Notice of Availability of the External Review Draft of a “Framework for Determining a Mutagenic Mode of Action for Carcinogenicity: Using EPA's 2005 Cancer Guidelines and Supplemental Guidance for Assessing Susceptibility From Early-Life Exposure to Carcinogens”, 54910-54911 [E7-19119]

Download as PDF rwilkins on PROD1PC63 with NOTICES 54910 Federal Register / Vol. 72, No. 187 / Thursday, September 27, 2007 / Notices research. The HSRB reports to the EPA Administrator through EPA’s Science Advisor. The October 24–26, 2007 meeting of the Human Studies Review Board will address scientific and ethical issues surrounding: • Review of EPA draft document Scientific and Ethical Approaches for Observational Exposure Studies. The document, prepared by researchers in EPA’s National Exposure Research Laboratory, identifies the types of issues that should be considered in planning and implementing observational human exposure studies and provides information and resources to assist EPA researchers in these studies. • A published report of a completed clinical trial measuring the effects of single and repeated treatments with sodium azide on blood pressure in human subjects. Sodium azide is a pesticidally active ingredient being proposed as a replacement for the fumigant methyl bromide. • A research proposal from CarrollLoye Biological Research to evaluate the field efficacy in repelling mosquitoes of three registered products containing picaridin. • A research proposal from CarrollLoye Biological Research to evaluate the laboratory efficacy in repelling ticks of three registered products containing picaridin. • A research proposal from Insect Control & Research, Inc. to evaluate the laboratory efficacy in repelling mosquitoes of the genus Culex of two registered products containing picaridin. • A report of a completed field study by Carroll-Loye Biological Research of the mosquito repellent efficacy of a registered product containing Oil of Lemon Eucalyptus. • Three closely related productspecific reports from a single completed field study by Carroll-Loye Biological Research of the mosquito repellent efficacy of four pesticides, all containing Deet. • At the Board’s request, discussion on the frequency and duration of exposure of subjects to potential mosquito landings. In addition, EPA will report to the Board on its consideration of issues relating to the design of sampling strategies for handler research programs proposed by the Agricultural Handlers Exposure Task Force and the Antimicrobials Exposure Assessment Task Force II. Finally, the Board may also discuss planning for future HSRB meetings. VerDate Aug<31>2005 16:40 Sep 26, 2007 Jkt 211001 B. Meeting Minutes and Reports Minutes of the meeting, summarizing the matters discussed and recommendations, if any, made by the advisory committee regarding such matters will be released within 90 calendar days of the meeting. Such minutes will be available at https:// www.epa.gov/osa/hsrb/ and https:// www.regulations.gov. In addition, information concerning a Board meeting report, if applicable, can be found at https://www.epa.gov/osa/hsrb/ or from the person listed under FOR FURTHER INFORMATION. Dated: September 21, 2007. George Gray, EPA Science Advisor. [FR Doc. E7–19125 Filed 9–26–07; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [FRL–8474–3] Notice of Availability of the External Review Draft of a ‘‘Framework for Determining a Mutagenic Mode of Action for Carcinogenicity: Using EPA’s 2005 Cancer Guidelines and Supplemental Guidance for Assessing Susceptibility From Early-Life Exposure to Carcinogens’’ Environmental Protection Agency (EPA). ACTION: Notice of Document Availability for Public Comment. AGENCY: SUMMARY: The Environmental Protection Agency (EPA) is announcing a 60-day public comment period for the External Review Draft of the ‘‘Framework for Determining a Mutagenic Mode of Action for Carcinogenicity: Using EPA’s 2005 Cancer Guidelines and Supplemental Guidance for Assessing Susceptibility from Early-Life Exposure to Carcinogens’’ (or Framework). EPA is releasing this draft document solely for the purpose of seeking public comment prior to external peer review. Following the period for public comment, the document will be reviewed by an external panel of experts. The date and other details about the external review will be published in a separate Federal Register notice. EPA will consider both the public and the external peer review comments when revising the draft Framework. Members of the public may obtain the draft guidance from https:// www.regulations.gov; or https:// www.epa.gov/osa/mmoaframework; or from Dr. Resha Putzrath via the contact information below. PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 The purpose of the Framework is to expand and clarify discussions found in the Cancer Guidelines and Supplemental Guidance on characteristics to be evaluated for a chemical’s potential for a mutagenic mode of action (MOA). These documents can be obtained from https://www.epa.gov/cancerguidelines. This Framework document is not a prescriptive guide on how any particular type of assessment should be conducted within an EPA program or regional office. Rather, it is a sciencebased document that is intended to help EPA’s risk assessors determine whether data support a finding of a mutagenic MOA for carcinogenicity. It discusses mutagenicity only within the context of a mutagenic MOA for carcinogenicity and not for other adverse endpoints that involve mutations. EPA’s Risk Assessment Forum oversaw the development of this draft document. EPA’s Cancer Guidelines emphasize using MOA information in interpreting and quantifying the potential cancer risk to humans. The Supplemental Guidance discusses the use of age-dependent adjustment factors (ADAFs) with the derived cancer slope factors (and appropriate age-specific estimates of exposure) in the development of risk estimates if the weight of evidence supports a mutagenic MOA. This default approach is used only when appropriate chemical-specific data are not available on susceptibility from early-life exposures. ADDRESSES: The draft document is available electronically through the EPA Office of the Science Advisor’s Web site at: https://www.epa.gov/osa/ mmoaframework. FOR FURTHER INFORMATION CONTACT: For more information, contact Dr. Resha Putzrath, Office of the Science Advisor, Mail Code 8105–R, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone number: (202) 564–3229; fax number: (202) 564–2070, e-mail: putzrath.resha@epa.gov. SUPPLEMENTARY INFORMATION: In response to requests from numerous stakeholders following EPA’s release of the Supplemental Guidance in 2005, the Risk Assessment Forum has prepared a framework document that expands and clarifies characteristics used to determine a chemical’s potential for a mutagenic MOA for carcinogenicity. This determination affects consideration of adjusting cancer potencies via the ADAFs when exposures of these carcinogens occur to children. The Framework is meant to complement EPA’s 2005 Cancer Guidelines and E:\FR\FM\27SEN1.SGM 27SEN1 Federal Register / Vol. 72, No. 187 / Thursday, September 27, 2007 / Notices Supplemental Guidance. In order to use the Framework properly, the chemical of interest must already have a weightof-evidence determination for carcinogenicity. The Framework does not provide an approach to hazard identification. Rather, it gives information useful to determining whether MOAs by which the chemical causes cancer include mutagenicity as an early key event; ‘‘key event’’ is a term of art described in the mode-of-action framework in the Cancer Guidelines. Dated: September 21, 2007. George M. Gray, EPA Science Advisor. [FR Doc. E7–19119 Filed 9–26–07; 8:45 am] BILLING CODE 6560–50–P FEDERAL COMMUNICATIONS COMMISSION Public Information Collection Requirement Submitted to OMB for Review and Approval, Comments Requested rwilkins on PROD1PC63 with NOTICES September 19, 2007. SUMMARY: The Federal Communications Commission, as part of its continuing effort to reduce paperwork burden, invites the general public and other Federal agencies to take this opportunity to comment on the following information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104–13. An agency may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid control number. Comments are requested concerning (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission’s burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology. DATES: Written Paperwork Reduction Act (PRA) comments should be submitted on or before October 29, 2007. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should VerDate Aug<31>2005 16:40 Sep 26, 2007 Jkt 211001 advise the contacts listed below as soon as possible. ADDRESSES: Direct all PRA comments to Nicholas A. Fraser, Office of Management and Budget, via Internet at Nicholas_A._Fraser@omb.eop.gov or via fax at (202) 395–5167 and to Cathy Williams, Federal Communications Commission, Room 1–C823, 445 12th Street, SW., Washington, DC, or via Internet at Cathy.Williams@fcc.gov. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the Web page https:// www.reginfo.gov/public/do/PRAMain, (2) look for the section of the Web page called ‘‘Currently Under Review,’’ (3) click on the downward-pointing arrow in the ‘‘Select Agency’’ box below the ‘‘Currently Under Review’’ heading, (4) select ‘‘Federal Communications Commission’’ from the list of agencies presented in the ‘‘Select Agency’’ box, (5) click the ‘‘Submit’’ button to the right of the ‘‘Select Agency’’ box, (6) when the list of FCC ICRs currently under review appears, look for the title of this ICR (or its OMB control number, if there is one) and then click on the ICR Reference Number to view detailed information about this ICR. For additional information or copies of the information collection(s), contact Cathy Williams at (202) 418–2918. SUPPLEMENTARY INFORMATION: OMB Control Number: 3060–0500. Title: Section 76.1713, Resolution of Complaints. Form Number: Not applicable. Type of Review: Extension of a currently approved collection. Respondents: Business or other forprofit entities. Number of Respondents: 10,750. Estimated Time per Response: 1–17 hours. Frequency of Response: Recordkeeping requirement; Annual reporting requirement; Third party disclosure requirement. Obligation to Respond: Required to obtain or retain benefits. Total Annual Burden: 193,500 hours. Total Annual Cost: None. Privacy Impact Assessment: No impact(s). Nature and Extent of Confidentiality: There is no need for confidentiality required for this information collection. Needs and Uses: 47 CFR 76.1713 states cable system operators shall establish a process for resolving complaints from subscribers about the quality of the television signal delivered. Aggregate data based upon these complaints shall be made available for inspection by the FOR FURTHER INFORMATION CONTACT: PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 54911 Commission and franchising authorities, upon request. These records shall be maintained for at least a one-year period. Prior to being referred to the Commission, complaints from subscribers about the quality of the television signal delivered must be referred to the local franchising authority and the cable system operator. Federal Communications Commission. Marlene H. Dortch, Secretary. [FR Doc. E7–19037 Filed 9–26–07; 8:45 am] BILLING CODE 6712–01–P FEDERAL COMMUNICATIONS COMMISSION [EB Docket No. 07–197; FCC 07–165] Kurtis J. Kintzel, Keanan Kintzel, and All Entities by Which They Do Business Before the Federal Communications Commission—Order To Show Cause and Notice of Opportunity for Hearing Federal Communications Commission. ACTION: Notice. AGENCY: SUMMARY: This document commences a hearing by directing Buzz Telecom Corporation, Business Options, Inc., U.S. Bell Corporation, Link Technologies, AVATAR, and/or their principals Kurtis J. Kintzel and/or Keanan Kintzel to show cause in an adjudicatory proceeding before an administrative law judge why their operating authority should not be revoked, and whether they should be required to refrain from providing any interstate common carrier services in the future without first obtaining prior Commission consent as a result of their apparent repeated and/or willful violations of the Commission’s rules and provisions of the Communications Act of 1934, as amended (the ‘‘Act’’), relating to the provision of interstate common carrier services. The hearing will be held at a time and place to be specified in a subsequent order. DATES: Petitions by persons desiring to participate as a party in the hearing, pursuant to 47 CFR 1.223, may be filed no later than October 29, 2007. See Summary of the Order section below for dates that named parties should file appearances. ADDRESSES: Please file documents with the Office of the Secretary, Federal Communications Commission, 445 12th Street, SW., Washington, DC 20554, and copies thereof shall be served on the Chief, Investigations and Hearings Division, Enforcement Bureau, Room 4– E:\FR\FM\27SEN1.SGM 27SEN1

Agencies

ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 72, Number 187 (Thursday, September 27, 2007)]
[Notices]
[Pages 54910-54911]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-19119]


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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-8474-3]


Notice of Availability of the External Review Draft of a 
``Framework for Determining a Mutagenic Mode of Action for 
Carcinogenicity: Using EPA's 2005 Cancer Guidelines and Supplemental 
Guidance for Assessing Susceptibility From Early-Life Exposure to 
Carcinogens''

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Document Availability for Public Comment.

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

SUMMARY: The Environmental Protection Agency (EPA) is announcing a 60-
day public comment period for the External Review Draft of the 
``Framework for Determining a Mutagenic Mode of Action for 
Carcinogenicity: Using EPA's 2005 Cancer Guidelines and Supplemental 
Guidance for Assessing Susceptibility from Early-Life Exposure to 
Carcinogens'' (or Framework). EPA is releasing this draft document 
solely for the purpose of seeking public comment prior to external peer 
review. Following the period for public comment, the document will be 
reviewed by an external panel of experts. The date and other details 
about the external review will be published in a separate Federal 
Register notice. EPA will consider both the public and the external 
peer review comments when revising the draft Framework. Members of the 
public may obtain the draft guidance from https://www.regulations.gov; 
or https://www.epa.gov/osa/mmoaframework; or from Dr. Resha Putzrath via 
the contact information below.
    The purpose of the Framework is to expand and clarify discussions 
found in the Cancer Guidelines and Supplemental Guidance on 
characteristics to be evaluated for a chemical's potential for a 
mutagenic mode of action (MOA). These documents can be obtained from 
https://www.epa.gov/cancerguidelines. This Framework document is not a 
prescriptive guide on how any particular type of assessment should be 
conducted within an EPA program or regional office. Rather, it is a 
science-based document that is intended to help EPA's risk assessors 
determine whether data support a finding of a mutagenic MOA for 
carcinogenicity. It discusses mutagenicity only within the context of a 
mutagenic MOA for carcinogenicity and not for other adverse endpoints 
that involve mutations. EPA's Risk Assessment Forum oversaw the 
development of this draft document.
    EPA's Cancer Guidelines emphasize using MOA information in 
interpreting and quantifying the potential cancer risk to humans. The 
Supplemental Guidance discusses the use of age-dependent adjustment 
factors (ADAFs) with the derived cancer slope factors (and appropriate 
age-specific estimates of exposure) in the development of risk 
estimates if the weight of evidence supports a mutagenic MOA. This 
default approach is used only when appropriate chemical-specific data 
are not available on susceptibility from early-life exposures.

ADDRESSES: The draft document is available electronically through the 
EPA Office of the Science Advisor's Web site at: https://www.epa.gov/
osa/mmoaframework.

FOR FURTHER INFORMATION CONTACT: For more information, contact Dr. 
Resha Putzrath, Office of the Science Advisor, Mail Code 8105-R, U.S. 
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., 
Washington, DC 20460; telephone number: (202) 564-3229; fax number: 
(202) 564-2070, e-mail: putzrath.resha@epa.gov.

SUPPLEMENTARY INFORMATION: In response to requests from numerous 
stakeholders following EPA's release of the Supplemental Guidance in 
2005, the Risk Assessment Forum has prepared a framework document that 
expands and clarifies characteristics used to determine a chemical's 
potential for a mutagenic MOA for carcinogenicity. This determination 
affects consideration of adjusting cancer potencies via the ADAFs when 
exposures of these carcinogens occur to children. The Framework is 
meant to complement EPA's 2005 Cancer Guidelines and

[[Page 54911]]

Supplemental Guidance. In order to use the Framework properly, the 
chemical of interest must already have a weight-of-evidence 
determination for carcinogenicity. The Framework does not provide an 
approach to hazard identification. Rather, it gives information useful 
to determining whether MOAs by which the chemical causes cancer include 
mutagenicity as an early key event; ``key event'' is a term of art 
described in the mode-of-action framework in the Cancer Guidelines.

    Dated: September 21, 2007.
George M. Gray,
EPA Science Advisor.
 [FR Doc. E7-19119 Filed 9-26-07; 8:45 am]
BILLING CODE 6560-50-P

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