International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Target Animal Safety for Veterinary Pharmaceutical Products, VICH GL43, Request for Comments; Availability, 28058-28059 [E7-9592]
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Federal Register / Vol. 72, No. 96 / Friday, May 18, 2007 / Notices
needs to withhold payments from an
obligor who owes child support. One of
the new fields on the form is for the
attachment of lump sum payments by
employers. This addition allows the
issuing entity to instruct the employer
with respect to the attachment and
remittance of lump sum payments.
Fields for child’s name and date of birth
have been moved to the front of the
form, allowing the employer community
to easily identify who the form is for
and to avoid implementation of
duplicate orders. Other changes that
have enhanced the form include: A
simplified title, clear identification of
who is sending the form, and
modifications to allow the employer to
easily report employee terminations.
The electronic IWO (e-IWO) allows
States to transmit IWOs electronically
and employers to notify States
electronically regarding the status of
IWOs.
Respondents: States, Territories,
Tribes, and Courts.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Income Withholding for Support (IWO) ...........................................................
ELECTRONIC Income Withholding for Support ..............................................
IWO—Submitted Manually ..............................................................................
Estimated Total Annual Burden
Hours: 221,095.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Administration, Office of Information
Services, 370 L’Enfant Promenade, SW.,
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395–6974, Attn: Desk Officer for the
Administration for Children and
Families.
Dated: May 15, 2007.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 07–2479 Filed 5–17–07; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D–0166]
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products (VICH);
Draft Guidance for Industry on Target
Animal Safety for Veterinary
Pharmaceutical Products, VICH GL43,
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
guidance document for industry (#185)
entitled ‘‘Draft Guidance for Industry on
Target Animal Safety for Veterinary
Pharmaceutical Products,’’VICH GL43.
This draft guidance has been developed
for veterinary use by the International
Cooperation on Harmonisation of
Technical Requirements for Registration
of Veterinary Medicinal Products
(VICH). This draft VICH guidance
document has been developed as a
harmonized standard to aid in
development of mutually acceptable
target animal safety (TAS) studies for
the relevant governmental regulatory
bodies.
Submit written or electronic
comments on the draft guidance by June
18, 2007, to ensure their adequate
consideration in preparation of the final
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
DATES:
pwalker on PROD1PC71 with NOTICES
58
20
1,800
VerDate Aug<31>2005
17:06 May 17, 2007
Jkt 211001
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average
burden hours
per response
206,897
60,000
1,321
.0017
.0008
.0840
Total burden
hours
20,400
960
199,735
for Veterinary Medicine, 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
guidance document.
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.
Comments should be identified with the
full title of the draft guidance and the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Laura Hungerford, Center for Veterinary
Medicine, (HFV–100), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–6439, email: laura.hungerford@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote the
international harmonization of
regulatory requirements. FDA has
participated in efforts to enhance
harmonization and has expressed its
commitment to seek scientifically based
harmonized technical procedures for the
development of pharmaceutical
products. One of the goals of
harmonization is to identify and then
reduce differences in technical
requirements for drug development
among regulatory agencies in different
countries.
FDA has actively participated in the
International Conference on
Harmonisation of Technical
E:\FR\FM\18MYN1.SGM
18MYN1
Federal Register / Vol. 72, No. 96 / Friday, May 18, 2007 / Notices
pwalker on PROD1PC71 with NOTICES
Requirements for Approval of
Pharmaceuticals for Human Use for
several years to develop harmonized
technical requirements for the approval
of human pharmaceutical and biological
products among the European Union,
Japan, and the United States. VICH is a
parallel initiative for veterinary
medicinal products. VICH is concerned
with developing harmonized technical
requirements for the approval of
veterinary medicinal products in the
European Union, Japan, and the United
States, and includes input from both
regulatory and industry representatives.
The VICH steering committee is
composed of member representatives
from the European Commission;
European Medicines Evaluation Agency;
European Federation of Animal Health;
Committee on Veterinary Medicinal
Products; FDA; the U.S. Department of
Agriculture; the Animal Health
Institute; the Japanese Veterinary
Pharmaceutical Association; the
Japanese Association of Veterinary
Biologics; and the Japanese Ministry of
Agriculture, Forestry, and Fisheries.
Four observers are eligible to
participate in the VICH steering
committee: One representative from the
government of Australia/New Zealand,
one representative from the industry in
Australia/New Zealand, one
representative from the government of
Canada, and one representative from the
industry of Canada. The VICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
Federation for Animal Health (IFAH).
An IFAH representative also
participates in the VICH steering
committee meetings.
II. Draft Guidance on Target Animal
Safety
The VICH steering committee held a
meeting in December 2006 and agreed
that the draft guidance document
entitled ‘‘Draft Guidance for Industry on
Target Animal Safety for Veterinary
Pharmaceutical Products,’’VICH GL43
should be made available for public
comment. This draft VICH guidance
document has been developed as a
harmonized standard to aid in
development of mutually acceptable
TAS studies for the relevant
governmental regulatory bodies. This
draft guidance document is intended to
cover TAS studies for any
Investigational Veterinary
Pharmaceutical Product used in the
following species: Bovine, ovine,
caprine, feline, canine, porcine, equine,
and poultry (chickens and turkeys).
Minor species and minor uses may be
excluded from this guidance for local
VerDate Aug<31>2005
17:06 May 17, 2007
Jkt 211001
registration. The guidance does not
provide information for the design of
TAS studies in other species including
aquatic animals. For other species, TAS
studies should be designed following
local guidance.
FDA and the VICH Expert Working
Group will consider comments about
the draft guidance document.
III. 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 section 1-5 of the draft
guidance have been approved under
OMB Control No. 0910–0032.
This draft document, developed
under the VICH process, has been
revised to conform to FDA’s good
guidance practices regulation (21 CFR
10.115). For example, the document has
been designated ‘‘guidance’’ rather than
‘‘guideline.’’ In addition, guidance
documents must not include mandatory
language such as ‘‘shall,’’ ‘‘must,’’
‘‘require,’’ or ‘‘requirement,’’ unless
FDA is using these words to describe a
statutory or regulatory requirement.
The draft VICH guidance (GFI #185) is
consistent with the agency’s current
thinking on this topic. This guidance
does not create or confer any rights for
or on any person and will not operate
to bind FDA or the public. An
alternative method may be used as long
as it satisfies the requirements of
applicable statutes and regulations.
IV. Comments
This draft guidance document is being
distributed for comment purposes only
and is not intended for implementation
at this time. Interested persons may
submit written or electronic comments
regarding this draft guidance document
to the Division of Dockets Management
(see ADDRESSES). 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. A copy of the draft guidance
and received comments may be seen in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
Frm 00041
Fmt 4703
Sfmt 4703
V. Electronic Access
Electronic comments may also be
submitted electronically on the Web site
at https://www.fda.gov/dockets/
ecomments. Once on this Internet site,
select Docket No. 2007D–0166 entitled
‘‘Draft Guidance for Industry on Target
Animal Safety for Veterinary
Pharmaceutical Products,’’VICH GL43
and follow the directions.
Copies of the draft guidance
document entitled ‘‘Draft Guidance for
Industry on Target Animal Safety for
Veterinary Pharmaceutical
Products,’’VICH GL43 may be obtained
on the Web site from the Center for
Veterinary Medicine home page at
https://www.fda.gov/cvm.
Dated: May 10, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–9592 Filed 5–17–07; 8:45 am]
BILLING CODE 4160–01–S
IV. Significance of Guidance
PO 00000
28059
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, call the HRSA Reports
Clearance Office on (301) 443–1129.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
Proposed Project: OAT Telehealth
Outcome Measures: NEW.
In order to help carry out its mission,
the Office for the Advancement of
Telehealth (OAT) created a set of
performance measures that grantees can
use to evaluate the effectiveness of their
services programs and monitor their
progress through the use of performance
reporting data.
As required by the Government
Performance and Review Act of 1993
(GPRA), all Federal agencies must
develop strategic plans describing their
overall goal and objectives. The Office
for the Advancement of Telehealth
(OAT) has worked with its grantees to
develop performance measures to be
used to evaluate and monitor the
E:\FR\FM\18MYN1.SGM
18MYN1
]]>Agencies
[Federal Register Volume 72, Number 96 (Friday, May 18, 2007)]
[Notices]
[Pages 28058-28059]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-9592]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D-0166]
International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products (VICH);
Draft Guidance for Industry on Target Animal Safety for Veterinary
Pharmaceutical Products, VICH GL43, 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 guidance document for industry
(185) entitled ``Draft Guidance for Industry on Target Animal
Safety for Veterinary Pharmaceutical Products,''VICH GL43. This draft
guidance has been developed for veterinary use by the International
Cooperation on Harmonisation of Technical Requirements for Registration
of Veterinary Medicinal Products (VICH). This draft VICH guidance
document has been developed as a harmonized standard to aid in
development of mutually acceptable target animal safety (TAS) studies
for the relevant governmental regulatory bodies.
DATES: Submit written or electronic comments on the draft guidance by
June 18, 2007, to ensure their adequate consideration in preparation of
the final 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, Food and Drug Administration, 7519 Standish Pl., Rockville,
MD 20855. Send one self-addressed adhesive label to assist that office
in processing your request. See the SUPPLEMENTARY INFORMATION section
for electronic access to the draft guidance document.
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. Comments should be identified
with the full title of the draft guidance and the docket number found
in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Laura Hungerford, Center for
Veterinary Medicine, (HFV-100), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-6439, e-mail:
laura.hungerford@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote the
international harmonization of regulatory requirements. FDA has
participated in efforts to enhance harmonization and has expressed its
commitment to seek scientifically based harmonized technical procedures
for the development of pharmaceutical products. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory agencies in
different countries.
FDA has actively participated in the International Conference on
Harmonisation of Technical
[[Page 28059]]
Requirements for Approval of Pharmaceuticals for Human Use for several
years to develop harmonized technical requirements for the approval of
human pharmaceutical and biological products among the European Union,
Japan, and the United States. VICH is a parallel initiative for
veterinary medicinal products. VICH is concerned with developing
harmonized technical requirements for the approval of veterinary
medicinal products in the European Union, Japan, and the United States,
and includes input from both regulatory and industry representatives.
The VICH steering committee is composed of member representatives
from the European Commission; European Medicines Evaluation Agency;
European Federation of Animal Health; Committee on Veterinary Medicinal
Products; FDA; the U.S. Department of Agriculture; the Animal Health
Institute; the Japanese Veterinary Pharmaceutical Association; the
Japanese Association of Veterinary Biologics; and the Japanese Ministry
of Agriculture, Forestry, and Fisheries.
Four observers are eligible to participate in the VICH steering
committee: One representative from the government of Australia/New
Zealand, one representative from the industry in Australia/New Zealand,
one representative from the government of Canada, and one
representative from the industry of Canada. The VICH Secretariat, which
coordinates the preparation of documentation, is provided by the
International Federation for Animal Health (IFAH). An IFAH
representative also participates in the VICH steering committee
meetings.
II. Draft Guidance on Target Animal Safety
The VICH steering committee held a meeting in December 2006 and
agreed that the draft guidance document entitled ``Draft Guidance for
Industry on Target Animal Safety for Veterinary Pharmaceutical
Products,''VICH GL43 should be made available for public comment. This
draft VICH guidance document has been developed as a harmonized
standard to aid in development of mutually acceptable TAS studies for
the relevant governmental regulatory bodies. This draft guidance
document is intended to cover TAS studies for any Investigational
Veterinary Pharmaceutical Product used in the following species:
Bovine, ovine, caprine, feline, canine, porcine, equine, and poultry
(chickens and turkeys). Minor species and minor uses may be excluded
from this guidance for local registration. The guidance does not
provide information for the design of TAS studies in other species
including aquatic animals. For other species, TAS studies should be
designed following local guidance.
FDA and the VICH Expert Working Group will consider comments about
the draft guidance document.
III. 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 section 1-5 of the draft guidance have
been approved under OMB Control No. 0910-0032.
IV. Significance of Guidance
This draft document, developed under the VICH process, has been
revised to conform to FDA's good guidance practices regulation (21 CFR
10.115). For example, the document has been designated ``guidance''
rather than ``guideline.'' In addition, guidance documents must not
include mandatory language such as ``shall,'' ``must,'' ``require,'' or
``requirement,'' unless FDA is using these words to describe a
statutory or regulatory requirement.
The draft VICH guidance (GFI 185) is consistent with the
agency's current thinking on this topic. This guidance does not create
or confer any rights for or on any person and will not operate to bind
FDA or the public. An alternative method may be used as long as it
satisfies the requirements of applicable statutes and regulations.
IV. Comments
This draft guidance document is being distributed for comment
purposes only and is not intended for implementation at this time.
Interested persons may submit written or electronic comments regarding
this draft guidance document to the Division of Dockets Management (see
ADDRESSES). 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. A copy of the draft
guidance and received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
V. Electronic Access
Electronic comments may also be submitted electronically on the Web
site at https://www.fda.gov/dockets/ecomments. Once on this Internet
site, select Docket No. 2007D-0166 entitled ``Draft Guidance for
Industry on Target Animal Safety for Veterinary Pharmaceutical
Products,''VICH GL43 and follow the directions.
Copies of the draft guidance document entitled ``Draft Guidance for
Industry on Target Animal Safety for Veterinary Pharmaceutical
Products,''VICH GL43 may be obtained on the Web site from the Center
for Veterinary Medicine home page at https://www.fda.gov/cvm.
Dated: May 10, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-9592 Filed 5-17-07; 8:45 am]
BILLING CODE 4160-01-S
