Physiological Parameters Database for PBPK Modeling, 17666-17667 [E9-8795]

Download as PDF mstockstill on PROD1PC66 with NOTICES 17666 Federal Register / Vol. 74, No. 72 / Thursday, April 16, 2009 / Notices completing a form available on the Web site for the Missouri River Ecosystem Restoration Plan, located at: https:// www.mrerp.org. Electronic comments may be submitted at: comments@mrerp.org. Written comments may be submitted by mail to the NEPA Document Manager for the Missouri River Ecosystem Restoration Plan: Ms. Jennifer Switzer, Project Manager, 601 E. 12th Street, Kansas City, MO 64106. FOR FURTHER INFORMATION CONTACT: For further information and/or questions about the proposed plan/EIS, please contact Ms. Jennifer Switzer, Project Manager, by telephone: (816) 389–3062, by mail: 601 E. 12th Street, Kansas City, MO 64106, or by e-mail: jennifer.l.switzer@usace.army.mil, or Mr. Randy Sellers, Project Manager, by telephone (402) 995–2689, by mail: CENWO–PM–AE, 1616 Capitol Avenue, Omaha, NE 68102, or by e-mail: randy.p.sellers@usace.army.mil. For inquiries from the media, please contact the Corps, Kansas City District Public Affairs Officer (PAO), Mr. David Kolarik by telephone: (816) 389–3486, by mail: 601 E. 12th Street, Kansas City, MO 64106, or by e-mail: david.s.kolarik@usace.army.mil. SUPPLEMENTARY INFORMATION: USACE is seeking public input on its proposed draft purpose and need statements for developing the Plan/EIS. The Plan is needed to fully implement the direction received in Subsection (a) of Section 5018 of the Water Resources Development Act of 2007; and address current trends indicating: diminished natural habitat; reduced populations of native species and communities; and reduced variability of physical processes such as flows, flooding, and sediment erosion/deposition. Therefore, the draft purpose of the Plan is to determine the actions required to mitigate losses of aquatic and terrestrial habitat; to recover federally listed species under the Endangered Species Act; and to restore the ecosystem to prevent further declines among other native species, while seeking to balance with social, economic, and cultural values for future generations. The overall goal of the planning process is to result in a sustainable decision that will guide mitigation, recovery, and restoration actions over the next 30 to 50 years. In addition to seeking input on the proposed draft purpose and need for the Plan, the USACE is also seeking comments on what specific natural resources should be addressed and other issues that should be considered in this type of plan. VerDate Nov<24>2008 16:47 Apr 15, 2009 Jkt 217001 USACE is hosting public scoping meetings throughout the basin to address the plan purpose, need, and target resources. For specific information regarding these meetings (dates, locations, and times) please see https://www.mrerp.org. All meetings are accessible to people with disabilities. Any individual with a disability who requires special assistance, such as a sign language interpreter, or a translator, please contact either project manager listed above at least 48 hours in advance of the meeting so that arrangements can be made. Additional information about the Missouri River Ecosystem Restoration Plan can be found at https:// www.mrerp.org. Brenda S. Bowen, Army Federal Register Liaison Officer. [FR Doc. E9–8739 Filed 4–15–09; 8:45 am] BILLING CODE 3720–58–P deletion is not within the purview of subsection (r) of the Privacy Act of 1974, (5 U.S.C. 552a), as amended, which requires the submission of a new or altered system report. Dated: April 13, 2009. Morgan E. Frazier, Alternate OSD Federal Register Liaison Officer, Department of Defense. DELETION: F036 AFPC G SYSTEM NAME: Medical Officer Personnel Utilization Records (May 9, 2003, 68 FR 24949). REASON: This is a duplicate system that is now merged with F036 AFPC M, Officer Utilization Records System (June 11, 1997, 62 FR 31793). There should be only one system for Utilization Records System. Therefore, this notice should be deleted. [FR Doc. E9–8716 Filed 4–15–09; 8:45 am] BILLING CODE 5001–06–P DEPARTMENT OF DEFENSE Department of the Air Force ENVIRONMENTAL PROTECTION AGENCY [Docket ID: USAF–2009–0026] Privacy Act of 1974; System of Records AGENCY: Department of the Air Force, DoD. ACTION: Notice to delete a system of records. SUMMARY: The Department of the Air Force proposes to delete a system of records to its inventory of record systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended. DATES: The changes will be effective on May 18, 2009 unless comments are received that would result in a contrary determination. ADDRESSES: Send comments to the Air Force Privacy Act Officer, Office of Warfighting Integration and Chief Information Officer, SAF/XCPPI, 1800 Air Force Pentagon, Suite 220, Washington, DC 20330–1800. FOR FURTHER INFORMATION CONTACT: Mr. Ben Swilley at (703) 696–6648. SUPPLEMENTARY INFORMATION: The Department of the Air Force systems of records notices subject to the Privacy Act of 1974, (5 U.S.C. 552a), as amended, have been published in the Federal Register and are available from the address above. The Department of the Air Force proposes to delete a system of records notice in its inventory of record systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended. The proposed PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 [FRL–8785–9; Docket ID No. EPA–HQ–ORD– 2009–0173] Physiological Parameters Database for PBPK Modeling AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of public comment period. SUMMARY: EPA is announcing a public comment period for an on-line database file, using the Microsoft® Access database management system, that contains a comprehensive collection of physiological parameter data intended to be suitable for application in physiologically based pharmacokinetic (PBPK) modeling. The public comment period will be for 30 days. EPA requests that interested users comment on the functionality or usability of this resource and provide comments that may be considered for improving the final product. The draft database represents a compilation of several individual databases developed over the past few years. It contains physiological parameter data for humans from infancy through old age, as well as data for experimental laboratory species. EPA requests that end-users provide feedback regarding their experience working with this database. Users are also encouraged to comment on specific studies or methods employed in the E:\FR\FM\16APN1.SGM 16APN1 Federal Register / Vol. 74, No. 72 / Thursday, April 16, 2009 / Notices mstockstill on PROD1PC66 with NOTICES studies included in the entire draft database. As a means of quality assurance and quality control (QA/QC), about 30% of the data entries, randomly selected, have been verified by an independent contractor. This QA/QC process will be ongoing. DATES: The 30-day public comment period begins April 16, 2009 and ends May 18, 2009. Technical comments should be in writing and must be received by EPA by close of business, May 18, 2009. ADDRESSES: The draft database is available for download from the U.S. EPA Web site https://cfpub.epa.gov/ ncea/cfm/ recordisplay.cfm?deid=204443. Users must have Microsoft® Access in order to open and manipulate the database file. Comments may be submitted electronically via EPA’s E-Docket, by mail, by facsimile, or by hand delivery/ courier. Please follow the detailed instructions as provided in the SUPPLEMENTARY INFORMATION section of this notice. FOR FURTHER INFORMATION CONTACT: For information on the public comment period, contact the Office of Environmental Information Docket; telephone: 202–566–1752; facsimile: 202–566–1753; or e-mail: ORD.Docket@epa.gov. If you have questions about the database, please contact the Information Management Staff, National Center for Environmental Assessment, U.S. Environmental Protection Agency, Washington, DC 20460; telephone: 703– 347–8561; facsimile: 703–347–8691; or e-mail: NCEADC.Comment@epa.gov. SUPPLEMENTARY INFORMATION: I. Information About the Product Physiologically based pharmacokinetic (PBPK) models represent an important class of dosimetry models that are useful for predicting internal dose at target organs for risk assessment applications. Doseresponse relationships that appear unclear or confusing at the administered dose level can become more understandable when expressed on the basis of internal dose of the chemical. To predict internal dose level, PBPK models use physiological data to construct mathematical representations of biological processes associated with the absorption, distribution, metabolism, and elimination of compounds. With the appropriate data, these models can be used to extrapolate across species, lifestages, and exposure scenarios, as well as address various sources of uncertainty in risk VerDate Nov<24>2008 16:47 Apr 15, 2009 Jkt 217001 assessments. This database contains a collection of physiological data relevant for parameterizing PBPK models for children, adults, and the elderly. In addition, the database contains physiological data for parameterizing PBPK models for young (i.e., developing) and adult rodents. II. How To Submit Technical Comments to the Docket at Regulations.gov Submit your comments, identified by Docket ID No. EPA–HQ–ORD–2009– 0173, by one of the following methods: • https://www.regulations.gov: Follow the on-line instructions for submitting comments. • E-mail: ORD.Docket@epa.gov. • Fax: 202–566–1753. • Mail: Office of Environmental Information (OEI) Docket (Mail Code: 2822T), U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. The phone number is 202–566–1752. • Hand Delivery: The OEI Docket is located in the EPA Headquarters Docket Center, Room 3334 EPA West Building, 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. Such deliveries are only accepted during the docket’s normal hours of operation, and special arrangements should be made for deliveries of boxed information. If you provide comments by mail or hand delivery, please submit an original and three copies of the comments. For attachments, provide an index, number pages consecutively with the comments, and submit an unbound original and three copies. Instructions: Direct your comments to Docket ID No. EPA–HQ–ORD–2009– 0173. Please ensure that your comments are submitted within the specified comment period. Comments received after the closing date will be marked ‘‘late,’’ and may only be considered if time permits. It is EPA’s policy to include all comments it receives in the public docket without change and to make the comments available online at https://www.regulations.gov, including any personal information provided, unless a 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 through https:// www.regulations.gov or e-mail. The https://www.regulations.gov Web site is PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 17667 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 https:// 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. For additional information about EPA’s public docket visit the EPA Docket Center homepage at https:// www.epa.gov/epahome/dockets.htm. Docket: Documents in the docket are listed in the https://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 materials, such as copyrighted material, are publicly available only in hard copy. Publicly available docket materials are available either electronically in https:// www.regulations.gov or in hard copy at the OEI Docket in the EPA Headquarters Docket Center. Dated: March 16, 2009. Rebecca Clark, Acting Director, National Center for Environmental Assessment. [FR Doc. E9–8795 Filed 4–15–09; 8:45 am] BILLING CODE 6560–50–P EQUAL EMPLOYMENT OPPORTUNITY COMMISSION Commission Meeting Equal Employment Opportunity Commission. DATE AND TIME: Wednesday, April 22, 2009, 10 a.m. Eastern Time. PLACE: Commission Meeting Room on the First Floor of the EEOC Office Building, 131 ‘‘M’’ Street, NE., Washington, DC 20507. STATUS: The meeting will be open to the public. MATTERS TO BE CONSIDERED: OPEN SESSION: 1. Announcement of Notation Votes, and AGENCY HOLDING THE MEETING: E:\FR\FM\16APN1.SGM 16APN1

Agencies

[Federal Register Volume 74, Number 72 (Thursday, April 16, 2009)]
[Notices]
[Pages 17666-17667]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-8795]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8785-9; Docket ID No. EPA-HQ-ORD-2009-0173]


Physiological Parameters Database for PBPK Modeling

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period.

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

SUMMARY: EPA is announcing a public comment period for an on-line 
database file, using the Microsoft[supreg] Access database management 
system, that contains a comprehensive collection of physiological 
parameter data intended to be suitable for application in 
physiologically based pharmacokinetic (PBPK) modeling. The public 
comment period will be for 30 days. EPA requests that interested users 
comment on the functionality or usability of this resource and provide 
comments that may be considered for improving the final product.
    The draft database represents a compilation of several individual 
databases developed over the past few years. It contains physiological 
parameter data for humans from infancy through old age, as well as data 
for experimental laboratory species. EPA requests that end-users 
provide feedback regarding their experience working with this database. 
Users are also encouraged to comment on specific studies or methods 
employed in the

[[Page 17667]]

studies included in the entire draft database.
    As a means of quality assurance and quality control (QA/QC), about 
30% of the data entries, randomly selected, have been verified by an 
independent contractor. This QA/QC process will be ongoing.

DATES: The 30-day public comment period begins April 16, 2009 and ends 
May 18, 2009. Technical comments should be in writing and must be 
received by EPA by close of business, May 18, 2009.

ADDRESSES: The draft database is available for download from the U.S. 
EPA Web site https://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=204443. Users must have Microsoft[supreg] Access 
in order to open and manipulate the database file.
    Comments may be submitted electronically via EPA's E-Docket, by 
mail, by facsimile, or by hand delivery/courier. Please follow the 
detailed instructions as provided in the SUPPLEMENTARY INFORMATION 
section of this notice.

FOR FURTHER INFORMATION CONTACT: For information on the public comment 
period, contact the Office of Environmental Information Docket; 
telephone: 202-566-1752; facsimile: 202-566-1753; or e-mail: 
ORD.Docket@epa.gov.
    If you have questions about the database, please contact the 
Information Management Staff, National Center for Environmental 
Assessment, U.S. Environmental Protection Agency, Washington, DC 20460; 
telephone: 703-347-8561; facsimile: 703-347-8691; or e-mail: 
NCEADC.Comment@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Information About the Product

    Physiologically based pharmacokinetic (PBPK) models represent an 
important class of dosimetry models that are useful for predicting 
internal dose at target organs for risk assessment applications. Dose-
response relationships that appear unclear or confusing at the 
administered dose level can become more understandable when expressed 
on the basis of internal dose of the chemical. To predict internal dose 
level, PBPK models use physiological data to construct mathematical 
representations of biological processes associated with the absorption, 
distribution, metabolism, and elimination of compounds. With the 
appropriate data, these models can be used to extrapolate across 
species, lifestages, and exposure scenarios, as well as address various 
sources of uncertainty in risk assessments. This database contains a 
collection of physiological data relevant for parameterizing PBPK 
models for children, adults, and the elderly. In addition, the database 
contains physiological data for parameterizing PBPK models for young 
(i.e., developing) and adult rodents.

II. How To Submit Technical Comments to the Docket at Regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2009-
0173, by one of the following methods:
     https://www.regulations.gov: Follow the on-line 
instructions for submitting comments.
     E-mail: ORD.Docket@epa.gov.
     Fax: 202-566-1753.
     Mail: Office of Environmental Information (OEI) Docket 
(Mail Code: 2822T), U.S. Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460. The phone number is 202-
566-1752.
     Hand Delivery: The OEI Docket is located in the EPA 
Headquarters Docket Center, Room 3334 EPA West Building, 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. Such deliveries are only accepted during 
the docket's normal hours of operation, and special arrangements should 
be made for deliveries of boxed information.
    If you provide comments by mail or hand delivery, please submit an 
original and three copies of the comments. For attachments, provide an 
index, number pages consecutively with the comments, and submit an 
unbound original and three copies.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2009-0173. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the closing date will 
be marked ``late,'' and may only be considered if time permits. It is 
EPA's policy to include all comments it receives in the public docket 
without change and to make the comments available online at https://www.regulations.gov, including any personal information provided, 
unless a 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 through https://www.regulations.gov or e-
mail. The https://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 https://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. For additional information about EPA's public docket visit the 
EPA Docket Center homepage at https://www.epa.gov/epahome/dockets.htm.
    Docket: Documents in the docket are listed in the https://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 materials, 
such as copyrighted material, are publicly available only in hard copy. 
Publicly available docket materials are available either electronically 
in https://www.regulations.gov or in hard copy at the OEI Docket in the 
EPA Headquarters Docket Center.

    Dated: March 16, 2009.
Rebecca Clark,
Acting Director, National Center for Environmental Assessment.
[FR Doc. E9-8795 Filed 4-15-09; 8:45 am]
BILLING CODE 6560-50-P
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