Submission for OMB Review; Comment Request; the Cardiovascular Health Study (CHS), 68587-68588 [E7-23515]
Download as PDF
<![CDATA[
68587
Federal Register / Vol. 72, No. 233 / Wednesday, December 5, 2007 / Notices
the clearance requests submitted to
OMB for review, call the HRSA Reports
Clearance Office on (301) 443–1129.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
Proposed Project: Data System for
Organ Procurement and
Transplantation Network (42 CFR Part
121, OMB No. 0915–0184): Extension
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 an extension of the
current recordkeeping and reporting
requirements associated with the OPTN.
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.
Information is needed to monitor
compliance of member organizations
with OPTN rules and requirements, to
ensure that all qualified entities are
accepted for membership in the OPTN,
and to ensure patient safety.
Estimated Annual Reporting and
Recordkeeping Burden
Number of
respondents
Responses
per
respondents
121.3(b)(2): OPTN membership requirements for OPOs, hospitals, and
histocompatibility laboratories ..............................................................
121.3: Application for Non-Institutional Members ....................................
121.3(b)(4): Appeal for OPTN membership ............................................
121.6(c) (Reporting): Submitting criteria for organ acceptance ..............
121.6(c) (Disclosure): Sending criteria to OPOs .....................................
121.7(b)(4): Reasons for Refusal ............................................................
121.7(e): Transplant to prevent organ wastage ......................................
121.9(b): Designated Transplant Program Requirements .......................
121.3: Personnel Change Application .....................................................
121.9(d): Appeal for designation .............................................................
40
20
2
900
900
900
260
10
324
2
1
1
1
1
1
38
1.5
1
1
1
40
20
2
900
900
34,200
390
10
324
2
45
10
3
0.5
0.5
0.5
0.5
5.0
10
6
1, 800
200
6
450
450
17,100
195
50
3,240
12
Total ..................................................................................................
974
....................
39,704
....................
23,503
Section and activity
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to
the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov
or by fax to 202–395–6974. Please direct
all correspondence to the ‘‘attention of
the desk officer for HRSA.’’
Dated: November 29, 2007.
Alexandra Huttinger,
Acting Director, Division of Policy Review
and Coordination.
[FR Doc. E7–23538 Filed 12–4–07; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
mstockstill on PROD1PC66 with NOTICES
Submission for OMB Review;
Comment Request; the Cardiovascular
Health Study (CHS)
SUMMARY: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Heart, Lung, and Blood Institute
(NHLBI), the National Institutes of
VerDate Aug<31>2005
19:05 Dec 04, 2007
Jkt 214001
Health (NIH) has submitted to the Office
of Management and Budget (OMB) a
request for review and approval the
information collection listed below.
This proposed information collection
was previously published in the Federal
Register on September 12, 2007, page
52155, and allowed 60 days for public
comment. One comment was received.
The purpose of this notice is to allow an
additional 30 days for public comment.
The National Institutes of Health may
not conduct or sponsor, and the
respondent is not required to respond
to, any information collection that has
been extended, revised, or implemented
on or after October 1, 1995, unless it
displays a currently valid OMB control
number.
Proposed Collection: Title: The
Cardiovascular Health Study. Type of
Information Request: Reinstatement
(OMB No. 0925–0334). Need and Use of
Information Collection: This study
quantifies associations between
conventional and hypothetical risk
factors and coronary heart disease
(CHD) and stroke in people age 65 years
and older. The primary objectives
include quantifying associations of risk
factors with subclinical disease;
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
Total
responses
Hours per
response
Total
burden
hours
characterizing the natural history of
CHD and stroke; and identifying factors
associated with clinical course. The
findings provide important information
on cardiovascular disease in an older
U.S. population and lead to early
treatment of risk factors associated with
disease and identification of factors that
may be important in disease prevention.
OBM clearance is being sought for data
collection activities at only one of the
four CHS field centers (the Pittsburgh
field center), which are expected to end
on May 31, 2008. Other data collection
efforts in the CHS cohort are supported
by various non-contract funding
sources. Frequency of response: Twice a
year (participants) or once per
cardiovascular disease event (proxies);
Affected public: Individuals. Types of
Respondents: Individuals recruited for
CHS and their selected proxies. The
annual reporting burden is as follows:
Estimated Number of Respondents: 467;
Estimated Number of Responses per
Respondent: 1.2; and Estimated Total
Annual Burden Hours Requested: 281.
The annualized cost to respondents is
estimated at: $5,225.
There are no capital, operating, or
maintenance costs to report.
E:\FR\FM\05DEN1.SGM
05DEN1
68588
Federal Register / Vol. 72, No. 233 / Wednesday, December 5, 2007 / Notices
Estimated
number of
respondents
Type of respondents
Estimated
number of
responses per
respondent *
Average
burden hours
per response
Estimated
total annual
burden hours
requested
346
121
1.2
1.2
0.5
0.5
208
73
Total ..................................................................................................
mstockstill on PROD1PC66 with NOTICES
Participants ..............................................................................................
Participant proxies ...................................................................................
467
1.2
0.5
281
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Evaluate 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) Evaluate 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) Enhance the quality, utility, and
clarity of the information to be
collected; and (4) 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.
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, New Executive
Office Building, Room 10235,
Washington, DC 20503, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact: Dr. Jean
Olson, Epidemiology Branch, Division
of Prevention and Population Sciences,
NHLBI, NIH, II Rockledge Centre, 6701
Rockledge Drive, Suite 10018, MSC #
7936, Bethesda, MD 20892–7936, or call
301–435–0397 (non-toll-free number), or
e-mail your request, including your
address to: OlsonJ@nhlbi.nih.gov.
Comments 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.
VerDate Aug<31>2005
19:05 Dec 04, 2007
Jkt 214001
Dated: November 1, 2007.
Mike Lauer,
Director, Division of Prevention and
Population Sciences, NHLBI, National
Institutes of Health.
Dated: November 20, 2007.
Suzanne Freeman,
OMB Clearance Officer, NHLBI, National
Institutes of Health.
[FR Doc. E7–23515 Filed 12–4–07; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
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.
ADDRESSES: 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
be required to receive copies of the
patent applications.
New Epitopes Recognized by
Antibodies Against Human and Avian
Influenza for Vaccines and Diagnostic
Assays
Description of Technology: Available
for licensing and commercial
development are intellectual properties
drawn to peptides and polypeptides that
elicit immunogenic responses in a
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
mammal; especially neutralizing
antibodies, against human and avian
influenza strains H1N1, H3N2, H5N1
and H7N7. Materials in the form of
immunogenic compositions including
these peptides and polypeptides can
also be in-licensed along with the patent
rights. Pharmaceutical compositions
including these peptides and
polypeptides with or without adjuvants
are within the scope of the invention.
Nucleic acids and expression cassettes
encoding these peptides and
polypeptides are also within the scope
of the invention. Methods of inhibiting
infection by influenza, with or without
cell entry, are also within the scope of
the invention using the aforementioned
peptides and polypeptides.
Applications: Vaccines; Therapeutics;
Diagnostics; Influenza.
Inventors: Hana Golding and Surender
Khurana (FDA).
Patent Status: U.S. Provisional
Application No. 60/929,119 filed 13
June 2007 (HHS Reference No. E–236–
2007/0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Michael A.
Shmilovich, Esq.; 301/435–5019;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity:
The FDA/CBER Laboratory of Retrovirus
Research is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize this technology. Please
contact Beatrice A. Droke at 301/827–
7008 or bdroke@oc.fda.gov for more
information.
Trifunctional Imaging Agent for
Monoclonal Antibody Tumor-Targeted
Imaging
Description of Technology: Available
for licensing and commercial
development is a novel lysine-based
trifunctional chelate which bears both a
chelating moiety (CHX–A″) for
sequestering radiometals (86Y or 111In)
and a near-infrared dye, e.g., Cy5.5, for
dual modality PET (or SPECT) and
fluorescence imaging. Successful
conjugation of monoclonal antibody
trastuzumab (Herceptin) or cetuximab
(Erbitux) has also been achieved by
efficient thiol-maleimide chemistry,
E:\FR\FM\05DEN1.SGM
05DEN1
]]>Agencies
[Federal Register Volume 72, Number 233 (Wednesday, December 5, 2007)]
[Notices]
[Pages 68587-68588]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-23515]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; the Cardiovascular
Health Study (CHS)
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Heart, Lung, and Blood Institute
(NHLBI), the National Institutes of Health (NIH) has submitted to the
Office of Management and Budget (OMB) a request for review and approval
the information collection listed below. This proposed information
collection was previously published in the Federal Register on
September 12, 2007, page 52155, and allowed 60 days for public comment.
One comment was received. The purpose of this notice is to allow an
additional 30 days for public comment. The National Institutes of
Health may not conduct or sponsor, and the respondent is not required
to respond to, any information collection that has been extended,
revised, or implemented on or after October 1, 1995, unless it displays
a currently valid OMB control number.
Proposed Collection: Title: The Cardiovascular Health Study. Type
of Information Request: Reinstatement (OMB No. 0925-0334). Need and Use
of Information Collection: This study quantifies associations between
conventional and hypothetical risk factors and coronary heart disease
(CHD) and stroke in people age 65 years and older. The primary
objectives include quantifying associations of risk factors with
subclinical disease; characterizing the natural history of CHD and
stroke; and identifying factors associated with clinical course. The
findings provide important information on cardiovascular disease in an
older U.S. population and lead to early treatment of risk factors
associated with disease and identification of factors that may be
important in disease prevention. OBM clearance is being sought for data
collection activities at only one of the four CHS field centers (the
Pittsburgh field center), which are expected to end on May 31, 2008.
Other data collection efforts in the CHS cohort are supported by
various non-contract funding sources. Frequency of response: Twice a
year (participants) or once per cardiovascular disease event (proxies);
Affected public: Individuals. Types of Respondents: Individuals
recruited for CHS and their selected proxies. The annual reporting
burden is as follows: Estimated Number of Respondents: 467; Estimated
Number of Responses per Respondent: 1.2; and Estimated Total Annual
Burden Hours Requested: 281. The annualized cost to respondents is
estimated at: $5,225.
There are no capital, operating, or maintenance costs to report.
[[Page 68588]]
----------------------------------------------------------------------------------------------------------------
Estimated
Estimated number of Average burden Estimated total
Type of respondents number of responses per hours per annual burden
respondents respondent * response hours requested
----------------------------------------------------------------------------------------------------------------
Participants................................ 346 1.2 0.5 208
Participant proxies......................... 121 1.2 0.5 73
----------------------------------------------------------------------------------------------------------------
Total................................... 467 1.2 0.5 281
----------------------------------------------------------------------------------------------------------------
Request for Comments: Written comments and/or suggestions from the
public and affected agencies should address one or more of the
following points: (1) Evaluate 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) Evaluate 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) Enhance the
quality, utility, and clarity of the information to be collected; and
(4) 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.
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, New Executive Office Building, Room 10235, Washington, DC
20503, Attention: Desk Officer for NIH. To request more information on
the proposed project or to obtain a copy of the data collection plans
and instruments, contact: Dr. Jean Olson, Epidemiology Branch, Division
of Prevention and Population Sciences, NHLBI, NIH, II Rockledge Centre,
6701 Rockledge Drive, Suite 10018, MSC 7936, Bethesda, MD
20892-7936, or call 301-435-0397 (non-toll-free number), or e-mail your
request, including your address to: OlsonJ@nhlbi.nih.gov.
Comments 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.
Dated: November 1, 2007.
Mike Lauer,
Director, Division of Prevention and Population Sciences, NHLBI,
National Institutes of Health.
Dated: November 20, 2007.
Suzanne Freeman,
OMB Clearance Officer, NHLBI, National Institutes of Health.
[FR Doc. E7-23515 Filed 12-4-07; 8:45 am]
BILLING CODE 4140-01-P
