SMG 1117.3284

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

OFFICE OF COMMISIONER

OFFICE OF OPERATIONS

OFFICE OF MANAGEMENT

OFFICE OF SHARED SERVICES

OFFICE OF PUBLIC INFORMATION AND LIBRARY SERVICES

DIVISION OF DOCKETS MANAGEMENT

Effective Date: 01/13/2009

1. DIVISION OF DOCKETS MANAGEMENT (DAMBCGD).

A. Receives, examines, and processes submissions required or permitted in Agency administrative proceedings; establishes and maintains docket files containing Agency official records relating to an administrative proceeding. Disseminates submissions to appropriate offices for action. Routinely coordinates activities of the branch with other appropriate components.

B. Serves as the Agency expert on requirements for submissions required or permitted in Agency administrative proceedings. Participates in the development of regulations and policy impacting on Agency administrative proceedings and the release of information under the Freedom of Information (FOI) Act.

C. Provides staff support for Agency rulemaking activities. Determines compliance of petitions, comments, request for hearings, motions, briefs, and objections with Agency regulations.

D. Maintains and operates a public reading room to make Agency official records available to any interested party, and provides copies upon request, under the provisions of the FOI Act. Provides electronic access to these records, via the Internet, and other means, as required by the EFOIA.

E. Analyzes data and prepares reports on docket management activities and administrative proceedings for Agency management officials.

F. Provides information access via the Intranet and other means to FDA personnel for Division of Dockets Management materials and to copyrighted documents.

G. Plans and conducts Agency-wide analytical reviews and studies to assess management information and access concerns. Makes recommendations and assists in the implementation of the recommendations.

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 January 13, 2009.