[Federal Register Volume 82, Number 205 (Wednesday, October 25, 2017)]
[Notices]
[Pages 49380-49382]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23172]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0656]


Animal Drug User Fee Act; Recommendations; Request for Comments; 
Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; request for comments; extension of 
comment period.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the availability of the Animal Drug User Fee Act (ADUFA) 
reauthorization draft recommendations and extending the comment period 
to allow interested persons 30 days to submit comments on these draft 
recommendations.

DATES: FDA is extending the comment period on the ADUFA reauthorization 
and draft recommendations. Submit either electronic or written comments 
on the draft recommendations by November 24, 2017.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before November 24, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end November 24, 2017. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to

[[Page 49381]]

the docket unchanged. Because your comment will be made public, you are 
solely responsible for ensuring that your comment does not include any 
confidential information that you or a third party may not wish to be 
posted, such as medical information, your or anyone else's Social 
Security number, or confidential business information, such as a 
manufacturing process. Please note that if you include your name, 
contact information, or other information that identifies you in the 
body of your comments, that information will be posted on https://www.regulations.gov.
    <bullet> If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2011-N-0656 for ``Animal Drug User Fee Act; Recommendations; 
Request for Comments; Extension of Comment Period.'' Received comments, 
those filed in a timely manner (see ADDRESSES), will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
    <bullet> Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Cassie Ravo, Center for Veterinary 
Medicine (HFV-10), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-6866, <a href="/cdn-cgi/l/email-protection#5a393b2929333f74283b2c351a3c3e3b74323229743d352c"><span class="__cf_email__" data-cfemail="4c2f2d3f3f2529623e2d3a230c2a282d6224243f622b233a">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of the proposed recommendations 
for the reauthorization of ADUFA, which authorizes FDA to collect user 
fees and use them for the process of reviewing new animal drug 
applications and associated submissions. The authority for ADUFA 
expires September 30, 2018. Without new legislation, FDA will no longer 
have the authority to collect user fees to fund the new animal drug 
review process for future fiscal years. Section 740A(d)(4) of the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379j-
13(d)(4)) requires that, after holding negotiations with regulated 
industry and periodic consultations with stakeholders, and before 
transmitting the Agency's final recommendation to Congress for the 
reauthorized program (ADUFA IV), we do the following: (1) Present the 
recommendation to the relevant Congressional committees, (2) publish 
such recommendations in the Federal Register, (3) provide for a period 
of 30 days for the public to provide written comments on such 
recommendations, (4) hold a meeting at which the public may present its 
views on such recommendations, and (5) consider such public views and 
comments and revise such recommendations as necessary. In the Federal 
Register of October 5, 2017 (82 FR 46503), we announced a public 
meeting to be held on November 2, 2017. In that notice we stated that 
we intended to publish in the Federal Register the full text of the 
proposed ADUFA IV Performance Goals and Procedures Letter and a summary 
of proposed statutory changes, as well as post them at https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/ucm042891.htm, before the public meeting, and would provide for a 
period of 30 days for the public to provide written comments. This 
notice announces the availability of these draft recommendations and 
extends the comment period to November 24, 2017 to provide for a period 
of 30 days for the public to comment on these draft recommendations. 
After the public meeting and closing of the comment period, we will 
revise the draft recommendations as necessary. In addition, the Agency 
will present the draft recommendations to the Congressional committees.

II. Proposed ADUFA IV Recommendations

A. Enhancing the Process for Premarket Review

    We are proposing the following changes to the performance 
commitments previously established to further enhance the process for 
review of new animal drug applications (NADAs).
    Beginning October 1, 2018, all applications and submissions under 
section 512(b) and 571 of the FD&C Act (21 U.S.C. 360b(b) and 21 U.S.C. 
360ccc, respectively) must be submitted to the Agency electronically 
using the eSubmitter tool.
    The Agency will review and act on 90 percent of ``Supplement-
Changes Being Effected'' manufacturing supplemental NADAs and 
reactivations submitted according to Sec.  514.8(b)(3)(vi) (21 CFR 
514.8(b)(3)(vi)) and in accordance with Guidance for Industry #83, 
``Chemistry, Manufacturing, and Controls Changes to an Approved NADA or 
ANADA'' including manufacturing changes not requiring prior approval 
according to Sec.  514.8(b)(3)(iv), within 180 days after the 
submission date. All other application and submission performance goals 
will remain the same as ADUFA III.
    The Agency commits to working on implementation of the United 
States-European Union Good Manufacturing

[[Page 49382]]

Practice Inspection Mutual Recognition Agreement. All other commitments 
related to pre-approval inspections will remain the same as ADUFA III.
    The Agency will review and act on 90 percent of qualifying Animal 
Drug Availability Act (ADAA) combination medicated feed applications 
within 60 days after the submission date when all of the following 
conditions are met:
    <bullet> Basic regulatory requirements for an ADAA combination 
medicated feed application has been met as outlined in 21 CFR 
514.4(c)(2)(ii).
    <bullet> A presubmission conference has been conducted and either:
    [cir] No data (no tissue residue non-interference study is 
required) are needed and this agreement is documented in the memorandum 
of conference for the presubmission conference; or
    [cir] A justification for not conducting a tissue residue non-
interference study has been submitted, reviewed, and found acceptable 
under an investigational new animal drug (INAD), prior to the 
submission of the ADAA combination medicated feed application; or
    [cir] A tissue residue non-interference study has been submitted, 
reviewed, and found acceptable under an INAD, prior to the submission 
of the ADAA combination medicated feed application.
    <bullet> No effectiveness or target animal safety data are 
required.
    <bullet> No manufacturing data requirements--sponsor can address in 
meeting assay non-interference, but data submission is not required.
    <bullet> All other information is referenced to previous drug 
experience reports.
    <bullet> Sponsor makes submission and it includes: Representative 
(Blue Bird) labeling, Veterinary Feed Directive (if applicable).
    <bullet> Includes a request for categorical exclusion from the need 
to prepare an environmental assessment (EA); i.e., no EA required.
    <bullet> Reference to presubmission conference.
    <bullet> Right of reference (if applicable) to NADA(s) not owned by 
the filing sponsor of the ADAA combination medicated feed application 
has been received by the Agency.
    The Agency will review and act on 90 percent of ADAA combination 
medicated feed applications within 100 days for those applications 
accepted for the 60-day timeframe and there is a need for minor 
amendments.
    If any of the above conditions cannot be met, the ADAA combination 
medicated feed application performance metric will be placed in the 
original NADA application cohort with a 180-day review timeframe.
    The Agency will review and act on 90 percent of resubmissions of 
previously completed Environmental Impact technical sections within 60 
days after the submission date where:
    <bullet> A categorical exclusion was issued;
    <bullet> All other technical sections have been submitted; and
    <bullet> Information contained in the other technical sections 
reveals a change in the conditions of use of the previously issued 
categorical exclusion.
    The Agency will conduct 90 percent of qualifying presubmission 
conferences within a 60-day timeframe when all of the following 
conditions are met:
    <bullet> All background materials, including presentations, have 
been submitted, and
    <bullet> A complete agenda has been agreed upon by the Agency and 
the sponsor.
    A sponsor and the Agency can mutually agree to exclude a particular 
presubmission conference from this performance goal. If a sponsor 
accepts a date beyond the 60-day timeframe for their scheduling 
purposes or is unable to meet with the Agency on Agency available 
dates, the submission will be excluded from the presubmission 
conference cohort.
    The Agency will commence 90 percent of tissue residue method 
demonstrations within 120 days of completion of the 3-hour meeting 
process or within 200 days from the receipt of a submission that 
supports a single laboratory validation tissue residue method 
demonstration.

B. Inflation Adjuster and Workload Adjuster

    The inflation adjuster will remain the same as for ADUFA III.
    The workload adjustment will continue to be calculated per Center 
for Veterinary Medicine Program Policy and Procedures Manual 1243.3022, 
except that, for purposes of calculating the workload adjustment, it 
has been agreed to reset the base years to fiscal year (FY) 2014 
through FY 2018. There will be no workload adjustment for FY 2019. 
Workload adjustments are one-time adjustments and are calculated 
annually.

C. Offset Provision and Excess Collections

    The proposal adds financial flexibility by eliminating the final 
year offset of over collections provision and making any excess 
collections available to enhance the review process in real time. The 
proposal provides authority for the Secretary of Health and Human 
Services (the Secretary) when setting fees to reduce a calculated 
workload adjustment up to the amount of excess collections in the 
second preceding fiscal year. The first fiscal year this provision 
could be applied while setting fees is FY 2021. Likewise, the proposal 
also provides authority to the Secretary to reduce an increase in fees 
to recover a shortfall in collections in a preceding year (after 2018) 
by any remaining prior year excess collections not already applied for 
purposes of reducing fee increases.

D. Impact of ADUFA IV Enhancements on User Fee Revenue

    The FY 2019 baseline for ADUFA IV is $30,331,240, which includes a 
$400,000 one-time cost for information technology enhancement. For each 
year from FY 2020 through FY 2023, the annual statutory revenue amounts 
established in section 741(b) of the FD&C Act (21 U.S.C. 379j-21(b)) 
will be further adjusted by the inflation adjuster, the workload 
adjuster, if applicable, and will include $900,000 per year for tissue 
method trials.
    The total 5-year revenue planned for ADUFA I was $47,000,000. The 
total 5-year revenue planned for ADUFA II was $98,000,000. The total 5-
year revenue planned for ADUFA III was $114,000,000. It is estimated 
that the total 5-year revenue for ADUFA IV will be $150,000,000.
    The fee revenue distribution in ADUFA IV will remain the same as 
ADUFA III: 20 percent from application fees; 27 percent from product 
fees; 26 percent from establishment fees; and 27 percent from sponsor 
fees.

    Dated: October 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-23172 Filed 10-24-17; 8:45 am]
BILLING CODE 4164-01-P


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