Agency Information Collection Activities: Submission for OMB Review; Comment Request, 56595 [E8-22728]
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56595
Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Notices
TABLE 2.—ESTIMATED REPORTING BURDENS FOR LABELING REVISIONS TO ALREADY-APPROVED DRUG PRODUCTS1—
Continued
Category (21 CFR Section)
Year(s) In Which Burdens Occur After
June 30, 2006
Burden associated with revised labeling for efficacy
supplements for generic
drug products (§ 201.57)
Beginning year 3,
continuing annually
thereafter
No. of Respondents
No. of Responses per
Respondent
42
Total Responses
8
Hours per
Response
336 (for
years 1–10)
Total Hours
27
$2.5 million
Up to $8.3
million
are no operating and maintenance costs associated with this collection of information.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: September 17, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–22731 Filed 9–26–08; 8:45 am]
BILLING CODE 4160–01–S
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. 3501 et seq.). To request a copy
of the clearance requests submitted to
OMB for review, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Office at (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: Data Collection Tool
for State Offices of Rural Health Grant
Program: (New)
The mission of the Office of Rural
Health Policy (ORHP) is to sustain and
improve access to quality care services
for rural communities. In its authorizing
language (Sec. 711 of the Social Security
Act [42 U.S.C. 912]), Congress charged
ORHP with ‘‘administer[ing] grants,
cooperative agreements, and contracts to
provide technical assistance and other
activities as necessary to support
activities related to improving health
care in rural areas.’’
The State Offices of Rural Health
Grant Program (SORH) is authorized by
Section 338J of the Public Health
Service Act (42 U.S.C. 254r). The
purpose of SORH is to assist States in
strengthening their rural health care
delivery systems by helping to support
a focal point for rural health within each
State. The program provides funding for
an institutional framework that links
rural hospitals, providers and
Number of
respondents
Form
Technical Assistance Report ...............................................
Total ..............................................................................
mstockstill on PROD1PC66 with NOTICES
9,072
112,952
Total
1 There
Total Capital Costs
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to
the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov
or by fax to 202–395–6974. Please direct
VerDate Aug<31>2005
16:48 Sep 26, 2008
Jkt 214001
50
50
Responses
per
respondent
Total
responses
Hours per
response
1
........................
50
........................
12.5
........................
all correspondence to the ‘‘attention of
the desk officer for HRSA.’’
PO 00000
communities with State and Federal
resources to help develop long term
solutions to rural health problems. The
average annual award for each State
based grantee is $150,000. The law
provides for a Federal-State partnership,
requiring a State funding match of $3 for
each $1 of Federal funding. Over the
past 16 years, this program has
leveraged in excess of $200 million in
State matching funds for rural health.
For SORH, program performance
measures were drafted to provide data
useful to the program and to enable
HRSA to provide aggregate program data
required by Congress under the
Government Performance and Results
Act (GPRA) of 1993. ORHP seeks to
collect information from grantees on
their efforts to provide technical
assistance to clients within their State.
SORH grantees would be required to
submit a Technical Assistance Report
that includes: 1) The total number of
technical assistance encounters
provided directly by the grantee; and, 2)
the total number of clients that received
direct technical assistance from the
grantee. Submission of the Technical
Assistance Report would be done via email to ORHP no later than 30 days after
the end of each twelve month budget
period.
The estimated average annual burden
is as follows:
Fmt 4703
Sfmt 4703
625
625
Dated: September 22, 2008
Alexandra Huttinger,
Director, Division of Policy Review and
Coordination.
[FR Doc. E8–22728 Filed 9–26–08; 8:45 am]
BILLING CODE 4165–15–P
Frm 00055
Total burden
hours
E:\FR\FM\29SEN1.SGM
29SEN1
Agencies
[Federal Register Volume 73, Number 189 (Monday, September 29, 2008)]
[Notices]
[Page 56595]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-22728]
-----------------------------------------------------------------------
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. 3501 et seq.). To
request a copy of the clearance requests submitted to OMB for review,
e-mail paperwork@hrsa.gov or call the HRSA Reports Clearance Office at
(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: Data Collection Tool for State Offices of Rural
Health Grant Program: (New)
The mission of the Office of Rural Health Policy (ORHP) is to
sustain and improve access to quality care services for rural
communities. In its authorizing language (Sec. 711 of the Social
Security Act [42 U.S.C. 912]), Congress charged ORHP with
``administer[ing] grants, cooperative agreements, and contracts to
provide technical assistance and other activities as necessary to
support activities related to improving health care in rural areas.''
The State Offices of Rural Health Grant Program (SORH) is
authorized by Section 338J of the Public Health Service Act (42 U.S.C.
254r). The purpose of SORH is to assist States in strengthening their
rural health care delivery systems by helping to support a focal point
for rural health within each State. The program provides funding for an
institutional framework that links rural hospitals, providers and
communities with State and Federal resources to help develop long term
solutions to rural health problems. The average annual award for each
State based grantee is $150,000. The law provides for a Federal-State
partnership, requiring a State funding match of $3 for each $1 of
Federal funding. Over the past 16 years, this program has leveraged in
excess of $200 million in State matching funds for rural health.
For SORH, program performance measures were drafted to provide data
useful to the program and to enable HRSA to provide aggregate program
data required by Congress under the Government Performance and Results
Act (GPRA) of 1993. ORHP seeks to collect information from grantees on
their efforts to provide technical assistance to clients within their
State. SORH grantees would be required to submit a Technical Assistance
Report that includes: 1) The total number of technical assistance
encounters provided directly by the grantee; and, 2) the total number
of clients that received direct technical assistance from the grantee.
Submission of the Technical Assistance Report would be done via e-mail
to ORHP no later than 30 days after the end of each twelve month budget
period.
The estimated average annual burden is as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Form respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Technical Assistance Report..... 50 1 50 12.5 625
Total....................... 50 .............. .............. .............. 625
----------------------------------------------------------------------------------------------------------------
Written comments and recommendations concerning the proposed
information collection should be sent within 30 days of this notice to
the desk officer for HRSA, either by e-mail to OIRA_
submission@omb.eop.gov or by fax to 202-395-6974. Please direct all
correspondence to the ``attention of the desk officer for HRSA.''
Dated: September 22, 2008
Alexandra Huttinger,
Director, Division of Policy Review and Coordination.
[FR Doc. E8-22728 Filed 9-26-08; 8:45 am]
BILLING CODE 4165-15-P