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]
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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]
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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.
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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:
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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: .
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
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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]
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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
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SUMMARY:
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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.
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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
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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