Agency Information Collection Activities; Proposed Collection; Comment Request; Outcomes Evaluation Survey for Graduates of the Food and Drug Administration Commissioner's Fellowship Program, 9202-9203 [2016-03791]
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Federal Register / Vol. 81, No. 36 / Wednesday, February 24, 2016 / Notices
requirement, CMS is publishing this
notice.
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Medicare
Current Beneficiary Survey; Use: CMS is
the largest single payer of health care in
the United States. With full
implementation of the Affordable Care
Act of 2010 (ACA), the agency will play
a direct or indirect role in administering
health insurance coverage for more than
120 million people across the Medicare,
Medicaid, CHIP, and Exchange
populations. One of our critical aims is
to be an effective steward, major force,
and trustworthy partner in leading the
transformation of the health care
system. We also aim to provide
Americans with high quality care and
better health at lower costs through
improvement. At the forefront of these
initiatives is the newly formed Center
for Medicare and Medicaid Innovation
(CMMI).
CMMI is authorized by Section 1115A
of the Social Security Act, as established
by section 3021 of the ACA and was
established to ‘‘test innovative payment
and service delivery models to reduce
program expenditures while preserving
or enhancing the quality of care
furnished’’ to Medicare, Medicaid and
CHIP beneficiaries. Implicit across all of
CMMI activities is an emphasis on
diffusion—finding and validating
innovative models that have the
potential to scale, facilitating rapid
adoption, and letting them take root in
organizations, health systems, and
communities across America.
The Medicare Current Beneficiary
Survey (MCBS) is the most
comprehensive and complete survey
available on the Medicare population
and is essential in capturing data not
otherwise collected through our
operations. The MCBS is an in-person,
nationally-representative, longitudinal
survey of Medicare beneficiaries that we
sponsor and is directed by the Office of
Enterprise Data and Analytics (OEDA)
in partnership with the CMMI. The
survey captures beneficiary information
whether aged or disabled, living in the
community or facility, or serviced by
managed care or fee-for-service. Data
produced as part of the MCBS are
enhanced with our administrative data
(e.g. fee-for-service claims, prescription
drug event data, enrollment, etc.) to
provide users with more accurate and
complete estimates of total health care
costs and utilization. The MCBS has
been continuously fielded for more than
20 years (encompassing over 1 million
interviews), and consists of three annual
interviews per survey participant.
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The MCBS continues to provide
unique insight into the Medicare
program and helps CMS and our
external stakeholders better understand
and evaluate the impact of existing
programs and significant new policy
initiatives. In the past, MCBS data have
been used to assess potential changes to
the Medicare program. For example, the
MCBS was instrumental in supporting
the development and implementation of
the Medicare prescription drug benefit
by providing a means to evaluate
prescription drug costs and out-ofpocket burden for these drugs to
Medicare beneficiaries. The revision
will streamline some questionnaire
sections, add a few new measures, and
update the wording of questions and
response categories. Most of the revised
questions reflect an effort to bring the
MCBS questionnaire in line with other
national surveys that have more current
wording of questions and response
categories with well-established
measures. As a whole, these revisions
do not change the respondent burden;
there is a small increase in overall
burden reflecting a program change to
oversample small population groups.
Form Number: CMS–P–0015A (OMB
control number: 0938–0568); Frequency:
Occasionally; Affected Public: Business
or other for-profits and Not-for-profit
institutions; Number of Respondents:
16,071; Total Annual Responses:
43,199; Total Annual Hours: 60,103.
(For policy questions regarding this
collection contact William Long at 410–
786–7927.)
Dated: February 19, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2016–03908 Filed 2–23–16; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0566]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Outcomes
Evaluation Survey for Graduates of the
Food and Drug Administration
Commissioner’s Fellowship Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
SUMMARY:
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proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
Outcomes Evaluation Survey for
Graduates of the FDA Commissioner’s
Fellowship Program.
DATES: Submit either electronic or
written comments on the collection of
information by April 25, 2016.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
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Federal Register / Vol. 81, No. 36 / Wednesday, February 24, 2016 / Notices
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
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Outcomes Evaluation Survey for
Graduates of the FDA Commissioner’s
Fellowship Program (OMB Control
Number 0910–NEW)
Collecting outcomes information from
the CFP graduates will allow FDA’s
Office of the Commissioner to easily and
efficiently elicit and review information
from the CFP graduates needed to
collect program feedback. The process
will reduce the time and cost of
submitting written documentation to the
Agency and lessen the likelihood of
surveys being misrouted within the
Agency mail system. It will assist the
Agency in promoting and protecting the
public health by encouraging outside
persons to share their experience with
the FDA while a Commissioner’s
Fellow.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Fellowship Program Survey .....................................
10
1
10
0.50 (30 minutes) ......
5
1 The
capital costs or operating and maintenance costs associated with this collection of information is $300 annually.
FDA based these estimates on the
number of fellows who that have
graduated and left the Agency over the
past 5 years.
Dated: February 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–03791 Filed 2–23–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0530]
Request for Expressions of Interest
From Coverage Organizations;
Coverage Organizations Interested in
Providing Input Regarding Private
Payer Coverage to Medical Device
Sponsors Who Request Their
Participation in a Pre-Submission
Meeting With the Food and Drug
Administration
AGENCY:
Food and Drug Administration,
HHS.
Notice; request for expressions
of interest.
ACTION:
The Food and Drug
Administration (FDA) is requesting
expressions of interest from
organizations that evaluate clinical
evidence used to support private payer
coverage decisions for medical devices
(coverage organizations) that wish to
provide input to medical device
developers (sponsors) on clinical trial
design or other plans for gathering
clinical evidence needed to support
positive coverage decisions. These
coverage organizations include thirdparty commercial health insurance
organizations, payer/provider
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organizations, health technology
assessment groups and various
organizations that evaluate clinical
evidence and make coverage
recommendations to and decisions for
private payers and health plans. The
Center for Devices and Radiological
Health (CDRH) is taking this step to
assist sponsors in identifying such
organizations and soliciting clinical trial
design or other evidence-gathering input
from them.
If coverage organizations express
interest, FDA intends to provide a
mechanism for such organizations to
identify themselves so that medical
device sponsors who would like to
obtain coverage input can voluntarily
contact them to participate in a FDA
Pre-Submission meeting. Early input
from payers regarding their evidentiary
needs can streamline the process from
FDA approval or clearance to payer
coverage and improve public health by
facilitating earlier access to innovative,
safe, and effective medical devices.
DATES: This notice will be effective
February 24, 2016.
ADDRESSES: Expressions of interest
should be emailed to CDRHInnovation@fda.hhs.gov and contain the
subject line ‘‘Expression of Interest in
Providing Input Regarding Private Payer
Coverage to Medical Device Sponsors.’’
The body of the email should contain
your organization’s name, email, and
mailing address.
FOR FURTHER INFORMATION CONTACT:
CDRH Innovation, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5410, Silver Spring,
MD 20993–0002, CDRH-Innovation@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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I. Background
The mission of CDRH is to protect and
promote public health. This is
accomplished in part by fulfilling its
vision that patients in the U.S. have
access to safe and effective high quality
medical devices of public health
importance first in the world.
In the September 17, 2010, Federal
Register notice (75 FR 57045), the
Centers for Medicare and Medicaid
Services (CMS) and FDA introduced
Parallel Review, which is intended to
reduce the time between FDA marketing
approval or clearance and CMS’s
National Coverage Determinations
(NCDs). As part of that program,
sponsors met with FDA and CMS at
various times, to discuss the type of
clinical evidence that would support
positive decisions by each agency. The
Parallel Review process improves the
public health and quality of patient care
by facilitating earlier access to
innovative medical devices for Medicare
beneficiaries. Based in part on the
lessons learned from the Parallel Review
program and from Pre-Submission
meetings involving CMS, FDA found
that early input from payers regarding
their evidentiary needs can streamline
the process from FDA approval or
clearance to payer coverage.
CDRH wishes to facilitate the
voluntary inclusion, by sponsors in
their Pre-Submission meetings, of those
organizations that evaluate clinical
evidence used to support private payer
coverage determinations for medical
devices (coverage organizations), so that
sponsors can obtain early input from
both FDA and private payers, and plan
accordingly. The communications
within the scope of this notice consist
of input from coverage organizations to
sponsors on clinical trial design or other
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]]>Agencies
[Federal Register Volume 81, Number 36 (Wednesday, February 24, 2016)]
[Notices]
[Pages 9202-9203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03791]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0566]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Outcomes Evaluation Survey for Graduates of the Food
and Drug Administration Commissioner's Fellowship Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on Outcomes Evaluation Survey for Graduates of
the FDA Commissioner's Fellowship Program.
DATES: Submit either electronic or written comments on the collection
of information by April 25, 2016.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and
[[Page 9203]]
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 respondents, including through the
use of automated collection techniques, when appropriate, and other
forms of information technology.
Outcomes Evaluation Survey for Graduates of the FDA Commissioner's
Fellowship Program (OMB Control Number 0910-NEW)
Collecting outcomes information from the CFP graduates will allow
FDA's Office of the Commissioner to easily and efficiently elicit and
review information from the CFP graduates needed to collect program
feedback. The process will reduce the time and cost of submitting
written documentation to the Agency and lessen the likelihood of
surveys being misrouted within the Agency mail system. It will assist
the Agency in promoting and protecting the public health by encouraging
outside persons to share their experience with the FDA while a
Commissioner's Fellow.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fellowship Program Survey................. 10 1 10 0.50 (30 minutes)....................... 5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The capital costs or operating and maintenance costs associated with this collection of information is $300 annually.
FDA based these estimates on the number of fellows who that have
graduated and left the Agency over the past 5 years.
Dated: February 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-03791 Filed 2-23-16; 8:45 am]
BILLING CODE 4164-01-P
