
[Federal Register Volume 84, Number 24 (Tuesday, February 5, 2019)]
[Notices]
[Pages 1743-1745]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01067]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Fiscal Year 2019 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 2019 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) 2020 
regulatory science initiatives.

DATES: The public workshop will be held on May 1, 2019, from 8:30 a.m. 
to 4:30 p.m. Submit either electronic or written comments on this 
public workshop by June 1, 2019. 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 Building 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

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filed comments will not be considered. Electronic comments must be 
submitted on or before June 1, 2019. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time at the end of June 1, 2019. 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. 
FDA-2017-N-6644 for ``FY 2019 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.gpo.gov/fdsys/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. 3742, Silver Spring, MD 20993, 240-402-
7960, Stephanie.Choi@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 regulatory science initiatives specific to generic drugs 
for each fiscal year covered by GDUFA I.
    In August 2017, GDUFA I was reauthorized until September 2022 
through 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 May 1, 2019, 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 
regulatory science initiatives for FY 2020.
    FDA is particularly interested in receiving input on the following 
three topics:
    1. FY 2019 regulatory science initiatives,\2\ including specific 
products or actions that FDA should consider as it implements those 
initiatives, including, for example:
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    \2\ The FY 2019 regulatory science initiatives are available at 
https://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/GenericDrugs/UCM626329.pdf.
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    a. The value to the generic drug product industry in expanding the 
Biopharmaceutics Classification System Class III waivers to include 
non-Q1/Q2 formulations,
    b. Scientific gaps that impact the prediction of the results of fed 
bioequivalence studies (when the drug product is administered shortly 
after a meal, as opposed to administration under fasting conditions), 
and
    c. Challenges for industry in implementing new analytical or 
computational methods that arise from regulatory science initiatives.
    2. Recently approved new drug applications that may pose scientific 
challenges to the future development of generic drug products 
referencing those applications.

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    3. Regulatory science initiatives that FDA should begin to consider 
in FY 2019, including, for example:
    a. Scientific challenges in the evaluation of sensitization for 
transdermal systems and
    b. The development of alternative approaches to in vivo 
bioequivalence studies to evaluate product equivalence.
    FDA will consider all comments made at this workshop or received 
through the docket (see ADDRESSES) as it develops its FY 2020 
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 email 
complete contact information for each attendee--including the 
attendee's name, title, affiliation, address, email, and telephone 
number--to GDUFARegulatoryScience@fda.hhs.gov. Please also indicate in 
the email whether attendance will be by webcast or in person.
    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 1, 2019, 11:59 p.m. Eastern 
Time. Early registration is recommended because seating is limited; 
therefore, FDA may limit the number of participants from each 
organization. Registrants will 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 1, 2019.
    Requests for Oral Presentations: During online registration you may 
indicate if you wish to present during a public comment session or 
participate in a specific 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 8, 2019. All requests 
to make oral presentations must be received by the close of 
registration on April 1, 2019, 11:59 p.m. Eastern Time. If selected for 
presentation, any presentation materials must be emailed to 
GDUFARegulatoryScience@fda.hhs.gov no later than April 22, 2019, 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 
also be webcast. Please register online by April 1, 2019, 11:59 p.m. 
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 period or during any other session of the workshop. To 
join the workshop via the webcast, please go to https://collaboration.fda.gov/gdufa2019/.
    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: January 16, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019-01067 Filed 2-4-19; 8:45 am]
 BILLING CODE 4164-01-P


