[Federal Register Volume 83, Number 81 (Thursday, April 26, 2018)]
[Notices]
[Pages 18311-18312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-08766]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1439]


Pediatric Advisory Committee and the Endocrinologic and Metabolic 
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.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Pediatric Advisory Committee 
(PAC) and the Endocrinologic and Metabolic Drugs Advisory Committee 
(EMDAC). At least one portion of the meeting will be closed to the 
public. The general function of the committees is to provide advice and 
recommendations to FDA on regulatory issues. FDA is establishing a 
docket for public comments on this document.

DATES: The meeting will be held on May 11, 2018, from 8 a.m. to 6 p.m. 
This is a reschedule of a postponed meeting announced in the Federal 
Register of January 23, 2018 (83 FR 3156), originally scheduled for 
March 22, 2018. An amendment to the Federal Register notice was 
published on March 16, 2018 (83 FR 11755).

ADDRESSES: Tommy Douglas Conference Center, 10000 New Hampshire Ave., 
Silver Spring, MD 20903. Answers to commonly asked questions about FDA 
Advisory Committee meetings may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. Information 
about the Tommy Douglas Conference Center can be accessed at https://www.tommydouglascenter.com.
    FDA is establishing a docket for public comment on this meeting. 
The docket number is FDA-2018-N-1439. The docket will close on May 10, 
2018. Submit either electronic or written comments on this public 
meeting by that date. Please note that late, untimely filed comments 
will not be considered. Electronic comments must be submitted on or 
before May 10, 2018. The https://www.regulations.gov electronic filing 
system will accept comments until midnight Eastern Time at the end of 
May 10, 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 May 4, 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 Docket No. FDA-
2018-N-1439 for ``Pediatric Advisory Committee and the Endocrinologic 
and Metabolic 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 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 the 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.gpo.gov/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: Marieann Brill, Office of the 
Commissioner, Food and Drug

[[Page 18312]]

Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5154, Silver 
Spring, MD 20993, 240-402-3838, 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 Agency'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: On Friday, May 11, 2018, the PAC and EMDAC will meet to 
discuss drug development for the treatment of children with 
achondroplasia. The following topics should be considered for 
discussion: Evidence required to establish dose-response, study design, 
study duration, intended population, and endpoints. In the open 
session, the committee does not intend to discuss any individual 
research programs.
    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: On May 11, 2018, from 12 p.m. to 6 p.m., the meeting is 
open to the public. 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 May 
4, 2018. Oral presentations from the public will be scheduled between 
approximately 1 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 May 4, 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 May 7, 2018.
    Closed Committee Deliberations: On May 11, 2018, from 8 a.m. to 11 
a.m., the meeting will be closed to permit discussion and review of 
trade secret and/or confidential commercial information (5 U.S.C. 
552b(c)(4)). During this session, the committees will discuss the 
premarketing drug development program of an investigational product.
    Persons attending FDA's advisory committee meetings are advised 
that FDA is not responsible for providing access to electrical outlets.
    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 accommodations due to a disability, please 
contact Marieann Brill (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: April 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-08766 Filed 4-25-18; 8:45 am]
 BILLING CODE 4164-01-P


