Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF DECEMBER 13, 2015 FBO #5133
SOURCES SOUGHT

68 -- Purchase of Eylea (aflibercept)

Notice Date

12/11/2015
 

Notice Type

Sources Sought
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

Department of Health and Human Services, National Institutes of Health, Clinical Center/Office of Purchasing & Contracts, 6707 Democracy Blvd, Suite 106, MSC 5480, Bethesda, Maryland, 20892-5480
 

ZIP Code

20892-5480
 

Solicitation Number

NIH-CC-16-003076
 

Archive Date

1/12/2016
 

Point of Contact

Lisa L. Schaupp, Phone: 3014020735
 

E-Mail Address

Lisa.Schaupp@nih.gov
(Lisa.Schaupp@nih.gov)
 

Small Business Set-Aside

N/A
 

Description

The National Institutes of Health ("NIH"), Clinical Center is conducting a market survey/sources sought notice to determine whether there is a reasonable expectation of a responsible/capable small business offeror to perform the work sought in the attached SOW. Accordingly, NIH is attempting to ascertain if there exists a reasonable expectation of at least two responsible/capable small business offerors in order for NIH to compete the requirement as a small business set aside. NIH is seeking capability statements as to the attached SOW from small businesses, veteran-owned small businesses, service disabled veteran-owned small businesses, HUBZONE small businesses, small businesses under the 8(a) program, and/or businesses under the GSA Schedule which can perform on-schedule. THIS MARKET SURVEY/SOURCES SOUGHT ANNOUNCEMENT IS NOT A REQUEST FOR PROPOSALS, AND THE GOVERNMENT IS NOT COMMITTED TO AWARD A CONTRACT PURSUANT TO THIS ANNOUNCEMENT. CONSEQUENTLY, DO NOT SEND A PROPOSAL IN RESPONSE TO THIS NOTICE. THE APPROPRIATE RESPONSE IS A CAPABILITY STATEMENT. ALTHOUGH A RESPONDENT CAN RESPOND WITH WHATEVER INFORMATION THE RESPONDENT SEES FIT, THE IDEAL CAPABILITY STATEMENT SPECIFICALLY ADDRESSES THE REQUIREMENTS IN THE SOW AND THE REQUESTS FOR INFORMATION BELOW, AND IS NOT A GENERIC SALES BROCHURE OR MARKETING HANDOUT; FURTHER, THE GOVERNMENT REQUESTS, BUT DOES NOT MANDATE, THAT THE CAPABILITY STATEMENT IS LIMITED TO NO MORE THAN TEN PAGES. ANY PROPRIETARY INFORMATION IN THE SUBMITTED CAPABILITY STATEMENT SHOULD BE CLEARLY MARKED AS SUCH. The information obtained from this market research is for Government planning purposes only, and will assist the Government in planning its acquisition strategy. This is strictly market research, and the Government is not opening a question and answer period concerning this market research. Further, the Government will not pay for any costs incurred in the preparation of information in response to this market survey. In addition to addressing the requirements in the below Statement of Work, the Government requests that your capability statement address the following requests for information, if relevant. 1) Please provide the full company/entity name, address including points of contact (phone number and e-mail address), DUNS numbers, and type/size of the company/entity by NAICS code. 2) If your company/entity is a dealer or service-provider, and not a manufacturer of the end items/products contemplated by the SOW, please identify your company as such and identify the end item/product manufacturers that you would be obtaining goods from in order to perform the contract, and where the manufacturers are geographically located. 3) According to the small business limitations on subcontracting standard provided by the amended Small Business Act at 15 U.S.C. § 657s, the requirement for a small business supplier is that the small business prime contractor "may not expend on subcontractors more than 50 percent of the amount, less the cost of materials, paid to the concern under the contract...." 15 U.S.C. § 657s(a)(2). However, "[c]ontract amounts expended by a covered small business concern on a subcontractor that is a similarly situated entity [(i.e., another small/small disadvantaged business of the same type)] shall not be considered subcontracted for purposes of determining whether the covered small business concern has violated [limitations on subcontracting.]" 15 U.S.C. § 657s(b). If you are a small business, please address your ability to adhere to limitations on subcontracting at 15 U.S.C. § 657s. To ascertain if you are a small business, use the size standard provided by NAICS Code 325412 (Pharmaceutical Preparation Manufacturing), with a size standard of no more than 750 employees. As part of this, if you are a small business that is a dealer/service-provider and not a manufacturer, please so state, and address whether you meet the following requirements from 13 C.F.R. § 121.406(b). Specifically, your company/entity: (1) Does not exceed 500 employees (notice that the employee standard under the non-manufacturer rule is more restrictive than for NAICS Code 325412); (2) Is primarily engaged in the retail or wholesale trade and normally sells the type of item being supplied; (3) Takes ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice; and (4) Will supply the end item of a small business manufacturer, processor, or producer made in the United States. NIH must receive written capability statements no later than December 28, 2015 at 9:00 a.m. Eastern Time. E-mail the written capability statement to Lisa Schaupp, the Contract Specialist, at the e-mail address Lisa.Schaupp@nih.gov. Respondents will NOT be notified as to the results of the Government's market research. Statement of Work Project Title: Purchase of formulary medication - Eylea® (aflibercept) Department: NIH Clinical Center, Pharmacy Department 1. Background 1.1 The National Institutes of Health (NIH) Clinical Center (CC) is a clinical research hospital providing all medical services for patients participating in human research protocols of the NIH. The CC provides patient facilities and services for clinical investigations by the NIH Institutes, research in related areas and supervises residency and other training programs. 1.2 The NIH Clinical Center Pharmacy Department provides pharmaceutical care and dispenses medications to inpatient and outpatients enrolled on clinical investigational studies. Clinical Center pharmacists provide research support to health care providers and investigators. Pharmacy staff members conduct and participate in research programs that enhance knowledge regarding optimal dosing and appropriate use of investigational and commercially available agents. 1.3 Eylea® (generic name = aflibercept) has been approved by the Pharmacy and Therapeutics committee as a formulary medication. Eylea® is an ophthalmic intravitreal injection indicated for treatment of Macular Edema. Formulary medications are required to be stocked in the Pharmacy Department at all times to fulfill medication orders for Clinical Center patients and research subjects. 2. Purpose 2.1 Purchase of Eylea® for use in patient care. 3. Scope of Work 3.1 The manufacturer of this medication (Regeneron Pharmaceuticals, Inc.) does not stock their product in pharmaceutical wholesalers, but uses pharmaceutical specialty distributors to distribute the medication. 3.2 We are requesting the establishment of a one year Indefinite Delivery/Indefinite Quantity (ID/IQ) contract with renewable option periods with an authorized distributor to facilitate the acquisition of Eylea® to support patient care. 3.3 Eylea® (NDC: 61755-0005-02) is supplied as a single-use, 3 mL vial, each kit contains the following: one 3-mL, glass vial designed to deliver 0.05 mL of 40 mg/mL Eylea® one 19-gauge x 1½-inch, 5-micron, filter needle one 30-gauge x ½-inch injection needle one 1-mL syringe one package insert 3.4 Period of Performance: Base year: January 15, 2016 thru January 14, 2017 Option Period One: January 15, 2017 thru January 14, 2018 Option Period Two: January 15, 2018 thru January 14, 2019 Option Period Three: January 15, 2019 thru January 14, 2020 Option Period Four: January 15, 2020 thru January 14, 2021 3.5 The delivery must be received within two business days after receipt of order, and be delivered to the address listed below.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/NIH-CC-16-003076/listing.html)
 

Place of Performance

Address: 9000 Rockville Pike, 10 Center Drive, Building 10, Clinical Center, Pharmacy Department, Bethesda, Maryland, 20892, United States

Zip Code: 20892
 

Record

SN03967654-W 20151213/151211234153-61d212578c0b7c615f8ac50eb3f4a2e6 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

---

| FSG Index  |  This Issue's Index  |  Today's FBO Daily Index Page |