Statement of Work for Dr. Didem Ozdemir

1.  [Objectives]{.underline}

> The contractor will work with Dr. Thomas Hart and other members of the
> Human and Craniofacial Genetics Section. The contractor will perform
> recruitment and clinical assessment of individuals from families
> segregating Amelogenesis imperfecta (AI). Dr. Ozdemir's work will
> focus on identification of families segregating amelogenesis
> imperfecta, diagnosing which family members are and which are not
> affected by AI, obtaining informed consent from individuals to
> participate in studies to identify the underlying genetic basis of AI
> in their families and understanding the mechanism of this disease. The
> areas of the investigation include ascertainment of affected AI
> probands and their family members, determination of who does and who
> does not have the disease, obtaining appropriate samples for DNA
> isolation including peripheral blood, buccal swabs or oral rinses.
> Isolated DNA will be used to perform genetic linkage studies and
> perform mutational analysis of candidate genes through DNA sequencing.
> These studies are aimed at identification of the underlying gene
> defect in each family and in determining how the mutations act to
> cause defective enamel development.

2.  [Approach]{.underline}

> The contractor will be involved in implementing clinical ascertainment
> of individuals with Amelogenesis Imperfecta. The contractor will be
> involved in ascertaining family members of individuals with AI, and
> diagnosing affected status. The Contractor will be involved with
> tissue procurement and treatment of affected individuals in her
> clinic. The contractor will be responsible for preparation of samples
> and shipment to the Human and Craniofacial Genetics laboratory for
> analysis. The contractor will work with personnel from the Human and
> Craniofacial Genetics section in preparation of reports including
> scientific manuscript describing findings of molecular genetic
> studies.

3.  [Methods]{.underline}

> The services will be performed as follows:

a)  The contractor will participate in ongoing research related to
    identification of the genetic basis of Amelogenesis Imperfecta and
    characterization of the functional defect that causes the disease.
    Specifically the contractor will ascertain individuals affected by
    Amelogenesis Imperfecta, including clinical diagnosis, collection of
    specimens and preparation of specimens for DNA extraction.

b)  The contractor must have expertise in clinical diagnosis of various
    forms of Amelogenesis Imperfecta and the ability to distinguish the
    condition from sporadic phenocopies of the condition. The contractor
    must have a background in genetics, and have the ability to record
    accurate pedigrees.

c)  The contractor will have expertise to perform lateral cephalometric
    examinations to permit characterization of changes in craniofacial
    bone relationships.

d)  The contractor will maintain clear and accurate records relating to
    clinical information as well as tracking samples.

e)  The contractor should have excellent oral communication skills and
    be able to participate in writing scientific reports as well as
    clinical records.

[Personnel, evaluation and schedule]{.underline}

> [A. Personnel]{.underline}
>
> The contractor must have a working knowledge of general dentistry and
> expertise in Pediatric Dentistry. The contractor must have a working
> knowledge of genetics including modes of transmission of Mendelian
> diseases. The contractor must have expertise in the various forms of
> Amelogenesis Imperfecta. The contractor will be skilled in sample
> preparation for DNA isolation and for transport of tissue samples
> cytogenetics when needed. Personnel provided under the contract will
> comply with the rules and policies of the NIDCR and its staff.
>
> [B. Evaluation]{.underline}
>
> The contractor is expected to work in an independent self-motivated
> fashion. The contractor is expected to work closely with the Section
> Chief and other members of the laboratory and will be evaluated at
> least once a week by discussing a weekly progress report with the
> section chief. If the contractor is considered to be substandard in
> the judgment of the section chief, the contractor will initially
> receive notice of the problem from the section chief and will be
> required to take corrective measures and to demonstrate improved
> performance.
>
> [C. Schedule]{.underline}
>
> The contractor will perform duties related to the study for a minimum
> of 12 hours a week. The contractor will have flexibility to determine
> the days the work is performed, as this will be dictated in large
> measure by subject availability and study subjects availability.
> Failure to schedule and perform the necessary duties shall be
> considered default of the contract.
>
> [D. Reporting Requirements]{.underline}
>
> The contractor shall provide professional services for the Human and
> Craniofacial Genetics Section, NIDCR during the period of September
> 25, 2006 to September 28, 2007. The contractor will participate in
> ongoing research related to identification of the genetic basis of
> Amelogenesis Imperfecta and characterization of the functional defect
> that causes the disease. She will ascertain individuals affected by
> Amelogenesis Imperfecta, including clinical diagnosis, collection of
> specimens and preparation of specimens for DNA extraction. She will
> prepare samples as well as clinical and research data from individuals
> having the condition of Amelogenesis imperfecta (AI). The information
> includes: ascertainment of affected AI probands and their family
> members, determination of who does and who does not have the disease,
> obtaining appropriate samples for DNA isolation including peripheral
> blood, buccal swabs or oral rinses. Isolated DNA will be used to
> perform genetic linkage studies and perform mutational analysis of
> candidate genes through DNA sequencing.
>
> The contractor will be paid a total of \$5,999.76 for this 12 month
> period.
>
> **Justification**
>
> Attached is a request for \$5,999.76 to provide per Diem and travel
> for the services of Dr. Didem Ozdemir. Under this contract, Dr.
> Ozdemir will provide clinical research services to the Human and
> Craniofacial Genetics Section, NIDCR. Her contract will run from
> September 25, 2006 to September 28, 2007. The work requires
> specialized clinical skills and basic research skills for sample
> preparation. Dr. Ozdemir is a dentist with specialized training in the
> field of Pediatric Dentistry. She also has received training in human
> genetics during a Clinical Research Fellowship performed at the NIDCR.
> Dr. Ozdemir is experienced in the area of Amelogenesis Imperfecta, and
> has published scientific manuscripts related to this topic. The
> procedures described need technical skill and expertise in the area of
> normal and abnormal enamel development. She is also proficient with
> the methods related to establishing the needed database and recording
> the appropriate information.
>
> Additionally, Dr. Ozdemir has the expertise and self motivation to
> successfully perform the project. She is familiar with all goals of
> the proposal, and understands when to support different aspects of the
> project to ensure successful completion. Her specific expertise in the
> area of amelogenesis imperfecta research makes her an ideal candidate
> for this work.
>
> **[Task Description:]{.underline}**
>
> Firm will issue 26 checks on the following payment days for the
> following amounts:
>
> 9/25/2006 -- 10/6/2006 - \$230.76
>
> 10/9/2006 -- 10/20/2006 - \$230.76
>
> 10/23/2006 -- 11/3/2006 - \$230.76
>
> 11/6/2006 -- 11/17/2006 - \$230.76
>
> 11/20/2006 -- 12/1/2006 - \$230.76
>
> 12/4/2006 -- 12/15/2006 - \$230.76
>
> 12/18/2006 -- 12/29/2006 - \$230.76
>
> 1/1/2007 -- 1/12/2007 - \$230.76
>
> 1/15/2007 -- 2/2/2007 - \$230.76
>
> 2/5/2007 -- 2/16/2007 - \$230.76
>
> 2/19/2007 -- 3/2/2007 - \$230.76
>
> 3/5/2007 -- 3/16/2007 - \$230.76
>
> 3/19/2007 -- 3/30/2007 - \$230.76
>
> 4/2/2007 -- 4/13/2007 - \$230.76
>
> 4/16/2007 -- 4/27/2007 - \$230.76
>
> 4/30/2007 -- 5/11/2007 - \$230.76
>
> 5/14/2007 -- 5/25/2007 - \$230.76
>
> 5/28/2007 -- 6/8/2007 - \$230.76
>
> 6/11/2007 -- 6/22/2007 - \$230.76
>
> 6/25/2007 -- 7/6/2007 - \$230.76
>
> 7/9/2007 -- 7/20/2007 - \$230.76
>
> 7/23/2007 -- 8/3/2007 - \$230.76
>
> 8/6/2007 -- 8/17/2007 - \$230.76
>
> 8/20/2007 -- 8/31/2007 - \$230.76
>
> 9/3/2007 -- 9/14/2007 - \$230.76
>
> 9/17/2007 -- 9/28/2007 - \$230.76
>
> Checks will be issued to Dr. Didem Ozdemir. Payment to Dr. Ozdemir for
> her clinical research services to the Human and Craniofacial Genetics
> Section, (HCGS)/ NIDCR. It is estimated that Dr. Ozdemir will provide
> specialized sample preparation to HCGS/NIDCR beginning on 9/25/2006. A
> total of \$5,999.76 shall be paid in 26 payments. The checks should be
> sent via express mail to the NIDCR, to the attention of Renata
> Baginski at the following address.
>
> Mailing Address:
>
> Renata Baginski, Administrative Officer
>
> Building 30, Room 508B

National Institutes of Health

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Bethesda, MD 20892-4324