Submission for OMB Review; 30-Day Comment Request; The NIH/NCATS GRDRSM, 2110 [2015-00554]
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Federal Register / Vol. 80, No. 10 / Thursday, January 15, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; The NIH/NCATS
GRDRSM Program: Global Rare
Diseases Patient Registry Data
Repository (GRDR)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on July 17, 2014,
page 44185 and allowed 60-days for
public comment. No public comments
were received. The purpose of this
notice is to allow an additional 30 days
for public comment. The National
Center for Advancing Translational
Sciences (NCATS), National Institutes of
Health, may not conduct or sponsor,
and the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB control number.
SUMMARY:
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project
contact: Dr. Yaffa Rubinstein, Director of
Patient Resources for Clinical and
Translational Research at the Office of
Rare Diseases Research (ORDR),
NCATS, NIH, Suite 1004, 6701
Democracy Boulevard, Bethesda, MD
20892–4874, or call non-toll-free
number (301) 402–4338 or Email your
request, including your address to:
yaffa.rubinstein@nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
Proposed Collection: NIH/NCATS
GRDRSM Program: Global Rare Diseases
Patient Registry Data (GRDR), The
National Center for Advancing
Translational Sciences (NCATS),
National Institutes of Health (NIH).
Need and Use of Information
Collection: The NIH created the GRDR
program https://grdr.ncats.nih.gov an
informatics system and central data
repository, housed at the NCATS/NIH
Center to support and accelerate
research in the cause, diagnosis, and
treatment of rare diseases. The GRDR
program collects a wide range of data
types, including phenotypic and clinical
information, as well as medical images,
derived from individuals who
participate in rare disease patient
registries, regardless of the source of
funding. The GRDR program provides
the infrastructure to store, search across,
retrieve, and analyze these varied types
of data. This valuable information will
help NIH understand and evaluate the
use of repositories/datasets in the
research community. The GRDR
program will support: (1) Mapping data
to standards; (2) increased visibility for
participating registries; (3) opportunity
for cross-disease research; (4) better and
faster rare disease clinical research.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
334.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Type of
respondent
Request for Open access ..................................
Request for Controlled access ..........................
Request to Submit .............................................
Individuals ........................
Individuals ........................
Individuals ........................
Dated: January 9, 2015.
Pamela McInnes,
Deputy Director, NCATS, NIH.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
licensing in the U.S. in accordance with
35 U.S.C. 209 and 37 CFR part 404 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.
National Institutes of Health
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2015–00554 Filed 1–14–15; 8:45 am]
rljohnson on DSK3VPTVN1PROD with NOTICES
BILLING CODE 4140–01–P
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
SUMMARY:
VerDate Sep<11>2014
14:13 Jan 14, 2015
Jkt 235001
Number of
respondents
2000
1000
100
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
PO 00000
Frm 00019
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1
1
1
Average
burden
per response
(in hours)
Total annual
burden hours
2/60
15/60
10/60
67
250
17
be required to receive copies of the
patent applications.
SUPPLEMENTARY INFORMATION:
Technology descriptions follow.
Highly Sensitive Tethered-Bead
Immune Sandwich Assay
Description of Technology: This
technology is a highly sensitive
tethered-bead immune sandwich assay.
Analyte molecules are captured between
two antibodies, a capture antibody and
a detection antibody. The capture
antibody on a micron-size bead binds
analyte from a sample fluid. The beadcaptured analyte is then exposed to a
‘‘detection’’ antibody that binds to the
bead-captured analyte, forming a
‘‘sandwich’’. The sandwiched analytebead complex then connects to a
flexible polymer (such as DNA)
E:\FR\FM\15JAN1.SGM
15JAN1
]]>Agencies
[Federal Register Volume 80, Number 10 (Thursday, January 15, 2015)]
[Notices]
[Page 2110]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-00554]
[[Page 2110]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request; The NIH/NCATS
GRDR\SM\ Program: Global Rare Diseases Patient Registry Data Repository
(GRDR)
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institutes of Health (NIH) has
submitted to the Office of Management and Budget (OMB) a request for
review and approval of the information collection listed below. This
proposed information collection was previously published in the Federal
Register on July 17, 2014, page 44185 and allowed 60-days for public
comment. No public comments were received. The purpose of this notice
is to allow an additional 30 days for public comment. The National
Center for Advancing Translational Sciences (NCATS), National
Institutes of Health, may not conduct or sponsor, and the respondent is
not required to respond to, an information collection that has been
extended, revised, or implemented on or after October 1, 1995, unless
it displays a currently valid OMB control number.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30-days
of the date of this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, submit comments in writing, or
request more information on the proposed project contact: Dr. Yaffa
Rubinstein, Director of Patient Resources for Clinical and
Translational Research at the Office of Rare Diseases Research (ORDR),
NCATS, NIH, Suite 1004, 6701 Democracy Boulevard, Bethesda, MD 20892-
4874, or call non-toll-free number (301) 402-4338 or Email your
request, including your address to: yaffa.rubinstein@nih.gov. Formal
requests for additional plans and instruments must be requested in
writing.
Proposed Collection: NIH/NCATS GRDR\SM\ Program: Global Rare
Diseases Patient Registry Data (GRDR), The National Center for
Advancing Translational Sciences (NCATS), National Institutes of Health
(NIH).
Need and Use of Information Collection: The NIH created the GRDR
program https://grdr.ncats.nih.gov an informatics system and central
data repository, housed at the NCATS/NIH Center to support and
accelerate research in the cause, diagnosis, and treatment of rare
diseases. The GRDR program collects a wide range of data types,
including phenotypic and clinical information, as well as medical
images, derived from individuals who participate in rare disease
patient registries, regardless of the source of funding. The GRDR
program provides the infrastructure to store, search across, retrieve,
and analyze these varied types of data. This valuable information will
help NIH understand and evaluate the use of repositories/datasets in
the research community. The GRDR program will support: (1) Mapping data
to standards; (2) increased visibility for participating registries;
(3) opportunity for cross-disease research; (4) better and faster rare
disease clinical research.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 334.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Type of Number of Number of burden per Total annual
Form name respondent respondents responses per response (in burden hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Request for Open access....... Individuals..... 2000 1 2/60 67
Request for Controlled access. Individuals..... 1000 1 15/60 250
Request to Submit............. Individuals..... 100 1 10/60 17
----------------------------------------------------------------------------------------------------------------
Dated: January 9, 2015.
Pamela McInnes,
Deputy Director, NCATS, NIH.
[FR Doc. 2015-00554 Filed 1-14-15; 8:45 am]
BILLING CODE 4140-01-P
