Update of the NICEATM-ICCVAM Five-Year Plan: Request for Comments, 71977-71978 [2011-30001]

Download as PDF Federal Register / Vol. 76, No. 224 / Monday, November 21, 2011 / Notices emcdonald on DSK5VPTVN1PROD with NOTICES definition of a nonfinancial company in the Y–10 glossary. Instructional Revisions. The Federal Reserve proposed to revise and clarify the FR Y–10 instructions to conform with the proposed changes to the reporting form. On the Banking, Nonbanking, and 4(k) Schedules, the Federal Reserve proposed to remove Appendix B— North American Industry Classification System (NAICS) Activity Codes and add the URL to the U.S. Census Bureau’s Web site where reporters may retrieve current NAICS Activity Codes. One commenter suggested that infrequent reporters might find it useful to retain a modified version of the table mapping the financial-in-nature activities of the old Federal Reserve alphanumeric codes to the corresponding NAICS codes. The Federal Reserve agrees and recommends including this table as Appendix B. A footnote would be added to clarify that the Federal Reserve converted from alphanumeric activity codes to NAICS codes in 2004. A bankers’ organization made several comments with regard to the instructional revision requiring that certain entities organized to hold other real estate owned properties be reported on the FR Y–10 Nonbanking Schedule. The commenter stated that reporting the entities holding debts previously contracted would not provide enhanced information to the Federal Reserve and recommended that this proposed revision not be included in the final FR Y–10 instructions. After considering these comments, the Federal Reserve will clarify the FR Y–10 instructions to indicate that a company that holds only foreclosed properties should not be reported. However, a company that holds a mixture of foreclosed properties and non-performing loans that are not yet in default should be reported. FR Y–6 and FR Y–7 The Federal Reserve proposed to change legal address to physical address on the FR Y–6 and FR Y–7. Also, the Federal Reserve proposed to add state and country of incorporation to the FR Y–6. Both commenters expressed concern regarding the proposal to require institutions to provide the state and country of incorporation for each entity provided in organization chart of the FR Y–6. After considering these comments, the Federal Reserve continues to believe that reporting the state and country of incorporation at the entity level is important in connection with section 165(d) of the Dodd-Frank Act, which requires institutions to submit annual resolution plans to VerDate Mar<15>2010 19:15 Nov 18, 2011 Jkt 226001 regulators. These plans will include, among other things, information on legal entities. However, the Federal Reserve recognizes that the reporting of the state and country of incorporation at the entity level may be particularly burdensome for some BHCs to report effective with the December 31, 2011, as-of date. Therefore, the Federal Reserve recommends delaying implementation of this requirement until fiscal years beginning December 31, 2012. Although no comments were received on a similar proposed requirement to provide the country of incorporation for each entity provided in organization chart on the FR Y–7, the Federal Reserve also recommends delaying implementation of this requirement until fiscal years beginning December 31, 2012. Proposal to approve under OMB delegated authority the extension for three years, without revision of the following report: Report title: Supplement to the Report of Changes in Organizational Structure. Agency form number: FR Y–10E. OMB control number: 7100–0297. Frequency: Event-generated. Reporters: BHCs, FBOs, state member banks, Edge and agreement corporations, and nationally chartered banks that are not controlled by a BHC. Estimated annual reporting hours: 1,700 hours. Estimated average hours per response: 0.50 hours. Number of respondents: 3,400. General description of report: This information collection is mandatory under the Federal Reserve Act, the Bank Holding Company Act (BHC Act), and the International Banking Act (12 U.S.C. 248(a)(1), 321, 601, 602, 611a, 615, and 625, 1843(k), 1844(c)(1)(A), 3106(a)) and Regulation K and Y (12 CFR 211.13(c), 225.5(b) and 225.87). Individual respondent data are not considered confidential. However, respondents may request confidential treatment for any information that they believe is subject to an exemption from disclosure under the Freedom of Information Act (FOIA), 5 U.S.C. 552(b). Abstract: The FR Y–10E is a free-form supplement that may be used to collect additional structural information deemed to be critical and needed in an expedited manner. Current Actions: On August 11, 2011, the Federal Reserve published a notice in the Federal Register (76 FR 49769) requesting public comment for 60 days on the extension, with revision, of the Supplement to the Report of Changes in Organizational Structure. The comment period for this notice expired on PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 71977 October 11, 2011. The Federal Reserve did not receive any comments. Board of Governors of the Federal Reserve System, November 16, 2011. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. 2011–29984 Filed 11–18–11; 8:45 am] BILLING CODE 6210–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Update of the NICEATM–ICCVAM FiveYear Plan: Request for Comments Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). ACTION: Request for Comments. AGENCY: The NIEHS and the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) request public comments that can be considered by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and agencies’ program offices in updating The NICEATM–ICCVAM Five-Year Plan (2008–2012) (ICCVAM, 2008). The current plan addresses: (1) Identification of areas of high priority for new and revised non-animal and alternative assays to reduce, refine (enhance animal well-being and lessen or avoid pain and distress), and replace the use of animals in testing and (2) research, development, translation, and validation of new and revised nonanimal and other alternatives assays for integration of relevant and reliable methods into Federal agencies’ testing programs. DATES: Submit comments on or before January 15, 2012. ADDRESSES: NICEATM prefers that comments be submitted electronically via the NICEATM–ICCVAM Web site (https://iccvam.niehs.nih.gov/contact/ FR_pubcomment.htm) or via email to niceatm@niehs.nih.gov. Written comments may also be sent by mail or fax to Dr. William S. Stokes, Director, NICEATM, NIEHS, P.O. Box 12233, Mail Stop: K2–16, Research Triangle Park, NC 27709; (fax) 919–541–0947. Courier address: NICEATM, NIEHS, Room 2034, 530 Davis Drive, Morrisville, NC 27560. FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes: (telephone) (919) 541–2384, (fax) (919) 541–0947, or (email) niceatm@niehs.nih.gov. SUPPLEMENTARY INFORMATION: SUMMARY: E:\FR\FM\21NON1.SGM 21NON1 71978 Federal Register / Vol. 76, No. 224 / Monday, November 21, 2011 / Notices Background Congress established ICCVAM to promote development, validation, and regulatory acceptance of new or revised alternative toxicological test methods that protect human and animal health and the environment while reducing, refining (enhancing animal well-being and lessening or avoiding pain and distress), or replacing animal tests and ensuring human safety and product effectiveness (42 U.S.C. 285l–3). In 2008 NICEATM and ICCVAM published a five-year plan for the years 2008 through 2012. The plan addressed (1) identification of areas of high priority for new and revised non-animal and alternative assays for reduction, refinement, and replacement of animal tests and (2) research, development, translation, and validation of new and revised non-animal and other alternative assays for integration into Federal agency testing programs (ICCVAM, 2008). Progress relevant to the five-year plan can be found in the Biennial Progress Report: Interagency Coordinating Committee on the Validation of Alternative Methods— 2008–2009 (ICCVAM, 2010) and on the ICCVAM Web site (https:// iccvam.niehs.nih.gov). ICCVAM and agencies’ program offices are preparing to update the plan and identify goals and priorities for the years 2013–2017. emcdonald on DSK5VPTVN1PROD with NOTICES Request for Public Comments The NIEHS and NICEATM invite public comments for consideration by ICCVAM and agencies’ program offices in updating the current NICEATM– ICCVAM five-year plan. With regard to reducing, refining, and replacing animal use, ICCVAM identified and ranked the types of regulatory safety tests in the 2008–2012 plan that it considered the highest priority for the development and validation of alternative test methods. These priorities were based on the severity of unrelieved pain and distress and the number of animals involved in each type of testing, as well as individual agency’s priorities. The priorities were as follows: • Highest priority testing areas: Acute eye irritation and corrosion, acute skin toxicity (including irritation/corrosion, sensitization, absorption), acute systemic toxicity (acute poisoning)— oral/dermal/inhalation, and biologics/ vaccines. • Other priority testing areas: immunotoxicity, endocrine disruptors, pyrogenicity, reproductive/ VerDate Mar<15>2010 16:00 Nov 18, 2011 Jkt 226001 developmental toxicity, and chronic toxicity/carcinogenicity. • Other testing areas of interest: neurotoxicity. The NIEHS and NICEATM seek public input on the following questions: 1. Do you have comments on the priority areas for the development and validation of alternative test methods listed above? 2. Considering available science and technology, what development, translation, and validation activities are most likely to have the greatest impacts within the next five years on reducing, refining, or replacing animal use in the priority areas? 3. What research and development activities hold the greatest promise in the long-term for reducing, refining, or replacing animal use in the priority areas? 4. What are appropriate measures for evaluating progress in enhancing the development and use of alternative test methods in the priority areas? Individuals submitting comments should include appropriate contact information (name, affiliation, mailing address, phone, fax, email, and sponsoring organization, if applicable). All comments received by January 15, 2012, will be posted on the NICEATM– ICCVAM Web site (https://ntpapps.niehs.nih.gov/iccvampb/ searchPubCom.cfm) and identified by the individual’s name and affiliation, as well as sponsoring organization, if applicable. Background Information on NICEATM and ICCVAM ICCVAM is an interagency committee composed of representatives from 15 Federal regulatory and research agencies that require, use, generate, or disseminate toxicological and safety testing information. ICCVAM conducts technical evaluations of new, revised, and alternative testing methods with regulatory applicability and promotes the scientific validation and regulatory acceptance of toxicological and safety testing methods that more accurately assess the safety and hazards of chemicals and products and that reduce, refine (enhance animal well-being and lessen or avoid pain and distress), or replace animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3) established ICCVAM as a permanent interagency committee of the NIEHS under NICEATM. NICEATM administers ICCVAM, provides scientific and operational support for PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 ICCVAM-related activities, and conducts independent validation studies to assess the usefulness and limitations of new, revised, and alternative test methods and strategies. NICEATM and ICCVAM welcome the public nomination of new, revised, and alternative test methods and strategies applicable to the needs of Federal agencies. Additional information about NICEATM and ICCVAM can be found on the NICEATM–ICCVAM Web site (https://iccvam.niehs.nih.gov). References ICCVAM. 2008. The NICEATM–ICCVAM Five-Year Plan (2008–2012). NIH Publication No. 08–6410. Research Triangle Park, NC: National Institute of Environmental Health Sciences. Available: https:// iccvam.niehs.nih.gov/docs/5yearplan.htm. ICCVAM. 2010. Biennial Progress Report: Interagency Coordinating Committee on the Validation of Alternative Methods—2008– 2009. NIH Publication No. 10–7612. Research Triangle Park, NC: National Institute of Environmental Health Sciences. Available: https://iccvam.niehs.nih.gov/about/ ICCVAMrpts.htm. Dated: November 10, 2011. John R. Bucher, Associate Director, National Toxicology Program. [FR Doc. 2011–30001 Filed 11–18–11; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Title: Interstate Referral Guide (IFR). OMB No.: 0970–0209. Description: The Intergovernmental Referral Guide (IRG) is a centralized and automated repository of state and Tribal profiles, which contain high-level descriptions of each state and Tribe’s child support enforcement (CSE) program. These profiles provide state and Tribal CSE agencies, and foreign countries with an effective and efficient method for updating and accessing information needed to process intergovernmental child support cases. Respondents: All state and Tribal CSE agencies; foreign countries and Canadian provinces with federal reciprocity; and, with limited access, the general public. E:\FR\FM\21NON1.SGM 21NON1

Agencies

[Federal Register Volume 76, Number 224 (Monday, November 21, 2011)]
[Notices]
[Pages 71977-71978]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-30001]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Update of the NICEATM-ICCVAM Five-Year Plan: Request for Comments

AGENCY: Division of the National Toxicology Program (DNTP), National 
Institute of Environmental Health Sciences (NIEHS), National Institutes 
of Health (NIH).

ACTION: Request for Comments.

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

SUMMARY: The NIEHS and the National Toxicology Program Interagency 
Center for the Evaluation of Alternative Toxicological Methods 
(NICEATM) request public comments that can be considered by the 
Interagency Coordinating Committee on the Validation of Alternative 
Methods (ICCVAM) and agencies' program offices in updating The NICEATM-
ICCVAM Five-Year Plan (2008-2012) (ICCVAM, 2008). The current plan 
addresses: (1) Identification of areas of high priority for new and 
revised non-animal and alternative assays to reduce, refine (enhance 
animal well-being and lessen or avoid pain and distress), and replace 
the use of animals in testing and (2) research, development, 
translation, and validation of new and revised non-animal and other 
alternatives assays for integration of relevant and reliable methods 
into Federal agencies' testing programs.

DATES: Submit comments on or before January 15, 2012.

ADDRESSES: NICEATM prefers that comments be submitted electronically 
via the NICEATM-ICCVAM Web site (https://iccvam.niehs.nih.gov/contact/FR_pubcomment.htm) or via email to niceatm@niehs.nih.gov. Written 
comments may also be sent by mail or fax to Dr. William S. Stokes, 
Director, NICEATM, NIEHS, P.O. Box 12233, Mail Stop: K2-16, Research 
Triangle Park, NC 27709; (fax) 919-541-0947. Courier address: NICEATM, 
NIEHS, Room 2034, 530 Davis Drive, Morrisville, NC 27560.

FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes: (telephone) 
(919) 541-2384, (fax) (919) 541-0947, or (email) niceatm@niehs.nih.gov.

SUPPLEMENTARY INFORMATION: 

[[Page 71978]]

Background

    Congress established ICCVAM to promote development, validation, and 
regulatory acceptance of new or revised alternative toxicological test 
methods that protect human and animal health and the environment while 
reducing, refining (enhancing animal well-being and lessening or 
avoiding pain and distress), or replacing animal tests and ensuring 
human safety and product effectiveness (42 U.S.C. 285l-3). In 2008 
NICEATM and ICCVAM published a five-year plan for the years 2008 
through 2012. The plan addressed (1) identification of areas of high 
priority for new and revised non-animal and alternative assays for 
reduction, refinement, and replacement of animal tests and (2) 
research, development, translation, and validation of new and revised 
non-animal and other alternative assays for integration into Federal 
agency testing programs (ICCVAM, 2008). Progress relevant to the five-
year plan can be found in the Biennial Progress Report: Interagency 
Coordinating Committee on the Validation of Alternative Methods--2008-
2009 (ICCVAM, 2010) and on the ICCVAM Web site (https://iccvam.niehs.nih.gov). ICCVAM and agencies' program offices are 
preparing to update the plan and identify goals and priorities for the 
years 2013-2017.

Request for Public Comments

    The NIEHS and NICEATM invite public comments for consideration by 
ICCVAM and agencies' program offices in updating the current NICEATM-
ICCVAM five-year plan. With regard to reducing, refining, and replacing 
animal use, ICCVAM identified and ranked the types of regulatory safety 
tests in the 2008-2012 plan that it considered the highest priority for 
the development and validation of alternative test methods. These 
priorities were based on the severity of unrelieved pain and distress 
and the number of animals involved in each type of testing, as well as 
individual agency's priorities. The priorities were as follows:
     Highest priority testing areas: Acute eye irritation and 
corrosion, acute skin toxicity (including irritation/corrosion, 
sensitization, absorption), acute systemic toxicity (acute poisoning)--
oral/dermal/inhalation, and biologics/vaccines.
     Other priority testing areas: immunotoxicity, endocrine 
disruptors, pyrogenicity, reproductive/developmental toxicity, and 
chronic toxicity/carcinogenicity.
     Other testing areas of interest: neurotoxicity.
The NIEHS and NICEATM seek public input on the following questions:
    1. Do you have comments on the priority areas for the development 
and validation of alternative test methods listed above?
    2. Considering available science and technology, what development, 
translation, and validation activities are most likely to have the 
greatest impacts within the next five years on reducing, refining, or 
replacing animal use in the priority areas?
    3. What research and development activities hold the greatest 
promise in the long-term for reducing, refining, or replacing animal 
use in the priority areas?
    4. What are appropriate measures for evaluating progress in 
enhancing the development and use of alternative test methods in the 
priority areas?
    Individuals submitting comments should include appropriate contact 
information (name, affiliation, mailing address, phone, fax, email, and 
sponsoring organization, if applicable). All comments received by 
January 15, 2012, will be posted on the NICEATM-ICCVAM Web site (https://ntp-apps.niehs.nih.gov/iccvampb/searchPubCom.cfm) and identified by 
the individual's name and affiliation, as well as sponsoring 
organization, if applicable.

Background Information on NICEATM and ICCVAM

    ICCVAM is an interagency committee composed of representatives from 
15 Federal regulatory and research agencies that require, use, 
generate, or disseminate toxicological and safety testing information. 
ICCVAM conducts technical evaluations of new, revised, and alternative 
testing methods with regulatory applicability and promotes the 
scientific validation and regulatory acceptance of toxicological and 
safety testing methods that more accurately assess the safety and 
hazards of chemicals and products and that reduce, refine (enhance 
animal well-being and lessen or avoid pain and distress), or replace 
animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3) 
established ICCVAM as a permanent interagency committee of the NIEHS 
under NICEATM. NICEATM administers ICCVAM, provides scientific and 
operational support for ICCVAM-related activities, and conducts 
independent validation studies to assess the usefulness and limitations 
of new, revised, and alternative test methods and strategies. NICEATM 
and ICCVAM welcome the public nomination of new, revised, and 
alternative test methods and strategies applicable to the needs of 
Federal agencies. Additional information about NICEATM and ICCVAM can 
be found on the NICEATM-ICCVAM Web site (https://iccvam.niehs.nih.gov).

References

    ICCVAM. 2008. The NICEATM-ICCVAM Five-Year Plan (2008-2012). NIH 
Publication No. 08-6410. Research Triangle Park, NC: National 
Institute of Environmental Health Sciences. Available: https://iccvam.niehs.nih.gov/docs/5yearplan.htm.
    ICCVAM. 2010. Biennial Progress Report: Interagency Coordinating 
Committee on the Validation of Alternative Methods--2008-2009. NIH 
Publication No. 10-7612. Research Triangle Park, NC: National 
Institute of Environmental Health Sciences. Available: https://iccvam.niehs.nih.gov/about/ICCVAMrpts.htm.


    Dated: November 10, 2011.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2011-30001 Filed 11-18-11; 8:45 am]
BILLING CODE 4140-01-P
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