Agency Information Collection Activities: Submission for OMB Review; Comment Request, 24962-24963 [2012-10032]
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24962
Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices
(Comment 4) One comment states that
Medication Guides increasingly become
accessible online for download and
print and the costs for printing,
including paper, toner, administrative,
and software costs, have shifted from
the manufacturers to the pharmacies.
(Response) While Medication Guides
are increasingly available online for
download and printing, the FDA does
not agree that a financial and
acquisition burden has shifted to or
been created for dispensers. The
comment mischaracterizes the cost to
dispensers associated with the
distribution of Medication Guides. For
purposes of information collection
requests under the PRA, capital costs
are costs for equipment, machinery, and
construction that, if not for FDA’s
request or requirement, the respondent
would not incur. Capital costs do not
include costs to achieve regulatory
compliance. The costs presented by the
comment are not capital costs because
they are costs associated with achieving
regulatory compliance with
requirements of the FD&C Act, not costs
associated specifically with equipment,
machinery, and construction needed to
retain appropriate substantiating
evidence.
(Comment 5) One comment states that
the length of Medication Guides
continues to be burdensome and
hinders a pharmacist from utilizing a
potentially effective tool. The comment
stresses the need for a succinct, onepage document that can be easily
integrated into current pharmacy
practice workflow.
(Response) FDA generally agrees with
the comment and is currently in the
process of evaluating whether a onepage solution can be implemented.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
Number of
respondents
Number of
responses per
respondent
208.20 ....................................
314.70(b)(3)(ii), 601.12(f) ......
208.24(e) ...............................
208.26(a) ...............................
25
5
59,000
1
1
1
5,000
1
Total ...............................
........................
........................
1 There
Total hours
25
5
295 million
1
320
72
3 minutes
4
8,000
360
14,750,000
4
...............................................
...............................................
14,758,364
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 20, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
[FR Doc. 2012–10022 Filed 4–25–12; 8:45 am]
BILLING CODE 4160–01–P
Proposed Project: Assessing Factors
That Impact AIDS Drug Assistance
Program (ADAP) Enrollment and
Management in the Face of ADAP
Waiting Lists (OMB No. 0915–xxxx)—
[New]
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, email
paperwork@hrsa.gov or call the HRSA
Reports Clearance Office on (301) 443–
1984.
tkelley on DSK3SPTVN1PROD with NOTICES
Average burden per
response
Total annual responses
HRSA’s AIDS Drug Assistance
Program (ADAP) provides assistance to
help low-income, uninsured and
underinsured individuals living with
HIV/AIDS get access to life-saving
medications. As part of the Ryan White
HIV/AIDS Program, ADAP is the payer
of last resort. Clients enrolled in ADAP
have exhausted all other resources to
obtain necessary medications and care.
In recent years, ADAP has experienced
an increase in enrollment while funding
resources have decreased.
This study will use case study
methods to identify and examine factors
that contribute to the rising enrollments
in ADAP and States’ abilities to meet
demands for ADAP services. Data
Number of
respondents
Activity
ADAP Site Visit Coordination ..........................
Instrument:
ADAP Personnel Interview .......................
State HIV/AIDS Lead Interview ................
VerDate Mar<15>2010
17:51 Apr 25, 2012
Jkt 226001
PO 00000
Responses per
respondent
collection will include interviews with
up to eight respondents in each of eight
selected states, for a maximum of 64
total respondents. Each interview will
last approximately one and a half hours.
The respondents fall into three general
categories—ADAP personnel, State HIV/
AIDS program leads, and personnel
from related State and local programs
such as Medicaid and pharmacy
assistance programs. Interviews will be
conducted over a period of two and a
half months.
The proposed study will assess factors
that may contribute to the rise in ADAP
enrollment and costs such as new HIV
cases, earlier use of antiretroviral
medications, lower attrition of existing
clients, unemployment and loss of
insurance, or increasing drug costs. In
addition, the study will examine factors
that may decrease ADAP costs such as
health care reform and cost containment
strategies. Findings from the study will
be used to develop policy and to
recommend promising practices for
managing ADAPs.
The annual estimate of burden is as
follows:
Total
responses
Hours per
response
Total burden
hours
8
8
1
8
32
8
Frm 00038
1
1
1
32
8
1.5
1.5
48
12
Fmt 4703
Sfmt 4703
E:\FR\FM\26APN1.SGM
26APN1
24963
Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices
Number of
respondents
Activity
Responses per
respondent
Total
responses
Hours per
response
Total burden
hours
Alternative State/Local Program Informant
Interview ................................................
24
1
24
1.5
36
Total ...................................................
72
............................
............................
............................
104
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: April 19, 2012.
Reva Harris,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2012–10032 Filed 4–25–12; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
and Budget for review under the
Paperwork Reduction Act of 1995:
Health Resources and Services
Administration
Proposed Project: Uncompensated
Services Assurance Report (OMB No.
0915–0077)—[Revision]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Under the Hill-Burton Act, the
Government provides grants and loans
for construction or renovation of health
care facilities. As a condition of
receiving this construction assistance,
facilities are required to provide
services to persons unable to pay. A
condition of receiving this assistance
requires facilities to provide assurances
periodically that the required level of
uncompensated care is being provided,
and that certain notification and record
keeping procedures are being followed.
These standard requirements are
referred to as the uncompensated
services assurance.
The annual estimate of burden is as
follows:
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, email paperwork@
hrsa.gov or call the HRSA Reports
Clearance Office on (301) 443–1984.
The following request has been
submitted to the Office of Management
ESTIMATE OF INFORMATION COLLECTION BURDEN
Responses
per
respondent
Number of
respondents
Instrument
Total
responses
Hours per
response
Total burden
hours
Disclosure Burden (42 CFR)
Published Notices (124.504(c)) ...........................................
Individual Notices (124.504(c)) ............................................
Determinations of Eligibility (124.507) .................................
63
63
63
1
1
99
63
63
6,237
0.75
43.60
0.75
47.25
2,746.80
4,677.75
Subtotal Disclosure Burden ..........................................
........................
........................
........................
........................
7,471.80
1
10
11.00
110.00
4
........................
........................
6.00
........................
........................
24.00
........................
........................
32
13
0
0.50
0.50
........................
16.00
6.50
........................
Reporting
Uncompensated Services Report—HRSA–710 Form
(124.509(a)) ......................................................................
10
Application for Compliance Alternatives
Public Facilities (124.513) ....................................................
Small Obligation Facilities (124.514(c)) ...............................
Charitable Facilities (124.516(c)) .........................................
4
0
0
1
........................
........................
Annual Certification for Compliance Alternatives
tkelley on DSK3SPTVN1PROD with NOTICES
Public Facilities (124.509(b)) ...............................................
Charitable Facilities (124.509(b)) .........................................
Small Obligation Facilities (124.509(c)) ...............................
32
13
0
1
1
........................
Complaint Information (124.511(a))
Individuals ............................................................................
Facilities ...............................................................................
10
10
1
1
10
10
0.25
0.50
2.50
5.00
Subtotal Reporting Burden ...........................................
........................
........................
........................
........................
164.00
VerDate Mar<15>2010
19:17 Apr 25, 2012
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PO 00000
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26APN1
]]>Agencies
[Federal Register Volume 77, Number 81 (Thursday, April 26, 2012)]
[Notices]
[Pages 24962-24963]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10032]
-----------------------------------------------------------------------
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, email
paperwork@hrsa.gov or call the HRSA Reports Clearance Office on (301)
443-1984.
The following request has been submitted to the Office of
Management and Budget for review under the Paperwork Reduction Act of
1995:
Proposed Project: Assessing Factors That Impact AIDS Drug Assistance
Program (ADAP) Enrollment and Management in the Face of ADAP Waiting
Lists (OMB No. 0915-xxxx)--[New]
HRSA's AIDS Drug Assistance Program (ADAP) provides assistance to
help low-income, uninsured and underinsured individuals living with
HIV/AIDS get access to life-saving medications. As part of the Ryan
White HIV/AIDS Program, ADAP is the payer of last resort. Clients
enrolled in ADAP have exhausted all other resources to obtain necessary
medications and care. In recent years, ADAP has experienced an increase
in enrollment while funding resources have decreased.
This study will use case study methods to identify and examine
factors that contribute to the rising enrollments in ADAP and States'
abilities to meet demands for ADAP services. Data collection will
include interviews with up to eight respondents in each of eight
selected states, for a maximum of 64 total respondents. Each interview
will last approximately one and a half hours. The respondents fall into
three general categories--ADAP personnel, State HIV/AIDS program leads,
and personnel from related State and local programs such as Medicaid
and pharmacy assistance programs. Interviews will be conducted over a
period of two and a half months.
The proposed study will assess factors that may contribute to the
rise in ADAP enrollment and costs such as new HIV cases, earlier use of
antiretroviral medications, lower attrition of existing clients,
unemployment and loss of insurance, or increasing drug costs. In
addition, the study will examine factors that may decrease ADAP costs
such as health care reform and cost containment strategies. Findings
from the study will be used to develop policy and to recommend
promising practices for managing ADAPs.
The annual estimate of burden is as follows:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses per Hours per Total burden
Activity respondents respondent Total responses response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
ADAP Site Visit Coordination.................................. 8 1 8 1 8
Instrument:
ADAP Personnel Interview.................................. 32 1 32 1.5 48
State HIV/AIDS Lead Interview............................. 8 1 8 1.5 12
[[Page 24963]]
Alternative State/Local Program Informant Interview....... 24 1 24 1.5 36
-----------------------------------------------------------------------------------------
Total................................................. 72 ................ ................ ................ 104
--------------------------------------------------------------------------------------------------------------------------------------------------------
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: April 19, 2012.
Reva Harris,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2012-10032 Filed 4-25-12; 8:45 am]
BILLING CODE 4165-15-P
