SSJ FE redacted.pdf

..,& U,5. DTPARTMINI OF HEATTH AND TIUMAN SERI/ICT!; PrSlio tleatth Service centgls fot Disease control ard Ptevefltion {CDC)

Ald{l|a GA 3S333

JUST|F|CATTON FOR SOLE SOURCE PROCUREI{ENT (OPEN MARKET OR GSA)

UNDER 3250,0q, Sole sourc€ acquisitions may be used on a limited basis and only when th€ Contracting OfficeCs

Representative (CoR/Program Offcial has provided suficient iusffication and the ConhactirE Officer has determined that lhe circumstances wanant such action. The contenl for a iustification must contain deiailed facts and rationale to iustify the sole source acquisition. Soliciting trom a single source must b€ done in accordance with FAR 13.10G1(b) or 8.405-6. At a minimum, lhe following information must be induded:

ldentification of PrcoEm Office. Cont?ctino Activity. and Prooo6€d Reouirement. Justificalion and Proaftrm

Offce Certifcation:

A. Prooram Ofnce:

Division of Viral Dbeases, National Center for lmmunization and Respiratory Diseases Roybal

Bldg 24152.13/MS H24-5 Centers for Diseas€ Control and Preventlon Atanta, GA 30329

B. contractinoAclivitv:

Centers for Dbease Control and Preyention Offic€ of Financial Resources Acquisfion grandr ffiffi

C. ldentificatlon of Reouirement:

'I . Nature of Action to be Approved by Contracting Officer:

a. Sole sour@ acquisitjon of: A surveitlance pilot Program to conduct rcglonal case finding tor pati€nts with acute fiaccid myelitts (AFll) in a morc tirEly manner than O|€ current existing survcllance system to promote 6pid collection of laboratory sp€cinEns and dala.

b. Prodrrement Requesl (PR) Number (if ava{able), iffi

2. Proposed Vendor and Estimated Proqurement Amount (if available):

a. Proposed Vendofi Universlty of Texas Southwestam

b. EstimatedProcurementAmount:I

3. ls the requirement on GSA Schedule? E Yes xl No.

lf yes, pmvide schedule number ffi

D. Justification:

D. Jusffication:

1 . The.iustification for this non-competitive action is: (NOTE: ilust sd€€ia ot U ONE of the tiste.! lusttfrcations tor other than full and open competition and fuW suPPott ahe jus$ncafion in the tottowing pangraphs. Please detete this note Pdor to suhmilting the Justification.)

$ In accordance with FAR 13.10e1(b)(1), "only on€ source [isl reasonably available" which states that, "For purchases not exceeding the simplified acqubitbn threshold. (i)

Contrac-ting officers may solicit from one source if the contracting oficer determines that the cir@mstances of the contract action deem only one source reasonably available (e.g., urgency, exdusive lic€nsing agreernentrs, brand-name or iMustrhl mobilization). (ii)

Where a single source is identilied b provi{re a portion of a purcftas€ because that portion of the purchase speciies a particular b(and-name item, the documentation in paragraph (bX1)(i) of lhis seclion only applies to the portion ot the purchase r€quiring brand-nime item. The documentation should state it is ooverir€ only the portion of the acouisition which is brand- name."

n urgency

E Exdusive licensing agr€sments/Proprietary data fl Brand name required fl lndustrid mobilizatron ' I Otner 1e.g., compatibitity, space issues, continuity, compatibility, etc.)

! ln accordance with FAR 8.405-6 "Limiting Sources" which states that' "the only circumstances that may justify the action are - (A) An urgent and comPelling need exists, and folbwirg lhe procedures would result in unacceptable delays; (B) Only on€ source is capable of providing the supdies or s€IvfrF3 required al the levd of qudity required because lhe supptbs or services are unique or highly specialized; or (C) In th€ inler€st of economy ard €ffcbncy, the new work ie a logical follow'up b an original Federal SuPdy

Wredule order provided that the origind otder was dac€d in accordanc€ with the applicable Federal Supply Schedule ordering procedures. The original BPA must not hive been previously issued under solesource or limited-sources pro@durcs."

tl Urgency

E onry one source

E Logicat Fdlow Up

! Brand name reouired

Other facts supporting sole source procurement:

a. What can this producUservic€ do that other produds/servic€s cannot do?

Tt|e University of Texas Southurestem {uT Southwesteml has altnost 10 years of experbnce in speclm€n blobanking ard enrollirg remote patients lnto longitudinal gtudhs fot the purpces of collecting intormation on rate diseass where patients may have to be enrolled across a wide geographical area' They have been funded for a remote study of Neuromyelit'E optica for over 7 years, which has utilized a nurs€ who t.avels actocs the US entolling patients, collecting samples and collecting data for longitudlnal reseatch ot this rare conditlon' Thls type of data collection for rare lllnesses is unlque to UT Southwestern and they have sp€flt 10 years testing and perfecting procedurec specitic to rare conditlons, Thls institutlon has mote experience than arry otfier academic Genter in the U.S. wlth respect to thls unique situation of rare and $rldely scattered patient enrollment.

Rev. Y14l19

b. What other produots/servioes were considered and why did they no1 meet the need?

Alternativ6 to UT southwestern ai an offeror include othel acad€mic centers with an intereni; AFM, hou'4et none have th€ experlence that UTsouttwestern has in thB data collection model to ex$apolate it to a novel illness like AFM'

3. Program Office efiorts to seek potential ofrerors:

Market res€arch was .;;;;i";J;", other potential vendors becaus€ this type of work is highly spec'nlized and other academic centers do not conduct outreach with a traveling nu]s€likeUTsouthwesterndoesforits'esea]chstudies.A|thoughotherinst|tutionsm€Y be able to initiate a p'i;""t tif" ttis, ttrey do not have experience with this model that ur southwestem does to carrY out thls type of data collection with a nod dlsease'

E. Program Office Ce rtification:

I have reviewed this sole source justification aM certry the-iusufication is tue and accurate to the il;i;i;;i;l"dg. ato aoeqJ"e io iupport other t'han full and open comp€tition'

Centeritnstitute/Ofiice COR/Program Ofiicial Name/TiSe: Halle Getachew

' Olqtdy nt{d b' H{'tuFh

Hallelujah Getachew -S illXH.ir.or,urrro-.r, Center/tnstitute/Office CoR/Program Official Signature:

Contracting Officer Signature:

Certification Date:

Certification Date:

F. ContractinoOffceCertification:

I have tullv rslied on the infotmation Provided hsrein and hereby certify that this justification is accurate ind complete to the b€st of my knowledge ano Del€T:

Pellumbeshe Hoxhaj -S

Contracting Office r N a me :

Oiqitdly signed bY Pellumbe,he

*f;jloio.', r ro,rrrr'*'*'

Rev.5/14i19