Maryland Bids > Bid Detail

Comparative Use Human Factors Studies to Assess the Impact of Differences Between the User Interface of a Generic Drug-Device Combination Product and its Reference Listed Drug

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Agency: HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Level of Government: Federal
Category:
  • B - Special Studies and Analyses - Not R&D
Opps ID: NBD00159476132998505
Posted Date: May 19, 2023
Due Date: May 23, 2023
Solicitation No: 75F40123R00058
Source: https://sam.gov/opp/99348bac62...
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Comparative Use Human Factors Studies to Assess the Impact of Differences Between the User Interface of a Generic Drug-Device Combination Product and its Reference Listed Drug
Active
Contract Opportunity
Notice ID
75F40123R00058
Related Notice
Department/Ind. Agency
HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier
FOOD AND DRUG ADMINISTRATION
Office
FDA OFFICE OF ACQ GRANT SVCS
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General Information View Changes
  • Contract Opportunity Type: Combined Synopsis/Solicitation (Updated)
  • All Dates/Times are: (UTC-04:00) EASTERN STANDARD TIME, NEW YORK, USA
  • Updated Published Date: May 18, 2023 03:25 pm EDT
  • Original Published Date: May 02, 2023 05:05 pm EDT
  • Updated Date Offers Due: May 23, 2023 03:00 pm EDT
  • Original Date Offers Due: May 23, 2023 03:00 pm EDT
  • Inactive Policy: 15 days after date offers due
  • Updated Inactive Date: Jun 07, 2023
  • Original Inactive Date: Jun 07, 2023
  • Initiative:
    • None
Classification
  • Original Set Aside:
  • Product Service Code: B599 - SPECIAL STUDIES/ANALYSIS- OTHER
  • NAICS Code:
    • 541720 - Research and Development in the Social Sciences and Humanities
  • Place of Performance:
    Silver Spring , MD 20903
    USA
Description View Changes

The primary objective of this project is to conduct multiple CUHF studies of complex drug-device combination products in relevant populations (e.g., patients and/or caregivers and/or health care providers) to assess the impact of “other” design differences between the user interfaces of an RLD and existing or potential generics referencing the RLD.



See Attachment for Detailed RFP.



See attachment for Contractor's questions and Government responses.


Attachments/Links
Attachments
Document File Size Access Updated Date
Response to questions.pdf (opens in new window)
75 KB
Public
May 18, 2023
Attachment No. 2 - USMCA Class Deviation 2020-05.pdf (opens in new window)
647 KB
Public
May 02, 2023
Attachment No. 3 Class Deviation 2020-02- Accelerated Payments Small Business.pdf (opens in new window)
454 KB
Public
May 02, 2023
Attachment No. 4 - Class Deviation 2018-01- Whistblower Protection.pdf (opens in new window)
270 KB
Public
May 02, 2023
Attachment No. 5 - Past Performance Questionnaire (Revised).doc (opens in new window)
62 KB
Public
May 02, 2023
Attachment No. 6 IDIQ SOW.docx (opens in new window)
58 KB
Public
May 02, 2023
Attachment No. 1 - Questions Template (Revised #2).docx (opens in new window)
26 KB
Public
May 02, 2023
Attachment No. 7.docx (opens in new window)
19 KB
Public
May 02, 2023
Sol_Doc_docx.pdf (opens in new window)
824 KB
Public
May 02, 2023
file uploads

Contact Information View Changes
Contracting Office Address
  • 4041 Powder Mill Road 4th Floor
  • Beltsville , MD 20705
  • USA
Primary Point of Contact
Secondary Point of Contact


History

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