DESCRIPTION:

The National Institute of Environmental Health Sciences (NIEHS), in support of the Division of the National Toxicology Program (DNTP), is conducting market research seeking information from industry to assist in requirements planning for the tasks and services outlined herein.

The purpose of this Request for Information (RFI) is to identify qualified contractors and gather information about interested parties who may meet the NIEHS DNTP requirements.

• This RFI should not be construed as a solicitation or as an obligation on the part of the Federal Government, the National Institutes of Health (NIH), and the National Institute of Environmental Health Sciences (NIEHS).
• This RFI is intended and issued solely for information and planning purposes within the NIEHS DNTP to facilitate the decision-making process. It DOES NOT constitute a Request for Proposals (RFP), Request for Quotations (RFQ), Invitation for Bid, or an announcement of a future solicitation at this time, nor does it restrict the Government as to the ultimate acquisition approach. Any contract that might be awarded based on information received or derived from this market research will be the outcome of a competitive process. Unsolicited proposals and/or quotations will not be accepted.
• The Government does not intend to award a contract on the basis of this RFI or to otherwise pay for the information solicited.
• If a solicitation is released, it may be synopsized on the Federal Business Opportunities (FedBizOpps) website or GSA eBuy electronic system. It is the sole responsibility of potential offerors to monitor these sites for additional information pertaining to this or future requirements.
• Response to this RFI is strictly voluntary and will not affect any firms' ability to submit an offer if a solicitation is released.
• Not responding to this RFI does not preclude participation in any future RFQ/RFP issued.
• Respondents are advised that the Government will not pay for any information or administrative costs incurred in response to this RFI. All costs associated with responding to this RFI will be solely at the expense of any interested party.

PURPOSE:

This is a Request for Information only. The notice is specifically intended to provide source material to formulate a procurement strategy for obtaining support to examine a variable number of test articles (e.g., chemicals, natural products, botanical dietary supplements, complex mixtures) annually for induction of genetic changes (changes in animal or human cells in the form of e.g., mutations, chromosomal changes, DNA damage, gene expression changes). Your responses to this RFI may guide the NIEHS in awarding a future contract for the support described at an undetermined time. There is no solicitation available at this time; no basis for claims against NIEHS shall arise as a result of this RFI, responses thereto, or the use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. The NIEHS invites all interested parties that have the resources, capabilities, and expertise to submit a written response to this RFI.

NAICS CODE AND SIZE STANDARD:

In the event that a Request for Proposal (RFP) is issued, North American Industry Classification System (NAICS) code 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) is being considered.

BACKGROUND:

The National Institute of Environmental Health Sciences (NIEHS), located in the Research Triangle Park, North Carolina, is one of the 27 Institutes and Centers composing the National Institutes of Health. The NIEHS is a multidisciplinary research institution with the primary mission of conducting research to discover how the environment influences the development and progression human disease in order to promote healthier lives. NIEHS focuses on basic science, disease-oriented research, global environmental health, clinical research, and multidisciplinary training for researchers.

The National Toxicology Program (NTP) was established within the Department of Health and Human Services and charged with coordinating toxicological testing programs within the Public Health Service of the Department. The NTP, as part of the National Institute of Environmental Health Sciences (NIEHS), is responsible for evaluating the toxic and carcinogenic potential of environmental agents that may pose a health hazard to citizens of the United States.

DESIRED CAPABILITIES/PROJECT NEEDS:

The NTP requires support to examine a variable number of test articles (e.g., chemicals, natural products, botanical dietary supplements, complex mixtures) annually for induction of genetic changes (changes in animal or human cells in the form of e.g., mutations, chromosomal changes, DNA damage, gene expression changes). For this requirement, the contractor must have the capability to: a) Test approximately 20 chemicals per year for induction of gene mutations in bacterial tester strains (Ames test); b) Measure chromosomal changes and DNA damage in tissue samples obtained from laboratory animals and shipped to the contractor from a remote NTP testing laboratory; approximately 400 such samples may be evaluated annually; c) Test approximately 20 chemicals per year for induction of chromosomal changes and DNA damage in human and mammalian cell cultures; and d) Measure molecular biomarkers of genetic change including but not limited to gene expression changes and DNA sequence changes. To fulfill these requirements, the contractor shall have the capability to conduct the following assays:

Assay 1: in vivo micronucleus assay - assess the frequencies of micronucleated red blood cells in blood (or occasionally bone marrow) samples obtained from animals, typically mice and rats, or humans (peripheral blood only).

Assay 2: in vivo comet assay - quantitate DNA damage (e.g., strand breaks, oxidative damage, alkali labile sites, crosslinks) using the single cell get electrophoresis (comet assay) method in tissues selected by the NTP in laboratory animals (typically mice and rats) or occasionally humans (blood samples only)

Assay 3 - Pig-a gene mutation assay - measure the frequency of X-linked Pig-a (phosphatidylinositol glycan, Class A) gene mutations in peripheral blood erythrocytes and reticulocytes obtained from animals, typically mice and rats, or occasionally from humans.

Assay 4 - in vitro comet assay - measure chemical-induced DNA damage in cultured cells using the single cell gel electrophoresis (comet) assay.

Assay 5 - in vitro micronucleus assay - assess the frequency of micronuclei in cells in cultured cells.

Assay 6 - bacterial mutagenicity assay - measure gene mutation frequencies in tester strains of Salmonella typhimurium and Escherichia coli following chemical exposures.

Assay 7 - MultiFlow DNA Damage assay - utilize the MultiFlow assay to characterize genotoxicity mode of action for compounds that have been shown to induce micronuclei in mammalian cell cultures.

Assay 8 - utilize RNA-Seq methods to characterize gene expression changes in tissues/cells treated in response to chemical exposures.

The Contractor should have experience conducting high throughput (96-well) in vitro mammalian cell assays for DNA damage and chromosome damage to enhance efficiency and statistical power. Data from in vivo and in vitro micronucleus assays will routinely be collected using flow cytometry methods.

The test articles shall be provided by the NTP. For animal studies conducted at the Contractor's laboratory, mice will be provided by the NTP and a designated vendor will be identified for the purchase of rats. In addition to the assays described above, the Contractor shall engage in research and development activities, as directed, for assay development and refinement as technology improvements and innovations occur during the course of this contract. The Contractor must have the ability to conduct the assays listed above as well as any required research and development efforts on site. The contractor must also have the ability to conduct multiple assays at the same time, as the number and type of assays may vary from year to year and within a year. Interested vendors should be proficient in each assay described above.

In the event that a Request for Proposal is issued, a cost reimbursement type contract with a twelve (12) month base period and nine (9), twelve (12) month option periods is being considered. The total estimated level of effort is anticipated to be between 12,500 and 15,000 labor hours per year depending on the needs of the NTP.

RFI RESPONSE INSTRUCTIONS:

All interested parties are requested to submit a Capability Statement containing the following information:

• Your firm's capability to perform the project requirements.
• Brief description of past experience regarding prior completed projects of a similar nature.
• Information on new technology, components, or scientific innovation that might provide additional benefit.
• Provide a list of potential problems/risks that may be encountered during the project, including ideas or suggestions about how such problems/risks should be addressed in a solicitation.
• Identify any portion(s) of a future procurement using these services for which fixed price contracting could be utilized and provide rationale.
• Provide any other feedback on contract type. You may suggest contract pricing strategies for the tasks referenced in the description above. For example, if a task could be priced on a fixed unit rate basis, please indicate that in your response.
• Indicate your firm's small business size for the suggested NAICS code. If a different NAICS code is more appropriate, please provide the code and the supporting rationale.
• Your company information shall include the following:
a) DUNS number
b) Company Name
c) Company Address (including point of contact, phone number and email address)
d) Business Type/Size of company, Classification code, NAICS code

Capability Statements shall be limited to 15 pages in total (pages shall be standard size 8.5 x 11 inches).

Capability Statements shall be submitted via e-mail only to Julie Bardo, Contracting Officer at [email protected].

Proprietary information, if any, shall be minimized and MUST BE CLEARLY MARKED.

• To aid the Government, please segregate proprietary information.
• Please be advised that all submissions become Government property and will not be returned.
• NIEHS will not meet or hold discussions with potential interested parties.

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