2017-03144. Pediatric 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 Advisory Committee. This meeting was announced in the Federal Register of January 5, 2017. The amendment is being made to reflect a change in the Center for Drug Evaluation and Research (CDER) products portion of the document. 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: [e-mail], 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 5, 2017 (82 FR 1345), FDA announced that a meeting of the Pediatric Advisory Committee (PAC) would be held on March 6 and 7, 2017. On page 1346, in the third column, the CDER products portion of the document is changed to read as follows:

On March 6, 2017, the PAC will meet to discuss the following products (listed by FDA Center):

(1) Center for Drug Evaluation and Research (CDER)

a. NITROPRESS (sodium nitroprusside)

b. KUVAN (sapropterin dihydrochloride)

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 13, 2017.

Janice M. Soreth,

Associate Commissioner for Special Medical Programs.