[Federal Register Volume 86, Number 55 (Wednesday, March 24, 2021)]
[Notices]
[Pages 15683-15685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06096]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6644]


Fiscal Year 2021 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 2021 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) 2022 GDUFA 
science and research initiatives.

DATES: The public workshop will be held on June 23, 2021, from 8:30 
a.m. to 4:30 p.m. Eastern Time. Submit either electronic or written 
comments on this public workshop by July 23, 2021. See the 
SUPPLEMENTARY INFORMATION section for registration date and 
information.

ADDRESSES: The public workshop will be held virtually.
    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 July 23, 2021. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time at the end of July 23, 2021. 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

[[Page 15684]]

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 2021 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 ``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, 
Sameersingh.Raney@fda.hhs.gov; 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, Robert.Lionberger@fda.hhs.gov.

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 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 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 June 23, 
2021, seeks to fulfill this agreement.
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    \1\ 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 
science and research initiatives for FY 2022.
    FDA is particularly interested in receiving input in the following 
five topic areas:
    1. What research is needed to determine how formulation differences 
in generic injectable products (that are not qualitatively (Q1) and 
quantitatively (Q2) the same as their reference listed drug products) 
affect the substitutability of these products?
    2. What research is needed to prepare for generic versions of 
oligonucleotide drug products (e.g., siRNA, chemically modified, 
antisense oligonucleotides)?
    3. What research relating to artificial intelligence (including 
machine learning) and/or the use of integrated data from multiple areas 
may facilitate and modernize the development of generic products?
    4. What research is needed to bridge the gap between existing 
scientific insights from GDUFA-funded research (e.g., related to 
product characterization techniques or modeling and simulation tools) 
and the development of suitable test procedures, study designs, model 
integrated evidence, and/or approaches for developing generic products?
    5. What research is needed to support identification of best 
bioequivalence practices and convergence of global bioequivalence 
standards?
    Specific presentations and discussions at this workshop will be 
announced at a later date and may differ from the topics above, 
however, input in the above topic areas will help the Agency identify 
and expand our 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 2022 science 
and research initiatives. Information concerning the science and 
research initiatives for generic drugs can be found at https://www.fda.gov/gdufaregscience.

III. Participating in the Public Workshop

    Registration: Registration is free. Persons interested in attending 
this public workshop must register online at https://www.fda.gov/drugs/
news-events-human-drugs/fy-2021-generic-drug-science-and-research-
initiatives-public-

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workshop-06232021-06232021. 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 April 30, 2021. 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. Following 
the close of registration on April 30, 2021, 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 May 21, 2021. All requests to make 
oral presentations must be received by the close of registration on 
April 30, 2021. If selected for presentation, any presentation 
materials must be emailed to GDUFARegulatoryScience@fda.hhs.gov no 
later than June 18, 2021, 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. Unless scheduled to participate in advance, 
attendees will not be able to speak or make presentations during the 
public comment period or during any other session of the workshop. To 
join the workshop via the webcast, please go to https://www.fda.gov/drugs/news-events-human-drugs/fy-2021-generic-drug-science-and-research-initiatives-public-workshop-06232021-06232021.
    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: 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). Closed caption scrolling text will be 
generated by the Adobe Connect system and displayed in real time. The 
closed caption scrolling text will also display when streaming the 
recorded presentations for viewing at a later date.

    Dated: March 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06096 Filed 3-23-21; 8:45 am]
BILLING CODE 4164-01-P


