[Federal Register Volume 85, Number 47 (Tuesday, March 10, 2020)]
[Notices]
[Pages 13905-13907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04866]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-6644]
Fiscal Year 2020 Generic Drug Regulatory Science Initiatives;
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 2020 Generic
Drug Regulatory Science Initiatives.'' The purpose of the public
workshop is to provide an overview of the status of regulatory science
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 regulatory science initiatives specific to
generic drugs. FDA will take the information it obtains from the public
workshop into account in developing its fiscal year (FY) 2021
regulatory science initiatives.
DATES: The public workshop will be held on May 4, 2020, from 8:30 a.m.
to 4:30 p.m. Submit either electronic or written comments on this
public workshop by June 4, 2020. See the SUPPLEMENTARY INFORMATION
section for registration date and information.
ADDRESSES: 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/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
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 4, 2020. The https://www.regulations.gov
electronic filing system will accept comments until midnight Eastern
Time at the end of June 4, 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,
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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-2017-N-6644 for ``FY 2020 Generic Drug Regulatory Science
Initiatives; 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.
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.
FOR FURTHER INFORMATION CONTACT: Stephanie Choi, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4732, Silver Spring, MD 20993, 240-402-
7960, [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 GDUFA I
commitment letter \1\ to work with industry and interested stakeholders
on identifying regulatory science initiatives specific to generic drugs
for each fiscal year covered by GDUFA I.
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\1\ The GDUFA I commitment letter is available at https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf.
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In August 2017, GDUFA I was reauthorized until September 2022
through GDUFA II (Pub. L. 115-52). In the GDUFA II commitment
letter,\2\ 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 4, 2020, seeks to fulfill this agreement.
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\2\ The GDUFA II commitment letter is available at https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM525234.pdf.
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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 the identification of generic drug
regulatory science initiatives for FY 2021.
FDA is particularly interested in receiving input in the following
four topic areas:
1. Post-market surveillance of generic drugs
2. Drug-device combination products
3. In vitro bioequivalence methods
4. Data analysis and model-based bioequivalence
FDA will consider all comments made at this workshop or received
through the docket (see ADDRESSES) as it develops its FY 2021
regulatory science initiatives. Information concerning the regulatory
science initiatives for generic drugs can be found at https://www.fda.gov/gdufaregscience.
III. Participating in the Public Workshop
Registration: To register for the public workshop, please provide
complete contact information for each attendee, including name, title,
affiliation, address, email, and telephone to
[email protected]. For planning purposes, please also
indicate in the email: (1) Whether attendance will be by webcast or in
person and (2) the desired breakout session of attendance. Four
breakout sessions will be held concurrently in the afternoon based on
the following 4 areas: (1) Post-market surveillance of generic drugs,
(2) drug-device combination drug products, (3) in-vitro bioequivalence
methods, and (4) data analysis and model-based bioequivalence.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register online by April 3, 2020, midnight Eastern Time.
Early registration is recommended because seating is limited;
therefore, FDA may limit the number of participants from each
organization. Registrants will
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receive confirmation when they have been accepted.
If you need special accommodations due to a disability, please
contact Stephanie Choi (see FOR FURTHER INFORMATION CONTACT) no later
than April 3, 2020.
Requests for Oral Presentations: During online registration you may
indicate if you wish to present during a public comment session for a
specific breakout session, and which topic(s) you wish to address. We
will do our best to accommodate requests to make public comments (and
requests to participate in the focused 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 April 10, 2020. All requests
to make oral presentations must be received by the close of
registration on April 3, 2020, midnight Eastern Time. If selected for
presentation, any presentation materials must be emailed to
[email protected] no later than April 24, 2020,
midnight Eastern Time. No commercial or promotional material will be
permitted to be presented or distributed at the public workshop.
Persons attending FDA's workshops are advised that FDA is not
responsible for providing access to electrical outlets.
Streaming Webcast of the Public Workshop: This public workshop will
also be webcast. Please register online by April 3, 2020, midnight
Eastern Time to attend the workshop remotely. Please note that remote
attendees will not be able to speak or make presentations during the
public comment session or during any other session of the workshop. To
join the main sessions of the workshop via the webcast, please go to
https://collaboration.fda.gov/gdrsipw2020/. Webcast information for the
four breakout sessions will be provided separately via email upon
successful registration.
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 workshop is available, it will be accessible at https://www.regulations.gov or at https://www.fda.gov/gdufaregscience. 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/gdufaregscience.
Dated: March 4, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04866 Filed 3-9-20; 8:45 am]
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