Exploring the Feasibility of Pursuing Statutory Revisions and Other Modifications to Existing Procedures and Requirements Related to the Approval of Combination Drug Medicated Feeds, 53431-53432 [2014-21226]

Download as PDF Federal Register / Vol. 79, No. 174 / Tuesday, September 9, 2014 / Notices tkelley on DSK3SPTVN1PROD with NOTICES beyond new animal drugs intended for minor species or for minor uses in major species to additional categories of new animal drugs as appropriate. DATES: 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 March 9, 2015. ADDRESSES: Submit electronic comments to https:// 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. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Matthew Lucia, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rm. E444, Rockville, MD 20855, 240–402– 0811, matthew.lucia@fda.hhs.gov. 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 VerDate Mar<15>2010 17:39 Sep 08, 2014 Jkt 232001 cycles and improve communications during reviews. In 2013, before ADUFA II expired, Congress passed the Animal Drug User Fee Amendments of 2013 (Pub. L. 113– 14; hereinafter referred to as ADUFA III), which was signed by the President on June 13, 2013. Like its predecessors, ADUFA III included its own comprehensive set of performance goals. One such goal, as stated in the ADUFA III goals letter, was: ‘‘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.’’ The conditional approval provisions are found in section 571 of the Federal Food, Drug and Cosmetic Act (the FD&C Act). These 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 FD&C Act (21 U.S.C. 360b(b)(1)), but before meeting the full requirements for demonstrating effectiveness by providing ‘‘substantial evidence’’ that the drug is effective. Instead, the applicant seeking conditional approval must demonstrate a ‘‘reasonable expectation of effectiveness’’ and has up to 5 years to meet the requirements for demonstrating ‘‘substantial evidence’’ of effectiveness and receive complete approval of an application filed under section 512(b) of the FD&C Act. Today, FDA is announcing that it is beginning the exploration process described in the ADUFA III goals letter. With this document, FDA is requesting comments in regard to the Agency exploring the use of statutory changes to expand the use of conditional approval to appropriate categories of new animal drugs beyond those intended for use either in minor species or for minor uses in major species. FDA is opening a public docket to receive comments on the issue. In particular, FDA is inviting comments on the following specific questions: 1. Which categories of new animal drugs, if any, beyond those intended for minor species or minor uses in major species, should be considered by FDA for conditional approval in accordance PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 53431 with the current conditional approval process and why? 2. How would expanding conditional approval positively or negatively affect animal health? FDA will be reviewing the docket and considering comments submitted as it moves forward with this process. The docket will remain open for 180 days following publication of this document in the Federal Register. II. Comments Interested persons may submit electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at https:// www.regulations.gov. Dated: September 2, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–21227 Filed 9–8–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–1050] Exploring the Feasibility of Pursuing Statutory Revisions and Other Modifications to Existing Procedures and Requirements Related to the Approval of Combination Drug Medicated Feeds AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that it is beginning the exploration process described in a stated performance goal in the Animal Drug User Fee Amendments of 2013 (ADUFA III) goals letter. Consistent with the performance goal, FDA is inviting comments in regard to the Agency exploring the use of statutory changes to modify the current requirement that the use of multiple new animal drugs in a combination drug medicated feed be the subject of an approved new animal drug application (NADA). The Agency also is inviting comment on potential changes to procedures and requirements related to the NADA approval process for such SUMMARY: E:\FR\FM\09SEN1.SGM 09SEN1 53432 Federal Register / Vol. 79, No. 174 / Tuesday, September 9, 2014 / Notices tkelley on DSK3SPTVN1PROD with NOTICES products that can be accomplished under the Agency’s existing statutory authority. DATES: 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 9, 2015. ADDRESSES: Submit electronic comments to https:// 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. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Linda Wilmot, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rm. E442, Rockville, MD 20855, 240–402– 0829, linda.wilmot@fda.hhs.gov. 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 VerDate Mar<15>2010 17:39 Sep 08, 2014 Jkt 232001 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. Today, FDA is announcing that it is beginning the exploration process described in the ADUFA III goals letter. With this document, FDA is requesting public comment on potential statutory changes, consistent with its mission to protect and promote the public health, to modify the current requirements related to feed use combination drugs. In addition, 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 related to the approval process for these products that can be accomplished under the Agency’s existing statutory authority. FDA is opening a public docket to receive comments on the issue. FDA will be reviewing the docket and considering comments submitted as it moves forward with this process. The docket will remain open for 365 days PO 00000 Frm 00027 Fmt 4703 Sfmt 9990 following publication of this document in the Federal Register. II. Comments Interested persons may submit electronic comments to regarding this document https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at https:// www.regulations.gov. Dated: September 2, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–21226 Filed 9–8–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Office of the Director; Notice of Charter Renewal In accordance with Title 41 of the U.S. Code of Federal Regulations, Section 102–3.65(a), notice is hereby given that the Charter for the Fogarty International Center Advisory Board (FICAB) was renewed for an additional two-year period on August 31, 2014. It is determined that the FICAB is in the public interest in connection with the performance of duties imposed on the National Institutes of Health by law, and that these duties can best be performed through the advice and counsel of this group. Inquires may be directed to Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy, Office of the Director, National Institutes of Health, 6701 Democracy Boulevard, Suite 1000, Bethesda, Maryland 20892 (Mail Code 4875), Telephone (301) 496– 2123, or spaethj@od.nih.gov. Dated: September 3, 2014. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2014–21338 Filed 9–8–14; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\09SEN1.SGM 09SEN1

Agencies

[Federal Register Volume 79, Number 174 (Tuesday, September 9, 2014)]
[Notices]
[Pages 53431-53432]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21226]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1050]


Exploring the Feasibility of Pursuing Statutory Revisions and 
Other Modifications to Existing Procedures and Requirements Related to 
the Approval of Combination Drug Medicated Feeds

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
is beginning the exploration process described in a stated performance 
goal in the Animal Drug User Fee Amendments of 2013 (ADUFA III) goals 
letter. Consistent with the performance goal, FDA is inviting comments 
in regard to the Agency exploring the use of statutory changes to 
modify the current requirement that the use of multiple new animal 
drugs in a combination drug medicated feed be the subject of an 
approved new animal drug application (NADA). The Agency also is 
inviting comment on potential changes to procedures and requirements 
related to the NADA approval process for such

[[Page 53432]]

products that can be accomplished under the Agency's existing statutory 
authority.

DATES: 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 9, 2015.

ADDRESSES: Submit electronic comments to https://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. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Linda Wilmot, Center for Veterinary 
Medicine, Food and Drug Administration, 7500 Standish Pl., Rm. E442, 
Rockville, MD 20855, 240-402-0829, linda.wilmot@fda.hhs.gov.

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 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.
    Today, FDA is announcing that it is beginning the exploration 
process described in the ADUFA III goals letter. With this document, 
FDA is requesting public comment on potential statutory changes, 
consistent with its mission to protect and promote the public health, 
to modify the current requirements related to feed use combination 
drugs. In addition, 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 related to the approval process for these 
products that can be accomplished under the Agency's existing statutory 
authority.
    FDA is opening a public docket to receive comments on the issue. 
FDA will be reviewing the docket and considering comments submitted as 
it moves forward with this process. The docket will remain open for 365 
days following publication of this document in the Federal Register.

II. Comments

    Interested persons may submit electronic comments to regarding this 
document https://www.regulations.gov or written comments to the Division 
of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at https://www.regulations.gov.

    Dated: September 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-21226 Filed 9-8-14; 8:45 am]
BILLING CODE 4164-01-P

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