Agency Information Collection Activities: Proposed Collection: Comment Request, 3782-3783 [2012-1496]
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Federal Register / Vol. 77, No. 16 / Wednesday, January 25, 2012 / Notices
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Act (the Act). The Act addresses
pediatric device needs by providing
financial incentives for development,
production, approval and distribution of
new devices for rare and unmet
pediatric needs; allowing for a pediatric
device approval pathway that permits
extrapolation of adult effectiveness data
to support a pediatric indication based
on similar course of the disease or
condition or a similar effect of the
device; and providing grants to pediatric
device consortia that provide technical
support and assistance to pediatric
device innovators.
FDA held a public workshop on
December 5, 2011, to support FDA’s
efforts to define pathways for approving
pediatric device indications by
leveraging available scientific research
data. An important, but not the only,
focus was a discussion of how to
determine when it is appropriate to use,
and how to use, existing scientific
research data to determine pediatric
effectiveness based on a similar course
of a disease or condition or a similar
effect of a device on adults and similar
extrapolation between pediatric
subpopulations.
The demand by health care
professionals and consumers for safe
and effective pediatric medical devices
continues to steadily increase. Pediatric
medical devices treat or diagnose
diseases and conditions occurring from
birth through the 21st year of life. Some
devices are designed specifically for
pediatric use, while others are adopted
from specific adult device applications
or produced for more general use.
Designing pediatric medical devices
can be challenging; children are often
smaller and more active than adults;
body structures and functions change
throughout childhood, and children
may be long-term device users—
bringing new concerns about device
longevity and long-term exposure to
implanted materials. The current
medical device market for children has
a higher demand than supply. FDA is
committed to supporting the
development and availability of safe and
effective pediatric medical devices.
Regardless of attendance at the public
workshop, interested persons may
submit either electronic or written
comments on the topics discussed at the
Public Workshop.
II. Topics Discussed at the Public
Workshop
The public workshop discussed the
following topic areas:
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1. The use of existing scientific
research data to support pediatric
effectiveness claims for medical devices
and pediatric device approvals or
clearance,
2. The scientific and regulatory
limitations and issues with the use of
existing scientific research data, and
3. The methods to overcome the
pitfalls and data gaps, including
statistical approaches and modeling.
III. Transcripts
Please be advised that a transcript of
the public workshop is available at
https://www.regulations.gov at FDA
docket number FDA–2011–N–0754. The
transcript may be viewed at the Division
of Dockets Management (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852. A transcript is also available
online at https://www.fda.gov/
MedicalDevices/NewsEvents/
WorkshopsConferences/
ucm278053.htm.
IV. 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. 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.
Dated: January 19, 2012.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2012–1443 Filed 1–24–12; 8:45 am]
BILLING CODE 4160–01–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
(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
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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–
1129.
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
use of automated collection techniques
or other forms of information
technology.
Proposed Project: The Health
Professions Student Loan (HPSL) and
Nursing Student Loan (NSL) Programs:
Forms (OMB No. 0915–0044)—
[Extension]
The HPSL Program provides longterm, low-interest loans to students
attending schools of medicine,
osteopathic medicine, dentistry,
veterinary medicine, optometry,
podiatric medicine, and pharmacy. The
NSL program provides long-term, lowinterest loans to students who attend
eligible schools of nursing in programs
leading to a diploma in nursing, or
associate, baccalaureate, or graduate
degrees in nursing.
Participating HPSL and NSL schools
are responsible for determining the
eligibility of applicants, making loans,
and collecting monies owed by
borrowers on their outstanding loans.
The Deferment Form (Deferment-HRSA
Form 519) provides the schools with
documentation of a borrower’s
eligibility for deferment. The Annual
Operating Report (AOR–HRSA Form
501) provides the Federal Government
with information from participating
schools (schools that are no longer
granting loans but are required to report
and maintain program records, student
records, and repayment records until all
student loans are repaid in full and all
monies due to the Federal Government
are returned) relating to HPSL and NSL
program operations and financial
activities.
The annual estimate of burden is as
follows:
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Federal Register / Vol. 77, No. 16 / Wednesday, January 25, 2012 / Notices
Number of
respondents
Instrument
Responses
per
respondent
Total
responses
Hours per
response
Total burden
hours
Deferment—HRSA Form 519 ..............................................
AOR—HRSA Form 501 .......................................................
2,011
907
1
1
2,011
907
0.166
4
334
3,628
Total ..............................................................................
2,918
........................
........................
........................
3,962
Email comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–33,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments
should be received within 60 days of
this notice.
Dated: January 18, 2012.
Reva Harris,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2012–1496 Filed 1–24–12; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Collection; Comment Request:
Revision of the National Diabetes
Education Program Comprehensive
Evaluation Plan
In compliance with the
requirement of Section 3506(c) (2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK),
the National Institutes of Health (NIH)
will publish periodic summaries of
proposed projects to be submitted to the
Office of Management and Budget
(OMB) for review and approval. This is
a request for a revision to an existing
approved information collection
request.
Proposed Collection: Title: The
National Diabetes Education Program
(NDEP) Comprehensive Evaluation Plan.
Type of Information Collection Request:
Revision of a currently approved
collection (#0925–0552). Need and Use
of Information Collection: The National
Diabetes Education Program is a
partnership of the National Institutes of
Health (NIH) and the Centers for Disease
Control and Prevention (CDC) and more
than 200 public and private
organizations. The longterm goal of the
NDEP is to reduce the burden of
diabetes and pre-diabetes in the United
States, and its territories, by facilitating
the adoption of proven strategies to
prevent or delay the onset of diabetes
and its complications. The NDEP
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SUMMARY:
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objectives are to: (1) Increase awareness
and knowledge of the seriousness of
diabetes, its risk factors, and effective
strategies for preventing type 2 diabetes
and complications associated with
diabetes; (2) increase the number of
people who live well with diabetes and
effectively manage their disease to
prevent or delay complications and
improve quality of life; (3) decrease the
number of Americans with undiagnosed
diabetes; (4) Among people at risk for
type 2 diabetes, increase the number
who make and sustain effective lifestyle
changes to prevent diabetes; (5)
facilitate efforts to improve diabetesrelated health care and education, as
well as systems for delivering care (6)
reduce health disparities in populations
disproportionately burdened by
diabetes, and (7) facilitate the
incorporation of evidence-based
research findings into health care
practices.
Multiple strategies have been devised
to address the NDEP objectives. These
have been described in the NDEP
Strategic Plan and include: (1)
Promoting and implementing culturally
and linguistically-appropriate diabetes
awareness and education campaigns for
a wide variety of audiences; (2)
identifying, disseminating, and
supporting the adoption of evidencebased, culturally and linguisticallyappropriate tools and resources that
support behavior change, improved
quality of life, and better diabetes
outcomes; (3) expanding NDEP reach
and visibility through collaborations
with public, private, and nontraditional
partners, and use of national, state, and
local media, traditional and social
media, and other relevant channels.;
and (4) conducting and supporting the
evaluation of NDEP resources,
promotions, and other activities to
improve future NDEP initiatives.
The NDEP evaluation will document
the extent to which the NDEP program
has been implemented, and how
successful it has been in meeting
program objectives. The evaluation
relies heavily on data gathered from
existing national surveys such as
National Health and Nutrition
Examination Survey (NHANES), the
National Health Interview Survey
(NHIS), the Behavioral Risk Factor
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Surveillance System (BRFSS), among
others for this information. This
revision request is continued collection
of additional primary data from NDEP
target audiences on some key process
and impact measures that are necessary
to effectively evaluate the program.
Continued approval and revision to
revise and/or add questions is requested
for a survey of audiences targeted by the
National Diabetes Education Program
including people at risk for diabetes,
people with diabetes and their families,
and the public.
Burden Statement: The burden for the
collection of information, conducted
every two to three years (2–3 years) is
estimated to average 0.03 hours per
response screening interview with
ineligible persons and 0.25 hours per
response for the eligible respondent
interview.
Respondents/Affected Entities: Adult
individuals.
Estimated Number of Respondents:
3759.
Frequency of Response: Once per
respondent.
Estimated Total Annual Hour Burden:
575. There are no Capital Costs,
Operating or Maintenance Costs to
report.
Changes in the Estimates: There is no
change in estimate from the last ICR
renewal.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) Ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
Ways to minimize the burden of the
collection of information on those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
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]]>Agencies
[Federal Register Volume 77, Number 16 (Wednesday, January 25, 2012)]
[Notices]
[Pages 3782-3783]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-1496]
-----------------------------------------------------------------------
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 (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) 443-1129.
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 use of automated collection techniques or other
forms of information technology.
Proposed Project: The Health Professions Student Loan (HPSL) and
Nursing Student Loan (NSL) Programs: Forms (OMB No. 0915-0044)--
[Extension]
The HPSL Program provides long-term, low-interest loans to students
attending schools of medicine, osteopathic medicine, dentistry,
veterinary medicine, optometry, podiatric medicine, and pharmacy. The
NSL program provides long-term, low-interest loans to students who
attend eligible schools of nursing in programs leading to a diploma in
nursing, or associate, baccalaureate, or graduate degrees in nursing.
Participating HPSL and NSL schools are responsible for determining
the eligibility of applicants, making loans, and collecting monies owed
by borrowers on their outstanding loans. The Deferment Form (Deferment-
HRSA Form 519) provides the schools with documentation of a borrower's
eligibility for deferment. The Annual Operating Report (AOR-HRSA Form
501) provides the Federal Government with information from
participating schools (schools that are no longer granting loans but
are required to report and maintain program records, student records,
and repayment records until all student loans are repaid in full and
all monies due to the Federal Government are returned) relating to HPSL
and NSL program operations and financial activities.
The annual estimate of burden is as follows:
[[Page 3783]]
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Instrument respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Deferment--HRSA Form 519........ 2,011 1 2,011 0.166 334
AOR--HRSA Form 501.............. 907 1 907 4 3,628
-------------------------------------------------------------------------------
Total....................... 2,918 .............. .............. .............. 3,962
----------------------------------------------------------------------------------------------------------------
Email comments to paperwork@hrsa.gov or mail the HRSA Reports
Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments should be received within 60 days
of this notice.
Dated: January 18, 2012.
Reva Harris,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2012-1496 Filed 1-24-12; 8:45 am]
BILLING CODE 4165-15-P
