FDA-SOL-1152321.pdf

FDA-SOL-1152321

Solicitation Number: FDA-SOL-1152321

Title: Evaluation of the Allergenicity and Sensitization Potential of Fragrance Substances based on Survey of Scientific Literature

Part 1 – Description

THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN

ACCORDANCE WITH THE FORMAT IN FAR SUBPART 12.6-STREAMLINED PROCEDURES

FOR EVALUATION AND SOLICITATION FOR COMMERCIAL ITEMS-AS SUPPLEMENTED

WITH ADDITIONAL INFORMATION INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT

CONSTITUTES THE ONLY SOLICITATION; QUOTATIONS ARE BEING REQUESTED. THIS

SOLICITATION IS BEING ISSUED USING SIMPLIFIED ACQUISITION PROCEDURES 13.5.

This solicitation is being issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-82.

The associated North American Industrial Classification System (NAICS) code for this procurement is 541712. Its associated Small Business size standard is 500 employees. The Government intends to award this purchase to a small business.

Part 2 – Supplies or services and Prices/Costs

Purchase Order Type: Firm-Fixed Price

Pricing/Payment Schedule

Task Deliverable Price

1 Work Plan $

2 Literature Search $

3 Reference Review and Summary $

4 Consensus Determination $

5 Final Report $

6 Final Report Presentation $

Total $

Part 3 – Description/Specifications

Background:

FDA is responsible for providing regulatory oversight of the safety and proper labeling of cosmetics. FDA is interested in evaluating the safety data of 26 fragrance ingredients in cosmetic products, specifically from dermal and inhalation routes of exposure. Other international regulatory bodies have developed a position on these fragrance ingredients and have identified them as allergens. However, the FDA does not currently have a regulatory position on these fragrance ingredients. Therefore, in order to develop a regulatory position that is based on the most relevant scientific literature, the FDA needs a review and evaluation of the existing published data that supports the safety (or lack thereof), of these fragrance ingredients, in particular when exposure is via the dermal and inhalation routes. Specifically, toxicological endpoints related to allergenicity and sensitization potential for these fragrance ingredients are of most interest to FDA. FDA will determine if the published scientific data support the conclusion that these fragrance ingredients warrant being identified as fragrance allergens or whether the data do not support such a conclusion. To this end, the FDA will commission a literature survey that includes a summary and evaluation of the scientific data related to the allergenicity and/or sensitization potential of the 26 fragrance ingredients listed in the table below.

Fragrances and fragrance ingredients are commonly used in various cosmetics such as perfumes and colognes as well as other products such as shampoos, shower gels, shaving creams and lotions. Even some products labeled as “unscented” may contain fragrance ingredients that mask other chemical odors.

FDA needs a better understanding of the potential hazards associated with fragrance ingredients.

This will be limited initially to a review of the literature on the fragrance ingredients introduced into annex III of the European Commission Cosmetics Directive. This survey asks for a review and summary of data relevant to toxicological endpoints of concern, based on the dermal and inhalation routes of exposure. The review and summary will be based on a systematic and critical review of the previous and most recent published scientific literature, as well as the review of any literature previously reviewed by international regulatory bodies that have developed and published a regulatory position on these fragrance ingredients.

Delineation of Tasks:

Independently and not as an agent of the Government, the Contractor shall furnish the necessary personnel, materials, services, facilities, and otherwise do all things necessary for or incident to the performing of the work as described below.

Task 1: Develop a Work Plan the outlines the activities and deliverables for each task along with the delivery date for each task.

The work plan will include the names and expertise of personnel involved in each task.

Submit the work plan to FDA for discussion and possible revision.

Deliverables: work plan, in electronic format, and meeting with FDA, either in-person or via telecom, to discuss and revise the work plan

Estimated time period to delivery: 1-2 months after contract award

Task 2: Conduct a comprehensive literature search of the published scientific literature on the 26 fragrance ingredients listed below and create a table of relevant references identified, according to criteria mentioned below.

The search shall focus on the toxicology of these ingredients, specifically on allergenicity and sensitization endpoints of toxicity.

Only the dermal and inhalation routes of exposure shall be considered

Each reference found shall be ranked as to how relevant it is and how much weight it should be given in evaluating the allergenicity and sensitization of each fragrance ingredient. Criteria for determining the relevance and weight to be given to each reference needs to be developed. Therefore, the Contractor will develop search criteria and provide an explanation of the rationale used in developing these criteria. Contractor shall meet with FDA to review criteria and obtain approval from FDA.

Animal studies and relevant in-vitro study results shall be reviewed, but the Contractor shall include a justification for all studies reviewed, why the data may or may not be acceptable, for the goals of this contract. Therefore, an explanation of the rationale used for including or excluding specific animal studies or in-vitro study results needs to be provided. Available human data shall also to be considered.

The search shall include all published scientific literature and include published positions on fragrance allergens from international regulatory agencies in the EU, Health Canada, and Japan. FDA understands that some of the published literature reviewed will have been reviewed as part of a published international regulatory position

The references cited in support of these published positions shall be included in the literature search and shall be reviewed by the Contractor and assessed according to the criteria.

The table of references comprising the literature search shall include:

• The substance name (all relevant names, and identifiers)

• The types of studies reviewed (in vitro, in vivo, clinical, species used, length of study, doses, route of administration, etc…)

• The endpoint(s) evaluated (sensitization, allergenicity, acute tox, chronic tox, cardiovascular tox, pulmonary tox, etc…)

• Any relevant methodologies that require description

• The results reported

• The conclusions reported

• What regulatory body used the specific study to support their conclusion, or if no regulatory body used the study

• Hyperlinks to the citations

Deliverables: Comprehensive literature search, a table of references in electronic format, meeting with FDA, either in-person or via telecom, to review the criteria used for determining the relevance and weight of each reference.

• The table of references shall be:

o Organized by individual fragrance ingredient, o Include the results of the Contractor’s literature search, o Include the literature cited in the position papers of the international regulatory agencies of the EU, Canada and Japan, o Indicate which references are cited by the international regulatory agencies of the EU, Canada, and Japan in their published regulatory positions.

FDA shall approve of the criteria used for determining the relevance and weight of each reference.

Estimated time period to delivery: 2-6 months after contract award

Task 3: Review, assess, and summarize each reference.

Develop conclusions and recommendations about the scientific evidence that supports the allergenicity and sensitization potential of the fragrance ingredients.

Write a narrative that summarizes the reviews, assessments, conclusions, and recommendations.

Create a table that presents a summary and conclusions for each of the individual references and includes the conclusions of both the study authors along with the Contractor’s conclusions.

Deliverables: Narrative summary of the reviews, assessments, conclusions, and recommendations, and a table, in electronic format, that presents both the study author’s conclusions and the Contractor’s conclusions on each reference.

Estimated time period to delivery: 6-9 months after contract award.

Task 4: Determine if there is consensus in the published scientific literature on a scientific definition or working definition of “allergen” and “sensitizer” and propose definitions based on these findings.

Determine if international regulatory bodies have identified a regulatory definition for “allergen” and “sensitizer.”

Create a table that lists the definitions found in the published scientific literature and from the international regulatory bodies.

Deliverable: Narrative explaining how definitions for “allergen” and “sensitizer” were proposed based on the published scientific literature, what these definitions are as per international regulatory bodies, and a table that lists the definitions found in the published scientific literature and from international regulatory bodies. The narrative and table shall be in electronic format.

Estimated time period to delivery: 9-11 months after contract award.

Task 5: Create a final report which contains:

Narrative summary of the reviews, assessments, conclusions, and recommendations

Table that presents both the study author’s and the Contractor’s conclusions on each reference

Narrative explaining how definitions for “allergen” and “sensitizer” were proposed based on the published scientific literature and what the definitions are as per international regulatory bodies

Table that lists the definitions found in the published scientific literature and from international regulatory bodies

Table of references comprising the literature search

Deliverables: Final report in electronic format on cd.

Estimated time period to delivery: 12 months after contract award

Task 6: Create and deliver a PowerPoint presentation of the final report to FDA

Deliverable: PowerPoint presentation, on cd, to FDA

Estimated time period to delivery: 12 months after contract award.

The 26 fragrance substances are in the table below:

Substance CAS

Number Amyl cinnamal 122-40-7 Benzyl alcohol 100-51-6 Cinnamyl alcohol 104-54-1 Citral 5392-40-5 Eugenol 97-53-0 Hydroxycitronellal 107-75-5 Isoeugenol 97-54-1 Amylcinnamyl Alcohol 101-85-9 Benzyl salicylate 118-58-1 Cinnamal 104-55-2 Coumarin 91-64-5 Geraniol 106-24-1

Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde

31906-04-4

Anisyl alcohol 105-13-5 Benzyl cinnamate 103-41-3 Farnesol 4602-84-0 2-(4-tert-Butylbenzyl)propionaldehyde Butylphenyl Methylpropional

80-54-6

Linalool 78-70-6 Benzyl benzoate 120-51-4 Citronellol 106-22-9 Hexyl Cinnamal 101-86-0 d-Limonene 5989-27-5 Methyl 2-Octynoate 111-12-6

Alpha-Isomethyl Ionone

127-51-5

Oak moss extract 90028-68-5 Treemoss extract 90028-67-4

Part 4 – Packing, Marking and Shipping

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

Delivery Location:

Attn: TBD The US Food and Drug Administration 4300 River Road - University Station College Park, MD 20740

Part 5 – Inspection and Acceptance

The Contracting Officer’s Representative (COR) will perform inspection and acceptance of materials and services to be provided. For the purpose of this PART, (COR – to be determined upon contract award) is the authorized representative of the Contracting Officer.

Invoice Submission:

A. The Contractor shall submit one original copy of each invoice to the address specified below:

Office of Financial Services Food and Drug Administration

W032- Second Floor

MAIL HUB 2145

10903 New Hampshire Avenue Bldg 32, Rm# 2162, Mail Hub 2145

Silver Spring MD 20993-0002 Attn: Vendor Payments

(301) 827-3742 or (866) 807-3742 fdavendorpaymentsteam@fda.gov

B. 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 – Central Contractor Registration) and/or applicable Far Clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(I) Name and address of the contractor;

(II) Invoice Date and Invoice Number;

(III) Purchase order/Award Number;

(IV) Description, Quantity, Unit of Measure, Unit Price, and Extended Price Supplies Delivered or Services Performed, including: (a) Period of Performance for which costs are claimed; (b) Itemized travel costs, including origin and destination; and (c) Any other supporting information necessary to clarify questionable expenditures;

(V) Shipping number and date of shipping, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(VI) Terms of any discount for prompt payment offered;

(VII) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment) mailto:fdavendorpaymentsteam@fda.gov

(VIII) Name, title and phone number of person to notify in event of defective invoice;

(IX) Taxpayer Identification Number (TIN);

(X) Electronic Funds Transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited;

(XI) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact, as referenced on the purchase order; and, (XII) Any other information or documentation required by the purchase order/award.

C. Questions regarding invoices shall be directed to the FDA at the telephone number provided above.

Part 6 – Contract clauses

FAR Clauses Incorporated by Reference:

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses 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. Also, the full text of a clause may be accessed electronically at: www.acquisition.gov/far/index.html

52.203-5 Covenant Against Contingent Fees (May 2014) 52.203-7 Anti-Kickback Procedures (May 2014) 52.212-4 Contract Terms and Conditions-Commercial Items (May 2015) 52.216-24 Limitation of Government Liability (April 1984) 52.216-25 Contract Definitization (October 2012)

FAR Clauses in Full Text:

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders— Commercial Items.

CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—

COMMERCIAL ITEMS (MAY 2015)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)).

___Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)).

(2) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(3) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Pub. L. 108-77, 108-78).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

__ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 253g and 10 U.S.C. 2402).

http://www.acquisition.gov/far/index.html https://www.acquisition.gov/far/current/html/52_222.html#wp1151848 http://uscode.house.gov/ https://www.acquisition.gov/far/current/html/52_222.html#wp1151848 http://uscode.house.gov/ https://www.acquisition.gov/far/current/html/52_233_240.html#wp1113329 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t29t32+1665+30++%2831%29%20%20AND%20%28%2831%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/current/html/52_233_240.html#wp1113344 https://www.acquisition.gov/far/current/html/52_200_206.html#wp1137622 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t41t42+2+13++%2841%29%20%20AND%20%28%2841%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t09t12+37+408++%2810%29%20%252

_X_ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

__ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jul 2010) (Pub. L.

109-282) (31 U.S.C. 6101 note).

__ (5) 52.204-11, American Recovery and Reinvestment Act—Reporting Requirements (Jul 2010) (Pub. L.

111-5).

__ (6) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Dec 2010) (31 U.S.C. 6101 note).

__ (7) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jan 2012) (41 U.S.C. 2313).

__ (8) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (section 740 of Division C of Pub. L. 111-117, section 743 of Division D of Pub. L. 111-8, and section 745 of Division D of Pub. L. 110-161).

__ (9) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).

__ (10) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Jan 2011) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (11) [Reserved] _X_ (12)(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C. 644).

__ (ii) Alternate I (Nov 2011).

__ (iii) Alternate II (Nov 2011).

__ (13)(i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

__ (ii) Alternate I (Oct 1995) of 52.219-7.

__ (iii) Alternate II (Mar 2004) of 52.219-7.

__ (14) 52.219-8, Utilization of Small Business Concerns (Jan 2011) (15 U.S.C. 637(d)(2) and (3)).

__ (15)(i) 52.219-9, Small Business Subcontracting Plan (Jan 2011) (15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (Oct 2001) of 52.219-9.

__ (iii) Alternate II (Oct 2001) of 52.219-9.

__ (iv) Alternate III (Jul 2010) of 52.219-9.

__ (16) 52.219-13, Notice of Set-Aside of Orders (Nov 2011)(15 U.S.C. 644(r)).

__ (17) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)).

__ (18) 52.219-16, Liquidated Damages—Subcon-tracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

__ (19)(i) 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns

(Oct 2008) (10 U.S.C. 2323) (if the offeror elects to waive the adjustment, it shall so indicate in its offer).

__ (ii) Alternate I (June 2003) of 52.219-23.

__ (20) 52.219-25, Small Disadvantaged Business Participation Program—Disadvantaged Status and Reporting (Dec 2010) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

__ (21) 52.219-26, Small Disadvantaged Business Participation Program— Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

_X_ (22) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657 f).

__ (23) 52.219-28, Post Award Small Business Program Rerepresentation (Apr 2009) (15 U.S.C. 632(a)(2)).

__ (24) 52.219-29 Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business

Concerns (Nov 2011).

__ (25) 52.219-30 Notice of Set-Aside for Women-Owned Small Business Concerns Eligible Under the

Women-Owned Small Business Program (Nov 2011).

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_X_ (26) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

_X_ (27) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jul 2010) (E.O. 13126).

_X_ (28) 52.222-21, Prohibition of Segregated Facilities (Feb 1999).

_X_ (29) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

_X_ (30) 52.222-35, Equal Opportunity for Veterans (Sep 2010)(38 U.S.C. 4212).

_X_ (31) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793).

_X_ (32) 52.222-37, Employment Reports on Veterans (Sep 2010) (38 U.S.C. 4212).

_X_ (33) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010)

(E.O. 13496).

_X_ (34) 52.222-54, Employment Eligibility Verification (Jan 2009). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

__ (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.)

__ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (36) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

__ (37)(i) 52.223-16, IEEE 1680 Standard for the Environmental Assessment of Personal Computer Products

(Dec 2007) (E.O. 13423).

__ (ii) Alternate I (Dec 2007) of 52.223-16.

_X_ (38) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) (E.O. 13513).

_X_ (39) 52.225-1, Buy American Act—Supplies (Feb 2009) (41 U.S.C. 10a-10d).

__ (40)(i) 52.225-3, Buy American Act—Free Trade Agreements—Israeli Trade Act (June 2009)

(41 U.S.C. 10a-10d, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, Pub. L. 108-77, 108-78, 108- 286, 108-302, 109-53, 109-169, 109-283, and 110-138).

__ (ii) Alternate I (Jan 2004) of 52.225-3.

__ (iii) Alternate II (Jan 2004) of 52.225-3.

__ (41) 52.225-5, Trade Agreements (Nov 2011) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

__ (42) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

__ (43) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

__ (44) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C.

5150).

__ (45) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)).

__ (46) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)).

_X_ (47) 52.232-33, Payment by Electronic Funds Transfer—Central Contractor Registration (Oct 2003)

(31 U.S.C. 3332).

__ (48) 52.232-34, Payment by Electronic Funds Transfer—Other than Central Contractor Registration

(May 1999) (31 U.S.C. 3332).

__ (49) 52.232-36, Payment by Third Party (Feb 2010) (31 U.S.C. 3332).

__ (50) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

__ (51)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006)

(46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).

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__ (ii) Alternate I (Apr 2003) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.] __ (1) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.).

__ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 1989) (29 U.S.C. 206 and

41 U.S.C. 351, et seq.).

__ (3) 52.222-43, Fair Labor Standards Act and Service Contract Act—Price Adjustment (Multiple Year and

Option Contracts) (Sep 2009) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

__ (4) 52.222-44, Fair Labor Standards Act and Service Contract Act—Price Adjustment (Sep 2009)

(29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

__ (5) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (Nov 2007) (41 351, et seq.).

__ (6) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services—

Requirements (Feb 2009) (41 U.S.C. 351, et seq.).

__ (7) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Mar 2009) (Pub. L. 110-247).

__ (8) 52.237-11, Accepting and Dispensing of $1 Coin (Sept 2008) (31 U.S.C. 5112(p)(1)).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records—Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)).

(ii) 52.219-8, Utilization of Small Business Concerns (Dec 2010) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $650,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(iii) [Reserved]

(iv) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

(v) 52.222-35, Equal Opportunity for Veterans (Sep 2010) (38 U.S.C. 4212).

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(vi) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793).

(vii) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O.

13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(viii) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.).

(ix) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)).

___Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)).

(x) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (Nov 2007) (41 U.S.C. 351, et seq.).

(xi) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services-

Requirements (Feb 2009) (41 U.S.C. 351, et seq.).

(xii) 52.222-54, Employment Eligibility Verification (Jan 2009).

(xiii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Mar 2009) (Pub. L. 110-

247). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xiv) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C.

Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247- 64.

(2) While not required, the contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of clause)

PART 7 – Instructions to Offerors

Quotes

The Offeror’s proposal shall consist of two (2) separate volumes. Volume 1 shall consist of the Technical, Personnel, and Relevant Experience with a page limit of 20 pages. Please include the resumes for Personnel in this volume (resumes not included in the page limit). Volume 2 shall include the Price Proposal.

Proprietary Data

The contractor shall provide a descriptive list of the data that is considered confidential, commercial value, and/or trade secret information.

Response Dates and Time

RFQ Due Date: All quotes and revisions shall be submitted via email to Sean.Wybenga@fda.hhs.gov prior to August 12, 2015, 3:30 EST.

52.212-1, Instructions to Offerors - Commercial Items (Apr 2014)

Technical Volume:

Technical Approach - Offeror shall identify the specific search strategy it will employ in conducting a scientific literature search. Offeror shall provide details on the search criteria and systematic approach to be used in evaluating and weighing the results of the literature search.

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Project Management - Offeror shall provide information relevant to the administration of the project. This should include management plans for oversight of the project.

Personnel – Offeror shall demonstrate that it employs the requisite personnel to perform the literature search and review as described above. The offeror shall name the participating personnel, identify their qualifications and experience, and for each person listed indicate the percentage of time that they would be devoting to this contract.

Relevant Experience - Offeror shall demonstrate experience relevant to conducting scientific literature reviews, reviewing, and producing narrative summaries of the literature. Experience conducting toxicological scientific literature reviews is highly desirable.

Price Volume:

The cost proposal shall be broken down to show a price for each deliverable listed in the pricing table of Part 2 as well as a total cumulative price for the entire project.

PART 8 – Evaluation and Award Decision

The technical volume will be evaluated based on the demonstrated ability to fulfill this requirement through a review of the technical approach, project management, personnel and relevant experience. Total price will also be a major factor in the award decision. The government will make a determination on the best value through considering a combination of the quality of the technical proposal and the price.

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items.