Draft Guidance for Industry on Safety Testing of Drug Metabolites; Availability, 32838-32839 [05-11205]
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32838
Federal Register / Vol. 70, No. 107 / Monday, June 6, 2005 / Notices
A panel of at least three reviewers
(primarily experts from outside the
Federal government) will use the
evaluation criteria described in this
announcement to evaluate each
application. The reviewers will
determine the strengths and weaknesses
of each application, provide comments
about the strengths and weaknesses and
give each application a numerical score.
The results of the competitive review
are a primary factor in making funding
decisions. In addition, Federal staff
conducts administrative reviews of the
applications and, in light of the results
of the competitive review, will
recommend applications for funding to
the ACYF Commissioner. ACYF
reserves the option of discussing
applications with other funding sources
when this is in the best interest of the
Federal government. ACYF may also
solicit and consider comments from
ACF Regional Office staff in making
funding decisions. ACYF may take into
consideration the involvement
(financial and/or programmatic) of the
private sector, national, or State or
community foundations; a favorable
balance between Federal and nonFederal funds for the proposed project;
or the potential for high benefit from
low Federal investment. ACYF may
elect not to fund any applicants having
known management, fiscal, reporting,
programmatic, or other problems which
make it unlikely that they would be able
to provide effective services or
effectively complete the proposed
activity.
With the results of the peer review
and the information from Federal staff,
the Commissioner of ACYF makes the
final funding decisions. The
Commissioner may give special
consideration to applications proposing
services of special interest to the
Government and to achieve geographic
distributions of grant awards.
Applications of special interest may
include, but are not limited to,
applications focusing on underserved or
inadequately served clients or service
areas and programs addressing diverse
ethnic populations.
Available Funds. Applicants should
note that grants to be awarded under
this program announcement are subject
to the availability of funds.
Approved but Unfunded Applications
Applications that are approved but
unfunded may be held over for funding
in the next funding cycle, pending the
availability of funds, for a period not to
exceed one year.
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14:25 Jun 03, 2005
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3. Anticipated Announcement and
Award Dates
Applications will be reviewed in the
summer of 2005. Grant awards will have
a start date no later than September 30,
2005.
VI. Award Administration Information
1. Award Notices
The successful applicants will be
notified through the issuance of a
Financial Assistance Award document
which sets forth the amount of funds
granted, the terms and conditions of the
grant, the effective date of the grant, the
budget period for which initial support
will be given, the non-Federal share to
be provided, and the total project period
for which support is contemplated. The
Financial Assistance Award will be
signed by the Grants Officer and
transmitted via postal mail.
Organizations whose applications will
not be funded will be notified in
writing.
2. Administrative and National Policy
Requirements
Grantees are subject to the
requirements in 45 CFR Part 74 (nongovernmental) or 45 CFR Part 92
(governmental).
Direct federal grants, sub-award
funds, or contracts under this program
shall not be used to support inherently
religious activities such as religious
instruction, worship, or proselytization.
Therefore, organizations must take steps
to separate, in time or location, their
inherently religious activities from the
services funded under this program.
Regulations pertaining to the
prohibition of Federal funds for
inherently religious activities can be
found on the HHS web site at https://
www.os.dhhs.gov/fbci/waisgate21.pdf
Special Terms and Conditions
None.
3. Reporting Requirements
Program Progress Reports: Semiannually.
Financial Reports: Semi-annually.
Grantees will be required to submit
program progress and financial reports
(SF–269) throughout the project period.
Program progress and financial reports
are due 30 days after the reporting
period. In addition, final programmatic
and financial reports are due 90 days
after the close of the project period.
Performance Indicator Data,
Programmatic Reports and Financial
Reports are required semi-annually. All
required reports will be submitted in a
timely manner, in recommended
formats (to be provided), and the final
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report will also be submitted on disk or
electronically using a standard wordprocessing program.
Within 90 days of project end date,
the applicant will submit a copy of the
final report and any program products
to the National Clearinghouse on Child
Abuse and Neglect Information, 330 C
Street, SW., Washington, DC 20447.
This is in addition to the standard
requirement that the final program and
evaluation report must also be
submitted to the Grants Management
Specialist and the Federal Project
Officer.
II. Agency Contacts
Program Office Contact: Jan Shafer,
Administration for Children and
Families, Children’s Bureau, 330 C
Street, SW., Washington, DC 20447,
phone: 202–205–8172, e-mail:
jshafer@acf.hhs.gov.
Grants Management Office Contact:
Peter Thompson, Grants Officer,
Administration for Children and
Families, Children’s Bureau, 330 C
Street, SW. Room 2070, Washington, DC
20447, phone: 202–401–4608, e-mail:
pathompson@acf.hhs.gov.
VIII. Other Information
Notice: Beginning with FY 2006, the
Administration for Children and
Families (ACF) will no longer publish
grant announcements in the Federal
Register. Beginning October 1, 2005
applicants will be able to find a
synopsis of all ACF grant opportunities
and apply electronically for
opportunities via: https://
www.Grants.gov. Applicants will also be
able to find the complete text of all ACF
grant announcements on the ACF Web
site located at: https://www.acf.hhs.gov/
grants/.
Additional information about this
program and its purpose can be located
on the following Web sites: https://
www.acf.hhs.gov/programs/cb/.
For general questions regarding this
announcement please contact: ACYF
Operations Center, The Dixon Group
ATTN: Children’s Bureau, 118 Q Street,
NE., Washington DC 20002–2132,
Telephone: 866–796–1591.
Applicants will not be sent
acknowledgements of received
applications.
Dated: May 25, 2005.
Susan Orr,
Acting Commissioner, Administration on
Children, Youth and Families.
[FR Doc. 05–11197 Filed 6–3–05; 8:45 am]
BILLING CODE 4184–01–P
E:\FR\FM\06JNN1.SGM
06JNN1
Federal Register / Vol. 70, No. 107 / Monday, June 6, 2005 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0203]
Draft Guidance for Industry on Safety
Testing of Drug Metabolites;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Safety Testing of
Drug Metabolites.’’ This draft guidance
provides recommendations on the safety
assessment of unique or major human
metabolites of small molecule
(nonbiologic) therapeutic products
under development. This draft guidance
is intended to serve as a resource for
general testing considerations as well as
provide recommendations on the timing
of these studies in relation to the
clinical development.
DATES: Submit written or electronic
comments on the draft guidance by
August 5, 2005. General comments on
agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for
single copies of the draft 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 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 electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Aisar Atrakchi, Center for Drug
Evaluation and Research (HFD–120),
Food and Drug Administration, 1451
Rockville Pike, Rockville, MD 20852,
301–594–2850.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Safety Testing of Drug Metabolites.’’
There are quantitative and qualitative
differences in metabolic profiles across
species. These differences become
VerDate jul<14>2003
14:25 Jun 03, 2005
Jkt 205001
important when exposure parameters of
a drug in a nonclinical species are used
to assess safety in humans during risk
assessment. In the past, contribution of
metabolites to the overall toxicological
potential of the parent drug was
generally unknown or not considered;
analytical technologies to identify and
measure metabolites have only become
available over the past decade.
Although in general there is adequate
correlation in metabolic profiles
between humans and those obtained in
standard nonclinical safety studies,
there are, however, cases when these
studies do not adequately evaluate
clinically relevant and/or biologically
active metabolites. This may be due to
such metabolites being unique to
humans or present at very low levels in
the animal species used in the standard
toxicity studies. As a result, FDA has
developed a draft guidance to provide
recommendations on the safety
assessment of unique or major human
metabolites of small molecule
(nonbiologic) therapeutic products.
These recommendations should help
applicants conduct adequate safety
assessments of metabolites.
This draft guidance provides general
testing considerations for unique or
major drug metabolites including study
design, identification of metabolites,
structure activity relationship, and types
of nonclinical studies needed to assess
metabolite toxicity. It also addresses the
timing of these studies in relation to the
clinical development.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on safety testing of drug metabolites. 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 regarding the 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 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.
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Fmt 4703
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32839
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: May 27, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–11205 Filed 6–3–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[USCG–2005–21322]
Collection of Information Under
Review by Office of Management and
Budget (OMB): OMB Control Number:
1625–0015
Coast Guard, DHS.
Request for comments.
AGENCY:
ACTION:
SUMMARY: In compliance with the
Paperwork Reduction Act of 1995, the
Coast Guard intends to seek the
approval of OMB for the renewal of one
Information Collection Request (ICR).
The ICR is for 1625–0015, Bridge Permit
Application Guide. Before submitting
the ICR to OMB, the Coast Guard is
inviting comments on it as described
below.
Comments must reach the Coast
Guard on or before August 5, 2005.
ADDRESSES: To make sure that your
comments and related material do not
enter the docket [USCG–2005–21322]
more than once, please submit them by
only one of the following means:
(1) By mail to the Docket Management
Facility, U.S. Department of
Transportation (DOT), room PL–401,
400 Seventh Street, SW., Washington,
DC 20590–0001.
(2) By delivery to room PL–401 on the
Plaza level of the Nassif Building, 400
Seventh Street SW., Washington, DC,
between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
The telephone number is 202–366–
9329.
(3) By fax to the Docket Management
Facility at 202–493–2251.
(4) Electronically through the Web
site for the Docket Management System
at https://dms.dot.gov.
The Docket Management Facility
maintains the public docket for this
notice. Comments and material received
from the public, as well as documents
mentioned in this notice as being
available in the docket, will become part
DATES:
E:\FR\FM\06JNN1.SGM
06JNN1
Agencies
[Federal Register Volume 70, Number 107 (Monday, June 6, 2005)]
[Notices]
[Pages 32838-32839]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-11205]
[[Page 32839]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0203]
Draft Guidance for Industry on Safety Testing of Drug
Metabolites; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Safety Testing
of Drug Metabolites.'' This draft guidance provides recommendations on
the safety assessment of unique or major human metabolites of small
molecule (nonbiologic) therapeutic products under development. This
draft guidance is intended to serve as a resource for general testing
considerations as well as provide recommendations on the timing of
these studies in relation to the clinical development.
DATES: Submit written or electronic comments on the draft guidance by
August 5, 2005. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
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 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 electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Aisar Atrakchi, Center for Drug
Evaluation and Research (HFD-120), Food and Drug Administration, 1451
Rockville Pike, Rockville, MD 20852, 301-594-2850.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Safety Testing of Drug Metabolites.'' There are quantitative
and qualitative differences in metabolic profiles across species. These
differences become important when exposure parameters of a drug in a
nonclinical species are used to assess safety in humans during risk
assessment. In the past, contribution of metabolites to the overall
toxicological potential of the parent drug was generally unknown or not
considered; analytical technologies to identify and measure metabolites
have only become available over the past decade.
Although in general there is adequate correlation in metabolic
profiles between humans and those obtained in standard nonclinical
safety studies, there are, however, cases when these studies do not
adequately evaluate clinically relevant and/or biologically active
metabolites. This may be due to such metabolites being unique to humans
or present at very low levels in the animal species used in the
standard toxicity studies. As a result, FDA has developed a draft
guidance to provide recommendations on the safety assessment of unique
or major human metabolites of small molecule (nonbiologic) therapeutic
products. These recommendations should help applicants conduct adequate
safety assessments of metabolites.
This draft guidance provides general testing considerations for
unique or major drug metabolites including study design, identification
of metabolites, structure activity relationship, and types of
nonclinical studies needed to assess metabolite toxicity. It also
addresses the timing of these studies in relation to the clinical
development.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on safety
testing of drug metabolites. 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 regarding the 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 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.
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: May 27, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-11205 Filed 6-3-05; 8:45 am]
BILLING CODE 4160-01-S