Abbreviated New Drug Applications: Pre-Submission Facility Correspondence Associated with Priority Submissions; Draft Guidance for Industry; Availability, 28072-28074 [2017-12836]
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Federal Register / Vol. 82, No. 117 / Tuesday, June 20, 2017 / Notices
DocumentsRegulatoryInformation/
AcidifiedLACF/ucm309376.htm.
2. Form FDA 2541. Food Process Filing for
All Methods Except Low-Acid Aseptic.
Available at https://www.fda.gov/
downloads/AboutFDA/
ReportsManualsForms/Forms/
UCM076778.pdf.
3. Form 2541d. Food Process Filing for LowAcid Retorted Method. Available at
https://www.fda.gov/downloads/
AboutFDA/ReportsManualsForms/
Forms/UCM465591.pdf.
4. Form 2541e. Food Process Filing for
Acidified Method. Available at https://
www.fda.gov/downloads/AboutFDA/
ReportsManualsForms/Forms/
UCM465593.pdf.
5. Form 2541f. Food Process Filing for Water
Activity/Formulation Control Method.
Available at https://www.fda.gov/
downloads/AboutFDA/
ReportsManualsForms/Forms/
UCM465595.pdf.
6. Form 2541g. Food Process Filing for LowAcid Aseptic Systems. Available at
https://www.fda.gov/downloads/
AboutFDA/ReportsManualsForms/
Forms/UCM465598.pdf.
Dated: June 14, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–12783 Filed 6–19–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–3101]
Abbreviated New Drug Applications:
Pre-Submission Facility
Correspondence Associated with
Priority Submissions; Draft Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘ANDAs:
Pre-Submission Facility
Correspondence Associated with
Priority Submissions.’’ The PreSubmission Facility Correspondence
(PFC) process was identified as part of
the performance goals and program
enhancements for the Generic Drug User
Fee Amendments reauthorization for
Fiscal Years 2018–2022 (GDUFA II). A
complete and accurate PFC allows the
Agency to begin the facility assessment
process in advance of the planned
abbreviated new drug application
(ANDA) submission. This draft
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
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guidance describes PFC content and
format, as well as the Agency’s
approach to assessing this information.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by September 18,
2017. Submit either electronic or
written comments concerning the
collection of information proposed in
the draft guidance by September 18,
2017.
ADDRESSES:
You may submit comments
as follows:
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–
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
2017–D–3101 for ‘‘ANDAs: PreSubmission Facility Correspondence
Associated with Priority Submissions.’’
Received comments 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
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/201523389.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.
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
E:\FR\FM\20JNN1.SGM
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Federal Register / Vol. 82, No. 117 / Tuesday, June 20, 2017 / Notices
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Nikhil Thakur, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4164,
Silver Spring, MD 20993, 301–796–
5536.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘ANDAs: Pre-Submission Facility
Correspondence Associated with
Priority Submissions.’’ As one of the
enhancements specified in the GDUFA
II commitment letter, the PFC is a
mechanism to achieve expedited review
of priority ANDAs, prior approval
supplements (PASs), and their
amendments (collectively ANDAs).
Under the performance goals and
program enhancements for GDUFA II,
FDA agreed to a shorter goal date for
action on a priority generic drug
submission if:
• A complete and accurate PFC is
submitted to FDA 2 months ahead of the
planned ANDA submission, and
• facility information remains
unchanged in the ANDA.
A complete and accurate PFC allows
the Agency to begin the facility
assessment process in advance of the
planned ANDA submission. This
critical 2-month lead time provides the
Agency the opportunity to determine
whether facility inspections will be
needed, and, when they are, to initiate
inspection planning earlier in the
review of the ANDA, enabling FDA to
meet the shorter review timeframe.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘ANDAs: Pre-Submission Facility
Correspondence Associated with
Priority Submissions.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
sradovich on DSK3GMQ082PROD with NOTICES
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act
(44 U.S.C. 3501–3520) (the PRA),
Federal agencies must obtain approval
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from the Office of Management and
Budget (OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing the
proposed collection of information set
forth in this notice of availability that
would result from the submission of
PFCs.
With respect to the following
collection of information, FDA invites
comment on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection on respondents, including
through the use of automated collection
techniques, when appropriate, and other
forms of information technology.
Title: Draft Guidance for Industry on
ANDAs: Pre-Submission Facility
Correspondence Associated with
Priority Submissions.
Description: As described in the draft
guidance, the GDUFA II commitments
included an agreement to establish a
mechanism to facilitate a shortened
GDUFA goal date for ANDAs, PASs, and
their amendments that have been
designated as a ‘‘Priority’’ by FDA. For
planned ANDAs that successfully meet
FDA’s priority review criteria,
applicants may submit a PFC as a
mechanism to facilitate evaluation of
facilities associated with a planned
ANDA.
Section IV of the draft guidance
describes the information that should be
submitted in the PFC to enable FDA’s
facility assessment:
A. General information, including the
planned ANDA pre-assigned number
PO 00000
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28073
(which the applicant must request from
FDA before submitting the PFC), PFC
submission date, and the applicant’s
identifying information;
B. statement of ANDA eligibility for
priority review;
C. manufacturing process and testing
facility information; and
D. bioequivalence summary and site/
organization information.
The Appendix of the draft guidance
describes the format that should be used
to submit the PFC, including a
standardized format for administrative
information related to manufacturing
process and testing sites, and summary
tables for bioequivalence sites and
organizations and for bioavailability
studies.
The PFC should be submitted in the
PDF file format through the FDA
electronic submissions gateway, and, as
explained in the draft guidance, should
be submitted 2 or 3 months ahead of the
planned ANDA submission.
We estimate that a total of
approximately 125 applicants ‘‘number
of respondents’’ in table 1) will submit
annually approximately 275 PFCs as
described in the draft guidance (‘‘total
annual responses’’ in table 1). We
estimate that preparing and submitting
each PFC as described in the draft
guidance will take approximately 32
hours ‘‘hours per response’’ in table 1).
We base our estimates for the number of
applicants and the number of PFCs on
information from our database of annual
ANDA submissions, and on the criteria
set forth in the FDA Center for Drug
Evaluation’s Manual of Policies and
Procedures 5240.3 and the number of
‘‘priority’’ submissions. Our estimate of
the time applicants would need to
prepare and submit each PFC takes into
consideration that much of the PFC
includes information already gathered
for the ANDA submission. Thus, the
burden estimate for the submission of
the PFC does not double-count the
burden of gathering information that is
accounted for under OMB control
number 0910–0001, under which OMB
has approved the submission of ANDAs
and related amendments, supplements,
and other information required under
Subpart C of Part 314 in Title 21 of the
CFR.
We invite comments on these
estimates.
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Federal Register / Vol. 82, No. 117 / Tuesday, June 20, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of
respondents
No. of
responses
per
respondent
Total
annual
responses
Hours per
response
Total hours
125
2.20
275
32
8,800
PFC ......................................................................................
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
III. Electronic Access
FOR FURTHER INFORMATION CONTACT:
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: June 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–12836 Filed 6–19–17; 8:45 am]
FDA Rapid Response Surveys (Generic
Collection)
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1496]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food and Drug
Administration Rapid Response
Surveys (Generic Clearance)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by July 20,
2017.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0500. Also
include the FDA docket number found
in brackets in the heading of this
document.
sradovich on DSK3GMQ082PROD with NOTICES
ADDRESSES:
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18:01 Jun 19, 2017
Jkt 241001
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
OMB Control Number 0910–0500—
Extension
Section 505 of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 355) requires that important
safety information relating to all human
prescription drug products be made
available to FDA so that it can take
appropriate action to protect the public
health when necessary. Section 702 of
the FD&C Act (21 U.S.C. 372) authorizes
investigational powers to FDA for
enforcement of the FD&C Act. Under
section 519 of the FD&C Act (21 U.S.C.
360i), FDA is authorized to require
manufacturers to report medical devicerelated deaths, serious injuries, and
malfunctions to FDA; to require user
facilities to report device-related deaths
directly to FDA and to manufacturers;
and to report serious injuries to the
manufacturer. Section 522 of the FD&C
Act (21 U.S.C. 360l) authorizes FDA to
require manufacturers to conduct
postmarket surveillance of medical
devices. Section 705(b) of the FD&C Act
(21 U.S.C. 375(b)) authorizes FDA to
collect and disseminate information
regarding medical products or cosmetics
in situations involving imminent danger
to health or gross deception of the
consumer. Section 1003(d)(2) of the
FD&C Act (21 U.S.C. 393(d)(2))
authorizes the Commissioner of Food
and Drugs to implement general powers
(including conducting research) to carry
out effectively the mission of FDA.
These sections of the FD&C Act enable
FDA to enhance consumer protection
from risks associated with medical
products usage that are not foreseen or
apparent during the premarket
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
notification and review process. FDA’s
regulations governing application for
Agency approval to market a new drug
(21 CFR part 314) and regulations
governing biological products (21 CFR
part 600) implement these statutory
provisions. Currently, FDA monitors
medical product related postmarket
adverse events via both the mandatory
and voluntary MedWatch reporting
systems using FDA Forms 3500 and
3500A (OMB control number 0910–
0291) and the vaccine adverse event
reporting system.
FDA is seeking OMB clearance to
collect vital information via a series of
rapid response surveys. Participation in
these surveys will be voluntary. This
request covers rapid response surveys
for community based health care
professionals, general type medical
facilities, specialized medical facilities
(those known for cardiac surgery,
obstetrics/gynecology services, pediatric
services, etc.), other health care
professionals, patients, consumers, and
risk managers working in medical
facilities. FDA will use the information
gathered from these surveys to quickly
obtain vital information about medical
product risks and interventions to
reduce risks so the Agency may take
appropriate public health or regulatory
action including dissemination of this
information as necessary and
appropriate.
FDA projects 6 emergency risk related
surveys per year with a sample of
between 50 and 10,000 respondents per
survey. FDA also projects a response
time of 0.5 hour per response. These
estimates are based on the maximum
sample size per questionnaire that FDA
may be able to obtain by working with
health care professional organizations.
The annual number of surveys was
determined by the maximum number of
surveys per year FDA has ever
conducted under this collection.
In the Federal Register of January 13,
2017 (82 FR 4354), FDA published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\20JNN1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 117 (Tuesday, June 20, 2017)]
[Notices]
[Pages 28072-28074]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12836]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-3101]
Abbreviated New Drug Applications: Pre-Submission Facility
Correspondence Associated with Priority Submissions; Draft Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``ANDAs:
Pre-Submission Facility Correspondence Associated with Priority
Submissions.'' The Pre-Submission Facility Correspondence (PFC) process
was identified as part of the performance goals and program
enhancements for the Generic Drug User Fee Amendments reauthorization
for Fiscal Years 2018-2022 (GDUFA II). A complete and accurate PFC
allows the Agency to begin the facility assessment process in advance
of the planned abbreviated new drug application (ANDA) submission. This
draft guidance describes PFC content and format, as well as the
Agency's approach to assessing this information.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 18, 2017. Submit either electronic or written
comments concerning the collection of information proposed in the draft
guidance by September 18, 2017.
ADDRESSES: You may submit comments as follows:
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-2017-D-3101 for ``ANDAs: Pre-Submission Facility Correspondence
Associated with Priority Submissions.'' Received comments 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 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.
Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY
[[Page 28073]]
INFORMATION section for electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT: Nikhil Thakur, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4164, Silver Spring, MD 20993, 301-796-
5536.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``ANDAs: Pre-Submission Facility Correspondence Associated
with Priority Submissions.'' As one of the enhancements specified in
the GDUFA II commitment letter, the PFC is a mechanism to achieve
expedited review of priority ANDAs, prior approval supplements (PASs),
and their amendments (collectively ANDAs). Under the performance goals
and program enhancements for GDUFA II, FDA agreed to a shorter goal
date for action on a priority generic drug submission if:
A complete and accurate PFC is submitted to FDA 2 months
ahead of the planned ANDA submission, and
facility information remains unchanged in the ANDA.
A complete and accurate PFC allows the Agency to begin the facility
assessment process in advance of the planned ANDA submission. This
critical 2-month lead time provides the Agency the opportunity to
determine whether facility inspections will be needed, and, when they
are, to initiate inspection planning earlier in the review of the ANDA,
enabling FDA to meet the shorter review timeframe.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``ANDAs: Pre-
Submission Facility Correspondence Associated with Priority
Submissions.'' It does not establish any rights for any person and is
not binding on FDA or the public. You can use an alternative approach
if it satisfies the requirements of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act (44 U.S.C. 3501-3520) (the PRA),
Federal agencies must obtain approval from the Office of Management and
Budget (OMB) for each collection of information they conduct or
sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3)
and 5 CFR 1320.3(c) and includes Agency requests or requirements that
members of the public submit reports, keep records, or provide
information to a third party. Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day
notice in the Federal Register concerning each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing the proposed collection
of information set forth in this notice of availability that would
result from the submission of PFCs.
With respect to the following collection of information, FDA
invites comment on these topics: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection on respondents, including through the use of automated
collection techniques, when appropriate, and other forms of information
technology.
Title: Draft Guidance for Industry on ANDAs: Pre-Submission
Facility Correspondence Associated with Priority Submissions.
Description: As described in the draft guidance, the GDUFA II
commitments included an agreement to establish a mechanism to
facilitate a shortened GDUFA goal date for ANDAs, PASs, and their
amendments that have been designated as a ``Priority'' by FDA. For
planned ANDAs that successfully meet FDA's priority review criteria,
applicants may submit a PFC as a mechanism to facilitate evaluation of
facilities associated with a planned ANDA.
Section IV of the draft guidance describes the information that
should be submitted in the PFC to enable FDA's facility assessment:
A. General information, including the planned ANDA pre-assigned
number (which the applicant must request from FDA before submitting the
PFC), PFC submission date, and the applicant's identifying information;
B. statement of ANDA eligibility for priority review;
C. manufacturing process and testing facility information; and
D. bioequivalence summary and site/organization information.
The Appendix of the draft guidance describes the format that should
be used to submit the PFC, including a standardized format for
administrative information related to manufacturing process and testing
sites, and summary tables for bioequivalence sites and organizations
and for bioavailability studies.
The PFC should be submitted in the PDF file format through the FDA
electronic submissions gateway, and, as explained in the draft
guidance, should be submitted 2 or 3 months ahead of the planned ANDA
submission.
We estimate that a total of approximately 125 applicants ``number
of respondents'' in table 1) will submit annually approximately 275
PFCs as described in the draft guidance (``total annual responses'' in
table 1). We estimate that preparing and submitting each PFC as
described in the draft guidance will take approximately 32 hours
``hours per response'' in table 1). We base our estimates for the
number of applicants and the number of PFCs on information from our
database of annual ANDA submissions, and on the criteria set forth in
the FDA Center for Drug Evaluation's Manual of Policies and Procedures
5240.3 and the number of ``priority'' submissions. Our estimate of the
time applicants would need to prepare and submit each PFC takes into
consideration that much of the PFC includes information already
gathered for the ANDA submission. Thus, the burden estimate for the
submission of the PFC does not double-count the burden of gathering
information that is accounted for under OMB control number 0910-0001,
under which OMB has approved the submission of ANDAs and related
amendments, supplements, and other information required under Subpart C
of Part 314 in Title 21 of the CFR.
We invite comments on these estimates.
[[Page 28074]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of
No. of responses per Total annual Hours per Total hours
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
PFC................................................................ 125 2.20 275 32 8,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
III. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.
Dated: June 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12836 Filed 6-19-17; 8:45 am]
BILLING CODE 4164-01-P
