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Federal Register
Vol. 74, No. 12
Wednesday, January 21, 2009
Vol. 74, No. 12
Wednesday, January 21, 2009
There are 6 announcements in this issue
1. ENERGY - PR/NM. DOE/Office of Energy Efficiency and Renewable Energy. Energy Conservation Program: Test Procedures for Fluorescent Lamp Ballasts in Standby Mode
2. AIR - FR. EPA. Air Quality: Revision to Definition of Volatile Organic
Compounds--Exclusion of Propylene Carbonate and Dimethyl Carbonate
Compounds--Exclusion of Propylene Carbonate and Dimethyl Carbonate
3. TOXICS - ICR. EPA. Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; Recordkeeping and Reporting Requirements for Allegations of Significant Adverse Reactions to Human Health or the Environment; EPA ICR No. 1031.09, OMB No. 2070-0017
4. TOXICS - ND. DHHS/FDA. Draft Guidance for Industry on Animal Models--Essential Elements to Address Efficacy Under the Animal Rule
5. TOXICS - ND. DHHS/FDA. Report of Quantitative Risk and Benefit Assessment of Commercial Fish Consumption, Focusing on Fetal Neurodevelopmental Effects (Measured by Verbal Development in Children) and on Coronary Heart Disease and Stroke in the General Population, and Summary of Published Research on the Beneficial Effects of Fish Consumption and Omega-3 Fatty Acids for Certain Neurodevelopmental and Cardiovascular Endpoints; Availability
6. ENERGY - ND. DOI/MMS. Request for Comments on the Draft Proposed 5-Year Outer Continental Shelf (OCS) Oil and Gas Leasing Program for 2010-2015 and Notice of Intent To Prepare an Environmental Impact Statement (EIS) for the Proposed 5-Year Program
CODES USED: THE FOLLOWING CODES ARE USED TO IDENTIFY THE TYPE OF ANNOUNCEMENT & ISSUE AREA.
REPORTING FORMAT: ISSUE CODE - TYPE CODE. AGENCY. ANNOUNCEMENT.
ISSUE CODES: AIR - Air; ALL - Cross-Media, ecosystems, Env. Justice; CLIMATE - Climate Change, Global Warming; DRINK - Drinking Water, SDWA, Underground Injection; ENERGY - Energy; GLAKES - Great Lakes; HAZ - Hazardous Waste, RCRA, HSWA, DOT/RSPA, Some Nuclear (NRC); LAND - Land Use, Forests; P2 - Pollution Prevention, Sustainability, Recycling, Pjt. XL; REMED - Remediation, Brownfields, Superfund; TANKS - AST, UST; TOXICS = Toxics, TRI, TSCA, Pesticides, Risks, RTK; TRANSPORT - Transportation; SOLID - Solid Waste, RCRA Subtitle D; WATER - Surface Water, NPS, NPDES, Wetlands; WILDLIFE = Wildlife, Biodiversity, Endangered Species.
TYPE CODES: ANPR - Advance Notice of Proposed Rulemaking; FR - Final Rule; FRD - Direct final rule; FRI - Interim final rule; ICR - Information Collection Request; ND - Notice of data, information, reports, etc. availability; NF - Notice of Fuding Opportunity; NM - Notice of Meeting; NS - Notice of administrative/court settlement; PR - Proposed Rule; ROD - Record of decision.
ANNOUNCEMENT 1
Subject: ENERGY - PR/NM. DOE/Office of Energy Efficiency and Renewable Energy. Energy Conservation Program: Test Procedures for Fluorescent Lamp Ballasts in Standby Mode
[Federal Register: January 21, 2009 (Volume 74, Number 12)]
[Proposed Rules]
[Page 3450-3462]
DEPARTMENT OF ENERGY
10 CFR Part 430
[Docket No. EERE-2008-BT-TP-0007]
RIN 1904-AB77
Energy Conservation Program: Test Procedures for Fluorescent Lamp
Ballasts in Standby Mode
AGENCY: Office of Energy Efficiency and Renewable Energy, U.S.
Department of Energy.
ACTION: Notice of proposed rulemaking and public meeting.
-----------------------------------------------------------------------
SUMMARY: The U.S. Department of Energy (DOE) is proposing amendments to
its test procedures for fluorescent lamp ballasts under the Energy
Policy and Conservation Act. These amendments address the measurement
of energy consumption of fluorescent lamp ballasts in the standby and
off modes. DOE is also announcing a public meeting to receive comment
on the issues presented in this notice.
DATES: DOE will hold a public meeting on February 2, 2009 beginning at
10:30 a.m. in Washington, DC. DOE must receive requests to speak at the
meeting before 4 p.m., January 26, 2009. DOE must receive a signed
original and an electronic copy of statements to be given at the public
meeting before 4 p.m., January 26, 2009.
DOE will accept comments, data, and information regarding this
notice of proposed rulemaking (NOPR) before or after the public
meeting, but no later than April 6, 2009. See Section V, ``Public
Participation,'' of this NOPR for details.
ADDRESSES: The public meeting will be held at the U.S. Department of
Energy, Forrestal Building, Room 8E-089, 1000 Independence Avenue, SW.,
Washington, DC 20585-0121. To attend the public meeting, please notify
Ms. Brenda Edwards at (202) 586-2945. Please note that foreign
nationals participating in the public meeting are subject to advance
security screening procedures, requiring a 30-day advance notice. If a
foreign national wishes to participate in the workshop, please inform
DOE of this fact as soon as possible by contacting Ms. Brenda Edwards
at (202) 586-2945 so that the necessary procedures can be completed.
Any comments submitted must identify the NOPR on Test Procedures
for Fluorescent Lamp Ballasts in Standby Mode, and provide the docket
number EERE-2008-BT-TP-0007 and/or Regulation Identifier Number (RIN)
1904-AB77. Comments may be submitted using any of the following
methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
E-mail: Ballasts_Standby.Rulemaking@hq.doe.gov. Include
the docket number EERE-2008-BT-TP-0007 and/or RIN 1904-AB77 in the
subject line of the message.
Postal Mail: Ms. Brenda Edwards, U.S. Department of
Energy, Building Technologies Program, Mailstop EE-2J, 1000
Independence Avenue, SW., Washington, DC 20585-0121. Please submit one
signed paper original.
Hand Delivery/Courier: Ms. Brenda Edwards, U.S. Department
of Energy, Building Technologies Program, 6th Floor, 950 L'Enfant
Plaza, SW., Washington, DC 20024. Telephone: (202) 586-2945. Please
submit one signed paper original.
For detailed instructions on submitting comments and additional
information on the rulemaking process, see Section V, ``Public
Participation,'' of this document.
Docket: For access to the docket to read background documents or
comments received, visit the U.S. Department of Energy, 6th Floor, 950
L'Enfant Plaza, SW., Washington, DC 20024, (202) 586-2945, between 9
a.m. and 4 p.m., Monday through Friday, except Federal holidays. Please
call Ms. Brenda Edwards at (202) 586-2945 for additional information
regarding visiting the Resource Room.
FOR FURTHER INFORMATION CONTACT: Mrs. Linda Graves, U.S. Department of
Energy, Office of Energy Efficiency and Renewable Energy, Building
Technologies Program, EE-2J, 1000 Independence Avenue, SW., Washington,
DC 20585-0121. Telephone: (202) 586-1851. E-mail:
Linda.Graves@ee.doe.gov. In the Office of the General Counsel, contact
Ms. Francine Pinto, U.S. Department of Energy, Office of the General
Counsel, GC-72, 1000 Independence Avenue, SW., Washington, DC 20585.
Telephone: (202) 586-9507. E-mail: Francine.Pinto@hq.doe.gov.
For additional information on how to submit or review public
comments and on how to participate in the public meeting, contact Ms.
Brenda Edwards, U.S. Department of Energy, Office of Energy Efficiency
and Renewable Energy, Building Technologies Program, EE-2J, 1000
Independence Avenue, SW., Washington, DC 20585-0121. Telephone: (202)
586-2945. E-mail: Brenda.Edwards@ee.doe.gov.
[Proposed Rules]
[Page 3450-3462]
DEPARTMENT OF ENERGY
10 CFR Part 430
[Docket No. EERE-2008-BT-TP-0007]
RIN 1904-AB77
Energy Conservation Program: Test Procedures for Fluorescent Lamp
Ballasts in Standby Mode
AGENCY: Office of Energy Efficiency and Renewable Energy, U.S.
Department of Energy.
ACTION: Notice of proposed rulemaking and public meeting.
-----------------------------------------------------------------------
SUMMARY: The U.S. Department of Energy (DOE) is proposing amendments to
its test procedures for fluorescent lamp ballasts under the Energy
Policy and Conservation Act. These amendments address the measurement
of energy consumption of fluorescent lamp ballasts in the standby and
off modes. DOE is also announcing a public meeting to receive comment
on the issues presented in this notice.
DATES: DOE will hold a public meeting on February 2, 2009 beginning at
10:30 a.m. in Washington, DC. DOE must receive requests to speak at the
meeting before 4 p.m., January 26, 2009. DOE must receive a signed
original and an electronic copy of statements to be given at the public
meeting before 4 p.m., January 26, 2009.
DOE will accept comments, data, and information regarding this
notice of proposed rulemaking (NOPR) before or after the public
meeting, but no later than April 6, 2009. See Section V, ``Public
Participation,'' of this NOPR for details.
ADDRESSES: The public meeting will be held at the U.S. Department of
Energy, Forrestal Building, Room 8E-089, 1000 Independence Avenue, SW.,
Washington, DC 20585-0121. To attend the public meeting, please notify
Ms. Brenda Edwards at (202) 586-2945. Please note that foreign
nationals participating in the public meeting are subject to advance
security screening procedures, requiring a 30-day advance notice. If a
foreign national wishes to participate in the workshop, please inform
DOE of this fact as soon as possible by contacting Ms. Brenda Edwards
at (202) 586-2945 so that the necessary procedures can be completed.
Any comments submitted must identify the NOPR on Test Procedures
for Fluorescent Lamp Ballasts in Standby Mode, and provide the docket
number EERE-2008-BT-TP-0007 and/or Regulation Identifier Number (RIN)
1904-AB77. Comments may be submitted using any of the following
methods:
Follow the instructions for submitting comments.
the docket number EERE-2008-BT-TP-0007 and/or RIN 1904-AB77 in the
subject line of the message.
Energy, Building Technologies Program, Mailstop EE-2J, 1000
Independence Avenue, SW., Washington, DC 20585-0121. Please submit one
signed paper original.
of Energy, Building Technologies Program, 6th Floor, 950 L'Enfant
Plaza, SW., Washington, DC 20024. Telephone: (202) 586-2945. Please
submit one signed paper original.
For detailed instructions on submitting comments and additional
information on the rulemaking process, see Section V, ``Public
Participation,'' of this document.
Docket: For access to the docket to read background documents or
comments received, visit the U.S. Department of Energy, 6th Floor, 950
L'Enfant Plaza, SW., Washington, DC 20024, (202) 586-2945, between 9
a.m. and 4 p.m., Monday through Friday, except Federal holidays. Please
call Ms. Brenda Edwards at (202) 586-2945 for additional information
regarding visiting the Resource Room.
FOR FURTHER INFORMATION CONTACT: Mrs. Linda Graves, U.S. Department of
Energy, Office of Energy Efficiency and Renewable Energy, Building
Technologies Program, EE-2J, 1000 Independence Avenue, SW., Washington,
DC 20585-0121. Telephone: (202) 586-1851. E-mail:
Linda.Graves@ee.doe.gov. In the Office of the General Counsel, contact
Ms. Francine Pinto, U.S. Department of Energy, Office of the General
Counsel, GC-72, 1000 Independence Avenue, SW., Washington, DC 20585.
Telephone: (202) 586-9507. E-mail: Francine.Pinto@hq.doe.gov.
For additional information on how to submit or review public
comments and on how to participate in the public meeting, contact Ms.
Brenda Edwards, U.S. Department of Energy, Office of Energy Efficiency
and Renewable Energy, Building Technologies Program, EE-2J, 1000
Independence Avenue, SW., Washington, DC 20585-0121. Telephone: (202)
586-2945. E-mail: Brenda.Edwards@ee.doe.gov.
ACCESS THE COMPLETE PUBLISHED ANNOUNCEMENT IN HTML OR PDF FORMATS AT:
ANNOUNCEMENT 2
Subject: AIR - FR. EPA. Air Quality: Revision to Definition of Volatile Organic
Compounds--Exclusion of Propylene Carbonate and Dimethyl Carbonate
[Federal Register: January 21, 2009 (Volume 74, Number 12)]
[Rules and Regulations]
[Page 3437-3441]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 51
[EPA-HQ-OAR-2006-0948; FRL-8763-7]
RIN 2060-AN75
Air Quality: Revision to Definition of Volatile Organic
Compounds--Exclusion of Propylene Carbonate and Dimethyl Carbonate
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This action revises EPA's definition of volatile organic
compounds (VOCs) for purposes of preparing state implementation plans
(SIPs) to attain the national ambient air quality standard for ozone
under Title I of the Clean Air Act (Act). This revision adds the
compounds propylene carbonate and dimethyl carbonate to the list of
compounds which are excluded from the definition of VOC on the basis
that these compounds make a negligible contribution to tropospheric
ozone formation.
DATES: This final rule is effective on February 20, 2009.
ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-HQ-OAR-2006-0948. All documents in the docket are
listed on the http://www.regulations.gov Web site. Although listed in
the index, some information is not publicly available, i.e.,
confidential business information (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 http://www.regulations.gov or in hard copy at the Docket ID No. EPA-
HQ-OAR-2006-0948, EPA/DC, EPA West, Room 3334, 1301 Constitution
Avenue, Northwest, 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 Docket ID No. EPA-HQ-OAR-
2006-0948 is (202) 566-1742.
FOR FURTHER INFORMATION CONTACT: William L. Johnson, Office of Air
Quality Planning and Standards, Air Quality Policy Division, Mail code
C539-01, Research Triangle Park, NC 27711, telephone (919) 541-5245.;
fax number: 919-541-0824; e-mail address: Johnson.WilliamL@epa.gov.
[Rules and Regulations]
[Page 3437-3441]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 51
[EPA-HQ-OAR-2006-0948; FRL-8763-7]
RIN 2060-AN75
Air Quality: Revision to Definition of Volatile Organic
Compounds--Exclusion of Propylene Carbonate and Dimethyl Carbonate
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This action revises EPA's definition of volatile organic
compounds (VOCs) for purposes of preparing state implementation plans
(SIPs) to attain the national ambient air quality standard for ozone
under Title I of the Clean Air Act (Act). This revision adds the
compounds propylene carbonate and dimethyl carbonate to the list of
compounds which are excluded from the definition of VOC on the basis
that these compounds make a negligible contribution to tropospheric
ozone formation.
DATES: This final rule is effective on February 20, 2009.
ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-HQ-OAR-2006-0948. All documents in the docket are
listed on the http://www.regulations.gov Web site. Although listed in
the index, some information is not publicly available, i.e.,
confidential business information (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 http://www.regulations.gov or in hard copy at the Docket ID No. EPA-
HQ-OAR-2006-0948, EPA/DC, EPA West, Room 3334, 1301 Constitution
Avenue, Northwest, 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 Docket ID No. EPA-HQ-OAR-
2006-0948 is (202) 566-1742.
FOR FURTHER INFORMATION CONTACT: William L. Johnson, Office of Air
Quality Planning and Standards, Air Quality Policy Division, Mail code
C539-01, Research Triangle Park, NC 27711, telephone (919) 541-5245.;
fax number: 919-541-0824; e-mail address: Johnson.WilliamL@epa.gov.
ANNOUNCEMENT 3
Subject: TOXICS - ICR. EPA. Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; Recordkeeping and Reporting
Requirements for Allegations of Significant Adverse Reactions to Human Health or the Environment; EPA ICR No. 1031.09, OMB No. 2070-0017
[Federal Register: January 21, 2009 (Volume 74, Number 12)]
[Notices]
[Page 3591-3592]
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2008-0221; FRL-8765-1]
Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Recordkeeping and Reporting
Requirements for Allegations of Significant Adverse Reactions to Human
Health or the Environment; EPA ICR No. 1031.09, OMB No. 2070-0017
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that the following Information
Collection Request (ICR) has been forwarded to the Office of Management
and Budget (OMB) for review and approval: TSCA Recordkeeping and
Reporting Requirements for Allegations of Significant Adverse Reactions
to Human Health or the Environment; EPA ICR No. 1031.09, OMB No. 2070-
0017. The ICR, which is abstracted below, describes the nature of the
information collection activity and its expected burden and costs.
DATES: Additional comments may be submitted on or before February 20,
2009.
ADDRESSES: Submit your comments, referencing docket ID Number EPA-HQ-
OPPT-2008-0221 to (1) EPA online using www.regulations.gov (our
preferred method), by e-mail to oppt.ncic@epa.gov or by mail to:
Document Control Office (DCO), Office of Pollution Prevention and
Toxics (OPPT), Environmental Protection Agency, Mail Code: 7407T, 1200
Pennsylvania Ave., NW., Washington, DC 20460, and (2) OMB at: Office of
Information and Regulatory Affairs, Office of Management and Budget
(OMB), Attention: Desk Officer for EPA, 725 17th Street, NW.,
Washington, DC 20503.
FOR FURTHER INFORMATION CONTACT: Barbara Cunningham, Director,
Environmental Assistance Division, Office of Pollution Prevention and
Toxics, Environmental Protection Agency, Mailcode: 7408-M, 1200
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 202-
554-1404; e-mail address: TSCA-Hotline@epa.gov.
[Notices]
[Page 3591-3592]
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2008-0221; FRL-8765-1]
Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Recordkeeping and Reporting
Requirements for Allegations of Significant Adverse Reactions to Human
Health or the Environment; EPA ICR No. 1031.09, OMB No. 2070-0017
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that the following Information
Collection Request (ICR) has been forwarded to the Office of Management
and Budget (OMB) for review and approval: TSCA Recordkeeping and
Reporting Requirements for Allegations of Significant Adverse Reactions
to Human Health or the Environment; EPA ICR No. 1031.09, OMB No. 2070-
0017. The ICR, which is abstracted below, describes the nature of the
information collection activity and its expected burden and costs.
DATES: Additional comments may be submitted on or before February 20,
2009.
ADDRESSES: Submit your comments, referencing docket ID Number EPA-HQ-
OPPT-2008-0221 to (1) EPA online using www.regulations.gov (our
preferred method), by e-mail to oppt.ncic@epa.gov or by mail to:
Document Control Office (DCO), Office of Pollution Prevention and
Toxics (OPPT), Environmental Protection Agency, Mail Code: 7407T, 1200
Pennsylvania Ave., NW., Washington, DC 20460, and (2) OMB at: Office of
Information and Regulatory Affairs, Office of Management and Budget
(OMB), Attention: Desk Officer for EPA, 725 17th Street, NW.,
Washington, DC 20503.
FOR FURTHER INFORMATION CONTACT: Barbara Cunningham, Director,
Environmental Assistance Division, Office of Pollution Prevention and
Toxics, Environmental Protection Agency, Mailcode: 7408-M, 1200
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 202-
554-1404; e-mail address: TSCA-Hotline@epa.gov.
ANNOUNCEMENT 4
Subject: TOXICS - ND. DHHS/FDA. Draft Guidance for Industry on Animal Models--Essential Elements to Address Efficacy Under the Animal Rule
[Federal Register: January 21, 2009 (Volume 74, Number 12)]
[Notices]
[Page 3610-3611]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0007]
Draft Guidance for Industry on Animal Models--Essential Elements
to Address Efficacy Under the Animal Rule
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: FDA is announcing the availability of a draft guidance
entitled ``Animal Models--Essential Elements to Address Efficacy Under
the Animal Rule.'' When human efficacy studies are neither ethical nor
feasible, animal efficacy studies may be relied on under the Animal
Rule to support approval or licensure of a drug or biological product.
This guidance identifies and discusses the critical characteristics of
an animal model that should be addressed when developing products for
approval under the Animal Rule. The guidance is intended to help
sponsors determine whether the model meets the requirements of the
Animal Rule.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by March 23, 2009.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002; or
Office of Communication, Training, and Manufacturers Assistance (HFM-
40), Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in
processing your requests. The draft guidance may also be obtained by
mail by calling CBER at 1-800-835-4709 or 301-827-1800. Send one self-
addressed adhesive label to assist that office in processing your
requests. Submit written comments on the draft guidance to the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Rosemary Roberts, Office of Counter-Terrorism and Emergency
Coordination, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 3342, Mail Stop
3329, Silver Spring, MD 20993, 301-796-2210 or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-
827-6210.
[Notices]
[Page 3610-3611]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0007]
Draft Guidance for Industry on Animal Models--Essential Elements
to Address Efficacy Under the Animal Rule
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: FDA is announcing the availability of a draft guidance
entitled ``Animal Models--Essential Elements to Address Efficacy Under
the Animal Rule.'' When human efficacy studies are neither ethical nor
feasible, animal efficacy studies may be relied on under the Animal
Rule to support approval or licensure of a drug or biological product.
This guidance identifies and discusses the critical characteristics of
an animal model that should be addressed when developing products for
approval under the Animal Rule. The guidance is intended to help
sponsors determine whether the model meets the requirements of the
Animal Rule.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by March 23, 2009.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002; or
Office of Communication, Training, and Manufacturers Assistance (HFM-
40), Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in
processing your requests. The draft guidance may also be obtained by
mail by calling CBER at 1-800-835-4709 or 301-827-1800. Send one self-
addressed adhesive label to assist that office in processing your
requests. Submit written comments on the draft guidance to the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Rosemary Roberts, Office of Counter-Terrorism and Emergency
Coordination, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 3342, Mail Stop
3329, Silver Spring, MD 20993, 301-796-2210 or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-
827-6210.
ANNOUNCEMENT 5
Subject: TOXICS - ND. DHHS/FDA. Report of Quantitative Risk and Benefit Assessment of Commercial Fish Consumption, Focusing on Fetal Neurodevelopmental Effects (Measured by Verbal Development in Children) and on Coronary Heart Disease and Stroke in the General Population, and Summary of Published Research on the Beneficial Effects of Fish Consumption and Omega-3
Fatty Acids for Certain Neurodevelopmental and Cardiovascular Endpoints; Availability
[Federal Register: January 21, 2009 (Volume 74, Number 12)]
[Notices]
[Page 3615-3617]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0018]
Report of Quantitative Risk and Benefit Assessment of Commercial
Fish Consumption, Focusing on Fetal Neurodevelopmental Effects
(Measured by Verbal Development in Children) and on Coronary Heart
Disease and Stroke in the General Population, and Summary of Published
Research on the Beneficial Effects of Fish Consumption and Omega-3
Fatty Acids for Certain Neurodevelopmental and Cardiovascular
Endpoints; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of two draft documents. The first is entitled ``Report of
Quantitative Risk and Benefit Assessment of Commercial Fish
Consumption, Focusing on Fetal Neurodevelopmental Effects (Measured by
Verbal Development in Children) and on Coronary Heart Disease and
Stroke in the General Population'' (draft risk and benefit assessment
report). The draft risk and benefit assessment report describes an
analysis done by FDA that results in quantitative estimates of the net
effect on fetal neurodevelopment in children of maternal consumption of
commercial fish, as measured by verbal development and the net effect
of eating commercial fish on coronary heart disease and stroke in the
general population. Effects with respect to each of these health
endpoints has been associated in the scientific literature with
methylmercury exposure (which primarily occurs through fish
consumption) and with the consumption of fish and of omega-3 fatty
acids, which are found in fish. The second draft document entitled
``Summary of Published Research on the Beneficial Effects of Fish
Consumption and Omega-3 Fatty Acids for Certain Neurodevelopmental and
Cardiovascular Endpoints'' (draft summary of published research) is a
compendium of research prepared by FDA for use in developing its
quantitative risk and benefit assessment. When peer and public review
are complete, the draft risk and benefit assessment report and the
draft summary of published research are intended to add to the growing
body of scientific literature investigating the
likelihood, magnitude, and direction of health impacts linked to
consumption of commercial fish. FDA is seeking public comment on the
draft risk and benefit assessment report and the draft summary of
published research.
DATES: Comments on the draft risk and benefit assessment and on the
draft summary of published research must be submitted by April 21,
2009.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Philip Spiller, Center for Food
Safety and Applied Nutrition (HFS-002), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1428, FAX
301-436-2668, e-mail: Philip.Spiller@fda.hhs.gov.
[Notices]
[Page 3615-3617]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0018]
Report of Quantitative Risk and Benefit Assessment of Commercial
Fish Consumption, Focusing on Fetal Neurodevelopmental Effects
(Measured by Verbal Development in Children) and on Coronary Heart
Disease and Stroke in the General Population, and Summary of Published
Research on the Beneficial Effects of Fish Consumption and Omega-3
Fatty Acids for Certain Neurodevelopmental and Cardiovascular
Endpoints; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of two draft documents. The first is entitled ``Report of
Quantitative Risk and Benefit Assessment of Commercial Fish
Consumption, Focusing on Fetal Neurodevelopmental Effects (Measured by
Verbal Development in Children) and on Coronary Heart Disease and
Stroke in the General Population'' (draft risk and benefit assessment
report). The draft risk and benefit assessment report describes an
analysis done by FDA that results in quantitative estimates of the net
effect on fetal neurodevelopment in children of maternal consumption of
commercial fish, as measured by verbal development and the net effect
of eating commercial fish on coronary heart disease and stroke in the
general population. Effects with respect to each of these health
endpoints has been associated in the scientific literature with
methylmercury exposure (which primarily occurs through fish
consumption) and with the consumption of fish and of omega-3 fatty
acids, which are found in fish. The second draft document entitled
``Summary of Published Research on the Beneficial Effects of Fish
Consumption and Omega-3 Fatty Acids for Certain Neurodevelopmental and
Cardiovascular Endpoints'' (draft summary of published research) is a
compendium of research prepared by FDA for use in developing its
quantitative risk and benefit assessment. When peer and public review
are complete, the draft risk and benefit assessment report and the
draft summary of published research are intended to add to the growing
body of scientific literature investigating the
likelihood, magnitude, and direction of health impacts linked to
consumption of commercial fish. FDA is seeking public comment on the
draft risk and benefit assessment report and the draft summary of
published research.
DATES: Comments on the draft risk and benefit assessment and on the
draft summary of published research must be submitted by April 21,
2009.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Philip Spiller, Center for Food
Safety and Applied Nutrition (HFS-002), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1428, FAX
301-436-2668, e-mail: Philip.Spiller@fda.hhs.gov.
ANNOUNCEMENT 6
Subject: ENERGY - ND. DOI/MMS. Request for Comments on the Draft Proposed 5-Year Outer Continental Shelf (OCS) Oil and Gas Leasing Program for 2010-2015 and
Notice of Intent To Prepare an Environmental Impact Statement (EIS) for the Proposed 5-Year Program
[Federal Register: January 21, 2009 (Volume 74, Number 12)]
[Notices]
[Page 3631-3635]
DEPARTMENT OF THE INTERIOR
Minerals Management Service
Request for Comments on the Draft Proposed 5-Year Outer
Continental Shelf (OCS) Oil and Gas Leasing Program for 2010-2015 and
Notice of Intent To Prepare an Environmental Impact Statement (EIS) for
the Proposed 5-Year Program
AGENCY: Minerals Management Service, Interior.
ACTION: Request for Comments.
-----------------------------------------------------------------------
SUMMARY: The Minerals Management Service (MMS) requests comments on the
Draft Proposed 5-year OCS Oil and Gas Leasing Program for 2010-2015
(DPP). This draft proposal is for a new oil and gas program to succeed
the current program that is currently set to expire on June 30, 2012,
and forms the basis for conducting the studies and analyses the
Secretary will consider in making future decisions on what areas of the
OCS to include in the program.
Section 18 of the OCS Lands Act (43 U.S.C. 1344) specifies a multi-
step process of consultation and analysis that must be completed before
the Secretary of the Interior may approve a new 5-year program. The
required steps following this notice include the development of a
proposed program, a proposed final program, and Secretarial approval.
Pursuant to the National Environmental Policy Act (NEPA), the MMS also
will prepare an EIS for the new 5-year program.
DATES: Please submit comments and information to the MMS no later than
March 23, 2009.
Public Comment Procedure
The MMS will accept comments in one of two formats: By mail or our
Internet commenting system. Please submit your comments using only one
of these formats, and include full names and addresses. Comments
submitted by other means may not be considered. We will not consider
anonymous comments, and we will make available for inspection in their
entirety all comments submitted by organizations and businesses or by
individuals identifying themselves as representatives of organizations
and businesses.
Our practice is to make comments, including the names and home
addresses of respondents, available for public review. An individual
commenter may ask that we withhold his or her name, home address, or
both from the public record, and we will honor such a request to the
extent allowable by law. If you submit comments and wish us to withhold
such information, you must so state prominently at the beginning of
your submission.
ADDRESSES: You may submit comments on the DPP by any of the following
methods.
Federal eRulemaking Portal: http://www.regulations.gov.
Under the tab ``More Search Options,'' click ``Advanced Docket
Search,'' then select ``Minerals Management Service'' from the agency
drop-down menu, then click the submit button. In the Docket ID column,
select MMS-2008-OMM-0045 to submit public comments and to view related
materials available for this Notice. Information on using
Regulations.gov, including instructions
for accessing documents, submitting comments, and viewing the docket
after the close of the comment period, is available through the site's
``User Tips'' link. The MMS will post all comments on the DPP.
Mail or hand-carry comments to the Department of the
Interior; Minerals Management Service; Attention: Leasing Division
(LD); 381 Elden Street, MS-4010; Herndon, Virginia 20170-4817. Please
reference ``2010-2015 Oil and Gas Leasing in the Outer Continental
Shelf,'' in your comments and include your name and return address.
FOR FURTHER INFORMATION CONTACT: Renee Orr, 5-Year Program Manager, at
(703) 787-1215.
[Notices]
[Page 3631-3635]
DEPARTMENT OF THE INTERIOR
Minerals Management Service
Request for Comments on the Draft Proposed 5-Year Outer
Continental Shelf (OCS) Oil and Gas Leasing Program for 2010-2015 and
Notice of Intent To Prepare an Environmental Impact Statement (EIS) for
the Proposed 5-Year Program
AGENCY: Minerals Management Service, Interior.
ACTION: Request for Comments.
-----------------------------------------------------------------------
SUMMARY: The Minerals Management Service (MMS) requests comments on the
Draft Proposed 5-year OCS Oil and Gas Leasing Program for 2010-2015
(DPP). This draft proposal is for a new oil and gas program to succeed
the current program that is currently set to expire on June 30, 2012,
and forms the basis for conducting the studies and analyses the
Secretary will consider in making future decisions on what areas of the
OCS to include in the program.
Section 18 of the OCS Lands Act (43 U.S.C. 1344) specifies a multi-
step process of consultation and analysis that must be completed before
the Secretary of the Interior may approve a new 5-year program. The
required steps following this notice include the development of a
proposed program, a proposed final program, and Secretarial approval.
Pursuant to the National Environmental Policy Act (NEPA), the MMS also
will prepare an EIS for the new 5-year program.
DATES: Please submit comments and information to the MMS no later than
March 23, 2009.
Public Comment Procedure
The MMS will accept comments in one of two formats: By mail or our
Internet commenting system. Please submit your comments using only one
of these formats, and include full names and addresses. Comments
submitted by other means may not be considered. We will not consider
anonymous comments, and we will make available for inspection in their
entirety all comments submitted by organizations and businesses or by
individuals identifying themselves as representatives of organizations
and businesses.
Our practice is to make comments, including the names and home
addresses of respondents, available for public review. An individual
commenter may ask that we withhold his or her name, home address, or
both from the public record, and we will honor such a request to the
extent allowable by law. If you submit comments and wish us to withhold
such information, you must so state prominently at the beginning of
your submission.
ADDRESSES: You may submit comments on the DPP by any of the following
methods.
Under the tab ``More Search Options,'' click ``Advanced Docket
Search,'' then select ``Minerals Management Service'' from the agency
drop-down menu, then click the submit button. In the Docket ID column,
select MMS-2008-OMM-0045 to submit public comments and to view related
materials available for this Notice. Information on using
Regulations.gov, including instructions
for accessing documents, submitting comments, and viewing the docket
after the close of the comment period, is available through the site's
``User Tips'' link. The MMS will post all comments on the DPP.
Interior; Minerals Management Service; Attention: Leasing Division
(LD); 381 Elden Street, MS-4010; Herndon, Virginia 20170-4817. Please
reference ``2010-2015 Oil and Gas Leasing in the Outer Continental
Shelf,'' in your comments and include your name and return address.
FOR FURTHER INFORMATION CONTACT: Renee Orr, 5-Year Program Manager, at
(703) 787-1215.
