National Institutes of Health, 31947-31948 [2013-12601]
Download as PDF
<![CDATA[
31947
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]
mstockstill on DSK4VPTVN1PROD with NOTICES
BILLING CODE 4165–15–P
VerDate Mar<15>2010
17:46 May 24, 2013
Jkt 229001
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
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\28MYN1.SGM
28MYN1
31948
Federal Register / Vol. 78, No. 102 / Tuesday, May 28, 2013 / Notices
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Proposed Collection: The National
Institute of Mental Health Data Access
Request and Use Certification
(previously National Database for
Autism Research Data Access Request),
0925–0667, Revision, Expiration Date:
01/31/2016; NIMH, NIH.
Need and Use of Information
Collection: NIMH recently received
OMB approval for use of the National
Database for Autism Research (NDAR)
Data Use Certification (DUC) Form.
NIMH is interested in renaming this
form the ‘‘NIMH Data Access Request
and Use Certification (DUC) Form’’ and
using it to meet the unique data access
needs of all NIMH data repositories. The
NIMH DUC form is necessary for
‘‘Recipient’’ Principal Investigators and
their organization or corporations with
approved assurance from the DHHS
Office of Human Research Protections to
access data or images from NIMH
repositories and datasets for research
purposes. The primary use of this
information is to document, track,
monitor, and evaluate the use of the
NIMH repositories/datasets, as well as
to notify interested recipients of
updates, corrections or other changes to
the database. There are currently three
data repositories/sets positioned to use
the NIMH DUC form: NDAR, the NIH
Pediatric MRI Data Repository
(PedsMRI), and the NIMH Clinical
Research Datasets (NCRD).
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
380.
ESTIMATED ANNUALIZED BURDEN HOURS
Form
Type of respondent
Number of
respondents
Frequency of
response
Average time
per response
(in hours)
Annual hour
burden
NIMH Data Access Request and
Use Certification.
Principal Investigators/Research Assistant.
240
1
95/60
380
Dated: May 16, 2013.
Sue Murrin,
Executive Officer, NIMH, NIH.
be required to receive copies of the
patent applications.
Assay for Quantifying Fragile X Mental
Retardation-1 Gene Product
[FR Doc. 2013–12601 Filed 5–24–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
mstockstill on DSK4VPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Licensing information and copies of the
U.S. patent applications listed below
may be obtained by writing to the
indicated licensing contact at the Office
of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301–
496–7057; fax: 301–402–0220. A signed
Confidential Disclosure Agreement will
VerDate Mar<15>2010
17:46 May 24, 2013
Jkt 229001
Description of Technology: The
invention is directed to a fluorescence
based assay to quantify the protein
product of the Fragile X Mental
Retardation-1 (FMR1) gene in a
biological sample.
Fragile X syndrome (FXS) is an Xlinked genetic disease that is
responsible for intellectual disability
and is also the most common single
gene cause of autism. FXS is typically
caused by loss of expression of the
FMR1 gene, which codes for an RNAbinding protein called FMRP. FXS
patients exhibit a wide spectrum of
symptoms with varying degrees of
cognitive and psychosocial impairment.
The severity of these symptoms
correlates well with the levels of FMRP
present in the FXS patient. Because the
FMR1 gene is silenced in varying
degrees, the levels of FMRP in any
particular FXS patient could vary
greatly.
Scientists at NIDDK and NCATS have
developed a sensitive, time resolved
fluorescence based assay to quantify
FMRP levels in a biological sample.
Unlike other assays, the invention assay
utilizes two highly-specific antibodies
that bind to different sites of FMRP so
as to enable precise and reliable
quantification. Currently, there is no
approved drug to treat FXS. The
invention assay can be used as a high
throughput screen to identify and
evaluate candidate drugs. In addition,
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
the invention assay can be used to
assess and/or predict the severity of a
patient’s condition based on the amount
of FMRP present.
Potential Commercial Applications:
• Diagnosis assay
• High throughput screen of drug
libraries
• Optimization assay to further develop
potential drug candidates
Competitive Advantages:
• Fast, accurate, and reliable assay to
quantify FMRP in easy-to-use
fluorescence based format
• Adaptable for high throughput use
Development Stage:
• Prototype
• Pilot
• In vitro data available
Inventors: Wei Zheng (NCATS), Karen
P. Usdin (NIDDK), Manju Swaroop
(NCATS), Daman Kumari (NIDDK)
Intellectual Property: HHS Reference
No. E–083–2013/0—US Application No.
61/793,577 filed 15 March 2013
Licensing Contact: Lauren NguyenAntczak, Ph.D., J.D.; 301–435–4074;
lauren.nguyen-antczak@nih.gov.
Collaborative Research Opportunity:
The National Center for Advancing
Translational Sciences (NCATS) is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate or commercialize
Assay for Quantifying Fragile X Mental
Retardation-1 Gene Product. For
collaboration opportunities, please
contact the NCATS Technology
Development Coordinator at
NCATSPartnerships@mail.nih.gov.
E:\FR\FM\28MYN1.SGM
28MYN1
]]>Agencies
[Federal Register Volume 78, Number 102 (Tuesday, May 28, 2013)]
[Notices]
[Pages 31947-31948]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-12601]
-----------------------------------------------------------------------
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
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.
[[Page 31948]]
Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
Proposed Collection: The National Institute of Mental Health Data
Access Request and Use Certification (previously National Database for
Autism Research Data Access Request), 0925-0667, Revision, Expiration
Date: 01/31/2016; NIMH, NIH.
Need and Use of Information Collection: NIMH recently received OMB
approval for use of the National Database for Autism Research (NDAR)
Data Use Certification (DUC) Form. NIMH is interested in renaming this
form the ``NIMH Data Access Request and Use Certification (DUC) Form''
and using it to meet the unique data access needs of all NIMH data
repositories. The NIMH DUC form is necessary for ``Recipient''
Principal Investigators and their organization or corporations with
approved assurance from the DHHS Office of Human Research Protections
to access data or images from NIMH repositories and datasets for
research purposes. The primary use of this information is to document,
track, monitor, and evaluate the use of the NIMH repositories/datasets,
as well as to notify interested recipients of updates, corrections or
other changes to the database. There are currently three data
repositories/sets positioned to use the NIMH DUC form: NDAR, the NIH
Pediatric MRI Data Repository (PedsMRI), and the NIMH Clinical Research
Datasets (NCRD).
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 380.
Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average time
Form Type of respondent Number of Frequency of per response Annual hour
respondents response (in hours) burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
NIMH Data Access Request and Use Certification.. Principal Investigators/Research 240 1 95/60 380
Assistant.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: May 16, 2013.
Sue Murrin,
Executive Officer, NIMH, NIH.
[FR Doc. 2013-12601 Filed 5-24-13; 8:45 am]
BILLING CODE 4140-01-P
