SOURCES SOUGHT
B -- Establishing a Biorepository of Amyotrophic Lateral Sclerosis (ALS) Specimens to Complement the National ALS Registry
- Notice Date
- 3/24/2015
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- HHS-CDC-ATSDR-SS-15-001-BV
- Archive Date
- 4/10/2015
- Point of Contact
- Betty B Vannoy, Phone: 770-488-2891, Vallerie M Redd, Phone: 770-488-2845
- E-Mail Address
-
bbv9@cdc.gov, gfj3@cdc.gov
(bbv9@cdc.gov, gfj3@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. Background: The ALS Registry Act (H.R. 2295) was passed on October 16, 2008. The ALS Registry Act amends the Public Health Service Act to require the Secretary of DHHS, acting through the Director of CDC/ATSDR, to (1) develop a system to collect data on amyotrophic lateral sclerosis (ALS); and (2) establish a national registry for the collection and storage of ALS data. In October, 2010, ATSDR officially launched the National ALS Registry. The purpose of the ALS Registry is to better describe the incidence and prevalence of ALS in the United States; examine factors, such as environmental and occupational, that might be associated with the disease; better outline key demographic factors (such as age, race or ethnicity, gender, and family history of individuals who are diagnosed with the disease) associated with the disease; and facilitate examination of the connection between ALS and other motor neuron disorders that can be confused with ALS, misdiagnosed as ALS, and in some cases progress to ALS. In July 2014, ATSDR released its first National ALS Registry report. During October 19, 2010-December 31, 2011, a total of 12,187 persons meeting the surveillance case definition of ALS were identified by the Registry, for a prevalence of 3.9 cases of ALS per 100,000 persons in the U.S. general population. In addition to tracking new ALS cases, ATSDR is now engaging in a series of activities to further enhance the National ALS Registry. Examples already underway include launching new survey modules to help identify potential risk factors for ALS and using comprehensive surveillance activities in select states and large metropolitan areas to help test the completeness of the Registry. Because little is known about the role genetics plays in ALS, ATSDR conducted a pilot study to determine the feasibility of establishing a biorepository of samples from persons with ALS. Samples from approximately 330 patients have been collected, including blood, urine, hair, and nails samples, as well as post-mortem specimens from up to 30 patients, such as whole brains, spinal cords, and cerebrospinal fluid. The findings of that pilot study indeed support the creation of a biorepository. Purpose and Objectives: The purpose of this contract is to establish an ongoing biorepository of specimens from persons with ALS enrolled in the National ALS Registry. ATSDR is particularly interested in samples such as blood, urine, saliva, hair, and nails, in addition to post-mortem specimens, such as bone, muscle, skin, whole brains, spinal cords, and cerebrospinal fluid. Collected samples (already collected via the pilot effort and future collections) may be used for the purposes such as genetic analysis, creating cell lines, or other analyses requested by CDC/ATSDR. While there are other biorepositories currently in existence that contain specimens from persons with ALS, these biorepositories are often limited and target select groups (e.g., military veterans with ALS). Additionally, these biorepositories do not necessarily collect epidemiological/risk factor data from the patients who contribute specimens (e.g., occupational, residential, and military history). Submission of specimens for this biorepository would be open to all persons with ALS enrolled in the congressionally mandated National ALS Registry. The ability to connect the biological material to information about risk factors and data about medical treatment will make the biorepository unique and especially valuable to ALS researchers. This contract will provide funding for the creation, operation, maintenance, cataloging, and ongoing analysis of sample supply and demand of a biorepository of specimens from persons with ALS enrolled in the National ALS Registry. Project Requirements. The Contractor would be responsible for the following: 1. The Contractor will establish an OMB/IRB approved biorepository linked to persons with ALS who are enrolled in the National ALS Registry, according to the specifications below: General Requirements - Biorepository Biospecimen collection: a. Biospecimens will be collected from 300-500 ALS Registry enrollees per year. Previously collected samples from the pilot study will undergo RNA extraction (up to 1200 samples) and DNA extraction (up to 175 samples). This DNA and RNA analysis will also apply for future collections. b. For each biospecimen collected, the collection will include up to 70 ml blood and up to 40-50ml urine, nail clippings, hair clippings. Blood tubes will be considered for: 1 tube EDTA for DNA, 1 tube plasma, 1 tube serum, 1 tube for RNA, and 1 tube for the creation of cell lines. Saliva will be collected only if blood draw is unsuccessful and if PALS requests it in lieu of blood sample. c. Plasma and serum will be processed and stored in an appropriate facility in a way that will enable future analysis of DNA, RNA, chemicals, and metals. d. Biospecimens will be stored for a period of time determined by the COR. e. Biospecimens will be transferred to a facility designated by COR at the end of the contract period. 2. The Contractor shall use the existing specimens already collected through the pilot program as the foundation for this Biorepository. This will entail working with the pilot Contractor to coordinate, gain access to, and transfer the existing retrospective samples to an appropriate facility. Biorepository Post-Mortem Specimen collection: a. Post-mortem biospecimens will be collected from 12-30 ALS Registry enrollees per year. Previously collected samples from the pilot study will undergo RNA extraction and DNA extraction. This DNA and RNA analysis will also apply for future collections. b. Post-mortem biospecimens collected will include whole brain and spinal cords, cerebrospinal fluid (CSF), bone, muscle, and skin. c. Brain and spinal cord tissue will be processed and stored in an appropriate facility according to the sample protocol and procedures of the VA ALS Registry Brain Banking Program (http://www.research.va.gov/programs/tissue_banking/als/). d. Brain and spinal cord tissues will be subject to a standard post-mortem pathology analysis and CSF will be collected in a standardized way if specified by CDC. e. Post-mortem tissue samples will be stored for a period of time determined by the COR. f. Post-mortem tissue samples will be transferred to a facility designated by COR at the end of the contract period. 3. In addition to biospecimens that will be collected prospectively, the Contractor shall receive, store, and maintain the samples collected from the pilot study mentioned above as well as all new samples collected. In addition, the Contractor, with input from the government, shall determine adequate storage supply/demand of specimens. This may include obtaining new consent forms from existing participants and facilitating the necessary and appropriate IRB approvals. 4. The Contractor shall develop a system for matching biospecimen IDs to those of National ALS Registry participants so that specimens and epidemiological data are linked. 5. The Contractor shall guarantee the security of Personal Identifiable Information (PII) during the custody chain. The Contractor will transfer all PII to the Government prior to the end of the contract. 6. The Contractor shall work closely with the Veterans Administration (VA) to determine how Registry enrollees with military experience can become part of the VA's Brain Banking program. PALS with no military experience will be handled by the National ALS Registry's biorepository. 7. The Contractor shall identify an appropriate facility (ies) for storage of the repository specimens. The facility (ies) shall be Good Laboratory Practices (GLP) compliant and certified. COR acceptance of the facility (ies) is required. 8. The Contractor shall provide the COR with quality assessment/quality control analysis procedures for all sample collections. 9. The Contractor shall determine specimen demand for sample requests as well as plan to market and promote the repository. 10. The contractor shall determine a cost-recovery mechanism for the storage and dissemination of samples. 11. Should scientific publications be developed based on this work, the contractor shall comply with ATSDR and CDC requirements for pre-submission review, possible co-authorship, and clearance of scientific documents. Anticipated period of performance. One 12-month base period and four 12-month option periods. Other important considerations. Deliverables in this requirement have mandated timeframes which, as a consequence are non-negotiable. It is imperative that high quality products are delivered within these strict timeframes. The Government intends to negotiate one cost reimbursement award. The NAICS code for this notice is 541712, Size standards in number of employees: 500 Capability statement /information sought. Respondents to this sources sought synopsis shall submit the following information: i. Introductory cover page identifying the respondent's organizational name, address and point of contact information including names, titles, phone numbers and email addresses. ii. Respondents' may submit comments or opinions about the difficulty and/or feasibility of the potential requirement or proposed acquisition, possible solutions and approaches that may currently exist in the marketplace, and information regarding innovative ideas or concepts; iii. Submit information regarding respondents': (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information; iv. Identify respondents' DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUB Zone, etc.) pursuant to the applicable NAICS code; v. Explain your experience relative to accomplishing each of the following topics; provide specific examples describing such experience if available: • Manage, collect, store, and disseminated biospecimens samples. • Prepare, deliver, and familiar with and have knowledge of all necessary internal/external clearances documents (e.g., clinical exemption, amendments, IT security certification and accreditation process (C&A), IRB, OMB). • Description of general and specific facilities and equipment available, including the lab services which should be Good Laboratory Practices (GLP) compliant and certified. 2. Information submission instructions. a. Submission method: submit responses via email to: bbv9@cdc.gov Note: FAX submission not authorized; b. File format: MS Word.doc or.PDF file format; c. Page format: pitch: 12-pt.; font style: Times New Roman; line spacing: single; paragraphs: double space; margins: one-inch; page size: 8.5 x 11; d. Page limit: 15 page limit includes cover page, table of contents and all attachments or appendices as well as any charts, graphs, diagrams, references, pictures etc.; e. Organization of Information: Respondents should organize their response in accordance with the paragraph structure identified in Capability statement /information sought paragraph above; f. Response due date and time: responses must be submitted not later than 2:00pm ET, April 9, 2015. g. Respondent's point of contact information: Identify respondents' technical and administrative points of contact, including names, titles, addresses, telephone and e-mail addresses; h. Note: respondents should be careful to respond to each subparagraph contained above and in particular the three (3) topics included in subparagraph 1(v). The government is not interested in receiving standard marketing brochures or white papers that do not specifically respond to the requested information. 3. Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications and capabilities to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). Primary Point of Contact. Betty Vannoy Secondary Point of Contact: Vallerie M Redd Contracting Office Address: 2920 Brandywine Road, Room 3000 Atlanta, Georgia 30341-4146
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/HHS-CDC-ATSDR-SS-15-001-BV/listing.html)
- Place of Performance
- Address: TBD, United States
- Record
- SN03676829-W 20150326/150324234629-f3e86b87bb23617627dd6637bc7ce78e (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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