ATTACHMENT_4__Revised_5_9_23_Reporting_Requirements_and_Deliverables_0001.pdf

ATTACHMENT 4, Reporting Requirements and Deliverables

RFP 75N94023R00007

ATTACHMENT 3 - REPORTING REQUIREMENTS AND DELIVERABLES

DATED: May 9, 2023 (revised from January 16, 2023) Page 1

ARTICLE C.2 -- REPORTING REQUIREMENTS AND DELIVERABLES

Alcohol and Epidemiologic Data System (AEDS) 2023 - 2028

Schedule of Technical Deliverables - Included below is a schedule for the technical deliverables required for this contract:

Deliverable Quantity SOW Reference

Delivery Schedule

Planning Meeting Agenda The Contractor and appropriate Contractor staff shall meet virtually (or in person at NIAAA, at the discretion of the COR) with the Government COR, CO, and appropriate NIAAA staff to plan activities to be conducted during the base period, and any exercised options, during the contract period of performance, with emphasis on activities to be conducted during the base contract year.

1 electronic copy via e-mail to CO, COR and other NIAAA attendees (TBD)

3) B) 1 Within four (4) weeks after Contract start date.

Annual Plan of Performance the Contractor shall submit a report including

(1) a general outline of issues discussed, and directions proposed at the Planning Meeting, and (2) a draft plan of performance for the first contract year.

1 e-copy to NICHD Contracts [deliverables] Portal https://contracts.nichd.nih.gov

3) C) One (1) draft and final copy per year, starting within five (5) weeks of contract start date, and annually on the Option Start Date in Years 2, 3, 4, and 5 (for tasks to be performed during that applicable 12-month performance period).

For subcontract agreements, one draft copy 30 days prior to the effective date of https://contracts.nichd.nih.gov/

DATED: May 9, 2023 (revised from January 16, 2023) Page 2

Deliverable Quantity SOW Reference

Delivery Schedule the agreement, with a final copy following approval of the draft.

Monthly Progress Report The Contractor shall submit a monthly report briefly stating the progress made on each task, including percent completion of the project as of the end of the reporting period.

The report shall include work completed and in-progress, difficulties encountered during the reporting period and remedial action taken, and a statement of activity anticipated during the subsequent reporting period.

The reports shall also include any changes of personnel concerned with the project.

https://contracts.nichd.nih.gov

3) E) 1. Monthly reports shall be submitted within ten (10) days after the end of the preceding month.

No monthly report is required when the Annual or Final report is due.

Annual Reports The Contractor shall submit each year an annual report summarizing progress made on each task. The report shall include work completed and in-progress. The report shall also include any changes of personnel concerned with the project. The annual report shall be submitted no later than 10 days before the end of the contract year.

https://contracts.nichd.nih.gov

3) E) 2. Annual reports shall be submitted annually on or before the completion date of the applicable 12-month period of performance (Base Period or 12-month Option Period). No Annual Report is due when the Final Report is due.

Surveillance Reports Surveillance Reports on three (3) topics shall be produced

1 electronic copy to CO and COR, delivery as directed by

COR

3) D) 1. The Surveillance report on apparent per capita

DATED: May 9, 2023 (revised from January 16, 2023) Page 3

Deliverable Quantity SOW Reference

Delivery Schedule

These three (3) topics are:

(a) Apparent per capita consumption of alcoholic beverages;

(b) Liver cirrhosis mortality;

(c) Trends in underage drinking in the United States consumption of alcoholic beverages shall be delivered annually (Once during Base Period, and once during each successive 12-month Option period).

The Surveillance report on Liver Cirrhosis mortality shall be delivered two (2) times in Option Period 1 [second year of contract] and two

(2) times in Option Period 3 [fourth year of contract]

The Surveillance report on underage drinking shall be delivered one (1) time in Option Period 2 [Year 3 of contract].

Alcohol Epidemiologic Data Directory The Alcohol Epidemiologic Data Directory is a report that provides a current listing of surveys and other relevant data suitable for epidemiologic research on alcohol.

1 electronic copy to CO and COR, delivery as directed by

COR

3) D) 2. The Contractor shall update the Alcohol Epidemiologic Data Directory one

(1) time during Option Period 3 [fourth year of contract]

Posters and Slides The Contractor shall prepare posters and slides for presentation at research

Review copies sent electronically to CO and COR, delivery as directed by COR

3) G) 8.b. As needed, approximately six (6) posters shall be printed

DATED: May 9, 2023 (revised from January 16, 2023) Page 4

Deliverable Quantity SOW Reference

Delivery Schedule conferences/meetings as required throughout the contract period of performance each year.

Draft Final Report** The Contractor shall submit a draft final report describing the activities and accomplishments of the Contractor in the performance of this contract.

https://contracts.nichd.nih.gov

3) E) 3. 60 days prior to the ultimate completion of the contract*

Final Report ** The Contractor shall submit a final report describing the activities and accomplishments of the Contractor in the performance of this contract.

The final report shall be typed double space or space and a half and shall include all illustrations, tables, drawings, charts, data sheets, and other pertinent material as is necessary and sufficient to comprehensively explain the results achieved under the contract.

https://contracts.nichd.nih.gov

3) E) 4. 15 days prior to the ultimate completion of the contract*

Transition Plan*** The Contractor shall facilitate and ensure the smooth continuation of AEDS operations and performance of the various contract activities by the successor organization.

https://contracts.nichd.nih.gov

3) H) 2. 30 days prior to the ultimate completion of the contract* https://contracts.nichd.nih.gov/

DATED: May 9, 2023 (revised from January 16, 2023) Page 5

Deliverable Quantity SOW Reference

Delivery Schedule

Data/Data Sets*** All data and data sets acquired and maintained by the Contractor under the AEDS Contract shall be returned to the NIAAA

As directed by the COR and NIAAA Information Systems Security Officer

3) A) 4. 15 days prior to the ultimate completion of the contract*

*Ultimate completion date of the contract depends on the exercising of options.

**Draft Final Report and Final Report will due 15 days and 1 day respectively before the end of the final period exercised.

***Transition Plan and Data/Data Sets are due at the end of the final period exercised.

Schedule of Information and Physical Access Security Deliverables - Included below is a schedule for the information and physical access security-related deliverables required for this contract (see Article C.2 Reporting Requirements and the related Article in Section H, “Information and Physical Access Security” for full details):

Roster of Employees Requiring Suitability Investigations

1 e-copy via e-mail to CO, COR, Project Officer and

NIAAA ISSO

Initial report due 30 days after contract award and thereafter written notice of updates to CO, COR and NIAAA ISSO, within two (2) calendar days before a new employee assumes a position that requires access to HHS information systems or data or upon departure for departing personnel with such access.

Security Assessment and Authorization (SA&A Package) – Government Owned/Contractor Operated or Contractor Owned/Contractor Operated Resources

1 e-copy via e-mail to CO, COR, Project Officer and

NIAAA ISSO

Due within 90 days after contract award.

Updated thereafter in accordance with the “Government Information Processed on GOCO or COCO Systems Sub-Article in Section H, and as requested by the NIAAA ISSO and directed/approved by the CO

Evidence of Completion of Mandatory HHS/NIH Contractor Information Security Awareness, Privacy, and Records Management Training Course

(link to online course to be provided by NIH)

1 e-copy of completion certificates to CO, COR, Project Officer and NIAAA

ISSO

Within 30 days of contract award and annually thereafter for each annual term option exercised.

Incident Reporting 1 e-copy via e-mail to NIAAA Within 1 hour of discovery

DATED: May 9, 2023 (revised from January 16, 2023) Page 6

ISSO, NIH Incident Response Team (IRT), COR, Project Officer and CO

IT SC&A* 1 e-copy via e-mail to CO, COR, Project Officer and

NIAAA ISSO

Due three (3) months after contract award with annual assessment and reporting of results/verification that the IT-SC&A remains valid thereafter as requested by the NIAAA ISSO

Reporting of New and Departing Employees

1 e-copy via e-mail to CO, COR, Project Officer and

NIAAA ISSO

Within two (2) calendar days of staffing changes and/or departures for positions that require Information Security access/suitability determinations

Vulnerability Scanning Reports

1 e-copy via e-mail to CO, COR, Project Officer and

NIAAA ISSO

First report due 60 days after contract award.

Thereafter, monthly or as requested by the NIAAA ISSO and approved by the

CO.

Certification of Sanitization of Government and Government Activity-Related Files, Information, and Devices

1 e-copy via e-mail to CO, COR, Project Officer and

NIAAA ISSO

2 weeks prior to contract expiration or as specified by the NIAAA ISSO with approval by the CO.

For information stored in a Cloud Environment, data must be available to NIH within one (1) business day from request date.

*[IT-SC&A]

At the completion of the AEDS IT Security Certification and Accreditation (IT-SC&A), a Plan of Action and Milestones (POA&M) will be created to schedule and track the process of any remediation tasks identified during the assessment. Progress on those tasks will be reported within this report.

Schedule of Administrative and Regulatory Deliverables - Included below is a schedule for the administrative and regulatory deliverables required for this contract:

Section 508 Annual Report

– Electronic and Information Technology Accessibility

(see Article C.2. Reporting Requirements and the related Article in Section H)

1 e-copy to NICHD Contracts Portal https://contracts.nichd.nih.gov

November 30 of each year

Report of Gov’t Owned, Contractor Held Property

(see related Article in Section G)

1 e-copy to NICHD Contracts

November 30 of each year (submit negative report if no Gov’t Property)

DATED: May 9, 2023 (revised from January 16, 2023) Page 7

Service Contract Annual Report

(see Article I.4., FAR Clause 52.204-14, “Service Contract Reporting Requirements”)

Electronic submission to www.sam.gov and 1 e-copy to NICHD Contracts Portal

October 31st of each contract year in accordance with FAR 52.204-14

Annual Invention Utilization Report

(see related Article in Section C)

If any inventions to disclose, electronic submission to NIH Interagency Edison reporting system, http://www.iedison.gov and 1 e-copy to NICHD Contracts Portal https://contracts.nichd.nih.gov

If no inventions to disclose, send a negative report to the NICHD Contracts Portal

First report due on or before September 26, 2024; subsequent annual reports due on or before September 26 of each contract year

Final Invention Statement

(see related Article in Section C)

1 e-copy to NICHD Contracts

On or before the expiration date of the contract

Reporting of Financial Conflict of Interest (FCOI)

(see related Articles in Sections C and H)

1 e-copy via e-mail to the Contracting Officer

[Submit FCOI report and mitigation plan if and when a FCOI is identified]

As applicable, per “Institutional Responsibility Regarding Investigator Conflicts of Interest” Article in Section H of contract; in accordance with 45 CFR Part 94

All electronic reports (also designated as “e-copy” in the chart above) submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at http://www.hhs.gov/web/508/html under “Making Files Accessible.”

All reports required herein, other than those specifically designated to be submitted by e-mail or other method in the “Quantity” column in the chart above, shall be submitted in electronic format via the NICHD Contracts Portal available at the following website:

https://contracts.nichd.nih.gov. The Contractor must provide to the Contracting Officer/Contract Specialist the name of the person(s) submitting electronic reports via the NICHD Contracts Portal in order to initiate access to the Portal.

http://www.sam.gov/ http://www.iedison.gov/ https://contracts.nichd.nih.gov/ https://contracts.nichd.nih.gov/ https://contracts.nichd.nih.gov/ http://www.hhs.gov/web/508/html