[Congressional Record Volume 164, Number 130 (Wednesday, August 1, 2018)]
[Senate]
[Pages S5576-S5577]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
ANIMAL GENERIC DRUG USER FEE AMENDMENTS OF 2018
Mr. ALEXANDER. Mr. President, I ask unanimous consent to have printed
in the Record the commitment letter for the Animal Generic Drug User
Fee Agreements of 2018.
There being no objection, the material was ordered to be printed in
the Record, as follows:
Animal Generic Drug User Fee Amendments of 2018
agdufa reauthorization performance goals and procedures for fy's 2019
thru 2023
The goals and procedures of the Food and Drug
Administration (FDA or the Agency) as agreed to under the
``Animal Generic Drug User Fee Amendments of 2018'' are
summarized as follows:
application/submission goals
Beginning October 1, 2018, all applications and submissions
under the Federal Food, Drug, and Cosmetic Act (FD&C Act)
section 512(b) must be created using the eSubmitter tool and
submitted to the Agency through the FDA Center for Veterinary
Medicine (CVM) Electronic Submission System (ESS).
1. Original Abbreviated New Animal Drug Applications (ANADAs)
and Reactivations
Review and act on 90 percent of original ANADAs within 240
days 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
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 after the
reactivated ANADA submission date.
2. Administrative ANADAs
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 (FD&C Act section 512(n)(1)(H)(iv)) submitted as
administrative ANADAs will be excluded from the
administrative ANADA cohort.
3. Prior Approval Manufacturing Supplemental ANADAs and
Reactivations
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 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 21 CFR
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 days 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 in 21 CFR 514.8(b)(3) and the drug made
with the change can be distributed 30 days after the
resubmission according to 21CFR 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 21 CFR 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 re-
submission date of a complete submission.
4. Supplement--Changes Being Effected Manufacturing
Supplemental ANADAs and Reactivations
Review and act on 90 percent of ``Supplement--Changes Being
Effected'' manufacturing supplemental ANADAs and
reactivations submitted according to 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 21 CFR 514.8(b)(3)(iv), within 270 days
after the submission date.
5. Generic Investigational New Animal Drug (JINAD) Study
Submissions
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.
6. JINAD Protocols
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. Allow comparability protocols as described
in 21 CFR 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.
For the application/submission goals above, the term
``review and act on'' means the issuance of either: (1) a
complete action letter that approves an original or
supplemental ANADA or notifies a sponsor that a JINAD
submission is complete; or (2) an ``incomplete letter'' that
sets forth in detail the specific deficiencies in an original
or supplemental ANADA or JINAD submission and, where
appropriate, the actions necessary to place such an original
or supplemental ANADA or JINAD submission in condition for
approval. Within 30 days of receipt of the application, FDA
shall refuse to file an original or supplemental ANADA, or
their reactivation, that is determined to be insufficient on
its face or otherwise of unacceptable quality for review upon
initial inspection as per 21 CFR 514.110. Thus, the agency
will refuse to file an application containing numbers or
types of errors, or flaws in the development plan, sufficient
to cause the quality of the entire submission to be
questioned to the extent that it cannot reasonably be
reviewed. Within 60 days of receipt of the submission, FDA
will refuse to review a JINAD submission that is determined
to be insufficient on its face or otherwise of unacceptable
quality upon initial inspection using criteria and procedures
similar to those found in 21 CFR 514.110. A decision to
refuse to file an application or to refuse to review a
submission as described above will result in the application
or submission not being entered into the cohort upon which
the relevant user fee goal is based. The agency will keep a
record of the numbers and types of such refusals and include
them in its annual performance report.
FDA may request minor amendments to original or
supplemental ANADAs and JINAD submissions during its review
of the application or submission. At its discretion, the
Agency may extend an internal due date (but not a user fee
goal) to allow for the complete review of an application or
submission for which a minor amendment is requested. If a
pending application is amended with significant changes, the
amended application may be considered resubmitted, thereby
effectively resetting the clock to the date FDA received the
amendment. The same policy applies for JINAD submissions.
Sponsors are not required to submit study protocols for
review. However, for each voluntarily submitted protocol for
a study 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 original
[[Page S5577]]
or supplemental ANADA, the Agency will issue a complete
action letter providing comments resulting from a complete
review of the protocol. The complete action letter will be as
detailed as possible considering the quality and level of
detail of the protocol submission; will include a succinct
assessment of the protocol; and will state whether the Agency
agrees, disagrees, or lacks sufficient information to reach a
decision that the protocol design, execution plans, and data
analyses are adequate to achieve the objectives of the study.
If the Agency determines that a protocol is acceptable, this
represents an agreement that the data generated by the
protocol can be used to support a safety or effectiveness
decision regarding the subject new animal drug. Having agreed
to the design, execution, or analyses proposed in protocols
reviewed under this process, the Agency will not later alter
its perspectives on the design, execution, or analyses unless
the Agency issues a written order that a substantiated
scientific requirement essential to the assessment of the
study appeared after the Agency's protocol assessment, or
public (human or animal) health concerns unrecognized at the
time of protocol assessment under this process are evident.
The term ``submission date'' means the date the FDA Center
for Veterinary Medicine (CVM) Electronic Submission System
(ESS) receives an application or submission. Upon receipt of
an application or submission, the CVM ESS creates an
electronic receipt that contains the date of receipt and is
sent to the submitter.
work queue review procedures
The Agency will review all submissions in accordance with
procedures for working within a queue. An application/
submission that is not reviewed within the applicable
Application/Submission Goal time frame will be reviewed with
the highest possible priority among those pending.
amending similar applications and submissions
The Agency and regulated industry agree that applications
and submissions to the Agency will be complete and of
sufficient quality to allow the Agency's complete and timely
review. The Agency will refuse to file poor quality and
incomplete applications and submissions rather than allowing
them to serve as ``placeholders'' in the review queue that
are subsequently amended to add the missing or inadequate
portions.
The Agency recognizes that there are circumstances in which
a controlled amendment process can make the review of
similar, pending submissions more efficient without
compromising the sponsor's responsibility for high quality
submissions. Thus, if the Agency requests an amendment to a
non-administrative original ANADA, manufacturing supplemental
ANADA, JINAD study submission, or a JINAD protocol submission
(a ``CVM-initiated amendment''), or issues an incomplete
letter for such an application or submission, a sponsor may
request to amend other, similar applications or submissions
it has pending with the Agency (``sponsor-initiated
amendment(s)'') in accordance with the following criteria:
1. The amended information for these similar applications
or submissions must be the same as in the CVM-initiated
amendment or incomplete letter; and
2. The amended information must not significantly change
the similar applications or submissions; and
3. The amended information for these similar applications
or submissions must be submitted no later than:
a. 120 days after the submission date for the similar
original ANADA, manufacturing supplemental ANADA; or
b. 100 days after the submission date for the similar JINAD
study submissions; or
c. 40 days after the submission date for the similar JINAD
protocol submissions.
If the Agency determines that the above criteria have been
met, it will not change the user fee goal for the similar
application or submission that has been amended by a sponsor-
initiated amendment. If the above criteria have not been met,
the Agency may consider the similar application or submission
resubmitted on the date of the sponsor-initiated amendment,
thereby resetting the clock to the date FDA received the
amendment.
multiple data submissions to the chemistry, manufacturing, and controls
technical section
The Agency will continue to allow two-phased Chemistry,
Manufacturing, and Controls technical section submissions
under the JINAD process. Timely Foreign Pre-Approval
Inspections
1. 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.
2. 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 of inspectional findings.
timely meetings with industry
The Agency and the regulated industry agree that the use of
both formal meetings (e.g., presubmission conferences,
workshops) and informal communication by both parties is
critical to ensure high submission quality such that the
above performance goals can be achieved.
workload adjustment
The workload adjustment will continue to be calculated per
CVM Program Policy and Procedures Manual 1243.3022, page 35,
except that, for purposes of calculating the workload
adjustment, it has been agreed to reset the base years to FY
2014-FY 2018. There will be no workload adjustment for FY
2019. Workload adjustments are one-time adjustments, and are
calculated annually.
____________________