Attachment 2 - Representation and Certification.pdf

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Attached to
Pharmaceutics / Formulation / Chemistry Manufacturing Control Consulting Services Federal contract opportunity
Solicitation number
NIH-NINDS-CSS-21-005340
Issued by
Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse

About this file

This solicitation requests consulting services to support the National Institute of Neurological Disorders and Stroke's HEAL Program and other neuroscience drug discovery and development programs. Key details include:

The solicitation seeks Pharmaceutics/Formulation/Chemistry Manufacturing Control consultants to provide senior-level expertise on projects through conference calls and emails. Responsibilities include evaluating CMC activities for compounds under development, identifying regulatory risks, developing strategies, assisting with documents for clinical trials and marketing applications, and recommending dose forms and development strategies. A minimum of 20 hours is required annually with up to 780 optional hours. Consultants must have extensive industry experience in drug discovery for nervous system conditions, strong team and communication skills, and a Ph.D. in a life science plus 15 years of CMC experience. The period of performance is one base year followed by two option years. The primary place of performance is the contractor's worksite with occasional work at government or investigator facilities. Payment will be via EFT on a labor-hour contract with options to extend.

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Other files for this federal contract opportunity

Other files attached to Pharmaceutics / Formulation / Chemistry Manufacturing Control Consulting Services, newest first.
File Type Posted
Attachment 1 - Price Template.xlsx XLSX spreadsheet
CSS_Pharmaceutics-Formulation-CMC.pdf PDF
Attachment 3 - Invoice Submission Instructions.pdf PDF
Attachment 4 - System of Records Notice 09-25-0118.pdf PDF

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Note: Please pay particular attention to the highlighted portions of this document and provide no more information than is required.

FAR 52.204-26 COVERED TELECOMMUNICATION EQUIPMENT OR SERVICES—REPRESENTATION (OCT 2020)

(a) Definitions. As used in this provision, “covered telecommunications equipment or services” has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM) (https://www.sam.gov) for entities excluded from receiving federal awards for “covered telecommunications equipment or services”.

(c) Representation. The Offeror represents that

It [ ] does, [ ] does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument.

(End of provision)

FAR 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE

SERVICES OR EQUIPMENT (OCT 2020)

The Offeror shall not complete the representation at paragraph (d)(1) of this provision if the Offeror has represented that it "does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument" in paragraph (c)(1) in the provision at 52.204-26, Covered Telecommunications Equipment or Services—Representation, or in paragraph (v)(2)(i) of the provision at 52.212-3, Offeror Representations and Certifications- Commercial Items. The Offeror shall not complete the representation in paragraph (d)(2) of this provision if the Offeror has represented that it "does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services" in paragraph (c)(2) of the provision at 52.204-26, or in paragraph (v)(2)(ii) of the provision at 52.212-3.

(a) Definitions. As used in this provision—

Backhaul, covered telecommunications equipment or services, critical technology, interconnection arrangements, reasonable inquiry, roaming, and substantial or essential component have the meanings provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

REPRESENTATIONS AND CERTIFICATION

NIH-NINDS-CSS-21-005340

“Pharmaceutics / Formulation /Chemistry Manufacturing Control Consulting Services” https://www.acquisition.gov/far/52.204-26#FAR_52_204_26 https://www.acquisition.gov/far/52.212-3#FAR_52_212_3 https://www.acquisition.gov/far/52.204-26#FAR_52_204_26 https://www.acquisition.gov/far/52.212-3#FAR_52_212_3 https://www.acquisition.gov/far/52.204-25#FAR_52_204_25

(b) Prohibition.

(1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. Nothing in the prohibition shall be construed to—

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(2) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115-232) prohibits the head of an executive agency on or after August 13, 2020, from entering into a contract or extending or renewing a contract with an entity that uses any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. This prohibition applies to the use of covered telecommunications equipment or services, regardless of whether that use is in performance of work under a Federal contract. Nothing in the prohibition shall be construed to—

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(c) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM) (https://www.sam.gov) for entities excluded from receiving federal awards for "covered telecommunications equipment or services".

(d) Representation. The Offeror represents that—

(1) It [ ] will, [ ] will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation. The Offeror shall provide the additional disclosure information required at paragraph (e)(1) of this section if the Offeror responds “will” in paragraph (d)(1) of this section; and

(2) After conducting a reasonable inquiry, for purposes of this representation, the Offeror represents that—

It [ ] does, [ ] does not use covered telecommunications equipment or services, or use any equipment, system, or service that uses covered telecommunications equipment or services. The Offeror shall provide the additional disclosure information required at paragraph (e)(2) of this section if the Offeror responds “does” in paragraph (d)(2) of this section.

https://www.sam.gov/

(e) Disclosures.

(1) Disclosure for the representation in paragraph (d)(1) of this provision. If the Offeror has responded "will" in the representation in paragraph (d)(1) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment—

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the original equipment manufacturer (OEM) or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand;

model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(ii) For covered services—

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the Product Service Code (PSC) of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(2) Disclosure for the representation in paragraph (d)(2) of this provision. If the Offeror has responded "does" in the representation in paragraph (d)(2) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment—

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the OEM or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand;

model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(ii) For covered services—

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the PSC of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(End of provision)

HHSAR 352.231-70 SALARY RATE LIMITATION (DECEMBER 18, 2015)

The Offeror represents that –

All quoted labor rates [ ] are, [ ] are not based on salaries that fully comply with HHSAR Clause 352.231- 70, Salary Rate Limitation, which is incorporated in full text into the terms and conditions of the above referenced solicitation.

(End of representation)

OFFEROR’S CERTIFICATION:

Signature of Authorized Individual Date

Title of Authorized Individual:

Organization Name:

File details come from the government source that posted it. Updated .