RFP_N01DA-16-5582_FINAL_04-23-2015.pdf

OMB #0990-0115

Request for Proposal (RFP) No. N01DA-16-5582

“Population Assessment of Tobacco and Health (PATH) Study”

Issued by:

Brian H. O’Laughlin, Contracting Officer NIDA R&D Contracts Management Branch Office of Acquisitions, NIDA National Institute on Drug Abuse, NIH 6001 Executive Boulevard Suite 4211, MSC 9559 Bethesda, MD 20892-9559

Point of Contact: Philip J. DeCastro, Contract Specialist E-Mail: decastropj@mail.nih.gov Phone: 301.443.6677

DATE ISSUED: April 23, 2015

PROPOSAL DUE DATE: June 8, 2015 3:00 P.M. (local time)

Ladies and Gentlemen:

The National Institute on Drug Abuse (NIDA) invites you to send a proposal responding to the requirements of this RFP No. N01DA-16-5582 for “Population Assessment of Tobacco and Health (PATH) Study.”

The Government releases this Request for Proposals (RFP) under FULL AND OPEN Competition Procedures.

The Government prepared this Request for Proposals in accordance with the Uniform Contract Format prescribed for Government Wide application by the Federal Acquisition Regulation (FAR). The Uniform Contract Format is both a Request for Proposal and a contract award document. The resulting contract will consist of Parts I, II, III of the Uniform Contract Format.

NIDA expects to award a single cost-reimbursement, completion type contract with a base period of performance of eight months plus eight one-year option periods. As defined in the Statement of Work, each option period will be for the completion of additional tasks. In addition to the options to extend the contract period of performance, option quantities are included. Option periods and option quantities are not guaranteed to be exercised. All funding will be dependent on programmatic needs and funding availability. NIDA anticipates substantial subcontracting opportunities under this project. NIDA plans a contract effective date and performance period starting on or around April 1, 2016. You should respond with technical and pricing proposals based on the assumptions provided in Sections C and L. Please include separate pricing for each individual option.

Particularly direct your attention to Part IV, which contains instructions, provisions, and evaluation factors for the submission and review of proposals. Further direct your attention to Attachment 2, "Proposal Intent Response Sheet." Please complete this form and return it to this office on or before May 7, 2015. The balance of Parts I, II, and III contain provisions, clauses, and special requirements that will be made a part of any resultant award. Review these parts as to the effects on performance capability and technical and cost considerations in the development of your proposal. However, you may not fill in blanks or otherwise complete portions of Parts I, II, and III that otherwise appear to require the insertion of data. The Government will complete those Parts prior to contract award. NIDA tailors Parts I, II, and III with the selected offeror to the final negotiation (if negotiations are conducted) and modified, as necessary, for the type of contractor organization, cost and/or fee arrangement, and other elements as negotiated prior to award.

An official authorized to contractually bind your organization must sign the proposal. The Contracting Officer must receive one (1) original and thirteen (13) copies of your technical proposal and one (1) original and eight (8) copies of your business proposal no later than 3:00 p.m., local prevailing time on June 8, 2015 (See Attachment 1, Instructions for Packaging and Delivery of Proposals).

Furnish in writing (by e-mail is acceptable) any areas of uncertainty, which, in your opinion, require clarification or correction to the Contracting Officer. You must submit your questions in sufficient time for receipt on or before May 7, 2015. Mark the envelope or e-mail, "Offeror's Questions, RFP No. N01DA-16-5582."

This RFP does not commit the Government to pay the costs for the preparation and submission of a proposal. The Contracting Officer is the only individual who legally can commit the Government to the expenditure of public funds in connection with this acquisition.

Following your proposal submission and our review, the Contracting Officer may seek more information. In accordance with FAR 15.306(a)(3) and FAR 52.215-1, NIDA advises you that the Government intends to evaluate proposals and award a contract without discussions (except clarifications). Therefore, your initial proposal should contain the best terms from cost or price and technical standpoints. However, NIDA reserves the right to conduct discussions if the Contracting Officer later decides them to be necessary.

You must have an authorized organizational official sign your Business Proposal. It must contain a detailed breakdown of costs by year and individual options. For each cost category/element, provide an explanation of the basis for all costs, and provide documentation to support these costs. Please direct special attention to the Breakdown of Proposed Estimated Costs (plus fixed fee) with Excel Spreadsheet contained in the Business Proposal Cost Information, Attachment 13. Please provide a hard copy of the spreadsheet in this format and include an electronic file on a CD. Do not send encrypted files. Use of the above format will hasten review and potential award. See Section L.2.c. Business Proposal Instructions for additional detail.

Please include a completed Form NIH-2043, “Proposal Summary and Data Record” with the Business Proposal. Note that in addition to telephone and fax numbers, you should include the e-mail addresses of both the Principal Investigator and the responsible business representative on the form. Section L.2.b. Technical Proposal details the format and content requirements of your Technical Proposal. You must list all professional personnel and organizations named in the proposal who will have any role in the proposed work. This requirement includes your staff, subcontractors, collaborating organizations, and consultants. Show the organization affiliation(s) for every person named. You may use extra sheets, as needed, following the format shown in the Technical Proposal Cover Sheet. NIDA will use this information to ensure that no conflicts of interest exist with the selected review committee members.

http://rcb.cancer.gov/rcb-internet/forms/2043.pdf

The Offeror must submit its Travel Policy, Total Compensation Plan, and Annual Report with the initial Business Proposal.

If you would like to receive an e-mail notice of any amendments to this RFP, you should register on the FedBizOpps website. Also, NIDA will post all amendments, or provide an appropriate link, on the NIDA Contracts Home Page.

Any contract award for this requirement is contingent on the availability of funds (see FAR 52.232-18, Availability of Funds – April 1984).

Please direct requests for any information concerning this RFP to Philip J. DeCastro, Contract Specialist, NIDA R&D Contracts Management Branch. Emails without the subject line of “Offeror’s Questions, RFP No. N01DA-16-5582” may not receive a response and collect calls will not be accepted. Discussions with any individual outside the NIDA R&D Contracts Management Branch should not occur.

Sincerely, Brian H. O’Laughlin, Contracting Officer NIDA R&D Contracts Management Branch Office of Acquisitions, NIDA/NIH

- 1 -

SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: P.L. 102.321 as amended

2. Request for Proposal (RFP) Number:

N01DA-16-5582

3. Issue Date:

04/23/2015

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Population Assessment of Tobacco and Health (PATH) Study

6. ISSUED BY:

NIDA R&D Contracts Management Branch Office of Acquisitions National Institute on Drug Abuse National Institutes of Health 6001 Executive Boulevard, Room 4211 - MSC 9559 Bethesda, MD 20892-9559* *If using FedEx, UPS, hand delivery or other non-USPS courier service use Rockville, MD 20852

7. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of the Proposal," ATTACHMENT 1 of this Solicitation.

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 3:00 PM local time on June 8, 2015. Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

9. This solicitation requires delivery of proposals as stated in ATTACHMENT 1, "PACKAGING AND DELIVERY

OF THE PROPOSAL."

IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT THE PLACE AND TIME SPECIFIED FOR THE OFFICE OF ACQUISITIONS, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH HHSAR Clause 352.215-70, "Late Proposals and Revisions"

LOCATED IN SECTION L.1. OF THIS SOLICITATION.

10. Offeror must be registered in the Central Contractor Registry (CCR) prior to award of a contract. Offerors must access the CCR through The System for Award Management (SAM) at http://www.sam.gov

11. FOR INFORMATION CALL: Philip DeCastro

PHONE: 301-443-6677

e-MAIL: philip.decastro@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Brian H. O'Laughlin Contracting Officer NIDA R&D Contracts Management Branch National Institute on Drug Abuse, NIH http://www.sam.gov

RFP Number : N01DA-16-5582

- 2 -

RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. ESTIMATE OF EFFORT

e. COMMITMENT OF PUBLIC FUNDS

f. PROMOTING EFFICIENT SPENDING

g. COMMUNICATIONS PRIOR TO CONTRACT AWARD

h. RELEASE OF INFORMATION

i. REFERENCE MATERIALS

j. PREPARATION COSTS

k. SERVICE OF PROTEST

l. LATE PROPOSALS AND REVISIONS

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

3. Proposal Summary and Data Record (NIH-2043)

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

- 3 -

9. Standards for Privacy of Individually Identifiable Health Information

10. Privacy Act - Treatment of Proposal Information

11. Selection of Offerors

12. Institutional Responsibility Regarding Investigator Conflicts of Interest

13. ROTC Access and Federal Military Recruiting on Campus

14. Certification of Filing and Payment of Taxes

15. Past Performance Information

16. Information and Physical Access Security

17. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Human Subjects

Notice to Offerors of Requirements of 45 CFR Part 46, Protection of Human Subjects, HHSAR 270-4(a)

Instructions to Offerors Regarding Protection of Human Subjects

Required Education in the Protection of Human Research Participants

Inclusion of Women and Minorities in Research Involving Human Subjects

Inclusion of Children in Research Involving Human Subjects

5. Obtaining and Disseminating Biomedical Research Resources

6. Electronic and Information Technology Accessibility, HHSAR 352.239-73(a)

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

4. Requirements for Cost or Pricing Data or Information Other than Cost and Pricing Data

5. Salary Rate Limitation

6. Small Business Subcontracting Plan

7. Mentor Protege Program, HHSAR 352.219-70

8. HUBZone Small Business Concerns

9. Total Compensation Plan

10. Other Administrative Data

11. Qualifications of the Offeror

12. Subcontractors

13. Proposer's Annual Financial Report

14. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. HUMAN SUBJECT EVALUATION

4. MANDATORY QUALIFICATION CRITERIA

5. EVALUATION OF OPTIONS

6. EVALUATION OF DATA SHARING PLAN

- 4 -

7. TECHNICAL EVALUATION FACTORS

8. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

9. PAST PERFORMANCE FACTOR

10. SUBCONTRACTING PROGRAM EVALUATION CRITERIA

- 5 -

PART I - THE SCHEDULE

THE INFORMATION SET FORTH IN SECTION A - SOLICITATION/CONTRACT FORM, HEREIN CONTAINS IMPORTANT INFORMATION FOR ANY OFFEROR INTERESTED IN RESPONDING TO THIS SOLICITATION.

ANY CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS SECTION A - SOLICITATION/ CONTRACT FORM, ACCOUNTING, APPROPRIATION AND GENERAL INFORMATION APPLICABLE TO THE

CONTRACT AWARD.

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN, CONTAINS CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS NOT AN EXACT REPRESENTATION OF THE CONTRACT DOCUMENT THAT WILL BE AWARDED AS A RESULT OF THIS SOLICITATION. THE CONTRACT COST OR PRICE AND OTHER CONTRACTUAL PROVISIONS PERTINENT TO THE OFFEROR (i.e., those relating to the organizational structure [e.g., Non-Profit, Commercial] and specific cost authorizations unique to the Offeror's proposal and requiring Contracting Officer Prior Approval) WILL BE DISCUSSED IN THE NEGOTIATION PROCESS, IF NECISSARY, AND WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED CONTRACT SCHEDULE IS INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION

TO UNDERSTAND THE TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The National Institutes of Health (NIH), through the National Institute on Drug Abuse (NIDA) and in partnership with the Center for Tobacco Products (CTP) of the Food and Drug Administration (FDA), seeks to continue the Population Assessment of Tobacco and Health (PATH) Study for an additional four waves of behavioral data and biospecimen collection.

If all options are exercised, this contract is for four additional waves of the PATH Study (Waves 4 through 7), each 12 months in length and conducted biennially. Wave 4 and Wave 6 of this contract require cohort replenishment to the baseline sample size of at least 45,971 current, former, and never tobacco-product users, including at least 32,320 adults, ages 18 years and older and 13,651 youth, ages 12 to 17 years.

ARTICLE B.2. ESTIMATED COST PLUS FIXED FEE- OPTION

a. The estimated cost of the Base Period of this contract is $ .

b. The fixed fee for the Base Period of this contract is $ . The fixed fee shall be paid in installments based on the percentage of completion of work, as determined by the Contracting Officer. Payment shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of this contract.

c. The total estimated amount of the contract, represented by the sum of the estimated cost plus the fixed fee for the Base Period is $ .

d. If the Government exercises its option pursuant to the OPTION PROVISION Article in SECTION H of this contract, the Government's total estimated contract amount represented by the sum of the estimated cost plus the fixed fee will be increased as follows:

Estimated Cost ($) Fixed Fee ($) Estimated Cost Plus Fixed Fee (CPFF) ($)

Base Period Option Period 1 Option Period 2 Option Period 3 Option Period 4 Option Period 5

- 6 -

Estimated Cost ($) Fixed Fee ($) Estimated Cost Plus Fixed Fee (CPFF) ($)

Option Period 6 Option Period 7 Option Period 8

Period of Performance

Description of Option Item or Option Service

Quantity (Units) Unit CPFF Total CPFF of Option

Option 9-Research Papers Up to 25 times Option 10-Analytic Reports Up to 15 times Option 11-Short-Turnaround Analyses Up to 25 times Option 12-Formative Nested Studies Up to 4 times Option 13-Small Nested Studies Up to 3 times Option 14-Medium Sized Nested Studies Up to 3 times

Base Period

Option 15-Large Nested Studies Up to 2 times

Period of Performance

Description of Option Item or Option Service

Quantity (Units) Unit CPFF Total CPFF of Option

Option 9-Research Papers Up to 25 times Option 10-Analytic Reports Up to 15 times Option 11-Short-Turnaround Analyses Up to 25 times Option 12-Formative Nested Studies Up to 4 times Option 13-Small Nested Studies Up to 3 times Option 14-Medium Sized Nested Studies Up to 3 times

Option Period 1

Option 15-Large Nested Studies Up to 2 times

Period of Performance

Description of Option Item or Option Service

Quantity (Units) Unit CPFF Total CPFF of Option

Option 9-Research Papers Up to 25 times Option 10-Analytic Reports Up to 15 times Option 11-Short-Turnaround Analyses Up to 25 times Option 12-Formative Nested Studies Up to 4 times Option 13-Small Nested Studies Up to 3 times Option 14-Medium Sized Nested Studies Up to 3 times

Option Period 2

Option 15-Large Nested Studies Up to 2 times

Period of Performance

Description of Option Item or Option Service

Quantity (Units) Unit CPFF Total CPFF of Option

Option 9-Research Papers Up to 25 times Option 10-Analytic Reports Up to 15 times Option 11-Short-Turnaround Analyses Up to 25 times Option 12-Formative Nested Studies Up to 4 times Option 13-Small Nested Studies Up to 3 times Option 14-Medium Sized Nested Studies Up to 3 times

Option Period 3

Option 15-Large Nested Studies Up to 2 times

Period of Performance

Description of Option Item or Option Service

Quantity (Units) Unit CPFF Total CPFF of Option

Option 9-Research Papers Up to 25 times Option 10-Analytic Reports Up to 15 times Option 11-Short-Turnaround Analyses Up to 25 times

Option Period 4

Option 12-Formative Nested Studies Up to 4 times

- 7 -

Period of Performance

Description of Option Item or Option Service

Quantity (Units) Unit CPFF Total CPFF of Option

Option 13-Small Nested Studies Up to 3 times Option 14-Medium Sized Nested Studies Up to 3 times Option 15-Large Nested Studies Up to 2 times

Period of Performance

Description of Option Item or Option Service

Quantity (Units) Unit CPFF Total CPFF of Option

Option 9-Research Papers Up to 25 times Option 10-Analytic Reports Up to 15 times Option 11-Short-Turnaround Analyses Up to 25 times Option 12-Formative Nested Studies Up to 4 times Option 13-Small Nested Studies Up to 3 times Option 14-Medium Sized Nested Studies Up to 3 times

Option Period 5

Option 15-Large Nested Studies Up to 2 times

Period of Performance

Description of Option Item or Option Service

Quantity (Units) Unit CPFF Total CPFF of Option

Option 9-Research Papers Up to 25 times Option 10-Analytic Reports Up to 15 times Option 11-Short-Turnaround Analyses Up to 25 times Option 12-Formative Nested Studies Up to 4 times Option 13-Small Nested Studies Up to 3 times Option 14-Medium Sized Nested Studies Up to 3 times

Option Period 6

Option 15-Large Nested Studies Up to 2 times

Period of Performance

Description of Option Item or Option Service

Quantity (Units) Unit CPFF Total CPFF of Option

Option 9-Research Papers Up to 25 times Option 10-Analytic Reports Up to 15 times Option 11-Short-Turnaround Analyses Up to 25 times Option 12-Formative Nested Studies Up to 4 times Option 13-Small Nested Studies Up to 3 times Option 14-Medium Sized Nested Studies Up to 3 times

Option Period 7

Option 15-Large Nested Studies Up to 2 times

Period of Performance

Description of Option Item or Option Service

Quantity (Units) Unit CPFF Total CPFF of Option

Option 9-Research Papers Up to 25 times Option 10-Analytic Reports Up to 15 times Option 11-Short-Turnaround Analyses Up to 25 times Option 12-Formative Nested Studies Up to 4 times Option 13-Small Nested Studies Up to 3 times Option 14-Medium Sized Nested Studies Up to 3 times

Option Period 8

Option 15-Large Nested Studies Up to 2 times

Estimated Cost ($) Fixed Fee ($) Estimated CPFF($) Option 16-Transition Option Total Base Period, Option Periods, and Option Quantities

- 8 -

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable: 1) Conferences & Meetings; 2) Food for Meals, Light Refreshments & Beverages; 3) Promotional Items; 4) Acquisition, by purchase or lease, of any interest in real property; 5) Special rearrangement or alteration of facilities; 6) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 7) Travel Costs including Foreign Travel; 8) Consultant Costs; 9) Subcontract Costs; 10) Patient Care Costs; 11) Accountable Government Property; 12) Printing costs; and 13) Research Funding.

ARTICLE B.4. ADVANCE UNDERSTANDINGS

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.

Remainder of page intentionally left blank

- 9 -

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

b. The applicable Privacy Act System of Records Number will be specified and shall be used in any design, development, or operation work to be performed under the resultant contract. Disposition of records shall be in accordance with SECTION C of the contract, and by direction of the Contracting Officer's Representative (COR).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format. In addition, hardcopies of certain reports shall be submitted to the Contracting Officer Representative and Contracting Officer, as specified in Section F.

All electronic reports 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/index.html under "Making Files Accessible."

All paper/hardcopy documents/reports submitted under this contract shall be printed or copied, double-sided, on at least 30 percent post consumer fiber paper, whenever practicable, in accordance with FAR 4.302(b).

a. Technical Progress Reports

1. In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award. Note: The Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.

All paper/hardcopy documents/reports submitted under this contract shall be printed or copied, double-sided, on at least 30 percent post consumer fiber paper, whenever practicable, in accordance with FAR 4.302(b).

For proposal preparation purposes only, it is estimated that in addition to the required electronic version(s) 1-3 hard copies of these reports will be required as follows:

[X] Monthly (For additional information see Part b.5.4 Additional Deliverables, below) [ ] Quarterly [ ] Semi-Annually [ ] Annually [ ] Annually (with a requirement for a Draft Annual Report) [ ] Final - Upon final completion of the contract [X] Final - Upon final completion of each contract period (with a requirement for a Draft Final Report) (For additional information see Part b.5.8 Additional Deliverables, below) http://www.hhs.gov/web/508/index.html

- 10 -

2. Summary of Salient Results

The Contractor will be required to prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. This report will be required on or before the expiration date of the contract.

3. Annual Technical Progress Report for Clinical Research Study Populations

The Contractor shall submit information about the inclusion of women and members of minority groups and their subpopulations (when appropriate) for each study being performed under this contract. The Contractor shall submit this information in the format indicated in the attachment entitled, "Cumulative Inclusion Enrollment Report," which is set forth in SECTION J of this contract.

The Contractor also shall use this format, modified to indicate that it is a final report, for reporting purposes in the contract period final report. If the clinical study(s) involves US and non-US sites, the US sites and non-US sites should be reported on separate Cumulative Inclusion Enrollment Reports.

The Contractor shall submit the report in accordance with the DELIVERIES Article in SECTION F of this contract.

In addition, the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, Amended, October, 2001 applies. If this contract is for Phase III clinical trials, see II.B of these guidelines. The Guidelines may be found at the following website: http://grants.nih.gov/ grants/funding/women_min/women_min.htm.

For NIH-defined Phase III Clinical Trials: Include a description of the plans for valid analysis in the study design and outcomes. This includes designing the study in a manner that potential differences, as appropriate, by sex/gender and/or racial/ethnic groups in the clinical trial protocol could be conducted. Also, provide a description of any analyses by sex/gender, race, and/or ethnicity, as appropriate, in the annual progress report and the final report. If the analysis reveals no subset differences, a brief statement to that effect, indicating the subsets analyzed, will suffice. The Government strongly encourages inclusion of the results of subset analysis in all publication submissions. In the final report, the Contractor shall include all final analyses of the data on sex/ gender, race and/or ethnicity.

b. Other Reports/Deliverables

1. Reporting of Financial Conflict of Interest (FCOI)

All reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be submitted to the Contracting Officer in Electronic format. Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part 94.

45 CFR Part 94 is available at: http://www.ecfr.gov/cgi-bin/text-idx?

c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45.

See Part 94.5, Management and reporting of financial conflicts of interest for complete information on reporting requirements.

(Reference subparagraph g. of the INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST Article in SECTION H of this contract.)

2. Source Code and Object Code

Unless otherwise specified herein, the Contractor shall deliver to the Government, upon the expiration date of the contract, all source code and object code developed, modified, and/or enhanced under this contract.

http://grants.nih.gov/grants/funding/women_min/women_min.htm http://grants.nih.gov/grants/funding/women_min/women_min.htm http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45 http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45

- 11 -

3. Information Security and Physical Access Reporting Requirements

The Contractor shall submit the following reports as required by the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract. Note: Each report listed below includes a reference to the appropriate subparagraph of this article.

a. Roster of Employees Requiring Suitability Investigations

The Contractor shall submit a roster, by name, position, e-mail address, phone number and responsibility, of all staff (including subcontractor staff) working under the contract who will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted to the Contracting Officer's Representative (COR), with a copy to the Contracting Officer, within 14 calendar days of the effective date of the contract. (Reference subparagraph A.d. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

b. IT Security Plan (IT-SP)

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the contractor shall submit the IT-SP within 30 days after contract award. The IT-SP shall be consistent with, and further detail the approach to, IT security contained in the Contractor's bid or proposal that resulted in the award of this contract. The IT-SP shall describe the processes and procedures that the Contractor will follow to ensure appropriate security of IT resources that are developed, processed, or used under this contract. If the IT-SP only applies to a portion of the contract, the Contractor shall specify those parts of the contract to which the IT-SP applies.

The Contractor shall review and update the IT-SP in accordance with NIST SP 800-53A, Guide for Assessing the Security Controls in Federal Information Systems and Organizations, on an annual basis.

(Reference subparagraph D.c.1. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

c. IT Risk Assessment (IT-RA)

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the contractor shall submit the IT-RA within 30 days after contract award. The IT-RA shall be consistent, in form and content, with NIST SP 800-30, Risk Management Guide for Information Technology Systems, and any additions or augmentations described in the HHS-OCIO Information Systems Security and Privacy Policy.

The Contractor shall update the IT-RA on an annual basis.

(Reference subparagraph D.c.2. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

d. FIPS 199 Assessment

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the Contractor shall submit a FIPS 199 Assessment within 30 days after contract award. The FIPS 199 Assessment shall be consistent with the cited NIST standard.

- 12 -

(Reference subparagraph D.c.3. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECITON H of this contract.

e. IT Security Certification and Accreditation (IT-SC&A)

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the Contractor shall submit written proof to the Contracting Officer that an IT-SC&A was performed within 3 months after contract award.

The Contractor shall perform an annual security control assessment and provide to the Contracting Officer verification that the IT-SC&A remains valid.

(Reference subparagraph D.c.4. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

f. Reporting of New and Departing Employees

The Contractor shall notify the Contracting Officer's Representative (COR) and Contracting Officer within five working days of staffing changes for positions that require suitability determinations as follows:

a. New Employees who have or will have access to HHS Information systems or data: Provide the name, position title, e-mail address, and phone number of the new employee. Provide the name, position title and suitability level held by the former incumbent. If the employee is filling a new position, provide a description of the position and the Government will determine the appropriate security level.

b. Departing Employees: 1) Provide the name, position title, and security clearance level held by or pending for the individual; and 2) Perform and document the actions identified in the "Employee Separation Checklist", attached in Section J, ATTACHMENTS of this contract, when a Contractor/Subcontractor employee terminates work under this contract. All documentation shall be made available to the COR and/or Contracting Officer upon request.

(Reference subparagraph E.3.a-c. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

g. Contractor - Employee Non-Disclosure Agreement(s) The contractor shall complete and submit a signed and witnessed "Commitment to Protect Non-Public Information

- Contractor Agreement" form for each contractor and subcontractor employee who may have access to non-public Department information under this contract. This form is located at: https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/ Nondisclosure.pdf.

(Reference subparagraph E.3.d. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

h. Vulnerability Scanning Reports

The Contractor shall report the results of the required monthly special vulnerability scans no later than 10 days following the end of each reporting period. If required monthly, this report may be included as part of the Technical Progress Report. Otherwise, this report shall be submitted under separate cover on a monthly basis.

- 13 -

(Reference subparagraph E.5. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

4. Section 508 Annual Report

The Contractor shall submit an annual Section 508 report in accordance with the schedule set forth in the ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY Article in SECTION H of this contract. The Section 508 Report Template and Instructions for completing the report are available at: http://www.hhs.gov/web/508/contracting/technology/vendors.html under "Vendor Information and Documents."

5. Additional Deliverables - Refer to the Statement of Work (See Section J - List of Attachments) for full details:

1. Meeting summary; agenda and minutes - At the conclusion of each meeting, the Contractor shall send an email summary to all participants of the meeting's action items and decisions. At least 1 week before each meeting, the Contractor shall send a calendar appointment invitation to all participants with information on when and where the meeting will be held and the teleconference number and passcode. The Contractor shall include an attached meeting agenda and minutes from the previous meeting, including the emailed summary of action items and decisions.

2. Discussion Summaries with Scientific Consultants - As specified by the NIDA COR, the Contractor shall draft summaries of discussions with scientific consultants, with recommended action items, and provide them to the NIDA COR for review.

3. Discussion Summaries with Subject Matter Experts - As specified by the NIDA COR, the Contractor shall draft summaries from discussions with individual subject-matter experts, including recommended action items, and provide them to the NIDA COR for review.

4. Monthly Progress Report, inclusive of four stand-alone sections - The Contractor shall submit a monthly progress report to the NIDA COR and the CO by the 10th of each month for the previous month. The progress report must include the following 4 sections:

(1) Progress and Plans. A description of: (a) all activities performed for each task during the month;

(b) progress toward meeting project and performance goals; (c) action items and their current status;

and (d) plans for the upcoming month.

(2) Problems and Implications. A description of: (a) problems encountered and proposed or enacted solutions; (b) among problems encountered, any that are significant, unresolved, or that require additional action; (c) among problems encountered, an assessment of any that impact the project's timeline, budget, and/or completion as specified by this Statement of Work (SOW).

(3) Budgetary Metrics. A description of: (a) the expenditure of funds in the past month; (b) any deviations in actual costs compared to projected costs, including their causes and implications; (c) the percentage of funds awarded the Contractor expended; and (d) the Contractor's recommended prescriptive measures and/or corrective actions undertaken.

(4) Stand-Alone Sections. The Contractor shall include the following stand-alone sections with the monthly progress report:

a. "Monthly Tobacco User Fee Report" (DELIVERABLE 5)

b. "Biospecimen Access - Status Update Report" (DELIVERABLE 26)

c. "Substudies" (DELIVERABLE 6a) (if options are exercised)

d. "Nested Studies" (DELIVERABLE 6b) (if options are exercised)

5. Monthly Tobacco User Fee Report, letter-type, in stand-alone section of Monthly Progress Report - The Contractor shall submit Monthly Tobacco User Fee Reports. The monthly progress report (above) must include a standalone, letter-type section entitled "Monthly Tobacco User Fee Report" that lists activities performed in the past month related to FDA Tobacco User Fee spending accounting and http://www.hhs.gov/web/508/contracting/technology/vendors.html

- 14 -reporting requirements. See PL 111-31, Sec 919 (c) (2) (A) at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_public_laws&docid=f:publ031.111.pdf for more information.

6. Substudy Summaries (6a) - Assuming NIDA exercises the option, in a stand-alone section of each Monthly Progress Report, the Contractor shall manage, track, and update the status of all substudy products, including papers and reports that have and have not yet been accepted for publication by peer-reviewed journals. Unless otherwise specified by the NIDA COR, the Contractor shall summarize the activities associated with each substudy, including the publication status of their products, in a standalone section in the corresponding monthly progress report.

Nested Studies Summaries (6b) - Assuming NIDA exercises the option, in a stand-alone section of each Monthly Progress Report, the Contractor shall manage, track, and update the status of each nested study. Unless otherwise specified by the NIDA COR, the Contractor shall summarize the activities, progress, response rates, action items, plans, and products for each nested study in a standalone section in the corresponding monthly progress report.

7. Weekly Data and Biospecimen Collection Progress Reports with Monthly Charts, Maps, and Graphs - In Option Periods 1, 3, 5, and 7 (i.e., the option periods for Waves 4, 5, 6, and 7, respectively), the Contractor shall submit to the NIDA COR on each Monday a data and biospecimen collection progress report. On the final Monday of each month, the Contractor shall include with the weekly progress report graphs, charts, and/or maps that summarize field operations and performance metrics over the past month and cumulatively to date. The Contractor shall consult with the NIDA COR on the specific metrics of interest and the types of graphs, charts, and/or maps to use for those metrics. For planning purposes, on the final Monday of the month, the Contractor shall provide with the weekly progress report the graphs, charts, and/or maps necessary to summarize: (1) the numbers of completed adult, parent, and youth interviews per week, by day of week and time of day; (2) the average hours per (a) completed adult interview without biospecimen collection, (b) completed adult interview with biospecimen collection, (c) completed parent interview, (d) completed youth interview, and (e) completed youth interview with biospecimen collection; (3) regional production, as depicted by adult interview completion rates and hours per completed interview for urban and rural geographic areas and for the four Census regions; and (4) adult interview refusal conversions, including numbers of initial and interim refusals as well as of refusal conversions.

8. Contract Period Final Reports - The Contractor shall submit Final Reports. The "Final Report" (~20 pages exclusive of tables, charts, and graphs) must include a description of the following: (1) all activities actually performed for each task up to one month before the end of each contract period;

(2) problems encountered, their proposed or enacted solutions, their current status, and their impacts on the budget and the achievement of contractual requirements as specified in this SOW; (3) work plans for the next Option Period if exercised; (4) a listing of significant action items, including those remaining open, unresolved, and/or that require additional action to close them; (5) the budget, including the actual expenditure rate relative to the predicted rate and the percentage of funds awarded the Contractor expended to date; (6) significant problems encountered, including their solutions or lack thereof and their implications on meeting performance goals; and (7) an overall assessment of whether the work conducted to date (up to 1 month before the end of the contract period) is on time, within budget, and in accordance with the established timeline specified in the delivery schedule of this SOW.

9. Substudies - Research Papers (Option 9, section d) - Upon exercise of the option, the Contractor shall plan substudies on topics selected by the NIDA COR and shall coordinate substudy teams to analyze data and prepare research papers on the findings. The Contractor shall produce a draft paper for each substudy in this option for submission to the NIDA COR.

10. Substudies - Analytic Reports, inclusive of coding program used for analysis (Option 10, section

d) - Upon exercise of the option, the Contractor shall analyze data and develop in-depth analytic reports on topics selected by the NIDA COR. The Contractor shall produce a draft analytic report to be submitted to the NIDA COR. As directed by the NIDA CO, the Contractor shall include with the report the program file (e.g., Statistical Analysis System (SAS) or "statistics and data" (STATA)) used for the analysis.

- 15 -

11. Substudies - Short-Turnaround Analyses (Option 11, section d) - Upon exercise of the option, the Contractor shall conduct short-turnaround analyses to address high-priority, time-sensitive questions and issues selected by the NIDA COR. The products of short-turnaround analyses may vary, from producing a Power Point document, an extensive set of tables, a poster presentation, and/or a brief report which may be developed for publication in peer-reviewed journals. The Contractor shall produce a draft of the specified deliverable for each substudy under Option 11 to be submitted to the

NIDA COR.

12. Nested Study Report (Option 12, section d) - Upon exercise of the option, the Contractor shall produce a Nested Study Report for each nested study completed under Option 12 for submission to the NIDA COR.

13. Nested Study Report (Option 13, section d) - Upon exercise of the option, the Contractor shall conduct small nested studies during and/or after a data-collection wave. Small nested studies shall involve data collection from subgroups of cohort participants; therefore, the Contractor shall plan, coordinate, develop, and embed the specified small nested study into the main study's Information Clearance Requests (ICR) for a biennial wave of data and biospecimen collection. The Contractor shall include estimates of burden hours and annualized costs for each small nested study in the total estimated burden and annualized cost for the respective biennial wave. The Contractor shall produce a Nested Study Report for each small nested study completed under Option 13 for submission to the

NIDA COR.

14. Nested Study Report (Option 14, section d) - Upon exercise of the option, the Contractor shall conduct medium-size nested studies during and/or after a data-collection wave. Medium-size nested studies shall involve data collection from a larger number of cohort participants than small nested studies. The Contractor shall plan, coordinate, develop, and embed the specified medium-size nested study into the main study's ICR for a biennial wave of data and biospecimen collection. The Contractor shall also include estimates of burden hours and annualized costs for each medium-size nested study in the total estimated burden and annualized cost for the respective biennial wave. The Contractor shall produce a Nested Study Report for each medium-size nested study completed under Option 14 for submission to the NIDA COR.

15. Nested Study Report (Option 15, section d) - Upon exercise of the option, the Contractor shall conduct large nested studies during and/or after a data-collection wave. Large nested studies shall involve data collection from larger samples of cohort participants than in either of the small or medium-size nested studies. The Contractor shall plan, coordinate, develop, and embed the specified large nested study into the main study's ICR for a biennial wave of data and biospecimen collection the Contractor shall also include estimates of burden hours and annualized costs for each large nested study in the total estimated burden and annualized cost for the respective biennial wave. The Contractor shall produce a Nested Study Report for each large nested study completed under Option 15 for submission to the NIDA COR.

16. Data-Collection Instruments - The Contractor shall prepare and submit draft electronic versions and final hard copy and electronic versions (in PDF format) of all data-collection instruments, including tobacco-product advertisements and images, to the NIDA COR for evaluation. Final versions shall be submitted in both English and Spanish for inclusion in the respective ICR for the next wave of data collection. Any updates to the final versions of the instruments during a data-collection wave shall be incorporated and submitted to the NIDA COR as updated final versions of the data-collection instruments, with tobacco-product advertisements and images, after completion of the wave. Each version of the data-collection instruments must have a table of contents and hard copies shall be double-sided, tabbed, and spiral-bound. As specified by the NIDA COR, the Contractor shall design and develop website-based versions of the PATH Study's assessment instruments.

17. Data Collection Materials - The Contractor shall prepare, furnish, and provide all data-collection materials to all field staff in both English and Spanish to ensure standardization in data collection.

Data-collection materials include study procedures to obtain informed consent and protect the confidentiality of data, field interviewer procedures manuals, training guides, biospecimen collection information and protocols, advance letters to prospective respondents, booklets, flash cards,

- 16 -advertisements and images, and as needed, appendices and references. Interview and biospecimen collection materials must reflect required Federal policy regarding confidentiality and informed-consent issues. The Contractor shall develop a complete set of all draft data-collection materials, inclusive of table of contents, for review and approval by the NIDA COR. Upon approval by the NIDA COR, the Contractor shall provide the final version of all data-collection materials to field interviewers.

18. Information Clearance Requests (ICR) for the PATH Study's Waves 5, 6, 7, and 8 - As directed by the NIDA CO, the Contractor shall plan, coordinate, and develop required ICRs for the next wave of longitudinal data collection among the national cohort (i.e., for Waves 5, 6, 7, and as specified by the NIDA COR, a future Wave 8). These ICRs must include required correspondence, memoranda, supporting statements, final versions of all data-collection instruments in both English and Spanish, and attachments, including a NIDA Certificate of Confidentiality, exhibits, and informed-consent documentation approved by the Contractor's Institutional Review Board (IRB). The Contractor shall conduct nested studies on topics specified by the NIDA COR with random or targeted subsamples of the PATH Study cohort during and/or after the respective wave. Therefore, the Contractor shall include any nested study that is exercised under Options 12, 13, 14, or 15 (see section (d) of this contract) in the PATH Study's ICRs for the corresponding wave of longitudinal data collection. The Contractor shall include estimates of burden hours and annualized costs for the particular nested study in the total estimated burden associated with that wave of data collection. The Contractor shall prepare ICRs for submission to OMB in electronic formats compatible with OMB's Information Collection Request, Review and Approval System (ICRAS).

19. Generic Clearance ICR for Cognitive Testing by the PATH Study and Cognitive Testing Substudies - The Contractor shall submit cognitive testing substudies with separate samples, both English and Spanish-speaking, under the PATH Study's Generic Clearance for Cognitive Testing.