Agency Information Collection Activities: Submission for OMB Review; Comment Request, 32126-32127 [2012-13125]
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32126
Federal Register / Vol. 77, No. 105 / Thursday, May 31, 2012 / Notices
Committees/default.htm and scroll
down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before coming to the meeting.
Agenda: During the morning session,
the committee will discuss
supplemental new drug application
(sNDA) 022059/014 with the trade name
Tykerb (lapatinib) tablets, application
submitted by SmithKline Beecham
(Cork) Ltd, Ireland d/b/a
GlaxoSmithKline. The proposed
indication (use) for this product is in
combination with trastuzumab for the
treatment of patients with metastatic
breast cancer whose tumors overexpress
HER2 and who have received prior
trastuzumab therapy(s).
During the afternoon session, the
committee will discuss the evaluation of
radiographic review in randomized
clinical trials using progression-free
survival (PFS) as a primary endpoint in
non-hematologic malignancies. They
will consider the merits of an
independent audit of investigator
progression assessment in a prespecified subgroup of patients instead of
an independent review of all
progression assessments. The
expectation is that an independent audit
would streamline the conduct of clinical
trials, as well as avoid missing data
when no additional protocol specified
progression assessments are mandated.
Hematologic malignancies are excluded
from this discussion because other
issues (e.g., blood counts, lymph node
exams, and other biomarkers) influence
the assessment of PFS.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before July 10, 2012. Oral
presentations from the public will be
scheduled between approximately 10:30
a.m. to 11 a.m., and 3:30 p.m. to 4 p.m.
Those individuals interested in making
formal oral presentations should notify
the contact person and submit a brief
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statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before June 29, 2012. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by July 2, 2012.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Caleb Briggs
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings. Notice of this
meeting is given under the Federal
Advisory Committee Act (5 U.S.C. app.
2).
Dated: May 24, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–13156 Filed 5–30–12; 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
(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
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
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: Rural Health
Information Technology Network
Development (OMB No. 0915–xxxx)—
[New]
The purpose of the Rural Health
Information Technology Network
Development (RHITND) Program,
authorized under the Public Health
Service Act, Section 330A(f) (42 U.S.C.
254c(f)) as amended by Section 201,
Public Law 107–251, of the Health Care
Safety Net Amendments of 2002, is to
improve health care and support the
adoption of Health Information
Technology (HIT) in rural America by
providing targeted HIT support to rural
health networks. HIT plays a significant
role in the advancement of the
Department of Health and Human
Services’ (HHS) priority policies to
improve health care delivery. Some of
these priorities include: Improving
health care quality, safety, efficiency
and reducing disparities, engaging
patients and families in managing their
health, enhancing care coordination,
improving population and public health
and ensuring adequate privacy and
security of health information.
The intent of the RHITND Program is
to support the adoption and use of
electronic health records (EHR) in
coordination with the ongoing HHS
activities related to the Health
Information Technology for Economic
and Clinical Health (HITECH) Act (Pub.
L. 111–5). This legislation provides HHS
with the authority to establish programs
to improve health care quality, safety,
and efficiency through the promotion of
health information technology,
including EHR. For this 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 (Pub. L.
103–62). These measures cover the
principal topic areas of interest to the
Office of Rural Health Policy, including:
(a) Access to care; (b) the underinsured
and uninsured; (c) workforce
recruitment and retention; (d)
sustainability; (e) health information
technology; (f) network development;
and (g) health related clinical measures.
Several measures will be used for this
program. These measures will speak to
the Office’s progress toward meeting the
goals set.
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Federal Register / Vol. 77, No. 105 / Thursday, May 31, 2012 / Notices
The Agency received no comments in
response to the 60-day notice published
in the Federal Register on February 21,
2012, vol. 77, No. 34; page 9949.
Number of
respondents
Instrument
Responses
per
respondent
The annual estimate of burden is as
follows:
Total
responses
Hours per
response
Total burden
hours
Rural Health Information Technology Network Development Program ...................................................................
41
1
41
3.77
154.57
Total ..............................................................................
41
1
41
3.77
154.57
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: May 24, 2012.
Reva Harris,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2012–13125 Filed 5–30–12; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
srobinson on DSK4SPTVN1PROD with NOTICES
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c) (2) (A) of Title 44,
United States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (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, email
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer at (301) 443–
1984.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the Agency; (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
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use of automated collection techniques
or other forms of information
technology.
Proposed Project: Sickle Cell Disease
Treatment Demonstration Program—
Quality Improvement Data Collection
for the Hemoglobinopathy Learning
Collaborative (OMB No. 0915–xxxx)—
[New]
Background: In response to the
growing need for resources devoted to
sickle cell disease and other
hemoglobinopathies, the United States
Congress, under Section 712 of the
American Jobs Creation Act of 2004
(Pub. L. 108–357), authorized a
demonstration program for the
prevention and treatment of sickle cell
disease (SCD) to be administered
through the Bureau of Primary Health
Care and the Maternal and Child Health
Bureau (MCHB) of the Health Resources
and Services Administration (HRSA) in
the U.S. Department of Health and
Human Services. The program is known
as the Sickle Cell Disease Treatment
Demonstration Program (SCDTDP). The
SCDTDP is designed to improve access
to services for individuals with sickle
cell disease, improve and expand
patient and provider education, and
improve and expand the continuity and
coordination of service delivery for
individuals with sickle cell disease and
sickle cell trait.
To achieve the goals and objectives of
the program, the Hemoglobinopathy
Learning Collaborative (HLC) uses a
process known as the Model for
Improvement, a widely used approach
to quality improvement (QI) in
healthcare settings. The Model for
Improvement utilizes a structured
process that asks grantee teams to build
on small tests of change in their
healthcare setting, while providing
monthly reporting on measurements.
The proposed QI data collection and
reporting system is an integral
component of the HLC.
Purpose: The purpose of the proposed
QI Data Collection strategy is to
implement a system to monitor the
progress of MCHB-funded activities in
improving care and health outcomes for
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
individuals living with sickle cell
disease/trait and meeting the goals of
the SCDTDP. Each grantee team will be
asked to report on a core set of measures
related to quality improvement for
hemoglobinopathies. Through an
evidence-based process, a bank of QI
measures within each grantee network
has been developed to assess health care
utilization of the SCD population as
well as several aspects of the system of
care.
The QI Data Collection strategy will
provide an effective and efficient
mechanism to do the following: (1)
Assess the services provided by grantees
under the SCDTDP and monitor and
drive improvement on quality measures;
(2) collect, coordinate, and distribute
data, best practices, and findings from
network sites; (3) refine a common
model protocol regarding the prevention
and treatment of sickle cell disease; (4)
examine/address barriers that
individuals and families living with
sickle cell disease face when accessing
quality health care and health
education; (5) evaluate the grantees’
performance in meeting the objectives of
the SCDTDP; and (6) provide HRSA/
Congress information on the overall
progress of the program.
Respondents: Grantees funded by
HRSA under the SCDTDP will be the
respondents for this data collection
activity. Each month, SCDTDP teams
will complete up to three data collection
forms for 20 patients with SCD or sickle
cell trait who were seen in their network
that month. The Participant Profile form
will collect demographic and basic
health information. The Acute Care
Visit and Ambulatory Care Visit forms
will assess care in acute and ambulatory
care settings, respectively.
All information will be collected via
chart review. Data will be entered
directly into a secure web-based data
collection tool, called Research
Electronic Data Capture (REDCap). The
data entered into REDCap will be
analyzed via a custom measurement
generator that will calculate and export
the QI measures for viewing by grantee
teams and the National Coordinating
Center.
E:\FR\FM\31MYN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 105 (Thursday, May 31, 2012)]
[Notices]
[Pages 32126-32127]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-13125]
-----------------------------------------------------------------------
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,
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: Rural Health Information Technology Network
Development (OMB No. 0915-xxxx)--[New]
The purpose of the Rural Health Information Technology Network
Development (RHITND) Program, authorized under the Public Health
Service Act, Section 330A(f) (42 U.S.C. 254c(f)) as amended by Section
201, Public Law 107-251, of the Health Care Safety Net Amendments of
2002, is to improve health care and support the adoption of Health
Information Technology (HIT) in rural America by providing targeted HIT
support to rural health networks. HIT plays a significant role in the
advancement of the Department of Health and Human Services' (HHS)
priority policies to improve health care delivery. Some of these
priorities include: Improving health care quality, safety, efficiency
and reducing disparities, engaging patients and families in managing
their health, enhancing care coordination, improving population and
public health and ensuring adequate privacy and security of health
information.
The intent of the RHITND Program is to support the adoption and use
of electronic health records (EHR) in coordination with the ongoing HHS
activities related to the Health Information Technology for Economic
and Clinical Health (HITECH) Act (Pub. L. 111-5). This legislation
provides HHS with the authority to establish programs to improve health
care quality, safety, and efficiency through the promotion of health
information technology, including EHR. For this 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 (Pub.
L. 103-62). These measures cover the principal topic areas of interest
to the Office of Rural Health Policy, including: (a) Access to care;
(b) the underinsured and uninsured; (c) workforce recruitment and
retention; (d) sustainability; (e) health information technology; (f)
network development; and (g) health related clinical measures. Several
measures will be used for this program. These measures will speak to
the Office's progress toward meeting the goals set.
[[Page 32127]]
The Agency received no comments in response to the 60-day notice
published in the Federal Register on February 21, 2012, vol. 77, No.
34; page 9949.
The annual estimate of burden is as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Instrument respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Rural Health Information 41 1 41 3.77 154.57
Technology Network Development
Program........................
-------------------------------------------------------------------------------
Total....................... 41 1 41 3.77 154.57
----------------------------------------------------------------------------------------------------------------
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: May 24, 2012.
Reva Harris,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2012-13125 Filed 5-30-12; 8:45 am]
BILLING CODE 4165-15-P
