Post Date/ Solicitation Issue Date
Closing Response Date
Proposed Award Date
Project Title
Protocol [18-M-0144] Estrogen receptor beta and mood
Contracting Office
National Institute on Drug Abuse (NIDA)
Contact Points
THIS IS A NOTICE OF INTENT, NOT A SOLICITATION FOR COMPETITIVE PROPOSALS. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED.
The purpose of the requirement is to evaluate the efficacy and safety of a selective estrogen receptor (ER) beta agonist (Lilly Compound LY500307) to prevent estradiol withdrawal-induced mood symptoms and to examine whether the duration of exposure to gonadal steroids (estradiol and progesterone) rather than their withdrawal is the critical determinant of symptom precipitation in postpartum depression. We are using estradiol and progesterone replacement to mimic the hormonal events of pregnancy and the postpartum. Participants are randomly assigned to either hormone withdrawal or continued replacement group to test the specificity of estradiol/progesterone withdrawal under blinded conditions.
Contractor will perform quality assurance (including stability testing) to maintain the active status and extend the expiration dates of medications employed in this study. Contractor will perform stability testing to provide evidence on how the quality and quantity of estradiol, progesterone and placebo tablets varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the drug The NIMH Section on Behavioral Endocrinology will provide the estradiol, progesterone and placebo.
The contractor will be responsible for performing stability testing on estradiol, progesterone and placebo tablets and will adhere to the following:
• maintain a continuous quality control program to ensure accuracy and effectiveness
• provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light;
• will establish a re-test period for the drug substance or a shelf life for the drug
The period of performance will be one year from the award of the contract.
THIS SYNOPSIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability to respond to this notice.
A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.
Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.www.sam.gov.”
All responses must be received by Monday, August 29, 2022 at 5:00 p.m., Eastern Standard Time, and reference number NIMH-22-006002. Responses may be submitted electronically to Tiffany Stone, Contract Specialist, at Tiffany.Stone@nih.gov and Christine Frate, Contracting Officer, at Christine.Frate@nih.gov.
Fax responses will not be accepted.
Extensions to the deadline will not be granted.
Please contact Tiffany Stone, Contract Specialist, at Tiffany.Stone@nih.gov or (301 480-7158 and/or Christine Frate, Contracting Offer, at Christine.Frate@nih.gov or (301) 443-3846 with any questions.
The purpose of the requirement is to evaluate the efficacy and safety of a selective estrogen receptor (ER) beta agonist (Lilly Compound LY500307) to prevent estradiol withdrawal-induced mood symptoms and to examine whether the duration of exposure to gonadal steroids (estradiol and progesterone) rather than their withdrawal is the critical determinant of symptom precipitation in postpartum depression. We are using estradiol and progesterone replacement to mimic the hormonal events of pregnancy and the postpartum. Participants are randomly assigned to either hormone withdrawal or continued replacement group to test the specificity of estradiol/progesterone withdrawal under blinded conditions.
Contractor will perform quality assurance (including stability testing) to maintain the active status and extend the expiration dates of medications employed in this study. Contractor will perform stability testing to provide evidence on how the quality and quantity of estradiol, progesterone and placebo tablets varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the drug The NIMH Section on Behavioral Endocrinology will provide the estradiol, progesterone and placebo.
The contractor will be responsible for performing stability testing on estradiol, progesterone and placebo tablets and will adhere to the following:
• maintain a continuous quality control program to ensure accuracy and effectiveness
• provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light;
• will establish a re-test period for the drug substance or a shelf life for the drug
The period of performance will be one year from the award of the contract.
THIS SYNOPSIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability to respond to this notice.
A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.
Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.www.sam.gov.”
All responses must be received by Monday, August 29, 2022 at 5:00 p.m., Eastern Standard Time, and reference number NIMH-22-006002. Responses may be submitted electronically to Tiffany Stone, Contract Specialist, at Tiffany.Stone@nih.gov and Christine Frate, Contracting Officer, at Christine.Frate@nih.gov.
Fax responses will not be accepted.
Extensions to the deadline will not be granted.
Please contact Tiffany Stone, Contract Specialist, at Tiffany.Stone@nih.gov or (301 480-7158 and/or Christine Frate, Contracting Offer, at Christine.Frate@nih.gov or (301) 443-3846 with any questions.
Estimated Period of Performance
One year from award of the contract
Single-Sole Source Determination
Element Pharmaceuticals has performed this same level of stability testing on the medications employed in this study (i.e., estradiol, progesterone and placebos) for the past 5 years since the commencement of the NIH Pharmacy’s out-sourcing of product manufacturing and quality assurance testing. It is critical that the results of future stability tests can be compared to previous testing within the same laboratory and testing protocols. One of the key elements of stability testing is the presence of a high correlation between past and current drug levels contained within each tablet and the stability of the contents of each tablet. Thus a change in laboratory and/or test procedures could confound these measures and disrupt our ability to administer these drugs (and require additional costs to perform comparisons across laboratories). Element Pharmaceuticals has the capacity to perform stability testing of pharmaceuticals.
Interested parties may identify in writing their interest and capability in response to this requirement. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.
All responses must be received by closing date and must reference the announcement. Responses may be submitted electronically to the attention of the contract specialist. Fax responses will not be accepted.
All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.