Notice2022-03368
Fiscal Year 2022 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Comments
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 16, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "FY 2022 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 2017 (GDUFA II) 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) 2023 Generic Drug User Fee Amendments (GDUFA) science and research initiatives.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 32 (Wednesday, February 16, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 32 (Wednesday, February 16, 2022)]
[Notices]
[Pages 8843-8845]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-03368]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-6644]
Fiscal Year 2022 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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public workshop entitled ``FY 2022 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 2017 (GDUFA II) 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) 2023 Generic
Drug User Fee Amendments (GDUFA) science and research initiatives.
DATES: The public workshop will be held on May 9, 2022, and May 10,
2022, from 8:30 a.m. to 4:30 p.m. Eastern Time. Submit either
electronic or written comments on this public workshop by June 10,
2022. See the SUPPLEMENTARY INFORMATION section for registration date
and information.
[[Page 8844]]
ADDRESSES: The public workshop will be held virtually. Registrants will
have an opportunity to indicate their interest in attending the public
workshop in person. If applicable health guidelines for in-person
gatherings are permissive, interested registrants will be contacted no
later than March 9, 2022 with details for attending the public workshop
in person 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. If in-person attendance is determined to
be feasible, the registration form will also be updated so that people
registering for the public workshop from that point forward will be
able to indicate their interest in attending the workshop in person,
even if they are registering after March 9, 2022. 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 <a href="https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm">https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm</a>.
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 10, 2022. The <a href="https://www.regulations.gov">https://www.regulations.gov</a>
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of June 10, 2022. 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2017-N-6644 for ``FY 2022 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.
FOR FURTHER INFORMATION CONTACT: Sam Raney, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 4706, Silver Spring, MD 20993, 240-402-7967,
<a href="/cdn-cgi/l/email-protection#b4e7d5d9d1d1c6c7dddad3dc9ae6d5dad1cdf4d2d0d59adcdcc79ad3dbc2"><span class="__cf_email__" data-cfemail="34675559515146475d5a535c1a66555a514d745250551a5c5c471a535b42">[email protected]</span></a>; 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, <a href="/cdn-cgi/l/email-protection#a5f7cac7c0d7d18be9cccacbc7c0d7c2c0d7e5c3c1c48bcdcdd68bc2cad3"><span class="__cf_email__" data-cfemail="c092afa2a5b2b4ee8ca9afaea2a5b2a7a5b280a6a4a1eea8a8b3eea7afb6">[email protected]</span></a>.
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 I was reauthorized until September 2022
through the Generic Drug User Fee Amendments of 2017 (GDUFA II) (Pub.
L. 115-52). In the GDUFA Reauthorization Performance Goals and Program
Enhancements Fiscal Years 2018-2022 (GDUFA II 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 II
[r]egulatory [s]cience initiatives.'' The public workshop scheduled for
May 9, 2022, and May 10, 2022, seeks to fulfill this agreement.
---------------------------------------------------------------------------
\1\ The GDUFA II commitment letter is available at <a href="https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM525234.pdf">https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM525234.pdf</a>.
---------------------------------------------------------------------------
[[Page 8845]]
II. Topics for Discussion at the Public Workshop
The purpose of the public workshop is to obtain input from industry
and other interested stakeholders on identifying generic drug science
and research initiatives for FY 2023. FDA is particularly interested in
receiving input about the next 5 years of the GDUFA science and
research program.
Specific presentations and discussions at this workshop will be
announced at a later date and may differ from the topic above. However,
input about the topic 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 2023 science
and research initiatives. Information concerning the science and
research initiatives for generic drugs can be found on the Science &
Research website at <a href="https://www.fda.gov/drugs/generic-drugs/science-research">https://www.fda.gov/drugs/generic-drugs/science-research</a>.
III. Participating in the Public Workshop
Registration: Registration is free. Persons interested in attending
this public workshop must register online at <a href="https://fda.zoomgov.com/webinar/register/WN_kY1uqyD1RLqyRL2XU1KDTA">https://fda.zoomgov.com/webinar/register/WN_kY1uqyD1RLqyRL2XU1KDTA</a>. 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. Public comment
presentation requests must be submitted by 11:59 p.m. Eastern Time at
the end of March 11, 2022. 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 11, 2022, 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 March 28, 2022. All
public comment presentation requests must be received by March 11,
2022, at 11:59 p.m. Eastern Time. If selected for presentation, any
presentation materials must be emailed to
<a href="/cdn-cgi/l/email-protection#90d7d4c5d6d1c2f5f7e5fcf1e4ffe2e9c3f3f9f5fef3f5d0f6f4f1bef8f8e3bef7ffe6"><span class="__cf_email__" data-cfemail="d7909382919685b2b0a2bbb6a3b8a5ae84b4beb2b9b4b297b1b3b6f9bfbfa4f9b0b8a1">[email protected]</span></a> no later than April 29, 2022, 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. 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or <a href="https://www.fda.gov/gdufaregscience">https://www.fda.gov/gdufaregscience</a>. It may be
viewed at the Dockets Management Staff (see ADDRESSES).
Dated: February 10, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03368 Filed 2-15-22; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on February 16, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.