[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, [email protected]; 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,
[email protected];
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 [email protected] 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 [email protected] 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