82 FR 46071 - Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Act; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 190 (October 3, 2017)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA.'' This draft guidance describes an enhanced pathway for discussions between FDA and a prospective applicant preparing to submit (or an applicant that has submitted) to FDA an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 Specifically, this draft guidance provides information on requesting and conducting product development meetings, pre-submission meetings, and mid-review-cycle meetings with FDA. This draft guidance will assist applicants in generating and submitting a meeting request and the associated meeting package to FDA for complex products to be submitted under the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).

[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)]
[Notices]
[Pages 46071-46072]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-21190]


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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Generic Drug User Fee Act; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Formal 
Meetings Between FDA and ANDA Applicants of Complex Products Under 
GDUFA.'' This draft guidance describes an enhanced pathway for 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 draft 
guidance provides information on requesting and conducting product 
development meetings, pre-submission meetings, and mid-review-cycle 
meetings with FDA. This draft 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).

DATES: Submit either electronic or written comments on the draft 
guidance by December 4, 2017 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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 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-5739 for ``Formal Meetings Between FDA and ANDA Applicants 
of Complex Products Under GDUFA; Draft Guidance for Industry; 
Availability.'' 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

[[Page 46072]]

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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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 INFORMATION section for electronic 
access to the draft 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 draft guidance for industry 
entitled ``Formal Meetings Between FDA and ANDA Applicants of Complex 
Products Under GDUFA.'' This draft guidance describes an enhanced 
pathway for discussions between FDA and an applicant (or prospective 
applicant) preparing to submit an ANDA for a complex product to FDA. 
Specifically, this draft guidance provides information on requesting 
and conducting product development meetings, pre-submission meetings, 
and mid-review-cycle meetings with FDA.
    This draft guidance reflects a unified approach to all formal 
meetings between FDA and ANDA applicants or prospective ANDA applicants 
for complex products. This draft 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), 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 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 ``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

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collection of information has been approved under OMB control number 
0910-0797.

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: September 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21190 Filed 10-2-17; 8:45 am]
BILLING CODE 4164-01-P