Document ID: FDA-2019-N-1620-0003
Agency: fda
Document Type: Notice
Title: Meetings: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Amendment of Notice
Posted Date: 2019-06-21T04:00Z

[Federal Register Volume 84, Number 120 (Friday, June 21, 2019)]
[Notices]
[Pages 29212-29213]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13142]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1620]

Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory 
Committee; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
amendment to the notice of meeting of the Pediatric Oncology 
Subcommittee of the Oncologic Drugs Advisory Committee. This meeting 
was announced in the Federal Register of May 6, 2019. The amendment is 
being made to reflect a change in the DATES, Agenda, and Procedure 
portions of the document. There are no other changes.

FOR FURTHER INFORMATION CONTACT: Lauren Tesh Hotaki, 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: ODAC@fda.hhs.gov; 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 May 6, 2019 (84 
FR 19788), FDA announced that a meeting of the Pediatric Oncology 
Subcommittee of the Oncologic Drugs Advisory Committee would be held on 
June 20, 2019. On page 19788, in the first column, the DATES portion of 
the document is changed to read as follows:
    Dates: The meeting will be held on June 20, 2019, from 9 a.m. to 
3:30 p.m.
    On page 19789, in the second column, the second paragraph of the 
Agenda portion of the document is changed to read as follows:
    During the afternoon session, information will be presented to 
gauge investigator interest in exploring potential pediatric 
development plans for one product in early stages of development for 
adult cancer indications. The subcommittee will consider and discuss 
issues concerning diseases to be studied, patient populations to be 
included, and possible study designs in the development of these 
products for pediatric use. The discussion will also provide 
information to the Agency pertinent to the formulation of written

[[Page 29213]]

requests for pediatric studies, if appropriate. The product under 
consideration is ONC201, presentation by Oncoceutics Inc.
    On page 19789, in the third column, the third sentence of the 
Procedure portion of the document is changed to read as follows:
    Oral presentations from the public will be scheduled between 
approximately 10:50 a.m. and 11:20 a.m. and 1:50 p.m. and 2:20 p.m.
    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: June 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13142 Filed 6-20-19; 8:45 am]
 BILLING CODE 4164-01-P