A randomized single blind safety and efficacy study of TOL-463 vaginal GEL or insert in the treatment of vaginitis (BV and/or VVC)

Ended Awarded Last action

Contract number
HHSN27200008
Awardee
Awarding agency
Obligated
$998,596

Award facts

Contract value 48% obligated
  • $998,595.82 Current, with exercised options
  • $2,076,810.82 Potential, with all options
Completion date 100% complete
Current and potential, with all options
Set-aside
No set-aside
Competition
Full and Open Competition · 2 offers Multiple Award, Fair Opportunity
Pricing
Cost No Fee
Place of performance
Birmingham, AL 35294, USA

Award details come from SAM.gov/FPDS.

Transactions

Action Obligated Date
Close Out 5 -$330,258
Exercise an Option 4 $141,754
Supplemental Agreement for work within scope 3 $62,563
Other Administrative Action 2 $0
Exercise an Option 1 $936,461
Original award $188,076

About this award

This is a federal contract award from the National Institute of Allergy and Infectious Diseases (NIAID), a civilian agency within the U.S. Department of Health and Human Services, to the University of Alabama at Birmingham (UAB) for a randomized, single-blind safety and efficacy study of a vaginal gel or insert called TOL-463 in the treatment of vaginitis. The contract has a ceiling value of $2,076,810.82 and a completion date of November 30, 2017. There is no set-aside designation for this award.

As part of this contract, UAB has awarded subcontracts to Family Health International (FHI 360) to serve as the Operations Coordinating Center and develop the phase 2 clinical trial protocol, as well as to the University of Washington to conduct participant enrollment and oversee clinical research activities. This study aims to evaluate the efficacy of the TOL-463 product in treating bacterial vaginosis and/or vulvovaginal candidiasis. The project involves collaboration between the NIAID, the contract awardees, and other scientific and technical personnel.

Quick answers

Who was awarded contract HHSN27200008?

HHSN27200008 was awarded to University Of Alabama At Birmingham by National Institute of Allergy and Infectious Diseases (National Institutes of Health) on September 8, 2015.

How much is contract HHSN27200008 worth?

The government has obligated $998,596 on HHSN27200008. Its potential value, with all options, is $2,076,811.

Is contract HHSN27200008 an order under another contract?

Yes. HHSN27200008 is a delivery order under HHSN272201300012I, an indefinite delivery contract.

Was contract HHSN27200008 competed?

The extent of competition for HHSN27200008 was full and open competition. The government received 2 offers.

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