Document ID: FDA-2008-0021-0001
Agency: fda
Document Type: Notice
Title: Food and Drug Administration's Transition to the Federal Dockets Management System
Posted Date: 2008-01-14T05:00Z

[Federal Register: January 14, 2008 (Volume 73, Number 9)]
[Notices]               
[Page 2264-2265]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14ja08-70]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Food and Drug Administration's Transition to the Federal Dockets 
Management System

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is providing notice 
that effective January 15, 2008, the public will no longer be able to 
submit electronic comments to its Dockets through FDA's Web site. 
Electronic comments to FDA's Dockets may continue to be submitted 
through the Federal eRulemaking Portal. In recent months, FDA has 
alerted the public through our published Federal Register documents 
that after the transition date, electronic submissions will only be 
accepted by FDA through Federal Dockets Management System (FDMS). 
Please note that the process for submitting written comments to FDA's 
Dockets will remain the same.

FOR FURTHER INFORMATION CONTACT: The Division of Dockets Management 
Public Room (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
1061, Rockville, MD 20852, 301-827-6860, or FAX: 301-827-6870.

SUPPLEMENTARY INFORMATION:

I. Background:

    FDMS is a major component of the President's e-Rulemaking 
Initiative, which provides easy access to the public dockets maintained 
by Federal agencies, while streamlining and increasing the efficiency 
of the internal, regulatory procedures for agencies. FDMS is designed 
so that the public has a single point of access to the public dockets 
across the Federal government and agencies have a standard, online 
procedure to manage and process dockets, documents, and public 
comments/submissions. The Initiative reduces costs by eliminating 
duplicative information systems and technical infrastructures.

A. What is FDMS?

    FDMS is a full-featured electronic docket management system that 
gives Federal personnel and docket managers the ability to better 
manage their rulemakings, adjudications, and other docketed program 
activities. FDMS also provides the public with a one-stop site to 
search, view and download documents, as well as post comments/
submissions to federal agencies.
    FDMS makes it easier for all segments of the public with access to 
a computer and the Internet--whether at home, at work, or at a local 
library-- to submit comments to agency dockets. FDMS is accessible on 
the Internet at http://www.Regulations.gov.

B. How Can I Access and Use FDMS?

    FDMS is accessible on the Internet at http://www.Regulations.gov. 

The public may use FDMS to access available public docket materials 
online, as well as submit electronic comments to a particular docket 
available in FDMS.

C. How Can I Search FDMS?

    FDMS provides two basic methods of searching to retrieve dockets 
and docket materials that are available in the system: (1) Quick Search 
to search using a full-text search engine and Browsing options or (2) 
Advance Search which displays various indexed fields such as

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the docket name, docket identification number, agency, date of 
issuance, document title, document identification (ID) number, type of 
documents, etc. Each data field in the advance search may be searched 
independently or in combination with other fields, as desired. Each 
search yields a simultaneous display of all available information found 
in FDMS that is relevant to the requested subject or topic.

D. How Can I Post Comments/Submissions to FDMS?

    The public may post comments/submissions online to FDMS on the 
Internet at http://www.Regulations.gov when a particular docket is open 

for public comment/submissions. For each Docket, FDA will issue a 
Federal Register notice or other document that provides information and 
instructions on posting comments/submissions to FDMS.

II. Migration from the Division of Dockets Management (DDM) to FDMS

A. Phased Migration

    Using a phased approach, all dockets currently managed by FDA's DDM 
will be moved to FDMS. After the migration, the public will be able to 
access FDA Dockets at Regulations.gov. On this Web site, the public 
will be able to read background dockets, public comments the agency has 
received, etc. Due to the tremendous amount of data to be transferred 
from FDA's DDM to FDMS, the migration will occur over the next few 
months. Until a Docket is migrated, the public will continue to be able 
to access it through FDA's Web Site at http://www.fda.gov/ohrms/dockets
.

B. Docket ID Numbers

    Any Docket created after January 15, 2008, will receive a docket ID 
established by FDMS. Any Docket created on or before January 15, 2008, 
and migrated to FDMS will receive a docket ID established by FDMS, but 
it will also include a reference to its original docket 
(identification) number that had been assigned by FDA (legacy numbers).

III. Additional Information

    Additional details about FDMS, as well as detailed instructions and 
assistance for using the system, are available at http://www.Regulations.gov
.

    Dated: January 8, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-428 Filed 1-11-08; 8:45 am]

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