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Access to Confidential Business Information by the Food and Drug Administration

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

 
[Federal Register: May 24, 2006 (Volume 71, Number 100)]
[Notices]
[Page 29952-29953]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24my06-84]

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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2003-0004; FRL-8069-2]
 
Access to Confidential Business Information by the Food and Drug 
Administration

AGENCY:  Environmental Protection Agency (EPA).
ACTION:  Notice.

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SUMMARY:  EPA has authorized the Food and Drug Administration (FDA) 
access to information which has been submitted to EPA under all 
sections of the Toxic Substances Control Act (TSCA). Some of the 
information may be claimed or determined to be Confidential Business 
Information (CBI).

DATES: Access to the confidential data will occur no sooner than May 
31, 2006.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby 
Lintner, Regulatory Coordinator, Environmental Assistance Division 
(7408M), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (202) 554-1404; e-mail address: TSCA-Hotline@.epa.gov.
    For technical information contact: Scott M. Sherlock, TSCA Security 
Staff, Environmental Assistance Division (7408M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 
(202)564-8257; e-mail address: sherlock.scott@epa.gov

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Notice Apply to Me?

    This action is directed to the public in general. This action may, 
however, be of interest to those persons who are or may be required to 
conduct testing of chemical substances under TSCA. Since other entities 
may also be interested, the Agency has not attempted to describe all 
the specific entities that may be affected by this action. If you have 
any questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Documents?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number EPA-HQ-OPPT-2003-0004. 
The official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include CBI or other information 
whose disclosure is restricted by statute.The official public docket is 
the collection of materials that is available for public viewing at the 
EPA Docket Center, Rm. B102-Reading Room, EPA West, 1301 Constitution 
Ave., NW., Washington, DC. The EPA Docket Center is open from 8:30 a.m. 
to 4:30 p.m., Monday through Friday, excluding legal holidays. The EPA 
Docket Center Reading Room telephone number is

[[Page 29953]]

(202) 566-1744, and the telephone number for the OPPT Docket, which is 
located in EPA Docket Center, is (202) 566-0280.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings athttp://www.epa.gov/fedrgstr/.

II. What Action is the Agency Taking?

    On March 22, 2006, in accordance with 40 CFR 2.209, the Associate 
Director for Research Policy and Implementation, of the Food and Drug 
Administration requested access to information collected through the 
authority of TSCA. Some of this information has been treated as CBI. 
FDA needs this information in connection to carrying out a pilot study 
with EPA by providing toxicology data and chemical structures for 
substances tested in genetic toxicity studies. FDA will supplement and 
enhance its battery Quantitative Structural Activity Relationship 
(QSAR) modules with the genetic toxicity data. The enhanced predictive 
genotoxicity QSAR modules will be made available to EPA to augment and 
improve EPA's capability to identify potentially genotoxic chemicals.
    EPA is issuing this notice to inform all submitters of information 
under all sections of TSCA that the Agency will be providing FDA access 
to these CBI materials on a need-to-know basis only. All access to TSCA 
CBI under this arrangement will take place at EPA Headquarters and FDA 
Headquarters located at 10903 New Hampshire Ave., Building 21, Room 
1525, Silver Spring, Maryland 20993-0002.
    Clearance for access to TSCA CBI under this arrangement may 
continue until June 1, 2011.
    FDA personnel will be required to sign non-disclosure agreements 
and be briefed on appropriate security procedures before they are 
permitted access to the CBI.

List of Subjects

    Environmental protection, Confidential business information.

    Dated: May 18, 2006.
Vicki Simons,
Acting Director, Information Management Division, Office of Pollution 
Prevention and Toxics.
[FR Doc. E6-7930 Filed 5-23-06; 8:45 am]
BILLING CODE 6560-50-S

 
 

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