Access to Confidential Business Information by the Food and Drug Administration, 29952-29953 [E6-7930]

Download as PDF 29952 Federal Register / Vol. 71, No. 100 / Wednesday, May 24, 2006 / Notices (7502P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 305–0786; e-mail address:croom.felicia@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action applies to the public in general. As such, 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 Information? 1. Docket. EPA has established a docket for this action under docket identification number (ID) EPA–HQ– OPP–2006–0237; FRL–8062–9. Publicly available docket materials are available either electronically at https:// www.regulations.gov or in hard copy at the OPP Regulatory Public Docket in Rm. S–4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, Va. This Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is (703) 305–5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at https://www.epa.gov/fedrgstr/. jlentini on PROD1PC65 with NOTICES II. Contractor Requirements Under the contract number EPA–W– 06–038, the contractor will perform the following: 1. Assist each OPP Division with document handling and preparation for ‘‘scan ready’’ condition. 2. Operate OPP-supplied scanning equipment to produce 300 dpi resolution PDF documents. 3. Copy documents to designated areas on OPP Storage Area Network. 4. Create and maintain project logs for progress tracking. 5. Establish a document quality control program. 6. Perform quality control for all scanned pages. This contract involves no subcontractors. The OPP has determined that the contract described in this document involves work that is being conducted in connection with FIFRA, in that VerDate Aug<31>2005 17:08 May 23, 2006 Jkt 208001 pesticide chemicals will be the subject of certain evaluations to be made under this contract. These evaluations may be used in subsequent regulatory decisions under FIFRA. Some of this information may be entitled to confidential treatment. The information has been submitted to EPA under sections 3, 4, 6, and 7 of FIFRA and under sections 408 and 409 of FFDCA. In accordance with the requirements of 40 CFR 2.307(h)(3), the contract with MTSI, prohibits use of the information for any purpose not specified in the contract; prohibits disclosure of the information to a third party without prior written approval from the Agency; and requires that each official and employee of the contractor sign an agreement to protect the information from unauthorized release and to handle it in accordance with the FIFRA Information Security Manual. In addition, MTSI is required to submit for EPA approval a security plan under which any CBI will be secured and protected against unauthorized release or compromise. No information will be provided to MTSI until the requirements in this document have been fully satisfied. Records of information provided to MTSI will be maintained by the EPA Project Officer for this contract. All information supplied to MTSI by EPA for use in connection with this contract will be returned to EPA when MTSI has completed its work. List of Subjects Environmental protection, Business and industry, Government contracts, Government property, Security measures. Dated: May 11, 2006. Robert Forrest, Acting Director, Office of Pesticide Programs. [FR Doc. E6–7831 Filed 5–23–06; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPPT–2003–0004; FRL–8069–2] Access to Confidential Business Information by the Food and Drug Administration Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: SUMMARY: EPA has authorized the Food and Drug Administration (FDA) access to information which has been submitted to EPA under all sections of PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 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 E:\FR\FM\24MYN1.SGM 24MYN1 Federal Register / Vol. 71, No. 100 / Wednesday, May 24, 2006 / Notices (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 athttps://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 jlentini on PROD1PC65 with NOTICES 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 VerDate Aug<31>2005 17:08 May 23, 2006 Jkt 208001 ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPPT–2006–0199;FRL–7767–6] Source Reduction Assistance Grants Program for Seven of the Regional Pollution Prevention Program Offices; Notice of Availability Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: SUMMARY: EPA is announcing the availability of grant funds to States, Tribes, Intertribal Consortia, local governments, colleges/universities and non-profits in fiscal year (FY) 2006 under the Source Reduction Assistance (SRA) Grants Program. The program will support source reduction/pollution prevention projects that address the reduction or elimination of pollution at the source across all environmental media: Air, land, and water. EPA will issue SRA awards under the statutory authorities of the Clean Air Act, section 103(b) and (g); Clean Water Act, section 104(b)(3); Federal Insecticide, Fungicide, and Rodenticide Act, section 20; Safe Drinking Water Act, section 1442 (a)(1) and (c); Solid Waste Disposal Act, section 8001(a); and Toxic Substances Control Act, section 10. The total amount of funding available in FY 2006 is up to $163,000 for each of the seven participating EPA regional program offices or approximately $1.14 million in total funding. SRA awards will support pollution prevention activities during the FY 2006–2007 budget cycle. The maximum funding level per project is $100,000. You may access the full text of the grant announcement at https://www.epa.gov/ oppt/p2home/grants/index.htm DATES: For specific regional submission dates for proposals, please refer to the grant announcement at https:// www.epa.gov/oppt/p2home/grants/ index.htm. FOR FURTHER INFORMATION CONTACT: Michele Amhaz, Pollution Prevention Division (7409M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460– 0001; telephone number: (202) 564– 8857; fax number: (202) 564–8899; email address: amhaz.michele@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to States, Federally-recognized Tribes, Intertribal Consortia, local governments, PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 29953 independent school districts, public and private colleges/universities and nonprofits. This notice may, however, be of interest to for-profit entities and individuals, who are not eligible to apply for funding under this program. 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 Information? 1. Docket. EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPPT–2006–0199. Publicly available docket materials are available electronically at https:// www.regulations.gov or in hard copy at the OPPT Docket, EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OPPT Docket is (202) 566–0280. 2. Electronic access. You may obtain electronic copies of this document through the EPA Internet under the ‘‘Federal Register’’ listings at https:// www.epa.gov/fedrgstr/. You may access copies of the grant announcement at https://www.epa.gov/oppt/p2home/ grants/index.htm. II. Overview The following listing provides certain key information concerning the proposal opportunity. • Federal agency name: Environmental Protection Agency. • Funding opportunity title: Source Reduction Assistance Grants Program. • Funding opportunity number: EPA– OPPT–06–008. • Announcement type: The initial announcement of a funding opportunity. • Catalog of Federal Domestic Assistance (CFDA) number: 66.717. • Dates: For specific regional submission dates for proposals, please refer to the grant announcement at https://www.epa.gov/oppt/p2home/ grants/index.htm. For detailed information concerning the grant announcement refer to the Agency website at https://www.epa.gov/ oppt/p2home/grants/index.htm. The full text of the grant announcement includes specific information regarding the: Purpose and scope; activities to be E:\FR\FM\24MYN1.SGM 24MYN1

Agencies

[Federal Register Volume 71, Number 100 (Wednesday, May 24, 2006)]
[Notices]
[Pages 29952-29953]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-7930]


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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.

-----------------------------------------------------------------------

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 athttps://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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