SOLICITATION NOTICE
B -- Human biospecimens
- Notice Date
- 9/4/2007
- Notice Type
- Solicitation Notice
- NAICS
- 541720
— Research and Development in the Social Sciences and Humanities
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Office of Administration, 6011 Executive Blvd, Rm 538, Rockville, MD, 20892-7663, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- 263-2007-Q-GZ-0197
- Response Due
- 9/18/2007
- Archive Date
- 10/3/2007
- Description
- The National Institutes of Health (NIH) along with the Office of Rare Diseases plans to procure on a sole source basis with the RAND CORP to facilitate research leading to treatments and cures for rare diseases, by improving researchers? access to needed human biospecimens through an expanded and updated Human Biospecimen Database. The interactive database when seen as viable by the Office of Rare Diseases (ORD) will be accessible to the researchers and the public through a Web browser, will be searchable on line, and will contain detailed information about biorepositories in the United States and worldwide that collect, store, and distribute biospecimens for research use. 1. Expanding and updating the Human Biospecimen Database for biorepositories in the United States and worldwide that collect, store, and distribute human biospecimens for research use. For rare diseases research it is essential to be able to access international repositories in addition to US repositories because human tissues and clinical data may need to be obtained from several sources, including some that are in countries outside the USA. 2. This approach will facilitate researchers? access to biospecimens for use in research by providing and maintaining a comprehensive system that enables access to information about biorepositories and their collections in the United States and worldwide in one location. 3. Identifying unmet needs of researchers in obtaining biospecimens for research on rare diseases. 4. Identifying specific constraints and other barriers relating to the access to biospecimens for research. 5. Providing information to rare diseases researchers, the wider research community and other interested parties including patient advocacy groups and the pharmaceutical industry about the types and locations of human biorepositories and the biospecimens and clinical data available from them. Diseases Research Working Group, established by the National Institutes of Health (NIH) Office of Rare Diseases (ORD), recognized the need for developing a system for accessing information on human biospecimen collections, storage, and distribution for rare diseases research, as well as research in general. The full development of such a comprehensive, searchable, Web-based database along with regular updates will allow researchers to realize the promise of genomics and proteomics by giving them information about and access to appropriately collected, consented, and annotated biospecimens. The database, called the Human Biospecimen Database, will be accessible via a Web browser, searchable online, and populated with information about biospecimens at biorepositories in the United States and worldwide. This Human Biospecimen Database is the first of its kind and will be extremely useful to rare diseases researchers when it includes appropriate USA and international resources. The new database will contain up-to-date information for biomedical researchers, other research funding entities, professional societies, patient advocacy groups, research administrators, and the biotechnology and pharmaceutical industries. All parties will be able to use the database to identify and obtain resources for basic and translational research as well as drug development in rare diseases, genetics, rare and common diseases studies, immunology, physiology, cell biology, etc. Task 1: Expanding the information contained in the Human Biospecimen Database with information from biorepositories in the United States and worldwide ? The RAND CORP staff will update and expand information about biorepositories in the United States and in other countries around the globe by inviting the biorepository leadership to update or provide new information about their repositories and collections. ? All biorepositories will be invited to provide information about their repositories for inclusion in the database as determined in the earlier design and development. ? Repositories will be invited to provide information using the data entry Web site built previously. The Web site already contains a standardized template for data entry. The repositories will be directed to the Web site, and will be given a unique identifier and PIN number to give them access to their organization?s information and allow them to complete the data entry in multiple sessions, if desired. The repositories will also be given the option to provide information using alternative formats. Technical assistance from the contractor will be offered to repositories sponsored by rare diseases patient advocacy groups or others who may not be able to enter the information without such assistance. Task 2: Hosting, maintaining, and updating the database The RAND CORP will maintain the database and Web-based interface, which is currently located on contractor?s internal server. To maintain the full utility of the Web site and to keep the information current, it will be important to update the database. Repositories will be invited to update the information on an as-needed basis. All repositories will be invited annually to update their information. The contractor will track and add newly established repositories and delete repositories that no longer exist. Task 3: Collecting information about unmet needs of the research community in obtaining human biospecimens for research purposes: To better understand unmet needs of the research community in obtaining human biospecimens for research on rare diseases, the contractor will monitor the Web interface to allow users of the Web site to provide feedback on their successes or failures in obtaining the human biospecimens needed for their research. Feedback from users of the Web site who are unable to locate biospecimens will be obtained through the following: A voluntary feedback box that is a pop-up window that appears after unsuccessful searches for biospecimens. Information collected through the voluntary feedback box and pop-up window on unfulfilled requests will be analyzed and used to generate periodic reports to ORD. This information will also be made available in its aggregate and after analysis to the biorepositories that are part of the database. ORD and the contractor will initiate a broad invitation to provide information through publishing a request in the NIH Guide for Grants and Contracts and sending individual letters containing information from the NIH Guide as needed. Task 4: Developing educational modules for inclusion in the Human Biospecimen Database Web site: Additional modules will be added to the Human Biospecimen Database Web site by the contractor. These additional modules will be developed by the contractor in collaboration with ORD senior staff and will include educational components to guide researchers and repositories. In addition to analyzing data from the Web site, information will be supplemented with information obtained by consulting with ORD, patient advocacy groups, and other experts. Educational modules will address issues in ? Sample collection, processing, storage, and distribution. ? Privacy and informed consent. ? Means that repositories can use to assess their success in fulfilling requests and ways to identify and solve problems that arise. ? Methods that researchers can use to optimize their ability to obtain human biospecimens for rare diseases research and orphan drug development. ANTICIPATED TIMELINE This project will be conducted over a two-year period beginning at the time of the award of the contract. REQUIRED Staff: Project Director and Principal Investigator, Research Programmer, and Research Assistant. Other project staff may be added as needed within the overall fiscal constraints of the contract once awarded. DELIVERABLES: The following deliverables to ORD are part of this contract: 1. A projected project plan with time lines and milestones within two weeks after award of the contract. 2. A database and archived Web site (on a disk or other appropriate medium) as well as detailed technical documentation to be delivered to ORD at the completion of the contract. The database and Web site will be located on contractor?s external Web site, and will be maintained and updated by contractor according to the terms of the contract. 3. Periodic reports on the level of utilization of the Web site and a summary of the unmet needs of the research community in obtaining human biospecimens for research purposes as determined by ORD. 4. Educational modules for biorepositories and the research community developed by the contractor for inclusion on the Web site including issues in sample collection, processing, storage, and distribution; privacy and informed consent; means that repositories can use to assess their success in fulfilling requests and ways to identify and solve problems that arise; and methods that researchers can use to optimize their ability to obtain human biospecimens for rare diseases research and orphan drug development. 5. Briefings for ORD to demonstrate the database and its capabilities and content and additional analysis as requested (at least quarterly) at the ORD location or via teleconferencing. 6. A peer-reviewed report describing the database and Web site, the methods used to develop and collect the information for the database, Web site documentation, and other components available on the Web site (e.g., the project description, User?s Guide, frequently asked questions) and analyses and findings that have resulted from information from the Web site and database. NIH believes that the above reference firm is the only source that can provide this requirement. However, if any other interested party believes that they can meet the requirements they may submit a statement of capabilities. The capability statement and any other information furnished must be in writing, and must contain detailed documentation to allow the government to perform a proper evaluation. Respondents will not be notified of evaluation results. The closing date will be 10 calendar days after publication. All vendors/prospective contractors must be registered with the Central Contractor?s Registration (www.ccr.gov) prior to award date. If not registered or active by that date, vendor proposals will be considered non responsive.
- Place of Performance
- Address: 9000 Rockville, Md
- Zip Code: 20892
- Country: UNITED STATES
- Zip Code: 20892
- Record
- SN01393802-W 20070906/070904220300 (fbodaily.com)
- Source
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