[Federal Register Volume 85, Number 228 (Wednesday, November 25, 2020)]
[Notices]
[Pages 75336-75338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26050]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5739]


Formal Meetings Between the Food and Drug Administration and 
Abbreviated New Drug Application Applicants of Complex Products Under 
Generic Drug User Fee Amendments; 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 final guidance for industry entitled ``Formal 
Meetings Between FDA and ANDA Applicants of Complex Products Under 
GDUFA.'' This guidance describes an enhanced pathway for discussions 
between FDA and a prospective applicant preparing to submit (or an 
applicant that has submitted) to FDA an abbreviated new drug 
application (ANDA) for a complex product. Specifically, this guidance 
provides information on requesting and conducting product development 
meetings, presubmission meetings, and midreview cycle meetings with 
FDA. This guidance will assist applicants in generating and submitting 
a meeting request and the associated meeting package to FDA for complex 
products to be submitted under the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) and as contemplated in the commitments made by FDA in 
connection with the reauthorization of the Generic Drug User Fee 
Amendments for Fiscal Years (FYs) 2018-2022 (GDUFA II). This guidance 
finalizes the draft guidance of the same title issued on October 3, 
2017.

DATES: The announcement of the guidance is published in the Federal 
Register on November 25, 2020.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time 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.''

[[Page 75337]]

    Instructions: All submissions received must include the Docket No 
FDA-2017-D-5739 for ``Formal Meetings Between FDA and ANDA Applicants 
of Complex Products Under GDUFA.'' 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, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of this 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 INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Giaquinto Friedman, Center 
for Drug Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993-0002, 
240-402-7930, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Formal Meetings Between FDA and ANDA Applicants of Complex 
Products Under GDUFA.'' This guidance describes an enhanced pathway for 
discussions between FDA and a prospective applicant preparing to submit 
(or an applicant that has submitted) to FDA an ANDA for a complex 
product. Specifically, this guidance provides information on requesting 
and conducting product development meetings, presubmission meetings, 
and midreview cycle meetings with FDA.
    This guidance reflects a unified approach to all formal meetings 
between FDA and ANDA applicants or prospective ANDA applicants for 
complex products. This guidance is intended to assist ANDA applicants 
and prospective ANDA applicants in generating and submitting to FDA a 
meeting request and the associated meeting package for these complex 
products, as defined in this guidance, to be submitted under section 
505(j) of the FD&C Act (21 U.S.C. 355(j)) and as contemplated in GDUFA 
II.
    As part of the commitments FDA made in connection with GDUFA II, 
FDA agreed to develop a program to assist ANDA applicants and 
prospective ANDA applicants of complex products before the submission 
of an ANDA to FDA. As stated in the GDUFA Reauthorization Performance 
Goals and Program Enhancements Fiscal Years 2018-2022 (GDUFA II Goals 
or Commitment Letter available at https://www.fda.gov/media/101052/download), this pre-ANDA program is intended to clarify regulatory 
expectations for prospective applicants early in product development, 
assist applicants to develop more complete submissions, promote a more 
efficient and effective ANDA review process, and reduce the number of 
review cycles required to obtain ANDA approval, particularly for 
complex products (GDUFA II Commitment Letter at 14).
    To facilitate development of complex products that may be submitted 
in an ANDA, FDA and industry agreed to a series of meetings between 
ANDA applicants and prospective ANDA applicants and FDA to discuss the 
proposed complex product and support submission of a high-quality, 
approvable ANDA.
    In addition to developing a robust pre-ANDA program, FDA agreed to 
respond to requests for and conduct meetings related to the development 
of complex products submitted on or after October 1, 2017, within 
specific timeframes.
    This guidance finalizes the draft guidance entitled ``Formal 
Meetings Between FDA and ANDA Applicants of Complex Products Under 
GDUFA'' issued on October 3, 2017 (82 FR 46071). FDA considered 
comments received on the draft guidance as the guidance was finalized. 
Changes from the draft to the final guidance were made to address 
requests for clarity in seeking such meetings, as described in the 
guidance, with FDA.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Formal Meetings Between FDA and ANDA 
Applicants of Complex Products Under GDUFA.'' 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

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The previously 
collections of information are subject to review by OMB under the PRA. 
The collections of information for meetings related to generic drug 
development have been approved under OMB control number 0910-0797.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.


[[Page 75338]]


    Dated: November 18, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26050 Filed 11-24-20; 8:45 am]
BILLING CODE 4164-01-P