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67148 Federal Register / Vol. 71, No.

223 / Monday, November 20, 2006 / Notices

may make searching for a record easier Dated: November 8, 2006. permit analysis of the associations of
and prevent delay. Michael O. Leavitt, gene variants with biomarker levels.
Secretary. Scientific Scope: The proposed study
RECORD ACCESS PROCEDURE:
[FR Doc. 06–9264 Filed 11–17–06; 8:45 am] will measure 150 or more evolving and
For purpose of access, use the same novel biomarkers from the FHS in 7000
BILLING CODE 4165–15–M
procedures outlined in Notification FHS subjects for whom subclinical and
Procedures above. Requestors should clinical CVD and its risk factors have
also specify the record contents being DEPARTMENT OF HEALTH AND been carefully characterized. Analyses
sought. (These procedures are in HUMAN SERVICES will be conducted for association of
accordance with department regulation biomarkers—individually and
45 CFR 5b.5(a)(2)). National Institutes of Health collectively—with clinically relevant
phenotypes.
CONTESTING RECORDS PROCEDURES:
National Heart, Lung, and Blood The aims of the project are to:
The subject individual should contact Institute: Circulating Biomarkers of 1. Identify the biochemical signature
the system manager named above, and Cardiovascular Risk in the NHLBI’s of atherosclerosis as determined by: (a)
reasonably identify the records and Framingham Heart Study Aortic and coronary calcification on CT
specify the information to be contested. (data available in 3500 people), (b)
State the corrective action sought and AGENCY: National Heart, Lung, and aortic plaque burden by MRI (n=2000),
the reasons for the correction with Blood Institute, NIH, HHS. (c) carotid intimal-medial thickness by
supporting justification. (These ACTION: Notice. ultrasound (n=3500), (d) clinical
Procedures are in accordance with atherosclerotic CVD (n=500), and (e) the
Department regulation 45 CFR 5b.7). SUMMARY: National Heart, Lung, and dynamic balance between arterial
Blood Institute (NHLBI) seeks partners calcification and bone demineralization
RECORDS SOURCE CATEGORIES: in a biomarker consortium to promote (n=3500).
Information for this system is research on novel serum/plasma/urine 2. Identify the biochemical signature
collected from the Inpatient biomarkers of cardiovascular disease of metabolic syndrome components
Rehabilitation Facilities—Patient (CVD) and related risk factors including including (a) systolic and diastolic
Assessment Instrument. atherosclerosis, obesity, insulin blood pressure (n=7000), (b) obesity
resistance, hypertension, and metabolic (n=7000) and visceral adiposity by CT
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
OF THE ACT:
syndrome. An immediate consequence (n=3500), (c) dyslipidemia (n=7000),
of this project will be the development and (d) impaired fasting glucose,
None. of new diagnostic tests to identify diabetes, and insulin resistance.
[FR Doc. E6–19506 Filed 11–17–06; 8:45 am] individuals at high risk for CVD and its Biomarkers for this project will be
BILLING CODE 4120–03–P risk factors at a time when intervention selected by expert consensus on the
is most feasible. A downstream result of basis of (a) a careful review of the
the identification of novel biomarkers of literature for biomarkers of
DEPARTMENT OF HEALTH AND CVD (and its risk factors) will be the atherosclerosis and metabolic
HUMAN SERVICES discovery of disease promoting syndrome, and (b) genes implicated in
pathways, which may serve as new atherosclerosis and metabolic syndrome
Health Resources and Services therapeutic targets for treating and (and their constituent components and
Administration preventing our nation’s leading cause of pathways), or showing evidence of
death. association with the phenotypes of
Delegation of Authority
Background: Despite steady declines interest.
Notice is hereby given that I have in CVD mortality, CVD remains the Technology: As part of this project,
delegated to the Administrator, Health leading cause of death in the developed new quantitative tests will be developed
Resources and Services Administration world. The NHLBI’s Framingham Heart to measure circulating biomarker levels
(HRSA), with authority to re-delegate, Study (FHS) has been instrumental in using antibody sandwich assays and/or
the authority vested in the Secretary of the identification and elucidation of key proteomic approaches that are amenable
Health and Human Services under Title modifiable risk factors for CVD, which to high throughput application. Critical
III, Part B, Section 319F–4, titled in turn have facilitated modern to this project is the implementation of
‘‘Covered Countermeasure Process,’’ of approaches to the prevention and methods to measure large numbers of
the Public Health Service Act, as treatment of CVD. Because of its biomarkers with minimal sample
amended, by the Public Readiness and prospective study design, the NHLBI’s volume; proteomic, bead-linked
Emergency Preparedness Act of 2006 FHS is ideally positioned to enable immunoassays, and nanotechnology
(Pub. L. 109–148), only insofar as it identification of novel risk factors for methods may be necessary to
pertains to the compensation program. CVD. The availability of frozen serum/ accomplish this aim. Pathways to be
This delegation shall be exercised plasma/urine samples from over 7000 studied include but are not limited to:
under the Department’s existing FHS participants in the Offspring and Adhesion/chemoattraction, adipokines,
delegation of authority and policy on Third Generation cohorts, in concert cytokines, growth factors, heat shock
regulations. with new high-throughput quantitative proteins, inflammation, lipoproteins,
This delegation is effective upon biomarker technology available from neurohormones, thrombosis/
signature. In addition, I hereby affirmed commercial collaborators, provides a fibrinolysis, and vascular calcification.
and ratified any actions taken by the unique opportunity to explore the Demonstrated rigorous assay validation
HRSA Administrator or other HRSA biochemical signatures of key CVD using non-FHS samples will be
sroberts on PROD1PC70 with NOTICES

officials which involved the exercise of phenotypes. In addition, by the end of necessary before FHS biospecimens can
this authority prior to the effective date 2007 genotyping of 550k SNPs will be be used for this project.
of this delegation. completed in nearly all the FHS Study Sample: The NHLBI’s FHS is
This delegation is effective upon date participants as part of the NHLBI’s community-based[N1], which should
of signature. SHARe project and these data will contribute to the generalizability of

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Federal Register / Vol. 71, No. 223 / Monday, November 20, 2006 / Notices 67149

study results. Frozen serum/plasma/ DEPARTMENT OF HOMELAND approval. All comments will become a
urine samples and buffy coats for WBC SECURITY matter of public record. In this
derived RNA are available in two document CBP is soliciting comments
carefully characterized cohorts Bureau of Customs and Border concerning the following information
comprising over 7000 individuals. The Protection collection:
presence of young, middle-aged, and Title: Visa Waiver Program Carrier
Proposed Collection; Comment Agreement.
elderly subjects will allow a more Request; Visa Waiver Program Carrier
complete exploration of biomarkers for OMB Number: 1651–0110.
Agreement (Form I–775) Form Number: Form–I–775.
relevant traits across a wide age range Abstract: The Form I–775 provides for
(20–90 years). The FHS main contracts Notice and request for
ACTION:
certain aliens to be exempt from the
(N01–HC–38038; N01–HC–25195) have comments. non-immigrant visa requirements if
provided for the core examinations of seeking entry as a visitor for no more
SUMMARY: As part of its continuing effort
the participants that include physical than 90 days, provided that no potential
to reduce paperwork and respondent
examination, ECG, multidetector CT burden, the Bureau of Customs and threat exists to the security of the
scans for coronary calcification and Border Protection (CBP) invites the United States.
visceral adiposity, and blood specimen general public and other Federal Current Actions: There are no changes
collection. In addition, buffy coats and agencies to comment on an information to the information collection. This
purified white blood cell RNA also are collection requirement concerning the submission is to extend the expiration
available for WBC-derived RNA Visa Waiver Program Carrier Agreement date.
expression profiling to complement (Form I–775). This request for comment Type of Review: Extension (without
circulating biomarker and genotypic is being made pursuant to the change).
characterization. Paperwork Reduction Act of 1995 (Pub. Affected Public: Individuals.
L. 104–13; 44 U.S.C. 3505(c)(2)). Estimated Number of Respondents:
ADDRESSES: Interest regarding this 400.
DATES: Written comments should be
notice should be forwarded to: Ms. Lili Estimated Time Per Respondent: 2
received on or before January 19, 2007,
Portilla, NHLBI Office of Technology hours.
to be assured of consideration. Estimated Total Annual Burden
Transfer and Development, 6705 ADDRESSES: Direct all written comments
Rockledge Drive, Suite 6018 MSC 7992, Hours: 800.
to the Bureau of Customs and Border Estimated Total Annualized Cost on
Bethesda, MD 20892–7992 (E-mail: Protection, Information Services Group, the Public: N/A.
PortillL@nhlbi.nih.gov). Scientific Room 3.2.C, 1300 Pennsylvania Avenue,
inquiries should be submitted to Daniel NW., Washington, DC 20229. Dated: November 14, 2006.
Levy, M.D., FACC, Director, Tracey Denning,
FOR FURTHER INFORMATION CONTACT:
Framingham Heart Study, Center for Requests for additional information Agency Clearance Officer, Information
Population Studies, National Heart, should be directed to Bureau of Customs Services Branch.
Lung, & Blood Institute, 73 Mt. Wayte and Border Protection, Attn.: Tracey [FR Doc. E6–19596 Filed 11–17–06; 8:45 am]
Avenue, Suite 2, Framingham, MA Denning, Room 3.2.C, 1300 BILLING CODE 9111–14–P
01702 (E-mail: LevyD@nih.gov). Pennsylvania Avenue, NW.,
Washington, DC 20229, Tel. (202) 344–
DATES: Effective Dates: Inquiries DEPARTMENT OF HOMELAND
1429.
regarding this Notice and scientific SECURITY
SUPPLEMENTARY INFORMATION: CBP
matters may be forwarded at any time.
invites the general public and other Bureau of Customs and Border
Confidential, written letters of interest,
Federal agencies to comment on Protection
preferably two pages or less, must be proposed and/or continuing information
submitted to NHLBI on or before collections pursuant to the Paperwork [CBP Dec. 06–35]
January 19, 2007. Guidelines on next Reduction Act of 1995 (Pub. L. 104–13;
steps will be communicated shortly 44 U.S.C. 3505(c)(2)). The comments Re-Accreditation and Re-Approval of
thereafter to all respondents with whom should address: (a) Whether the Inspectorate America Corporation as a
initial confidential discussions will collection of information is necessary Commercial Gauger and Laboratory
have established sufficient mutual for the proper performance of the AGENCY: Bureau of Customs and Border
interest. functions of the agency, including Protection, Department of Homeland
Dated: November 3, 2006. whether the information shall have Security.
Suzanne Freeman,
practical utility; (b) the accuracy of the ACTION: Notice of re-approval of
agency’s estimates of the burden of the Inspectorate America Corporation of
NHLBI Project Clearance Liaison, National
collection of information; (c) ways to Aston, Pennsylvania, as a commercial
Institutes of Health.
enhance the quality, utility, and clarity gauger and laboratory.
Dated: November 3, 2006. of the information to be collected; (d)
Daniel Levy, ways to minimize the burden including SUMMARY: Notice is hereby given that,
Director of the NHLBI Framingham Heart the use of automated collection pursuant to 19 CFR 151.12 and 151.13,
Study, National Institutes of Health. techniques or the use of other forms of Inspectorate America Corporation, 507
[FR Doc. E6–19522 Filed 11–17–06; 8:45 am] information technology; and (e) Duttons Mill Road, Suite A–1, Aston,
BILLING CODE 4140–01–P estimates of capital or start-up costs and Pennsylvania 19014, has been re-
costs of operations, maintenance, and approved to gauge petroleum and
sroberts on PROD1PC70 with NOTICES

purchase of services to provide petroleum products, organic chemicals


information. The comments that are and vegetable oils, and to test petroleum
submitted will be summarized and and petroleum products for customs
included in the request for Office of purposes, in accordance with the
Management and Budget (OMB) provisions of 19 CFR 151.12 and 151.13.

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