Laboratory Animal Welfare: Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals, 74803-74804 [2011-30764]

Download as PDF emcdonald on DSK5VPTVN1PROD with NOTICES Federal Register / Vol. 76, No. 231 / Thursday, December 1, 2011 / Notices and stakeholder feedback in an efficient, timely manner, in accordance with the Administration’s commitment to improving service delivery. By qualitative feedback we mean information that provides useful insights on perceptions and opinions, but are not statistical surveys that yield quantitative results that can be generalized to the population of study. This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between the Agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management. Feedback collected under this generic clearance will provide useful information, but it will not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: the target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential nonresponse bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results. No comments were received in response to the 60-day notice published in the Federal Register of December 22, 2010 (75 FR 80542). Below we provide OD’s projected average estimates for the next three years: Current Actions: New collection of information. Type of Review: New collection. Affected Public: Individuals and households, businesses and organizations, State, Local or Tribal Government. VerDate Mar<15>2010 17:34 Nov 30, 2011 Jkt 226001 Average Expected Annual Number of Activities: 30. Respondents: 253,000. Annual Responses: 253,000. Frequency of Response: Once per request. Average Minutes per Response: 10. Burden Hours: 49,358. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid Office of Management and Budget control number. Dated: November 22, 2011. Mikia P. Currie, Program Analyst, Office of policy for Extramural Research Administration, Office of the Director. [FR Doc. 2011–30904 Filed 11–30–11; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Laboratory Animal Welfare: Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals AGENCY: National Institutes of Health, HHS. ACTION: Notice. The National Institutes of Health (NIH) has analyzed public comments received regarding adoption and implementation of the 8th Edition of the Guide for the Care and Use of Laboratory Animals (Guide) and has determined to adopt the 8th Edition of the Guide. (The comments, received by NIH from February 24 to May 24, 2011, may be viewed at https://grants.nih.gov/ grants/olaw/2011guidecomments/ web_listing.htm.) In NIH’s judgment, the 8th Edition of the Guide empowers continued advancement in the humane care and use of vertebrate animals in research, research training, and biological testing. Effective January 1, 2012, institutions that receive Public Health Service (PHS) support for animal activities must base their animal care and use programs on the 8th Edition of the Guide and must complete at least one semiannual program review and facilities inspection using the 8th Edition of the Guide as the basis for evaluation by December 31, 2012. It is not required that all necessary changes be completed by December 31, 2012, but rather that an evaluation must be conducted and a plan and schedule for implementation of the standards in the 8th Edition of the Guide must be SUMMARY: PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 74803 developed by December 31, 2012. Institutions must verify to the Office of Laboratory Animal Welfare (OLAW), the organizational component of NIH that provides guidance and interpretation of the PHS Policy on Humane Care and Use of Laboratory Animals, that they have met the required schedule. This will be done through the Annual Report to OLAW covering the 2012 reporting period due January 31, 2013. In addition, institutions must document the implementation of the 8th Edition of the Guide in their next Animal Welfare Assurance renewal. OLAW has developed Position Statements located at https:// grants.nih.gov/grants/olaw/ 2011positionstatement.htm. The Position Statements clarify the ways in which NIH expects Assured institutions to implement the 8th Edition of the Guide by addressing the following concerns: cost of implementing the 8th Edition of the Guide; animal housing specifications; use of nonpharmaceutical-grade compounds; food and fluid restrictions; multiple surgical procedures; and application of the 8th Edition of the Guide to agricultural animals used in biomedical research. In addition, there is a summary of OLAW’s position on performance standards and practice standards. The public is invited to submit comments on their understanding of the Position Statements for a period of 60 days from December 1, 2011, to January 29, 2012. In response, OLAW may further clarify the Position Statements. DATES: Written comments on the public’s understanding of the Position Statements must be received by NIH on or before January 29, 2012, to be considered. ADDRESSES: Public comments on the Position Statements may be entered at https://grants.nih.gov/grants/olaw/ 2011positionstatement.htm. Comments will be made publicly available. Personally identifiable information (except organizational affiliations) will be removed prior to making comments publicly available. FOR FURTHER INFORMATION CONTACT: Office of Laboratory Animal Welfare, Office of Extramural Research, National Institutes of Health, RKL1, Suite 360, 6705 Rockledge Drive, Bethesda, MD 20892–7982; or telephone: (301) 496– 7163. SUPPLEMENTARY INFORMATION: I. Background Since 1985, the PHS Policy on Humane Care and Use of Laboratory Animals, authorized by Public Law 99– E:\FR\FM\01DEN1.SGM 01DEN1 emcdonald on DSK5VPTVN1PROD with NOTICES 74804 Federal Register / Vol. 76, No. 231 / Thursday, December 1, 2011 / Notices 158, 42 U.S.C. 289d, and incorporated by reference at 42 CFR 52.8 and 42 CFR 52a.8, has required that institutions receiving PHS support for animal activities base their animal care and use programs on the current edition of the Guide. Since 1996, programs have been based on the 7th Edition of the Guide. The 8th Edition of the Guide was published in January 2011, following a study by the Institute for Laboratory Animal Research of the National Academy of Sciences. The 8th Edition of the Guide contains substantive changes and additions from the previous edition. To gain insight from institutions on the impact of changes to the Guide on their animal care and use programs, NIH sought comments on whether it should adopt the 8th Edition of the Guide and on the proposed implementation plan. On February 24, 2011, NIH issued a Federal Register Notice (see https:// edocket.access.gpo.gov/2011/pdf/2011– 4172.pdf) requesting public comments on (1) NIH’s adoption of the 8th Edition of the Guide as a basis for evaluating institutional programs receiving or proposing to receive PHS support for activities involving animals and (2) NIH’s proposed implementation plan (if NIH decided to adopt the 8th Edition of the Guide). The original implementation plan proposed that institutions complete at least one semiannual program and facility evaluation using the 8th Edition of the Guide as the basis for evaluation by March 31, 2011. Comments were collected via the Internet through a Web link available in the Federal Register and on the OLAW Web site, where respondents could also access both the 7th and 8th Editions of the Guide. The original comment period was scheduled from February 24, 2011, to March 24, 2011. This comment period was extended twice, on March 18 and April 21. Ultimately, the comment period spanned 90 days, closing on May 24, 2011. In addition to the time extension, the NIH removed the original 6,000-character limit on the comment form fields in the April 21 extension to maximize the opportunity for individuals and organizations to provide comments to NIH. A total of 806 responses were submitted by Assured institutions, professional organizations, animal advocacy organizations, and individuals. The comments and an analysis may be viewed at https:// grants.nih.gov/grants/olaw/ 2011guidecomments/web_listing.htm. II. Electronic Access The 8th Edition of the Guide is available on the OLAW Web site at https://olaw.nih.gov. VerDate Mar<15>2010 17:34 Nov 30, 2011 Jkt 226001 Dated: November 22, 2011. Francis S. Collins, Director, National Institutes of Health. [FR Doc. 2011–30764 Filed 11–30–11; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR–5410–N–02] Federal Housing Administration (FHA) First Look Sales Method Under the Neighborhood Stabilization Programs (NSP) Technical Assistance: Availability of Universal Name and Address Identification Number (NAID) Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD. ACTION: Notice. AGENCY: On July 15, 2010, HUD published a Federal Register notice establishing the process by which eligible purchasers under the Neighborhood Stabilization Program (NSP) are provided a preference to acquire real estate-owned (REO) properties of FHA under the temporary First Look Sales Method. The July 15, 2010, notice requires that eligible NSP purchasers obtain a HUD-issued Name and Address Identification Number (NAID) to participate in the First Look Sales Method. This notice announces the availability of a universal NAID to aid eligible purchasers under the First Look Sales method. DATES: The dates announced in the July 15, 2010, notice are unchanged. The FHA First Look Sales Method shall be in effect through May 31, 2013. FOR FURTHER INFORMATION CONTACT: Ivery Himes, Director, Office of Single Family Asset Management, Office of Housing, Department of Housing and Urban Development, 451 7th Street SW., Room 9172, Washington, DC 20410; telephone number (202) 708–1672 (this is not a toll-free number). Persons with hearing or speech impairments may access this number via TTY by calling the toll-free Federal Relay Service at (800) 877–8339. SUPPLEMENTARY INFORMATION: On July 15, 2010, at 75 FR 41255, HUD published a Federal Register notice establishing the process by which governmental entities, nonprofit organizations, and subrecipients participating in the NSP (eligible NSP purchasers) are provided a preference to acquire REO properties under FHA’s temporary NSP First Look Sales Method. This temporary REO sales method furthers the goals of both NSP, SUMMARY: PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 to aid in the redevelopment of abandoned and foreclosed homes, and of HUD’s REO sales program, to expand homeownership opportunities and strengthen communities. Through the FHA First Look Sales Method, HUD provides eligible NSP purchasers with a preference (a ‘‘first look’’) to acquire FHA REO properties that are available for purchase within NSP areas. Eligible NSP purchasers may acquire such REO properties with the assistance of NSP funds for any eligible uses under the NSP, including rental or homeownership. The July 15, 2010, notice provides that governmental entities, nonprofit organizations, and subrecipients that have received a HUD-issued NAID are eligible to participate in the First Look Sales Method (see 75 FR 41226, first column). Through this notice, HUD announces that it has issued a universal NAID to the National Community Stabilization Trust (NCST). The NCST has entered into a partnership agreement with HUD to facilitate implementation of the First Look Sales Method. The NCST will use the universal NAID to aid eligible NSP purchasers in the purchase of properties under First Look Sales Method. Eligible NSP purchasers will not be charged a fee for use of the universal NAID. Additional information regarding the NCST and its role in implementing the First Look Sales Method can be found on the NCST Web site at: https:// www.stabilizationtrust.com/ Dated: November 23, 2011. Carol J. Galante, Acting Assistant Secretary for Housing— Federal Housing Commissioner. [FR Doc. 2011–30890 Filed 11–30–11; 8:45 am] BILLING CODE 4210–67–P DEPARTMENT OF THE INTERIOR Office of the Secretary Reopening the Comment Period for the Klamath Facilities Removal Draft Environmental Impact Statement/ Environmental Impact Report Office of Environmental Policy and Compliance, Interior. ACTION: Notice. AGENCY: We, the Department of the Interior, are reopening the comment period on the content for the Klamath Facilities Removal Draft Environmental Impact Statement/Environmental Impact Report (Draft EIS/EIR). We will accept comments until December 30, 2011. SUMMARY: E:\FR\FM\01DEN1.SGM 01DEN1

Agencies

[Federal Register Volume 76, Number 231 (Thursday, December 1, 2011)]
[Notices]
[Pages 74803-74804]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-30764]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Laboratory Animal Welfare: Adoption and Implementation of the 
Eighth Edition of the Guide for the Care and Use of Laboratory Animals

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: The National Institutes of Health (NIH) has analyzed public 
comments received regarding adoption and implementation of the 8th 
Edition of the Guide for the Care and Use of Laboratory Animals (Guide) 
and has determined to adopt the 8th Edition of the Guide. (The 
comments, received by NIH from February 24 to May 24, 2011, may be 
viewed at https://grants.nih.gov/grants/olaw/2011guidecomments/web_listing.htm.) In NIH's judgment, the 8th Edition of the Guide empowers 
continued advancement in the humane care and use of vertebrate animals 
in research, research training, and biological testing.
    Effective January 1, 2012, institutions that receive Public Health 
Service (PHS) support for animal activities must base their animal care 
and use programs on the 8th Edition of the Guide and must complete at 
least one semiannual program review and facilities inspection using the 
8th Edition of the Guide as the basis for evaluation by December 31, 
2012. It is not required that all necessary changes be completed by 
December 31, 2012, but rather that an evaluation must be conducted and 
a plan and schedule for implementation of the standards in the 8th 
Edition of the Guide must be developed by December 31, 2012. 
Institutions must verify to the Office of Laboratory Animal Welfare 
(OLAW), the organizational component of NIH that provides guidance and 
interpretation of the PHS Policy on Humane Care and Use of Laboratory 
Animals, that they have met the required schedule. This will be done 
through the Annual Report to OLAW covering the 2012 reporting period 
due January 31, 2013. In addition, institutions must document the 
implementation of the 8th Edition of the Guide in their next Animal 
Welfare Assurance renewal.
    OLAW has developed Position Statements located at https://grants.nih.gov/grants/olaw/2011positionstatement.htm. The Position 
Statements clarify the ways in which NIH expects Assured institutions 
to implement the 8th Edition of the Guide by addressing the following 
concerns: cost of implementing the 8th Edition of the Guide; animal 
housing specifications; use of nonpharmaceutical-grade compounds; food 
and fluid restrictions; multiple surgical procedures; and application 
of the 8th Edition of the Guide to agricultural animals used in 
biomedical research. In addition, there is a summary of OLAW's position 
on performance standards and practice standards. The public is invited 
to submit comments on their understanding of the Position Statements 
for a period of 60 days from December 1, 2011, to January 29, 2012. In 
response, OLAW may further clarify the Position Statements.

DATES: Written comments on the public's understanding of the Position 
Statements must be received by NIH on or before January 29, 2012, to be 
considered.

ADDRESSES: Public comments on the Position Statements may be entered at 
https://grants.nih.gov/grants/olaw/2011positionstatement.htm. Comments 
will be made publicly available. Personally identifiable information 
(except organizational affiliations) will be removed prior to making 
comments publicly available.

FOR FURTHER INFORMATION CONTACT: Office of Laboratory Animal Welfare, 
Office of Extramural Research, National Institutes of Health, RKL1, 
Suite 360, 6705 Rockledge Drive, Bethesda, MD 20892-7982; or telephone: 
(301) 496-7163.

SUPPLEMENTARY INFORMATION:

I. Background

    Since 1985, the PHS Policy on Humane Care and Use of Laboratory 
Animals, authorized by Public Law 99-

[[Page 74804]]

158, 42 U.S.C. 289d, and incorporated by reference at 42 CFR 52.8 and 
42 CFR 52a.8, has required that institutions receiving PHS support for 
animal activities base their animal care and use programs on the 
current edition of the Guide. Since 1996, programs have been based on 
the 7th Edition of the Guide. The 8th Edition of the Guide was 
published in January 2011, following a study by the Institute for 
Laboratory Animal Research of the National Academy of Sciences. The 8th 
Edition of the Guide contains substantive changes and additions from 
the previous edition. To gain insight from institutions on the impact 
of changes to the Guide on their animal care and use programs, NIH 
sought comments on whether it should adopt the 8th Edition of the Guide 
and on the proposed implementation plan. On February 24, 2011, NIH 
issued a Federal Register Notice (see https://edocket.access.gpo.gov/2011/pdf/2011-4172.pdf) requesting public comments on (1) NIH's 
adoption of the 8th Edition of the Guide as a basis for evaluating 
institutional programs receiving or proposing to receive PHS support 
for activities involving animals and (2) NIH's proposed implementation 
plan (if NIH decided to adopt the 8th Edition of the Guide). The 
original implementation plan proposed that institutions complete at 
least one semiannual program and facility evaluation using the 8th 
Edition of the Guide as the basis for evaluation by March 31, 2011.
    Comments were collected via the Internet through a Web link 
available in the Federal Register and on the OLAW Web site, where 
respondents could also access both the 7th and 8th Editions of the 
Guide. The original comment period was scheduled from February 24, 
2011, to March 24, 2011. This comment period was extended twice, on 
March 18 and April 21. Ultimately, the comment period spanned 90 days, 
closing on May 24, 2011. In addition to the time extension, the NIH 
removed the original 6,000-character limit on the comment form fields 
in the April 21 extension to maximize the opportunity for individuals 
and organizations to provide comments to NIH. A total of 806 responses 
were submitted by Assured institutions, professional organizations, 
animal advocacy organizations, and individuals. The comments and an 
analysis may be viewed at https://grants.nih.gov/grants/olaw/2011guidecomments/web_listing.htm.

II. Electronic Access

    The 8th Edition of the Guide is available on the OLAW Web site at 
https://olaw.nih.gov.

    Dated: November 22, 2011.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. 2011-30764 Filed 11-30-11; 8:45 am]
BILLING CODE 4140-01-P
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