[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