Document ID: FDA-2020-N-1153-0002
Agency: fda
Document Type: Notice
Title: Post-Marketing Pediatric-Focused Product Safety Reviews; Establishment of a Public Docket; Request for Comments; Correction
Posted Date: 2020-09-15T04:00Z

[Federal Register Volume 85, Number 179 (Tuesday, September 15, 2020)]
[Notices]
[Page 57217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20329]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1153]

Post-Marketing Pediatric-Focused Product Safety Reviews; 
Establishment of a Public Docket; Request for Comments; Correction

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register of September 2, 2020. The 
document announced the availability of post-marketing pediatric-focused 
safety reviews of products posted between September 23, 2019, and 
September 1, 2020, on FDA's website but not presented at the September 
15, 2020, Pediatric Advisory Committee meeting. The document was 
published with the incorrect product name for one of the post-marketing 
pediatric-focused safety reviews listed under Center for Biologics 
Evaluation and Research. This document corrects that error.

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.

SUPPLEMENTARY INFORMATION:

Correction

    In the Federal Register of September 2, 2020 (85 FR 54580), 
appearing on page 54580 in FR Doc. 2020-19835, the following correction 
is made:
    On page 54581, in the first column, under Center for Biologics 
Evaluation and Research, ``9. QPAN H5N1 Vaccine (Influenza A (H5N1) 
virus monovalent vaccine, adjuvanted)'' is corrected to read ``9. 
Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.''

    Dated: September 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-20329 Filed 9-14-20; 8:45 am]
BILLING CODE 4164-01-P