[Federal Register Volume 82, Number 205 (Wednesday, October 25, 2017)]
[Notices]
[Pages 49377-49379]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23173]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0655]


Animal Generic 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 Generic Drug User Fee Act 
(AGDUFA) 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 AGDUFA 
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 of 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:
     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 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.
     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:
     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.
     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-0655 for ``Animal Generic 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.
     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

[[Page 49378]]

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, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of the proposed recommendations 
for the reauthorization of AGDUFA, which authorizes FDA to collect user 
fees and use them for the process of reviewing generic new animal drug 
applications and associated submissions. The authority for AGDUFA 
expires September 30, 2018. Without new legislation, FDA will no longer 
have the authority to collect user fees to fund the generic new animal 
drug review process for future fiscal years. Section 742(d)(4) of the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379j-
22(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 (AGDUFA III), we do the following: (1) Present the 
recommendations 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 46506), 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 AGDUFA III Performance Goals and Procedures Letter and a 
summary of proposed statutory changes, as well as post them at https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/ucm270232.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 AGDUFA III 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 generic new animal drug applications.
    Beginning October 1, 2018, all applications and submissions under 
section 512(b) of the FD&C Act (21 U.S.C. 360b(b)) must be submitted to 
the Agency electronically using the eSubmitter tool.
    The Agency will review and act on 90 percent of original 
abbreviated new animal drug applications (ANADAs) within 240 days (180-
day review plus 60-day administrative review) after the submission 
date. An application is incomplete if it would require additional data 
or information to enable the Agency to complete a comprehensive review 
of the application and reach a decision on the issue(s) presented in 
the application. If the Agency determines that the deficiencies are not 
substantial, the Agency will review and act on 90 percent of 
reactivated applications within 120 days (60-day review plus 60-day 
administrative review) after the reactivated ANADA submission date. 
This shorter review time for reactivated ANADAs for which the 
deficiencies are determined not to be substantial is not intended to 
prevent the use of minor amendments during Agency review of an 
application. If the Agency determines that the deficiencies are 
substantial or new substantial information is provided, the Agency will 
review and act on 90 percent of reactivated applications within 240 
days (180-day review plus 60-day administrative review) after the 
reactivated ANADA submission date.
    The Agency will review and act on 90 percent of administrative 
ANADAs (ANADAs submitted after all scientific decisions have been made 
in the generic investigational new animal drug (JINAD) process, i.e., 
prior to the submission of the ANADA) within 60 days after the 
submission date. Paragraph IV certification applications (section 
512(n)(1)(H)(iv) of the FD&C Act) submitted as administrative ANADAs 
will be excluded from the administrative ANADA cohort.
    The Agency will review and act on 90 percent of Prior Approval 
manufacturing supplemental ANADAs within 180 days after the submission 
date. A Prior Approval manufacturing supplemental ANADA includes: One 
or more major manufacturing changes according to Sec.  514.8(b)(2)(ii) 
(21 CFR 514.8(b)(2)(ii)) and in accordance with Guidance for Industry 
#83, ``Chemistry, Manufacturing, and Controls Changes to an Approved 
NADA or ANADA''; and changes submitted as ``Supplement-Changes Being 
Effected in 30 Days'' that require prior approval according to Sec.  
514.8(b)(3)(v)(A). If a Prior Approval supplement does not clearly 
identify any major manufacturing changes, the Prior Approval supplement 
will be designated by the Agency as a ``Supplement--Changes Being 
Effected'' with a 270-day review goal (see ``Supplement--Changes Being 
Effected Manufacturing Supplemental ANADAs and Reactivations'' below).
    A submission is incomplete if it requires additional data or 
information to enable the Agency to complete a comprehensive review of 
the submission and reach a decision on the issue(s) presented in the 
submission. If the Agency determines that the deficiencies are not 
substantial for manufacturing supplements requiring prior approval, the 
Agency will allow the manufacturing supplements to be resubmitted as 
``Supplement-Changes Being Effected in 30 Days'' as described

[[Page 49379]]

in Sec.  514.8(b)(3) and the drug made with the change can be 
distributed 30 days after the resubmission according to Sec.  
514.8(b)(3)(iv). The Agency will review and act on 90 percent of these 
reactivated manufacturing supplements within 270 days after the 
resubmission date of a complete submission. If the Agency determines 
that the deficiencies remain substantial or new substantial information 
is provided, prior approval is required according to Sec.  
514.8(b)(3)(v)(A). The Agency will review and act on 90 percent of 
these reactivated manufacturing supplements within 180 days after the 
resubmission date of a complete submission.
    The Agency will review and act on 90 percent of ``Supplement-
Changes Being Effected'' manufacturing supplemental ANADAs and 
reactivations submitted according to Sec.  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 270 days after the submission date.
    The Agency will review and act on 90 percent of JINAD study 
submissions within 180 days after the submission date.
    A submission is incomplete if it would require additional data or 
information to enable the Agency to complete a comprehensive review of 
the study submission and reach a decision on the issue(s) presented in 
the submission. If the Agency determines that the deficiencies are not 
substantial, the Agency will review and act on 90 percent of 
resubmitted JINAD study submissions within 60 days after the receipt 
date of a complete study submission. This shorter review time for 
resubmitted JINAD study submissions is not intended to prevent the use 
of minor amendments during Agency review of a study submission. If the 
Agency determines that the deficiencies are substantial or new 
substantial information is provided, the Agency will review and act on 
90 percent of resubmitted JINAD study submissions within 180 days after 
the receipt date of a complete study submission.
    The Agency will review and act on 90 percent of JINAD submissions 
consisting of protocols without substantial data, that the Agency and 
the sponsor consider to be an essential part of the basis for making 
the decision to approve or not approve an ANADA or supplemental ANADA, 
within 75 days after the submission date.
    The Agency will allow comparability protocols as described in Sec.  
514.8(b)(2)(v) to be submitted as protocols without substantial data in 
a JINAD file. The Agency will review and act on 90 percent of JINAD 
submissions consisting of protocols without substantial data within 75 
days after the submission date of the protocol. For potentially more 
complex comparability protocols, for example sterile process validation 
protocols, the sponsor should discuss and have Agency concurrence 
regarding the appropriate filing strategy.
    The Agency will continue to allow two-phased Chemistry, 
Manufacturing, and Controls technical section submissions under the 
JINAD process.
    The Agency and regulated industry are committed to improving the 
review and business processes that will facilitate the timely 
scheduling and conducting of pre-approval inspections (PAIs). To 
improve the timeliness and predictability of foreign PAIs, sponsors may 
voluntarily submit: (1) At the beginning of the calendar year, a list 
of foreign manufacturing facilities that are specified in an 
abbreviated application, supplemental abbreviated application, or 
generic investigational file and may be subject to foreign PAIs for the 
following fiscal year; and (2) a notification 30 days prior to 
submitting an abbreviated application, a supplemental abbreviated 
application, or generic investigational file that informs the Agency 
that the application includes a foreign manufacturing facility. Should 
any changes to the annual list occur after its submission to the 
Agency, the sponsor may provide the updated information to the Agency.
    The Agency will keep a record of the number of foreign PAIs 
conducted for abbreviated applications, along with the average time for 
completing the PAIs, and include this information in its annual 
performance report. The time for completing the PAI is understood to 
mean the time from the inspection scheduling request through 
notification to the Center for Veterinary Medicine (CVM) of 
inspectional findings.
    The Agency and regulated industry agree that the use of both formal 
meetings (e.g., pre-submission conferences, workshops) and informal 
communication by both parties is critical to ensure high submission 
quality such that the above performance goals can be achieved.

B. Inflation Adjuster and Workload Adjuster

    The Agency and regulated industry agree to change the current fixed 
4 percent inflation adjuster to a variable inflation adjuster 
calculated using payroll cost and benefits and the Consumer Price Index 
less food and energy.
    The workload adjustment will continue to be calculated per CVM 
Program Policy and Procedures Manual 1243.3022, except that, for 
purposes of calculating the workload adjustment, it is 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 the over collections provision and making any excess 
collections available to enhance the review process in real time. In 
addition, the proposal provides authority for the Secretary of Health 
and Human Services 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 fiscal year 2021.

D. Impact of AGDUFA III Changes on User Fee Revenue

    The FY 2019 baseline for AGDUFA III is $18,336,340. 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 according to the new statutory provision for 
the inflation adjuster and may be further adjusted by the workload 
adjuster, if applicable.
    The planned total 5-year revenue for AGDUFA I was $27,100,000. The 
planned total 5-year revenue for AGDUFA II was $38,100,000, which also 
included one-time information technology funding in the amount of 
$850,000 for FY 2014. It is estimated that the planned total 5-year 
revenue for AGDUFA III will be $95,000,000.
    The fee revenue distribution in AGDUFA III will remain the same as 
AGDUFA II: 25 percent in application fees; 37.5 percent in product 
fees; and 37.5 percent in sponsor fees.

    Dated: October 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-23173 Filed 10-24-17; 8:45 am]
BILLING CODE 4164-01-P