82_FR_46255 82 FR 46065 - Topical Dermatological Generic Drug Products: Overcoming Barriers to Development and Improving Patient Access; Public Workshop; Request for Comments

82 FR 46065 - Topical Dermatological Generic Drug Products: Overcoming Barriers to Development and Improving Patient Access; Public Workshop; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 190 (October 3, 2017)

Page Range46065-46066
FR Document2017-21186

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Topical Dermatological Generic Drug Products: Overcoming Barriers to Development and Improving Patient Access.'' The purpose of the public workshop is to provide an overview of current regulatory science initiatives related to generic topical dermatological drug products, solicit public input on scientific barriers that may limit patient access to such drug products, and discuss approaches to overcome/ address any such barriers. FDA is seeking public input from a variety of stakeholders, including industry, academia, patient advocates, and professional associations.

Federal Register, Volume 82 Issue 190 (Tuesday, October 3, 2017)
[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)]
[Notices]
[Pages 46065-46066]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-21186]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-5437]


Topical Dermatological Generic Drug Products: Overcoming Barriers 
to Development and Improving Patient Access; Public Workshop; Request 
for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the following public workshop entitled ``Topical 
Dermatological Generic Drug Products: Overcoming Barriers to 
Development and Improving Patient Access.'' The purpose of the public 
workshop is to provide an overview of current regulatory science 
initiatives related to generic topical dermatological drug products, 
solicit public input on scientific barriers that may limit patient 
access to such drug products, and discuss approaches to overcome/
address any such barriers. FDA is seeking public input from a variety 
of stakeholders, including industry, academia, patient advocates, and 
professional associations.

DATES: The public workshop will be held on October 20, 2017, from 8:30 
a.m. to 4:30 p.m., Eastern Standard Time. Submit either electronic or 
written comments on this public workshop by November 20, 2017. See the 
SUPPLEMENTARY INFORMATION section for registration date and 
information.

ADDRESSES: The public workshop will be held at FDA White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503A), 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 
filed comments will not be considered. Electronic comments must be 
submitted on or before November 20, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of November 20, 2017. 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-5437 for ``Topical Dermatological Generic Drug Products: 
Overcoming Barriers to Development and Improving Patient Access.'' 
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

[[Page 46066]]

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: 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, email: 
[email protected]; or Markham Luke, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 4712, Silver Spring, MD 20993, 301-796-
5556, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    The conventional approach to establish bioequivalence (BE) for most 
topical dermatological generic drug products relies upon clinical 
endpoint BE studies. The risk of failing to demonstrate BE due to the 
relative insensitivity of these clinical endpoint studies, combined 
with their burden and length, may represent a barrier to generic drug 
development and may adversely impact patient access to some topical 
dermatological generic drug products. FDA is evaluating alternative BE 
approaches for topical dermatological generic drug products, using 
methods that are more efficient, and also more sensitive and 
reproducible. FDA believes that these BE approaches would benefit from 
public discussion.

II. Topics for Discussion at the Public Workshop

    This public workshop will focus on a discussion of current 
regulatory science initiatives intended to foster the development of 
topical dermatological generic drug products, examining alternative BE 
approaches that may be more efficient and less risky than traditional 
approaches. FDA is also interested in receiving public input about any 
barriers that may limit the use of such alternative BE approaches in 
the development of topical dermatological generic drug products. Public 
input is also sought about strategies to overcome these barriers.

III. Participating in the Public Workshop

    Registration: Persons interested in attending this public workshop 
must register online at https://survey.co1.qualtrics.com/jfe/form/SV_9YQDLZJRjXtYiXz. Please provide complete contact information for 
each attendee, including name, title, affiliation, address, email, and 
telephone.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
workshop must register by October 13, 2017, midnight, Eastern Time. 
Early registration is recommended because seating is limited; 
therefore, FDA may limit the number of participants from each 
organization.
    If you need special accommodations due to a disability, please 
contact Sam Raney (see FOR FURTHER INFORMATION CONTACT) no later than 
October 13, 2017.
    Requests for Oral Presentations: During online registration you may 
indicate if you wish to present during a 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, and to request time for a joint presentation, or to 
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 October 16, 2017. All requests to make oral 
presentations must be received by the close of registration on October 
9, 2017. If selected for presentation, any presentation materials must 
be emailed to [email protected] no later than October 
13, 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 webcast. A live webcast of this workshop will be viewable at 
https://collaboration.fda.gov/ogddermaldrug/ on the day of the 
workshop.
    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 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 Dockets Management Staff 
(see ADDRESSES). A link to the transcript will also be available on the 
internet at https://www.fda.gov/Drugs/NewsEvents/ucm557252.htm.

    Dated: September 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21186 Filed 10-2-17; 8:45 am]
BILLING CODE 4164-01-P



                                                                                              Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices                                                                                                                              46065

                                                                                                                                                                                                                                                                                  Average             Total
                                                                    Type of                                                                                                         Estimated number of                            Number of responses                            time per           burden
                                                                                                                                Form name
                                                                  respondent                                                                                                            respondents                                  per respondent                              response             hours
                                                                                                                                                                                                                                                                                 (in hours)         (annual)

                                                    Project staff ...............................   Semi-annual Performance Report .....................                           18 ................................     Twice a year .............................                         8          288
                                                    Local agency leaders ................           Program Information Cover Sheet/Participant                                    700 leaders .................           Twice a year (one set per pro-                                   .50          700
                                                                                                      Information Form/Attendance Log/Post Pro-                                                                              gram).
                                                                                                      gram Survey.
                                                    Local data entry staff ................                                                                                        46 data entry staff ......              Once per program x 1400 pro-                                     .50          700
                                                                                                                                                                                                                             grams.
                                                    Local organization staff and                    Host Organization Data Form ...........................                        700 staff ......................        1 ...............................................               .05            35
                                                      local database entry staff.
                                                    Program participants .................          Participant Information Form .............................                     16,390 .........................        1 ...............................................               .10         1,639
                                                    Program participants .................          Post Program Survey ........................................                   983 ..............................      1 ...............................................               .10           983

                                                          Total Burden Hours ...........            ............................................................................   .....................................   ...................................................   ................      4,345



                                                      Dated: September 20, 2017.                                                      ADDRESSES:   The public workshop will                                                    comments, that information will be
                                                    Mary Lazare,                                                                      be held at FDA White Oak Campus,                                                         posted on https://www.regulations.gov.
                                                    Principal Deputy Administrator.                                                   10903 New Hampshire Ave., Bldg. 31                                                         • If you want to submit a comment
                                                    [FR Doc. 2017–21179 Filed 10–2–17; 8:45 am]                                       Conference Center, the Great Room (Rm.                                                   with confidential information that you
                                                    BILLING CODE 4154–01–P
                                                                                                                                      1503A), Silver Spring, MD 20993–0002.                                                    do not wish to be made available to the
                                                                                                                                      Entrance for the public workshop                                                         public, submit the comment as a
                                                                                                                                      participants (non-FDA employees) is                                                      written/paper submission and in the
                                                    DEPARTMENT OF HEALTH AND                                                          through Building 1 where routine                                                         manner detailed (see ‘‘Written/Paper
                                                    HUMAN SERVICES                                                                    security check procedures will be                                                        Submissions’’ and ‘‘Instructions’’).
                                                                                                                                      performed. For parking and security                                                      Written/Paper Submissions
                                                    Food and Drug Administration                                                      information, please refer to https://
                                                                                                                                      www.fda.gov/AboutFDA/Workingat                                                              Submit written/paper submissions as
                                                    [Docket No. FDA–2017–N–5437]                                                      FDA/BuildingsandFacilities/WhiteOak                                                      follows:
                                                                                                                                      CampusInformation/ucm241740.htm.                                                            • Mail/Hand delivery/Courier (for
                                                    Topical Dermatological Generic Drug                                                                                                                                        written/paper submissions): Dockets
                                                    Products: Overcoming Barriers to                                                     You may submit comments as
                                                                                                                                                                                                                               Management Staff (HFA–305), Food and
                                                    Development and Improving Patient                                                 follows. Please note that late, untimely
                                                                                                                                                                                                                               Drug Administration, 5630 Fishers
                                                    Access; Public Workshop; Request for                                              filed comments will not be considered.
                                                                                                                                                                                                                               Lane, Rm. 1061, Rockville, MD 20852.
                                                    Comments                                                                          Electronic comments must be submitted                                                       • For written/paper comments
                                                                                                                                      on or before November 20, 2017. The                                                      submitted to the Dockets Management
                                                    AGENCY:         Food and Drug Administration,                                     https://www.regulations.gov electronic                                                   Staff, FDA will post your comment, as
                                                    HHS.                                                                              filing system will accept comments                                                       well as any attachments, except for
                                                    ACTION: Notice of public workshop;                                                until midnight Eastern Time at the end                                                   information submitted, marked and
                                                    request for comments.                                                             of November 20, 2017. Comments                                                           identified, as confidential, if submitted
                                                                                                                                      received by mail/hand delivery/courier                                                   as detailed in ‘‘Instructions.’’
                                                    SUMMARY:   The Food and Drug                                                      (for written/paper submissions) will be                                                     Instructions: All submissions received
                                                    Administration (FDA, the Agency, or                                               considered timely if they are                                                            must include the Docket No. FDA–
                                                    we) is announcing the following public                                            postmarked or the delivery service                                                       2017–N–5437 for ‘‘Topical
                                                    workshop entitled ‘‘Topical                                                       acceptance receipt is on or before that                                                  Dermatological Generic Drug Products:
                                                    Dermatological Generic Drug Products:                                             date.                                                                                    Overcoming Barriers to Development
                                                    Overcoming Barriers to Development
                                                                                                                                      Electronic Submissions                                                                   and Improving Patient Access.’’
                                                    and Improving Patient Access.’’ The
                                                                                                                                                                                                                               Received comments, those filed in a
                                                    purpose of the public workshop is to                                                Submit electronic comments in the                                                      timely manner (see ADDRESSES), will be
                                                    provide an overview of current                                                    following way:                                                                           placed in the docket and, except for
                                                    regulatory science initiatives related to                                           • Federal eRulemaking Portal:                                                          those submitted as ‘‘Confidential
                                                    generic topical dermatological drug                                               https://www.regulations.gov. Follow the                                                  Submissions,’’ publicly viewable at
                                                    products, solicit public input on                                                 instructions for submitting comments.                                                    https://www.regulations.gov or at the
                                                    scientific barriers that may limit patient                                        Comments submitted electronically,                                                       Dockets Management Staff between 9
                                                    access to such drug products, and                                                 including attachments, to https://                                                       a.m. and 4 p.m., Monday through
                                                    discuss approaches to overcome/address                                            www.regulations.gov will be posted to                                                    Friday.
                                                    any such barriers. FDA is seeking public                                          the docket unchanged. Because your                                                          • Confidential Submissions—To
                                                    input from a variety of stakeholders,                                             comment will be made public, you are                                                     submit a comment with confidential
                                                    including industry, academia, patient                                             solely responsible for ensuring that your                                                information that you do not wish to be
                                                    advocates, and professional                                                       comment does not include any                                                             made publicly available, submit your
                                                    associations.
asabaliauskas on DSKBBXCHB2PROD with NOTICES




                                                                                                                                      confidential information that you or a                                                   comments only as a written/paper
                                                    DATES:  The public workshop will be                                               third party may not wish to be posted,                                                   submission. You should submit two
                                                    held on October 20, 2017, from 8:30                                               such as medical information, your or                                                     copies total. One copy will include the
                                                    a.m. to 4:30 p.m., Eastern Standard                                               anyone else’s Social Security number, or                                                 information you claim to be confidential
                                                    Time. Submit either electronic or                                                 confidential business information, such                                                  with a heading or cover note that states
                                                    written comments on this public                                                   as a manufacturing process. Please note                                                  ‘‘THIS DOCUMENT CONTAINS
                                                    workshop by November 20, 2017. See                                                that if you include your name, contact                                                   CONFIDENTIAL INFORMATION.’’ The
                                                    the SUPPLEMENTARY INFORMATION section                                             information, or other information that                                                   Agency will review this copy, including
                                                    for registration date and information.                                            identifies you in the body of your                                                       the claimed confidential information, in


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                                                    46066                        Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices

                                                    its consideration of comments. The                      reproducible. FDA believes that these                 selected for presentation, any
                                                    second copy, which will have the                        BE approaches would benefit from                      presentation materials must be emailed
                                                    claimed confidential information                        public discussion.                                    to GDUFARegulatoryScience@
                                                    redacted/blacked out, will be available                                                                       fda.hhs.gov no later than October 13,
                                                                                                            II. Topics for Discussion at the Public
                                                    for public viewing and posted on                                                                              2017. No commercial or promotional
                                                                                                            Workshop
                                                    https://www.regulations.gov. Submit                                                                           material will be permitted to be
                                                    both copies to the Dockets Management                      This public workshop will focus on a               presented or distributed at the public
                                                    Staff. If you do not wish your name and                 discussion of current regulatory science              workshop.
                                                    contact information to be made publicly                 initiatives intended to foster the                       Streaming webcast of the public
                                                    available, you can provide this                         development of topical dermatological                 workshop: This public workshop will
                                                    information on the cover sheet and not                  generic drug products, examining                      also be webcast. A live webcast of this
                                                    in the body of your comments and you                    alternative BE approaches that may be                 workshop will be viewable at https://
                                                    must identify this information as                       more efficient and less risky than                    collaboration.fda.gov/ogddermaldrug/
                                                    ‘‘confidential.’’ Any information marked                traditional approaches. FDA is also                   on the day of the workshop.
                                                    as ‘‘confidential’’ will not be disclosed               interested in receiving public input                     If you have never attended a Connect
                                                    except in accordance with 21 CFR 10.20                  about any barriers that may limit the use             Pro event before, test your connection at
                                                    and other applicable disclosure law. For                of such alternative BE approaches in the              https://collaboration.fda.gov/common/
                                                    more information about FDA’s posting                    development of topical dermatological                 help/en/support/meeting_test.htm. To
                                                    of comments to public dockets, see 80                   generic drug products. Public input is                get a quick overview of the Connect Pro
                                                    FR 56469, September 18, 2015, or access                 also sought about strategies to overcome              program, visit https://www.adobe.com/
                                                    the information at: https://www.gpo.gov/                these barriers.                                       go/connectpro_overview. FDA has
                                                    fdsys/pkg/FR-2015-09-18/pdf/2015-                       III. Participating in the Public                      verified the Web site addresses in this
                                                    23389.pdf.                                              Workshop                                              document, as of the date this document
                                                       Docket: For access to the docket to                                                                        publishes in the Federal Register, but
                                                                                                               Registration: Persons interested in                Web sites are subject to change over
                                                    read background documents or the
                                                                                                            attending this public workshop must                   time.
                                                    electronic and written/paper comments
                                                                                                            register online at https://                              Transcripts: Please be advised that as
                                                    received, go to https://
                                                                                                            survey.co1.qualtrics.com/jfe/form/SV_                 soon as a transcript of the public
                                                    www.regulations.gov and insert the
                                                                                                            9YQDLZJRjXtYiXz. Please provide                       workshop is available, it will be
                                                    docket number, found in brackets in the
                                                                                                            complete contact information for each                 accessible at https://
                                                    heading of this document, into the
                                                                                                            attendee, including name, title,                      www.regulations.gov. It may be viewed
                                                    ‘‘Search’’ box and follow the prompts
                                                                                                            affiliation, address, email, and                      at the Dockets Management Staff (see
                                                    and/or go to the Dockets Management
                                                                                                            telephone.                                            ADDRESSES). A link to the transcript will
                                                    Staff, 5630 Fishers Lane, Rm. 1061,                        Registration is free and based on
                                                    Rockville, MD 20852.                                                                                          also be available on the internet at
                                                                                                            space availability, with priority given to            https://www.fda.gov/Drugs/NewsEvents/
                                                    FOR FURTHER INFORMATION CONTACT: Sam                    early registrants. Persons interested in
                                                    Raney, Center for Drug Evaluation and                                                                         ucm557252.htm.
                                                                                                            attending this public workshop must
                                                    Research, Food and Drug                                                                                         Dated: September 28, 2017.
                                                                                                            register by October 13, 2017, midnight,
                                                    Administration, 10903 New Hampshire                     Eastern Time. Early registration is                   Anna K. Abram,
                                                    Ave., Bldg. 75, Rm. 4706, Silver Spring,                recommended because seating is                        Deputy Commissioner for Policy, Planning,
                                                    MD 20993, 240–402–7967, email:                                                                                Legislation, and Analysis.
                                                                                                            limited; therefore, FDA may limit the
                                                    Sameersingh.Raney@fda.hhs.gov; or                       number of participants from each                      [FR Doc. 2017–21186 Filed 10–2–17; 8:45 am]
                                                    Markham Luke, Center for Drug                           organization.                                         BILLING CODE 4164–01–P
                                                    Evaluation and Research, Food and                          If you need special accommodations
                                                    Drug Administration, 10903 New                          due to a disability, please contact Sam
                                                    Hampshire Ave., Bldg. 75, Rm. 4712,                     Raney (see FOR FURTHER INFORMATION                    DEPARTMENT OF HEALTH AND
                                                    Silver Spring, MD 20993, 301–796–                       CONTACT) no later than October 13, 2017.              HUMAN SERVICES
                                                    5556, email: Markham.Luke@                                 Requests for Oral Presentations:
                                                    fda.hhs.gov.                                                                                                  Food and Drug Administration
                                                                                                            During online registration you may
                                                    SUPPLEMENTARY INFORMATION:                              indicate if you wish to present during a              [Docket No. FDA–2017–D–5670]
                                                                                                            public comment session, and which
                                                    I. Background                                           topic(s) you wish to address. We will do              Abbreviated New Drug Applications
                                                       The conventional approach to                         our best to accommodate requests to                   Submissions—Amendments To
                                                    establish bioequivalence (BE) for most                  make public comments. Individuals and                 Abbreviated New Drug Applications
                                                    topical dermatological generic drug                     organizations with common interests are               Under the Generic Drug User Fee Act;
                                                    products relies upon clinical endpoint                  urged to consolidate or coordinate their              Draft Guidance for Industry;
                                                    BE studies. The risk of failing to                      presentations, and to request time for a              Availability
                                                    demonstrate BE due to the relative                      joint presentation, or to submit requests             AGENCY:    Food and Drug Administration,
                                                    insensitivity of these clinical endpoint                for designated representatives to                     HHS.
                                                    studies, combined with their burden                     participate in the focused sessions.                  ACTION:   Notice of availability.
asabaliauskas on DSKBBXCHB2PROD with NOTICES




                                                    and length, may represent a barrier to                  Following the close of registration, we
                                                    generic drug development and may                        will determine the amount of time                     SUMMARY:  The Food and Drug
                                                    adversely impact patient access to some                 allotted to each presenter and the                    Administration (FDA or Agency) is
                                                    topical dermatological generic drug                     approximate time each oral presentation               announcing the availability of a draft
                                                    products. FDA is evaluating alternative                 is to begin, and will select and notify               guidance for industry entitled ‘‘ANDA
                                                    BE approaches for topical                               participants by October 16, 2017. All                 Submissions—Amendments to
                                                    dermatological generic drug products,                   requests to make oral presentations                   Abbreviated New Drug Applications
                                                    using methods that are more efficient,                  must be received by the close of                      Under GDUFA.’’ This draft guidance is
                                                    and also more sensitive and                             registration on October 9, 2017. If                   intended to explain to applicants how


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Document Created: 2017-10-03 01:01:47
Document Modified: 2017-10-03 01:01:47
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 October 20, 2017, from 8:30 a.m. to 4:30 p.m., Eastern Standard Time. Submit either electronic or written comments on this public workshop by November 20, 2017. See the SUPPLEMENTARY INFORMATION section for registration date and information.
ContactSam 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, email: [email protected]; or Markham Luke, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4712, Silver Spring, MD 20993, 301-796- 5556, email: [email protected]
FR Citation82 FR 46065 

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