SMG 1260.23

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

OFFICE OF MEDICAL PRODUCTS AND TOBACCO

CENTER FOR DRUG EVALUATION AND RESEARCH

OFFICE OF REGULATORY POLICY

DIVISION OF INFORMATION DISCLOSURE POLICY

Effective Date: 07/08/2011

[PDF Version]

1. DIVISION OF INFORMATION DISCLOSURE POLICY (DKKNAAC)

A. Provides overall policy direction, coordination, and clearance of all requests for information that raises issues concerning the appropriateness of the disclosure

B. Prepares, develops, and coordinates Center and Agency responses to drug-related requests under the Freedom of Information Act, Privacy Act and other statutes, insuring that all requests are processed under the law, in accordance with established FDA regulations, policies, and procedures

C. Works with the FDA's Office of Chief Counsel in handling all aspects of litigation involving the Agency's information disclosure policies including preparation and execution of affidavits and interrogatories. Incumbent may be required to testify in court about the facts surrounding the case and the Agency's actions

D. Negotiates with foreign governments or companies on the release of sensitive information. Serves as expert consultant on foreign inquiries either by providing assistance in the redaction and release of information or providing expert knowledge in their efforts to set policy on information disclosure issues

E. Directs the design, development and implementation of information disclosure policies throughout the Center to ensure compliance with the Freedom of Information Act and the Privacy Act and compliance with FDA's information disclosure regulations

2. AUTHORITY AND EFFECTIVE DATE

The functional statements for this Division were approved by the Secretary of the Department of Health and Human Services on July 8, 2011.