Federal Register / Vol. 75, No. 219 / Monday, November 15, 2010 / Notices 69687 

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 

Centers for Disease Control and 

Prevention 

Board of Scientific Counselors, Office 

of Infectious Diseases, (BSC, OID) 

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. 

[FR Doc. 2010–28581 Filed 11–12–10; 8:45 am] 

BILLING CODE 4163–18–P 

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 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 

(http://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: <http:// 

oba.od.nih.gov/oba/index.html>. 

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 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 


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