Agency Information Collection Activities: Proposed Collection: Public Comment Request, 69694-69695 [2013-27798]
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69694
Federal Register / Vol. 78, No. 224 / Wednesday, November 20, 2013 / Notices
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/Biologics
BloodVaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: November 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–27774 Filed 11–19–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Changing Regulatory and
Reimbursement Paradigms for Medical
Devices in the Treatment of Obesity
and Metabolic Diseases: How To
Estimate and Reward True PatientCentric Value in Innovation; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA) is announcing a
public workshop entitled ‘‘Changing
Regulatory and Reimbursement
Paradigms for Medical Devices in the
Treatment of Obesity and Metabolic
Diseases: How to Estimate and Reward
True Patient-Centric Value in
Innovation.’’ FDA is cosponsoring the
workshop with the American
Gastroenterological Association (AGA).
The purpose of the workshop is to
facilitate discussion between FDA,
AGA, and other interested parties of the
development of medical devices for the
treatment of morbid obesity and other
metabolic diseases and evolving
approaches for the regulation and
reimbursement of minimally invasive
procedures. The public workshop is
being rescheduled due to the
government shutdown. The title of the
workshop has also been changed.
DATES AMD TIMES: The public workshop
will be held on December 19, 2013, from
8:30 a.m. to 5 p.m. and on December 20,
2013, from 8:30 a.m. to 12:15 p.m.
Location: The public workshop will
be held at the Grand Hyatt Washington,
DC, 1000 H St. NW., Washington, DC
20001, 202–582–1234.
Contact Person: Herbert Lerner,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:04 Nov 19, 2013
Jkt 232001
Rm. G114, Silver Spring, MD 20993–
0002, 301–796–6511, email:
herbert.lerner@fda.hhs.gov.
Registration: Registration is limited
and is available on a first-come, firstserved basis. Persons interested in
attending this public workshop must
register online by 4 p.m. (EDT),
December 10, 2013. Onsite registration
will be available after this date. To
register for the public workshop, please
visit the American Gastroenterological
Association (AGA) Web site: https://
www.gastro.org/education-meetings/
live-meetings/aga-fda-regulation-andreimbursement-workshop. For more
information on the workshop, please see
the FDA’s Medical Devices News &
Events—Workshops & Conferences
calendar at https://www.fda.gov/
MedicalDevices/NewsEvents/
WorkshopsConferences/default.htm.
(Select this public workshop from the
posted events list.)
The AGA will collect a registration fee
to cover its share of the expenses
associated with the public workshop,
which is included in the registration
information on the AGA Web site.
If you need special accommodations
due to a disability, please contact
Herbert Lerner (see Contact Person) at
least 7 days before the public workshop.
SUPPLEMENTARY INFORMATION:
I. Background
The purpose of the public workshop
is to facilitate discussion between FDA,
the AGA and other interested parties on
the issues of device development,
public and private payer
reimbursement, venture capital, and
regulatory pathways for device
innovation and marketing. The
workshop will provide a forum for
discussing new approaches for the
treatment of morbid obesity and other
metabolic diseases as well as evolving
approaches for the regulation and
reimbursement of minimally invasive
procedures.
II. Topics for Discussion at the Public
Workshop
Topics to be discussed at the public
workshop include, but are not limited
to:
• Challenges to MedTech Innovation
in the United States;
• Evolving Approaches for the
Regulation of Minimally Invasive
Procedures: The FDA Benefit/Risk
Paradigm;
• Evolving Approaches for the
Reimbursement of Minimally Invasive
Procedures: How to Put a Price on
Value;
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• Obesity as a Disease: Redefining the
Regulatory and Reimbursement Context;
and
• The ‘‘Process’’—Investigational
Device Exemption Review.
Dated: November 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–27771 Filed 11–19–13; 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: Public
Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this Information
Collection Request must be received
within 60 days of this notice.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 10–29, Parklawn
Building, 5600 Fishers Lane, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: 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 Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
The National Health Service Corps and
NURSE Corps Interest Capture Form.
OMB No.: 0915–0337—Revision.
Abstract: The National Health Service
Corps (NHSC) and the NURSE Corps of
SUMMARY:
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69695
Federal Register / Vol. 78, No. 224 / Wednesday, November 20, 2013 / Notices
the Bureau of Clinician Recruitment and
Service (BCRS), HRSA, are both
committed to improving the health of
the nation’s underserved by uniting
communities in need with caring health
professionals and by supporting
communities’ efforts to build better
systems of care. The NHSC and NURSE
Corps Interest Capture Form, which will
be used when exhibiting at national and
regional conferences, as well as when
presenting on campuses to health
profession students, is an optional form
that a health profession student,
licensed clinician, faculty member, or
clinical site administrator can fill out
and submit to BCRS representatives at
the recruitment event. The purpose of
the form is to enable individuals and
clinical sites to ask BCRS for periodic
program updates and other general
information regarding opportunities
with the NHSC and/or the NURSE Corps
via email. Completed forms will contain
information such as the names of the
individuals, their email address(es),
their city and state, the organization
where they are employed (or the school
which they attend), the year they intend
to graduate (if applicable), how they
heard about the NHSC/NURSE Corps,
and the programs in which they are
interested. Assistance in completing the
form will be given by the BCRS staff
person (or BCRS representative) who is
present at the event.
Need and Proposed Use of the
Information: The need and purpose of
this information collection is to share
resources and information regarding the
NHSC and Nurse Corps programs with
interested conference/event
participants.
Likely Respondents: Conference/event
participants interested in the NHSC or
Nurse Corps programs.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
NHSC and NURSE Corps Interest Capture Form ..............
2,400
1
2,400
.025
60
Total ..............................................................................
2,400
1
2,400
.025
60
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Dated: November 13, 2013.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2013–27798 Filed 11–19–13; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
tkelley on DSK3SPTVN1PROD with NOTICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
VerDate Mar<15>2010
16:04 Nov 19, 2013
Jkt 232001
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this Information
Collection Request must be received
within 60 days of this notice.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 10–29, Parklawn
Building, 5600 Fishers Lane, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: 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 Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
SUMMARY:
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information, please include the
information request collection title for
reference.
Information Collection Request Title:
Data System for Organ Procurement and
Transplantation Network. OMB No.
0915–0184– Revision.
Abstract: The operation of the Organ
Procurement and Transplantation
Network (OPTN) necessitates certain
recordkeeping and reporting
requirements in order to perform the
functions related to organ
transplantation under contract to HHS.
This is a request for a revision of the
current recordkeeping and reporting
requirements associated with the OPTN
membership application requirements.
The proposed data collection includes
information pertinent to OPTN
membership eligibility and designation,
transplant program eligibility
requirements to receive organs for
transplantation, and changes in OPTN
transplant member personnel. These
data will be used by HRSA in
monitoring the contracts for the OPTN
and the Scientific Registry of Transplant
Recipients (SRTR) and in carrying out
other statutory responsibilities.
Need and Proposed Use of the
Information: Information is needed to
collect and review submission of
application materials and determine
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]]>Agencies
[Federal Register Volume 78, Number 224 (Wednesday, November 20, 2013)]
[Notices]
[Pages 69694-69695]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27798]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects (Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995), the Health Resources and Services
Administration (HRSA) announces plans to submit an Information
Collection Request (ICR), described below, to the Office of Management
and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks
comments from the public regarding the burden estimate, below, or any
other aspect of the ICR.
DATES: Comments on this Information Collection Request must be received
within 60 days of this notice.
ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance Officer, Room 10-29, Parklawn
Building, 5600 Fishers Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: 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
Information Collection Clearance Officer at (301) 443-1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
Information Collection Request Title: The National Health Service
Corps and NURSE Corps Interest Capture Form.
OMB No.: 0915-0337--Revision.
Abstract: The National Health Service Corps (NHSC) and the NURSE
Corps of
[[Page 69695]]
the Bureau of Clinician Recruitment and Service (BCRS), HRSA, are both
committed to improving the health of the nation's underserved by
uniting communities in need with caring health professionals and by
supporting communities' efforts to build better systems of care. The
NHSC and NURSE Corps Interest Capture Form, which will be used when
exhibiting at national and regional conferences, as well as when
presenting on campuses to health profession students, is an optional
form that a health profession student, licensed clinician, faculty
member, or clinical site administrator can fill out and submit to BCRS
representatives at the recruitment event. The purpose of the form is to
enable individuals and clinical sites to ask BCRS for periodic program
updates and other general information regarding opportunities with the
NHSC and/or the NURSE Corps via email. Completed forms will contain
information such as the names of the individuals, their email
address(es), their city and state, the organization where they are
employed (or the school which they attend), the year they intend to
graduate (if applicable), how they heard about the NHSC/NURSE Corps,
and the programs in which they are interested. Assistance in completing
the form will be given by the BCRS staff person (or BCRS
representative) who is present at the event.
Need and Proposed Use of the Information: The need and purpose of
this information collection is to share resources and information
regarding the NHSC and Nurse Corps programs with interested conference/
event participants.
Likely Respondents: Conference/event participants interested in the
NHSC or Nurse Corps programs.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this Information Collection Request are summarized in the table below.
Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
NHSC and NURSE Corps Interest 2,400 1 2,400 .025 60
Capture Form...................
-------------------------------------------------------------------------------
Total....................... 2,400 1 2,400 .025 60
----------------------------------------------------------------------------------------------------------------
HRSA specifically requests comments on (1) the necessity and
utility of the proposed information collection for the proper
performance of the agency's functions, (2) the accuracy of the
estimated burden, (3) ways to enhance the quality, utility, and clarity
of the information to be collected, and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden.
Dated: November 13, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-27798 Filed 11-19-13; 8:45 am]
BILLING CODE 4165-15-P
