MODIFICATION
B -- Genetic Predisposition to Allergic Contact Dermatitis
- Notice Date
- 7/20/2011
- Notice Type
- Modification/Amendment
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Acquisition and Assistance Field Branch (Morgantown), 1095 Willowdale Road, Morgantown, West Virginia, 26505
- ZIP Code
- 26505
- Solicitation Number
- 000HCCCB-2011-99692
- Archive Date
- 9/5/2011
- Point of Contact
- Rebecca S Mullenax, Phone: 304-285-5880, Kimberly P Groves, Phone: 304-285-5885
- E-Mail Address
-
rmullenax@cdc.gov, kgroves@cdc.gov
(rmullenax@cdc.gov, kgroves@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- Please delete prior notice and replace with modification to a purchase order notice below: ORIGINAL NOTICE: NOTICE OF INTENT TO ISSUE A PURCHASE ORDER. The Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health (NIOSH), Health Effects Laboratory Division (HELD), Toxicology and Molecular Biology Branch (TMBB), 1095 Willowdale Road, Morgantown, WV 26505, hereby announces its intent to issue a purchase order to the Trustees of Dartmouth College for the study to investigate genetic factors involved in the development and clinical presentation of allergic contact dermatitis. The frequency and distribution of genetic variations in specific candidate genes will be investigated. Responsible sources that believe they possess the expertise and capabilities identified above are encouraged to submit to the Contracting Officer within 15 days from the posting date of this notice, their written capabilities statement and pricing information in the format they choose, not to exceed 10 pages. Please forward the capability statement and pricing information to Rebecca Mullenax, Purchasing Agent, Reference 000HCCCB-2011-99692, Centers for Disease Control, NIOSH, ATTN: Rebecca Mullenax, MS: GD, 1095 Willowdale Road, Morgantown, WV 26505. All vendors must be registered in the Central Contractor Registry (CCR) prior to an award of a federal contract. The website is: www.ccr.gov. The Government will review any/all capabilities statements and pricing information submitted and determine if other qualified sources do exist that could provide this requirement. Information received in response to this announcement will be used solely for the purpose of determining whether to conduct a competitive procurement. If no affirmative responses are received within 15 days, in accordance with FAR 13.106-1(b)(1), negotiations will be conducted with the Trustees of Dartmouth college, 1 Hinman - Dartmouth College, Hanover, NH 03755-4099, as the only source and a purchase order will be issued without any additional notices being posted. AMENDED NOTIFICATION: NOTICE OF INTENT TO ISSUE A MODIFICATION TO PURCHASE ORDER #212-2008-M-26966. The Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health (NIOSH), Health Effects Laboratory Division (HELD), Toxicology and Molecular Biology Branch (TMBB), 1095 Willowdale Road, Morgantown, WV 26505, hereby announces its intent to issue a modification to purchase order # 212-2008-M-26966 to the Trustees of Dartmouth College for the study to investigate genetic factors involved in the development and clinical presentation of allergic contact dermatitis. The frequency and distribution of genetic variations in specific candidate genes will be investigated. Introduction: Allergic contact dermatitis (ACD) is a delayed type of induced sensitivity resulting from cutaneous contact with a specific allergen to which the patient has developed a specific sensitivity. ACD accounts for 25 % of all contact dermatitis reactions. Among sensitizers, the prevalence of metal sensitivity is approximately 10% to 15% in the general population with nickel sensitivity having the highest prevalence (approximately 14%) [1,2]. Nickel may be considered a possible occupational allergen [3,4]. Workers in whom nickel may be an occupational allergen primarily include machinists, assemblers, horticulturists, caterers, hairdressers, health care workers, printers, and electroplaters [5]. Sensitization to the metals may also depend on general susceptibility factors. Polysensitization to more than 1 structurally unrelated hapten is considered as a phenotypic marker of increased susceptibility to contact sensitization [6]. There is a wide range of inter-individual variation in the development of ACD independent of atopic status and mechanisms underlying these differences in susceptibility are not clearly understood. Twin and family studies suggest that the tendency to sensitization might be influenced by genetic factors [7]. The individual susceptibility has been attributed to genetic factors, such as the carriage of certain human leukocyte antigens (HLA), cytokine or antioxidant enzyme alleles. Purpose: This study aims to investigate genetic factors involved in the development and clinical presentation of ACD. The frequency and distribution of genetic variations in specific candidate genes will be investigated in 1. Metal sensitized patients-- Positive patch test greater than 1+ and without irritant morphology at either reading to nickel sulfate, cobalt, gold sodium thiosulfate, or potassium dichromate. 2. Patients sensitized to allergens that require metabolism in the skin-- Positive patch test greater than 1+ at either reading to neomycin, para-phenylendiame, tixocortal pivolate, budesonide, potassium dichromate. 3. Patients with reactions to more than 3 allergens of the 70 tested on the standard screening series. Multiple positive patch tests defined as 3 or more unrelated allergens without evidence of excited skin syndrome (dermatitis impinging on the patch test sites or 4 or more adjacent positive patch tests). 4. Patients sensitized to weak allergens-- Positive patch test of any strength at final reading or 1+ or greater at early reading to paraben mix, propylene glycol, eugenol, vanillin. 5. Control population-- The control group will include individuals previously enrolled in a study of irritant contact dermatitis in health care workers. Individuals who had no irritant 2 contact dermatitis and no history of allergic skin disease based on questionnaire will be selected as controls. Tasks: All patients (at least 18 years old, Caucasian, with no existing skin disease other than needing to see a dermatologist for patch testing of allergens and are capable of giving informed consent will be eligible to participate in the study)who are to be patch tested to a standard screening series of 70 or more allergens/antigens (and to appropriate specialty series as clinically indicated) in the Dartmouth Hitchcock Medical Center (DHMC) Dermatology Section will be invited to participate at the time of their initial consultation or patch test application. The patients who agree to be in this study will have their demographic information (age, gender, race, atopy history, occupation, areas of skin involved with rash) as well as patch test results entered into a separate Access database similar to the one used to generate summary letters to referring physicians for the routine clinical patients. Initial reading of patch tests will be at day 3-4, and final reading at day 5-7. Blood samples for genetic analyses will be collected on the day of the final reading (5-7 days after patch test application). Patients who have been on immunomodulatory medications, those who are receiving ultraviolet therapy or using a tanning salon and those who are currently pregnant will be excluded. This effort will be held by contractor in the Dermatology Section at DHMC (Lebanon, NH). The genetic (polymorphism and gene expression) and statistical analyses will be conducted in the Toxicology and Molecular Biology and Biostatistics and Epidemiology Branches at NIOSH, Morgantown, WV. Genotyping will be carried out using 5' nuclease assay chemistry and microarray platform. Genetic variations in immune, inflammatory and antioxidant enzyme genes and in other genes of interest hypothesized to be associated with allergic contact dermatitis will be investigated. HSRB: HSRB approval is on file. Timeline: Period of performance is for one year starting from the expected date of the modification in August, 2011. The contractor will provide questionnaire information and blood samples from 50 subjects at the end of this performance period. Through statistical power analysis we determined that these samples will be required to detect significant ssociations. This is not a request for proposals or a request for quotations, but responsible sources that believe they possess the expertise and capabilities identified above are encouraged to submit to the Contracting Officer within 15 days from the posting date of this notice, their written capabilities statement and pricing information in the format they choose, not to exceed 10 pages. Please forward the capability statement and pricing information to Rebecca Mullenax, Purchasing Agent, Reference 000HCCCB-2011-99692, Centers for Disease Control, NIOSH, ATTN: Rebecca Mullenax, MS: GD, 1095 Willowdale Road, Morgantown, WV 26505. All vendors must be registered in the Central Contractor Registry (CCR) prior to an award of a federal contract. The website is: www.ccr.gov. The Government will review any/all capabilities statements and pricing information submitted and determine if other qualified sources do exist that could provide this requirement. Information received in response to this announcement will be used solely for the purpose of determining whether to conduct a competitive procurement. The Government intends to issue a modification to a purchase order # 212-2008-M-26966 to the Trustees of Dartmouth College on a sole source basis in accordance with FAR 6.302-1 considering the Trustees of Dartmouth College as the only responsible source and no other services will saisfy the agency's requirments for the following reasons: Dartmouth-Hitchcock Medical Center (DHMC) under the existing purchae order # 212-2008-M-26966 has already recruited 100 subjects for the Allergic Contact Dermatitis project according to the criteria outlined in the above Statement of Work. Statistical analysis of data from this group of subjects has determined that we require questionnaire information and blood samples from additional 50 subjects to be able to detect significant associations. Without the information and samples from all 50 subjects, the statistical analysis will not be powerful enough to support our investigation into the genetic factors involved in the development and clinical presentation of Allergic Contact Dermatitis. Therefore, we will require data from all 50 subjects in order to obtain a dataset that will provide meaningful results. Genetic association studies in admixed populations may be confounded by population stratification. The heterogeneity of genetic backgrounds among individuals and different patterns of referral may lead to spurious associations. Therefore, in the new recruitment, referral patterns, patient characteristics and evaluation criteria of contact dermatitis should be similar to previous recruitment patterns in order to obtain consistency in the study population. DHMC-Dermatology has great expertise in the evaluation of contact dermatitis and patch testing services. The center follows the criteria set by North American Contact Dermatitis (NACD) group in diagnosis and treatment of contact dermatitis and serves as the major referral center for the area. Prior subject recruitment was conducted by a doctor who is an Associate Professor of Medicine (Dermatology) at Dartmouth-Hitchcock Medical Center. This doctor is well known expertise in the area of contact dermatitis and follows the NACD criteria in the doctor's practice. Therefore, additional subjects should be recruited by Dartmouth-Hitchcock Medical Center and their dermatitis status should be assessed by the same dermatologist following the same criteria. If no affirmative responses are received within 15 days, in accordance with FAR 13.106-1(b)(1), negotiations will be conducted with the Trustees of Dartmouth college, 1 Hinman - Dartmouth College, Hanover, NH 03755-4099, as the only source and a modification under purchase order # 212-2008-M-26966 will be issued without any additional notices being posted.
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