NOT-HD-04-004: NATIONAL CHILDREN'S STUDY REPOSITORY

Department of Health
and Human Services (HHS)

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NATIONAL CHILDREN'S STUDY REPOSITORY RELEASE DATE: January 16, 2004 NOTICE: NOT-HD-04-004 SOURCES SOUGHT: SS-NICHD-2004-03 National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) The National Institute of Child Health and Human Development (NICHD)/NIH, seeks capability statements from interested and qualified potential sources to support a repository for the National Children's Study. The support services being sought are related to the establishment and operation of a large repository to receive, store, and aliquot biological, medical, and environmental samples that will be collected throughout the study (as described below). It is anticipated that the repository will distribute samples to investigators at the direction of the Government. It is also desirable to include storage of data from sample analyses and completed data collection forms in an integrated repository system. NICHD is seeking information on the capabilities and limitations of organizations interested in providing one or more of the services described below. Given the broad scope of materials being considered for this repository, NICHD may consider both single company/single site and integrated multi-company/multi-site offerors. BACKGROUND The Children's Health Act of 2000 authorized the NICHD and a consortium of other Federal Agencies to "...plan, develop, and implement a prospective cohort study, from birth to adulthood, to ...incorporate behavioral, emotional, educational, and contextual consequences to enable a complete assessment of the physical, chemical, biological, and psychosocial environmental influences of children's well-being. That study is now known as the National Children's Study (NCS). Investigators in the Department of Health and Human Services (DHHS), including NICHD, the National Institute of Environmental Health Sciences (NIEHS), the Centers for Disease Control and Prevention (CDC), and the U.S. Environmental Protection Agency (EPA), as well as at other Federal agencies, have begun to plan and implement this study. The NCS will study the complex relationship between health and the environment for approximately 100,000 U.S. children and their families. Enrollment of subjects will begin before birth (and possibly before conception) and follow-up will continue at least until each child is 21 years of age. Study planners have identified the following child health areas as priorities for the NCS: pregnancy outcomes, neurodevelopment and behavior, injury, asthma, obesity, and physical development. As a result of the many study hypotheses being considered for the NCS, as well as the anticipation that other hypotheses will emerge during the course of the Study and afterward, a very significant number of diverse specimens (two billion to 20 billion) will be collected over the life of the project. Specimens will include a wide variety of biological and environmental samples. Biological specimens may include, but are not limited to, blood, urine, hair, nails, saliva, stool, semen, buccal cells, breast milk, amniotic fluid, colostrom, placentas, cord blood, meconium, nasal swipes, teeth, autopsy tissues and slides. Environmental samples may include, but are not limited to, duplicate diets, dryer lint, household dust (vacuum and wipes), mattress dust, water, allergens, pesticides, handwipes, soil, air samples, mold/mildew, toys, carpets, and floor mats. Because Study planning is still underway, plans for a repository for the study are still evolving. Concepts that are being discussed include shipping all samples from a sampling technician to a central receiving repository where they will be processed and aliquotted, and then sending aliquots to the primary analytic and clinical laboratories. Alternatively, most or all samples may be shipped first to the primary analytic and clinical laboratories where they will be aliquotted, with remaining material sent to the main repository. Discussions also relate to having regional sub-repositories for dynamic handling and storage, with a central repository for long-term storage. In all cases, having a second repository to handle some fraction of material for disaster mitigation is being discussed. Given the long-term nature of the study, the repository will need to have the capability for testing to ensure the long-term integrity and viability of the stored samples. It must also have the capability for testing outside investigator-suggested analytic procedures for compatibility with the storage conditions of the NCS samples, to ensure that the valuable stored samples are not wasted. Included in this concept is developing or verifying thawing procedures, etc., as necessary, removing the samples from the repository, and getting them to outside investigators in an appropriate condition/form. EXPECTATIONS OF A FUTURE CONTRACTOR A service contract is anticipated to be used for the National Children’s Study Sample Repository, which shall be located in a dedicated facility or facilities owned or operated by the contractor for the specific purpose of this contract. The successful contractor shall possess the following qualifications, or meet the following requirements at the time of proposal submission: (1) Have extensive experience managing large biological and/or environmental sample repositories. (2) Have the capability to rapidly develop the capacity to process and store a large number of samples. [The estimated maximum number of samples is two billion-20 billion over the 20plus years life of the study, with the heaviest sample load being during the early years of the study.] (3) Have experience in archiving environmental samples (such as soil samples, filters, bags, molds, sediments, ampulated extracts) and special samples (such as carpet sections, floor mats, toys, food). (4) Have experience in archiving biological samples (such as blood, urine, hair, nails, teeth, buccal cells, breast milk, meconium, cord blood, umbilical cords, autopsy samples, tissues such as placentas). (5) Have experience in archiving documents and/or other materials, such as questionnaires, paper records, electronic images/pictures, 3D ultrasounds, X-rays. (6) Have the ability to aliquot and do general laboratory analyses on the various types of samples. (7) Have the capability to handle unfrozen, frozen, and liquid nitrogen frozen samples (e.g. -20 degrees C, -70 degrees C, -80 degrees C). (8) Have the capability to handle raw samples and extracted samples. (9) Possess, or show evidence of, the ability to develop a computerized sample tracking system. (10) Have the capability to handle emergency situations, such as problems with control of room temperature and humidity, control and backup of freezer conditions, hardware and software failures of computer systems. (11) Have the ability to provide the appropriate climate controlled space for the repository needs over the life of the Study. This is to include sample receiving and shipping facilities, sample storage facilities, laboratory facilities, and office and computer space. The total required space is not needed initially; however, the facility must be expandable to the total estimated capacity. (12) Have personnel with the demonstrated ability to manage a large, long-term project like the NCS repository. This includes personnel with expertise in the handling, storage, and analysis of the sample types as indicated in items 4 and 5, above. Expertise in computerized data management is also required. RESPONSE PROCESS This announcement is not a Request for Proposals (RFP). The purpose of this synopsis is to determine the availability of interested organizations that have the capability of providing some or all of the services stated herein. The NICHD is also interested in determining whether adequate competition exists among small businesses to warrant restricting this acquisition to small businesses alone. This requirement is assigned a code of 541710 in the North American Industry Classification System (NAICS), and the small business size standard for such requirements is 500 employees. Interested organizations, both large and small companies (please declare the size of your business), should submit a brief letter of interest and must respond to a brief questionnaire, presented below under INFORMATION REQUIRED. You may complete and submit the questionnaire to nichdcmb@mail.nih.gov or you may mail it to the address listed below. A copy of the questionnaire is available by fax by calling (301) 435-6947. Your capability statement, composed of a brief cover letter and response to the questions, must be submitted within 30 days of the date of this publication to the following address: Ms. Virginia A. DeSeau, at the address listed below under INQUIRIES. The Sources Sought Announcement is also available through the FedBizOpps website at http://www.fedbizopps.gov. The NICHD does not intend to produce hard copies. The reference number to be used for this announcement is: SS-NICHD-2004-03. All correspondence must cite the reference number as provided. All responses must be submitted on or before January 31, 2004. INFORMATION REQUIRED (1) Provide a breakdown of experience with the following services. Please give names of projects, size of repository, description of services provided in sufficient detail to demonstrate satisfactory achievement of stated capabilities, indicating/designating previous experience versus current projects: A. Managing large repositories for biological and/or environmental samples. B. Ability to rapidly develop the capacity to process and store a large number of samples. C. Experience in archiving biological samples. D. Experience in archiving environmental samples. E. Experience in archiving paper records, images, etc. F. Ability to aliquot and do laboratory analyses on various types of samples (biological and environmental). G. Capability to handle unfrozen, frozen, and liquid nitrogen frozen samples (e.g. -20 degrees C, -70 degrees C, -80 degrees C). H. Capability to handle raw samples and extracted samples. I. Capability of operating and maintaining a computerized sample tracking system to produce a chain of custody for all samples. J. Capability to handle emergency situations resulting from monitoring of room temperature and humidity, freezer conditions, hardware and software failures of computer systems. K. Provide appropriate climate controlled space for repository needs over the life of the study, including sample receiving and shipping facilities, storage facilities, laboratory facilities, and office and computer space. L. Personnel with the demonstrated ability to manage a large long-term project like the repository, including expertise in computerized sample and data management. M. Personnel with demonstrated ability to accurately and safely receive, inventory, store, retrieve and aliquot samples, and to conduct offered laboratory services. N. Maintain appropriate quality assurance and quality control procedures. (2)Does the institution have the capability and space available? If so, please provide a brief description of the facility or facilities; if not, please address how this would be handled. (3) Can the institution provide services in the following areas: A. Project Management: a. Long-term services (approximately 25 years); b. wide range of support, including secretarial, clerical, housekeeping, technical, telecommunications, computer support, security, and equipment maintenance; c. space for administrative activities as well as storage space. B. Establishment of the site: a. Facilities and equipment to receive, store, and ship various biological and environmental samples; b. storage under various conditions (liquid nitrogen, -80 degrees C, specific room temperatures); c. emergency backup of power, storage facilities, computer tracking. C. Quality Assurance and Quality Control: a. Development of Quality Manual, evidence of compliance with ISO and other standards organizations; b. regular performance evaluation reviews; c. yearly and random facility inspections; d. specific QA/QC program for archived samples. D. Receiving and Preparing Aliquots: a. Adequate trained personnel to receive and track samples, handle hazardous materials, aliquot samples; b. adequate capabilities for lyophilizing, cell separation, etc. E. Permanent Storage: a. Maintain and update a computerized tracking inventory control database producing a chain of custody for all specimens that would stand up in litigation; b. backup of inventory control system. F. Shipping Samples: a. Ship under appropriate conditions, in appropriate containers, to the requesting destination; b. Maintain records on all shipments; c. verify arrival of all samples at destination. INQUIRIES Virginia A. DeSeau Contracting Officer National Institute of Child Health and Human Development 6100 Executive Boulevard, Suite 7A07, MSC 7510 Bethesda MD 20892-7510 Rockville, MD 20852 (for express/courier service) Telephone: 301-435-6947 Fax: 301-402-3676 E-mail: vd9t@nih.gov OR Charles W. Grewe Deputy Chief Contracting Officer National Institute of Child Health and Human Development 6100 Executive Boulevard, Suite 7A07, MSC 7510 Bethesda MD 20892-7510 Rockville, MD 20852 (for express/courier service) Telephone: 301-435-6957 Fax: 301-402-3676 E-mail: cg59b@nih.gov

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