Agency Information Collection Activities; Proposed Collection; Public Comment Request, 31946-31947 [2013-12557]
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Federal Register / Vol. 78, No. 102 / Tuesday, May 28, 2013 / Notices
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–1175,
Lisa.Basham@fda.hhs.gov.
Registration to Attend the Workshop
and Requests to Participate in Open
Public Hearing: As part of the public
workshop, an open public hearing will
be held between 10: 15 a.m. and 11:15
a.m. on July 29, 2013. If you wish to
attend the public workshop or provide
testimony for the open public hearing,
please email your registration to: Issues
WithOpioids@fda.hhs.gov by July 15,
2013. Those without email access may
register by contacting one of the persons
listed in the Contact Persons section of
the document. Please provide complete
contact information for each attendee,
including name, title, affiliation,
address, email address, and telephone
number.
For those interested in providing
testimony for the Open Public Hearing,
please also provide a short abstract of
your remarks by July 15, 2013. We will
try to accommodate all persons who
wish to testify; however, the duration of
each speaker’s testimony during this
open public hearing may be limited by
time constraints.
Registration for the public workshop
is free and will be on a first-come, firstserved basis. Early registration is
recommended, because seating is
limited. FDA may limit the number of
participants from each organization as
well as the total number of participants
based on space limitations. Registrants
will receive confirmation once they
have been accepted for the workshop.
Onsite registration on the day of the
meeting will be based on space
availability. If registration reaches
maximum capacity, FDA will post a
notice closing meeting registration for
the workshop at: https://www.fda.gov/
Drugs/NewsEvents/ucm340470.htm.
Comments: Submit either electronic
or written comments by August 29,
2013. Submit electronic comments to
https://www.regulations.gov. Submit
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. 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, and
will be posted to the docket at https://
www.regulations.gov.
If you need special accommodations
due to a disability, please contact
Elizabeth Giaquinto or Lisa Basham (see
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Contact Persons) at least 7 days in
advance of the public workshop.
SUPPLEMENTARY INFORMATION:
(ELEM–1029), Food and Drug
Administration, 12420 Parklawn Dr.,
Element Bldg., Rockville, MD 20857.
I. Introduction
FDA is announcing this workshop to
address public health concerns
associated with the inclusion of
equianalgesic opioid conversion tables
in opioid product labels. Use of these
conversion tables, intended for safe
conversion between opioid products,
has resulted in prescribing errors,
serious adverse events, and deaths.
While FDA will be giving a brief
presentation on the use of conversion
tables in the current product labels, we
are holding this scientific workshop to
bring the academic experts together to
achieve consensus on what does or does
not need to be done to improve how
opioids are converted in clinical
practice.
During the public workshop
participants will do the following:
1. Review the data available
supporting the basis of equianalgesic
opioid conversion tables.
2. Review the problems associated
with the use of equianalgesic opioid
conversion tables, including prescribing
errors and the occurrence of serious
adverse events and deaths, with
emphasis on the risks associated with
extended-release opioids.
3. Review clinical strategies used for
converting patients from one opioid
product to another opioid product and
the data to support the safety of those
strategies.
4. Discuss gaps in the existing
knowledge regarding equianalgesic
opioid analgesic doses and opioid
conversion in clinical practice.
5. Develop a research agenda to
address those gaps.
6. Discuss the mechanisms for
communicating about safe opioid
analgesic conversion strategies to
prescribers.
FDA will post the agenda and
additional workshop background
material approximately 5 days before
the workshop at: https://www.fda.gov/
Drugs/NewsEvents/ucm340470.htm.
Dated: May 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
II. Transcripts
Please be advised that approximately
30 days after the public workshop, a
transcript will be available. It will be
accessible at https://
www.regulations.gov, and may be
viewed at the Division of Dockets
Management (see Comments). A
transcript will also be available in either
hardcopy or on CD–ROM, after
submission of a Freedom of Information
request. Written requests are to be sent
to Division of Freedom of Information
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[FR Doc. 2013–12537 Filed 5–24–13; 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:
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:
Children’s Hospital Graduate Medical
Education Payment Program (CHGME
PP) Annual Report OMB No. 0915–
0313—Extension
Abstract: The CHGME Payment
Program was enacted by Public Law
106–129 to provide Federal support for
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Federal Register / Vol. 78, No. 102 / Tuesday, May 28, 2013 / Notices
graduate medical education (GME) to
freestanding children’s hospitals,
similar to Medicare GME support
received by other, non-children’s
hospitals. The legislation indicates that
eligible children’s hospitals will receive
payments for both direct and indirect
medical education. Direct payments are
designed to offset the expenses
associated with operating approved
graduate medical residency training
programs and indirect payments are
designed to compensate hospitals for
expenses associated with the treatment
of more severely ill patients and the
additional costs relating to teaching
residents in such programs.
The CHGME Payment Program statute
Public Law 109–307 requires that
CHGME-participating hospitals provide
information about their residency
training programs in an annual report to
HRSA that will be an addendum to the
hospitals’ annual applications for funds.
Data are required to be collected on (1)
the types of training programs that the
hospital provided for residents such as
general pediatrics, internal medicine/
pediatrics, and pediatric subspecialties
including both medical subspecialties
certified and non-medical
subspecialties; (2) the number of
training positions for residents, the
number of such positions recruited to
fill, and the number of positions filled;
(3) the types of training that the hospital
provided for residents related to the
health care needs of different
populations such as children who are
underserved for reasons of family
income or geographic location,
including rural and urban areas; (4)
changes in residency training including:
(i) Changes in curricula, training
experiences, and types of training
programs, and benefits that have
resulted from such changes, and (ii)
changes for purposes of training
residents in the measurement and
improvement of the quality and safety of
patient care; and (5) the numbers of
residents (disaggregated by specialty
and subspecialty) who completed their
training at the end of the academic year
Number of
respondents
Form name
Number of
responses per
respondent
and care for children within the borders
of the service area of the hospital or
within the borders of the State in which
the hospital is located.
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
burden
per response
(in hours)
Total
responses
Total burden
hours
Screening Instrument (HRSA 100–1) ..................................
Annual Report: Hospital and Program-Level Information
(HRSA 100–2 and 3) ........................................................
56
1
56
9.2
515.2
56
1
56
78.7
4,407.2
Total ..............................................................................
56
........................
........................
........................
4,922.4
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: May 21, 2013.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2013–12557 Filed 5–24–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request: National Institute of Mental
Health Data Access Request and Use
Certification
SUMMARY: 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 Mental Health
(NIMH), 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.
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
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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.
To Submit Comments and for Further
Information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact: Keisha Shropshire,
NIMH Project Clearance Liaison,
Science Policy and Evaluation Branch,
OSPPC, NIMH, NIH, Neuroscience
Center, 6001 Executive Boulevard, MSC
9667, Rockville Pike, Bethesda, MD
20892, or call 301–443–4335 or Email
your request, including your address to:
kshropsh@mail.nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.
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[Federal Register Volume 78, Number 102 (Tuesday, May 28, 2013)]
[Notices]
[Pages 31946-31947]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-12557]
-----------------------------------------------------------------------
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: Children's Hospital Graduate
Medical Education Payment Program (CHGME PP) Annual Report OMB No.
0915-0313--Extension
Abstract: The CHGME Payment Program was enacted by Public Law 106-
129 to provide Federal support for
[[Page 31947]]
graduate medical education (GME) to freestanding children's hospitals,
similar to Medicare GME support received by other, non-children's
hospitals. The legislation indicates that eligible children's hospitals
will receive payments for both direct and indirect medical education.
Direct payments are designed to offset the expenses associated with
operating approved graduate medical residency training programs and
indirect payments are designed to compensate hospitals for expenses
associated with the treatment of more severely ill patients and the
additional costs relating to teaching residents in such programs.
The CHGME Payment Program statute Public Law 109-307 requires that
CHGME-participating hospitals provide information about their residency
training programs in an annual report to HRSA that will be an addendum
to the hospitals' annual applications for funds. Data are required to
be collected on (1) the types of training programs that the hospital
provided for residents such as general pediatrics, internal medicine/
pediatrics, and pediatric subspecialties including both medical
subspecialties certified and non-medical subspecialties; (2) the number
of training positions for residents, the number of such positions
recruited to fill, and the number of positions filled; (3) the types of
training that the hospital provided for residents related to the health
care needs of different populations such as children who are
underserved for reasons of family income or geographic location,
including rural and urban areas; (4) changes in residency training
including: (i) Changes in curricula, training experiences, and types of
training programs, and benefits that have resulted from such changes,
and (ii) changes for purposes of training residents in the measurement
and improvement of the quality and safety of patient care; and (5) the
numbers of residents (disaggregated by specialty and subspecialty) who
completed their training at the end of the academic year and care for
children within the borders of the service area of the hospital or
within the borders of the State in which the hospital is located.
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)
----------------------------------------------------------------------------------------------------------------
Screening Instrument (HRSA 100- 56 1 56 9.2 515.2
1).............................
Annual Report: Hospital and 56 1 56 78.7 4,407.2
Program-Level Information (HRSA
100-2 and 3)...................
-------------------------------------------------------------------------------
Total....................... 56 .............. .............. .............. 4,922.4
----------------------------------------------------------------------------------------------------------------
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: May 21, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-12557 Filed 5-24-13; 8:45 am]
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