Document ID: FDA-2018-N-0045-0054
Agency: fda
Document Type: Notice
Title: Pediatric Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee; Amendment of Notice
Posted Date: 2018-03-16T04:00Z

[Federal Register Volume 83, Number 52 (Friday, March 16, 2018)]
[Notices]
[Pages 11755-11756]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05413]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0045]

Pediatric Advisory Committee and the Endocrinologic and Metabolic 
Drugs Advisory Committee; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
amendment to the notice of meeting of the Pediatric Advisory Committee 
(PAC) and the Endocrinologic and Metabolic Drugs Advisory Committee 
(EMDAC). This meeting was announced in the Federal Register of January 
23, 2018. The amendment is being made to reflect a change in the agenda 
for the open session of the meeting and to extend the amount of time 
allotted for the closed session. There are no other changes.

DATES: The meeting will be held on March 22, 2018, from 8 a.m. to 6 
p.m.

FOR FURTHER INFORMATION CONTACT: Marieann Brill, Office of the 
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 32, Rm. 5154, Silver Spring, MD 20993, 240-402-3838, 
[email protected], or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington, DC area). Please call 
the Information Line for up-to-date information on this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 23, 2018 
(83 FR 3156), FDA announced that a meeting of the PAC and EMDAC would 
be held on March 22, 2018.

[[Page 11756]]

    FDA is revising the first paragraph of the agenda for that meeting 
to read as follows:
    On Thursday, March 22, 2018, the PAC and EMDAC will meet to discuss 
drug development for the treatment of children with achondroplasia 
(ACH). 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 is also changing the meeting procedure and closed committee 
deliberations as follows:
    Procedure: On March 22, 2018, from 12 p.m. to 6 p.m., the meeting 
is open to the public.
    Closed Committee Deliberations: On March 22, 2018, from 8 a.m. to 
11 a.m., the meeting will be closed to permit committee review and 
discussion of trade secret and/or confidential commercial information.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: March 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-05413 Filed 3-15-18; 8:45 am]
 BILLING CODE 4164-01-P