Agency Information Collection Activities: Submission for OMB Review: Comment Request, 61105-61106 [2011-25339]
Download as PDF
<![CDATA[
61105
Federal Register / Vol. 76, No. 191 / Monday, October 3, 2011 / Notices
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Submission of information for de novo petition program
Number of
respondents
Number of
responses per
respondent
per year
Average
burden per
respondent
(in hours)
Total annual
responses
Total hours
CDRH ...................................................................................
CBER ...................................................................................
25
1
1
1
25
1
100
100
2,500
100
Total ..............................................................................
........................
........................
........................
........................
2,600
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Respondents are medical device
manufacturers seeking to market
medical device products that have been
classified into class III under section
513(f)(2) of the FD&C Act. Based on
FDA’s experience with the de novo
petition program, FDA expects the
program to continue to be utilized as a
viable program in the future. It is
expected that the number of petitions
will increase over its current rate and
reach a steady rate of approximately 26
submissions per year
FDA estimates from past experience
with the de novo petition program that
the complete process involved with the
program takes approximately 100 hours.
This average is based upon estimates by
FDA administrative and technical staff
who are familiar with the requirements
for submission of a de novo petition
(and related materials), have consulted
and advised manufacturers on these
requirements, and have reviewed the
documentation submitted.
Therefore, the total reporting burden
hours is estimated to be 2,600 hours.
TABLE 2
Number of respondents
Total burden
hours
annualized
Hourly wage
rate
Total cost
annualized
26 .................................................................................................................................................
100
$150
$390,000
The average to industry per hour for
this type of work is $150, resulting in
a cost of $15,000 per respondent. The
estimated submission cost of $15,000
multiplied by 26 submissions per year
equals $390,000, which is the
aggregated industry reporting cost
annualized.
This draft guidance also refers to
currently approved information
collections found in FDA regulations.
The collections of information in 21
CFR part 807, subpart E, are approved
under OMB control number 0910–0120.
srobinson on DSK4SPTVN1PROD with NOTICES
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments 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.
VerDate Mar<15>2010
16:42 Sep 30, 2011
Jkt 223001
Dated: September 27, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2011–25367 Filed 9–30–11; 8:45 am]
BILLING CODE 4160–01–P
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, 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 at (301) 443–1129. The
following request has been submitted to
OMB for review under the Paperwork
Reduction Act of 1995:
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
Proposed Project: ADAP Data Report—
[New]
HRSA’s AIDS Drug Assistance
Program (ADAP) is funded through the
Ryan White HIV/AIDS Program, Part B,
of Title XXVI of the Public Health
Service Act, which provides grants to
states and territories. Each of the 50
states, the District of Columbia, Puerto
Rico, and several territories receive
ADAP grants. The ADAP provides
medications for the treatment of HIV/
AIDS. Program funds may also be used
to purchase health insurance for eligible
clients or for services that enhance
access, adherence, and monitoring of
drug treatments.
The Ryan White HIV/AIDS Program
specifies HRSA’s responsibilities in the
administration of grant funds, the
allocation of funds, the evaluation of
programs for the population served, and
the improvement of quality of care.
Accurate records of the grantees
receiving Ryan White HIV/AIDS
Program funding, the services provided,
and the clients served, continue to be
critical issues for the implementation of
the legislation and are necessary for
HRSA to fulfill its responsibilities.
The ADAP Data Report (ADR)
provides data on the characteristics of
ADAP grantees and the clients being
served with program funds. The ADR is
E:\FR\FM\03OCN1.SGM
03OCN1
61106
Federal Register / Vol. 76, No. 191 / Monday, October 3, 2011 / Notices
intended to support clinical quality
management, performance
measurement, service delivery, and
client monitoring at the system and
client levels. The reporting system
consists of an online data form—the
Grantee Report—and a data file
containing the client-level data
elements. Data will be submitted every
six months. The Grantee Report
includes information about program
administration, funding, and
expenditures, in addition to the
medication formulary. The client-level
data include demographic, clinical,
enrollment, and service data for each
patient who is determined eligible and
enrolled in the ADAP.
The legislation specifies grantee
accountability and links budget to
performance. The ADR will be used to
ensure compliance with the
requirements of the legislation, to
evaluate the progress of programs, to
monitor grantee performance, to
measure the Government Performance
and Results Act (GPRA) and the
Performance Assessment Rating Tool
(PART) goals, and to meet reporting
responsibilities to the Department,
Congress, and OMB.
In addition to meeting the goal of
accountability to Congress, clients,
advocacy groups, and the general
public, information collected through
the ADR is critical to HRSA and
grantees for assessing the status of
existing HIV-related service delivery
systems, investigating trends in service
utilization, and identifying the areas of
greatest need.
Discussions were held with nine
volunteer grantee agencies representing
a variety of ADAP models, as a basis for
the burden estimates for the ADR that
follows. These burden estimates are
presented in two tables. The first table
represents the estimated burden for the
Number of
respondents
Instrument
Responses
per
respondent
first year, including the estimated time
to adjust existing or develop new data
collection systems to collect the
elements that HRSA is requesting. This
is a one-time burden for grantees and
will not be a factor after the first year.
The second table represents the
estimated burden for subsequent years.
The Grantee Report burden remains
unchanged across the three years of the
information collection, as the
submission is consistent with current
reporting requirements. The Client
Report burden is expected to decrease
slightly in subsequent years as grantees
become more proficient with reporting
client-level data, based on feedback and
technical assistance resources that
HRSA will provide.
The annual estimate of burden for the
first year of the information collection is
as follows:
Total
responses
Hours per
response
Total burden
hours
Grantee Report ....................................................................
Client Report ........................................................................
Data Collection System .......................................................
57
57
57
2
2
1
114
114
57
12.50
34.19
826.00
1,425.00
3,897.66
47,082.00
Total: .............................................................................
........................
........................
........................
........................
52,404.66
Number of
respondents
Responses
per
respondent
Total
responses
Hours per
response
The annual estimate of burden for
subsequent years is as follows:
Instrument
Total burden
hours
Grantee Report ....................................................................
Client Report ........................................................................
57
57
2
2
114
114
12.50
24.00
1,425.00
2,736.00
Total: .............................................................................
........................
........................
........................
........................
4,161.00
srobinson on DSK4SPTVN1PROD with NOTICES
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 all
correspondence to the ‘‘attention of the
desk officer for HRSA.’’
Dated: September 26, 2011.
Wendy Ponton,
Director, Office of Management.
[FR Doc. 2011–25339 Filed 9–30–11; 8:45 am]
BILLING CODE 4165–15–P
VerDate Mar<15>2010
16:42 Sep 30, 2011
Jkt 223001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Notice of Intent To Prepare an
Environmental Impact Statement
Summary: In accordance with the
National Environmental Policy Act, the
National Institutes of Health (NIH), an
agency of the Department of Health and
Human Services (HHS), is issuing this
notice to advise the public that an
environmental impact statement will be
prepared for the NIH Animal Center at
Poolesville Master Plan, Poolesville,
Montgomery County, Maryland.
For Further Information Contact:
Valerie Nottingham, Chief,
Environmental Quality Branch, Division
of Environmental Protection, Office of
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
Research Facilities, NIH, B13/2S11,
9000 Rockville Pike, Bethesda,
Maryland 20892, telephone 301–496–
7775; fax 301–480–8056; or e-mail
nihnepa@mail.nih.gov.
Supplementary Information: The NIH
Animal Center is located on 513 acres
4 miles southwest of the City of
Poolesville, a small agricultural
community located in western
Maryland. The campus is a component
of the National Institutes of Health
(NIH), one of the world’s largest
biomedical research facilities and the
Federal government’s focal point for
medical and behavioral research. The
NIH Animal Center at Poolesville is a
major extension of animal holding and
production facilities at Bethesda and
consists of a number of buildings used
to house, quarantine, and study the
E:\FR\FM\03OCN1.SGM
03OCN1
]]>Agencies
[Federal Register Volume 76, Number 191 (Monday, October 3, 2011)]
[Notices]
[Pages 61105-61106]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25339]
-----------------------------------------------------------------------
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, 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 at (301) 443-1129. The following request
has been submitted to OMB for review under the Paperwork Reduction Act
of 1995:
Proposed Project: ADAP Data Report--[New]
HRSA's AIDS Drug Assistance Program (ADAP) is funded through the
Ryan White HIV/AIDS Program, Part B, of Title XXVI of the Public Health
Service Act, which provides grants to states and territories. Each of
the 50 states, the District of Columbia, Puerto Rico, and several
territories receive ADAP grants. The ADAP provides medications for the
treatment of HIV/AIDS. Program funds may also be used to purchase
health insurance for eligible clients or for services that enhance
access, adherence, and monitoring of drug treatments.
The Ryan White HIV/AIDS Program specifies HRSA's responsibilities
in the administration of grant funds, the allocation of funds, the
evaluation of programs for the population served, and the improvement
of quality of care. Accurate records of the grantees receiving Ryan
White HIV/AIDS Program funding, the services provided, and the clients
served, continue to be critical issues for the implementation of the
legislation and are necessary for HRSA to fulfill its responsibilities.
The ADAP Data Report (ADR) provides data on the characteristics of
ADAP grantees and the clients being served with program funds. The ADR
is
[[Page 61106]]
intended to support clinical quality management, performance
measurement, service delivery, and client monitoring at the system and
client levels. The reporting system consists of an online data form--
the Grantee Report--and a data file containing the client-level data
elements. Data will be submitted every six months. The Grantee Report
includes information about program administration, funding, and
expenditures, in addition to the medication formulary. The client-level
data include demographic, clinical, enrollment, and service data for
each patient who is determined eligible and enrolled in the ADAP.
The legislation specifies grantee accountability and links budget
to performance. The ADR will be used to ensure compliance with the
requirements of the legislation, to evaluate the progress of programs,
to monitor grantee performance, to measure the Government Performance
and Results Act (GPRA) and the Performance Assessment Rating Tool
(PART) goals, and to meet reporting responsibilities to the Department,
Congress, and OMB.
In addition to meeting the goal of accountability to Congress,
clients, advocacy groups, and the general public, information collected
through the ADR is critical to HRSA and grantees for assessing the
status of existing HIV-related service delivery systems, investigating
trends in service utilization, and identifying the areas of greatest
need.
Discussions were held with nine volunteer grantee agencies
representing a variety of ADAP models, as a basis for the burden
estimates for the ADR that follows. These burden estimates are
presented in two tables. The first table represents the estimated
burden for the first year, including the estimated time to adjust
existing or develop new data collection systems to collect the elements
that HRSA is requesting. This is a one-time burden for grantees and
will not be a factor after the first year. The second table represents
the estimated burden for subsequent years. The Grantee Report burden
remains unchanged across the three years of the information collection,
as the submission is consistent with current reporting requirements.
The Client Report burden is expected to decrease slightly in subsequent
years as grantees become more proficient with reporting client-level
data, based on feedback and technical assistance resources that HRSA
will provide.
The annual estimate of burden for the first year of the information
collection is as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Instrument respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Grantee Report.................. 57 2 114 12.50 1,425.00
Client Report................... 57 2 114 34.19 3,897.66
Data Collection System.......... 57 1 57 826.00 47,082.00
-------------------------------------------------------------------------------
Total:...................... .............. .............. .............. .............. 52,404.66
----------------------------------------------------------------------------------------------------------------
The annual estimate of burden for subsequent years is as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Instrument respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Grantee Report.................. 57 2 114 12.50 1,425.00
Client Report................... 57 2 114 24.00 2,736.00
-------------------------------------------------------------------------------
Total:...................... .............. .............. .............. .............. 4,161.00
----------------------------------------------------------------------------------------------------------------
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 26, 2011.
Wendy Ponton,
Director, Office of Management.
[FR Doc. 2011-25339 Filed 9-30-11; 8:45 am]
BILLING CODE 4165-15-P
