment. Although in the
request for comments. and modernize the new animal drug ADUFA III performance goals letter FDA
review program. The Agency agreed to only agreed to explore the feasibility of
The Food and Drug Administration meet a comprehensive set of pursuing statutory changes, the Agency
(FDA) is announcing a public meeting to performance goals established to show also invites comment on potential
explore the feasibility of pursuing significant improvement in the changes to procedures and requirements
VerDate Sep<11>2014 21:56 Feb 12, 2015 Jkt 235001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\13FEN1.SGM 13FEN1](https://thefederalregister.org/doc/80_FR_8121/page/2.svg)
Document Created: 2015-12-18 13:17:52
Document Modified: 2015-12-18 13:17:52
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notification of public meeting; request for comments. | |
| FR Citation | 80 FR 8091 |
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