Office of Biotechnology Activities; Recombinant DNA Research: Action Under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines), 3150-3151 [2011-1037]
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Federal Register / Vol. 76, No. 12 / Wednesday, January 19, 2011 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of Biotechnology Activities;
Recombinant DNA Research: Action
Under the NIH Guidelines for Research
Involving Recombinant DNA Molecules
(NIH Guidelines)
National Institutes of Health
(NIH), PHS, DHHS.
ACTION: Action under the NIH
Guidelines.
AGENCY:
The NIH Guidelines currently
require that recombinant DNA
experiments designed to create new
transgenic rodents be registered with the
Institutional Biosafety Committee (IBC).
Specifically, Section III–E–3 of the NIH
Guidelines addresses the generation of
transgenic rodents that may be housed
under biosafety level (BL) 1 conditions
and allows the work to proceed
simultaneously with registration of the
experiment with the IBC. The IBC must
then review and approve the
experiment. The NIH Guidelines
address two pathways for generation of
a transgenic rodent: altering the
animal’s genome using recombinant
DNA technology, or breeding one or
more transgenic rodents to create a new
transgenic rodent (i.e., breeding of two
different transgenic rodents or the
breeding of a transgenic rodent and a
non-transgenic rodent).
On July 20, 2010 the NIH Office of
Biotechnology Activities (OBA)
published a proposed action (75 FR
42114) to amend Section III–E–3 and to
add a new Section to Appendix C
(Appendix C–VII) of the NIH Guidelines
so as to exempt breeding of almost all
transgenic rodents that can be housed at
BL1, with the exception of rodents that
contain a transgene encoding more than
fifty percent of an exogenous eukaryotic
virus and transgenic rodents in which
the transgene is under the control of a
gammaretroviral promoter. After
receiving public comment on the
proposed changes, OBA is
implementing these changes.
FOR FURTHER INFORMATION CONTACT: If
you have questions, or require
additional information about these
changes, please contact OBA by e-mail
at oba@od.nih.gov, telephone, 301–496–
9838 or mail to the Office of
Biotechnology Activities, National
Institutes of Health, 6705 Rockledge
Drive, Suite 750, MSC 7985, Bethesda,
Maryland 20892.
Background: Section III–E of the NIH
Guidelines addresses experiments for
which IBC registration is required at the
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time the research is initiated.
Experiments covered in this section of
the NIH Guidelines are considered to be
of low biosafety risk and although IBC
review and approval is still required,
such approval need not be obtained
prior to initiating the research. This is
in contrast to all other experiments
described in the NIH Guidelines for
which IBC review and approval is
required prior to initiation of the
experiment.
Under the NIH Guidelines (Section
III–F–6), certain experiments can be
exempted from the NIH Guidelines if
they do not present a significant risk to
public health or the environment and
the NIH Director approves this action.
These exemptions are delineated in
Appendix C of the NIH Guidelines.
Currently, the purchase or transfer of
transgenic rodents that require BL1
containment are exempt from the NIH
Guidelines under Appendix C. This
action would extend that exemption to
most experiments that involve the
generation of transgenic rodents by
breeding, as long as the transgenic
rodents can be appropriately maintained
under BL1 conditions. The rationale for
this change is that three decades of
working with and breeding transgenic
rodents have demonstrated that the
overwhelming majority of experiments
involving breeding of transgenic rodents
that can be housed under BL1
conditions results in progeny that can
also be housed under BL1 conditions.
Thus these breeding experiments do not
pose an appreciable risk to human
health or to the environment. In
addition, while registration with the IBC
is not a significant burden, the total
number of registrations required can
constitute a significant collective
administrative burden on the IBC and
researchers that does not appear to be
commensurate with the very low
biosafety risk.
There are still two categories of
breeding experiments for which IBC
registration will be required in order to
ensure that a risk assessment is
conducted and that the resulting rodent
is disposed of appropriately:
(a) Breeding experiments involving
transgenic rodents that contain more
than 50 percent of the genome of an
exogenous eukaryotic virus from a
single family, in order to prevent
inadvertent reconstitution of an
exogenous virus in the resultant
transgenic rodent; and
(b) breeding experiments in which the
transgenic rodent’s transgene is under
the control of a gammaretroviral long
terminal repeat (LTR), in order to
address the small risk of recombination
with endogenous retroviruses which
PO 00000
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Fmt 4703
Sfmt 4703
could potentially result in mobilization
of the transgene via a replicationcompetent mouse retrovirus.
As the risk of recombination and
possible transmission to humans is
more likely with gammaretroviral LTRs
(e.g., murine leukemia virus, feline
leukemia virus, xenotropic murine
leukemia-related virus), the requirement
for registration is limited to rodents
containing a transgene under control of
these LTRs.
OBA received nine comments in
response to the July 20, 2010 Federal
Register notice of proposed changes. All
were supportive of the change and
emphasized that the current registration
requirements impose a significant
administrative burden on IBCs that is
not necessary to protect public health,
laboratory workers or the environment.
One comment noted that making these
experiments exempt would free up
valuable resources (time and money) for
their IBC, Institutional Animal Care and
Use Committee, and researchers. One
comment asked for clarification
regarding how to assess whether
breeding a transgenic rodent containing
a partial gammaretroviral LTR sequence
must be registered with the IBC. The key
issue is not the percentage of the LTR
sequence, but rather whether it is
functional or not, i.e. whether there is
sufficient LTR sequence to direct the
expression of a transgene.
The following changes will be made
to Appendix C of the NIH Guidelines:
Appendix C–VII. Generation of BL1
Transgenic Rodents via Breeding
The breeding of two different transgenic
rodents or the breeding of a transgenic rodent
and a non-transgenic rodent with the intent
of creating a new strain of transgenic rodent
that can be housed at BL1 containment will
be exempt from the NIH Guidelines if:
(1) Both parental rodents can be housed
under BL1 containment; and
(2) Neither parental transgenic rodent
contains the following genetic modifications:
(a) Incorporation of more than one-half of
the genome of an exogenous eukaryotic virus
from a single family of viruses; or
(b) Incorporation of a transgene that is
under the control of a gammaretroviral long
terminal repeat (LTR); and
(3) The transgenic rodent that results from
this breeding is not expected to contain more
than one-half of an exogenous viral genome
from a single family of viruses.
The current Appendix C–VII and
Appendices C–VII–A through C–VII–E
will be renumbered to Appendix C–VIII
and Appendices C–VIII–A though C–
VIII–E, respectively.
For clarity the following is added to
Section III–E–3.
Section III–E–3–a. Experiments
involving the breeding of certain BL1
E:\FR\FM\19JAN1.SGM
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Federal Register / Vol. 76, No. 12 / Wednesday, January 19, 2011 / Notices
transgenic rodents are exempt under
Section III–F, Exempt Experiments (See
Appendix C–VII, Generation of BL1
Transgenic Rodents via Breeding).
Dated: January 10, 2011.
Jacqueline Corrigan-Curay,
Acting Director, Office of Biotechnology
Activities, National Institutes of Health.
[FR Doc. 2011–1037 Filed 1–18–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
Agency Information Collection
Activities: Record of Vessel Foreign
Repair or Equipment Purchase
U.S. Customs and Border
Protection (CBP), Department of
Homeland Security.
ACTION: 60-Day Notice and request for
comments; Extension of an existing
collection of information: 1651–0027.
AGENCY:
As part of its continuing effort
to reduce paperwork and respondent
burden, CBP invites the general public
and other Federal agencies to comment
on an information collection
requirement concerning the Record of
Vessel Foreign Repair or Equipment
Purchase (CBP Form 226). This request
for comment is being made pursuant to
the Paperwork Reduction Act of 1995
(Pub. L. 104–13).
DATES: Written comments should be
received on or before March 21, 2011, to
be assured of consideration.
ADDRESSES: Direct all written comments
to U.S. Customs and Border Protection,
Attn: Tracey Denning, Regulations and
Rulings, Office of International Trade,
799 9th Street, NW., 5th Floor,
Washington, DC 20229–1177.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information
should be directed to Tracey Denning,
U.S. Customs and Border Protection,
Regulations and Rulings, Office of
International Trade, 799 9th Street,
NW., 5th Floor, Washington, DC 20229–
1177, at 202–325–0265.
SUPPLEMENTARY INFORMATION: CBP
invites the general public and other
Federal agencies to comment on
proposed and/or continuing information
collections pursuant to the Paperwork
Reduction Act of 1995 (Pub. L. 104–13).
The comments should address: (a)
Whether the collection of information is
necessary for the proper performance of
the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
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17:04 Jan 18, 2011
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agency’s estimates of the burden of the
collection of information; (c) ways to
enhance the quality, utility, and clarity
of the information to be collected; (d)
ways to minimize the burden including
the use of automated collection
techniques or the use of other forms of
information technology; and (e) the
annual costs burden to respondents or
record keepers from the collection of
information (a total capital/startup costs
and operations and maintenance costs).
The comments that are submitted will
be summarized and included in the CBP
request for Office of Management and
Budget (OMB) approval. All comments
will become a matter of public record.
In this document CBP is soliciting
comments concerning the following
information collection:
Title: Record of Vessel Foreign Repair
or Equipment Purchase.
OMB Number: 1651–0027.
Form Number: CBP Form 226.
Abstract: 19 U.S.C. 1466(a) provides
for a 50 percent ad valorem duty
assessed on a vessel master or owner for
any repairs, purchases, or expenses
incurred in a foreign country by a
commercial vessel registered in the
United States. CBP Form 226, Record of
Vessel Foreign Repair or Equipment
Purchase, is used by the master or
owner of a vessel to declare and file
entry on equipment, repairs, parts, or
materials purchased for the vessel in a
foreign country. This information
enables CBP to assess duties on these
foreign repairs, parts or materials. CBP
Form 226 is provided for by 19 CFR 4.7
and 4.14 and is accessible at https://
forms.cbp.gov/pdf/CBP_Form_226.pdf.
Current Actions: CBP proposes to
extend the expiration date of this
information collection with a change to
the burden hours. There is no change to
the information being collected.
Type of Review: Extension (with
change).
Affected Public: Businesses.
Estimated Number of Respondents:
100.
Estimated Number of Responses per
Respondent: 11.
Estimated Number of Total Annual
Responses: 1,100.
Estimated Time per Response: 45
minutes.
Estimated Total Annual Burden
Hours: 825.
Dated: January 12, 2011.
Tracey Denning,
Agency Clearance Officer, U.S. Customs and
Border Protection.
[FR Doc. 2011–947 Filed 1–18–11; 8:45 am]
BILLING CODE 9111–14–P
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3151
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[Docket No. FR–5496–N–01]
Notice of Federal Advisory Committee
Meeting—the Manufactured Housing
Consensus Committee
Office of the Assistant
Secretary for Housing—Federal Housing
Commissioner, HUD.
ACTION: Announcement of meeting.
AGENCY:
This notice sets forth the
schedule and proposed agenda of an
upcoming meeting of the Manufactured
Housing Consensus Committee (the
Committee) to be held via telephone
conference. This meeting is open to the
general public, which may participate
by following the instructions below.
DATES: The conference call meeting will
be held on Thursday, January 27, 2011,
by conference call from 11 a.m. to 1
p.m. EST.
Conference Call: Members of the
public who wish to join the call may
call the toll free number 877–320–2367
and enter pass code 4191690.
Additional information concerning the
conference call can be obtained from the
Department’s Consensus Committee
Administering Organization, the
National Fire Protection Association
(NFPA). Interested parties can access
the NFPA Web site to obtain additional
information about the Manufactured
Housing Consensus Committee and the
Administering Organization. The link
can be found at: https://www.nfpa.org/
categoryList.asp?categoryID=858. Locate
Quick Links on the webpage and select
Meeting Notices.
Alternately, interested parties may
contact Jill McGovern of NFPA at (617)
984–7404 (this is not a toll-free number)
for conference call information.
FOR FURTHER INFORMATION CONTACT:
Elizabeth A. Cocke, Deputy
Administrator, Office of Manufactured
Housing Programs, Department of
Housing and Urban Development, 451
7th Street SW., Washington, DC 20410,
telephone (202) 708–6409 (this is not a
toll-free number). Persons who have
difficulty hearing or speaking may
access this number via TTY by calling
the toll-free Federal Information Relay
Service at (800) 877–8339.
SUPPLEMENTARY INFORMATION: Notice of
this meeting is provided in accordance
with Sections 10(a) and (b) of the
Federal Advisory Committee Act (5
U.S.C. App. 2) and 41 CFR 102–3.150.
The Manufactured Housing Consensus
Committee was established under
Section 604(a)(3) of the National
Manufactured Housing Construction
SUMMARY:
E:\FR\FM\19JAN1.SGM
19JAN1
]]>Agencies
[Federal Register Volume 76, Number 12 (Wednesday, January 19, 2011)]
[Notices]
[Pages 3150-3151]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-1037]
[[Page 3150]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Office of Biotechnology Activities; Recombinant DNA Research:
Action Under the NIH Guidelines for Research Involving Recombinant DNA
Molecules (NIH Guidelines)
AGENCY: National Institutes of Health (NIH), PHS, DHHS.
ACTION: Action under the NIH Guidelines.
-----------------------------------------------------------------------
SUMMARY: The NIH Guidelines currently require that recombinant DNA
experiments designed to create new transgenic rodents be registered
with the Institutional Biosafety Committee (IBC). Specifically, Section
III-E-3 of the NIH Guidelines addresses the generation of transgenic
rodents that may be housed under biosafety level (BL) 1 conditions and
allows the work to proceed simultaneously with registration of the
experiment with the IBC. The IBC must then review and approve the
experiment. The NIH Guidelines address two pathways for generation of a
transgenic rodent: altering the animal's genome using recombinant DNA
technology, or breeding one or more transgenic rodents to create a new
transgenic rodent (i.e., breeding of two different transgenic rodents
or the breeding of a transgenic rodent and a non-transgenic rodent).
On July 20, 2010 the NIH Office of Biotechnology Activities (OBA)
published a proposed action (75 FR 42114) to amend Section III-E-3 and
to add a new Section to Appendix C (Appendix C-VII) of the NIH
Guidelines so as to exempt breeding of almost all transgenic rodents
that can be housed at BL1, with the exception of rodents that contain a
transgene encoding more than fifty percent of an exogenous eukaryotic
virus and transgenic rodents in which the transgene is under the
control of a gammaretroviral promoter. After receiving public comment
on the proposed changes, OBA is implementing these changes.
FOR FURTHER INFORMATION CONTACT: If you have questions, or require
additional information about these changes, please contact OBA by e-
mail at oba@od.nih.gov, telephone, 301-496-9838 or mail to the Office
of Biotechnology Activities, National Institutes of Health, 6705
Rockledge Drive, Suite 750, MSC 7985, Bethesda, Maryland 20892.
Background: Section III-E of the NIH Guidelines addresses
experiments for which IBC registration is required at the time the
research is initiated. Experiments covered in this section of the NIH
Guidelines are considered to be of low biosafety risk and although IBC
review and approval is still required, such approval need not be
obtained prior to initiating the research. This is in contrast to all
other experiments described in the NIH Guidelines for which IBC review
and approval is required prior to initiation of the experiment.
Under the NIH Guidelines (Section III-F-6), certain experiments can
be exempted from the NIH Guidelines if they do not present a
significant risk to public health or the environment and the NIH
Director approves this action. These exemptions are delineated in
Appendix C of the NIH Guidelines.
Currently, the purchase or transfer of transgenic rodents that
require BL1 containment are exempt from the NIH Guidelines under
Appendix C. This action would extend that exemption to most experiments
that involve the generation of transgenic rodents by breeding, as long
as the transgenic rodents can be appropriately maintained under BL1
conditions. The rationale for this change is that three decades of
working with and breeding transgenic rodents have demonstrated that the
overwhelming majority of experiments involving breeding of transgenic
rodents that can be housed under BL1 conditions results in progeny that
can also be housed under BL1 conditions. Thus these breeding
experiments do not pose an appreciable risk to human health or to the
environment. In addition, while registration with the IBC is not a
significant burden, the total number of registrations required can
constitute a significant collective administrative burden on the IBC
and researchers that does not appear to be commensurate with the very
low biosafety risk.
There are still two categories of breeding experiments for which
IBC registration will be required in order to ensure that a risk
assessment is conducted and that the resulting rodent is disposed of
appropriately:
(a) Breeding experiments involving transgenic rodents that contain
more than 50 percent of the genome of an exogenous eukaryotic virus
from a single family, in order to prevent inadvertent reconstitution of
an exogenous virus in the resultant transgenic rodent; and
(b) breeding experiments in which the transgenic rodent's transgene
is under the control of a gammaretroviral long terminal repeat (LTR),
in order to address the small risk of recombination with endogenous
retroviruses which could potentially result in mobilization of the
transgene via a replication-competent mouse retrovirus.
As the risk of recombination and possible transmission to humans is
more likely with gammaretroviral LTRs (e.g., murine leukemia virus,
feline leukemia virus, xenotropic murine leukemia-related virus), the
requirement for registration is limited to rodents containing a
transgene under control of these LTRs.
OBA received nine comments in response to the July 20, 2010 Federal
Register notice of proposed changes. All were supportive of the change
and emphasized that the current registration requirements impose a
significant administrative burden on IBCs that is not necessary to
protect public health, laboratory workers or the environment. One
comment noted that making these experiments exempt would free up
valuable resources (time and money) for their IBC, Institutional Animal
Care and Use Committee, and researchers. One comment asked for
clarification regarding how to assess whether breeding a transgenic
rodent containing a partial gammaretroviral LTR sequence must be
registered with the IBC. The key issue is not the percentage of the LTR
sequence, but rather whether it is functional or not, i.e. whether
there is sufficient LTR sequence to direct the expression of a
transgene.
The following changes will be made to Appendix C of the NIH
Guidelines:
Appendix C-VII. Generation of BL1 Transgenic Rodents via Breeding
The breeding of two different transgenic rodents or the breeding
of a transgenic rodent and a non-transgenic rodent with the intent
of creating a new strain of transgenic rodent that can be housed at
BL1 containment will be exempt from the NIH Guidelines if:
(1) Both parental rodents can be housed under BL1 containment;
and
(2) Neither parental transgenic rodent contains the following
genetic modifications:
(a) Incorporation of more than one-half of the genome of an
exogenous eukaryotic virus from a single family of viruses; or
(b) Incorporation of a transgene that is under the control of a
gammaretroviral long terminal repeat (LTR); and
(3) The transgenic rodent that results from this breeding is not
expected to contain more than one-half of an exogenous viral genome
from a single family of viruses.
The current Appendix C-VII and Appendices C-VII-A through C-VII-E
will be renumbered to Appendix C-VIII and Appendices C-VIII-A though C-
VIII-E, respectively.
For clarity the following is added to Section III-E-3.
Section III-E-3-a. Experiments involving the breeding of certain
BL1
[[Page 3151]]
transgenic rodents are exempt under Section III-F, Exempt Experiments
(See Appendix C-VII, Generation of BL1 Transgenic Rodents via
Breeding).
Dated: January 10, 2011.
Jacqueline Corrigan-Curay,
Acting Director, Office of Biotechnology Activities, National
Institutes of Health.
[FR Doc. 2011-1037 Filed 1-18-11; 8:45 am]
BILLING CODE 4140-01-P
