82 FR 13634 - Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives; Public Workshop; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 48 (March 14, 2017)

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives.'' The topics to be discussed will provide an overview of the current status of regulatory science initiatives for generic drugs and an opportunity for public input on research priorities in this area. 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 2012 (GDUFA) 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 the fiscal year (FY) 2018 Regulatory Science Plan.

[Federal Register Volume 82, Number 48 (Tuesday, March 14, 2017)]
[Notices]
[Pages 13634-13635]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-04981]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0402]


Generic Drug User Fee Amendments of 2012; Regulatory Science 
Initiatives; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the following public workshop entitled ``Generic Drug User 
Fee Amendments of 2012; Regulatory Science Initiatives.'' The topics to 
be discussed will provide an overview of the current status of 
regulatory science initiatives for generic drugs and an opportunity for 
public input on research priorities in this area. 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 
2012 (GDUFA) 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 the fiscal 
year (FY) 2018 Regulatory Science Plan.

DATES: The public workshop will be held on May 3, 2017, from 8:30 a.m. 
to 4:30 p.m. The registration deadline to attend either in person, or 
virtually via web cast, is April 5, 2017. Comments regarding this 
public workshop may be submitted March 2, 2017, through June 2, 2017.

ADDRESSES: The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the 
Great Room (Rm. 1503, Section A), 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 http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows:

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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2013-N-0402 for ``Generic Drug User Fee Amendments of 2012; 
Regulatory Science Initiatives; Public Workshop; Request for 
Comments.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at https://www.regulations.gov or at the Division of Dockets Management 
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 Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Stephanie Choi, Center for Drug

[[Page 13635]]

Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg 75, Rm. 4736, 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 GDUFA (Title III of the Food and Drug 
Administration Safety and Innovation Act (Pub. L. 112-144)). GDUFA is 
designed to enhance public access to safe, high-quality generic drugs 
and modernize the generic drug program. To support this goal, FDA 
agreed in the GDUFA commitment letter to work with industry and 
interested stakeholders on identifying regulatory science research 
priorities specific to generic drugs for each fiscal year covered by 
GDUFA. The commitment letter outlines FDA's performance goals and 
procedures under the GDUFA program for the years 2012-2017. The 
commitment letter can be found at http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf.

II. Topics for Discussion at the Public Workshop

    The purpose of the May public workshop is to obtain input from 
industry and other interested stakeholders on the identification of 
generic drug regulatory science priorities for FY 2018. FDA is holding 
this public workshop because the Agency intends to continue its 
regulatory science initiatives upon reauthorization of GDUFA (i.e., 
GDUFA II) for FYs 2018-2022 (see Generic Drug User Fees; Public 
Meeting; Request for Comments, 81 FR 66035, September 26, 2016). To 
help fulfill its mission, FDA is particularly interested in receiving 
input on the following topics:
     Opportunities for scientific or technical advancements 
that would help to overcome specific barriers for industry that 
currently limit the availability of generic drug products.
     Innovative approaches to pre-approval development of 
generic drugs, including new methodologies for product design and 
manufacturing, and design and conduct of in vitro, ex vivo, and 
clinical studies and identification of scientifically robust strategies 
for demonstration of bioequivalence for various product classes.
     Innovation in scientific approaches to evaluating the 
therapeutic equivalence of generic drug products throughout their life 
cycle.
     Identification of high-impact public health issues 
involving generic drugs that can be addressed by the prioritized 
allocation of FY 2018 funding for regulatory science research.
     Identification of specific issues related to generic drug 
products where scientific recommendations and/or clarifications are 
needed in developing and/or revising FDA's guidance for industry.
     Strategies for enhancing quality and equivalence risk 
management during generic drug product development, during regulatory 
review, and/or throughout the drug product's life cycle.
    FDA will consider all comments made at this workshop or received 
through the docket (see ADDRESSES) as it develops its FY 2018 
regulatory science priorities. Additional information concerning GDUFA, 
including the text of the law and the commitment letter, can be found 
at http://www.fda.gov/gdufa.

III. Participating in the Public Workshop

    Registration: To register to attend ``Generic Drug User Fee 
Amendments of 2012; Regulatory Science Initiatives; Public Workshop'' 
in-person, or to attend virtually via web cast, please send an email to 
[email protected] by April 5, 2017. Please provide 
complete contact information for each attendee, including name, title, 
affiliation, address, email, and telephone. Any person without email 
access can register by contacting Stephanie Choi (see FOR FURTHER 
INFORMATION CONTACT). If you need special accommodations because of a 
disability, please contact Stephanie Choi (see FOR FURTHER INFORMATION 
CONTACT) at least 7 days before the workshop.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
workshop must register by April 5, 2017, midnight eastern standard 
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.
    Requests for Oral Presentations: During online registration you may 
indicate if you wish to present during the public comment session and 
which topic(s) you wish to address. 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. Following the close of registration, FDA 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 19, 2017. All requests to make oral presentations 
must be received by the close of registration on April 5, 2017, 
midnight eastern standard time. If selected for presentation, any 
presentation materials must be emailed to 
[email protected] no later than April 26, 2017. 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 web cast. To join via the web cast, please go to https://collaboration.fda.gov/gpw517/. Please register in advance for web cast 
per the instructions provided in this section.
    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 http://www.adobe.com/go/connectpro_overview. FDA has verified the 
Web site addresses in this document, as of the date this document 
publishes in the Federal Register, but Web sites 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. It may be viewed at the Division of Dockets 
Management (see ADDRESSES). A link to the transcript will also be 
available on the Internet at http://www.fda.gov/GDUFARegScience.

    Dated: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-04981 Filed 3-13-17; 8:45 am]
 BILLING CODE 4164-01-P