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- Abbreviated New Drug Applications: Pre-Submission Facility Correspondence Associated with Priority Submissions; Draft Guidance for Industry; Availability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

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions.''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 This draft guidance describes PFC content and format, as well as the Agency's approach to assessing this information.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Correspondence Associated with Priority Submissions; Draft Guidance for 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

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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the availability of a draft guidance for industry entitled ``ANDAs: 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draft guidance describes PFC content and format, as well as the 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\
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                                                                                           No. of
                                                                          No. of       responses  per   Total  annual      Hours per       Total hours
                                                                       respondents       respondent       responses         response
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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