Attachment13-Proposal_Summary_and_Data_Record_NIH-2043.pdf

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Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances
Solicitation number
75N95023R00020
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL INSTITUTES OF HEALTH

PROPOSAL SUMMARY AND DATA RECORD

RFP NUMBER/CONTRACT NUMBER

PROJECT TITLE (Title of RFP or Contract Proposal)

LEGAL NAME AND ADDRESS OF OFFEROR PLACE OF PERFORMANCE (Full address including ZIP)

TYPE OF CONTRACT PROPOSED

COST-REIMBURSEMENT FIXED PRICE COST-PLUS FIXED-FEE OTHER

ESTIMATED TIME REQUIRED TO COMPLETE PROJECT PROPOSED STARTING DATE

ESTIMATED DIRECT COSTS IN PROPOSED YEAR (From Budget)

DOES THIS PROPOSAL INCLUDE A SUBCONTRACT? YES NO

(If yes, please furnish name and location of organization, description of services, basis for selection, responsible person employed by subcontractor and cost information.) (Use attachment if necessary.)

NAME AND TITLE OF PRINCIPAL INVESTIGATOR EST. HOURS WEEKLY AREA CODE/TEL. NO.

NAME AND TITLE OF CO-INVESTIGATOR (Use attachment if necessary) EST. HOURS WEEKLY AREA CODE/TEL. NO.

NAME AND TITLE OF INDIVIDUAL(S) AUTHORIZED TO NEGOTIATE CONTRACTS

NAME AND TITLE OF INDIVIDUAL(S) AUTHORIZED TO EXECUTE CONTRACTS

DOES THIS PROPOSAL INVOLVE HUMAN

SUBJECTS RESEARCH? YES NO EXEMPTION NUMBER (IFAPPLICABLE)

If YES to Human Subjects, is the IRB review Pending? YES NO If IRB Review Not Pending, IRB Approval Date

Human Subjects Assurance Number

An example of the informed consent for this study is enclosed YES NO N/A A Clinical Protocol is enclosed YES NO N/A

Are Vertebrate Animals Used? YES NO

If YES to Vertebrate Animals, is the IACUC review Pending? YES NO

If IACUC Review Not Pending, IRB Approval Date Animal Welfare Assurance Number

OFFEROR’S ACKNOWLEDGEMENT OF AMENDMENTS TO THE RFP (use attachment if necessary)

ERRATA

NUMBER

DATE ERRATA

NUMBER

DATE

NAME, ADDRESS, AND PHONE NUMBER OF COGNIZANT

GOVERNMENT AUDIT AGENCY

NUMBER OF EMPLOYEES CURRENTLY EMPLOYED

DOLLAR VOLUME OF BUSINESS PER ANNUM

THIS OFFER EXPIRES DAYS FROM THE DATE OF THIS OFFER.

(120 DAYS IF NOT SPECIFIED)

FOR THE INSTITUTION

SIGNATURE OF PRINCIPAL INVESTIGATOR SIGNATURE OF BUSINESS REPRESENTATIVE

TYPED NAME AND TITLE TYPED NAME AND TITLE

EMPLOYER IDENTIFICATION NUMBER DATE OF OFFER

NIH-2043 (Rev. 07/08) Attachment 8

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