SBSSN_NESARC-III_DNA_Storage_75N94022R00004_1.pdf

Small Business Sources Sought Notice No. 75N94022R00004 - NESARC-III DNA Storage

SMALL BUSINESS SOURCES SOUGHT NOTICE (SBSSN)

National Epidemiologic Survey on Alcohol and Related Conditions-III (NESARC-III)

DNA Storage

SBSSN No. 75N94022R00004

This notice is issued by the NICHD Office of Acquisitions on behalf of the National Institute on Alcohol Abuse and Alcoholism (NIAAA).

This is a Small Business Sources Sought Notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. There is no solicitation available at this time.

The purpose of this notice is to obtain information regarding: (1) the availability and capability of all 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 according to the North American Industry Classification System, (NAICS) code for the proposed acquisition.

Responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible or if it is necessary to proceed through full and open competition.

NIAAA is seeking capability statements from small business organizations under

NAICS code 541714 (Research and Development in Biotechnology, except nanobiotechnology), and size standard of 1000 employees, an organization that is not considered a small business under the applicable NAICS code identified should not submit a response to this notice.

Per FAR 19.001, a small business concern means any business entity organized for profit (even if its ownership is in the hands of a nonprofit entity) with a place of business in the United States or its outlying areas and that makes a significant contribution to the U.S.

economy through payment of taxes and/or use of American products, material and/or labor, etc. Please note that to qualify as an eligible small business concern for purposes of a small business set-aside (where large businesses, universities and non-profits would be excluded from competing for part of or the entire requirement), at least 50% of the direct labor amount must be “in-house”. Specifically, FAR 52.219-14, “Limitations on Subcontracting” states that, “(1) Services (except construction), it will not pay more than 50 percent of the amount paid by the Government for contract performance to subcontractors that are not similarly situated entities. Any work that a similarly situated entity further subcontracts will count towards the prime contractor's 50 percent subcontract amount that cannot be exceeded. When a contract includes both services and supplies, the 50 percent limitation shall apply only to the service portion of the contract.” To be eligible for a small business set-aside, the small business will need to demonstrate its ability to perform the project requirements “in-house” or coordinate/subcontract with other small business sources [only] to meet the above stated “small business” requirement.

Background: The National Institute on Alcohol Abuse and Alcoholism (NIAAA) supports clinical and biomedical research on alcohol use, abuse and dependence and their associated physical and psychiatric disabilities. The Epidemiology and Biometry Branch supports epidemiological and genetic epidemiological research on alcohol use and alcohol use disorders. NIAAA is seeking capability statements from small business organizations under NAICS code 541714 (Research and Development in Biotechnology, except nanobiotechnology); small business size standard of 1000 employees, with experience in storage of DNA and for the potential transfer of aforementioned DNA from its current repository. This would include safe DNA preparation, shipping and manifest creation for aliquots of DNA (associated with DNA samples) in a highly efficient and cost-effective manner.

The planned acquisition is a follow-on requirement to Contract HHSN275201800001C, awarded to Rutgers, The State University of New Jersey, with a period of performance of

12/01/2017 through 11/30/2022. A fixed-price type contract for continued NESARC-III DNA storage is anticipated for a base period plus four 12-month option periods, beginning on or about December 1, 2022.

Project Requirements: The Capability Statements must demonstrate the organization’s ability to:

A. STORE DNA

1. Develop a plan to pull, prepare, ship and receive all 38,786 aliquots of DNA

(associated with 24,233 DNA samples) in a highly efficient and cost-effective manner to selected contractor that adheres to all federal, state and local regulations. Understanding of the importance of maintaining the integrity of biospecimens is imperative.

2. Provide technical and administrative infrastructure to ensure efficient implementation and management of all storage activities carried out under this contract.

3. Perform and maintain storage systems for NESARC-III DNA in accordance with all applicable Federal, State and local regulations, especially those Federal provisions associated with the NESARC-III.

B. PROVIDE HEALTH AND SAFETY OF PERSONNEL

1. Comply with all procedures prescribed by the HHSAR 352.223.70 for the control and safety of persons performing the storage requirements.

C. PROVIDE BIOSAMPLE SECURITY

1. All storage activities from the current storage facility must be safely and efficiently assumed and implemented, consistent with Federal regulations governing NESARC-III DNA data as follows:

2. DNA must be stored in a secured facility that strictly limits access to current storage facility employees and designated emergency personnel.

3. Each authorized individual must have a coded key card for entry into the locked facility and storage areas. Computer records must be generated and archived for all key card entries.

4. Closed circuit TV cameras must be positioned at all access points and critical areas to monitor interior and perimeter of the facility (video archived records).

5. Facility must conform to the strictest standards outlined in both the latest

International Society for Biological and Environmental Repositories (ISBER) best practices (v3 released in 2012) and National Cancer Institute (NCI) guidelines (v2 released in 2011; formerly Office of Biorepositories and Biological Research

(OBBR) for all facilities, documentation, storage best practices.

6. Must hold College of American Pathologists (CAP) Biorepository Program certification.

7. DNA storage equipment must be connected to telephone-based alarm systems to monitor fire, smoke, ambient O2 levels and door entry activity and visually monitored and inspected daily (24/7).

8. Mechanical freezer storage building must have fully redundant, duplicate HVAC systems on emergency power.

9. Mechanical freezers must be inspected daily and results recorded daily.

10. Mechanical freezer temperatures must be recorded in real time and assure that temperatures are recorded through a computer-based system. Assure that designated employee are notified in the event of an out-of-compliance event.

11. Mechanical freezers must be all -80°C rated with internal alarms and must be designated exclusively to house only NESARC-III data.

12. A full-time Director must be maintained to coordinate and ensure safety of

NESARC-III biospecimens and coordinate safety specifications.

13. Spare empty freezers for storage of NESARC-III data must be maintained for use in the event of mechanical failure.

14. Emergency backup systems must be maintained for use in event of power failure using multiple independent emergency power backup systems. This includes co-generation power plant located within the storage space and multiple gas or diesel fuel powered generators. Must test generators and switch gears weekly.

Information Requested: Capability Statements submitted as a result of this announcement will be evaluated on the organization’s technical capability and qualifications, Organization’s qualifications and experience should be demonstrated, specifically providing evidence as to their capability to perform the requirement, with particular attention to the following:

Personnel/Management: Adequacy, appropriateness and relevance of expertise, experience, qualifications, and availability of the key professional and technical staff with a project of similar size, scope and complexity.

Facilities: Availability and description of facilities and equipment required.

Past Performance: Past performance is considered essential. In addition to demonstrating the qualifications have been met, interested parties must identify and provide information to include detail on at least three contracts of similar size and complexity. Names, titles, contract number, price or cost, the telephone numbers of Project and Contracting Officers, and any other information serving to document the organization’s capability to perform the requirement should be included.

Other: Any other specific and relevant information that would improve the Government’s consideration and evaluation of the information presented is desirable.

Information Submission Instructions: Interested organizations that believe they posses the capabilities necessary to undertake this project must address all the technical information request and should submit an electronic version only of their capability statement in response to this notice. Responses should include the organization’s name, address, point of contact, contact phone number, and email address, Small Business status, NAICS code along with Unique Entity ID (UEI) number, size and type of business

(e.g., 8(a), HUBZone, etc.). Generic marketing brochures or generally worded capability statements that do not address the specific project requirements are unlikely to receive a favorable evaluation.

Please limit responses to five (5) pages using font size 10 or larger or less, exclusive of resumes. Capability Statements will assist the Government in selecting the appropriate acquisition mechanism. Additionally, the response should provide answers to the following questions:

1. Is your organization a small business under NAICS code 541714?

2. Does your firm qualify as a small disadvantaged small business?

3. If disadvantaged, is your firm certified under section 8(a) of the Small

Business Act?

4. Are you a certified HUB Zone firm?

5. Are you a woman-owned or operated business?

6. Are you a certified Service-Disabled Veteran Owned or Veteran

Owned business?

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 pre-solicitation synopsis and solicitation may be published in Sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

This notice is for information and planning purposes only and does not commit the

Government to any contractual agreement. This is not a Request for Proposals (RFP). The

Government DOES NOT intend to award a contract based on responses under this announcement. Interested parties shall not be reimbursed for costs associated with preparation of their responses.

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).

Interested organizations presenting a Capability Statement in response to this Small

Business Sources Sought Synopsis must identify their size status.

All capability statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via email) to the Point of Contact below in MS Word or

Adobe Portable Document Format (PDF). The subject line of your email submittal must specify this Small Business Sources Sought Notice No. 75N94022R00004. Facsimile responses will not be accepted. Electronically submitted capability statements are due no later than 5:00 PM (Eastern Time) on Tuesday, June 7, 2022. Late responses will not be accepted. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME

WILL NOT BE CONSIDERED. This notice is strictly market research, and the Government will not entertain any questions. No collect calls will be accepted. Respondents will not be notified of the results of the evaluation.

Point of Contact: Patricia N. Hanacek, Contracting Officer, Phone: 301-594-6226;

Email: hanacekp@mail.nih.gov.

mailto:hanacekp@mail.nih.gov