Notice of Availability of the External Review Draft of an Interim Guidance for Microarray-Based Assays, 11873-11874 [E7-4650]

Download as PDF Federal Register / Vol. 72, No. 49 / Wednesday, March 14, 2007 / Notices III. Conditional Approval Form EPA issued a notice, published in the Federal Register of February 15, 2006 (71 FR 7954) (FRL–7761–5), which announced that Jabb of the Carolinas, P.O. Box 310, Pine Level, NC 27568, had submitted an application to conditionally register the pesticide products, Beauveria bassiana HF23 Technical, insecticide (EPA File Symbol 70787-1), containing the fungal active ingredient at 95 percent, an active ingredient not included in any previously registered product. Listed below are the applications conditionally approved on December 27, 2006 for an end-use product and a technical. 1. EPA File Symbol 70787-1: Beauveria bassiana HF23 Technical at 95 percent for use as a Manufacturing product for insecticides. Manufacturer: Jabb of the Carolinas, P.O. Box 310, Pine Level, NC 27568. The registrant must provide analyses of five production batches of this Technical Grade Active Ingredient which is to be used for manufacture of other End-use Products. 2. EPA File Symbol 70787-2: End-use Product (EP) balEnce containing 1.18 percent of Beauveria bassiana HF23 Technical for treatment of poultry houses to control house fly in chicken manure. List of Subjects Environmental protection, Chemicals, Pesticides and pests. Dated: February 28, 2007. Janet L. Andersen, Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs. [FR Doc. E7–4275 Filed 3–13–07; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–ORD–2007–0212; FRL–8287–6] Notice of Availability of the External Review Draft of an Interim Guidance for Microarray-Based Assays Environmental Protection Agency (EPA). ACTION: Notice of document availability for public comment. cprice-sewell on PROD1PC66 with NOTICES AGENCY: SUMMARY: The U.S. Environmental Protection Agency is announcing a 45 day public comment period for the External Review Draft of the ‘‘Interim Guidance for Microarray-Based Assays: Data Submission, Quality, Analysis, Management and Training Considerations.’’ EPA is releasing this VerDate Aug<31>2005 15:03 Mar 13, 2007 Jkt 211001 draft document solely for the purpose of seeking public comment prior to external peer review. The contractorlead external expert peer review will be conducted by letter and closed teleconference in the May 2007 timeframe. All comments received, submitted in accordance with this notice, will be shared with the external peer review panel for their consideration. Comments received after the close of the comment period may be considered by EPA when it finalizes the document. This document has not been formally disseminated by EPA. This draft interim guidance does not represent and should not be construed to represent any EPA policy, viewpoint, or determination. Members of the public may obtain the draft interim guidance from www.regulations.gov; or www.epa.gov/osa/spc/ genomicsguidance.htm; or from Dr. Kathryn Gallagher via the contact information below. This draft Interim Guidance for Microarray-Based Assays outlines recommendations for: (1) What data to submit to the Agency for microarray studies, (2) performance approach considerations regarding quality assessment parameters, (3) data analysis approaches that should be considered; and (4) data management and storage issues for data submitted to or used by the Agency. The guidance applies to both human health and ecological DNA microarray data. The draft document was developed to provide information to the regulated community and other interested parties about submitting microarray data to the Agency and to provide guidance for EPA staff in evaluating such data and/or information. DATES: All comments received by April 30, 2007 will be shared with the external peer review panel for their consideration. Comments received beyond that time may be considered by EPA when it finalizes the document. ADDRESSES: Submit your comments, identified by Docket ID No. EPA–HQ– ORD–2007–0212, by one of the following methods: • www.regulations.gov: Follow the on-line instructions for submitting comments. • E-mail: ORD.Docket@epa.gov. • Mail: ORD Docket, Environmental Protection Agency, Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460. • Hand Delivery: EPA Docket Center (EPA/DC), Room 3334, EPA West Building, 1301 Constitution Avenue, NW., Washington, DC 20460, Attention Docket ID No. EPA–HQ–ORD–2007– PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 11873 0212. Deliveries are only accepted from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. Special arrangements should be made for deliveries of boxed information. Instructions: Direct your comments to Docket ID No. EPA–HQ–ORD–2007– 0212. EPA’s policy is that all comments received will be included in the public docket without change and may be made available online at www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected by statute through www.regulations.gov or e-mail. The www.regulations.gov Web site is an ‘‘anonymous access’’ system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA, without going through www.regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD–ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. Docket: All documents in the docket are listed in the www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in www.regulations.gov or in hard copy at the ORD Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The 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 ORD Docket is (202) 566–1752. E:\FR\FM\14MRN1.SGM 14MRN1 11874 Federal Register / Vol. 72, No. 49 / Wednesday, March 14, 2007 / Notices Dr. Kathryn Gallagher, Office of the Science Advisor, Mail Code 8105–R, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone number: (202) 564–1398; fax number: (202) 564–2070, E-mail: Gallagher.kathryn@epa.gov. SUPPLEMENTARY INFORMATION: The mapping of diverse animal, plant, and microbial species genomes using molecular technologies has significantly affected research across all areas of the life sciences. The current understanding of biological systems is rapidly changing in ways previously unimagined and novel applications of this technology have already been commercialized. These advances in genomics are likely to have significant implications for risk assessment policies and regulatory decision making. In 2002, EPA issued its Interim Policy on Genomics (available at https://www.epa.gov/osa/ spc/genomics.htm) that communicated the Agency’s initial approach to using genomics information in risk assessment and decision making. The Interim Policy described genomics as the study of all the genes of a cell or tissue, at the DNA (genotype), mRNA (transcriptome), or protein (proteome) level. While noting that the understanding of genomics is far from established, the Agency stated that such data may be considered in the decision making process, but that these data alone were insufficient as a basis for decisions. Following the release of the Interim Policy, EPA’s Science Policy Council (SPC) created a cross-EPA Genomics Task Force and charged it with examining the broader implications genomics is likely to have on EPA programs and policies. The Genomics Task Force developed a Genomics White Paper entitled ‘‘Potential Implications of Genomics for Regulatory and Risk Assessment Applications at EPA’’ (available at https://www.epa.gov/ osa/genomics.htm). That document identified four areas likely to be influenced by the generation of genomics information within EPA and the submission of such information to EPA: (1) Prioritization of contaminants and contaminated sites; (2) monitoring; (3) reporting provisions; and (4) risk assessment. The Task Force identified the establishment of a framework for analysis and acceptance criteria for genomics information for scientific and regulatory purposes as a critical need. The Task Force recommended that the Agency charge a workgroup to establish such a framework and in doing so consider the performance of assays cprice-sewell on PROD1PC66 with NOTICES FOR FURTHER INFORMATION CONTACT: VerDate Aug<31>2005 15:03 Mar 13, 2007 Jkt 211001 across genomic platforms (e.g., reproducibility, sensitivity, pathway analysis tools) and the criteria for accepting genomics data for use in a risk assessment (e.g., assay validity, biologically meaningful response). In 2004, EPA’s Genomics Technical Framework and Training Workgroups were formed with the responsibility to ensure that the technical framework and training activities build upon the Agency’s Interim Policy on Genomics while continuing to engage other interested parties. Information developed by these workgroups is intended for use by the EPA program offices and regions to determine the applicability of specific genomics information to the evaluation of risks under various statutes. To this end, EPA’s Genomics Technical Workgroup considered all of the ‘‘omics’’ technologies and applications and decided that an interim guidance document on the use of data generated by DNA microarray technology would be most beneficial to the Agency and regulated community at this time. Consequently, this document describes data submission, quality, analysis, management and training considerations for microarray-based assays. It is important to note that microarray technology is rapidly changing, such that methodologies for generating such data and ensuring its quality will likely change; however the need to ensure consistency and quality in generating, analyzing and using the data will not. As the state of the science develops, EPA plans to revisit this guidance as necessary. EPA will consider all peer review and public comments in finalizing its Interim Guidance for Microarray-Based Assays. To obtain additional information, visit: https://www.epa.gov/ osa/spc/genomicsguidance.htm Dated: March 9, 2007. Elizabeth Lee Hofmann, Acting Chief Scientist, Office of the Science Advisor. [FR Doc. E7–4650 Filed 3–13–07; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [FRL–8287–5] Notice of Approval of Revisions to Delaware’s National Pollutant Discharge Elimination System (NPDES) Program Environmental Protection Agency (EPA). ACTION: Notice of approval. AGENCY: PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 SUMMARY: Notice is hereby given of approval of the submittal by the State of Delaware of its new and revised NPDES regulations to maintain consistency with the requirements of the Clean Water Act and its implementing regulations at 40 CFR 122, 123 and 124, as amended. DATES: EPA’s approval is effective on March 14, 2007. FOR FURTHER INFORMATION CONTACT: Evelyn MacKnight, U.S. EPA, Region 3, 1650 Arch Street, Philadelphia, PA 19103, or telephone her at (215) 814– 5717. Copies of materials considered by EPA in its decision are available for review by appointment at U.S. EPA, Region 3, 1650 Arch Street, Philadelphia, PA 19103. Appointments may be made by calling Ms. MacKnight. SUPPLEMENTARY INFORMATION: Section 402 of the Federal Clean Water Act (CWA) created the NPDES program under which the Administrator of EPA may issue permits for the discharge of pollutants into waters of the United States when consistent with the CWA. Section 402(b) allows States to assume NPDES program responsibilities upon approval by EPA. On April 1, 1974, Delaware was authorized by EPA to administer the NPDES program; the State also received the authority to administer the General Permits program on October 23, 1992. EPA has established a regulation at 40 CFR Part 123 that establishes the requirements for NPDES State Programs. Section 123.62 establishes procedures for the revision of authorized NPDES State Programs. Pursuant to § 123.62(a), a State may initiate a program revision and must keep EPA informed of any proposed modifications to its regulatory authority. On July 28, 2003, the State of Delaware submitted to EPA for review and approval revisions to the regulations implementing the State’s NPDES program. The State made significant revisions to sections 1 through 8 and sections 10 through 14 of its Department of Natural Resources and Environmental Control’s (DNREC) March 15, 1974 Regulations Governing the Control of Water Pollution, which EPA has determined constituted a substantial revision to Delaware’s authorized NPDES program. EPA determined that the State’s submittal was complete on November 19, 2003, with the submittal of a statement from the State’s Attorney General’s office which certified that the regulations were duly adopted pursuant to State law. EPA solicited public comments as to whether it should approve or disapprove the revisions on February 10, 2004 (69 FR 6289) pursuant to E:\FR\FM\14MRN1.SGM 14MRN1

Agencies

[Federal Register Volume 72, Number 49 (Wednesday, March 14, 2007)]
[Notices]
[Pages 11873-11874]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-4650]


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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2007-0212; FRL-8287-6]


Notice of Availability of the External Review Draft of an Interim 
Guidance for Microarray-Based Assays

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of document availability for public comment.

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

SUMMARY: The U.S. Environmental Protection Agency is announcing a 45 
day public comment period for the External Review Draft of the 
``Interim Guidance for Microarray-Based Assays: Data Submission, 
Quality, Analysis, Management and Training Considerations.'' EPA is 
releasing this draft document solely for the purpose of seeking public 
comment prior to external peer review. The contractor-lead external 
expert peer review will be conducted by letter and closed 
teleconference in the May 2007 timeframe. All comments received, 
submitted in accordance with this notice, will be shared with the 
external peer review panel for their consideration. Comments received 
after the close of the comment period may be considered by EPA when it 
finalizes the document. This document has not been formally 
disseminated by EPA. This draft interim guidance does not represent and 
should not be construed to represent any EPA policy, viewpoint, or 
determination. Members of the public may obtain the draft interim 
guidance from www.regulations.gov; or www.epa.gov/osa/spc/
genomicsguidance.htm; or from Dr. Kathryn Gallagher via the contact 
information below.
    This draft Interim Guidance for Microarray-Based Assays outlines 
recommendations for: (1) What data to submit to the Agency for 
microarray studies, (2) performance approach considerations regarding 
quality assessment parameters, (3) data analysis approaches that should 
be considered; and (4) data management and storage issues for data 
submitted to or used by the Agency. The guidance applies to both human 
health and ecological DNA microarray data. The draft document was 
developed to provide information to the regulated community and other 
interested parties about submitting microarray data to the Agency and 
to provide guidance for EPA staff in evaluating such data and/or 
information.

DATES: All comments received by April 30, 2007 will be shared with the 
external peer review panel for their consideration. Comments received 
beyond that time may be considered by EPA when it finalizes the 
document.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
ORD-2007-0212, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for 
submitting comments.
     E-mail: ORD.Docket@epa.gov.
     Mail: ORD Docket, Environmental Protection Agency, 
Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
     Hand Delivery: EPA Docket Center (EPA/DC), Room 3334, EPA 
West Building, 1301 Constitution Avenue, NW., Washington, DC 20460, 
Attention Docket ID No. EPA-HQ-ORD-2007-0212. Deliveries are only 
accepted from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding 
legal holidays. Special arrangements should be made for deliveries of 
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2007-0212. EPA's policy is that all comments received will be included 
in the public docket without change and may be made available online at 
www.regulations.gov, including any personal information provided, 
unless the comment includes information claimed to be Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Do not submit information that you consider to 
be CBI or otherwise protected by statute through www.regulations.gov or 
e-mail. The www.regulations.gov Web site is an ``anonymous access'' 
system, which means EPA will not know your identity or contact 
information unless you provide it in the body of your comment. If you 
send an e-mail comment directly to EPA, without going through 
www.regulations.gov, your e-mail address will be automatically captured 
and included as part of the comment that is placed in the public docket 
and made available on the Internet. If you submit an electronic 
comment, EPA recommends that you include your name and other contact 
information in the body of your comment and with any disk or CD-ROM you 
submit. If EPA cannot read your comment due to technical difficulties 
and cannot contact you for clarification, EPA may not be able to 
consider your comment. Electronic files should avoid the use of special 
characters, any form of encryption, and be free of any defects or 
viruses.
    Docket: All documents in the docket are listed in the 
www.regulations.gov index. Although listed in the index, some 
information is not publicly available, e.g., CBI or other information 
whose disclosure is restricted by statute. Certain other material, such 
as copyrighted material, will be publicly available only in hard copy. 
Publicly available docket materials are available either electronically 
in www.regulations.gov or in hard copy at the ORD Docket, EPA/DC, EPA 
West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The 
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 ORD 
Docket is (202) 566-1752.

[[Page 11874]]


FOR FURTHER INFORMATION CONTACT: Dr. Kathryn Gallagher, Office of the 
Science Advisor, Mail Code 8105-R, U.S. Environmental Protection 
Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone 
number: (202) 564-1398; fax number: (202) 564-2070, E-mail: 
Gallagher.kathryn@epa.gov.

SUPPLEMENTARY INFORMATION: The mapping of diverse animal, plant, and 
microbial species genomes using molecular technologies has 
significantly affected research across all areas of the life sciences. 
The current understanding of biological systems is rapidly changing in 
ways previously unimagined and novel applications of this technology 
have already been commercialized. These advances in genomics are likely 
to have significant implications for risk assessment policies and 
regulatory decision making. In 2002, EPA issued its Interim Policy on 
Genomics (available at https://www.epa.gov/osa/spc/genomics.htm) that 
communicated the Agency's initial approach to using genomics 
information in risk assessment and decision making. The Interim Policy 
described genomics as the study of all the genes of a cell or tissue, 
at the DNA (genotype), mRNA (transcriptome), or protein (proteome) 
level. While noting that the understanding of genomics is far from 
established, the Agency stated that such data may be considered in the 
decision making process, but that these data alone were insufficient as 
a basis for decisions.
    Following the release of the Interim Policy, EPA's Science Policy 
Council (SPC) created a cross-EPA Genomics Task Force and charged it 
with examining the broader implications genomics is likely to have on 
EPA programs and policies. The Genomics Task Force developed a Genomics 
White Paper entitled ``Potential Implications of Genomics for 
Regulatory and Risk Assessment Applications at EPA'' (available at 
https://www.epa.gov/osa/genomics.htm). That document identified four 
areas likely to be influenced by the generation of genomics information 
within EPA and the submission of such information to EPA: (1) 
Prioritization of contaminants and contaminated sites; (2) monitoring; 
(3) reporting provisions; and (4) risk assessment. The Task Force 
identified the establishment of a framework for analysis and acceptance 
criteria for genomics information for scientific and regulatory 
purposes as a critical need. The Task Force recommended that the Agency 
charge a workgroup to establish such a framework and in doing so 
consider the performance of assays across genomic platforms (e.g., 
reproducibility, sensitivity, pathway analysis tools) and the criteria 
for accepting genomics data for use in a risk assessment (e.g., assay 
validity, biologically meaningful response).
    In 2004, EPA's Genomics Technical Framework and Training Workgroups 
were formed with the responsibility to ensure that the technical 
framework and training activities build upon the Agency's Interim 
Policy on Genomics while continuing to engage other interested parties. 
Information developed by these workgroups is intended for use by the 
EPA program offices and regions to determine the applicability of 
specific genomics information to the evaluation of risks under various 
statutes.
    To this end, EPA's Genomics Technical Workgroup considered all of 
the ``omics'' technologies and applications and decided that an interim 
guidance document on the use of data generated by DNA microarray 
technology would be most beneficial to the Agency and regulated 
community at this time. Consequently, this document describes data 
submission, quality, analysis, management and training considerations 
for microarray-based assays. It is important to note that microarray 
technology is rapidly changing, such that methodologies for generating 
such data and ensuring its quality will likely change; however the need 
to ensure consistency and quality in generating, analyzing and using 
the data will not. As the state of the science develops, EPA plans to 
revisit this guidance as necessary.
    EPA will consider all peer review and public comments in finalizing 
its Interim Guidance for Microarray-Based Assays. To obtain additional 
information, visit: https://www.epa.gov/osa/spc/genomicsguidance.htm

    Dated: March 9, 2007.
Elizabeth Lee Hofmann,
Acting Chief Scientist, Office of the Science Advisor.
[FR Doc. E7-4650 Filed 3-13-07; 8:45 am]
BILLING CODE 6560-50-P
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