National Heart, Lung, and Blood Institute: Circulating Biomarkers of Cardiovascular Risk in the NHLBI's Framingham Heart Study, 67148-67149 [E6-19522]

Download as PDF 67148 Federal Register / Vol. 71, No. 223 / Monday, November 20, 2006 / Notices may make searching for a record easier and prevent delay. RECORD ACCESS PROCEDURE: For purpose of access, use the same procedures outlined in Notification Procedures above. Requestors should also specify the record contents being sought. (These procedures are in accordance with department regulation 45 CFR 5b.5(a)(2)). CONTESTING RECORDS PROCEDURES: The subject individual should contact the system manager named above, and reasonably identify the records and specify the information to be contested. State the corrective action sought and the reasons for the correction with supporting justification. (These Procedures are in accordance with Department regulation 45 CFR 5b.7). RECORDS SOURCE CATEGORIES: Information for this system is collected from the Inpatient Rehabilitation Facilities—Patient Assessment Instrument. SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT: None. [FR Doc. E6–19506 Filed 11–17–06; 8:45 am] BILLING CODE 4120–03–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration sroberts on PROD1PC70 with NOTICES Delegation of Authority Notice is hereby given that I have delegated to the Administrator, Health Resources and Services Administration (HRSA), with authority to re-delegate, the authority vested in the Secretary of Health and Human Services under Title III, Part B, Section 319F–4, titled ‘‘Covered Countermeasure Process,’’ of the Public Health Service Act, as amended, by the Public Readiness and Emergency Preparedness Act of 2006 (Pub. L. 109–148), only insofar as it pertains to the compensation program. This delegation shall be exercised under the Department’s existing delegation of authority and policy on regulations. This delegation is effective upon signature. In addition, I hereby affirmed and ratified any actions taken by the HRSA Administrator or other HRSA officials which involved the exercise of this authority prior to the effective date of this delegation. This delegation is effective upon date of signature. VerDate Aug<31>2005 17:10 Nov 17, 2006 Jkt 211001 Dated: November 8, 2006. Michael O. Leavitt, Secretary. [FR Doc. 06–9264 Filed 11–17–06; 8:45 am] BILLING CODE 4165–15–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute: Circulating Biomarkers of Cardiovascular Risk in the NHLBI’s Framingham Heart Study National Heart, Lung, and Blood Institute, NIH, HHS. ACTION: Notice. AGENCY: SUMMARY: National Heart, Lung, and Blood Institute (NHLBI) seeks partners in a biomarker consortium to promote research on novel serum/plasma/urine biomarkers of cardiovascular disease (CVD) and related risk factors including atherosclerosis, obesity, insulin resistance, hypertension, and metabolic syndrome. An immediate consequence of this project will be the development of new diagnostic tests to identify individuals at high risk for CVD and its risk factors at a time when intervention is most feasible. A downstream result of the identification of novel biomarkers of CVD (and its risk factors) will be the discovery of disease promoting pathways, which may serve as new therapeutic targets for treating and preventing our nation’s leading cause of death. Background: Despite steady declines in CVD mortality, CVD remains the leading cause of death in the developed world. The NHLBI’s Framingham Heart Study (FHS) has been instrumental in the identification and elucidation of key modifiable risk factors for CVD, which in turn have facilitated modern approaches to the prevention and treatment of CVD. Because of its prospective study design, the NHLBI’s FHS is ideally positioned to enable identification of novel risk factors for CVD. The availability of frozen serum/ plasma/urine samples from over 7000 FHS participants in the Offspring and Third Generation cohorts, in concert with new high-throughput quantitative biomarker technology available from commercial collaborators, provides a unique opportunity to explore the biochemical signatures of key CVD phenotypes. In addition, by the end of 2007 genotyping of 550k SNPs will be completed in nearly all the FHS participants as part of the NHLBI’s SHARe project and these data will PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 permit analysis of the associations of gene variants with biomarker levels. Scientific Scope: The proposed study will measure 150 or more evolving and novel biomarkers from the FHS in 7000 FHS subjects for whom subclinical and clinical CVD and its risk factors have been carefully characterized. Analyses will be conducted for association of biomarkers—individually and collectively—with clinically relevant phenotypes. The aims of the project are to: 1. Identify the biochemical signature of atherosclerosis as determined by: (a) Aortic and coronary calcification on CT (data available in 3500 people), (b) aortic plaque burden by MRI (n=2000), (c) carotid intimal-medial thickness by ultrasound (n=3500), (d) clinical atherosclerotic CVD (n=500), and (e) the dynamic balance between arterial calcification and bone demineralization (n=3500). 2. Identify the biochemical signature of metabolic syndrome components including (a) systolic and diastolic blood pressure (n=7000), (b) obesity (n=7000) and visceral adiposity by CT (n=3500), (c) dyslipidemia (n=7000), and (d) impaired fasting glucose, diabetes, and insulin resistance. Biomarkers for this project will be selected by expert consensus on the basis of (a) a careful review of the literature for biomarkers of atherosclerosis and metabolic syndrome, and (b) genes implicated in atherosclerosis and metabolic syndrome (and their constituent components and pathways), or showing evidence of association with the phenotypes of interest. Technology: As part of this project, new quantitative tests will be developed to measure circulating biomarker levels using antibody sandwich assays and/or proteomic approaches that are amenable to high throughput application. Critical to this project is the implementation of methods to measure large numbers of biomarkers with minimal sample volume; proteomic, bead-linked immunoassays, and nanotechnology methods may be necessary to accomplish this aim. Pathways to be studied include but are not limited to: Adhesion/chemoattraction, adipokines, cytokines, growth factors, heat shock proteins, inflammation, lipoproteins, neurohormones, thrombosis/ fibrinolysis, and vascular calcification. Demonstrated rigorous assay validation using non-FHS samples will be necessary before FHS biospecimens can be used for this project. Study Sample: The NHLBI’s FHS is community-based[N1], which should contribute to the generalizability of E:\FR\FM\20NON1.SGM 20NON1 Federal Register / Vol. 71, No. 223 / Monday, November 20, 2006 / Notices study results. Frozen serum/plasma/ urine samples and buffy coats for WBC derived RNA are available in two carefully characterized cohorts comprising over 7000 individuals. The presence of young, middle-aged, and elderly subjects will allow a more complete exploration of biomarkers for relevant traits across a wide age range (20–90 years). The FHS main contracts (N01–HC–38038; N01–HC–25195) have provided for the core examinations of the participants that include physical examination, ECG, multidetector CT scans for coronary calcification and visceral adiposity, and blood specimen collection. In addition, buffy coats and purified white blood cell RNA also are available for WBC-derived RNA expression profiling to complement circulating biomarker and genotypic characterization. Interest regarding this notice should be forwarded to: Ms. Lili Portilla, NHLBI Office of Technology Transfer and Development, 6705 Rockledge Drive, Suite 6018 MSC 7992, Bethesda, MD 20892–7992 (E-mail: PortillL@nhlbi.nih.gov). Scientific inquiries should be submitted to Daniel Levy, M.D., FACC, Director, Framingham Heart Study, Center for Population Studies, National Heart, Lung, & Blood Institute, 73 Mt. Wayte Avenue, Suite 2, Framingham, MA 01702 (E-mail: LevyD@nih.gov). ADDRESSES: Effective Dates: Inquiries regarding this Notice and scientific matters may be forwarded at any time. Confidential, written letters of interest, preferably two pages or less, must be submitted to NHLBI on or before January 19, 2007. Guidelines on next steps will be communicated shortly thereafter to all respondents with whom initial confidential discussions will have established sufficient mutual interest. DATES: Dated: November 3, 2006. Suzanne Freeman, NHLBI Project Clearance Liaison, National Institutes of Health. Dated: November 3, 2006. Daniel Levy, Director of the NHLBI Framingham Heart Study, National Institutes of Health. [FR Doc. E6–19522 Filed 11–17–06; 8:45 am] sroberts on PROD1PC70 with NOTICES BILLING CODE 4140–01–P VerDate Aug<31>2005 17:10 Nov 17, 2006 Jkt 211001 DEPARTMENT OF HOMELAND SECURITY Bureau of Customs and Border Protection Proposed Collection; Comment Request; Visa Waiver Program Carrier Agreement (Form I–775) Notice and request for comments. ACTION: SUMMARY: As part of its continuing effort to reduce paperwork and respondent burden, the Bureau of Customs and Border Protection (CBP) invites the general public and other Federal agencies to comment on an information collection requirement concerning the Visa Waiver Program Carrier Agreement (Form I–775). This request for comment is being made pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104–13; 44 U.S.C. 3505(c)(2)). DATES: Written comments should be received on or before January 19, 2007, to be assured of consideration. ADDRESSES: Direct all written comments to the Bureau of Customs and Border Protection, Information Services Group, Room 3.2.C, 1300 Pennsylvania Avenue, NW., Washington, DC 20229. FOR FURTHER INFORMATION CONTACT: Requests for additional information should be directed to Bureau of Customs and Border Protection, Attn.: Tracey Denning, Room 3.2.C, 1300 Pennsylvania Avenue, NW., Washington, DC 20229, Tel. (202) 344– 1429. SUPPLEMENTARY INFORMATION: CBP invites the general public and other Federal agencies to comment on proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104–13; 44 U.S.C. 3505(c)(2)). The comments should address: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimates of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden including the use of automated collection techniques or the use of other forms of information technology; and (e) estimates of capital or start-up costs and costs of operations, maintenance, and purchase of services to provide information. The comments that are submitted will be summarized and included in the request for Office of Management and Budget (OMB) PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 67149 approval. All comments will become a matter of public record. In this document CBP is soliciting comments concerning the following information collection: Title: Visa Waiver Program Carrier Agreement. OMB Number: 1651–0110. Form Number: Form–I–775. Abstract: The Form I–775 provides for certain aliens to be exempt from the non-immigrant visa requirements if seeking entry as a visitor for no more than 90 days, provided that no potential threat exists to the security of the United States. Current Actions: There are no changes to the information collection. This submission is to extend the expiration date. Type of Review: Extension (without change). Affected Public: Individuals. Estimated Number of Respondents: 400. Estimated Time Per Respondent: 2 hours. Estimated Total Annual Burden Hours: 800. Estimated Total Annualized Cost on the Public: N/A. Dated: November 14, 2006. Tracey Denning, Agency Clearance Officer, Information Services Branch. [FR Doc. E6–19596 Filed 11–17–06; 8:45 am] BILLING CODE 9111–14–P DEPARTMENT OF HOMELAND SECURITY Bureau of Customs and Border Protection [CBP Dec. 06–35] Re-Accreditation and Re-Approval of Inspectorate America Corporation as a Commercial Gauger and Laboratory Bureau of Customs and Border Protection, Department of Homeland Security. ACTION: Notice of re-approval of Inspectorate America Corporation of Aston, Pennsylvania, as a commercial gauger and laboratory. AGENCY: SUMMARY: Notice is hereby given that, pursuant to 19 CFR 151.12 and 151.13, Inspectorate America Corporation, 507 Duttons Mill Road, Suite A–1, Aston, Pennsylvania 19014, has been reapproved to gauge petroleum and petroleum products, organic chemicals and vegetable oils, and to test petroleum and petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 151.13. E:\FR\FM\20NON1.SGM 20NON1

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[Federal Register Volume 71, Number 223 (Monday, November 20, 2006)]
[Notices]
[Pages 67148-67149]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-19522]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Heart, Lung, and Blood Institute: Circulating Biomarkers 
of Cardiovascular Risk in the NHLBI's Framingham Heart Study

AGENCY: National Heart, Lung, and Blood Institute, NIH, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: National Heart, Lung, and Blood Institute (NHLBI) seeks 
partners in a biomarker consortium to promote research on novel serum/
plasma/urine biomarkers of cardiovascular disease (CVD) and related 
risk factors including atherosclerosis, obesity, insulin resistance, 
hypertension, and metabolic syndrome. An immediate consequence of this 
project will be the development of new diagnostic tests to identify 
individuals at high risk for CVD and its risk factors at a time when 
intervention is most feasible. A downstream result of the 
identification of novel biomarkers of CVD (and its risk factors) will 
be the discovery of disease promoting pathways, which may serve as new 
therapeutic targets for treating and preventing our nation's leading 
cause of death.
    Background: Despite steady declines in CVD mortality, CVD remains 
the leading cause of death in the developed world. The NHLBI's 
Framingham Heart Study (FHS) has been instrumental in the 
identification and elucidation of key modifiable risk factors for CVD, 
which in turn have facilitated modern approaches to the prevention and 
treatment of CVD. Because of its prospective study design, the NHLBI's 
FHS is ideally positioned to enable identification of novel risk 
factors for CVD. The availability of frozen serum/plasma/urine samples 
from over 7000 FHS participants in the Offspring and Third Generation 
cohorts, in concert with new high-throughput quantitative biomarker 
technology available from commercial collaborators, provides a unique 
opportunity to explore the biochemical signatures of key CVD 
phenotypes. In addition, by the end of 2007 genotyping of 550k SNPs 
will be completed in nearly all the FHS participants as part of the 
NHLBI's SHARe project and these data will permit analysis of the 
associations of gene variants with biomarker levels.
    Scientific Scope: The proposed study will measure 150 or more 
evolving and novel biomarkers from the FHS in 7000 FHS subjects for 
whom subclinical and clinical CVD and its risk factors have been 
carefully characterized. Analyses will be conducted for association of 
biomarkers--individually and collectively--with clinically relevant 
phenotypes.
    The aims of the project are to:
    1. Identify the biochemical signature of atherosclerosis as 
determined by: (a) Aortic and coronary calcification on CT (data 
available in 3500 people), (b) aortic plaque burden by MRI (n=2000), 
(c) carotid intimal-medial thickness by ultrasound (n=3500), (d) 
clinical atherosclerotic CVD (n=500), and (e) the dynamic balance 
between arterial calcification and bone demineralization (n=3500).
    2. Identify the biochemical signature of metabolic syndrome 
components including (a) systolic and diastolic blood pressure 
(n=7000), (b) obesity (n=7000) and visceral adiposity by CT (n=3500), 
(c) dyslipidemia (n=7000), and (d) impaired fasting glucose, diabetes, 
and insulin resistance.
    Biomarkers for this project will be selected by expert consensus on 
the basis of (a) a careful review of the literature for biomarkers of 
atherosclerosis and metabolic syndrome, and (b) genes implicated in 
atherosclerosis and metabolic syndrome (and their constituent 
components and pathways), or showing evidence of association with the 
phenotypes of interest.
    Technology: As part of this project, new quantitative tests will be 
developed to measure circulating biomarker levels using antibody 
sandwich assays and/or proteomic approaches that are amenable to high 
throughput application. Critical to this project is the implementation 
of methods to measure large numbers of biomarkers with minimal sample 
volume; proteomic, bead-linked immunoassays, and nanotechnology methods 
may be necessary to accomplish this aim. Pathways to be studied include 
but are not limited to: Adhesion/chemoattraction, adipokines, 
cytokines, growth factors, heat shock proteins, inflammation, 
lipoproteins, neurohormones, thrombosis/fibrinolysis, and vascular 
calcification. Demonstrated rigorous assay validation using non-FHS 
samples will be necessary before FHS biospecimens can be used for this 
project.
    Study Sample: The NHLBI's FHS is community-based[N1], 
which should contribute to the generalizability of

[[Page 67149]]

study results. Frozen serum/plasma/urine samples and buffy coats for 
WBC derived RNA are available in two carefully characterized cohorts 
comprising over 7000 individuals. The presence of young, middle-aged, 
and elderly subjects will allow a more complete exploration of 
biomarkers for relevant traits across a wide age range (20-90 years). 
The FHS main contracts (N01-HC-38038; N01-HC-25195) have provided for 
the core examinations of the participants that include physical 
examination, ECG, multidetector CT scans for coronary calcification and 
visceral adiposity, and blood specimen collection. In addition, buffy 
coats and purified white blood cell RNA also are available for WBC-
derived RNA expression profiling to complement circulating biomarker 
and genotypic characterization.

ADDRESSES: Interest regarding this notice should be forwarded to: Ms. 
Lili Portilla, NHLBI Office of Technology Transfer and Development, 
6705 Rockledge Drive, Suite 6018 MSC 7992, Bethesda, MD 20892-7992 (E-
mail: PortillL@nhlbi.nih.gov). Scientific inquiries should be submitted 
to Daniel Levy, M.D., FACC, Director, Framingham Heart Study, Center 
for Population Studies, National Heart, Lung, & Blood Institute, 73 Mt. 
Wayte Avenue, Suite 2, Framingham, MA 01702 (E-mail: LevyD@nih.gov).

DATES: Effective Dates: Inquiries regarding this Notice and scientific 
matters may be forwarded at any time. Confidential, written letters of 
interest, preferably two pages or less, must be submitted to NHLBI on 
or before January 19, 2007. Guidelines on next steps will be 
communicated shortly thereafter to all respondents with whom initial 
confidential discussions will have established sufficient mutual 
interest.

    Dated: November 3, 2006.
Suzanne Freeman,
NHLBI Project Clearance Liaison, National Institutes of Health.
    Dated: November 3, 2006.
Daniel Levy,
Director of the NHLBI Framingham Heart Study, National Institutes of 
Health.
[FR Doc. E6-19522 Filed 11-17-06; 8:45 am]
BILLING CODE 4140-01-P

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