36C77019Q0475-003.pdf
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- Multiple Pharmaceuticals Federal contract opportunity
- Solicitation number
- 36C77019Q0475
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36C77019Q0475 P03-PM-PART806.3_ATCH2_far6_JA_OVer_Sat_ Tr Signed-Redacted.pdf
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| File | Type | Posted |
|---|---|---|
| 36C77019Q0475-002.xlsx | XLSX spreadsheet | |
| 36C77019Q0475-001.docx | DOCX document | |
| 36C77019Q0475-000.docx | DOCX document |
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VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >SAT
DEPARTMENT OF VETERANS AFFAIRS
Justification and Approval (J&A)
For
Other Than Full and Open Competition (>SAT)
Acquisition Plan Action ID: __ 36C770-19-AP-0692 _______________ _
1. Contracting Activity: Chelmsford VA CMOP
IFCAP 2237# 761-19-3-015-1427
2. Nature and/or Description of the Action Being Processed:
BRAND NAME SPECIFIC MEDICATION AS REQUESTED BY THE VA MEDICAL CENTERS THE Chelmsford
VA CMOP SERVES. AS REQUESTED ON 2237# 761-19-3-015-1427
3. Description of Supplies/Services Required to Meet the Agency's Needs:
Line 1 - (R0191) RECLIPSEN TAB,28
• NOC 00093-3304-16
• Quantity of request: 36
• Supplier: TEVA PHARM
• Reclipsen™ (desoge'strel and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
• Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception.
The efficacy of these contraceptive methods, except sterilization, the IUD, and the
Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates.
• In a clinical trial with Reclipsen (desogestrel and ethinyl estradiol tablets USP), 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly .
4. FAR13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the
Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-l(b}{2).
OFOC SOP Revision 08
Original Date: 03/22/11 Revision 08 Date: 04/18/2018
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