82_FR_46700 82 FR 46508 - Health Canada and United States Food and Drug Administration Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting and Webcast

82 FR 46508 - Health Canada and United States Food and Drug Administration Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting and Webcast

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 192 (October 5, 2017)

Page Range46508-46509
FR Document2017-21437

The Food and Drug Administration (FDA or Agency) is announcing a regional public meeting entitled ``Health Canada and U.S. Food and Drug Administration Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).'' The purpose of this public meeting is to provide information and solicit public input on the current activities of ICH as well as the upcoming ICH Assembly Meeting and the Expert Working Group Meetings in Geneva, Switzerland, scheduled for November 11 through 16, 2017. The topics to be discussed are the topics for discussion at the forthcoming ICH Assembly Meeting in Geneva.

Federal Register, Volume 82 Issue 192 (Thursday, October 5, 2017)
[Federal Register Volume 82, Number 192 (Thursday, October 5, 2017)]
[Notices]
[Pages 46508-46509]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-21437]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-5017]


Health Canada and United States Food and Drug Administration 
Joint Public Consultation on International Council for Harmonisation of 
Technical Requirements for Pharmaceuticals for Human Use; Public 
Meeting and Webcast

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting and webcast; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
a regional public meeting entitled ``Health Canada and U.S. Food and 
Drug Administration Joint Public Consultation on International Council 
for Harmonisation of Technical Requirements for Pharmaceuticals for 
Human Use (ICH).'' The purpose of this public meeting is to provide 
information and solicit public input on the current activities of ICH 
as well as the upcoming ICH Assembly Meeting and the Expert Working 
Group Meetings in Geneva, Switzerland, scheduled for November 11 
through 16, 2017. The topics to be discussed are the topics for 
discussion at the forthcoming ICH Assembly Meeting in Geneva.

DATES: The public meeting will be held on October 19, 2017, from 9 a.m. 
to 12 noon Eastern Time. Submit either electronic or written comments 
on this public meeting by October 26, 2017. See the SUPPLEMENTARY 
INFORMATION section for registration date and information. Registration 
to attend the meeting and requests for oral presentations must be 
received by October 16, 2017; see the SUPPLEMENTARY INFORMATION section 
for information on how to register for the meeting.

ADDRESSES: The public meeting will be held at the Sir Frederick G. 
Banting Research Centre, 251 Sir Frederick Banting Dr., Ottawa, ON K1Y 
0M1, Canada. It will also be broadcast on the web allowing participants 
to join in person OR via the Web.
    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 October 26, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of October 27, 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-5017 for ``Health Canada and U.S. Food and Drug 
Administration Joint Public Consultation on International Council on 
Harmonisation of Technical Requirements for Pharmaceuticals for Human 
Use; Public

[[Page 46509]]

Meeting.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at http://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, October 12, 2017, 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: Amanda Roache, Food and Drug 
Administration, Center for Drug Evaluation and Research, Office of 
Strategic Programs, 10903 New Hampshire Ave., Bldg. 51, Rm. 1176, 
Silver Spring MD, 20993, 301-796-4548, email: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The ICH, formerly known as the International Conference on 
Harmonisation, was established in 1990 as a joint regulatory/industry 
project to improve, through harmonization, the efficiency of the 
process for developing and registering new medicinal products in 
Europe, Japan, and the United States without compromising the 
regulatory obligations of safety and effectiveness. In 2015 the ICH was 
reformed to make the ICH a true global initiative that expands beyond 
the previous ICH members. More involvement from regulators around the 
world is expected, as they will join their counterparts from Europe, 
Japan, the United States, Canada, and Switzerland as ICH regulatory 
members. The reforms build on a 25-year track record of successful 
delivery of harmonized guidelines for global pharmaceutical 
development, and their regulation. In recent years, many important 
initiatives have been undertaken by regulatory authorities and industry 
associations to promote international harmonization of regulatory 
requirements. FDA has participated in many meetings designed to enhance 
harmonization and is committed to seeking scientifically based 
harmonized technical procedures for pharmaceutical development. One of 
the goals of harmonization is to identify and then reduce differences 
in technical requirements for medical product development among 
regulatory Agencies. ICH was organized to provide an opportunity for 
harmonization initiatives to be developed with input from both 
regulatory and industry representatives. The ICH process has achieved 
significant harmonization of the technical requirements for the 
approval of pharmaceuticals for human use in the ICH regions over the 
past two decades. The current ICH process and structure can be found at 
the following Web site: http://www.ich.org. (FDA has verified the Web 
site addresses as of the date this document publishes in the Federal 
Register, but Web sites are subject to change over time.)

II. Webinar Attendance and Participation

A. Registration

    If you wish to attend the meeting, please register at the following 
Web site: https://healthcanada-usfda_ich_consultation.eventbrite.ca. 
For those attending online, a link will be provided upon registration. 
In person registrations may be limited, so early registration is 
recommended. Registration is free and will be on a first-come, first-
served basis. However, the number of participants from each 
organization may be limited based on space limitations. Registrants 
will receive confirmation once they have been accepted. If you need 
special accommodations because of a disability, please contact Amanda 
Roache (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the 
webinar.

B. Requests for Oral Presentations

    Interested persons may present data, information, or views orally 
or in writing on issues pending at the public webinar. Public oral 
presentations will be scheduled between approximately 11:30 a.m. and 12 
noon. Time allotted for oral presentations may be limited to 5 minutes. 
Those desiring to make oral presentations should notify Amanda Roache 
(see FOR FURTHER INFORMATION CONTACT) by October 12, 2017, and submit a 
brief statement of the general nature of the evidence or arguments they 
wish to present; the names and addresses, telephone number, fax, and 
email of proposed participants; and an indication of the approximate 
time requested to make their presentation. The agenda for the public 
webinar will be made available on the internet at https://www.fda.gov/Drugs/NewsEvents/ucm574251.htm.

    Dated: September 29, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21437 Filed 10-4-17; 8:45 am]
BILLING CODE 4164-01-P



                                               46508                        Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices

                                               Ravo (see FOR FURTHER INFORMATION                         Dated: September 29, 2017.                          filed comments will not be considered.
                                               CONTACT) no later than October 26, 2017.                Anna K. Abram,                                        Electronic comments must be submitted
                                                  Requests for Oral Presentations: When                Deputy Commissioner for Policy, Planning,             on or before October 26, 2017. The
                                               registering, you may indicate if you                    Legislation, and Analysis.                            https://www.regulations.gov electronic
                                               wish to present during a public                         [FR Doc. 2017–21438 Filed 10–4–17; 8:45 am]           filing system will accept comments
                                               comment session or participate in a                     BILLING CODE 4164–01–P                                until midnight Eastern Time at the end
                                               specific session, and which topic(s) you                                                                      of October 27, 2017. Comments received
                                               wish to address. We will do our best to                                                                       by mail/hand delivery/courier (for
                                               accommodate requests to make public                     DEPARTMENT OF HEALTH AND                              written/paper submissions) will be
                                               comments. Individuals and                               HUMAN SERVICES                                        considered timely if they are
                                               organizations with common interests are                                                                       postmarked or the delivery service
                                               urged to consolidate or coordinate their                Food and Drug Administration                          acceptance receipt is on or before that
                                               presentations, and request time for a                   [Docket No. FDA–2017–N–5017]                          date.
                                               joint presentation, or submit requests for                                                                    Electronic Submissions
                                               designated representatives to participate               Health Canada and United States Food
                                               in the focused sessions. Following the                  and Drug Administration Joint Public                    Submit electronic comments in the
                                               close of registration, we will determine                Consultation on International Council                 following way:
                                               the amount of time allotted to each                     for Harmonisation of Technical                          • Federal eRulemaking Portal:
                                               presenter and the approximate time                      Requirements for Pharmaceuticals for                  https://www.regulations.gov. Follow the
                                               each oral presentation is to begin, and                 Human Use; Public Meeting and                         instructions for submitting comments.
                                               will select and notify participants by                  Webcast                                               Comments submitted electronically,
                                               October 27, 2017. All requests to make                                                                        including attachments, to https://
                                               oral presentations must be received by                  AGENCY:    Food and Drug Administration,              www.regulations.gov will be posted to
                                               the close of registration on October 26,                HHS.                                                  the docket unchanged. Because your
                                               2017. If selected for presentation, any                 ACTION:Notice of public meeting and                   comment will be made public, you are
                                               presentation materials must be emailed                  webcast; request for comments.                        solely responsible for ensuring that your
                                               to Cassie Ravo (see FOR FURTHER                                                                               comment does not include any
                                               INFORMATION CONTACT) no later than
                                                                                                       SUMMARY:    The Food and Drug                         confidential information that you or a
                                               October 31, 2017. No commercial or                      Administration (FDA or Agency) is                     third party may not wish to be posted,
                                               promotional material will be permitted                  announcing a regional public meeting                  such as medical information, your or
                                               to be presented or distributed at the                   entitled ‘‘Health Canada and U.S. Food                anyone else’s Social Security number, or
                                               public meeting.                                         and Drug Administration Joint Public                  confidential business information, such
                                                                                                       Consultation on International Council                 as a manufacturing process. Please note
                                                  Streaming Webcast of the Public
                                                                                                       for Harmonisation of Technical                        that if you include your name, contact
                                               Meeting: This public meeting will also
                                                                                                       Requirements for Pharmaceuticals for                  information, or other information that
                                               be webcast.
                                                                                                       Human Use (ICH).’’ The purpose of this                identifies you in the body of your
                                                  Event: AGDUFA III Public Meeting.
                                                                                                       public meeting is to provide information              comments, that information will be
                                               Event address for attendees: https://
                                                                                                       and solicit public input on the current               posted on https://www.regulations.gov.
                                               fda.webex.com/fda/onstage/
                                                                                                       activities of ICH as well as the                        • If you want to submit a comment
                                               g.php?MTID=ec1c356734bcf010b59
                                                                                                       upcoming ICH Assembly Meeting and                     with confidential information that you
                                               e0b885726ccad0. Date and time:
                                                                                                       the Expert Working Group Meetings in                  do not wish to be made available to the
                                               Thursday, November 2, 2017, 1 p.m.
                                                                                                       Geneva, Switzerland, scheduled for                    public, submit the comment as a
                                               Eastern Daylight Time (New York,
                                                                                                       November 11 through 16, 2017. The                     written/paper submission and in the
                                               GMT–4). Duration: 3 hours. Event
                                                                                                       topics to be discussed are the topics for             manner detailed (see ‘‘Written/Paper
                                               number: 817 527 611. Event password:
                                                                                                       discussion at the forthcoming ICH                     Submissions’’ and ‘‘Instructions’’).
                                               110217. Teleconference: Provide your
                                                                                                       Assembly Meeting in Geneva.
                                               number when you join the event to                                                                             Written/Paper Submissions
                                               receive a call back. (1) Call one of the                DATES: The public meeting will be held
                                                                                                       on October 19, 2017, from 9 a.m. to 12                  Submit written/paper submissions as
                                               following numbers: Local: 1–301–796–                                                                          follows:
                                                                                                       noon Eastern Time. Submit either
                                               7777; toll free: 1–855–828–1770. (2)
                                                                                                       electronic or written comments on this                  • Mail/Hand delivery/Courier (for
                                               Follow the instructions that you hear on                                                                      written/paper submissions): Dockets
                                               the phone. Cisco Unified MeetingPlace                   public meeting by October 26, 2017. See
                                                                                                       the SUPPLEMENTARY INFORMATION section                 Management Staff (HFA–305), Food and
                                               meeting ID: 817 527 611.                                                                                      Drug Administration, 5630 Fishers
                                                  FDA has verified the Web site                        for registration date and information.
                                                                                                       Registration to attend the meeting and                Lane, Rm. 1061, Rockville, MD 20852.
                                               addresses in this document, as of the                                                                           • For written/paper comments
                                               date this document publishes in the                     requests for oral presentations must be
                                                                                                                                                             submitted to the Dockets Management
                                               Federal Register, but Web sites are                     received by October 16, 2017; see the
                                                                                                                                                             Staff, FDA will post your comment, as
                                               subject to change over time.                            SUPPLEMENTARY INFORMATION section for
                                                                                                                                                             well as any attachments, except for
                                                  Transcripts: Please be advised that as               information on how to register for the
                                                                                                                                                             information submitted, marked and
                                               soon as a transcript of the public                      meeting.
                                                                                                                                                             identified, as confidential, if submitted
                                               meeting is available, it will be accessible             ADDRESSES:   The public meeting will be               as detailed in ‘‘Instructions.’’
                                               at https://www.regulations.gov. It may                  held at the Sir Frederick G. Banting                    Instructions: All submissions received
ethrower on DSK3G9T082PROD with NOTICES




                                               be viewed at the Dockets Management                     Research Centre, 251 Sir Frederick                    must include the Docket No. FDA–
                                               Staff (see ADDRESSES). A link to the                    Banting Dr., Ottawa, ON K1Y 0M1,                      2017–N–5017 for ‘‘Health Canada and
                                               transcript will also be available on the                Canada. It will also be broadcast on the              U.S. Food and Drug Administration
                                               internet at https://www.fda.gov/                        web allowing participants to join in                  Joint Public Consultation on
                                               ForIndustry/UserFees/AnimalGeneric                      person OR via the Web.                                International Council on Harmonisation
                                               DrugUserFeeActAGDUFA/                                     You may submit comments as                          of Technical Requirements for
                                               ucm270232.htm.                                          follows: Please note that late, untimely              Pharmaceuticals for Human Use; Public


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                                                                            Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices                                                46509

                                               Meeting.’’ Received comments will be                    I. Background                                         number of participants from each
                                               placed in the docket and, except for                       The ICH, formerly known as the                     organization may be limited based on
                                               those submitted as ‘‘Confidential                       International Conference on                           space limitations. Registrants will
                                               Submissions,’’ publicly viewable at                     Harmonisation, was established in 1990                receive confirmation once they have
                                               http://www.regulations.gov or at the                    as a joint regulatory/industry project to             been accepted. If you need special
                                               Dockets Management Staff between 9                      improve, through harmonization, the                   accommodations because of a disability,
                                               a.m. and 4 p.m., Monday through                         efficiency of the process for developing              please contact Amanda Roache (see FOR
                                               Friday.                                                 and registering new medicinal products                FURTHER INFORMATION CONTACT) at least 7
                                                                                                       in Europe, Japan, and the United States               days before the webinar.
                                                  • Confidential Submissions—To
                                               submit a comment with confidential                      without compromising the regulatory                   B. Requests for Oral Presentations
                                               information that you do not wish to be                  obligations of safety and effectiveness.
                                                                                                                                                               Interested persons may present data,
                                               made publicly available, submit your                    In 2015 the ICH was reformed to make
                                                                                                                                                             information, or views orally or in
                                               comments only as a written/paper                        the ICH a true global initiative that
                                                                                                                                                             writing on issues pending at the public
                                                                                                       expands beyond the previous ICH
                                               submission. You should submit two                                                                             webinar. Public oral presentations will
                                                                                                       members. More involvement from
                                               copies total. One copy will include the                                                                       be scheduled between approximately
                                                                                                       regulators around the world is expected,
                                               information you claim to be confidential                                                                      11:30 a.m. and 12 noon. Time allotted
                                                                                                       as they will join their counterparts from
                                               with a heading or cover note that states                                                                      for oral presentations may be limited to
                                                                                                       Europe, Japan, the United States,
                                               ‘‘THIS DOCUMENT CONTAINS                                                                                      5 minutes. Those desiring to make oral
                                                                                                       Canada, and Switzerland as ICH
                                               CONFIDENTIAL INFORMATION.’’ The                                                                               presentations should notify Amanda
                                                                                                       regulatory members. The reforms build
                                               Agency will review this copy, including                                                                       Roache (see FOR FURTHER INFORMATION
                                                                                                       on a 25-year track record of successful
                                               the claimed confidential information, in                                                                      CONTACT) by October 12, 2017, and
                                                                                                       delivery of harmonized guidelines for
                                               its consideration of comments. The                                                                            submit a brief statement of the general
                                                                                                       global pharmaceutical development,
                                               second copy, which will have the                                                                              nature of the evidence or arguments
                                                                                                       and their regulation. In recent years,
                                               claimed confidential information                                                                              they wish to present; the names and
                                                                                                       many important initiatives have been
                                               redacted/blacked out, will be available                                                                       addresses, telephone number, fax, and
                                                                                                       undertaken by regulatory authorities
                                               for public viewing and posted on                                                                              email of proposed participants; and an
                                                                                                       and industry associations to promote
                                               https://www.regulations.gov. Submit                                                                           indication of the approximate time
                                                                                                       international harmonization of
                                               both copies to the Dockets Management                                                                         requested to make their presentation.
                                                                                                       regulatory requirements. FDA has
                                               Staff. If you do not wish your name and                 participated in many meetings designed                The agenda for the public webinar will
                                               contact information to be made publicly                 to enhance harmonization and is                       be made available on the internet at
                                               available, you can provide this                         committed to seeking scientifically                   https://www.fda.gov/Drugs/NewsEvents/
                                               information on the cover sheet and not                  based harmonized technical procedures                 ucm574251.htm.
                                               in the body of your comments and you                    for pharmaceutical development. One of                  Dated: September 29, 2017.
                                               must identify this information as                       the goals of harmonization is to identify             Anna K. Abram,
                                               ‘‘confidential.’’ Any information marked                and then reduce differences in technical              Deputy Commissioner for Policy, Planning,
                                               as ‘‘confidential’’ will not be disclosed               requirements for medical product                      Legislation, and Analysis.
                                               except in accordance with 21 CFR 10.20                  development among regulatory                          [FR Doc. 2017–21437 Filed 10–4–17; 8:45 am]
                                               and other applicable disclosure law. For                Agencies. ICH was organized to provide                BILLING CODE 4164–01–P
                                               more information about FDA’s posting                    an opportunity for harmonization
                                               of comments to public dockets, see 80                   initiatives to be developed with input
                                               FR 56469, October 12, 2017, or access                   from both regulatory and industry                     DEPARTMENT OF HEALTH AND
                                               the information at: https://www.gpo.gov/                representatives. The ICH process has                  HUMAN SERVICES
                                               fdsys/pkg/FR-2015-09-18/pdf/2015-                       achieved significant harmonization of
                                                                                                       the technical requirements for the                    Health Resources and Services
                                               23389.pdf.                                                                                                    Administration
                                                                                                       approval of pharmaceuticals for human
                                                  Docket: For access to the docket to                  use in the ICH regions over the past two              [OMB No. 0906–xxxx—New]
                                               read background documents or the                        decades. The current ICH process and
                                               electronic and written/paper comments                   structure can be found at the following               Agency Information Collection
                                               received, go to https://                                Web site: http://www.ich.org. (FDA has                Activities: Submission to OMB for
                                               www.regulations.gov and insert the                      verified the Web site addresses as of the             Review and Approval; Public Comment
                                               docket number, found in brackets in the                 date this document publishes in the                   Request; Information Collection
                                               heading of this document, into the                      Federal Register, but Web sites are                   Request Title: Scientific Registry of
                                               ‘‘Search’’ box and follow the prompts                   subject to change over time.)                         Transplant Recipients Information
                                               and/or go to the Dockets Management                                                                           Collection Effort for Potential Donors
                                               Staff, 5630 Fishers Lane, Rm. 1061,                     II. Webinar Attendance and
                                                                                                                                                             for Living Organ Donation
                                               Rockville, MD 20852.                                    Participation
                                                                                                       A. Registration                                       AGENCY: Health Resources and Services
                                               FOR FURTHER INFORMATION CONTACT:                                                                              Administration (HRSA), Department of
                                               Amanda Roache, Food and Drug                               If you wish to attend the meeting,                 Health and Human Services (HHS).
                                               Administration, Center for Drug                         please register at the following Web site:            ACTION: Notice.
                                               Evaluation and Research, Office of                      https://healthcanada-usfda_ich_
ethrower on DSK3G9T082PROD with NOTICES




                                               Strategic Programs, 10903 New                           consultation.eventbrite.ca. For those                 SUMMARY:  In compliance with the
                                               Hampshire Ave., Bldg. 51, Rm. 1176,                     attending online, a link will be provided             Paperwork Reduction Act of 1995,
                                               Silver Spring MD, 20993, 301–796–                       upon registration. In person                          HRSA has submitted an Information
                                               4548, email: Amanda.Roache@                             registrations may be limited, so early                Collection Request (ICR) to the Office of
                                               fda.hhs.gov.                                            registration is recommended.                          Management and Budget (OMB) for
                                                                                                       Registration is free and will be on a first-          review and approval. Comments
                                               SUPPLEMENTARY INFORMATION:                              come, first-served basis. However, the                submitted during the first public review


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Document Created: 2017-10-05 00:53:25
Document Modified: 2017-10-05 00:53:25
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 meeting and webcast; request for comments.
DatesThe public meeting will be held on October 19, 2017, from 9 a.m. to 12 noon Eastern Time. Submit either electronic or written comments on this public meeting by October 26, 2017. See the SUPPLEMENTARY INFORMATION section for registration date and information. Registration to attend the meeting and requests for oral presentations must be received by October 16, 2017; see the SUPPLEMENTARY INFORMATION section for information on how to register for the meeting.
ContactAmanda Roache, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Strategic Programs, 10903 New Hampshire Ave., Bldg. 51, Rm. 1176, Silver Spring MD, 20993, 301-796-4548, email: [email protected]
FR Citation82 FR 46508 

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