Loren Data's SAM Daily™

FBO DAILY ISSUE OF AUGUST 05, 2010 FBO #3176
SOLICITATION NOTICE

B -- Testing Services - Full FBO Posting

Notice Date

8/3/2010
 

Notice Type

Presolicitation
 

NAICS

611310 — Colleges, Universities, and Professional Schools
 

Contracting Office

Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
 

ZIP Code

20892-7902
 

Solicitation Number

NHLBI-PB-HG-2010-271
 

Archive Date

8/22/2010
 

Point of Contact

Rashida S. Ferebee, Phone: 3014352605
 

E-Mail Address

ferebeers@nhlbi.nih.gov
(ferebeers@nhlbi.nih.gov)
 

Small Business Set-Aside

N/A
 

Description

Full FedBizOpps Posting THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSALS. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. It is the intent of the National Heart, Lung, and Blood Institute (NHLBI) for the National Human Genome Research Institute (NHGRI), Center for Research on Genomics and Global Health (CRGGH), to negotiate/award a purchase order to the University of Texas M.D. Anderson Cancer Center, 1155 Pressler Blvd., Houston, Texas, 77030-4409 for testing services related to the project entitled: “Genetics of Type 2 Diabetes in Diverse Population”. The Center for Research on Genomics and Global Health (CRGGH) is working in collaboration with the laboratory of Melissa Bondy, Ph.D. at University of Texas MD Anderson Cancer Center, in Houston, Texas to enroll and examine 400 Mexican Americans (200 cases with type 2 diabetes—T2D—and 200 controls) as a phase I of identifying genetic variants associated with T2D. The success of this major genomic project requires extensive familiarity with the Mexican American communities that will form the basis for the enrollment and examination of all study participants. Dr. Bondy has successfully managed a long-term prospective cohort (Mano a Mano) in the Houston area, which has enrolled and examined more than 17,000 primary respondents and has enumerated over 40,000 household members. The ongoing collaboration between the CRGGH and Dr. Bondy is a nested study within the Mano a Mano cohort in which the CRGGH has already begun analyzing preliminary summary data provided by Dr. Bondy on the Mexican American participants. In order to expand the study to include genetic analyses, we are requesting the services of Dr. Bondy and her laboratory to collect DNA samples from 400 enrolled Mano a Mano participants. Dr. Bondy’s laboratory will require minimum training in sample processing, labeling, storage and shipment as well as field training. In this regard, Dr. Bondy’s laboratory is uniquely qualified to conduct this research project in a timely and cost efficient manner given the existing logistical infrastructure and experienced personnel. In order to continue with this established collaboration, it is essential to enlist the assistance and services of Dr. Bondy and her laboratory. The overall goal of the CRGGH project on the genetics of type 2 diabetes (T2D) among Mexican Americans is to accumulate a sufficient number of cases and controls (n = 4000 persons) to conduct genome-wide searches for susceptibility genes for T2D, including genome-wide association studies (GWAS). The current proposal will contribute 400 persons (200 unrelated T2D and 200 ethnicity-matched controls) to the larger, proposed case-control study. Objectives for the contracted project are: 1.Enroll and examine 200 unrelated cases of T2D and 200 ethnicity matched controls from the Houston area (Harris County and surrounding counties) in Texas. 2.Conduct clinical examination and complete study questionnaires to obtain demographic and clinical data including age, gender, personal and family health history, blood pressure and anthropometrics. 3.Obtain and process blood samples on each participant. Separate collected biological samples into required aliquots including plasma, serum and DNA. 4.Ship collected samples to the CRGGH located at the NHGRI/NIH Building 12, Room 4047 12 South Drive, MSC 5635, Bethesda, MD 20892-5635. The project is expected to be completed in 12 months starting from the date of initial funding. Period of Performance: September 15, 2010 – September 14, 2011. II. CONTRACTOR REQUIREMENTS A.Contractor must have a Protection of Human Subjects Assurance Identification Certification B. Enroll 200 cases and 200 controls using the following eligibility and exclusion criteria: Cases – Persons already diagnosed with T2D and on oral or insulin medication for diabetes. Cases may also include persons with fasting plasma glucose (FPG) reading ≥ 126 mg/dl on more than one occasion. All cases must be above the age of 25 years. Controls – will include persons who did not self identify as having diabetes and are confirmed by FPG reading ≤ 100 mg/dl (≤ 5.6 mmol/l). Controls must be at least 40 years old and should be ethnically and gender matched to the cases. Note: controls may not reside in the same household as that of a related individual that has diabetes regardless if that individual was selected as a case or not (if the latter, the affected individual is still eligible to be recruited as a case). However, controls may reside in the same household as that of an unrelated diabetic individual. C. Specimen Collection and Processing Flowchart: D. Storage and Shipment Policy Properly labeled vials should be stored sequentially in the provided cryogenic freeze-storage boxes by type of specimen (i.e., plasma, DNA, and urine samples should be stored in separate boxes). The corresponding barcode for each specimen type should be placed into the space provided in the storage forms. These entries should be double-checked for errors by entering the barcodes and sample locations into the provided Access Microsoft database. An electronic copy of the completed inventory forms should accompany all shipment to the United States. Sample types per vacutainer are to be evenly distributed into the appropriate vial sizes listed as follows: Vacutainer colorStorage/processing (vial size)Sample typeVial sizeDelivery Grey (5 ml)plasma2 mlBARC plasma2 mlNIH buffy coat2 mlMD Anderson Red (7ml)serum2 mlBARC serum2 mlNIH serum2 mlMD Anderson blood clot15 mlNIH* Lavendar (7 ml)plasma2 mlBARC plasma2 mlNIH plasma2 mlMD Anderson buffy coat2 mlNIH N/Aurine2 mlNIH urine2 mlMD Anderson (optional) *aliquot of extracted DNA could be shared with MD Anderson if requested. Frozen urine, plasma, serum, clot and buffy coat should be shipped frozen in dry ice packed in the large styrofoam shipping containers provided to each site. The containers should be completely covered (filled to the top) with dry ice before sealing the box. The samples are going to under initial processing at MD Anderson where they will batched and shipped according to agreed upon schedule. For samples not retained at MD Anderson as outlined above, shipments are to be made with established express courier services such as FedEx and DHL with samples shipped to CRGGH for storage and analysis: Charles N. Rotimi, Ph.D. Center for Research on Genomics and Global Health National Human Genome Research Institute National Institutes of Health 12 South Drive Bldg. 12A, Room 4047 Bethesda, MD 20892 or to: Bio Analytical Research Corporation (BARC) for biochemistry analysis. III. GOVERNMENT RESPONSIBILITIES A. Conduct an eight-hour training workshop for home visitations with study participants in Houston, TX before the initial start of the project. B. The CRGGH will provide to vendor the following items: 1.Develop and implement quality control procedures for the project, and 2.Provide timely feedback on materials received from vendor. C. Conduct one to two site visits during the 12 months of the project to monitor project progress and to provide additional training to study staff as needed. D. Inspection and acceptance All collected data items will be checked by the CRGGH data manger for errors and outliers. All detected inconsistencies will be sent back to the vendor for checking and correction or replacement. Collected biological specimens must be kept frozen at -80°C at the site and during shipment to the Bethesda, MD. Samples are to be in dry ice and shipped by express couriers. Samples with inconsistencies occurring due to vendor laboratory processing error (e.g., gender) will be replaced by the vendor. E. CRGGH will cover expenses for shipping of samples from MD Anderson to BARC and the following field equipment: 4 glucometers, 2 blood pressure monitors, 2 Seca scales, and Seca stadiometers. IV. REPORTING REQUIREMENTS AND DELIVERABLES A. Deliverables will include: 1.De-identified preliminary descriptive statistics on self-identified cases and controls. 2.Electronic copies of signed page of completed informed consent forms on all enrolled participants, 3.Electronic database of information from completed questionnaires on all enrolled participants, 4.Electronic databases containing information from other study instruments on all enrolled paricipants, and 5.Shipments of processed biological samples from participants delivered to the NIH, MD Anderson, or BARC as outlined in the Storage and Shipment Policy (Section II.C) every month at 30 samples per batch (cases and controls). Batching can be reassessed to accommodate sample collection rates. This acquisition is being conducted under FAR Part 13, Simplified Acquisition Procedures, and is exempt from the requirements of FAR Part 6, Competition Requirements. The North American Industry Classification (NAICS) Code is 611310 and the Size Standard is $7.0 Million. This notice of intent is not a request for competitive proposals. The determination by the Government not to compete the proposed purchase order based upon responses to this notice is solely within the discretion of the Government. Comments to this announcement, referencing synopsis number NHLBI-PB-HG-2010-271-RSF may be submitted by mail to the National Heart, Lung and Blood Institute, Office of Acquisitions, Procurement Branch, 6701 Rockledge Drive, Suite 6151, Bethesda, MD 20892-7902, Attention: Rashida Ferebee, by fax transmission to (301) 480-3345 or by email to ferebeers@nhlbi.nih.gov This action is under the authority of 41.U.S.C.253(c)(1), as set forth in FAR 13.106(b)(2), and HHSAR 306-302-1. Interested parties responding to this announcement need to do so by 9:00am Eastern Standard Time on August 6, 2010.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-PB-HG-2010-271/listing.html)
 

Place of Performance

Address: The University of Texas M.D. Anderson Cancer Center, 1155 Pressler Blvd., Houston, Texas, 77030, United States

Zip Code: 77030
 

Record

SN02227531-W 20100805/100804000003-84159c2a3a5a5e7f2d0c0f434f01394b (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

---

| FSG Index  |  This Issue's Index  |  Today's FBO Daily Index Page |