Attachment_6_-_Reporting_Requirements.pdf

ATTACHMENT 6: REPORTING REQUIREMENTS AND DELIVERABLES

EVALUATION AND TESTING SERVICES (ETS) FOR VACCINES AND OTHER

BIOLOGICS FOR INFECTIOUS DISEASES

75N93024R00019

A. REPORTING REQUIREMENTS

A. Technical Reports:

In addition to those reports required by the other terms of this contract, the Contractor shall prepare and submit the following reports in the manner stated:

Format of Cover page: All reports shall include a cover page prepared in accordance with the following format:

• Contract and Task Order Number and Project Title

• Name and Sequence of Report (e.g., “Year 1, 2nd Study Report”)

• Period of Performance Being Reported

• Contractor’s Name and Address

• Author(s)

• Date of Submission

• Delivery Address

1) Monthly Progress Reports: The Contractor shall submit to the Contracting

Officer and to the Contracting Officer’s Representative (COR) electronic copies of Monthly Progress Reports covering the work accomplished during each reporting period to be delivered by the 15th of the month following each reporting period. These reports are subject to technical inspection and requests for clarification by the COR. These reports shall be brief and factual and shall include the following:

a. Progress on Milestones and Deliverables (actions taken to achieve the task);

b. All products, procedures and outcomes achieved;

c. Brief descriptions of pertinent data; graphs and tables of data obtained;

d. Updated schedule (i.e., Gantt chart);

e. Schedule analyses of estimated completion date with actual;

f. Discussion of schedule variance;

g. Financial summary by task (a summary of cost related to estimated effort completed) including cost variance;

h. Other information as may be required by the COR.

2) Study Report(s) Upon the completion of each study as indicated in the Task

Order, the Contractor shall submit a Final Study Report as described below. The

Study Report shall be concise, comply with relevant FDA and ICH guidelines, and consist of the following:

a. a description of the goals of the study and how the study was designed to

ii. achieve that goal;

1. a report of all products, procedures and outcomes achieved;

2. graphs and tables of data obtained;

3. a discussion and interpretation of the results

4. appendices with raw data such that the report is adequate for review by the

Food and Drug Administration.

II. REPORTS AND DELIVERABLES

Satisfactory performance of the completion of the Task Order shall be deemed to occur upon performance of the work described in the Statement of Work (Attachment 3), the Task Orders Statement of Work, and upon delivery and acceptance by the Contracting Officer, or duly authorized representative, of the following items in accordance with the stated delivery schedule.

If the Contractor becomes unable to deliver the reports or other deliverables herein specified within the period of performance because of unforeseen difficulties, notwithstanding the exercise of good faith and diligent effort in performance of the work, the Contractor shall give the Contracting Officer immediate written notice of anticipated delays with reasons therefore at the address given below.

The items stated below, and as described in Attachment 3: Statement of Work, in Attachment 6: Reporting Requirements and Deliverables, and in the Task Orders Statement of Work, shall be delivered F.o.b. Destination as set forth in FAR 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1994), and in accordance with and by the date(s) specified below and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING of the solicitation.

A. Technical Progress Reports

Item Deliverables Recipient Delivery Schedule 1 Monthly Progress Reports including updated Gantt chart for each individual Task Order

Submission via eRDS

Each report shall be submitted on or before the 15th of the month following each reporting period.

B. Other Reports and Deliveries

Item Deliverables Recipient Delivery Schedule 2 Draft Task Order Project

Management Plan Submission to

COR

Draft to be submitted within 30 calendar days of Task Order award.

3 Final Task Order Project Management Plan

Submission via eRDS

Final to be submitted within 10 business days after receipt of the COR comments

4 Draft Task Order Quality Management Plan

Submission to

COR

Within 30 calendar days of Task Order award.

5 Final Task Order Quality Management Plan

Submission via eRDS

10 business days after receipt of the COR comments

6 Materials for Meetings/Teleconference

Submission via eRDS

Agendas and Background Materials at least 2 days prior to the meeting/teleconference;

Written summaries no later than 3 business days after meeting/teleconference.

7 Copies of publications, abstracts, presentations, and any other information prior to public dissemination

Submission via eRDS

At least 30 calendar days prior to publication/release

SOW Task Area B (Assay Development, Clinical and Non-clinical Sample Testing) 8 Assay Development/ Reagent

Procurement Plan Draft submission to COR Final Submission via eRDS

Draft 30 calendar days after completion; Final within 10 business days of the after receipt of the COR comments

9 Study Plan/ Protocol

Draft submission to COR Final Submission via eRDS

Draft upon request by the COR; Final within 10 business days of the after receipt of the COR

10 Assay Development Report

Final Submission via eRDS

Draft 30 calendar days after completion; Final within 10 business days of the after receipt of the COR comments

11 Assay Qualification or Validation Protocol

Draft submission to COR Final Submission via eRDS

Draft upon request by the COR; Final within 10 business days of the after receipt of the COR comments

12 Assay Qualification or Validation Reports

Final Submission via eRDS

Draft 30 calendar days after completion; Final within 10 business days of the after receipt of the COR

13 Tech Transfer Plan as required by

COR

Draft submission to COR Final Submission via eRDS

Draft 30 calendar days after completion; Final within 10 business days of the after receipt of the COR comments

14 Sample Testing Plan Draft submission to COR Final Submission via eRDS

Draft upon request by the COR; Final within 10 business days of the after receipt of the COR comments

15 Study Report with Sample testing Results

Draft submission to COR Final Submission via eRDS

Draft upon request by the COR; Final within 10 business days of the after receipt of the COR comments

SOW Task Area C (Non-clinical Immunogenicity and Efficacy Testing) 16 Study Plan Draft submission to COR Final Submission via eRDS

Draft upon request by the COR; Final within 10 business days of the after receipt of the COR comments

17 Quality Agreement if study is conducted at Subcontractor site

Draft submission to COR Final Submission via eRDS

Draft upon request by the COR; Final within 10 business days of the after receipt of the COR comments

18 Study Protocol(s) Draft submission to COR Final Submission via eRDS

Draft upon request by the COR; Final within 10 business days of the after receipt of the COR comments

19 Study Report Draft submission to COR Final Submission via eRDS

Draft within 26 weeks of completion of the in-life phase; Final within 10 business days after the receipt of the COR comments

20 E-data Set (and delivery of all associated data), if applicable

Submission via eRDS

Within 30 calendar days of receipt of the final study report or as requested by the COR

21 Animal CRFs and scanned raw data, if applicable

Submission via eRDS

Within 30 calendar days of receipt of the final study report or as requested by the COR

22 Site visit/audit reports if study is conducted at Subcontractor site

Submission via eRDS

Within 30 calendar days of site visit or as requested by the COR

SOW Task Area D (Safety and Toxicity Testing including specialty toxicology) 23 Study Plan Draft submission to COR Final Submission via eRDS

Draft upon request by the COR; Final within 10 business days of the after receipt of the COR comments

24 Quality Agreement if study is conducted at Subcontractor site

Draft submission to COR Final Submission via eRDS

Draft upon request by the COR; Final within 10 business days of the after receipt of the COR comments

25 Study Protocol Draft submission to COR Final Submission via eRDS

Draft upon request by the COR; Final within 10 business days of the after receipt of the COR comments

26 Safety and Toxicology Study Report

Draft submission to COR Final Submission via eRDS

Draft within 4 months after completion of the in-life portion of the study; Final Study report within 10 business days after the receipt of the COR comments

27 E-data Set (and delivery of all associated data)

Submission via eRDS

Within 30 calendar days of receipt of the final study report or as requested by the COR

28 Site visit/audit reports Submission via eRDS

Within 30 calendar days of site visit or as requested by the COR

C. Copies of all reports shall be submitted as follows:

The above items shall be submitted in electronic format via the NIAID electronic Reports and Deliverables System, at https://erds.niaid.nih.gov/ or:

https://erds.niaid.nih.gov/

Number of Copies Addressee 1 electronic copy submitted via eRDS. Paper copies only as directed by the COR.

Contracting Officer’s Representative (COR), TBD Office of Biodefense, Research Resources and Translational Research (OBRRTR) National Institute of Allergy and Infectious Diseases National Institutes of Health 5601 Fishers Lane, Room TBD, MSC 9825 Rockville, MD 20852 Email: TBD

1 electronic copy submitted via eRDS.

Paper copies only as directed by the COR/CO.

Contracting Officer (CO), TBD Office of Acquisitions Division of Extramural Activities National Institute of Allergy and Infectious Diseases National Institutes of Health 5601 Fishers Lane, Room TBD, MSC 9825 Rockville, MD 20852 Email: TBD