[Federal Register Volume 88, Number 24 (Monday, February 6, 2023)]
[Notices]
[Pages 7735-7736]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02453]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0119]
Fiscal Year 2023 Generic Drug Science and Research Initiatives
Workshop; Public Workshop; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public workshop entitled ``FY 2023 Generic
Drug Science and Research Initiatives Workshop.'' The purpose of the
public workshop is to provide an overview of the status of science and
research initiatives for generic drugs and an opportunity for public
input on these initiatives. FDA is seeking this input from a variety of
stakeholders--industry, academia, patient advocates, professional
societies, and other interested parties--as it fulfills its commitment
under the Generic Drug User Fee Amendments of 2022 (GDUFA III) to
develop an annual list of science and research initiatives specific to
generic drugs. FDA will take the information it obtains from the public
workshop into account in developing its Fiscal Year (FY) 2024 Generic
Drug User Fee Amendments (GDUFA) science and research initiatives.
DATES: The public workshop will be held on May 11, 2023 from 8 a.m. to
4:30 p.m., and May 12, 2023, from 9 a.m. to 2:30 p.m. Eastern Time.
Submit either electronic or written comments on this public workshop by
June 12, 2023. See the SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public workshop will be held in person and will be
accessible virtually. Registrants will have an opportunity to indicate
their interest in attending the public workshop in person. If there are
restrictions imposed by applicable health guidelines for in-person
gatherings, or seating capacity limitations, registrants interested in
attending the public workshop in person will be contacted. The public
workshop will be held at the FDA White Oak Campus, 10903 New Hampshire
Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503, sections B,
and C), Silver Spring, MD 20993-0002. Entrance for the public workshop
participants (non-FDA employees) is through Bldg. 1, where routine
security check procedures will be performed. For parking and security
information, please refer to https://www.fda.gov/about-fda/visitor-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 June 12, 2023. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of June 12, 2023. 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.
for ``FY 2023 Generic Drug Science and Research Initiatives Workshop;
Public Workshop; 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
[[Page 7736]]
``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.
FOR FURTHER INFORMATION CONTACT: Sam Raney, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 4732, Silver Spring, MD 20993, 240-402-7967,
[email protected]; or Robert Lionberger, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4722, Silver Spring, MD 20993, 240-402-
7957, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In July 2012, Congress passed the Generic Drug User Fee Amendments
of 2012 (GDUFA I) (Pub. L. 112-144). GDUFA I was designed to enhance
public access to safe, high-quality generic drugs and to modernize the
generic drug program. To support this goal, FDA agreed in the Generic
Drug User Fee Act Program Performance Goals and Procedures (GDUFA I
commitment letter) to work with industry and interested stakeholders on
identifying science and research initiatives specific to generic drugs
for each fiscal year covered by GDUFA I.
In August 2017, GDUFA was reauthorized until September 2022 through
the Generic Drug User Fee Amendments of 2017 (GDUFA II) (Pub. L. 115-
52), and in September 2022, GDUFA was reauthorized until September 2027
through the Generic Drug User Fee Amendments of 2022 (GDUFA III) (Pub.
L. 117-180, 136 Stat. 2155). In the GDUFA Reauthorization Performance
Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III
commitment letter),\1\ FDA agreed to conduct annual public workshops
``to solicit input from industry and stakeholders for inclusion in an
annual list of GDUFA III regulatory science initiatives.'' This public
workshop scheduled for May 11, 2023, and May 12, 2023, seeks to fulfill
this agreement.
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\1\ The GDUFA III commitment letter is available at https://www.fda.gov/media/153631/download.
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II. Topics for Discussion at the Public Workshop
The purpose of this public workshop is to obtain input from
industry and other interested stakeholders on identifying generic drug
science and research initiatives for FY 2024. FDA is interested in
receiving input about regulatory science initiatives for the ongoing
years of the GDUFA III science and research program, and particularly
for FY 2024.
Topics discussed during the workshop will likely include challenges
and considerations for oral, parenteral, and other generic products,
including complex products. Specific presentations and discussions at
this workshop will be announced at a later date and may differ from the
topics above. However, input about the topics above will help the
Agency identify and expand its scientific focus for the next fiscal
year.
FDA will consider all comments made at this workshop or received
through the docket (see ADDRESSES) as it develops its FY 2024 science
and research initiatives. Information concerning the science and
research initiatives for generic drugs can be found on the Science &
Research website at https://www.fda.gov/drugs/generic-drugs/science-research.
III. Participating in the Public Workshop
Registration: Registration is free. Persons interested in attending
this public workshop must register online at https://fda.zoomgov.com/webinar/register/WN_J3MsCbCWQwyuA1AojKF_8Q. Registration may be
performed at any time before or during the workshop.
Requests for Oral Presentations: During online registration you may
indicate if you wish to present your public comments. Requests to
provide public comments via a pre-recorded presentation or a live
presentation, including in-person or virtual presentations, should be
submitted by 11:59 p.m. Eastern Time at the end of March 31, 2023. We
will do our best to accommodate requests to make public comments.
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 workshop. Based upon the public comment
presentation requests received by March 31, 2023, at 11:59 p.m. Eastern
Time, we will determine the amount of time allotted to each presenter
and the approximate time each oral presentation is to begin; we will
select and notify participants by April 11, 2023. If selected for
presentation, any presentation materials must be emailed to
[email protected] no later than May 1, 2023, 11:59
p.m. Eastern Time. No commercial or promotional material will be
permitted to be presented or distributed at the public workshop.
Streaming Webcast of the Public Workshop: This public workshop will
be webcast. Please register online (as described above) to attend the
workshop remotely (virtually). Registrants will receive a hyperlink
that provides access to the webcast on both days.
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 workshop is available, it will be accessible at https://www.regulations.gov or on the Science & Research FDA website accessible
at https://www.fda.gov/drugs/generic-drugs/science-research. It may
also be viewed at the Dockets Management Staff (see ADDRESSES).
Dated: February 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02453 Filed 2-3-23; 8:45 am]
BILLING CODE 4164-01-P