Agency Information Collection Activities: Submission for OMB Review; Comment Request, 28059-28060 [E7-9536]
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Federal Register / Vol. 72, No. 96 / Friday, May 18, 2007 / Notices
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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 Draft Guidance on Target Animal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that the draft guidance document
entitled ‘‘Draft Guidance for Industry on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draft guidance document is intended to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
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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
28060
Federal Register / Vol. 72, No. 96 / Friday, May 18, 2007 / Notices
progress of the grantees. Grantee goals
are to: Improve access to needed
services, reduce rural practitioner
isolation, improve health system
productivity and efficiency, and
improve patient outcomes. In each of
these categories, specific indicators
were designed to be reported through a
performance monitoring Web site.
The Program Assessment Response
Tool (PART) is the newest instrument
created for use by Federal agencies. The
Office of Management and Budget
(OMB) uses the PART to assess Federal
programs. The PART is a series of
diagnostic questions used to assess and
evaluate programs across a set of
performance-related criteria including
program design and purpose, strategic
planning, program management, and
results. PART results are used to inform
the budget process and improve
program management. OAT’s Telehealth
Network Grant Program has been
undergoing a PART assessment this
year. Thus, in addition to responding to
the GPRA initiative, OAT now has the
added responsibility of responding to
the PART assessment of its Telehealth
Network Grant Program. The proposed
performance measures will provide
performance data that will address the
PART assessment, monitor progress,
and evaluate program effectiveness.
The estimates of burden are as
follows:
Form
Number of
respondents
Responses
per
respondent
Total
responses
Hour burden
Total burden
hours
Performance Measurement Tool .........................................
667
2
1,334
7
9,338
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to:
Karen Matsuoka, Human Resources and
Housing Branch, Office of Management
and Budget, New Executive Office
Building, Room 10235, Washington, DC
20503.
Dated: May 11, 2007.
Caroline Lewis,
Associate Administrator for Management.
[FR Doc. E7–9536 Filed 5–17–07; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects (44
U.S.C. 3506(c)(2)(A)), the Health
Resources and Services Administration
(HRSA) publishes periodic summaries
of proposed projects being developed
for submission to OMB under the
Paperwork Reduction Act of 1995. To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, call the HRSA Reports
Clearance Officer on (301) 443–1129.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Proposed Project: Data System for
Organ Procurement and
Transplantation Network (42 CFR Part
121, OMB No. 0915–0184): Extension
The operation of the Organ
Procurement and Transplantation
Network (OPTN) necessitates certain
recordkeeping and reporting
requirements in order to perform the
functions related to organ
transplantation under contract to HHS.
This is a request for an extension of the
current recordkeeping and reporting
requirements associated with the OPTN.
These data will be used by HRSA in
monitoring the contracts for the OPTN
and the Scientific Registry of Transplant
Recipients (SRTR) and in carrying out
other statutory responsibilities.
Information is needed to match donor
organs with recipients, to monitor
compliance of member organizations
with OPTN rules and requirements, to
ensure that all qualified entities are
accepted for membership in the OPTN,
and to ensure patient safety.
ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN
Number of
respondents
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Section and Activity
121.3(b)(2).
OPTN membership and application requirements for
OPOs, hospitals, and histocompatibility laboratories
121.3(b)(4)
Appeal for OPTN membership .................................
121.6(c) (Reporting)
Submitting criteria for organ acceptance ..................
121.6(c) (Disclosure)
Sending criteria to OPOs ..........................................
121.7(b)(4)
Reasons for Refusal .................................................
121.7(e)
Transplant to prevent organ wastage .......................
121.9(b)
Designated Transplant Program Requirements .......
121.9(d)
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Jkt 211001
PO 00000
Frm 00042
Responses per
respondents
Total
responses
Hours per
response
Total burden
hours
40
3
120
15
1, 800
2
1
2
3
6
900
1
900
0.5
450
900
1
900
0.5
450
900
38
34,200
0.5
17,100
390
0.5
195
10
5.0
50
260
1.5
10
Fmt 4703
1
Sfmt 4703
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18MYN1
]]>Agencies
[Federal Register Volume 72, Number 96 (Friday, May 18, 2007)]
[Notices]
[Pages 28059-28060]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-9536]
-----------------------------------------------------------------------
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
[[Page 28060]]
progress of the grantees. Grantee goals are to: Improve access to
needed services, reduce rural practitioner isolation, improve health
system productivity and efficiency, and improve patient outcomes. In
each of these categories, specific indicators were designed to be
reported through a performance monitoring Web site.
The Program Assessment Response Tool (PART) is the newest
instrument created for use by Federal agencies. The Office of
Management and Budget (OMB) uses the PART to assess Federal programs.
The PART is a series of diagnostic questions used to assess and
evaluate programs across a set of performance-related criteria
including program design and purpose, strategic planning, program
management, and results. PART results are used to inform the budget
process and improve program management. OAT's Telehealth Network Grant
Program has been undergoing a PART assessment this year. Thus, in
addition to responding to the GPRA initiative, OAT now has the added
responsibility of responding to the PART assessment of its Telehealth
Network Grant Program. The proposed performance measures will provide
performance data that will address the PART assessment, monitor
progress, and evaluate program effectiveness.
The estimates of burden are as follows:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses per Total Total burden
Form respondents respondent responses Hour burden hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Performance Measurement Tool....................................... 667 2 1,334 7 9,338
--------------------------------------------------------------------------------------------------------------------------------------------------------
Written comments and recommendations concerning the proposed
information collection should be sent within 30 days of this notice to:
Karen Matsuoka, Human Resources and Housing Branch, Office of
Management and Budget, New Executive Office Building, Room 10235,
Washington, DC 20503.
Dated: May 11, 2007.
Caroline Lewis,
Associate Administrator for Management.
[FR Doc. E7-9536 Filed 5-17-07; 8:45 am]
BILLING CODE 4165-15-P
