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SMG 1263.65

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

OFFICE OF NEW DRUGS

OFFICE OF DRUG EVALUATION IV

DIVISION OF NONPRESCRIPTION REGULATION DEVELOPMENT

Effective Date: 01/12/2010

[PDF Version]

1. DIVISION OF NONPRESCRIPTION REGULATION DEVELOPMENT (DBNREE).

A. Coordinates and/or reviews and decides on the appropriate action, for all Over-the-Counter (OTC) drug monographs.

B. Develops and implements standards for the safety and effectiveness of nonprescription drug products marketed under OTC monograph.

C. Develops and coordinates rulemaking regarding the regulation on nonprescription drug products.

D. Develops policy and procedures for the review of nonprescription drug products.

E. Coordinates Center-wide research activities on nonprescription product issues related to OTC monographs.

F. Serves as the primary Agency contact for nonprescription drug product monographs.

G. Maintains information management systems for the nonprescription drug monographs within the Office of Nonprescription Products, with the Office of Regulatory Policy and the Office of the Chief Counsel, and for all the federal Register publications.

H. Solicits and nominates candidates for the Nonprescription Drug Advisory committee (NDAC), and determines what topics are discussed with the NDAC. Initiates actions based on recommendations made by nonprescription advisory panels, public comments and new data received.

I. Participates in consumer and professional education programs on nonprescription drug products.

J. Maintains updated information on nonprescription drug internet and intranet web sites.

K. Interacts with regulatory agencies regarding issues relevant to the development of OTC monographs (e.g. Environmental Protection Agency (EPA), Drug Enforcement Agency (DEA), and Office of Management and Budget (OMB)).

L. Interacts with trade groups associated with OTC drug product manufacturers.

M. Provides responses to press inquiries related to OTC monographs.

N. Participates in initiatives that foster development and harmonization of testing methodology for drug products marketed under monographs.

O. Provides responses to inquires on issues related to OTC drug monographs from external sources (e.g. Congressional, General Accounting Office (GAO)).

P. Develop guidance documents related to OTC drug monograph.

Q. Interact with other centers in the Food and Drug Administration (FDA) and the Office of the Commissioner on issues related to the development of OTC monographs.

R. Works collaboratively with the Office of Drug Safety to conducts continuing surveillance and medical evaluation of the labeling, clinical experience, and reports submitted by IND sponsors, NDA applicants, and from other sources.

S. Develops, in coordination with other Agency components, guidance for staff, sponsors and the public that describes the Agency’s interpretation of or policy on regulatory issues that involve the division.

2. AUTHORITY AND EFFECTIVE DATE.

This functional statement was approved by the Commissioner of Food and Drugs on January 12, 2010.

STATUS
(I, R, C)
DATE APPROVEDLOCATION
OF CHANGE HISTORY
CONTACTAPPROVING OFFICIAL
Initial05/01/2005N/aOC/OO/
OM/OMP
Acting Director, Center for Drug Evaluation and Research
Revised01/12/2010N/aOC/OA/
OM/OMP
Commissioner of Food and Drugs