Source: https://stratvocate.com/grow/find-opportunities/view-opportunity?noticeid=154216&solnbr=FDA-SOL-1217056
Timestamp: 2019-12-15 23:03:08
Document Index: 475691754

Matched Legal Cases: ['art 127', 'art 126', 'art 25', '§6212', '§6320', '§6159', '§362']

Solicitation Number FDA-SOL-1217056
Pigment orange 13 [Bisphenly-14C(U)]
Subject: Pigment orange 13 [Bisphenly-14C(U)]
Solicitation Number: FDA-SOL-1217056
Contact: ROOSEVELT D. WALKER, CONTRACT SPECIALIST, Phone 8705437405, Email This email address is being protected from spambots. You need JavaScript enabled to view it.
Office Address: 3900 NCTR Road, HFT-320Bldg 50 | Rm 421 Jefferson AR 72079
Place of Performance: US Food and Drug AdministrationNational Center for Toxicological Research (NCTR) 3900 NCTR RD, Jefferson, AR 72079 Jefferson, AR 72070
The solicitation number is FDA_SOL_1217056. This solicitation is issued as a Request for Quote (RFQ).
The solicitation document and incorporated provisions and clauses in effect through the Federal Acquisition Circular 2019-01 dated January 22,2019.
The appropriate North American Industry Classification System (NAICS) Code is 325413 Diagnostic Substance. The Small Business Size standard is 1,250 employees. This requirement is solicited as a Total Set-aside for Small Business competition.
The FDA/NCTR/OR/DBT requires Pigment orange 13 [Bisphenly-14C(U)] for research on tattoos pigments in pregnant female SKH-1 mice. The highest prevalence of tattooing has been shown to be in of women of childbearing years. While thought to permanent, it has been noted some pigments in tattoos begin to fade which suggest the pigments are either decomposing or migrating in the body. One of the pigments to be studied is Pigment Orange 13, to track the pigment and its possible breakdown products, post tattooing. The dorsal skin of pregnant mice will be tattooed with the 14C-Pigment Orange 13 and placed in metabolic cages for the collection of urine and feces. After specified gestation period, the animals will be sacrificed, tissues harvested and analyzed for to determine location and quantitation of 14C present.
The Specifications for the radiolabeled avobenzone are:
1. The 14C shall be attached to the phenyl rings of the compound.
2. The quantity required shall not be less than 5 mCi
3. The specific activity of the radiolabeled compound shall be greater than > 80 mCI/mmol
4. The minimum acceptable purity of the radiochemical shall be greater than > 98% by HPLC
5. Delivers shall be received within 6-7 weeks of time of the award
Schedule of Supplies or Services and Prices/Costs (inclusive of delivery, and installation)
01 Pigment orange 13 [Bisphenly-14C(U)]
Unit Issue: mCi (Millicurie)
Unit Price: ____________________________
Extended Price: ____________________________
Delivery Address (*FOB Destination):
Attn: to be completed at award
3900 NCTR RD,
All questions shall be received via email to Roosevelt Walker at This email address is being protected from spambots. You need JavaScript enabled to view it. before 1:00 P.M. (Central Time) on July 16, 2019.
This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es): https://www.acquisition.gov/browse/index/far
Paragraph (b)(4): Technical Capability: Will be determined by review of information submitted by the offeror which must provide sufficient technical information for the Government to conclusively determine that the offered meets or exceeds the technical requirements identified above. In addition to identifying manufacturer, make, and model of offered products it is incumbent of offerors that they unequivocally demonstrate that offered products meet the requirements herein through the submission of technical specifications, descriptive material, scientific literature, brochures, scientific publications where proposed solution has been used for same or similar purposes, and other information which demonstrates the capability of the offered instrument. Offerors shall address the technical requirements identified above, as well as detailed information on the items in the solicitation.
Price: Provide detailed price quote for each item proposed to meet the Schedule of Items. Include the firm's DUNS number with quote.
The price proposed shall represent the offeror's response to the schedule of supplies/services above.
The government intends to award a firm‐fixed‐price order resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government is defined as lowest price technically acceptable. The following factors shall be used to evaluate offers:
The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Oct 2018), applies to this acquisition.
The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (u) of this provision. (a) Definitions. As used in this provision-
"Arbitral award or decision" means an arbitrator or arbitral panel determination that a labor law violation occurred, or that enjoined or restrained a violation of labor law. It includes an award or decision that is not final or is subject to being confirmed, modified, or vacated by a court, and includes an award or decision resulting from private or confidential proceedings. To determine whether a particular award or decision is covered by this definition, it is necessary to consult section II.B. in the DOL Guidance. "Civil judgment" means-
"Economically disadvantaged women-owned small business (EDWOSB) concern" means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13
CFR part 127. It automatically qualifies as a women-owned small business eligible under the WOSB Program.
"Enforcement agency" means any agency granted authority to enforce the Federal labor laws. It includes the enforcement components of DOL (Wage and Hour Division, Office of Federal Contract Compliance Programs, and Occupational Safety and Health Administration), the Equal
Employment Opportunity Commission, the Occupational Safety and Health Review Commission, and the National Labor Relations Board. It also means a State agency designated to administer an OSHA-approved State Plan, but only to the extent that the State agency is acting in its capacity as administrator of such plan. It does not include other Federal agencies which, in their capacity as contracting agencies, conduct investigations of potential labor law violations.
The enforcement agencies associated with each labor law under E.O. 13673 are- (1) Department of Labor Wage and Hour Division (WHD) for- (i) The Fair Labor Standards Act;
(2) Department of Labor Occupational Safety and Health Administration (OSHA) for- (i) The Occupational Safety and Health Act of 1970; and
(3) Department of Labor Office of Federal Contract Compliance Programs (OFCCP) for- (i) Section 503 of the Rehabilitation Act of 1973;
(5) Equal Employment Opportunity Commission (EEOC) for- (i) Title VII of the Civil Rights Act of 1964;
(iii) The Age Discrimination in Employment Act of 1967; and (iv) Section 6(d) of the Fair Labor Standards Act (Equal Pay Act). "Forced or indentured child labor" means all work or service-
"Highest-level owner" means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner. "Immediate owner" means an entity, other than the offeror, that has direct control of the offeror. Indicators of control include, but are not limited to, one or more of the following: ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.
"Manufactured end product" means any end product in product and service codes (PSCs) 1000-
9999, except-
"Service-disabled veteran-owned small business concern"- (1) Means a small business concern-
(ii) Each individual claiming economic disadvantage has a net worth not exceeding $750,000 after taking into account the applicable exclusions set forth at 13 CFR 124.104(c)(2); and (2) The management and daily business operations of which are controlled (as defined at 13.CFR 124.106) by individuals, who meet the criteria in paragraphs (1)(i) and (ii) of this definition. "Subsidiary" means an entity in which more than 50 percent of the entity is owned-
(2) The management and daily business operations of which are controlled by one or more veterans. "Successor" means an entity that has replaced a predecessor by acquiring the assets and carrying out the affairs of the predecessor under a new name (often through acquisition or merger). The term "successor" does not include new offices/divisions of the same company or a company that only changes its name. The extent of the responsibility of the successor for the liabilities of the predecessor may vary, depending on State law and specific circumstances.
(1) That is at least 51 percent owned by one or more women; or, in the case of any publicly owned business, at least 51 percent of the stock of which is owned by one or more women; and (2) Whose management and daily business operations are controlled by one or more women.
(10) HUBZone small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, as part of its offer, that- (i) It □ is, □ is not a HUBZone small business concern listed, on the date of this representation, on the List of Qualified HUBZone Small Business Concerns maintained by the Small Business Administration, and no material changes in ownership and control, principal office, or HUBZone employee percentage have occurred since it was certified in accordance with 13 CFR Part 126; and
(1) The offeror certifies that each end product, except those listed in paragraph (f)(2) of this provision, is a domestic end product and that for other than COTS items, the offeror has considered components of unknown origin to have been mined, produced, or manufactured outside the United States. The offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products, i.e., an end product that is not a COTS item and does not meet the component test in paragraph (2) of the definition of "domestic end product." The terms "commercially available off-the-shelf (COTS) item" "component," "domestic end product," "end product," "foreign end product," and "United
States" are defined in the clause of this solicitation entitled "Buy American-Supplies." (2) Foreign End Products: Line Item No.
(iii) The offeror shall list those supplies that are foreign end products (other than those listed in paragraph (g)(1)(ii) of this provision) as defined in the clause of this solicitation entitled "Buy American-Free Trade Agreements-Israeli Trade Act." The offeror shall list as other foreign end products those end products manufactured in the United States that do not qualify as domestic end products, i.e., an end product that is not a COTS item and does not meet the component test in paragraph (2) of the definition of "domestic end product." Other Foreign End Products:
(g)(1)(ii) The offeror certifies that the following supplies are Canadian end products as defined in the clause of this solicitation entitled "Buy American-Free Trade Agreements-Israeli Trade
(g)(1)(ii) The offeror certifies that the following supplies are Canadian end products or Israeli end products as defined in the clause of this solicitation entitled "Buy American-Free Trade
Agreements-Israeli Trade Act":
(iii) The Government will evaluate offers in accordance with the policies and procedures of FAR Part 25. For line items covered by the WTO GPA, the Government will evaluate offers of U.S.made or designated country end products without regard to the restrictions of the Buy American statute. The Government will consider for award only offers of U.S.-made or designated country end products unless the Contracting Officer determines that there are no offers for such products or that the offers for such products are insufficient to fulfill the requirements of the solicitation. (h) Certification Regarding Responsibility Matters (Executive Order 12689). (Applies only if the contract value is expected to exceed the simplified acquisition threshold.) The offeror certifies, to the best of its knowledge and belief, that the offeror and/or any of its principals-
(A) The taxpayer has received a statutory notice of deficiency, under I.R.C. §6212, which entitles the taxpayer to seek Tax Court review of a proposed tax deficiency. This is not a delinquent tax because it is not a final tax liability. Should the taxpayer seek Tax Court review, this will not be a final tax liability until the taxpayer has exercised all judicial appeal rights. (B) The IRS has filed a notice of Federal tax lien with respect to an assessed tax liability, and the taxpayer has been issued a notice under I.R.C. §6320 entitling the taxpayer to request a hearing with the IRS Office of Appeals contesting the lien filing, and to further appeal to the Tax Court if the IRS determines to sustain the lien filing. In the course of the hearing, the taxpayer is entitled to contest the underlying tax liability because the taxpayer has had no prior opportunity to contest the liability. This is not a delinquent tax because it is not a final tax liability. Should the taxpayer seek tax court review, this will not be a final tax liability until the taxpayer has exercised all judicial appeal rights.
(C) The taxpayer has entered into an installment agreement pursuant to I.R.C. §6159. The taxpayer is making timely payments and is in full compliance with the agreement terms. The taxpayer is not delinquent because the taxpayer is not currently required to make full payment. (D) The taxpayer has filed for bankruptcy protection. The taxpayer is not delinquent because enforced collection action is stayed under 11 U.S.C. §362 (the Bankruptcy Code).
(i) Certification Regarding Knowledge of Child Labor for Listed End Products (Executive Order 13126). [The Contracting Officer must list in paragraph (i)(1) any end products being acquired under this solicitation that are included in the List of Products Requiring Contractor Certification as to Forced or Indentured Child Labor, unless excluded at .] (1) Listed end products. Listed End Product
Listed Countries of Origin ___________________
□ (i) The offeror will not supply any end product listed in paragraph (i)(1) of this provision that was mined, produced, or manufactured in the corresponding country as listed for that product. □ (ii) The offeror may supply an end product listed in paragraph (i)(1) of this provision that was mined, produced, or manufactured in the corresponding country as listed for that product. The offeror certifies that it has made a good faith effort to determine whether forced or indentured child labor was used to mine, produce, or manufacture any such end product furnished under this contract. On the basis of those efforts, the offeror certifies that it is not aware of any such use of child labor.
(1) □ In the United States (Check this box if the total anticipated price of offered end products manufactured in the United States exceeds the total anticipated price of offered end products manufactured outside the United States); or (2) □ Outside the United States.
□ (1) Maintenance, calibration, or repair of certain equipment as described in FAR 22.10034(c)(1). The offeror □ does □ does not certify that-
□ Offeror is an agency or instrumentality of a foreign government; □ Offeror is an agency or instrumentality of the Federal Government.
(i) It □ is, □ is not an inverted domestic corporation; and (ii) It □ is, □ is not a subsidiary of an inverted domestic corporation.
(1) The offeror shall e-mail questions concerning sensitive technology to the Department of State at This email address is being protected from spambots. You need JavaScript enabled to view it. .
(p) Ownership or Control of Offeror. (Applies in all solicitations when there is a requirement to be registered in SAM or a requirement to have a unique entity identifier in the solicitation. (1) The Offeror represents that it □ has or □ does not have an immediate owner. If the Offeror has more than one immediate owner (such as a joint venture), then the Offeror shall respond to paragraph (2) and if applicable, paragraph (3) of this provision for each participant in the joint venture.
Immediate owner CAGE code: ____________________. Immediate owner legal name: _____________________.
Highest-level owner CAGE code: __________________. Highest-level owner legal name: ___________________.
(2) If the Offeror checked "does" in paragraph (s)(1)(i) or (ii) of this provision, the Offeror represents to the best of the Offeror's knowledge and belief [Offeror to check appropriate block]: □ (i) There has been no administrative merits determination, arbitral award or decision, or civil judgment for any labor law violation(s) rendered against the offeror (see definitions in paragraph (a) of this section) during the period beginning on October 25, 2015 to the date of the offer, or for three years preceding the date of the offer, whichever period is shorter; or
(3)(i) If the box at paragraph (s)(2)(ii) of this provision is checked and the Contracting Officer has initiated a responsibility determination and has requested additional information, the Offeror shall provide-
(D) The information in paragraphs (s)(3)(i)(A) and (s)(3)(i)(C) of this provision to the Contracting Officer, if the Offeror meets an exception to SAM registration (see FAR 4.1102(a)). (ii)(A) The Contracting Officer will consider all information provided under (s)(3)(i) of this provision as part of making a responsibility determination.
(B) A representation that any labor law decision(s) were rendered against the Offeror will not necessarily result in withholding of an award under this solicitation. Failure of the Offeror to furnish a representation or provide such additional information as requested by the Contracting Officer may render the Offeror non-responsible.
(iii) A publicly accessible website includes the Offeror's own website or a recognized, thirdparty greenhouse gas emissions reporting program.
The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (Oct 2018), applies to this acquisition. The following addenda apply:
The following FAR and HHSAR provisions and clauses, incorporated by reference, apply to this acquisition and can be obtained at https://www.acquisition.gov/far/ and http://farsite.hill.af.mil/VFHHSAR1.htm
52.204-18 Commercial and Government Entity Code Maintenance. (Jul 2016)
HHSAR Clause
The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the Governments Technical Point of Contact (TPOC) specified at award. If the supplies or services are acceptable, the TPOC shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the TPOC shall document the nonconforming items/services and immediately notify the Contracting Officer.
Name: Roosevelt Walker
Technical Representative (TR) Point of Contact
The following TR will represent the Government for the purpose of this contact: (To be completed at time of award) Name: Phone: Email:
The TR is responsible for:
(1) Monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements;
(2) Interpreting the statement of work and any other technical performance requirements;
(3) Performing technical evaluation as required;
(4) Performing technical inspections and acceptances required by this contract; and (5) Assisting in the resolution of technical problems encountered during performance.
The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to:
(1) Direct or negotiate any changes in the statement of work;
(2) Modify or extend the period of performance;
(3) change the delivery schedule;
(4) Authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or
(5) Otherwise change any terms and conditions of this contract.
The contractor shall submit all invoices to:
FDA Three-Way Match Invoice Submission
Invoices shall contain all necessary
information per FAR 52.212-4(g) in
accordance with the following instructions.
*** *** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail. Provide a copy marked courtesy to the Technical Point of Contact (TPOC) identified above.
Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:
(iii) Contract/Order number (including a reference to any base award for Indefinite-
Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements);
(x) Electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment;
(xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other
Program Center/Office point of contact, as referenced on the award;
(xii) For all Time-and-Materials and Labor-Hour Awards, Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:
(a) list of all invoices submitted to date under the subject award, including the following:
(1) invoice number, amount, & date submitted
(2) corresponding payment amount & date received
(b) total amount of all payments received to date under the subject contract or order
(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance;
(xiii) Any other information or documentation required by the award.
D. Questions regarding invoice payments should be directed to the Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at This email address is being protected from spambots. You need JavaScript enabled to view it. . Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.
52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items. (May 2019) applies to this acquisition. The following additional FAR clauses cited in this clause.
_X_ (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) (31 U.S.C. 6101 note).
_X_ (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C. 644).
__ (17)(i) 52.219-9, Small Business Subcontracting Plan (Aug 2018) (15 U.S.C. 637(d)(4)).
__ (20) 52.219-16, Liquidated Damages-Subcon-tracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).
__X_(28)(i) 52.222-26, Equal Opportunity (Sept 2016) (E.O. 11246).
__ _(29)(i) 52.222-35, Equal Opportunity for Veterans (Oct 2015)(38 U.S.C. 4212).
__ _(30)(i) 52.222-36, Equal Opportunity for Workers with Disabilities (July 2014) (29 U.S.C. 793).
__ (35)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)
__ (38)(i) 52.223-13, Acquisition of EPEAT Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and 13514).
__ (39)(i) 52.223-14, Acquisition of EPEAT Registered Televisions (JUN 2014) (E.O.s 13423 and 13514).
__ (41)(i) 52.223-16, Acquisition of EPEAT-Registered Personal Computer Products (OCT 2015) (E.O.s 13423 and 13514).
_X_ (47)(i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.
_ _ (48) 52.225-5, Trade Agreements (AUG 2018) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).
_X_ (55) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Jul 2013) (31 U.S.C. 3332).
__ (56) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) (31 U.S.C. 3332).
All quotes are due in person, by postal mail or email to the point of contact listed below on or before July 22, 2019 by 12:00 pm (CT) at:
OO/OFBA/OAGS/DAP/FOB
Attn: Roosevelt Walker
HFT-322; Bldg. 50, Rm. 432
Jefferson, AR 72079.
For information regarding this solicitation, please contact Roosevelt Walker at (870) 543-7405, fax (870) 543-7450 or email: This email address is being protected from spambots. You need JavaScript enabled to view it. .