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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