Draft Animal Cloning Risk Assessment; Proposed Risk Management Plan; Draft Guidance for Industry; Availability; Extension of Comment Period, 15887-15888 [E7-6170]
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Federal Register / Vol. 72, No. 63 / Tuesday, April 3, 2007 / Notices
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ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Oncologic Drugs
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on May 9, 2007, from 8 a.m. to 4
p.m. and May 10, 2007, from 8 a.m. to
5 p.m.
Location: Hilton Washington DC/
Silver Spring, 8727 Colesville Rd.,
Silver Spring, MD, 301–589–5200.
Contact Person: Johanna Clifford,
Center for Drug Evaluation and Research
(HFD–21), Food and Drug
Administration, 5630 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm.
1093) Rockville, MD 20857, 301–827–
6761, FAX: 301–827–6776, e-mail:
johanna.clifford@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512542. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: On May 9, 2007, the
committee will do the following: (1)
Discuss new drug application (NDA)
022–092, proposed trade name
JUNOVAN (mifamurtide), IDM Pharma,
Inc., proposed indication for the
treatment of newly diagnosed resectable
high grade osteosarcoma following
surgical resection in combination with
multiple agent chemotherapy; and (2)
discuss NDA 022–062, proposed trade
name ORBEC (beclomethasone
dipropionate), DOR BioPharma, Inc.,
proposed indication for the treatment of
graft versus host disease (GvHD)
involving the gastrointestinal tract in
conjunction with an induction course of
high-dose prednisone or prednisolone.
On May 10, 2007, the committee will
discuss updated information on risks of
erythropoeisis-stimulating agents
(ARANESP, Amgen, Inc., EPOGEN,
Amgen, Inc., and PROCRIT, Amgen,
Inc.) for use in the treatment of anemia
due to cancer chemotherapy.
FDA intends to make background
material available to the public no later
than 1 business day before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
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the meeting. Background material is
available at https://www.fda.gov/ohrms/
dockets/ac/acmenu.htm, click on the
year 2007 and scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before April 25, 2007. Oral
presentations from the public will be
scheduled between approximately 10:30
a.m. to 11 a.m. and 3:30 p.m. to 4 p.m.
on May 9 and from 10:45 a.m. to 11:45
a.m. on May 10. Those desiring to make
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before April 19, 2007. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by April 18, 2007.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Johanna
Clifford at least 7 days in advance of the
meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: March 28, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and
Planning.
[FR Doc. E7–6171 Filed 4–2–07; 8:45 am]
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15887
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; Extension of
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; extension of comment
period.
SUMMARY: The Food and Drug
Administration (FDA) is extending to
May 3, 2007, the comment period for
the notice of availability that appeared
in the Federal Register of January 3,
2007 (72 FR 136). In the notice, FDA
requested comments on the draft risk
assessment, the proposed risk
management plan, and the draft
guidance for industry on animal
cloning. The agency is taking this action
in response to requests for an extension
to allow interested persons additional
time to submit comments.
DATES: Submit written and electronic
comments by May 3, 2007.
ADDRESSES: 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 the Federal Register of January 3,
2007 (72 FR 136), FDA published a
notice of availability with a 90-day
comment period to request comments
on a draft risk assessment to evaluate
the health effects 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 also announced the availability for
public comment of a proposed risk
management plan for animal clones and
their progeny and a draft guidance for
industry describing FDA’s
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Federal Register / Vol. 72, No. 63 / Tuesday, April 3, 2007 / Notices
recommendations regarding the use of
edible products from animal clones and
their progeny in human food or in
animal feed.
The agency has received requests for
an extension of the comment period for
the draft risk assessment, proposed risk
management plan, and draft guidance.
These requests conveyed concern that
the current 90-day comment period does
not allow sufficient time to develop a
meaningful or thoughtful response to
the cloning documents.
FDA has considered the requests and
is extending the comment period for the
draft risk assessment, proposed risk
management plan, and draft guidance
until May 3, 2007. The agency believes
this extension allows adequate time for
interested persons to submit comments.
II. Request for Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on these documents. 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
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: March 27, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–6170 Filed 4–2–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Docket No. 2005D–0468
Guidance for Industry and Food and
Drug Administration Staff; Class II
Special Controls Guidance Document:
Herpes Simplex Virus Types 1 and 2
Serological Assays; Availability
AGENCY:
Food and Drug Administration,
HHS.
ycherry on PROD1PC64 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the guidance document
entitled ‘‘Class II Special Controls
Guidance Document: Herpes Simplex
Virus Types 1 and 2 Serological
Assays.’’ This guidance document
describes a means by which herpes
simplex virus type 1 and 2 (HSV 1 and
2) serological assays may comply with
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the requirement of special controls for
class II devices. Elsewhere in this issue
of the Federal Register, FDA is
publishing a final rule reclassifying
these devices from class III (premarket
approval) into class II (special controls).
DATES: Submit written or electronic
comments on agency guidances at any
time. General comments on agency
guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for
single copies of the guidance document
entitled ‘‘Class II Special Controls
Guidance Document: Herpes Simplex
Virus Types 1 and 2 Serological Assays’’
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 selfaddressed adhesive label to assist that
office in processing your request, or fax
your request to 240–276–3151. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance.
Submit written comments concerning
this 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.
Identify comments with the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Sally Hojvat, Center for Devices and
Radiological Health (HFZ–440), Food
and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
240–276–0496.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 9,
2006 (71 FR 1399), FDA published a
proposed rule to reclassify herpes
simplex virus types 1 and 2 serological
assays from class III (premarket
approval) into class II (special controls).
In addition, FDA issued a draft class II
special controls guidance document
entitled ‘‘Class II Special Controls
Guidance Document: Herpes Simplex
Virus Types 1 and 2 Serological Assays’’
to support the proposed reclassification.
Herpes simplex virus types 1 and 2
serological assays are in vitro diagnostic
devices that test for specific antibodies.
In conjunction with other clinical
laboratory findings, the detection of
these HSV type 1 and/or 2 -specific
antibodies aids in the clinical laboratory
diagnosis of an acute or past infection
by HSV type 1 and/or 2. FDA did not
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receive any comments on the proposed
reclassification. FDA is now identifying
the guidance document entitled ‘‘Class
II Special Controls Guidance Document:
Herpes Simplex Virus Types 1 and 2
Serological Assays’’ as the guidance
document that will serve as the special
control for these devices.
The guidance document provides a
means by which herpes simplex virus
types 1 and 2 serological assays may
comply with the requirement of special
controls for class II devices. Following
the effective date of the final
reclassification rule, any firm
submitting a premarket notification
(510(k)) for herpes simplex virus type 1
and 2 serological assays will need to
address the issues covered in the special
controls guidance document. However,
the firm need only show that its device
meets the recommendations of the
guidance document or in some other
way provides equivalent assurances of
safety and effectiveness.
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on herpes simplex
virus types 1 and 2 serological assays.
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 guidance may do so by using the
Internet. To receive ‘‘Class II Special
Controls Guidance Document: Herpes
Simplex Virus Types 1 and 2
Serological Assays’’ 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 1305 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,
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[Federal Register Volume 72, Number 63 (Tuesday, April 3, 2007)]
[Notices]
[Pages 15887-15888]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-6170]
-----------------------------------------------------------------------
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; Extension of Comment
Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; extension of comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is extending to May 3,
2007, the comment period for the notice of availability that appeared
in the Federal Register of January 3, 2007 (72 FR 136). In the notice,
FDA requested comments on the draft risk assessment, the proposed risk
management plan, and the draft guidance for industry on animal cloning.
The agency is taking this action in response to requests for an
extension to allow interested persons additional time to submit
comments.
DATES: Submit written and electronic comments by May 3, 2007.
ADDRESSES: 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 the Federal Register of January 3, 2007 (72 FR 136), FDA
published a notice of availability with a 90-day comment period to
request comments on a draft risk assessment to evaluate the health
effects 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 also announced the
availability for public comment of a proposed risk management plan for
animal clones and their progeny and a draft guidance for industry
describing FDA's
[[Page 15888]]
recommendations regarding the use of edible products from animal clones
and their progeny in human food or in animal feed.
The agency has received requests for an extension of the comment
period for the draft risk assessment, proposed risk management plan,
and draft guidance. These requests conveyed concern that the current
90-day comment period does not allow sufficient time to develop a
meaningful or thoughtful response to the cloning documents.
FDA has considered the requests and is extending the comment period
for the draft risk assessment, proposed risk management plan, and draft
guidance until May 3, 2007. The agency believes this extension allows
adequate time for interested persons to submit comments.
II. Request for Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on these documents.
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 document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: March 27, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-6170 Filed 4-2-07; 8:45 am]
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