About this file

This document is a Proposal Summary and Data Record form related to a federal contract opportunity. The key details are:

The Request for Proposal (RFP) is for manufacturing and nonclinical studies support for the development of therapeutic biotechnology products (Biologics) for neurological-related disorders. The National Institutes of Neurological Disorders and Stroke (NINDS) has a need for current Good Manufacturing Practices (cGMP) manufacturing and Good Laboratory Practice (GLP) nonclinical (preclinical) support services to support translational development of therapeutic Biologics. The contract would provide support for both Biologics cGMP manufacturing and GLP nonclinical services, including executing studies and completing documentation for regulatory filing and clinical trials. The work may be performed internally and/or through subcontractors. The contract has a 9-year ordering period expiring on September 29, 2030.

The proposal summary form contains general administrative details about the offeror, such as legal name, place of performance, principal investigator, and cost information. It also indicates whether the proposal involves human subjects, informed consent, and a clinical protocol. The form requires acknowledgment of amendments to the RFP.

View the file

Other files

File Type Posted
Pre-Proposal Conference_Transcript.pdf PDF
Amendment 3_Questions and Responses_6.10.2024.pdf PDF
Pre-Proposal Conference_Slides.pptx PPTX presentation
Amendment 2_Questions and Responses_5.31.2024.pdf PDF
Amendment 1_Questions and Responses_5.17.2024.pdf PDF
RFP Att. 17_SF-LLL.pdf PDF
RFP No. 75N95024R00050_Cover Letter.pdf PDF
RFP Att. 23_STO 3 - ASO Manufacturing Task Order.pdf PDF
RFP Att. 10_HHS Subcontracting Plan Template.docx DOCX document
RFP Att. 24_STO 4 - BPN-Biologics PK and Tox Task Order.pdf PDF
RFP Att. 8_Additional Technical Proposal Instructions.pdf PDF
RFP Att. 22_STO 2 - AAV Manufacturing Task Order.pdf PDF
RFP Att. 3_IDIQ Contract SOW.pdf PDF
RFP Att. 1_Packaging and Delivery of Proposals.pdf PDF
RFP Att. 19_Invoice Instructions NIH(RC)2.pdf PDF
RFP Att. 18_Invoice Instructions NIH(RC)1.pdf PDF
RFP Att. 7_VAS Worksheet.pdf PDF
RFP Att. 5_Technical Proposal Cost Summary.pdf PDF
RFP Att. 15_Points-of-contact.pdf PDF
RFP Att. 14_Business Proposal Budget Template_TO_4.xlsx XLSX spreadsheet
RFP Att. 20_DEC Acknowledgment.pdf PDF
RFP Att. 2_Proposal Intent Response Form.pdf PDF
RFP Att. 11_Business Proposal Budget Template_TO_1.xlsx XLSX spreadsheet
RFP Att. 21_STO 1- Kickoff and Project Management Plan.pdf PDF
RFP Att. 16_Wage Rate Determination (2023).pdf PDF
RFP Att. 4_Section K RepsandCerts.pdf PDF
RFP Att. 12_Business Proposal Budget Template_TO_2.xlsx XLSX spreadsheet
RFP No. 75N95024R00050.pdf PDF
RFP Att. 6_Summary_of_Related_Activities.pdf PDF
RFP Att. 13_Business Proposal Budget Template_TO_3.xlsx XLSX spreadsheet
Show all 30

On GovTribe

Work with this file

  • Download the original file
  • Contacts named in this file
  • Similar government files
  • Ask GovTribe AI about this file

Text version

DEPARTMENT OF HEALTH AND HUMAN SERVICES

PUBLIC HEALTH SERVICE

NATIONAL INSTITUTES OF HEALTH

PROPOSAL SUMMARY AND DATA RECORD

PROJECT TITLE (Title or RFP or Contract Proposal)

RFP/CONTRACT NUMBER

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

TYPE OF CONTRACT PROPOSED

� COST-REIMBURSEMENT � FIXED PRICE

ESTIMATED TIME REQUIRED TO COMPLETE PROJECT

ESTIMATED DIRECT COSTS IN PROPOSED YEAR (From Budget

� COST-PLUS-FIXED-FEE

PROPOSED STARTING DATE

� OTHER

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.)

NAME AND TITLE OF PRINCIPAL INVESTIGATOR SOCIAL SECURITY

NO.

EST. HOURS

WEEKLY

AREA

CODE/TEL.NO.

NAME AND TITLE OF CO-INVESTIGATOR (Use attachment if necessary.)

NAME AND TITLE OF INDIVIDUAL(S) AUTHORIZED TO

NEGOTIATE CONTRACTS

AREA CODE/TELEPHONE NUMBER

NAME AND TITLE OF INDIVIDUAL(S) AUTHORIZED TO

EXECUTE CONTRACTS

AREA CODE/TELEPHONE NUMBER

DOES THIS PROPOSAL INVOLVE EXPERIMENTS WITH HUMAN SUBJECTS � YES � NO

Institution’s General Assurance re: Human Subjects DATE APPROVED � PENDING Institution’s Review Board’s Approval of this Proposal DATE APPROVED � PENDING An example of the informed consent for this study is enclosed � YES � NO A Clinical Protocol is enclosed � YES � NO

OFFEROR’S ACKNOWLEDGMENT 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

June 1982

Attachment #9

Provision of the Social Security Number is voluntary. Social Security

Numbers are requested for the purpose of accurate and efficient identification, review, and management of NIH Extramural Programs.

Authority for requesting this information is provided by Title III, Section

301, and Title IV of the Public Health Service Act, as amended.

NIH-2043

June 1982

RFPCONTRACT NUMBER:
LEGAL NAME AND ADDRESS OF OFFEROR:
PLACE OF PERFORMANCE Full address including ZIP:
ESTIMATED DIRECT COSTS IN PROPOSED YEAR From Budget:
PROPOSED STARTING DATE:
NAME AND TITLE OF PRINCIPAL INVESTIGATOR:
SOCIAL SECURITY NONAME AND TITLE OF COINVESTIGATOR Use attachment if necessary:
EST HOURS WEEKLYNAME AND TITLE OF COINVESTIGATOR Use attachment if necessary:
AREA CODETELNONAME AND TITLE OF COINVESTIGATOR Use attachment if necessary:
NAME AND TITLE OF INDIVIDUALS AUTHORIZED TO NEGOTIATE CONTRACTS:
AREA CODETELEPHONE NUMBER:
NAME AND TITLE OF INDIVIDUALS AUTHORIZED TO EXECUTE CONTRACTS:
AREA CODETELEPHONE NUMBER_2:
DATE APPROVED:
DATE APPROVED_2:
ERRATA NUMBER:
DATE:
ERRATA NUMBER_2:
DATE_2:
NAME ADDRESS AND PHONE NUMBER OF COGNIZANT GOVERNMENT AUDIT AGENCY:
NUMBER OF EMPLOYEES CURRENTLY EMPLOYED:
DOLLAR VOLUME OF BUSINESS PER ANNUM:
THIS OFFER EXPIRES:
SIGNATURE OF PRINCIPAL INVESTIGATOR:
SIGNATURE OF BUSINESS REPRESENTATIVE:
TYPED NAME AND TITLE:
TYPED NAME AND TITLE_2:
EMPLOYER IDENTIFICATION NUMBER:
DATE OF OFFER:
Project Title (Title or RFP or Contract Proposal:
Type of Contract-CR: Off
Type of Contract-FP: Off
Type of Contract-CPFF: Off
Type of Contract-Other: Off
Estimated Time to Complete Project:
Subcontract?02: NO
Subcontract Name, address & Contact Information:
Social Security Number:
Estimated Hours for the PI:
Telephone Number - PI:
Name & Title of Co-Investigator:
Human Subjects? 02: Off
Pending-Assurance: Off
Pending-IRB: Off
Clinical Protocol Enclosed? 02: Off
Informed consent Enclosed? 02: Off

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