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This pre-solicitation notice describes a forthcoming request for proposals from the National Institutes of Health seeking indefinite delivery/indefinite quantity contracts to provide manufacturing and nonclinical studies support services. Offerors will support the development of therapeutic biotechnology products for neurological disorders through tasks including cGMP manufacturing, process development, analytical methods development, formulation, fill-finish and release testing as well as nonclinical efficacy testing, ADME studies, toxicology studies, bioassay development and nonclinical study reporting. Services will aid programs such as the Neurotherapeutics Network Biologics initiative and the Ultra-Rare Gene Therapy program. The anticipated award date is Q1 FY2025 for an ordering period through September 2030. Responses to the forthcoming RFP will be accepted electronically via SAM.gov on or after March 14, 2024.

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PRESOLICITATION QUESTIONS AND RESPONSES

Presolicita�on No�ce No. 75N95024R00050

MANUFACTURING AND NONCLINICAL STUDIES SUPPORT FOR THE DEVELOPMENT OF THERAPEUTIC

BIOTECHNOLOGY PRODUCTS (BIOLOGICS) FOR NEUROLOGICAL RELATED DISORDERS

QUESTION 1: Can a vendor apply for Task Area 2 without applying for Task Area 1?

GOVERNMENT RESPONSE: No. Offerors must propose on the en�re Statement of Work. In cases where a vendor may not be able to fulfill all requirements using purely internal resources, vendors are encouraged to consider partnering / subcontrac�ng arrangements that would enable the vendor to complement their own internal exper�se and capabili�es.

QUESTION 2: Would our company qualify for the solicita�on?

GOVERNMENT RESPONSE: Please see the pre-solicita�on no�ce for a descrip�on of the requirement.

The solicita�on will also include all necessary informa�on and instruc�ons related to submission requirements and evalua�on criteria. All interested vendors are encouraged to apply.

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