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U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary

Washington, D.C. 20201 Request for Proposal No. AHRQ-16-10011 Amendment 1

PART I - THE SCHEDULE

SECTION A - SOLICITATION FORM

Date Issued: February 23, 2016 Date Questions Due: March 1, 2016 Please Note: All questions and inquires will be processed on a non-attribution basis.

Date Notice of Intent Due: March 15, 2016 Date Proposals Due: April 4, 2016, 11:00 AM, EST

You are invited to submit a proposal to the Agency for Healthcare Research and Quality (AHRQ) for Request for Proposal (RFP) No. AHRQ-16-10011 entitled “Support to Implement Increased Transparency of the Processes of the USPSTF”. Your proposal must be developed and submitted in accordance with the requirements and instructions of this RFP.

Solicitation Information: Please review the table of contents and refer to the appropriate section of this RFP for requirements, proposal instructions and evaluation information. The Government intends to award this contract without negotiations, so it is imperative that all questions are addressed during the solicitation phase, and that all proposals submitted include the required information and accept the terms and conditions as stated. Failure to comply with proposal instructions or submit required information may result in the removal of a proposal from consideration for award. Please review Section L carefully.

Proposal Intent: If you intend to submit a proposal in response to this solicitation, please inform the Contracting Officer of your intent by completing the Proposal Intent Response Form (See section L.10 and Attachment A) and send it to the Contracting Officer no later than March 15, 2016. You may mail it to the address below; fax it to 301-427-1740, Attention: Scott Henderson, Contract Specialist/Contracting Officer or email it to scott.henderson@ahrq.hhs.gov.

Questions: All Questions regarding this solicitation shall be received in this office no later than the date shown above. All questions shall be submitted electronically by e-mail to Scott Henderson, Contract Specialist/Contracting Officer, at the following email address: scott.henderson@ahrq.hhs.gov. Subject line shall read: Proposal Questions RFP No. AHRQ-16-10011. Answers to questions and all solicitation amendments will be posted to the Federal Business Opportunities web page: www.fbo.gov. It is your responsibility to monitor the web site.

Additional Information:

· A cost plus fixed fee contract is contemplated for a period of one year, with four one-year options.

· The Government anticipates awarding one contract from this solicitation on or about July 1, 2016.

· Proposals submitted in response to this solicitation must state that they are valid for a period of at least 120 days (reference FAR clause 52.215-1 in Section L of this document.

· The NAICS code for this requirement is 541990 with a size standard of $15.0 million.

Proposal Submission: The proposal shall be signed by an authorized official to bind your organization and must be received in our Contracts Office by the due date specified above. Your proposal must be mailed to the following address:

Agency for Healthcare Research and Quality Division of Contracts Management 5600 Fishers Lane, Mail Stop: 06N34B Rockville, Maryland 20857 Attn: Scott Henderson, (301) 427-1764

Hand carried proposals may be delivered to the above location. Please bring all packages to the loading dock. Please mark each box: AHRQ, OMS/DCM, Attn: Scott Henderson, Mail Stop 06N34B. The packages will be accepted and date/time stamped in the mail room. However, please allow ample time as proposals cannot be accepted until they have gone through security. We will not be held responsible for any delays that may be incurred getting your proposal through security.

NOTE: The U.S. Postal Service’s “Express Mail” does not deliver to our Rockville, Maryland address. Please do not use this means of delivery for proposal submission.

System for Award Management: In accordance with Federal Acquisition Regulation, all contractors must be registered in the System for Award Management (SAM) database in order to conduct business with the government [See Section I - FAR clause 52.204-7 System for Award Management]. Access the System for Award Management (SAM) at http://www.sam.gov.

Reminder: The Procurement Integrity Act prohibits the unauthorized disclosure of, inquiry about, or acceptance of procurement information. Communications with any other individual outside the AHRQ contracting office may result in rejection of an offeror’s proposal. All requests for any information concerning this RFP should be referred to Scott Henderson, (301) 427-1764 or e-mail: scott.henderson@ahrq.hhs.gov. Please note e-mail requests should state subject as RFP AHRQ-16-10011.

Table of Contents

PART I - THE SCHEDULE1
SECTION A - SOLICITATION FORM1
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS4
SECTION C - DESCRIPTION/SPECIFICATION/WORK STATEMENT7
SECTION D - PACKAGING AND MARKING15
SECTION E - INSPECTION AND ACCEPTANCE16
SECTION F - DELIVERIES or PERFORMANCE17
SECTION G - CONTRACT ADMINISTRATION DATA20
SECTION H - SPECIAL CONTRACT REQUIREMENTS24
PART II – CONTRACT CLAUSES40
SECTION I - CONTRACT CLAUSES40
PART III- LIST OF DOCUMENTS, EXHIBITS AND ATTACHMENTS45
SECTION J – SOLICITATION LIST OF ATTACHMENTS45
PART IV– REPRESENTATIONS AND INSTRUCTIONS47
SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS47
SECTION L - INSTRUCTIONS, CONDITIONS AND NOTICES TO OFFERORS56
SECTION M- EVALUATION FACTORS FOR AWARD74

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

“Support to Implement Increased Transparency of the Processes of the USPSTF”. See Section C for a complete description.

B.2 ESTIMATED COST AND FIXED FEE

a. The Estimated Cost (exclusive of fees) for performance of the work under the base period of this contract, including direct and indirect costs is $ To Be Determined (TBD).

b. The Fixed Fee for the base period of this contract is $TBD. 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 Clause ALLOWABLE COST AND PAYMENT and FIXED FEE incorporated herein.

c. The total contract value, represented by the sum of the estimated cost plus the fixed fee for the base period is $TBD.

Period of Performance
Services
Estimated Cost
Fixed Fee
Total
Base Period
Severable
$
$
$

B.3 OPTION COSTS

If the Government exercises its option(s) pursuant to the option article in Section H of this contract, the Government’s total contract amount represented by the sum of the estimated cost and fixed fee will be revised as follows:

Period of Performance
Services
Estimated Cost
Fixed Fee
Total
Option Period 1
Severable
$
$
$
Option Period 2
Severable
$
$
$
Option Period 3
Severable
$
$
$
Option Period 4
Severable
$
$
$

The base period and each option are separate and distinct from one another for accumulation of costs and billing purposes.

B. 4 PROVISIONS APPLICABLE TO DIRECT COSTS

a. Items Unallowable Unless Otherwise Provided

Notwithstanding the clauses, ALLOWABLE COST AND PAYMENT, and FIXED FEE, incorporated into this contract, unless authorized in writing by the Contracting Officer, the costs of the following items or activities shall be unallowable as direct costs:

(1) Acquisition, by purchase or lease, of any interest in real property;

(2) Rearrangement or alteration of facilities;

(3) Purchase or lease of any item of general purpose-office furniture or office equipment regardless of dollar value. (General purpose equipment is defined as any items of personal property which are usable for purposes other than research, such as office equipment and furnishings, pocket calculators, etc.);

(4) Accountable Government property;

(5) Travel to attend general scientific meetings;

(6) Foreign Travel;

(7) Any costs incurred prior to the contract's effective date;

(8) Rental of meeting rooms not otherwise expressly paid for by the contract;

(9) Any formal subcontract arrangements not otherwise expressly provided for in the contract;

(10) Consultant fees;

(11) Information Technology hardware or software;

(12) Food and Beverages; and

(13) No funding or expenditures are authorized under this contract for travel or meeting expenses of any person that is not an employee of the contractor or approved subcontractor in accordance with the terms of the contract. See 31 USC § 1345 for appropriations restrictions.

Note: Food and Beverages are unallowable costs. Contracting Officer Authorization for Food and Beverages will be only made as specifically authorized by statute, which is extremely rare. The contractor shall not provide food or beverages of any type. The contractor shall not accept food or beverages, even if included in, or provided ‘free’ as part of a meeting/conference ‘package’.

b. Travel Costs

This contract is subject to the provisions of Public Law (P.L.) 99-234 which amends the Office of Federal Procurement Policy Act to provide that contractor costs for travel, including lodging, other subsistence, and incidental expenses, shall be allowable only to the extent that they do not exceed the amount allowed for Federal employees. The Contractor, therefore, shall invoice and be reimbursed for all travel costs in accordance with Federal Acquisition Regulations (FAR) 31.205-46.

The following applies to Educational Institutions: The Contractor shall invoice and be reimbursed for all travel costs in accordance with OMB Circular A-21 - "Cost Principles for Educational Institutions."

B.5 CONTRACTING OFFICER AUTHORIZATION

Other provisions of this contract notwithstanding, approval of the following items within the limits set forth is hereby granted without further authorization from the Contracting Officer.

To Be Determined

SECTION C - DESCRIPTION/SPECIFICATION/WORK STATEMENT

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 as follows:

Statement of Work Unless otherwise noted under a specific task, this Statement of Work applies to the base period and all options (if exercised).

Once awarded, AHRQ will supply the contractor with “read only” access to the content management system (CMS) for the redesigned USPSTF Web site; a weekly calendar of USPSTF topics for release and a template for the citation disposition table and suggested codes (see Task 2.3 below).

Background/References The U.S. Preventive Services Task Force (USPSTF or Task Force) is an independent, volunteer panel of national experts in prevention and evidence-based medicine. Since its inception in 1984, the Task Force has worked to improve the health of all Americans by making evidence-based recommendations about clinical preventive services and health promotion. These recommendations for adults and children address screening tests, counseling about healthful behaviors, and preventive medications.

Since 2009, the Task Force has focused on making its work as transparent as possible so that stakeholders and the public better understand and have more confidence in the approach of the Task Force. This also ensures that its work is open, credible, independent, and unbiased, and is recognized as such. By expanding opportunities for the public and stakeholders to engage in the process, the Task Force believes that its recommendations will be more accurate and relevant.

As a result of these efforts, stakeholders and the public can:

· Nominate new members to serve on the Task Force

· Nominate new topics for Task Force consideration or request an update of an existing topic

· Provide comments on all draft research plans

· Provide comments on all draft evidence reports

· Provide comments on all draft recommendation statements

For additional information on the Task Force, its procedures including opportunities for public comment, and all documents (e.g., research plans; systematic evidence reviews and recommendation statements), please visit the USPSTF Procedure Manual at http://www.uspreventiveservicestaskforce.org/uspstf08/methods/procmanual.htm.

The USPSTF also has been working to redesign its Web site (www.uspreventiveservicestaskforce.org) to enhance the look and feel, and functionality of the site. The new Web site features an automated system for posting and receiving public comments on draft documents. The redesigned Web site was launched in September 2014; version 2.0 was made available March 2015.

The purpose of this contract is to have a contractor 1) develop tables for all of the public comments received in response to postings of USPSTF draft research plans, draft systematic evidence reviews, and draft recommendation statements and 2) to aggregate, review, analyze and synthesize public comments received in response to USPSTF draft recommendation statements.

This contract has a base year plus four option years. The work performed in the base year will be the same as the work performed in the option years, if the government decides to exercise the options.

A. Overview/Objectives

Independently and not as an agent of the Government, the Contractor and its subcontractors shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the specific requirements below.

Under this contract the Contractor shall:

1. Understand the basic principles of evidence-based medicine and prevention, and the methods and processes inherent in making and communicating evidence-based recommendations to be implemented in primary care.

2. Understand the importance of timing, as well as historical perspectives and stakeholder engagement as it relates to the Task Force.

3. Develop tables of public comments received in response to 30 – 45 USPSTF research plans, draft evidence reports and draft recommendation statements postings each year for use by Principal Investigators at Evidence-based Practice Centers , Task Force and AHRQ staff.

4. Establish a methodology for coding the public comments received in response to USPSTF draft recommendation statements (e.g., develop a coding scheme and process for how coders would be trained, how agreement among coders will be determined, quality control measures, how the data will be analyzed and synthesized).

5. Aggregate, Review, analyze and synthesize public comments received in response to USPSTF draft recommendation statements.

6. Write a report for all draft recommendation statements.

B. Specific Requirements/Tasks

Task 1: Administration

Subtask 1.1 Kick-Off Call

Within 2 weeks of the award, the Contractor shall meet with the COR and other relevant AHRQ personnel to review and clarify the scope of work and delivery schedule, to delineate further roles and responsibilities, and to establish communication protocols. This meeting may take place by teleconference or in-person in the base year. The contractor shall provide meeting notes no later than one week after the call.

Subtask 1.2: Quarterly Progress Reports

The Contractor shall submit a quarterly progress report that includes:

· Accomplishments during the reporting period

· Problems or delays the contractor has experienced in the conduct of performance requirements including what specific action is proposed to alleviate the problem(s)

· Activities planned for the next reporting period, including anticipated staffing requirements, level of effort and cost

Quarterly progress reports will be submitted in electronic format to the COR within ten (10) days after the end of the quarter being reported.

Subtask 1.3: Monthly Progress Calls

The Contractor shall participate in a monthly progress call with the AHRQ COR to discuss overall progress, issues related to specific draft products/USPSTF topics, other problems or delays. The monthly calls also may be used for the Contractor to give AHRQ staff a short briefing on the synthesis of public comments on specific USPSTF draft recommendation statements. The Contractor shall provide an agenda at least 3 days prior to the call and a call summary no later than 1 week after the call.

Subtask 1.4: Attend USPSTF Meetings.

The Contractor shall attend 3 USPSTF in-person meetings each year where the USPSTF deliberates upcoming topics.

Task 2: Reports on Draft USPSTF Documents

Subtask: 2.1: Develop tables of all public comments received in response to USPSTF draft research plans and draft systematic evidence reviews

1. Weekly table of comments for draft research plans and draft systematic evidence reviews.

The Contractor shall develop weekly tables that include all public comments received to date on draft research plans and draft systematic evidence reviews. Public Comments are open for 4 weeks, but may be extended for specific topics.

The Contractor shall have access to the content management system (CMS) of the redesigned USPSTF Web site for aggregating and creating tables of all the public comments received. The CMS will generate a table of the comments that were submitted via the website and the Contractor will use the CMS to produce the weekly table of comments in the format requested by AHRQ. In addition, the Contractor shall add letters received in the mail or email into the table of aggregated public comments. The contractor shall also include comments that are submitted directly to the AHRQ program staff within 2 weeks of the closing date of the comments for the topic.

In the weekly tables, the Contractor shall provide all the public comments, with a unique ID, question number, type of respondent, and the actual comment. The Contractor shall remove any empty cells that occur as a result of non-response by the commenter, i.e., if a respondent only enters comments in response to questions 1, 3 and 5, the empty cells associated with questions 2, 4 and 6 would be deleted. These tables should be sorted by respondent, i.e., answers to all questions for Respondent 1 would be shown in sequential rows.

See appendix A and B for example of standard questionnaires for the draft research plan and evidence review.

The weekly tables shall be provided on an agreed upon day each week, including a count of the number of comments and estimated due dates of the various final tables.

2. Final table of comments for draft research plans and draft systematic evidence reviews. After the public comment period closes, the contractor shall provide final tables that include all public comments received on draft research plans and draft systematic evidence reviews. The Contractor shall provide 3 versions of the final table of all public comments: 1) sorted by respondent, i.e., answers to all questions for Respondent 1 would be shown in sequential rows; 2) sorted by question, i.e., all answers to question 1 would be shown in sequential rows for all respondents; and 3) sorted by question but with all standard answers from the questionnaire removed (version for the Evidence-Based Practice Centers).

In the final tables, the Contractor shall also remove any empty cells that occur as a result of non-response by the commenter, i.e., if a respondent only enters comments in response to questions 1, 3 and 5, the empty cells associated with questions 2, 4 and 6 would be deleted.

The final tables shall be provided no later than 2 weeks after the comment period closes. For topics receiving more than 200 comments, the Contractor shall provide the tables no later than 4 weeks after the comment period closes.

The USPSTF anticipates posting 10 - 15 draft research plans and 10 - 15 draft systematic evidence reviews each year. A preliminary plan for how the Contractor will produce the tables of comments should be described in response to this solicitation.

Subtask 2.2: Develop Reports on Draft Recommendation Statements

1. Weekly Table of Comments for Draft Recommendation Statements.

The Contractor shall develop weekly tables for use by the Task Force and AHRQ program staff that include all public comments received up to that date on draft recommendation statements. The weekly tables shall be due to the COR on an agreed upon day each week, including a count of the number of comments and estimated due dates of the various final tables. Public Comments are open for 4 weeks, but may be extended for specific topics.

The Contractor shall have access to the content management system (CMS) of the redesigned USPSTF Web site for aggregating and creating tables of all the public comments received. The CMS will generate a table of the comments that were entered via the website and the contractor will use the CMS to produce the weekly table of comments in the format requested by AHRQ. In addition, the Contractor shall add letters received in the mail or email into the table of aggregated public comments. The contractor shall also include comments that are submitted directly to the AHRQ program staff within 2 weeks of the closing date of the comments for the topic.

In the weekly tables, the Contractor shall provide all the public comments, with a unique ID, question number, type of respondent, and the actual comment. They shall remove any empty cells, i.e.., if a respondent only enters comments in response to questions 1, 3 and 5, the empty cells associated with questions 2, 4 and 6 would be deleted. These tables should be sorted by respondent, i.e., answers to all questions for Respondent 1 would be shown in sequential rows.

See appendix C for example of standard questionnaires for the draft recommendation statement.

The weekly tables shall be provided on an agreed upon day each week, including a count of the number of comments and estimated due dates of the various final tables.

2. Final table of comments for draft recommendation statement. After the public comment period closes, the contractor shall provide final tables that include all public comments received on draft recommendation statements.

In the final tables, the Contractor shall also remove any empty cells that occur as a result of non-response by the commenter, i.e., if a respondent only enters comments in response to questions 1, 3 and 5, the empty cells associated with questions 2, 4 and 6 would be deleted

The final tables shall be provided no later than 2 weeks after the comment period closes. For topics receiving more than 200 comments, the Contractor shall provide the tables no later than 4 weeks after the comment period closes.

3. Final Report for Draft Recommendation Statements.

The Contractor shall establish a methodology for coding the public comments received in response to USPSTF draft recommendation statements (e.g., develop a coding scheme and process for how coders would be trained, how agreement among coders will be determined, quality control measures, how the data will be analyzed and synthesized). A preliminary methodology should be described in response to this solicitation.

Using this methodology, the Contractor shall review, analyze and synthesize all the comments received during the public comment period for all draft recommendation statements. The Contractor shall write a report for all draft recommendation statements. The type of report will vary depending on the number of public comments received.

1. For draft recommendation statements that receive comments from 25 or fewer respondents, the Contractor shall produce a Summary Report that will include at minimum:

a. Summary of Respondents, Responses - the contractor shall provide the total number of comments received, the distribution of comments by respondent type, a list of organizations that provided comments, and a summary of the number of respondents who agreed or disagreed with the draft recommendation statement. The number of comments to the Draft Evidence Report shall also be provided.

b. Comprehensive Table of Public Comments on Draft Recommendation Statement – final table of all public comments received in the format described above.

c. Reference Disposition Table - a disposition table of all citations for additional studies listed in the public comments that includes: the full citation provided, whether the study was included, excluded or not considered in the systematic evidence review (this information is provided as part of the systematic evidence review) and a disposition for the reference, e.g., excluded due to study design (Letter to the Editor; Opinion Piece; Clinical Guideline, etc.). AHRQ will provide the Contractor with a template for the citation disposition table and suggested codes.

The Summary Report shall be provided no later than 2 weeks after the comment period closes.

2. For draft recommendation statements that receive comments from more than 25 respondents, the Contractor will produce a Full Report, which will include at minimum:

a. Summary of Respondents, Responses, and References – the contractor shall summarize the types of respondents that commented on the Draft Recommendation Statement, the nature of the public comments received (e.g., whether respondents agreed/disagreed with the draft recommendation statement), and the number and types of references suggested by respondents. The number of comments to the Draft Evidence Report shall also be provided.

b. Themes Memo (Summary of Findings and Recommendations)– using the approved qualitative methodology, the Contractor shall summarize comments received by describing the themes that emerged in the review of the public comments to the Draft Recommendation Statement. For each theme, the Contractor shall also highlight any comments that are related specifically to revisions to the draft recommendation statement that would address the themes/major concerns expressed in the public comments.

A Preliminary Themes Memo shall be provided no later than 2 weeks after the comment period closes. For topics receiving more than 200 comments, the Contractor shall provide the memo no later than 4 weeks after the comment period closes.

c. Quotes Table - the contractor shall provide a table that highlights specific comments from respondents that illustrate the major themes/concerns identified during the review and synthesis of all public comments.

d. Methods - the contractor shall provide a section describing the methods for reviewing and synthesizing all the public comments. This should include, but is not limited to, how a coding scheme was developed, how coders were trained, how agreement among coders was determined, what quality control measures will be used, and how the data are analyzed and synthesized. The contractor shall also provide the codebook that was used to code the data.

e. Comments of Particular Importance – the contract shall identify and highlight comments that raise salient issues to which the USPSTF might want to give particular attention

f. Attachments will include:

· Comprehensive Table of Public Comments for the Draft Recommendation Statement – final table of public comments to the draft recommendation statement that also includes information about how each response was coded using the established codebook.

· Comprehensive Table of Public Comments for the Draft Evidence Review – final table of public comments to the draft evidence review.

· Draft Recommendation Statement Reference Disposition Table – same as described for the summary table above.

· Draft Evidence Review Reference Disposition Table – same as described for the summary table above.

The Full Report shall be provided no later than 4 weeks after the comment period closes. For topics receiving more than 200 comments, the Contractor shall provide the report no later than 6 weeks after the comment period closes.

The USPSTF anticipates posting 10 – 15 Draft Recommendation Statements. A preliminary plan for how the Contractor will produce the full report should be described in response to this solicitation.

Appendix A – Draft Research Plan Questionnaire Template

Open-Ended Comment Question:

Do you have any comments about the Analytic Framework?

Background information:

Top of Form Proposed Key Question 1 Does screening for visual impairment in children ages 6 months to 5 years reduce long-term amblyopia or improve visual acuity, school performance, functioning, and/or quality of life?

a. Does the effectiveness of vision screening in children ages 6 months to 5 years vary among different age groups?

Single Choice List - Radio Buttons Question:

Please select one of these options.

I agree with it; I have no comments Generally, I agree with it; see comments below I have concerns; see comments below I do not wish to give comments on this question Open-Ended Comment Question:

Do you have any comments about Key Question 1?

Bottom of Form

Top of Form

Proposed Key Question 2 What is the accuracy and reliability of screening tests for visual impairment in children ages 6 months to 5 years?

a. Does the accuracy or reliability of screening tests for visual impairment vary among different age groups?

Single Choice List - Radio Buttons Question:

Please select one of these options.

I agree with it; I have no comments Generally, I agree with it; see comments below I have concerns; see comments below I do not wish to give comments on this question Open-Ended Comment Question:

Do you have any comments about Key Question 2?

Bottom of Form

Top of Form Proposed Key Question 3 What are the harms of screening for visual impairment in children ages 6 months to 5 years?

Single Choice List - Radio Buttons Question:

Please select one of these options.

I agree with it; I have no comments Generally, I agree with it; see comments below I have concerns; see comments below I do not wish to give comments on this question Open-Ended Comment Question:

Do you have any comments about Key Question 3?

Bottom of Form

Top of Form Proposed Key Question 4 4a. Does treatment of visual impairment in children ages 6 months to 5 years improve visual acuity?

4b. Does treatment of visual impairment in children ages 6 months to 5 years reduce long-term amblyopia or improve school performance, functioning, and/or quality of life?

Single Choice List - Radio Buttons Question:

Please select one of these options.

I agree with them; I have no comments Generally, I agree with them; see comments below I have concerns; see comments below I do not wish to give comments on this question Open-Ended Comment Question:

Do you have any comments about Key Question 4?

Bottom of Form

Top of Form Proposed Key Question 5 What are the harms of treatment of visual impairment in children ages 6 months to 5 years?

Single Choice List - Radio Buttons Question:

Please select one of these options.

I agree with it; I have no comments Generally, I agree with it; see comments below I have concerns; see comments below I do not wish to give comments on this question Open-Ended Comment Question:

Do you have any comments about Key Question 5?

Bottom of Form

Top of Form Proposed Contextual Question 1 What is the minimal clinically perceptible change in visual acuity?

Single Choice List - Radio Buttons Question:

Please select one of these options.

I agree with it; I have no comments Generally, I agree with it; see comments below I have concerns; see comments below I do not wish to give comments on this question Open-Ended Comment Question:

Do you have any comments about Contextual Question 1?

Bottom of Form

Top of Form Proposed Research Approach Single Choice List - Radio Buttons Question:

Please select one of these options.

I agree with it; I have no comments Generally, I agree with it; see comments below I have concerns; see comments below I do not wish to give comments on this question Open-Ended Comment Question:

Do you have any comments about the Research Approach?

Bottom of Form

Appendix B – Draft Evidence Review Questionnaire Template

Single Choice List - Radio Buttons Question:

Do you think this report includes all of the relevant studies?

Yes. The report is complete.

No. The report is not complete.

Unsure Open-Ended Comment Question:

Please share citations for the studies you believe should be added.

Single Choice List - Radio Buttons Question:

Do you agree with how the included studies and the overall evidence have been interpreted?

Yes. The report correctly summarizes the available evidence.

No. The report should be revised.

Unsure Open-Ended Comment

The report should be revised in the following ways:

Question input controls are shown as a preview. Inputs do not operate.

Single Choice List - Radio Buttons Question:

What could be done to make the evidence findings in this draft evidence report clearer?

Nothing. The findings of the report are clear.

The findings of report could be made clearer.

Unsure Open-Ended Comment Question:

The findings of report could be made clearer in the following ways:

Open-Ended Comment

Please share anything else about this evidence report that you have not already mentioned.

Appendix C – Draft Recommendation Statement Questionnaire Template

Question input controls are shown a preview. Inputs do not operate.

How could the USPSTF make this draft Recommendation Statement clearer?

Open-Ended Comment Question:

What information, if any, did you expect to find in this draft Recommendation Statement that was not included?

Open-Ended Comment Question:

Based on the evidence presented in this draft Recommendation Statement, do you believe that the USPSTF came to the right conclusions? Please provide additional evidence or viewpoints that you think should have been considered.

Question input controls are shown as a preview. Inputs do not operate.

What resources or tools could the USPSTF provide that would make this Recommendation Statement more useful to you in its final form?

Open-Ended Comment Question:

The USPSTF is committed to understanding the needs and perspectives of the public it serves. Please share any experiences that you think could further inform the USPSTF on this draft Recommendation Statement.

Open-Ended Comment

Do you have other comments on this draft Recommendation Statement?

SECTION D - PACKAGING AND MARKING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the Contract Number, Contractor Name and Item Number. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition. Note as appropriate on the face page of each deliverable, or on the binding, (1) one volume only, or (2) volume 1 of 2, etc.

SECTION E - INSPECTION AND ACCEPTANCE

E.1 INSPECTION AND ACCEPTANCE

a. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

b. For the purpose of this SECTION the Contracting Officer’s Representative is the authorized technical representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

Agency for Healthcare Research and Quality
5600 Fishers Lane
Rockville, Maryland 20857

E.2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text.

FAR Clause No. Title and Date

52.246-5 Inspection of Services-Cost Reimbursement (April 1984)

SECTION F - DELIVERIES or PERFORMANCE

F.1 PERIOD OF PERFORMANCE

a. The base period of performance of this contract shall be from July 1, 2016 through June 30, 2017.

b. If the Government exercises any Options pursuant to the OPTION PROVISION Article in Section H of this contract, the period of performance will be revised as follows:

Option Year
Option Period
Option Year 1
July 1, 2017 - June 30, 2018
Option Year 2
July 1, 2018 - June 30, 2019
Option Year 3
July 1, 2019 - June 30, 2020
Option Year 4
July 1, 2020 - June 30, 2021

F.2 DELIVERABLE SCHEDULE

The items specified for delivery below are subject to the review and approval of the Contracting Officer’s Representative (COR) before final acceptance. The contractor shall be required to make revisions deemed necessary by the COR. The deliverable schedule may not be changed without the agreement of the COR and an authorized modification completed by an AHRQ Contracting Officer (CO). Delivery dates reflect calendar time unless otherwise specified.

Unless otherwise noted under a specific task, this Deliverables Schedule applies to the base period and all options (if exercised).

The contractor shall submit the following items electronically to the COR:

Task
Format
Deliverable
Due Date

Task 1: Administration

Subtask 1.1
Electronic
Kick-off Meeting Notes
No later than one week after the call

Subtask 1.2

Electronic

Submit Quarterly Progress Report
Within ten (10) days after the end of the quarter being reported.

Subtask 1.3

Electronic
Participate in a monthly progress call with the AHRQ Staff and provide agenda and summary notes
Agenda No later than three days prior to the call

Call summary no later than one week after the call

Task 2: Reports on Draft USPSTF Documents

Subtask 2.1.1
Electronic
Weekly tables for the draft research and draft systematic evidence review comments

(4 weeks unless extended) First table due one week after the public comment period posted

Subtask 2.1.2

Electronic
Final Table for the draft research and draft systematic evidence review comments

(3 versions) Within two weeks of public comment period closing

Subtask 2.2.1
Electronic
Weekly tables for the draft recommendation statement comments

(4 weeks unless extended) First table due one week after the public comment period posted

Subtask 2.2.2
Electronic
Final Table for the draft recommendation statement comments

Within two weeks of public comment period closing

Subtask 2.2.3.1
*Electronic

Must be 508 compliant

Summary Report
No later than two weeks after the comment period closing
Subtask 2.2.3.2
Electronic
Themes Memo
No later than two weeks after the comment period closes for less than 200 comments

No later than four weeks after the comment period closes for more than 200 comments

Subtask 2.2.3.2
*Electronic

Must be 508 compliant

Report for each draft Recommendation Statements
No later than four weeks after the comment period closes for less than 200 comments

No later than six weeks after the comment period closes for more than 200 comments

*Denotes 508 Accessibility Standards Applicable

The Contracting Officer shall receive one copy of each progress report, annual report and final report/ final deliverable.

Agency for Healthcare Research and Quality ATTN: Contracting Officer Division of Contracts Management, OMS 5600 Fishers Lane, Mail Stop: 06N34B Rockville, Maryland 20857

F.3 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates the following clause by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSE:
52.242-15, Stop Work Order (AUG 1989) with Alternate I (APRIL 1984).

SECTION G - CONTRACT ADMINISTRATION DATA

G.1 KEY PERSONNEL, HHSAR 352.242-70 (January 2006)

Pursuant to the Key Personnel clause incorporated in Section I of this contract, the following individual(s) is/are considered to be essential to the work being performed hereunder:

NAME TITLE

(To Be Determined)

The clause cited above contains a requirement for review and approval by the Contracting Officer of written requests for a change of Key Personnel reasonably in advance of diverting any of these individuals from this contract. Receipt of written requests at least 30 days prior to a proposed change is considered reasonable.

G.2 CONTRACTING OFFICER’S REPRESENTATIVE

The following Contracting Officer’s Representative will represent the Government for the purpose of this contract:

(TO BE COMPLETED AT TIME OF CONTRACT AWARD)

The Contracting Officer’s Representative is responsible for: (1) monitoring the contractor's technical progress, including the surveillance and assessment of performance and recommending to the contracting officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Government may unilaterally change its Contracting Officer’s Representative designation.

G.3 CONTRACTING OFFICER

The Contracting Officer is the only person with authority to act as an agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the contractor of any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

G.4 INVOICE SUBMISSION – Cost Reimbursement

a. INVOICE SUBMISSION

The following directions for the submission of invoices must be followed to meet the requirements of a "proper" payment request pursuant to FAR 32.9, and must be in accordance with the General Provisions clause 52.232-25 Prompt Payment (OCT 2008).

Invoices/financing requests shall be submitted in an original and two (2) copies to:

Contracting Officer
Agency for Healthcare Research and Quality
Division of Contracts Management
5600 Fishers Lane, Mail Stop: 06N34B
Rockville, Maryland 20857

b. INFORMATION ON INVOICES

(1)The Contractor is REQUIRED to include the following minimum information
on invoices:
(a)Contractor’s name and invoice date;
(b)Contract Number;
(c)Description and price of services actually rendered;
(d)Other substantiating documentation or information as required by the contract;
(e)Name (where practicable), title, phone number, and complete mailing address or responsible official to whom payment is to be sent; and
(f)The Internal Revenue Service Taxpayer Identification Number.

(2) The Contractor shall furnish the following minimum information in support of costs submitted:

(a) Direct Labor – include all persons, listing the person’s name, title, number of hours or days worked, hourly rate (unburdened), the total cost per person and a total amount of this category.

(b) Fringe Costs - show rate, base and total amount as well as verification/allowability or rate changes (when applicable);

(c) Overhead or Indirect Costs - show rate, base and total amount as well as verification/allowability or rate changes (when applicable);

(d) Consultants - include the name, number of days or hours worked, a total amount per consultant and a total amount for this category;

(e) Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation, shown separately, and per diem costs. Other travel costs shall also be listed. A total amount for this category shall be provided;

(f) Subcontractors - include for each subcontractor, the same data that is being provided for the prime contractor. A total number for this category shall be provided.

(g) Data Processing - include all non-labor costs, i.e., computer time, equipment purchase, lease or rental, data tapes, etc. A total amount for this category shall be provided.

(h) Other - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, equipment rental, duplication, etc.

(i) Equipment Cost - itemize and identify separately from material costs including reference to approval in all cases;

(j) G&A - show rate, base and total as well as verification/allowability of rate changes (when applicable);

(k) Fee - show rate, base and total and;

(l) Current amount billed by individual cost element and total dollar amount and cumulative amount billed by individual cost element and total dollar amount.

(3) Payment shall be made by:

Program Support Center
Twinbrook Place
DFO Accounting Operations, Suite 200
12501 Ardennes Avenue
Rockville, Maryland 20857
Telephone Number (301) 443-3020

G.5 INDIRECT COST RATES and FEES

In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clause 52.216-7(d)(2), Allowable Cost and Payment, incorporated by reference in this contract, in Part II, Section I, the primary contact point responsible for negotiating provisional and/or final indirect cost rates is the cognizant contracting official as set forth in FAR Subpart 42.7 - Indirect Cost Rates.

Reimbursement will be limited to the rates and time periods covered by the negotiated agreements. The rates, if negotiated, are hereby incorporated without further action of the Contracting Officer, subject to any specific limitations stated elsewhere in this contract.

G.6 ELECTRONIC FUNDS TRANSFER

Pursuant to FAR 52.232-33, Payment by Electronic Funds Transfer - Central Contractor Registration (OCT 2003), the Contractor shall designate a financial institution for receipt of electronic funds transfer payments. This designation shall be submitted, in writing, to the finance office designated in the contract.

G.7 POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

Interim and final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The final performance evaluation will be prepared at the time of completion of work. In addition to the final evaluation, interim evaluation(s) will be prepared annually.

Interim and final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

Contractors may access evaluations through a secure Web site for review and comment at the following address: https://www.cpars.csd.disa.mil

G.8 GOVERNMENT PROPERTY

The contractor shall provide ALL property required to perform all requirements under the contract. Only in extremely limited circumstances shall property be approved. Refer to FAR 45.102 for additional information. If the Contracting Officer authorizes the use of government property or the acquisition of government property (other than real property), the HHS Publication, entitled, “HHS Contracting Guide for Contract of Government Property” shall apply.

SECTION H - SPECIAL CONTRACT REQUIREMENTS

H.1 RELEASE AND USE AND COPYRIGHT OF DATA FIRST PRODUCED FROM WORK PERFORMED UNDER THIS CONTRACT

(a) Release and Use – Data first produced in the performance of the Contract. As permitted in FAR 52.227-17, the provisions of this Section H.1 shall apply to any release or use of data first produced in the performance of the Contract and any analysis, tools, methodologies, or recorded product based on such data.

(b) Release and Use – Requirements related to confidentiality and quality. To ensure public trust in the confidentiality protections afforded participants in Agency for Healthcare Research and Quality (AHRQ)-supported research, AHRQ requires and monitors compliance by its contractors with section 934(c) of the Public Health Service Act (PHS Act) (42 U.S.C. 299c-3(c)), which states in part that

No information, if the establishment or person supplying the information or described in it is identifiable, obtained in the course of activities undertaken or supported under this title, may be used for any purpose other than the purpose for which it was supplied unless such establishment or person has consented...to its use for such other purpose. Such information may not be published or released in other form if the person who supplied the information or who is described in it is identifiable unless such person has consented...to its publication or release in other form.

In addition to this requirement, section 933(b)(1) of the PHS Act (42 U.S.C. 299c-2(b)(1)) requires AHRQ to assure that statistics and analyses developed with Agency support are of high quality, comprehensive, timely, and adequately analyzed. Accordingly --

(1) prior to the release or use of data based upon work performed under this Contract, the Contractor agrees to consult with the Contracting Officer’s Representative and Contract Officers regarding the proposed release or use. The Contractor will in good faith consider, discuss, and respond to any comments or suggested modifications that are provided by AHRQ within two months of receiving the proposed release or use.

The purpose of such consultation is to assure that:

(A) identifiable information is being used exclusively for the purpose(s) for which it was supplied or appropriate consents have been obtained;

(B) the confidentiality promised to individuals and establishments supplying identifiable information or described in it is not violated; and

(C) the quality of statistical and analytical work meets the statutory standards cited above.

(2) The Contractor must satisfy conditions (1)(A) and (1)(B). At the conclusion of any consultation required by paragraph (b)(1) above, if AHRQ and the Contractor cannot agree that a proposed use or release satisfies condition (1)(C) above:

(A)the research professional at the Contractor responsible for the quality of the Contract work will, in advance of any release or use of such data, certify in a letter to the Contracting Officer what differences of opinion cannot be resolved regarding the statutory standards referenced in condition (1)(C) and the basis for Contractor assertions that these standards have been met; and
(B)the Contractor must print prominently on the release or other product, or on any portion that is released, or state prior to any oral presentation or release of such material, the following disclaimer:

THIS PRESENTATION/ PUBLICATION/OR OTHER PRODUCT IS…

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