75F40124R00126_0001_6-21-2024.pdf
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- Attached to
- Investigating the Impact of Non-tobacco Nicotine Enantiomeric Ratio on ENDS Abuse Liability
- Solicitation number
- 75F40124R00126
About this file
This document is an amendment to Solicitation Number 75F40124R00126 titled "Investigating the Impact of Non-tobacco Nicotine Enantiomeric Ratio on ENDS Abuse Liability". The primary purpose of this amendment is to extend the due date for proposal submissions to July 25, 2024, no later than 10:00 AM ET. The solicitation seeks to conduct a randomized, double-blinded, within-subjects, crossover clinical laboratory study to determine whether abuse liability, as measured by nicotine exposure, subjective measures, and product use behavior, differs between e-liquids formulated with tobacco-derived nicotine (TDN) and non-tobacco nicotine (NTN) with varying enantiomeric ratios of S-: R-nicotine (99:1, 75:25, 50:50). The Contractor shall perform chemical characterization of the e-liquids, collect serial blood samples during prescribed and ad libitum use conditions, and assess pharmacodynamics, subjective effects, and use topography measures. All results and source documents shall be submitted to the Contracting Officer's Representative and Study Project Lead(s).
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Other files
| File | Type | Posted |
|---|---|---|
| August 7_QA.pdf | ||
| 75F40124R00126.docx | DOCX document |
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(x)
75F40124R00126 x x copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE
RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR
OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.
x
Silver Spring MD 20903
DAP
WO2/3rd Floor 10903 New Hampshire Ave.
ATTN:
DHHS/FDA/OAGS/DAP
Silver Spring MD 20903
DAP
WO2/3rd Floor 10903 New Hampshire Ave.
ATTN: Pamela Lee
DHHS/FDA/OAGS/DAP
06/21/2024
13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.
12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning
Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing
The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
FACILITY CODE CODE
10B. DATED (SEE ITEM 13)
10A. MODIFICATION OF CONTRACT/ORDER NO.
9B. DATED (SEE ITEM 11)
9A. AMENDMENT OF SOLICITATION NO.
CODE
8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)
7. ADMINISTERED BY (If other than Item 6)CODE 6. ISSUED BY
PAGE OF PAGES
4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)
1. CONTRACT ID CODE
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
06/20/2024
CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
D. OTHER (Specify type of modification and authority) appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).
E. IMPORTANT: Contractor is not is required to sign this document and return __________________ copies to the issuing office.
ORDER NO. IN ITEM 10A.
15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED
(Signature of person authorized to sign) (Signature of Contracting Officer)
MADELINE R. BRYANT
STANDARD FORM 30 (REV. 11/2016)
Prescribed by GSA FAR (48 CFR) 53.243
Previous edition unusable
14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
Title: Investigating the Impact of Non-tobacco Nicotine Enantiomeric Ratio on ENDS Abuse Liability
The purpose of this amendment is to change the due date of proposals to July 25, 2024, no later than 10:00 AM ET. Reference Page 39, Section 8.3 entitled "Proposal Submission."
15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)
Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .
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