Laboratory Animal Welfare: Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals, 10379-10380 [2011-4172]

Download as PDF Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Notices production of a digestion product with a homogeneous C-terminus. emcdonald on DSK2BSOYB1PROD with NOTICES Applications • Removal short C-terminal affinity tags from recombinant proteins without leaving any nonnative residues behind when used in combination with MeCPA. • Identification and removal of disordered residues from the C-termini of native (untagged) proteins, thereby increasing their propensity to crystallize. Inventors: David Waugh et al. (NCI) Related Publications: None. Patent Status: HHS Reference No. E– 027–2011/0—Research Tool. Patent protection is not being pursued for this technology. Licensing Status: Available for licensing. Licensing Contact: Whitney Hastings; 301–451–7337; hastingw@mail.nih.gov. Collaborative Research Opportunity: The National Cancer Institute, Protein Engineering Section, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize recombinant BoCPB and/ or similar enzymes. Please contact John Hewes, PhD at 301–435–3121 or hewesj@mail.nih.gov for more information. A DsbC Expression Vector for the Production of Proteins With Disulfide Bonds in the Cytosol of E. coli Description of Technology: Many proteins of biomedical importance contain disulfide bonds and such proteins are notoriously difficult to produce in Escherichia coli. Current methods to address this problem either export the protein to the periplasmic space, which is a more favorable redox environment for disulfide bond formation, or utilize genetically modified strains of E. coli to alter the redox potential of the cytosol (such as ‘‘Origami’’ or ‘‘Shuffle’’ cells). Unfortunately, these methods generally result in very low yields of the desired product, thus emphasizing the need for a novel method. The NIH inventors have designed a DsbC expression vector that can be used to improve the yield of correctly oxidized recombinant proteins in the cytosol of E. coli. By overproducing DsbC on a separate plasmid and coexpressing it with carboxypeptidases in the cytosol of E. coli, the inventors were able to increase the amount of properly oxidized, active carboxypeptidases that could be recovered from the cytosol by at least 4fold. Further, they believe that co- VerDate Mar<15>2010 17:21 Feb 23, 2011 Jkt 223001 expression of DsbC from a multicopy plasmid vector will also improve the yield of other disulfide bond-containing proteins in E. coli. Applications: Improving the yield of correctly oxidized recombinant proteins in the cytosol of E. coli. Advantages: Substantial increase in the amount of active carboxypeptidases recovered from the cytosol and improved yield of disulfide bondcontaining proteins in E. coli. Inventors: David Waugh et al. (NCI) Related Publications 1. Prinz WA, Aslund F, Holmgren A, Beckwith J. The role of the thioredoxin and glutaredoxin pathways in reducing protein disulfide bonds in the Escherichia coli cytoplasm. J Biol Chem. 1997 Jun 20;272(25):15661–15667. [PubMed: 9188456] 2. Levy R, Weiss R, Chen G, Iverson BL, Georgiou G. Production of correctly folded Fab antibody fragment in the cytoplasm of Escherichia coli trxB gor mutants via the coexpression of molecular chaperones. Protein Expr Purif. 2001 Nov;23(2):338–347. [PubMed: 11676610] Patent Status: HHS Reference No. E– 028–2011/0—Research Tool. Patent protection is not being pursued for this technology. Licensing Status: Available for licensing. Licensing Contact: Whitney Hastings; 301–451–7337; hastingw@mail.nih.gov. Dated: February 16, 2011. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2011–4168 Filed 2–23–11; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Laboratory Animal Welfare: Proposed 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) requests public comments on (1) NIH’s adoption of the eighth edition of the Guide for the Care and Use of Laboratory Animals (Guide) as a basis for evaluation of institutional programs receiving or proposing to receive Public Health Service (PHS) SUMMARY: PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 10379 support for activities involving animals; and (2) if NIH decides to adopt the eighth edition of the Guide, NIH’s proposed implementation plan, which would require that institutions complete at least one semiannual program and facility evaluation using the eighth edition of the Guide as the basis for evaluation by March 31, 2012. NIH will consider comments on (1) the adoption of the Guide and (2) the implementation plan. DATES: Written comments on the adoption and implementation of the eighth edition of the Guide must be received by NIH within 30 days of the date of publication of this notice in order to be considered. ADDRESSES: Public comments may be entered at https://grants.nih.gov/grants/olaw/ 2011guidecomments/add.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; telephone 301–496–7163. SUPPLEMENTARY INFORMATION: I. Background The Guide, first published in 1963, is a widely accepted primary reference on animal care and use. Recommendations in the Guide are based on published data, scientific principles, expert opinion, and experience with methods and practices that are determined to be consistent with high quality, humane animal care and use. The eighth 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 (NAS). The NAS study process began in 2008 and followed the requirements of Section 15 of the Federal Advisory Committee Act. The NAS study process is described at the NAS Web site: https:// www.nationalacademies.org/ studyprocess/. Since 1985, the PHS Policy on Humane Care and Use of Laboratory Animals, authorized by Public Law 99– 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 and comply, as applicable, with the Animal Welfare Act and other Federal statutes and regulations relating E:\FR\FM\24FEN1.SGM 24FEN1 10380 Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Notices to animal activities. The PHS Policy is applicable to all PHS-conducted or -supported activities (including research, research training, experimentation, biological testing, or related purposes) involving live vertebrate animals. The eighth 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 seeks comments on whether it should adopt the eighth edition of the Guide. NIH simultaneously proposes an implementation plan for the eighth edition of the Guide and seeks comments on the proposed plan. The implementation plan proposed by NIH would require institutions to complete at least one semiannual program and facility evaluation, using the eighth edition of the Guide as the basis for evaluation, by March 31, 2012. For such an evaluation to be considered complete by NIH, it would need to include reasonable and specific plans and schedules for corrections of deficiencies where appropriate. II. Electronic Access The eighth edition of the Guide is available on the NIH Office of Laboratory Animal Welfare Web site at https://olaw.nih.gov. Date: March 16, 2011. Time: 9 a.m. to 10:30 a.m. Eastern Time. Agenda: The subcommittee plans to discuss safety issues related to autism spectrum disorder. Place: No in-person meeting; conference call only. Conference Call Access: Dial: 888–390– 3417. Access code: 4684708. Contact Person: Ms. Lina Perez, Office of Autism Research Coordination, National Institute of Mental Health, NIH, 6001 Executive Boulevard, NSC, Room 8185a, Rockville, MD 20852, Phone: 301–443–6040, E-mail: IACCPublicInquiries@mail.nih.gov. Please Note: The conference call will be accessible to the public through a conference call-in number and access code. Members of the public who participate using the conference call phone number will be able to listen to the meeting but will not be heard. If you experience any technical problems with the conference call, please e-mail IACCTechSupport@acclaroresearch.com or call the IACC Technical Support Help Line at 443–680–0098. Individuals who participate by using this electronic service and who need special assistance, such as captioning of the conference call or other reasonable accommodations, should submit a request to the Contact Person listed on this notice at least 7 days prior to the meeting. Schedule subject to change. Information about the IACC and a registration link for this meeting are available on the Web site: https://www.iacc.hhs.gov. Dated: February 17, 2011. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. Dated: February 16, 2011. Francis S. Collins, Director, National Institutes of Health. [FR Doc. 2011–4164 Filed 2–23–11; 8:45 am] [FR Doc. 2011–4172 Filed 2–23–11; 8:45 am] BILLING CODE 4140–01–P BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute of Mental Health; Notice of Closed Meetings emcdonald on DSK2BSOYB1PROD with NOTICES National Institute of Mental Health; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Interagency Autism Coordinating Committee (IACC) Subcommittee on Safety. The IACC Subcommittee on Safety will be having a conference call on Wednesday, March 16, 2011. The subcommittee plans to discuss safety issues related to autism spectrum disorder (ASD). This meeting will be accessible to the public through a conference call. Name of Committee: Interagency Autism Coordinating Committee (IACC). Type of meeting: Subcommittee on Safety. Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Mental Health Special Emphasis Panel; VerDate Mar<15>2010 17:21 Feb 23, 2011 Jkt 223001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 Dated: February 17, 2011. Jennifer S. Spaeth Director, Office of Federal Advisory Committee Policy. [FR Doc. 2011–4166 Filed 2–23–11; 8:45 am] BILLING CODE 4140–01–P National Institutes of Health National Institutes of Health National Cooperative Drug Discovery Development Groups. Date: March 10, 2011. Time: 10 a.m. to 12 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Vinod Charles, PhD, Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6151, MSC 9606, Bethesda, MD 20892–9606, 301–443–1606, charlesvi@mail.nih.gov. Name of Committee: National Institute of Mental Health Special Emphasis Panel; Viral and Host Genetics in NeuroAIDS. Date: March 16, 2011. Time: 12 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person: David W Miller, PhD, Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive BLVD, Room 6140, MSC 9608, Bethesda, MD 20892–9608, 301–443– 9734, millerda@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.242, Mental Health Research Grants; 93.281, Scientist Development Award, Scientist Development Award for Clinicians, and Research Scientist Award; 93.282, Mental Health National Research Service Awards for Research Training, National Institutes of Health, HHS) DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of General Medical Sciences; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant E:\FR\FM\24FEN1.SGM 24FEN1

Agencies

[Federal Register Volume 76, Number 37 (Thursday, February 24, 2011)]
[Notices]
[Pages 10379-10380]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4172]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Laboratory Animal Welfare: Proposed 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) requests public 
comments on (1) NIH's adoption of the eighth edition of the Guide for 
the Care and Use of Laboratory Animals (Guide) as a basis for 
evaluation of institutional programs receiving or proposing to receive 
Public Health Service (PHS) support for activities involving animals; 
and (2) if NIH decides to adopt the eighth edition of the Guide, NIH's 
proposed implementation plan, which would require that institutions 
complete at least one semiannual program and facility evaluation using 
the eighth edition of the Guide as the basis for evaluation by March 
31, 2012. NIH will consider comments on (1) the adoption of the Guide 
and (2) the implementation plan.

DATES: Written comments on the adoption and implementation of the 
eighth edition of the Guide must be received by NIH within 30 days of 
the date of publication of this notice in order to be considered.

ADDRESSES: Public comments may be entered at https://grants.nih.gov/grants/olaw/2011guidecomments/add.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; telephone 
301-496-7163.

SUPPLEMENTARY INFORMATION:

I. Background

    The Guide, first published in 1963, is a widely accepted primary 
reference on animal care and use. Recommendations in the Guide are 
based on published data, scientific principles, expert opinion, and 
experience with methods and practices that are determined to be 
consistent with high quality, humane animal care and use. The eighth 
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 (NAS). The NAS study process began in 2008 and followed the 
requirements of Section 15 of the Federal Advisory Committee Act. The 
NAS study process is described at the NAS Web site: https://www.nationalacademies.org/studyprocess/.
    Since 1985, the PHS Policy on Humane Care and Use of Laboratory 
Animals, authorized by Public Law 99-158, 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 
and comply, as applicable, with the Animal Welfare Act and other 
Federal statutes and regulations relating

[[Page 10380]]

to animal activities. The PHS Policy is applicable to all PHS-conducted 
or -supported activities (including research, research training, 
experimentation, biological testing, or related purposes) involving 
live vertebrate animals.
    The eighth 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 seeks comments on whether it should adopt the eighth 
edition of the Guide. NIH simultaneously proposes an implementation 
plan for the eighth edition of the Guide and seeks comments on the 
proposed plan.
    The implementation plan proposed by NIH would require institutions 
to complete at least one semiannual program and facility evaluation, 
using the eighth edition of the Guide as the basis for evaluation, by 
March 31, 2012. For such an evaluation to be considered complete by 
NIH, it would need to include reasonable and specific plans and 
schedules for corrections of deficiencies where appropriate.

II. Electronic Access

    The eighth edition of the Guide is available on the NIH Office of 
Laboratory Animal Welfare Web site at https://olaw.nih.gov.

    Dated: February 16, 2011.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. 2011-4172 Filed 2-23-11; 8:45 am]
BILLING CODE 4140-01-P
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