[Federal Register Volume 85, Number 124 (Friday, June 26, 2020)]
[Notices]
[Pages 38378-38380]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13749]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1459]


Generic Drug User Fee Amendments; Public Meeting; Request for 
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
hosting a virtual public meeting entitled ``Generic Drug User Fee

[[Page 38379]]

Amendments (GDUFA) of 2017.'' At the end of September 2022, new 
legislation will be required for FDA to continue to collect generic 
drug user fees for future fiscal years. The Federal Food, Drug, and 
Cosmetic Act (FD&C Act) requires that before FDA begins negotiations 
with the regulated industry on GDUFA reauthorization, we publish a 
notice in the Federal Register requesting public input on the 
reauthorization, hold a public meeting at which the public may present 
its views on the reauthorization, including specific suggestions for 
changes to the goals referred to in the GDUFA Reauthorization 
Performance Goals and Program Enhancements Fiscal Years 2018-2022 
(i.e., the GDUFA II Commitment Letter), provide a period of 30 days 
after the public meeting to obtain written comments from the public, 
and publish the comments on FDA's website. FDA invites public comment 
on the GDUFA program and suggestions regarding the features FDA should 
propose for the next GDUFA program cycle. These comments will be 
published and available on FDA's website.

DATES: The public meeting will be held on July 21, 2020, from 8:30 a.m. 
to 3:30 p.m., and will take place virtually and will be held by webcast 
only. Submit either electronic or written comments on this public 
meeting by August 20, 2020. See the SUPPLEMENTARY INFORMATION section 
for registration date and information.
    You may submit comments as follows. Please note that late, untimely 
filed comments will not be considered. Electronic comments must be 
submitted on or before August 20, 2020. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time at the end of August 20, 2020. Comments received by mail/hand 
delivery/courier (for written/paper submissions) will be considered 
timely if they are postmarked or the delivery service acceptance 
receipt is on or before that date.

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-2020-N-1459 for ``Generic Drug User Fee Amendments; Public Meeting; 
Request for Comments.'' Received comments, those filed in a timely 
manner (see ADDRESSES), 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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Tiana Barnes, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6196, Silver Spring, MD 20993, 301-796-
2882, Tiana.Barnes@fda.hhs.gov; or Dat Doan, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 3334, Silver Spring, MD 20993, 240-402-8926, 
Dat.Doan@fda.hhs.gov;

SUPPLEMENTARY INFORMATION: 

I. Background

    On July 9, 2012, the Food and Drug Administration Safety and 
Innovation Act, which included GDUFA (Pub. L. 112-144, Title III), was 
signed into law by the President. In 2017, the GDUFA program was 
reauthorized (GDUFA II) under the FDA Reauthorization Act of 2017 (Pub. 
L. 115-52, Title III), which authorizes FDA to collect fees for certain 
generic human drug applications, drug master files, and facilities. 
Designed to speed access to safe and effective generic drugs to the 
public, GDUFA II requires that generic drug manufacturers and other 
relevant entities pay user fees to finance critical and measurable 
generic drug program enhancements. As described in the GDUFA II 
Commitment Letter, FDA committed to achieve certain performance goals, 
provide enhanced communication intended to streamline abbreviated new 
drug application (ANDA) development and assessment, and take other 
steps to increase the efficiency of the assessment process.

[[Page 38380]]

GDUFA II also includes a pre-ANDA program to clarify regulatory 
expectations for complex generic product developers early in product 
development and during application review.
    Additional information concerning GDUFA, including the text of the 
law, the GDUFA II Commitment Letter, key Federal Register documents, 
GDUFA-related guidances, performance reports, and financial reports may 
be found on the FDA website at https://www.fda.gov/gdufa.

II. Topics for Discussion at the Public Meeting

    FDA is interested in responses to the following general questions:

     What is your assessment of the overall performance of the 
GDUFA program to date?
     What aspects of GDUFA should be retained, changed, or 
discontinued to further strengthen and improve the program?
     What new features should FDA consider adding to the 
program to enhance efficiency and effectiveness of the generic drug 
review process?

    FDA welcomes any other relevant information the public would like 
to share as it relates to the GDUFA program, including but not limited 
to the following topic areas:

     supply chain security and drug shortages;
     drug quality and advanced manufacturing; and
     complex products.

    In general, the public meeting's format will include presentations 
by FDA and our stakeholders, which may include scientific and academic 
experts, health care professionals, representatives of patient and 
consumer advocacy groups, the generic drug industry, and the general 
public. The amount of time available for public testimony will be 
determined by the number of persons who register to present during the 
virtual public meeting. A draft agenda and other background information 
for the public meeting will be posted at https://www.fda.gov/gdufa by 
July 14, 2020.

III. Participating in the Public Meeting

    Registration: FDA is seeking participation (i.e., oral remote 
presentations) during the virtual public meeting by all interested 
parties, including but not limited to scientific and academic experts, 
health care professionals, representatives of patient and consumer 
advocacy groups, the generic drug industry, and the general public. 
Persons interested in attending this virtual public meeting should 
register online by 11:59 p.m. Eastern Time on July 7, 2020, at https://collaboration.fda.gov/e8a35s83so0x/event/registration.html. Please 
provide complete contact information for each attendee, including name, 
title, affiliation, and email.
    Requests for Oral Presentations: If you wish to present during a 
public comment session or participate in a specific session, please 
submit your request to GenericDrugPolicy@fda.hhs.gov by 11:59 p.m. 
Eastern Time on July 7, 2020. Your email should contain which topic(s) 
you wish to address and include complete contact information, including 
name, title, affiliation, address, and email address. We will do our 
best to accommodate requests to make public comments and requests to 
participate in specific sessions. Individuals and organizations with 
common interests are urged to consolidate or coordinate their 
presentations, and request time for a joint presentation, or submit 
requests for designated representatives to participate in the focused 
sessions. Following the close of registration, we will determine the 
amount of time allotted to each presenter and the approximate time each 
oral presentation is to begin, and will select and notify participants 
by July 8, 2020. All requests to make oral presentations must be 
received by the close of registration on July 7, 2020, 11:59 p.m. 
Eastern Time. If selected for presentation, any presentation materials 
must be emailed to GenericDrugPolicy@fda.hhs.gov no later than July 14, 
2020. No commercial or promotional material will be permitted to be 
presented or distributed during the virtual public meeting.
    Streaming Webcast of the Public Meeting: This virtual public 
meeting will be accessible via webcast only. In order to connect to the 
webcast, you must have Adobe Connect. The link for the webcast will be 
sent to all registered attendees in advance of the event.
    If you have never attended a Connect Pro event before, test your 
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, 
visit https://www.adobe.com/go/connectpro_overview. FDA has verified 
the website addresses in this document, as of the date this document 
publishes in the Federal Register, but websites are subject to change 
over time.
    Transcripts: Please be advised that as soon as a transcript of the 
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(see ADDRESSES). A link to the transcript will also be available on the 
internet at https://www.fda.gov/gdufa.

    Dated: June 22, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13749 Filed 6-25-20; 8:45 am]
BILLING CODE 4164-01-P


