SOURCES SOUGHT
Q -- HANDLS Longitudinal Homocysteine Assays
- Notice Date
- 7/1/2022 5:31:01 AM
- Notice Type
- Sources Sought
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N95022Q00357
- Response Due
- 7/15/2022 7:00:00 AM
- Point of Contact
- Renee Dougherty, Karen Mahon
- E-Mail Address
-
Renee.Dougherty@nih.gov, Karen.Mahon@nih.gov
(Renee.Dougherty@nih.gov, Karen.Mahon@nih.gov)
- Description
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition.� It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract.� Responses will not be considered as proposals or quotes.� No award will be made as a result of this notice.� The Government will NOT be responsible for any costs incurred by the respondents to this notice.� This notice is strictly for research and information purposes only. Background:� The Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) study examines changes in health associated with disparities due to race and socioeconomic status. Presently in the 7th wave of data collection, HANDLS established a longitudinal biomaterials bank of frozen blood serum and plasma for which participants have consented to further biological study in every wave in which they were examined. HANDLS has accumulated sufficient frozen samples to adequately address questions surrounding issues in health disparities associated with total homocysteine levels. These questions include, but are not limited to, examining changes over time in homocysteine levels by age, sex, race, poverty status, and their interactions; examining whether the relationships among B12, folate, and homocysteine levels are consistent regardless of age, sex, race, and poverty status; examining whether the risk for cardiovascular diseases such as hypertension, myocardial infarction, and stenotic blood vessels are associated with homocysteine regardless of age, sex, race, and poverty status; and examining the association of homocysteine with existing measures of neurological and brain health. The objective of this requirement is to acquire the services of an established laboratory with a CLIA-approved method for assaying homocysteine in frozen blood samples. To avoid introducing biases in these assay levels, it is crucial to assay all the samples from all the waves using the same methodology and the same time. This avoids contaminating the data with ""batch"" effects in which there are statistical differences due to the assay method but not due to actual changes over time or due to differences to participants' demographic backgrounds. Purpose and Objectives: Homocysteine is an intermediate metabolite produced by several physiological biochemical pathways. Homocysteine is a known toxic metabolite, particularly in the cardiovascular and nervous systems. Elevated levels of total homocysteine have been implicated as a significant risk for cardiovascular disease. There is also accumulating evidence that elevated total homocysteine is associated with accelerated age-associated cognitive decline and perhaps as a risk for Alzheimer�s disease. There is also evidence that elevated total homocysteine is associated with neuropathies in older adults. It is known that men have generally greater homocysteine levels than women. It is also known that homocysteine increases with age in older adults.� However, it is not known whether there are differences in homocysteine levels by age, sex, race, poverty status, and their interactions. Health disparities in cardiovascular disease and cognitive decline may be associated with differences in homocysteine levels over time. Inadequate homocysteine metabolism is usually due to insufficient consumption of folate and B12. Fortunately, most causes of hyperhomocysteinemia are treatable by administering folate and B12 vitamin supplementation. However, it is unclear whether treatment is sufficiently adequate for everyone regardless of age, sex, race, or socioeconomic status. Project requirements: Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the�Statement of Work below: A CLIA-approved clinical laboratory shall perform homocysteine assays on frozen blood provided by the Government. The Contractor must have experience performing homocysteine assays on frozen blood samples, and demonstrate consistency and accuracy in their assay by methods such as reference samples and repeated assays on the same samples. Based on statistical considerations, the Government has determined that 2,500 samples are required to perform the purposes of this solicitation. This number of samples is based on considerations of statistical power for the envisioned longitudinal analyses. GOVERNMENT RESPONSIBILITIES The Government will supply frozen blood samples in sufficient quantity and in a manner mutually acceptable to the Contractor that is consistent with Federal requirements for shipment of biomaterials. DELIVERY OR DELIVERABLES The Contractor shall provide homocysteine values for all samples provided by the Government in an electronic file. In addition, the Contractor shall supply technical details demonstrating reliability and accuracy of the homocysteine assays performed including information on quality controls as well as information on methods to use in future publications. Following electronic data delivery and upon request by the Government, the Contractor shall participate in Government laboratory meetings to provide technical consultations as needed regarding the delivered data. The Contractor shall also return any remaining sample material to the Government that is consistent with Federal requirements for shipment of biomaterials. Anticipated period of performance: September 1, 2022 � August 31, 2023 Capability statement /information sought. Small business concerns that believe they possess the capabilities to provide the required services should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately.� Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents� technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. Interested companies are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2� x 11� paper size, with 1� top, bottom, left and right margins, and with single or double spacing. The information submitted must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein.� A cover page and an executive summary may be included but is not required. The response is limited to ten (10) page limit.� The 10-page limit does not include the cover page, executive summary, or references, if requested. All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer.� Facsimile responses are NOT accepted. The response must be submitted to Renee Dougherty, Contracting Officer, at e-mail address Renee.Dougherty@nih.gov and Karen Mahon, Contracting Officer, at e-mail address Karen.Mahon@nih.gov. The response must be received on or before July 15, 2022, 10:00 am Eastern Time. �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 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 presolicitation synopsis and solicitation may be published in www.sam.gov. 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).�
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/03b5301b751f48eba3e5d564192e1616/view)
- Place of Performance
- Address: Baltimore, MD, USA
- Country: USA
- Country: USA
- Record
- SN06377163-F 20220703/220701230100 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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