82 FR 28072 - Abbreviated New Drug Applications: Pre-Submission Facility Correspondence Associated with Priority Submissions; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 117 (June 20, 2017)

Page Range		28072-28074
FR Document		2017-12836

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions.''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 This draft guidance describes PFC content and format, as well as the Agency's approach to assessing this information.

Federal Register, Volume 82 Issue 117 (Tuesday, June 20, 2017)

[Federal Register Volume 82, Number 117 (Tuesday, June 20, 2017)]
[Notices]
[Pages 28072-28074]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-12836]

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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Correspondence Associated with Priority Submissions; Draft Guidance for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the availability of a draft guidance for industry entitled ``ANDAs: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draft guidance describes PFC content and format, as well as the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.thefederalregister.org/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

Federal Register / Vol. 82, No. 117 / Tuesday, June 20, 2017 / Notices 28073

INFORMATION section for electronic from the Office of Management and (which the applicant must request from
access to the draft guidance document. Budget (OMB) for each collection of FDA before submitting the PFC), PFC
FOR FURTHER INFORMATION CONTACT: information they conduct or sponsor. submission date, and the applicant’s
Nikhil Thakur, Center for Drug ‘‘Collection of information’’ is defined identifying information;
Evaluation and Research, Food and in 44 U.S.C. 3502(3) and 5 CFR B. statement of ANDA eligibility for
Drug Administration, 10903 New 1320.3(c) and includes Agency requests priority review;
Hampshire Ave., Bldg. 51, Rm. 4164, or requirements that members of the
public submit reports, keep records, or C. manufacturing process and testing
Silver Spring, MD 20993, 301–796– facility information; and
5536. provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44 D. bioequivalence summary and site/
SUPPLEMENTARY INFORMATION:
U.S.C. 3506(c)(2)(A)) requires Federal organization information.
I. Background agencies to provide a 60-day notice in The Appendix of the draft guidance
the Federal Register concerning each describes the format that should be used
FDA is announcing the availability of
proposed collection of information to submit the PFC, including a
a draft guidance for industry entitled
before submitting the collection to OMB standardized format for administrative
‘‘ANDAs: Pre-Submission Facility
for approval. To comply with this information related to manufacturing
Correspondence Associated with
requirement, FDA is publishing the process and testing sites, and summary
Priority Submissions.’’ As one of the proposed collection of information set
enhancements specified in the GDUFA tables for bioequivalence sites and
forth in this notice of availability that organizations and for bioavailability
II commitment letter, the PFC is a would result from the submission of
mechanism to achieve expedited review studies.
PFCs.
of priority ANDAs, prior approval With respect to the following The PFC should be submitted in the
supplements (PASs), and their collection of information, FDA invites PDF file format through the FDA
amendments (collectively ANDAs). comment on these topics: (1) Whether electronic submissions gateway, and, as
Under the performance goals and the proposed collection of information explained in the draft guidance, should
program enhancements for GDUFA II, is necessary for the proper performance be submitted 2 or 3 months ahead of the
FDA agreed to a shorter goal date for of FDA’s functions, including whether planned ANDA submission.
action on a priority generic drug the information will have practical We estimate that a total of
submission if: utility; (2) the accuracy of FDA’s approximately 125 applicants ‘‘number
• A complete and accurate PFC is estimate of the burden of the proposed of respondents’’ in table 1) will submit
submitted to FDA 2 months ahead of the collection of information, including the annually approximately 275 PFCs as
planned ANDA submission, and validity of the methodology and described in the draft guidance (‘‘total
• facility information remains assumptions used; (3) ways to enhance annual responses’’ in table 1). We
unchanged in the ANDA. the quality, utility, and clarity of the estimate that preparing and submitting
A complete and accurate PFC allows information to be collected; and (4) each PFC as described in the draft
the Agency to begin the facility ways to minimize the burden of the guidance will take approximately 32
assessment process in advance of the collection on respondents, including hours ‘‘hours per response’’ in table 1).
planned ANDA submission. This through the use of automated collection We base our estimates for the number of
critical 2-month lead time provides the techniques, when appropriate, and other applicants and the number of PFCs on
Agency the opportunity to determine forms of information technology. information from our database of annual
whether facility inspections will be Title: Draft Guidance for Industry on ANDA submissions, and on the criteria
needed, and, when they are, to initiate ANDAs: Pre-Submission Facility set forth in the FDA Center for Drug
inspection planning earlier in the Correspondence Associated with Evaluation’s Manual of Policies and
review of the ANDA, enabling FDA to Priority Submissions. Procedures 5240.3 and the number of
meet the shorter review timeframe. Description: As described in the draft
This draft guidance is being issued ‘‘priority’’ submissions. Our estimate of
guidance, the GDUFA II commitments
consistent with FDA’s good guidance the time applicants would need to
included an agreement to establish a
practices regulation (21 CFR 10.115). prepare and submit each PFC takes into
mechanism to facilitate a shortened
The draft guidance, when finalized, will consideration that much of the PFC
GDUFA goal date for ANDAs, PASs, and
represent the current thinking of FDA includes information already gathered
their amendments that have been
on ‘‘ANDAs: Pre-Submission Facility for the ANDA submission. Thus, the
designated as a ‘‘Priority’’ by FDA. For
Correspondence Associated with burden estimate for the submission of
planned ANDAs that successfully meet
Priority Submissions.’’ It does not the PFC does not double-count the
FDA’s priority review criteria,
establish any rights for any person and burden of gathering information that is
applicants may submit a PFC as a
is not binding on FDA or the public. accounted for under OMB control
mechanism to facilitate evaluation of
You can use an alternative approach if number 0910–0001, under which OMB
facilities associated with a planned
it satisfies the requirements of the has approved the submission of ANDAs
ANDA.
applicable statutes and regulations. Section IV of the draft guidance and related amendments, supplements,
describes the information that should be and other information required under
II. Paperwork Reduction Act of 1995 submitted in the PFC to enable FDA’s Subpart C of Part 314 in Title 21 of the
Under the Paperwork Reduction Act facility assessment: CFR.
(44 U.S.C. 3501–3520) (the PRA), A. General information, including the We invite comments on these
sradovich on DSK3GMQ082PROD with NOTICES

Federal agencies must obtain approval planned ANDA pre-assigned number estimates.

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28074 Federal Register / Vol. 82, No. 117 / Tuesday, June 20, 2017 / Notices

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of Total
No. of responses Hours per
annual Total hours
respondents per response
responses
respondent

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 FOR FURTHER INFORMATION CONTACT: notification and review process. FDA’s
Amber Sanford, Office of Operations, regulations governing application for
Persons with access to the Internet
Food and Drug Administration, Three Agency approval to market a new drug
may obtain the draft guidance at either
White Flint North, 10A63, 11601 (21 CFR part 314) and regulations
https://www.fda.gov/Drugs/Guidance
Landsdown St., North Bethesda, MD governing biological products (21 CFR
ComplianceRegulatoryInformation/
20852, 301–796–8867, PRAStaff@ part 600) implement these statutory
Guidances/default.htm or https://
fda.hhs.gov. provisions. Currently, FDA monitors
www.regulations.gov.
SUPPLEMENTARY INFORMATION: In medical product related postmarket
Dated: June 15, 2017. adverse events via both the mandatory
compliance with 44 U.S.C. 3507, FDA
Anna K. Abram, has submitted the following proposed and voluntary MedWatch reporting
Deputy Commissioner for Policy, Planning, collection of information to OMB for systems using FDA Forms 3500 and
Legislation, and Analysis. review and clearance. 3500A (OMB control number 0910–
[FR Doc. 2017–12836 Filed 6–19–17; 8:45 am] 0291) and the vaccine adverse event
BILLING CODE 4164–01–P
FDA Rapid Response Surveys (Generic reporting system.
Collection) FDA is seeking OMB clearance to
OMB Control Number 0910–0500— collect vital information via a series of
DEPARTMENT OF HEALTH AND Extension rapid response surveys. Participation in
HUMAN SERVICES these surveys will be voluntary. This
Section 505 of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21 request covers rapid response surveys
Food and Drug Administration for community based health care
U.S.C. 355) requires that important
safety information relating to all human professionals, general type medical
[Docket No. FDA–2013–N–1496] facilities, specialized medical facilities
prescription drug products be made
available to FDA so that it can take (those known for cardiac surgery,
Agency Information Collection obstetrics/gynecology services, pediatric
Activities; Submission for Office of appropriate action to protect the public
health when necessary. Section 702 of services, etc.), other health care
Management and Budget Review; professionals, patients, consumers, and
Comment Request; Food and Drug the FD&C Act (21 U.S.C. 372) authorizes
investigational powers to FDA for risk managers working in medical
Administration Rapid Response facilities. FDA will use the information
Surveys (Generic Clearance) enforcement of the FD&C Act. Under
section 519 of the FD&C Act (21 U.S.C. gathered from these surveys to quickly
AGENCY: Food and Drug Administration, 360i), FDA is authorized to require obtain vital information about medical
HHS. manufacturers to report medical device- product risks and interventions to
related deaths, serious injuries, and reduce risks so the Agency may take
ACTION: Notice. appropriate public health or regulatory
malfunctions to FDA; to require user
SUMMARY: The Food and Drug facilities to report device-related deaths action including dissemination of this
Administration (FDA) is announcing directly to FDA and to manufacturers; information as necessary and
that a proposed collection of and to report serious injuries to the appropriate.
information has been submitted to the manufacturer. Section 522 of the FD&C FDA projects 6 emergency risk related
Office of Management and Budget Act (21 U.S.C. 360l) authorizes FDA to surveys per year with a sample of
(OMB) for review and clearance under require manufacturers to conduct between 50 and 10,000 respondents per
the Paperwork Reduction Act of 1995. postmarket surveillance of medical survey. FDA also projects a response
devices. Section 705(b) of the FD&C Act time of 0.5 hour per response. These
DATES: Fax written comments on the
(21 U.S.C. 375(b)) authorizes FDA to estimates are based on the maximum
collection of information by July 20, sample size per questionnaire that FDA
collect and disseminate information
2017. may be able to obtain by working with
regarding medical products or cosmetics
ADDRESSES: To ensure that comments on in situations involving imminent danger health care professional organizations.
the information collection are received, to health or gross deception of the The annual number of surveys was
OMB recommends that written consumer. Section 1003(d)(2) of the determined by the maximum number of
comments be faxed to the Office of FD&C Act (21 U.S.C. 393(d)(2)) surveys per year FDA has ever
Information and Regulatory Affairs, authorizes the Commissioner of Food conducted under this collection.
OMB, Attn: FDA Desk Officer, FAX: and Drugs to implement general powers In the Federal Register of January 13,
sradovich on DSK3GMQ082PROD with NOTICES

202–395–7285, or emailed to oira_ (including conducting research) to carry 2017 (82 FR 4354), FDA published a 60-
submission@omb.eop.gov. All out effectively the mission of FDA. day notice requesting public comment
comments should be identified with the These sections of the FD&C Act enable on the proposed collection of
OMB control number 0910–0500. Also FDA to enhance consumer protection information. No comments were
include the FDA docket number found from risks associated with medical received.
in brackets in the heading of this products usage that are not foreseen or FDA estimates the burden of this
document. apparent during the premarket collection of information as follows:

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Document Created: 2017-06-20 02:21:02
Document Modified: 2017-06-20 02:21:02

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
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.
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.
FR Citation		82 FR 28072

82 FR 28072 - Abbreviated New Drug Applications: Pre-Submission Facility Correspondence Associated with Priority Submissions; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 117 (June 20, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration