83_FR_13552 83 FR 13491 - Fiscal Year 2018 Generic Drug Regulatory Science Initiatives; Public Workshop; Request for Comments

83 FR 13491 - Fiscal Year 2018 Generic Drug Regulatory Science Initiatives; Public Workshop; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 61 (March 29, 2018)

Page Range13491-13493
FR Document2018-06260

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``FY 2018 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) 2019 regulatory science initiatives.

Federal Register, Volume 83 Issue 61 (Thursday, March 29, 2018)
[Federal Register Volume 83, Number 61 (Thursday, March 29, 2018)]
[Notices]
[Pages 13491-13493]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-06260]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Fiscal Year 2018 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 2018 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) 2019 
regulatory science initiatives.

DATES: The public workshop will be held on May 24, 2018 from 8:30 a.m. 
to 4:30 p.m. Submit either electronic or written comments on this 
public workshop by June 25, 2018. 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 25, 2018. The https://www.regulations.gov 
electronic filing system will accept comments until midnight Eastern 
Time at the end of June 25, 2018. 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

[[Page 13492]]

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 2018 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.thefederalregister.org/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. 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 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 24, 2018, 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.
---------------------------------------------------------------------------

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 2019.
    FDA is particularly interested in receiving input regarding the 
following three topics:
    1. FY 2018 regulatory science initiatives,\2\ including specific 
products or actions that FDA should consider as it implements those 
initiatives,
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    \2\ The FY 2018 regulatory science initiatives are available at 
https://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/GenericDrugs/UCM582777.pdf.
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    2. newly approved new drug applications that may pose scientific 
challenges to the future development of generic products referencing 
those applications, and
    3. regulatory science initiatives that FDA should begin to consider 
in FY 2019.
    FDA will consider all comments made at this workshop or received 
through the docket (see ADDRESSES) as it develops its FY 2019 
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]. 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 24, 2018, midnight 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 24, 2018.
    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

[[Page 13493]]

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 May 8, 2018. All requests to make oral presentations must be 
received by the close of registration on April 24, 2018, midnight 
Eastern Time. If selected for presentation, any presentation materials 
must be emailed to [email protected] no later than May 
17, 2018, midnight 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 24, 2018, 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 period or during any other session of the workshop. To 
join the workshop via the webcast, please go to https://collaboration.fda.gov/gdufa2018/.
    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 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06260 Filed 3-28-18; 8:45 am]
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                                                                             Federal Register / Vol. 83, No. 61 / Thursday, March 29, 2018 / Notices                                           13491

                                                Advisory Committee Information Line,                    conduct a lottery to determine the                    fulfills its commitment under the
                                                1–800–741–8138 (301–443–0572 in the                     speakers for the scheduled open public                Generic Drug User Fee Amendments of
                                                Washington, DC area). A notice in the                   hearing session. The contact person will              2017 (GDUFA II) to develop an annual
                                                Federal Register about last minute                      notify interested persons regarding their             list of regulatory science initiatives
                                                modifications that impact a previously                  request to speak by May 1, 2018.                      specific to generic drugs. FDA will take
                                                announced advisory committee meeting                       Persons attending FDA’s advisory                   the information it obtains from the
                                                cannot always be published quickly                      committee meetings are advised that                   public workshop into account in
                                                enough to provide timely notice.                        FDA is not responsible for providing                  developing its fiscal year (FY) 2019
                                                Therefore, you should always check the                  access to electrical outlets.                         regulatory science initiatives.
                                                FDA’s website at https://www.fda.gov/                      For press inquiries, please contact the            DATES: The public workshop will be
                                                AdvisoryCommittees/default.htm and                      Office of Media Affairs at fdaoma@                    held on May 24, 2018 from 8:30 a.m. to
                                                scroll down to the appropriate advisory                 fda.hhs.gov or 301–796–4540.                          4:30 p.m. Submit either electronic or
                                                committee meeting link, or call the                        FDA welcomes the attendance of the                 written comments on this public
                                                advisory committee information line to                  public at its advisory committee                      workshop by June 25, 2018. See the
                                                learn about possible modifications                      meetings and will make every effort to                SUPPLEMENTARY INFORMATION section for
                                                before coming to the meeting.                           accommodate persons with disabilities.                registration date and information.
                                                SUPPLEMENTARY INFORMATION:                              If you require accommodations due to a                ADDRESSES: The public workshop will
                                                   Agenda: The committees will be                       disability, please contact Moon Hee V.                be held at the FDA White Oak Campus,
                                                asked to discuss new drug application                   Choi (see FOR FURTHER INFORMATION                     10903 New Hampshire Ave., Bldg. 31
                                                (NDA) 209588, for buprenorphine                         CONTACT) at least 7 days in advance of                Conference Center, the Great Room (Rm.
                                                sublingual spray, submitted by INSYS                    the meeting.                                          1503, sections B and C), Silver Spring,
                                                Development Company, Inc., for the                         FDA is committed to the orderly                    MD 20993–0002. Entrance for the public
                                                treatment of moderate-to-severe acute                   conduct of its advisory committee                     workshop participants (non-FDA
                                                pain where the use of an opioid                         meetings. Please visit our website at                 employees) is through Bldg. 1, where
                                                analgesic is appropriate. The                           https://www.fda.gov/Advisory                          routine security check procedures will
                                                committees will also be asked to discuss                Committees/AboutAdvisoryCommittees/                   be performed. For parking and security
                                                whether this product should be                          ucm111462.htm for procedures on                       information, please refer to https://
                                                approved.                                               public conduct during advisory                        www.fda.gov/AboutFDA/
                                                   FDA intends to make background                       committee meetings.                                   WorkingatFDA/BuildingsandFacilities/
                                                material available to the public no later                  Notice of this meeting is given under              WhiteOakCampusInformation/
                                                than 2 business days before the meeting.                the Federal Advisory Committee Act (5                 ucm241740.htm.
                                                If FDA is unable to post the background                 U.S.C. app. 2).                                          You may submit comments as
                                                material on its website prior to the                      Dated: March 21, 2018.                              follows. Please note that late, untimely
                                                meeting, the background material will                   Leslie Kux,                                           filed comments will not be considered.
                                                be made publicly available at the                       Associate Commissioner for Policy.                    Electronic comments must be submitted
                                                location of the advisory committee                      [FR Doc. 2018–06307 Filed 3–28–18; 8:45 am]           on or before June 25, 2018. The https://
                                                meeting, and the background material                                                                          www.regulations.gov electronic filing
                                                                                                        BILLING CODE 4164–01–P
                                                will be posted on FDA’s website after                                                                         system will accept comments until
                                                the meeting. Background material is                                                                           midnight Eastern Time at the end of
                                                available at https://www.fda.gov/                       DEPARTMENT OF HEALTH AND                              June 25, 2018. Comments received by
                                                AdvisoryCommittees/Calendar/                            HUMAN SERVICES                                        mail/hand delivery/courier (for written/
                                                default.htm. Scroll down to the                                                                               paper submissions) will be considered
                                                appropriate advisory committee meeting                  Food and Drug Administration                          timely if they are postmarked or the
                                                link.                                                                                                         delivery service acceptance receipt is on
                                                   Procedure: Interested persons may                    [Docket No. FDA–2017–N–6644]
                                                                                                                                                              or before that date.
                                                present data, information, or views,
                                                                                                        Fiscal Year 2018 Generic Drug                         Electronic Submissions
                                                orally or in writing, on issues pending
                                                                                                        Regulatory Science Initiatives; Public
                                                before the committees. Written                                                                                  Submit electronic comments in the
                                                                                                        Workshop; Request for Comments
                                                submissions may be made to the contact                                                                        following way:
                                                person on or before May 8, 2018. Oral                   AGENCY:    Food and Drug Administration,                • Federal eRulemaking Portal:
                                                presentations from the public will be                   HHS.                                                  https://www.regulations.gov. Follow the
                                                scheduled between approximately 1                       ACTION: Notice of public workshop;                    instructions for submitting comments.
                                                p.m. and 2 p.m. Those individuals                       request for comments.                                 Comments submitted electronically,
                                                interested in making formal oral                                                                              including attachments, to https://
                                                presentations should notify the contact                 SUMMARY:  The Food and Drug                           www.regulations.gov will be posted to
                                                person and submit a brief statement of                  Administration (FDA, the Agency, or                   the docket unchanged. Because your
                                                the general nature of the evidence or                   we) is announcing the following public                comment will be made public, you are
                                                arguments they wish to present, the                     workshop entitled ‘‘FY 2018 Generic                   solely responsible for ensuring that your
                                                names and addresses of proposed                         Drug Regulatory Science Initiatives.’’                comment does not include any
                                                participants, and an indication of the                  The purpose of the public workshop is                 confidential information that you or a
                                                approximate time requested to make                      to provide an overview of the status of               third party may not wish to be posted,
sradovich on DSK3GMQ082PROD with NOTICES




                                                their presentation on or before April 30,               regulatory science initiatives for generic            such as medical information, your or
                                                2018. Time allotted for each                            drugs and an opportunity for public                   anyone else’s Social Security number, or
                                                presentation may be limited. If the                     input on these initiatives. FDA is                    confidential business information, such
                                                number of registrants requesting to                     seeking this input from a variety of                  as a manufacturing process. Please note
                                                speak is greater than can be reasonably                 stakeholders—industry, academia,                      that if you include your name, contact
                                                accommodated during the scheduled                       patient advocates, professional societies,            information, or other information that
                                                open public hearing session, FDA may                    and other interested parties—as it                    identifies you in the body of your


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                                                13492                        Federal Register / Vol. 83, No. 61 / Thursday, March 29, 2018 / Notices

                                                comments, that information will be                      more information about FDA’s posting                     FDA is particularly interested in
                                                posted on https://www.regulations.gov.                  of comments to public dockets, see 80                 receiving input regarding the following
                                                  • If you want to submit a comment                     FR 56469, September 18, 2015, or access               three topics:
                                                with confidential information that you                  the information at: https://www.gpo.gov/                 1. FY 2018 regulatory science
                                                do not wish to be made available to the                 fdsys/pkg/FR-2015-09-18/pdf/2015-                     initiatives,2 including specific products
                                                public, submit the comment as a                         23389.pdf.                                            or actions that FDA should consider as
                                                written/paper submission and in the                        Docket: For access to the docket to                it implements those initiatives,
                                                manner detailed (see ‘‘Written/Paper                    read background documents or the                         2. newly approved new drug
                                                Submissions’’ and ‘‘Instructions’’).                    electronic and written/paper comments                 applications that may pose scientific
                                                Written/Paper Submissions                               received, go to https://                              challenges to the future development of
                                                                                                        www.regulations.gov and insert the                    generic products referencing those
                                                   Submit written/paper submissions as                  docket number, found in brackets in the               applications, and
                                                follows:                                                heading of this document, into the                       3. regulatory science initiatives that
                                                   • Mail/Hand delivery/Courier (for                    ‘‘Search’’ box and follow the prompts                 FDA should begin to consider in FY
                                                written/paper submissions): Dockets                     and/or go to the Dockets Management                   2019.
                                                Management Staff (HFA–305), Food and                    Staff, 5630 Fishers Lane, Rm. 1061,                      FDA will consider all comments made
                                                Drug Administration, 5630 Fishers                       Rockville, MD 20852.                                  at this workshop or received through the
                                                Lane, Rm. 1061, Rockville, MD 20852.
                                                   • For written/paper comments                         FOR FURTHER INFORMATION CONTACT:                      docket (see ADDRESSES) as it develops its
                                                submitted to the Dockets Management                     Stephanie Choi, Center for Drug                       FY 2019 regulatory science initiatives.
                                                Staff, FDA will post your comment, as                   Evaluation and Research, Food and                     Information concerning the regulatory
                                                well as any attachments, except for                     Drug Administration, 10903 New                        science initiatives for generic drugs can
                                                information submitted, marked and                       Hampshire Ave., Bldg. 75, Rm. 4736,                   be found at https://www.fda.gov/
                                                identified, as confidential, if submitted               Silver Spring, MD 20993, 240–402–                     gdufaregscience.
                                                as detailed in ‘‘Instructions.’’                        7960, Stephanie.Choi@fda.hhs.gov; or
                                                                                                                                                              III. Participating in the Public
                                                   Instructions: All submissions received               Robert Lionberger, Center for Drug
                                                                                                                                                              Workshop
                                                must include the Docket No. FDA–                        Evaluation and Research, Food and
                                                2017–N–6644 for ‘‘FY 2018 Generic                       Drug Administration, 10903 New                           Registration: To register for the public
                                                Drug Regulatory Science Initiatives;                    Hampshire Ave., Bldg. 75, Rm. 4722,                   workshop, please provide complete
                                                Public Workshop; Request for                            Silver Spring, MD 20993, 240–402–                     contact information for each attendee,
                                                Comments.’’ Received comments, those                    7957, Robert.Lionberger@fda.hhs.gov.                  including name, title, affiliation,
                                                filed in a timely manner (see                           SUPPLEMENTARY INFORMATION:                            address, email, and telephone to
                                                ADDRESSES), will be placed in the docket
                                                                                                                                                              GDUFARegulatoryScience@fda.hhs.gov.
                                                                                                        I. Background                                         Please also indicate in the email
                                                and, except for those submitted as
                                                ‘‘Confidential Submissions,’’ publicly                     In July 2012, Congress passed the                  whether attendance will be by webcast
                                                viewable at https://www.regulations.gov                 Generic Drug User Fee Amendments of                   or in person.
                                                or at the Dockets Management Staff                      2012 (GDUFA I) (Pub. L. 112–144).                        Registration is free and based on
                                                between 9 a.m. and 4 p.m., Monday                       GDUFA I was designed to enhance                       space availability, with priority given to
                                                through Friday.                                         public access to safe, high-quality                   early registrants. Persons interested in
                                                   • Confidential Submissions—To                        generic drugs and to modernize the                    attending this public workshop must
                                                submit a comment with confidential                      generic drug program. To support this                 register online by April 24, 2018,
                                                information that you do not wish to be                  goal, FDA agreed in the GDUFA I                       midnight Eastern Time. Early
                                                made publicly available, submit your                    commitment letter to work with                        registration is recommended because
                                                comments only as a written/paper                        industry and interested stakeholders on               seating is limited; therefore, FDA may
                                                submission. You should submit two                       identifying regulatory science initiatives            limit the number of participants from
                                                copies total. One copy will include the                 specific to generic drugs for each fiscal             each organization. Registrants will
                                                information you claim to be confidential                year covered by GDUFA I.                              receive confirmation when they have
                                                with a heading or cover note that states                   In August 2017, GDUFA I was                        been accepted.
                                                ‘‘THIS DOCUMENT CONTAINS                                reauthorized until September 2022                        If you need special accommodations
                                                CONFIDENTIAL INFORMATION.’’ The                         through GDUFA II (Pub. L. 115–52). In                 due to a disability, please contact
                                                Agency will review this copy, including                 the GDUFA II commitment letter,1 FDA                  Stephanie Choi (see FOR FURTHER
                                                the claimed confidential information, in                agreed to conduct annual public                       INFORMATION CONTACT) no later than
                                                its consideration of comments. The                      workshops ‘‘to solicit input from                     April 24, 2018.
                                                second copy, which will have the                        industry and stakeholders for inclusion                  Requests for Oral Presentations:
                                                claimed confidential information                        in an annual list of GDUFA II                         During online registration you may
                                                redacted/blacked out, will be available                 [r]egulatory [s]cience initiatives.’’ The             indicate if you wish to present during a
                                                for public viewing and posted on                        public workshop scheduled for May 24,                 public comment session or participate
                                                https://www.regulations.gov. Submit                     2018, seeks to fulfill this agreement.                in a specific session, and which topic(s)
                                                both copies to the Dockets Management                   II. Topics for Discussion at the Public               you wish to address. We will do our
                                                Staff. If you do not wish your name and                 Workshop                                              best to accommodate requests to make
                                                contact information to be made publicly                                                                       public comments (and requests to
                                                                                                           The purpose of the public workshop                 participate in the focused sessions).
                                                available, you can provide this
sradovich on DSK3GMQ082PROD with NOTICES




                                                                                                        is to obtain input from industry and                  Individuals and organizations with
                                                information on the cover sheet and not
                                                                                                        other interested stakeholders on the                  common interests are urged to
                                                in the body of your comments and you
                                                                                                        identification of generic drug regulatory             consolidate or coordinate their
                                                must identify this information as
                                                                                                        science initiatives for FY 2019.
                                                ‘‘confidential.’’ Any information marked                                                                        2 The FY 2018 regulatory science initiatives are
                                                as ‘‘confidential’’ will not be disclosed                 1 The GDUFA II commitment letter is available at    available at https://www.fda.gov/downloads/Drugs/
                                                except in accordance with 21 CFR 10.20                  https://www.fda.gov/downloads/ForIndustry/            ResourcesForYou/Consumers/BuyingUsing
                                                and other applicable disclosure law. For                UserFees/GenericDrugUserFees/UCM525234.pdf.           MedicineSafely/GenericDrugs/UCM582777.pdf.



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                                                                             Federal Register / Vol. 83, No. 61 / Thursday, March 29, 2018 / Notices                                           13493

                                                presentations, and request time for a                   DEPARTMENT OF HEALTH AND                                You may submit comments as
                                                joint presentation, or submit requests for              HUMAN SERVICES                                        follows:
                                                designated representatives to participate                                                                     Electronic Submissions
                                                in the focused sessions. Following the                  Food and Drug Administration
                                                close of registration, we will determine                                                                        Submit electronic comments in the
                                                                                                        [Docket No. FDA–2018–N–1015]
                                                the amount of time allotted to each                                                                           following way:
                                                                                                        Joint Meeting of the Arthritis Advisory                 • Federal eRulemaking Portal:
                                                presenter and the approximate time
                                                                                                        Committee and the Drug Safety and                     https://www.regulations.gov. Follow the
                                                each oral presentation is to begin, and
                                                                                                        Risk Management Advisory                              instructions for submitting comments.
                                                will select and notify participants by                                                                        Comments submitted electronically,
                                                May 8, 2018. All requests to make oral                  Committee; Notice of Meeting;
                                                                                                        Establishment of a Public Docket;                     including attachments, to https://
                                                presentations must be received by the                                                                         www.regulations.gov will be posted to
                                                close of registration on April 24, 2018,                Request for Comments
                                                                                                                                                              the docket unchanged. Because your
                                                midnight Eastern Time. If selected for                  AGENCY:    Food and Drug Administration,              comment will be made public, you are
                                                presentation, any presentation materials                HHS.                                                  solely responsible for ensuring that your
                                                must be emailed to                                      ACTION: Notice; establishment of a                    comment does not include any
                                                GDUFARegulatoryScience@fda.hhs.gov                      public docket; request for comments.                  confidential information that you or a
                                                no later than May 17, 2018, midnight                                                                          third party may not wish to be posted,
                                                Eastern Time. No commercial or                          SUMMARY:   The Food and Drug                          such as medical information, your or
                                                promotional material will be permitted                  Administration (FDA) announces a
                                                                                                                                                              anyone else’s Social Security number, or
                                                                                                        forthcoming public advisory committee
                                                to be presented or distributed at the                                                                         confidential business information, such
                                                                                                        meeting of the Arthritis Advisory
                                                public workshop.                                                                                              as a manufacturing process. Please note
                                                                                                        Committee and the Drug Safety and Risk
                                                  Streaming Webcast of the Public                                                                             that if you include your name, contact
                                                                                                        Management Advisory Committee. The
                                                Workshop: This public workshop will                                                                           information, or other information that
                                                                                                        general function of the committees is to
                                                                                                                                                              identifies you in the body of your
                                                also be webcast. Please register online                 provide advice and recommendations to
                                                                                                                                                              comments, that information will be
                                                by April 24, 2018, midnight Eastern                     FDA on regulatory issues. The meeting
                                                                                                                                                              posted on https://www.regulations.gov.
                                                Time to attend the workshop remotely.                   will be open to the public. FDA is
                                                                                                                                                                • If you want to submit a comment
                                                Please note that remote attendees will                  establishing a docket for public
                                                                                                                                                              with confidential information that you
                                                not be able to speak or make                            comment on this document.
                                                                                                                                                              do not wish to be made available to the
                                                presentations during the public                         DATES: The meeting will be held on                    public, submit the comment as a
                                                comment period or during any other                      April 24 and 25, 2018, from 8 a.m. to 5               written/paper submission and in the
                                                session of the workshop. To join the                    p.m.                                                  manner detailed (see ‘‘Written/Paper
                                                workshop via the webcast, please go to                  ADDRESSES: FDA White Oak Campus,                      Submissions’’ and ‘‘Instructions’’).
                                                https://collaboration.fda.gov/                          10903 New Hampshire Ave., Bldg. 31
                                                                                                        Conference Center, the Great Room (Rm.                Written/Paper Submissions
                                                gdufa2018/.
                                                                                                        1503), Silver Spring, MD 20993–0002.                    Submit written/paper submissions as
                                                  If you have never attended a Connect                  Answers to commonly asked questions                   follows:
                                                Pro event before, test your connection at               including information regarding special                 • Mail/Hand delivery/Courier (for
                                                https://collaboration.fda.gov/common/                   accommodations due to a disability,                   written/paper submissions): Dockets
                                                help/en/support/meeting_test.htm. To                    visitor parking, and transportation may               Management Staff (HFA–305), Food and
                                                get a quick overview of the Connect Pro                 be accessed at: https://www.fda.gov/                  Drug Administration, 5630 Fishers
                                                program, visit https://www.adobe.com/                   AdvisoryCommittees/AboutAdvisory                      Lane, Rm. 1061, Rockville, MD 20852.
                                                go/connectpro_overview. FDA has                         Committees/ucm408555.htm.                               • For written/paper comments
                                                verified the website addresses in this                     FDA is establishing a docket for                   submitted to the Dockets Management
                                                document, as of the date this document                  public comment on this meeting. The                   Staff, FDA will post your comment, as
                                                publishes in the Federal Register, but                  docket number is FDA–2018–N–1015.                     well as any attachments, except for
                                                websites are subject to change over time.               The docket will close on April 23, 2018.              information submitted, marked and
                                                  Transcripts: Please be advised that as                Submit either electronic or written                   identified, as confidential, if submitted
                                                soon as a transcript of the public                      comments on this public meeting by                    as detailed in ‘‘Instructions.’’
                                                                                                        April 23, 2018. Please note that late,                  Instructions: All submissions received
                                                workshop is available, it will be
                                                                                                        untimely filed comments will not be                   must include the Docket No. FDA–
                                                accessible at https://
                                                                                                        considered. Electronic comments must                  2018–N–1015 for ‘‘Joint Meeting of the
                                                www.regulations.gov or at https://                                                                            Arthritis Advisory Committee and the
                                                                                                        be submitted on or before April 23,
                                                www.fda.gov/gdufaregscience. It may be                  2018. The https://www.regulations.gov                 Drug Safety and Risk Management
                                                viewed at the Dockets Management Staff                  electronic filing system will accept                  Advisory Committee; Notice of Meeting;
                                                (see ADDRESSES). A link to the transcript               comments until midnight Eastern Time                  Establishment of a Public Docket;
                                                will also be available on the internet at               at the end of April 23, 2018. Comments                Request for Comments.’’ Received
                                                https://www.fda.gov/gdufaregscience.                    received by mail/hand delivery/courier                comments, those filed in a timely
                                                  Dated: March 21, 2018.                                (for written/paper submissions) will be               manner (see the ADDRESSES section),
                                                Leslie Kux,                                             considered timely if they are                         will be placed in the docket and, except
sradovich on DSK3GMQ082PROD with NOTICES




                                                                                                        postmarked or the delivery service                    for those submitted as ‘‘Confidential
                                                Associate Commissioner for Policy.
                                                                                                        acceptance receipt is on or before that               Submissions,’’ publicly viewable at
                                                [FR Doc. 2018–06260 Filed 3–28–18; 8:45 am]
                                                                                                        date.                                                 https://www.regulations.gov or at the
                                                BILLING CODE 4164–01–P                                     Comments received on or before April               Dockets Management Staff between 9
                                                                                                        10, 2018, will be provided to the                     a.m. and 4 p.m., Monday through
                                                                                                        committees. Comments received after                   Friday.
                                                                                                        that date will be taken into                            • Confidential Submissions—To
                                                                                                        consideration by FDA.                                 submit a comment with confidential


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Document Created: 2018-03-29 00:25:54
Document Modified: 2018-03-29 00:25:54
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of public workshop; request for comments.
DatesThe public workshop will be held on May 24, 2018 from 8:30 a.m. to 4:30 p.m. Submit either electronic or written comments on this public workshop by June 25, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information.
ContactStephanie Choi, Center for Drug 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, Rob[email protected]
FR Citation83 FR 13491 

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