83_FR_13013 83 FR 12955 - Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

83 FR 12955 - Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 58 (March 26, 2018)

Page Range12955-12956
FR Document2018-06040

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Antimicrobial Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

Federal Register, Volume 83 Issue 58 (Monday, March 26, 2018)
[Federal Register Volume 83, Number 58 (Monday, March 26, 2018)]
[Notices]
[Pages 12955-12956]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-06040]



[[Page 12955]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1044]


Antimicrobial Drugs Advisory Committee; Notice of Meeting; 
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Antimicrobial Drugs Advisory 
Committee. The general function of the committee is to provide advice 
and recommendations to FDA on regulatory issues. The meeting will be 
open to the public. FDA is establishing a docket for public comment on 
this document.

DATES: The meeting will be held on May 2, 2018, from 8:30 a.m. to 4 
p.m.

ADDRESSES: DoubleTree by Hilton Hotel Bethesda--Washington, DC, Grand 
Ballroom, 8120 Wisconsin Ave., Bethesda, MD 20814-3624. The hotel and 
conference center's telephone number is 301-652-2000. Answers to 
commonly asked questions about FDA Advisory Committee meetings, 
including information regarding special accommodations due to a 
disability, visitor parking, and transportation, may be accessed at: 
https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. Information about the DoubleTree by Hilton Hotel 
Bethesda--Washington, DC Hotel and Conference Center can be accessed 
at: http://doubletree3.hilton.com/en/hotels/maryland/doubletree-by-hilton-hotel-bethesda-washington-dc-WASBHDT/index.html.
    FDA is establishing a docket for public comment on this meeting. 
The docket number is FDA-2018-N-1044. The docket will close on April 
30, 2018. Submit either electronic or written comments on this public 
meeting by April 30, 2018. Please note that late, untimely filed 
comments will not be considered. Electronic comments must be submitted 
on or before April 30, 2018. The https://www.regulations.gov electronic 
filing system will accept comments until midnight Eastern Time at the 
end of April 30, 2018. Comments received by mail/hand delivery/courier 
(for written/paper submissions) will be considered timely if they are 
postmarked or the delivery service acceptance receipt is on or before 
that date.
    Comments received on or before April 17, 2018, will be provided to 
the committee. Comments received after that date will be taken into 
consideration by FDA.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): 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-2018-N-1044 for ``Antimicrobial Drugs Advisory Committee; Notice of 
Meeting; Establishment of a Public Docket; Request for Comments.'' 
Received comments, those filed in a timely manner (see ADDRESSES), will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review 
this copy, including the claimed confidential information, in its 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://www.regulations.gov. Submit both 
copies to the Dockets Management Staff. If you do not wish your name 
and contact information to be made publicly available, you can provide 
this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Cindy Chee, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, Fax: 
301-847-8533, email: [email protected], or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area). A notice in the Federal Register about last minute modifications 
that impact a previously announced advisory committee meeting cannot 
always be published quickly enough to provide timely notice. Therefore, 
you should always check the

[[Page 12956]]

FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm and 
scroll down to the appropriate advisory committee meeting link, or call 
the advisory committee information line to learn about possible 
modifications before coming to the meeting.

SUPPLEMENTARY INFORMATION: 
    Agenda: The committee will discuss new drug application (NDA) 
210303 for plazomicin, sponsored by Achaogen, Inc., for the proposed 
indications for the treatment of complicated urinary tract infections 
and blood stream infections in adults.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its website prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's website after the meeting. Background material is 
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before 
April 17, 2018. Oral presentations from the public will be scheduled 
between approximately 1:30 p.m. and 2:30 p.m. Those individuals 
interested in making formal oral presentations should notify the 
contact person and submit a brief statement of the general nature of 
the evidence or arguments they wish to present, the names and addresses 
of proposed participants, and an indication of the approximate time 
requested to make their presentation on or before April 9, 2018. Time 
allotted for each presentation may be limited. If the number of 
registrants requesting to speak is greater than can be reasonably 
accommodated during the scheduled open public hearing session, FDA may 
conduct a lottery to determine the speakers for the scheduled open 
public hearing session. The contact person will notify interested 
persons regarding their request to speak by April 10, 2018.
    Persons attending FDA's advisory committee meetings are advised 
that FDA is not responsible for providing access to electrical outlets.
    For press inquiries, please contact the Office of Media Affairs at 
[email protected]s.gov or 301-796-4540.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require special accommodations due to a 
disability, please contact Cindy Chee (see FOR FURTHER INFORMATION 
CONTACT) at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: March 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06040 Filed 3-23-18; 8:45 am]
 BILLING CODE 4164-01-P



                                                                              Federal Register / Vol. 83, No. 58 / Monday, March 26, 2018 / Notices                                            12955

                                                DEPARTMENT OF HEALTH AND                                postmarked or the delivery service                    https://www.regulations.gov or at the
                                                HUMAN SERVICES                                          acceptance receipt is on or before that               Dockets Management Staff between 9
                                                                                                        date.                                                 a.m. and 4 p.m., Monday through
                                                Food and Drug Administration                              Comments received on or before April                Friday.
                                                [Docket No. FDA–2018–N–1044]
                                                                                                        17, 2018, will be provided to the                        • Confidential Submissions—To
                                                                                                        committee. Comments received after                    submit a comment with confidential
                                                Antimicrobial Drugs Advisory                            that date will be taken into                          information that you do not wish to be
                                                Committee; Notice of Meeting;                           consideration by FDA.                                 made publicly available, submit your
                                                Establishment of a Public Docket;                         You may submit comments as                          comments only as a written/paper
                                                Request for Comments                                    follows:                                              submission. You should submit two
                                                                                                        Electronic Submissions                                copies total. One copy will include the
                                                AGENCY:    Food and Drug Administration,                                                                      information you claim to be confidential
                                                HHS.                                                      Submit electronic comments in the                   with a heading or cover note that states
                                                ACTION: Notice; establishment of a                      following way:                                        ‘‘THIS DOCUMENT CONTAINS
                                                public docket; request for comments.                      • Federal eRulemaking Portal:                       CONFIDENTIAL INFORMATION.’’ FDA
                                                                                                        https://www.regulations.gov. Follow the               will review this copy, including the
                                                SUMMARY:   The Food and Drug                            instructions for submitting comments.                 claimed confidential information, in its
                                                Administration (FDA) announces a                        Comments submitted electronically,                    consideration of comments. The second
                                                forthcoming public advisory committee                   including attachments, to https://                    copy, which will have the claimed
                                                meeting of the Antimicrobial Drugs                      www.regulations.gov will be posted to                 confidential information redacted/
                                                Advisory Committee. The general                         the docket unchanged. Because your                    blacked out, will be available for public
                                                function of the committee is to provide                 comment will be made public, you are                  viewing and posted on https://
                                                advice and recommendations to FDA on                    solely responsible for ensuring that your             www.regulations.gov. Submit both
                                                regulatory issues. The meeting will be                  comment does not include any                          copies to the Dockets Management Staff.
                                                open to the public. FDA is establishing                 confidential information that you or a                If you do not wish your name and
                                                a docket for public comment on this                     third party may not wish to be posted,                contact information to be made publicly
                                                document.                                               such as medical information, your or                  available, you can provide this
                                                DATES:  The meeting will be held on May                 anyone else’s Social Security number, or              information on the cover sheet and not
                                                2, 2018, from 8:30 a.m. to 4 p.m.                       confidential business information, such               in the body of your comments and you
                                                                                                        as a manufacturing process. Please note               must identify this information as
                                                ADDRESSES: DoubleTree by Hilton Hotel
                                                                                                        that if you include your name, contact                ‘‘confidential.’’ Any information marked
                                                Bethesda—Washington, DC, Grand                          information, or other information that
                                                Ballroom, 8120 Wisconsin Ave.,                                                                                as ‘‘confidential’’ will not be disclosed
                                                                                                        identifies you in the body of your                    except in accordance with 21 CFR 10.20
                                                Bethesda, MD 20814–3624. The hotel                      comments, that information will be
                                                and conference center’s telephone                                                                             and other applicable disclosure law. For
                                                                                                        posted on https://www.regulations.gov.                more information about FDA’s posting
                                                number is 301–652–2000. Answers to                        • If you want to submit a comment
                                                commonly asked questions about FDA                                                                            of comments to public dockets, see 80
                                                                                                        with confidential information that you
                                                Advisory Committee meetings,                                                                                  FR 56469, September 18, 2015, or access
                                                                                                        do not wish to be made available to the
                                                including information regarding special                                                                       the information at: https://www.gpo.gov/
                                                                                                        public, submit the comment as a
                                                accommodations due to a disability,                                                                           fdsys/pkg/FR-2015-09-18/pdf/2015-
                                                                                                        written/paper submission and in the
                                                visitor parking, and transportation, may                                                                      23389.pdf.
                                                                                                        manner detailed (see ‘‘Written/Paper
                                                be accessed at: https://www.fda.gov/                                                                             Docket: For access to the docket to
                                                                                                        Submissions’’ and ‘‘Instructions’’).
                                                AdvisoryCommittees/AboutAdvisory                                                                              read background documents or the
                                                Committees/ucm408555.htm.                               Written/Paper Submissions                             electronic and written/paper comments
                                                Information about the DoubleTree by                       Submit written/paper submissions as                 received, go to https://
                                                Hilton Hotel Bethesda—Washington, DC                    follows:                                              www.regulations.gov and insert the
                                                Hotel and Conference Center can be                        • Mail/Hand delivery/Courier (for                   docket number, found in brackets in the
                                                accessed at: http://                                    written/paper submissions): Dockets                   heading of this document, into the
                                                doubletree3.hilton.com/en/hotels/                       Management Staff (HFA–305), Food and                  ‘‘Search’’ box and follow the prompts
                                                maryland/doubletree-by-hilton-hotel-                    Drug Administration, 5630 Fishers                     and/or go to the Dockets Management
                                                bethesda-washington-dc-WASBHDT/                         Lane, Rm. 1061, Rockville, MD 20852.                  Staff, 5630 Fishers Lane, Rm. 1061,
                                                index.html.                                               • For written/paper comments                        Rockville, MD 20852.
                                                   FDA is establishing a docket for                     submitted to the Dockets Management                   FOR FURTHER INFORMATION CONTACT:
                                                public comment on this meeting. The                     Staff, FDA will post your comment, as                 Cindy Chee, Center for Drug Evaluation
                                                docket number is FDA–2018–N–1044.                       well as any attachments, except for                   and Research, Food and Drug
                                                The docket will close on April 30, 2018.                information submitted, marked and                     Administration, 10903 New Hampshire
                                                Submit either electronic or written                     identified, as confidential, if submitted             Ave., Bldg. 31, Rm. 2417, Silver Spring,
                                                comments on this public meeting by                      as detailed in ‘‘Instructions.’’                      MD 20993–0002, 301–796–9001, Fax:
                                                April 30, 2018. Please note that late,                    Instructions: All submissions received              301–847–8533, email: AMDAC@
                                                untimely filed comments will not be                     must include the Docket No. FDA–                      fda.hhs.gov, or FDA Advisory
                                                considered. Electronic comments must                    2018–N–1044 for ‘‘Antimicrobial Drugs                 Committee Information Line, 1–800–
                                                be submitted on or before April 30,                     Advisory Committee; Notice of Meeting;                741–8138 (301–443–0572 in the
sradovich on DSK3GMQ082PROD with NOTICES




                                                2018. The https://www.regulations.gov                   Establishment of a Public Docket;                     Washington, DC area). A notice in the
                                                electronic filing system will accept                    Request for Comments.’’ Received                      Federal Register about last minute
                                                comments until midnight Eastern Time                    comments, those filed in a timely                     modifications that impact a previously
                                                at the end of April 30, 2018. Comments                  manner (see ADDRESSES), will be placed                announced advisory committee meeting
                                                received by mail/hand delivery/courier                  in the docket and, except for those                   cannot always be published quickly
                                                (for written/paper submissions) will be                 submitted as ‘‘Confidential                           enough to provide timely notice.
                                                considered timely if they are                           Submissions,’’ publicly viewable at                   Therefore, you should always check the


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                                                12956                         Federal Register / Vol. 83, No. 58 / Monday, March 26, 2018 / Notices

                                                FDA’s website at https://www.fda.gov/                   meetings and will make every effort to                Musculoskeletal and Skin Diseases Research,
                                                AdvisoryCommittees/default.htm and                      accommodate persons with disabilities.                National Institutes of Health, HHS)
                                                scroll down to the appropriate advisory                 If you require special accommodations                   Dated: March 20, 2018.
                                                committee meeting link, or call the                     due to a disability, please contact Cindy             Sylvia L. Neal,
                                                advisory committee information line to                  Chee (see FOR FURTHER INFORMATION                     Program Analyst, Office of Federal Advisory
                                                learn about possible modifications                      CONTACT) at least 7 days in advance of                Committee Policy.
                                                before coming to the meeting.                           the meeting.                                          [FR Doc. 2018–05991 Filed 3–23–18; 8:45 am]
                                                SUPPLEMENTARY INFORMATION:                                 FDA is committed to the orderly                    BILLING CODE 4140–01–P
                                                   Agenda: The committee will discuss                   conduct of its advisory committee
                                                new drug application (NDA) 210303 for                   meetings. Please visit our website at
                                                plazomicin, sponsored by Achaogen,                      https://www.fda.gov/Advisory                          DEPARTMENT OF HEALTH AND
                                                Inc., for the proposed indications for the              Committees/AboutAdvisoryCommittees/                   HUMAN SERVICES
                                                treatment of complicated urinary tract                  ucm111462.htm for procedures on
                                                infections and blood stream infections                  public conduct during advisory                        National Institutes of Health
                                                in adults.                                              committee meetings.
                                                   FDA intends to make background                          Notice of this meeting is given under              Office of the Director; Notice of Charter
                                                material available to the public no later               the Federal Advisory Committee Act (5                 Renewal
                                                than 2 business days before the meeting.                U.S.C. app. 2).                                          In accordance with Title 41 of the
                                                If FDA is unable to post the background                   Dated: March 20, 2018.                              U.S. Code of Federal Regulations,
                                                material on its website prior to the                                                                          Section 102–3.65(a), notice is hereby
                                                                                                        Leslie Kux,
                                                meeting, the background material will                                                                         given that the Charter for the National
                                                be made publicly available at the                       Associate Commissioner for Policy.
                                                                                                        [FR Doc. 2018–06040 Filed 3–23–18; 8:45 am]
                                                                                                                                                              Science Advisory Board for Biosecurity
                                                location of the advisory committee                                                                            will be renewed for an additional two-
                                                meeting, and the background material                    BILLING CODE 4164–01–P
                                                                                                                                                              year period on April 7, 2018.
                                                will be posted on FDA’s website after                                                                            It is determined that the National
                                                the meeting. Background material is                                                                           Science Advisory Board for Biosecurity
                                                available at https://www.fda.gov/                       DEPARTMENT OF HEALTH AND
                                                                                                        HUMAN SERVICES                                        is in the public interest in connection
                                                AdvisoryCommittees/Calendar/                                                                                  with the performance of duties imposed
                                                default.htm. Scroll down to the                                                                               on the National Institutes of Health by
                                                                                                        National Institutes of Health
                                                appropriate advisory committee meeting                                                                        law, and that these duties can best be
                                                link.                                                   National Institute of Arthritis and                   performed through the advice and
                                                   Procedure: Interested persons may                    Musculoskeletal and Skin Diseases;                    counsel of this group.
                                                present data, information, or views,                    Notice to Close Meeting                                  Inquiries may be directed to Claire
                                                orally or in writing, on issues pending                                                                       Harris, Acting Director, Office of Federal
                                                before the committee. Written                             Pursuant to section 10(d) of the                    Advisory Committee Policy, Office of
                                                submissions may be made to the contact                  Federal Advisory Committee Act, as                    the Director, National Institutes of
                                                person on or before April 17, 2018. Oral                amended, notice is hereby given of the                Health, 6701 Democracy Boulevard,
                                                presentations from the public will be                   following meeting.                                    Suite 1000, Bethesda, Maryland 20892
                                                scheduled between approximately 1:30                      The meeting will be closed to the                   (Mail code 4875), harriscl@nih.gov or
                                                p.m. and 2:30 p.m. Those individuals                    public in accordance with the                         Telephone (301) 496–2123.
                                                interested in making formal oral                        provisions set forth in sections
                                                presentations should notify the contact                 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,              Dated: March 20, 2018.
                                                person and submit a brief statement of                  as amended. The grant applications and                David Clary,
                                                the general nature of the evidence or                   the discussions could disclose                        Program Analyst, Office of Federal Advisory
                                                arguments they wish to present, the                     confidential trade secrets or commercial              Committee Policy.
                                                names and addresses of proposed                         property such as patentable material,                 [FR Doc. 2018–05992 Filed 3–23–18; 8:45 am]
                                                participants, and an indication of the                  and personal information concerning                   BILLING CODE 4140–01–P
                                                approximate time requested to make                      individuals associated with the grant
                                                their presentation on or before April 9,                applications, the disclosure of which
                                                2018. Time allotted for each                            would constitute a clearly unwarranted                DEPARTMENT OF HEALTH AND
                                                presentation may be limited. If the                     invasion of personal privacy.                         HUMAN SERVICES
                                                number of registrants requesting to                       Name of Committee: National Institute of            National Institutes of Health
                                                speak is greater than can be reasonably                 Arthritis and Musculoskeletal and Skin
                                                accommodated during the scheduled                       Diseases Special Emphasis Panel; NIAMS                Center for Scientific Review; Notice of
                                                open public hearing session, FDA may                    Loan Repayment Review.                                Closed Meetings
                                                conduct a lottery to determine the                        Date: April 13, 2018.
                                                speakers for the scheduled open public                    Time: 8:00 a.m. to 5:00 p.m.                          Pursuant to section 10(d) of the
                                                hearing session. The contact person will                  Agenda: To review and evaluate contract             Federal Advisory Committee Act, as
                                                notify interested persons regarding their               proposals.                                            amended, notice is hereby given of the
                                                                                                          Place: National Institute of Health/NIAMS,          following meetings.
                                                request to speak by April 10, 2018.
                                                                                                        6701 Democracy Boulevard, Bethesda, MD                  The meetings will be closed to the
                                                   Persons attending FDA’s advisory                     20892.                                                public in accordance with the
sradovich on DSK3GMQ082PROD with NOTICES




                                                committee meetings are advised that                       Contact Person: Kan Ma, Ph.D., Scientific
                                                FDA is not responsible for providing                    Review Officer, National Institute Arthritis,
                                                                                                                                                              provisions set forth in sections
                                                access to electrical outlets.                           Musculoskeletal, and Skin Diseases, NIH,              552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                                   For press inquiries, please contact the              6701 Democracy Blvd., Suite 814, Bethesda,            as amended. The grant applications and
                                                Office of Media Affairs at fdaoma@                      MD 20892, (301) 451–4838, mak2@                       the discussions could disclose
                                                fda.hhs.gov or 301–796–4540.                            mail.nih.gov.                                         confidential trade secrets or commercial
                                                   FDA welcomes the attendance of the                   (Catalogue of Federal Domestic Assistance             property such as patentable material,
                                                public at its advisory committee                        Program Nos. 93.846, Arthritis and                    and personal information concerning


                                           VerDate Sep<11>2014   16:38 Mar 23, 2018   Jkt 244001   PO 00000   Frm 00019   Fmt 4703   Sfmt 4703   E:\FR\FM\26MRN1.SGM   26MRN1



Document Created: 2018-03-24 01:00:01
Document Modified: 2018-03-24 01:00:01
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; establishment of a public docket; request for comments.
DatesThe meeting will be held on May 2, 2018, from 8:30 a.m. to 4 p.m.
ContactCindy Chee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, Fax: 301-847-8533, email: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.
FR Citation83 FR 12955 

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