2015-06425. Advisory Committee; Antiviral Drugs Advisory Committee; Termination

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the termination of the Antiviral Drugs Advisory Committee. This document removes the Antiviral Drugs Advisory Committee from the Agency's list of standing advisory committees.

DATES:

This rule is effective March 20, 2015.

FOR FURTHER INFORMATION CONTACT:

Michael Ortwerth, Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002, 301-796-8220, FAX: [phone], or [e-mail].

SUPPLEMENTARY INFORMATION:

The Antiviral Drugs Advisory Committee was established on October 7, 1980 (see 45 FR 79025, November 28, 1980). The Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of acquired immune deficiency syndrome, human immunodeficiency virus related illnesses, and other viral, fungal and mycobacterial infections. The Committee is no longer needed and was terminated on February 15, 2015.

Under 5 U.S.C. 553(b)(3)(B) and (d) and 21 CFR 10.40(d) and (e), the Agency finds good cause to dispense with notice and public comment procedures and to proceed to an immediate effective date on this rule. Notice and public comment and a delayed effective date are unnecessary and are not in the public interest as this final rule merely removes the name of the Antiviral Drugs Advisory Committee from the list of standing advisory committees in § 14.100 (21 CFR 14.100).

Therefore, the Agency is amending § 14.100(c) as set forth in the regulatory text of this document.

List of Subjects in 21 CFR Part 14

• Administrative practice and procedure
• Advisory committees
• Color additives
• Drugs
• Radiation protection

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 14 is amended as follows:

PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

1. The authority citation for 21 CFR part 14 continues to read as follows:

Authority: 5 U.S.C. App. 2; 15 U.S.C. 1451-1461, 21 U.S.C. 41-50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b, 264; Pub. L. 107-109; Pub. L. 108-155; Pub. L. 113-54.

§ 14.100

[Amended]

2. Section 14.100 is amended by removing paragraph (c)(3) and redesignating paragraphs (c)(4) through (18) as paragraphs (c)(3) through (17).

Dated: March 16, 2015.

Jill Hartzler Warner,

Associate Commissioner for Special Medical Programs.