Document ID: FDA-2017-N-6928-0002
Agency: fda
Document Type: Notice
Title: Pediatric Advisory Committee; Establishment of a Public Docket; Request for Comments; Amendment of Notice
Posted Date: 2018-02-16T05:00Z

[Federal Register Volume 83, Number 33 (Friday, February 16, 2018)]
[Notices]
[Pages 7058-7059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03231]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6928]

Pediatric Advisory Committee; Establishment of a Public Docket; 
Request for Comments; 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). This meeting was announced in the Federal Register of January 2, 
2018. The amendment is being made to reflect a change in the Center for 
Devices and Radiological Health (CDRH) products portion of the document 
and to include the topics that will be discussed during the meeting. 
There are no other changes.

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 2, 2018 
(83 FR 125), FDA announced that a meeting

[[Page 7059]]

of the Pediatric Advisory Committee would be held on March 23, 2018.
    FDA will provide updates on the following topics without vote by 
the committee:
     Update regarding labeling change for inhaled 
corticosteroid long-acting [beta]-2 agonists (ICS/LABAs);
     Safety labeling for gadolinium products;
     Overview of the FDA Adverse Event Reporting System (FAERS) 
and reports on reduced or lack of efficacy for certain generic drugs; 
and
     Generic drug approval process; and discussion on the 
differences in the approval process for brand name drugs versus generic 
drugs; exceptions.
    On page 126, in the third column, the CDRH products portion of the 
document is changed to read as follows:
    The PAC will meet to discuss the following products (listed by FDA 
Center):

(2) Center for Devices and Radiological Health
    a. MEDTRONIC ACTIVA DYSTONIA THERAPY (Humanitarian Device Exemption 
(HDE))
    b. LIPOSORBER LA-15 SYSTEM (HDE)

CDRH will update the committee on the regulatory status of a previously 
reviewed HDE.
    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: February 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03231 Filed 2-15-18; 8:45 am]
BILLING CODE 4164-01-P