Guidance for Industry and Review Staff on Recommended Approaches to Integration of Genetic Toxicology Study Results; Availability, 350-351 [E5-8224]
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Federal Register / Vol. 71, No. 2 / Wednesday, January 4, 2006 / Notices
better comply with labeling
requirements, especially in light of
growing concerns about obesity and
food allergens. Information presented
will be based on agency position as
articulated through regulation,
compliance policy guides, and
information previously made available
to the public. Topics to be discussed at
the workshop include: (1) Mandatory
label elements, (2) nutrition labeling
requirements, (3) health and nutrition
claims, (4) the Food Allergen Labeling
and Consumer Protection Act of 2004,
and (5) special labeling issues such as
exemptions. FDA expects that
participation in this public workshop
will provide regulated industry with
greater understanding of the regulatory
and policy perspectives on food labeling
and increase voluntary compliance.
Dated: December 27, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5–8225 Filed 1–3–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D–0468]
Guidance for Industry on Development
of Target Animal Safety and
Effectiveness Data to Support
Approval of Non-Steroidal AntiInflammatory Drugs for Use in
Animals; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
(#123) entitled ‘‘Development of Target
Animal Safety and Effectiveness Data to
Support Approval of Non-Steroidal
Anti-Inflammatory Drugs for Use in
Animals.’’ This guidance provides
recommendations regarding the
development of target animal safety and
effectiveness data to support approval of
veterinary non-steroidal antiinflammatory drugs (NSAIDs),
specifically cyclooxygenase (COX)
inhibitors.
DATES: Submit written or electronic
comments on agency guidances at any
time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
wwhite on PROD1PC61 with NOTICES
SUMMARY:
VerDate Aug<31>2005
17:18 Jan 03, 2006
Jkt 208001
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
Submit written comments on the
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.
Comments should be identified with the
full title of the guidance and the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Linda Wilmot, Center for Veterinary
Medicine (HFV–114), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0135, email: lwilmot@cvm.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of November
10, 2004 (69 FR 65202), FDA published
a notice of availability for a draft
guidance entitled ‘‘Development of
Target Animal Safety and Effectiveness
Data to Support Approval of NonSteroidal Anti-Inflammatory Drugs for
Use in Animals’’ giving interested
persons until January 24, 2005, to
comment on the draft guidance. This
final guidance reflects changes in
response to comments received on the
draft guidance. In addition, FDA
provided further clarification regarding
recommendations on the generation of
pharmacokinetic (PK) data. In
particular, FDA included several
examples of the type of PK information
that would be recommended for certain
types of products including those
involving repeated administration or
multiple dosage forms.
II. Paperwork Reduction Act of 1995
This 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
addressed in this guidance have been
approved under OMB control number
0910–0032.
III. Significance of Guidance
This level 1 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
This guidance represents the agency’s
current thinking on the development of
target animal safety and effectiveness
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data to support approval of nonsteroidal anti-inflammatory drugs for
use in animals. 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 statutes
and regulations.
IV. Comments
As with all FDA guidances, the public
is encouraged to submit written or
electronic comments with new data or
other new information pertinent to this
guidance. FDA periodically will review
the comments in the docket, and where
appropriate, will amend the guidance.
The agency will notify the public of any
such amendments through a notice in
the Federal Register.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments should be identified with the
docket number found in brackets in the
heading of this document. A copy of the
guidance and received comments are
available for public examination in the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
V. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/cvm or https://
www.fda.gov/ohrms/dockets/
default.htm.
Dated: December 21, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5–8223 Filed 1–3–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D–0493]
Guidance for Industry and Review Staff
on Recommended Approaches to
Integration of Genetic Toxicology
Study Results; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
E:\FR\FM\04JAN1.SGM
04JAN1
Federal Register / Vol. 71, No. 2 / Wednesday, January 4, 2006 / Notices
and review staff entitled
‘‘Recommended Approaches to
Integration of Genetic Toxicology Study
Results.’’ This guidance is intended to
inform industry and the review staff in
the Center for Drug Evaluation and
Research (CDER) on how CDER views
positive findings in genetic toxicology
assays during drug development. The
guidance provides recommendations on
how to proceed with clinical studies
while ensuring the safety of study
participants when results in
genotoxicity studies suggest a potential
cancer or genetic hazard.
DATES: Submit written or electronic
comments on agency guidances at any
time.
Submit written requests for
single copies of this guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send one selfaddressed adhesive label to assist that
office in processing your requests.
Submit written comments on the
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 electronic access to the guidance
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
David Jacobson-Kram, Center for Drug
Evaluation and Research (6411), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6488,
Silver Spring, MD 20993, 301–796–
0175.
SUPPLEMENTARY INFORMATION:
wwhite on PROD1PC61 with NOTICES
I. Background
FDA is announcing the availability of
a guidance for industry and review staff
entitled ‘‘Recommended Approaches to
Integration of Genetic Toxicology Study
Results.’’ Pharmaceuticals administered
through oral, intravenous, topical, and
other routes, as appropriate, are subject
to this guidance.
In the Federal Register of December 2,
2004 (69 FR 70153), FDA announced the
availability of a draft version of the
guidance entitled ‘‘Recommended
Approaches to Integration of Genetic
Toxicology Study Results.’’ When the
draft guidance was published, FDA
requested comments on the document.
Some changes were made to the draft
document based on comments
submitted to the docket including the
following changes: (1) The guidance
VerDate Aug<31>2005
17:18 Jan 03, 2006
Jkt 208001
now suggests that for a compound
giving positive results in a genetic
toxicology assay, an alternative to
demonstrating ‘‘mechanism of action’’
would be ruling out mechanisms
involving direct interaction with
dexoyribonucleic acid (DNA) and (2)
alkaline elution is included as an
example of an assay for measuring DNA
damage. Other editorial changes were
also made.
A number of comments to the docket
suggested that the fourth test in the
International Conference on
Harmonisation (ICH) battery should be
an option for compounds giving a
positive response in one of the initial
assays. This change was not included.
Positive responses are primarily seen in
the in vitro chromosomal aberration
assay and/or the mouse lymphoma
assay. Because these two tests measure
common genetic lesions and have
similar drug exposure protocols, the
data from the two assays can be used to
corroborate results.
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 recommended
approaches to integration of genetic
toxicology study results. 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 statutes and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the guidance at any time.
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. The guidance
and received comments may be seen in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/cder/guidance/
index.htm or https://www.fda.gov/
ohrms/dockets/default.htm.
Dated: December 21, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5–8224 Filed 1–3–06; 8:45 am]
BILLING CODE 4160–01–S
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351
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 1999D–2215] (formerly 99D–
2215)
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products; Draft
Revised Guidance for Industry on
Impurities in New Veterinary Drug
Substances (Revision); Request for
Comments; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability for comments of a draft
revised guidance for industry (#92)
entitled ‘‘Impurities in New Veterinary
Drug Substances (Revision)’’ VICH
GL10(R). This draft revised guidance,
which updates a final guidance on the
same topic for which a Notice of
Availability was published in the
Federal Register of July 7, 2000 (the
2000 guidance), has been developed for
veterinary use by the International
Cooperation on Harmonisation of
Technical Requirements for Registration
of Veterinary Medicinal Products
(VICH). The draft revised document is
intended to provide guidance for
registration applicants on the content
and qualification of impurities in new
veterinary drug substances produced by
chemical syntheses and not previously
registered in a country, region, or
member state.
DATES: Submit written or electronic
comments by February 3, 2006 to ensure
their adequate consideration in
preparation of the final guidance
document. General comments on agency
guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine (CVM), Food
and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your request. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft revised
guidance document.
Submit written comments on the draft
revised 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.
E:\FR\FM\04JAN1.SGM
04JAN1
]]>Agencies
[Federal Register Volume 71, Number 2 (Wednesday, January 4, 2006)]
[Notices]
[Pages 350-351]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-8224]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0493]
Guidance for Industry and Review Staff on Recommended Approaches
to Integration of Genetic Toxicology Study Results; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry
[[Page 351]]
and review staff entitled ``Recommended Approaches to Integration of
Genetic Toxicology Study Results.'' This guidance is intended to inform
industry and the review staff in the Center for Drug Evaluation and
Research (CDER) on how CDER views positive findings in genetic
toxicology assays during drug development. The guidance provides
recommendations on how to proceed with clinical studies while ensuring
the safety of study participants when results in genotoxicity studies
suggest a potential cancer or genetic hazard.
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to
assist that office in processing your requests. Submit written comments
on the 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 electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: David Jacobson-Kram, Center for Drug
Evaluation and Research (6411), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6488, Silver Spring, MD 20993, 301-796-
0175.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry and
review staff entitled ``Recommended Approaches to Integration of
Genetic Toxicology Study Results.'' Pharmaceuticals administered
through oral, intravenous, topical, and other routes, as appropriate,
are subject to this guidance.
In the Federal Register of December 2, 2004 (69 FR 70153), FDA
announced the availability of a draft version of the guidance entitled
``Recommended Approaches to Integration of Genetic Toxicology Study
Results.'' When the draft guidance was published, FDA requested
comments on the document. Some changes were made to the draft document
based on comments submitted to the docket including the following
changes: (1) The guidance now suggests that for a compound giving
positive results in a genetic toxicology assay, an alternative to
demonstrating ``mechanism of action'' would be ruling out mechanisms
involving direct interaction with dexoyribonucleic acid (DNA) and (2)
alkaline elution is included as an example of an assay for measuring
DNA damage. Other editorial changes were also made.
A number of comments to the docket suggested that the fourth test
in the International Conference on Harmonisation (ICH) battery should
be an option for compounds giving a positive response in one of the
initial assays. This change was not included. Positive responses are
primarily seen in the in vitro chromosomal aberration assay and/or the
mouse lymphoma assay. Because these two tests measure common genetic
lesions and have similar drug exposure protocols, the data from the two
assays can be used to corroborate results.
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 recommended approaches to integration of
genetic toxicology study results. 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 statutes and regulations.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the guidance at any
time. 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. The guidance and received
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/cder/guidance/index.htm or https://
www.fda.gov/ohrms/dockets/default.htm.
Dated: December 21, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5-8224 Filed 1-3-06; 8:45 am]
BILLING CODE 4160-01-S
