Office of Biotechnology Activities Recombinant DNA Research: Proposed Actions Under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines), 69687-69688 [2010-28698]

Download as PDF Federal Register / Vol. 75, No. 219 / Monday, November 15, 2010 / Notices Dated: November 4, 2010. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2010–28597 Filed 11–12–10; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES srobinson on DSKHWCL6B1PROD with NOTICES In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC), announces the following meeting of the aforementioned committee: Time and Date: 8:30 a.m.–5 p.m., December 6, 2010. Place: CDC, Global Communications Center, 1600 Clifton Road, NE., Building 19, Auditorium B1–B2, Atlanta, Georgia 30333. Status: Open to the public, limited only by the space available. Purpose: The BSC, OID, provides advice and guidance to the Secretary, Department of Health and Human Services; the Director, CDC; the Director, OID; and the Directors of the National Center for Immunization and Respiratory Diseases, the National Center for Emerging and Zoonotic Infectious Diseases, and the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, CDC, in the following areas: strategies, goals, and priorities for programs; research within the national centers; and overall strategic direction and focus of OID and the national centers. Matters to be Discussed: The agenda will include OID and center updates, followed by a focused discussion to solicit recommendations from the board on a strategic document designed to increase the public health impact of CDC’s infectious disease prevention and control efforts. Agenda items are subject to change as priorities dictate. Contact Person for More Information: Robin Moseley, M.A.T., Designated Federal Officer, OID, CDC, 1600 Clifton Road, NE., Mailstop D10, Atlanta, Georgia 30333, Telephone: (404)639–4461. The Director, Management Analysis and Services office has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: November 4, 2010. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. VerDate Mar<15>2010 18:04 Nov 12, 2010 Jkt 223001 Office of Biotechnology Activities Recombinant DNA Research: Proposed Actions Under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) Notice of consideration of proposed actions under the NIH Guidelines. Board of Scientific Counselors, Office of Infectious Diseases, (BSC, OID) BILLING CODE 4163–18–P National Institutes of Health ACTION: Centers for Disease Control and Prevention [FR Doc. 2010–28581 Filed 11–12–10; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES A request to certify Kluyveromyces lactis as a new hostvector system has been submitted to the NIH Office of Biotechnology Activities (OBA). The data to be considered for certifying a new host-vector system can be found in Appendix I of the NIH Guidelines. A new host-vector system may be certified only after review by the NIH Recombinant DNA Advisory Committee (RAC) and specifically approved by the NIH Director as a Major Action. Part of this request is to exempt from the NIH Guidelines certain types of research when performed in K. lactis, if K. lactis and its affiliated plasmids meet the requirements for certification as a host-vector system. Research that is exempt from the NIH Guidelines when performed with other certified hostvector systems can be found in Appendix C of the NIH Guidelines. DATES: The public is encouraged to submit written comments on these proposed actions. Comments may be submitted to OBA in paper or electronic form at the OBA mailing, fax, and e-mail addresses shown below under the heading FOR FURTHER INFORMATION CONTACT. The NIH will consider all comments submitted by December 1, 2010. Written comments submitted by December 1, 2010 will be reproduced and distributed to the RAC for consideration at its December 7–8, 2010 meeting. In addition, an opportunity for public comment will be provided at that meeting. Please check the meeting agenda for the time of this discussion (https://oba.od.nih.gov/rdna_rac/ rac_meetings.html). All written comments received in response to this notice will be available for public inspection at the NIH OBA office, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892 (telephone, 301–496–9838), weekdays between the hours of 8:30 a.m. and 5 p.m. FOR FURTHER INFORMATION CONTACT: OBA by e-mail at oba@od.nih.gov, or telephone at 301–496–9838, if you have questions, or require additional SUMMARY: PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 69687 information about these proposed actions. Comments may be submitted to the same e-mail address or by fax at 301–496–9839 or sent by U.S. mail to the Office of Biotechnology Activities, National Institutes of Health, 6705 Rockledge Drive, Suite 750, MSC 7985, Bethesda, Maryland 20892–7985. For additional information about the RAC meeting at which these proposed actions will be deliberated, please visit the NIH OBA Web site at: <https:// oba.od.nih.gov/oba/>. OBA has received a request from the Institutional Biosafety Committee at New England BioLabs to exempt from the requirements of the NIH Guidelines research with certain plasmids when performed in K. lactis. In order for a broad class of research to qualify for exemption, it must be determined by the NIH Director that the research does not pose a significant risk to human health or the environment (Section III–F–6). One way to exempt a broad class of research from the requirements of the NIH Guidelines is to perform the research in specific certified host-vector systems (as outlined in Appendix C of the NIH Guidelines). Currently research with only three certified host-vector systems is exempt from the NIH Guidelines. These three certified systems are based upon two bacterial genera: Escherichia (E. coli K–12) and Bacillus (B. subtilis or B. licheniformis) and one lower eukaryotic genus: Saccharomyces (S. cerevisiae or S. uvarum). In order to certify a new hostvector system, data as outlined in Appendix I–II–B of the NIH Guidelines must be submitted for review. Specifically, this application will be considered under Appendix I–II–B–1 (Host-Vector 1 Systems Other than Escherichia coli K–12). Data to be considered include: (i) The strain’s natural habitat and growth requirements; its physiological properties, particularly those related to its reproduction, survival, and the mechanisms by which it exchanges genetic information; the range of organisms with which this organism normally exchanges genetic information and the type of information that is exchanged; and any relevant information about its pathogenicity or toxicity; (ii) a description of the history of the particular strains and vectors to be used, including data on any mutations which render this organism less able to survive or transmit genetic information; and (iii) a general description of the range of experiments contemplated with emphasis on the SUPPLEMENTARY INFORMATION: E:\FR\FM\15NON1.SGM 15NON1 69688 Federal Register / Vol. 75, No. 219 / Monday, November 15, 2010 / Notices need for developing such an HostVector 1 system. Background information may be obtained by contacting NIH OBA via email at oba@od.nih.gov. Alternatively, information is available on the OBA Web site at https://oba.od.nih.gov/oba/ news_events_oba.html. Dated: November 3, 2010. Jacqueline Corrigan-Curay, Acting Director, Office of Biotechnology Activities, National Institutes of Health. [FR Doc. 2010–28698 Filed 11–12–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Agency Information Collection Activities: Various Contract Related Forms That Will Be Included in the Homeland Security Acquisition Regulation, DHS Form 0700–01, DHS Form 0700–02, DHS Form 0700–03, DHS FORM 0700–04 Office of Chief Procurement Officer, Acquisition Policy and Legislation Office, DHS. ACTION: 60–Day Notice and request for comments; Extension without Change, 1600–0002. AGENCY: The Department of Homeland Security, Office of Chief Procurement Officer, Acquisition Policy and Legislation Office, will submit the following Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104–13, 44 U.S.C. chapter 35). DATES: Comments are encouraged and will be accepted until January 14, 2011. This process is conducted in accordance with 5 CFR 1320.1 ADDRESSES: Written comments and questions about this Information Collection Request should be forwarded to the Office of Chief Procurement Officer, Acquisition Policy and Legislation Office, DHS Attn.: Camara Francis, Department of Homeland Security, Office of the Chief Procurement Officer, Room 3114, Washington, DC 20528, Camara.Francis@hq.dhs.gov, 202–447– 5904. SUPPLEMENTARY INFORMATION: This information collection under the HSAR is necessary in order to implement applicable parts of the FAR (48 CFR). The four forms under this collection of information request are used by offerors, contractors, and the general public to srobinson on DSKHWCL6B1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 18:04 Nov 12, 2010 Jkt 223001 comply with requirements in contracts awarded by the Department of Homeland Security (DHS). The four forms are DHS Form 0700–01, Cumulative Claim and Reconciliation Statement; DHS Form 0700–02, Contractor’s Assignment of Refund, Rebates, Credits and Other Amounts; DHS Form 0700–03, Contractor’s Release; and DHS Form 0700–04, Employee Claim for Wage Restitution. These four forms will be used by contractors and/or contract employees during contract administration. The information will be used by DHS contracting officers to ensure compliance with terms and conditions of DHS contracts and to complete reports required by other Federal agencies such as the General Services Administration and the Department of Labor. If this information is not collected, the DHS could inadvertently violate statutory or regulatory requirements and the DHS’s interest concerning inventions and contractor’s claims would not be protected. There has been an increase in the estimated annual burden hours previously reported for this collection. An adjustment in annual burden is necessary at this time in the amount of 1534 actions and hours. The initial annual burden was based on a lower number of contract actions which related to the fact that DHS was a new agency with consolidated acquisition procedures, processes, and policies. Although, there is an increase in the estimated burdened hours, there is no change in the information being collected. The Office of Management and Budget is particularly interested in comments which: 1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; 2. Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; 3. Enhance the quality, utility, and clarity of the information to be collected; and 4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses. PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 Analysis Agency: Office of Chief Procurement Officer, Acquisition Policy and Legislation Office, DHS. Title: Various contract related forms that will be included in the Homeland Security Acquisition Regulation. OMB Number: 1600–0002. Frequency: On Occasion. Affected Public: Private Sector. Number of Respondents: 8,635. Estimated Time per Respondent: 1 hour. Total Burden Hours: 8,635. Total Burden Cost (capital/startup): $236,253.60. Dated: November 2, 2010. Richard Spires, Chief Information Officer. [FR Doc. 2010–28575 Filed 11–12–10; 8:45 am] BILLING CODE 9110–9B–P DEPARTMENT OF HOMELAND SECURITY Agency Information Collection Activities: Regulation on Agency Protests Office of Chief Procurement Officer, Acquisition Policy and Legislation Office, DHS. ACTION: 60-Day Notice and request for comments; Extension without Change, 1600–0004. AGENCY: The Department of Homeland Security, Office of Chief Procurement Officer, Acquisition Policy and Legislation Office, will submit the following Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104–13, 44 U.S.C. chapter 35). DATES: Comments are encouraged and will be accepted until January 14, 2011. This process is conducted in accordance with 5 CFR 1320.1. ADDRESSES: Written comments and questions about this Information Collection Request should be forwarded to Office of Chief Procurement Officer, Acquisition Policy and Legislation Office, DHS Attn.: Camara Francis, Department of Homeland Security, Office of the Chief Procurement Officer, Room 3114, Washington, DC 20528, Camara.Francis@hq.dhs.gov, 202–447– 5904. SUMMARY: The Federal Acquisition Regulation (FAR); 48 CFR Chapter 1 provides general procedures on handling protests submitted by contractors to federal SUPPLEMENTARY INFORMATION: E:\FR\FM\15NON1.SGM 15NON1

Agencies

[Federal Register Volume 75, Number 219 (Monday, November 15, 2010)]
[Notices]
[Pages 69687-69688]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28698]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Office of Biotechnology Activities Recombinant DNA Research: 
Proposed Actions Under the NIH Guidelines for Research Involving 
Recombinant DNA Molecules (NIH Guidelines)

ACTION: Notice of consideration of proposed actions under the NIH 
Guidelines.

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

SUMMARY: A request to certify Kluyveromyces lactis as a new host-vector 
system has been submitted to the NIH Office of Biotechnology Activities 
(OBA). The data to be considered for certifying a new host-vector 
system can be found in Appendix I of the NIH Guidelines. A new host-
vector system may be certified only after review by the NIH Recombinant 
DNA Advisory Committee (RAC) and specifically approved by the NIH 
Director as a Major Action.
    Part of this request is to exempt from the NIH Guidelines certain 
types of research when performed in K. lactis, if K. lactis and its 
affiliated plasmids meet the requirements for certification as a host-
vector system. Research that is exempt from the NIH Guidelines when 
performed with other certified host-vector systems can be found in 
Appendix C of the NIH Guidelines.

DATES: The public is encouraged to submit written comments on these 
proposed actions. Comments may be submitted to OBA in paper or 
electronic form at the OBA mailing, fax, and e-mail addresses shown 
below under the heading FOR FURTHER INFORMATION CONTACT. The NIH will 
consider all comments submitted by December 1, 2010. Written comments 
submitted by December 1, 2010 will be reproduced and distributed to the 
RAC for consideration at its December 7-8, 2010 meeting. In addition, 
an opportunity for public comment will be provided at that meeting. 
Please check the meeting agenda for the time of this discussion (https://oba.od.nih.gov/rdna_rac/rac_meetings.html). All written comments 
received in response to this notice will be available for public 
inspection at the NIH OBA office, 6705 Rockledge Drive, Suite 750, 
Bethesda, MD 20892 (telephone, 301-496-9838), weekdays between the 
hours of 8:30 a.m. and 5 p.m.

FOR FURTHER INFORMATION CONTACT: OBA by e-mail at oba@od.nih.gov, or 
telephone at 301-496-9838, if you have questions, or require additional 
information about these proposed actions. Comments may be submitted to 
the same e-mail address or by fax at 301-496-9839 or sent by U.S. mail 
to the Office of Biotechnology Activities, National Institutes of 
Health, 6705 Rockledge Drive, Suite 750, MSC 7985, Bethesda, Maryland 
20892-7985. For additional information about the RAC meeting at which 
these proposed actions will be deliberated, please visit the NIH OBA 
Web site at: <https://oba.od.nih.gov/oba/>.

SUPPLEMENTARY INFORMATION: OBA has received a request from the 
Institutional Biosafety Committee at New England BioLabs to exempt from 
the requirements of the NIH Guidelines research with certain plasmids 
when performed in K. lactis. In order for a broad class of research to 
qualify for exemption, it must be determined by the NIH Director that 
the research does not pose a significant risk to human health or the 
environment (Section III-F-6). One way to exempt a broad class of 
research from the requirements of the NIH Guidelines is to perform the 
research in specific certified host-vector systems (as outlined in 
Appendix C of the NIH Guidelines). Currently research with only three 
certified host-vector systems is exempt from the NIH Guidelines. These 
three certified systems are based upon two bacterial genera: 
Escherichia (E. coli K-12) and Bacillus (B. subtilis or B. 
licheniformis) and one lower eukaryotic genus: Saccharomyces (S. 
cerevisiae or S. uvarum). In order to certify a new host-vector system, 
data as outlined in Appendix I-II-B of the NIH Guidelines must be 
submitted for review. Specifically, this application will be considered 
under Appendix I-II-B-1 (Host-Vector 1 Systems Other than Escherichia 
coli K-12). Data to be considered include: (i) The strain's natural 
habitat and growth requirements; its physiological properties, 
particularly those related to its reproduction, survival, and the 
mechanisms by which it exchanges genetic information; the range of 
organisms with which this organism normally exchanges genetic 
information and the type of information that is exchanged; and any 
relevant information about its pathogenicity or toxicity; (ii) a 
description of the history of the particular strains and vectors to be 
used, including data on any mutations which render this organism less 
able to survive or transmit genetic information; and (iii) a general 
description of the range of experiments contemplated with emphasis on 
the

[[Page 69688]]

need for developing such an Host-Vector 1 system.
    Background information may be obtained by contacting NIH OBA via e-
mail at oba@od.nih.gov. Alternatively, information is available on the 
OBA Web site at https://oba.od.nih.gov/oba/news_events_oba.html.

    Dated: November 3, 2010.
Jacqueline Corrigan-Curay,
Acting Director, Office of Biotechnology Activities, National 
Institutes of Health.
[FR Doc. 2010-28698 Filed 11-12-10; 8:45 am]
BILLING CODE 4140-01-P
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