Draft Animal Cloning Risk Assessment; Proposed Risk Management Plan; Draft Guidance for Industry; Availability, 136-137 [06-9927]
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Federal Register / Vol. 72, No. 1 / Wednesday, January 3, 2007 / Notices
Dated: December 22, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and
Planning.
[FR Doc. E6–22450 Filed 12–29–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N–0573]
Draft Animal Cloning Risk
Assessment; Proposed Risk
Management Plan; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
rwilkins on PROD1PC63 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of, and is requesting
comment on, a draft risk assessment on
animal cloning. FDA’s Center for
Veterinary Medicine (CVM) developed
this draft risk assessment to evaluate the
health risks to animals involved in the
process of cloning and to evaluate the
food consumption risks that may result
from edible products derived from
animal clones or their progeny. FDA is
also announcing the availability of, and
is requesting comment on, a proposed
risk management plan for animal clones
and their progeny. The proposed risk
management plan takes into account the
risks identified in the draft risk
assessment and sets out proposed
measures that FDA might use to manage
those risks. In addition, FDA is
announcing availability of draft
guidance for industry #179 for public
comment. This draft guidance describes
FDA’s recommendations regarding the
use of edible products from animal
clones and their progeny in human food
or in animal feed.
DATES: Submit written or electronic
comments on the draft risk assessment
document, the proposed risk
management plan, and the draft
guidance for industry by April 3, 2007.
FDA will accept comments, data, and
information after the deadline, but to
ensure consideration by the agency in
any final documents, comments must be
received by this date. Comments on
agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for
single copies of the draft risk
assessment, proposed risk management
plan, or the draft guidance for industry
to the Communications Staff (HFV–12),
Center for Veterinary Medicine, Food
VerDate Aug<31>2005
19:02 Dec 29, 2006
Jkt 211001
and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855. Send a selfaddressed, adhesive label to assist that
office in processing your request.
Submit written comments on the draft
risk assessment, proposed risk
management plan, or draft guidance for
industry to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the documents.
FOR FURTHER INFORMATION CONTACT:
Larisa Rudenko, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–453–6842, email: clones@cvm.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In July 2001, FDA’s CVM issued an
update on livestock cloning (available at
https://www.fda.gov/cvm/CVM_Updates/
clones.htm) and indicated its intention
to work with stakeholders to assess
potential risks presented by cloning
food-producing animals. It also
requested that companies voluntarily
refrain from introducing animal clones,
their progeny, or their food products
(such as milk or meat) into the human
or animal food supply, pending
completion of the risk assessment
process. The public participation phase
of this process begins with the release
of draft documents entitled ‘‘Animal
Cloning: A Draft Risk Assessment,’’
‘‘Animal Cloning: Proposed Risk
Management Plan for Clones and Their
Progeny,’’ and ‘‘Draft Guidance for
Industry #179: Use of Edible Products
From Animal Clones or Their Progeny
for Human Food or Animal Feed.’’
Among the goals of our draft risk
assessment were the determination of
whether somatic cell nuclear transfer
(SCNT), the process used to produce the
clones being considered in the risk
assessment, poses any unique risks to
animals involved in cloning relative to
other assisted reproductive
technologies, and whether foods derived
from animal clones or their progeny
pose consumption risks greater than
those posed by foods derived from their
conventional counterparts. It
specifically does not consider risk
issues that may be posed by genetically
engineered animals.
The draft risk assessment has been
peer reviewed in accordance with the
Office of Management and Budget’s
Information Quality Peer Review
Bulletin. The peer reviewers’ comments
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
and the agency’s response to them are
posted on the Internet with the draft risk
assessment (see the Electronic Access
section of this document).
The proposed risk management plan
describes proposed measures that the
agency might use to address animal
health and food consumption risks
identified in the draft risk assessment
that are within the agency’s purview. It
also describes the agency’s plans with
regard to issues that are not within the
agency’s authority to manage (e.g.,
ethics) regarding animal cloning.
The draft guidance for industry
describes FDA’s recommendations
regarding the introduction of edible
products from animal clones and their
progeny into the food and feed supply.
FDA will consider information received
during the comment period in its
preparation of a final risk assessment.
To that end, FDA requests that any
producers or breeders of clones who
have additional data on the health of the
clones or their progeny or composition
of food products (i.e., meat or milk)
derived from clones or their progeny
share those data with us. Additionally,
the agency reiterates that the release of
these draft documents does not affect its
request to industry to continue to refrain
from introducing food products from
clones and their progeny into the
marketplace.
II. Significance of Guidance
The draft guidance for industry is a
level 1 draft guidance that is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft guidance represents
the agency’s current thinking on the
topic. The draft guidance document
does not create or confer any rights for
or on any person and will not operate
to bind FDA or the public. Alternative
methods may be used as long as they
satisfy the requirements of the
applicable statutes and regulations.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding the draft risk
assessment document, the proposed risk
management plan, and the draft
guidance for industry. For convenience
in reviewing the comments, FDA
requests that comments be separately
identified as to which document they
address. Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
E:\FR\FM\03JAN1.SGM
03JAN1
Federal Register / Vol. 72, No. 1 / Wednesday, January 3, 2007 / Notices
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cvm/cloning.htm. In an
effort to better ensure broad awareness
of this Federal Register notice, FDA will
announce it and make copies available
through the FDA Dockets Listserv
(https://www.fda.gov/ohrms/dockets/
FDAMAIL/DMBemaillist.htm). To be
added to any of FDA’s free e-mail
subscription services go to https://
www.fda.gov. Click on ‘‘Subscribe to
FDA’s E-mail Lists,’’ then follow the
instructions provided.
Dated: August 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06–9927 Filed 12–28–06; 11:00 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D–0504]
Draft Guidance for Industry and Food
and Drug Administration Staff; RadioFrequency Wireless Technology in
Medical Devices; Availability
AGENCY:
Food and Drug Administration,
HHS.
rwilkins on PROD1PC63 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Draft Guidance for Industry
and FDA Staff; Radio-Frequency
Wireless Technology in Medical
Devices.’’ This draft guidance document
addresses issues relevant to the safe and
effective use of radio frequency (RF)
wireless technology in medical devices,
including wireless coexistence,
performance, data integrity, security,
and electromagnetic compatibility
(EMC). These issues involve all stages of
the product life cycle and should be
considered in preparing premarket
submissions; identifying, documenting,
and implementing product design
requirements, as well as design
verification and validation; and risk
management processes and procedures.
DATES: Submit written or electronic
comments on the draft guidance by
April 2, 2007.
ADDRESSES: Submit written requests for
single copies of the draft guidance
VerDate Aug<31>2005
19:02 Dec 29, 2006
Jkt 211001
entitled ‘‘Draft Guidance for Industry
and FDA Staff: Radio-Frequency
Wireless Technology in Medical
Devices’’ to the Division of Small
Manufacturers, International, and
Consumer Assistance (HFZ–220), Center
for Devices and Radiological Health,
Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850. Send
one self-addressed adhesive label to
assist that office in processing your
request, or fax your request to 240–276–
3151.
Submit written comments on the draft
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for information on electronic access to
the guidance.
FOR FURTHER INFORMATION CONTACT:
Donald Witters, Center for Devices and
Radiological Health (HFZ–130), Food
and Drug Administration, 12725
Twinbrook Pkwy., Rockville, MD 20852,
301–827–4955.
SUPPLEMENTARY INFORMATION:
I. Background
FDA has developed this draft
guidance document to assist industry,
systems and service providers,
consultants, FDA staff, and others in the
design, development, and evaluation of
RF wireless technology in medical
devices. The RF wireless emissions from
one product or device can affect the
function of another, the electromagnetic
environments where medical devices
are used may contain many sources of
RF energy, and the use of RF wireless
technology in and around medical
devices is increasing. As a result, the
draft guidance recommends that
manufacturers address concerns about
the potential effects of the use of RF
wireless technology in and around
medical devices on the ability of
medical devices to function properly
and the resultant safety of patients and
operators.
This draft guidance references
national and international standards
and discusses some of FDA’s regulatory
requirements, including premarket
requirements (21 CFR parts 807 and
814). The draft guidance document also
discusses quality system requirements
as they specifically apply to RF wireless
technology in medical devices,
including design and development
activities (21 CFR part 820).
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
137
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on RF wireless technology in and
around medical devices. It does not
create or confer any rights for or on any
person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by using
the Internet. To receive ‘‘Draft Guidance
for Industry and FDA Staff; RadioFrequency Wireless Technology in
Medical Devices’’ you may either send
an e-mail request to dsmica@fda.hhs.gov
to receive an electronic copy of the
document or send a fax request to 240–
276–3151 to receive a hard copy. Please
use the document number 1618 to
identify the guidance you are
requesting.
CDRH maintains an entry on the
Internet for easy access to information
including text, graphics, and files that
may be downloaded to a personal
computer with Internet access. Updated
on a regular basis, the CDRH home page
includes device safety alerts, Federal
Register reprints, information on
premarket submissions (including lists
of approved applications and
manufacturers’ addresses), small
manufacturer’s assistance, information
on video conferencing and electronic
submissions, Mammography Matters,
and other device-oriented information.
The CDRH Web site may be accessed at
https://www.fda.gov/cdrh. A search
capability for all CDRH guidance
documents is available at https://
www.fda.gov/cdrh/guidance.html.
Guidance documents are also available
on the Division of Dockets Management
Internet site at https://www.fda.gov/
ohrms/dockets.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 801 have
been approved under OMB control
number 0910–0485; the collections of
information in 21 CFR part 807 have
been approved under OMB control
number 0910–0120; the collections of
information in 21 CFR part 814 have
been approved under OMB control
number 0910–0231; and the collections
E:\FR\FM\03JAN1.SGM
03JAN1
]]>Agencies
[Federal Register Volume 72, Number 1 (Wednesday, January 3, 2007)]
[Notices]
[Pages 136-137]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-9927]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0573]
Draft Animal Cloning Risk Assessment; Proposed Risk Management
Plan; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of, and is requesting comment on, a draft risk assessment
on animal cloning. FDA's Center for Veterinary Medicine (CVM) developed
this draft risk assessment to evaluate the health risks to animals
involved in the process of cloning and to evaluate the food consumption
risks that may result from edible products derived from animal clones
or their progeny. FDA is also announcing the availability of, and is
requesting comment on, a proposed risk management plan for animal
clones and their progeny. The proposed risk management plan takes into
account the risks identified in the draft risk assessment and sets out
proposed measures that FDA might use to manage those risks. In
addition, FDA is announcing availability of draft guidance for industry
179 for public comment. This draft guidance describes FDA's
recommendations regarding the use of edible products from animal clones
and their progeny in human food or in animal feed.
DATES: Submit written or electronic comments on the draft risk
assessment document, the proposed risk management plan, and the draft
guidance for industry by April 3, 2007. FDA will accept comments, data,
and information after the deadline, but to ensure consideration by the
agency in any final documents, comments must be received by this date.
Comments on agency guidance documents are welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft risk
assessment, proposed risk management plan, or the draft guidance for
industry to the Communications Staff (HFV-12), Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville,
MD 20855. Send a self-addressed, adhesive label to assist that office
in processing your request. Submit written comments on the draft risk
assessment, proposed risk management plan, or draft guidance for
industry to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
documents.
FOR FURTHER INFORMATION CONTACT: Larisa Rudenko, Center for Veterinary
Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-453-6842, e-mail: clones@cvm.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In July 2001, FDA's CVM issued an update on livestock cloning
(available at https://www.fda.gov/cvm/CVM_Updates/clones.htm) and
indicated its intention to work with stakeholders to assess potential
risks presented by cloning food-producing animals. It also requested
that companies voluntarily refrain from introducing animal clones,
their progeny, or their food products (such as milk or meat) into the
human or animal food supply, pending completion of the risk assessment
process. The public participation phase of this process begins with the
release of draft documents entitled ``Animal Cloning: A Draft Risk
Assessment,'' ``Animal Cloning: Proposed Risk Management Plan for
Clones and Their Progeny,'' and ``Draft Guidance for Industry
179: Use of Edible Products From Animal Clones or Their
Progeny for Human Food or Animal Feed.''
Among the goals of our draft risk assessment were the determination
of whether somatic cell nuclear transfer (SCNT), the process used to
produce the clones being considered in the risk assessment, poses any
unique risks to animals involved in cloning relative to other assisted
reproductive technologies, and whether foods derived from animal clones
or their progeny pose consumption risks greater than those posed by
foods derived from their conventional counterparts. It specifically
does not consider risk issues that may be posed by genetically
engineered animals.
The draft risk assessment has been peer reviewed in accordance with
the Office of Management and Budget's Information Quality Peer Review
Bulletin. The peer reviewers' comments and the agency's response to
them are posted on the Internet with the draft risk assessment (see the
Electronic Access section of this document).
The proposed risk management plan describes proposed measures that
the agency might use to address animal health and food consumption
risks identified in the draft risk assessment that are within the
agency's purview. It also describes the agency's plans with regard to
issues that are not within the agency's authority to manage (e.g.,
ethics) regarding animal cloning.
The draft guidance for industry describes FDA's recommendations
regarding the introduction of edible products from animal clones and
their progeny into the food and feed supply. FDA will consider
information received during the comment period in its preparation of a
final risk assessment. To that end, FDA requests that any producers or
breeders of clones who have additional data on the health of the clones
or their progeny or composition of food products (i.e., meat or milk)
derived from clones or their progeny share those data with us.
Additionally, the agency reiterates that the release of these draft
documents does not affect its request to industry to continue to
refrain from introducing food products from clones and their progeny
into the marketplace.
II. Significance of Guidance
The draft guidance for industry is a level 1 draft guidance that is
being issued consistent with FDA's good guidance practices regulation
(21 CFR 10.115). The draft guidance represents the agency's current
thinking on the topic. The draft guidance document does not create or
confer any rights for or on any person and will not operate to bind FDA
or the public. Alternative methods may be used as long as they satisfy
the requirements of the applicable statutes and regulations.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding the draft risk
assessment document, the proposed risk management plan, and the draft
guidance for industry. For convenience in reviewing the comments, FDA
requests that comments be separately identified as to which document
they address. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified with the docket number found
in brackets in the heading of this
[[Page 137]]
document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet may obtain the documents at
https://www.fda.gov/cvm/cloning.htm. In an effort to better ensure broad
awareness of this Federal Register notice, FDA will announce it and
make copies available through the FDA Dockets Listserv (https://
www.fda.gov/ohrms/dockets/FDAMAIL/DMBemaillist.htm). To be added to any
of FDA's free e-mail subscription services go to https://www.fda.gov.
Click on ``Subscribe to FDA's E-mail Lists,'' then follow the
instructions provided.
Dated: August 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-9927 Filed 12-28-06; 11:00 am]
BILLING CODE 4160-01-S
