RFP.pdf

PAGES

15A. NAME

AND

ADDRESS

OF

OFFEROR

SEC. PAGE(S) SEC. PAGE(S)

(Date) (Hour)

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amend-ments to the SOLICITATION for offerors and related documents numbered and dated:

(Type or Print)

SOLICITATION, OFFER AND AWARD 1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

1 51

2. CONTRACT NO.

3. SOLICITATION NO.

2017-N-66628

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

6. REQUISITION/PURCHASE

NO.

00HCVLEE-2017-08242

7. ISSUED BY CODE 2536 8. ADDRESS OFFER TO (If other than Item 7)

Centers for Disease Control and Prevention

Acquisition and Assistance Branch 1

2920 Brandywine Road, MS E-15

Atlanta, GA 30341-5539

Approved as to Form and Legality: _____________________________

NOTE: In sealed bid solicitations “offer” and “offeror” mean “bid” and “bidder.”

SOLICITATION

9. Sealed offers in original and copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in until 2:00p local time 6/16/2017

CAUTION -- LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME

Germaine Mullins

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(770) 488-1938

C. E-MAIL ADDRESS

Gmullins@cdc.gov

11. TABLE OF CONTENTS

(x) DESCRIPTION (x) DESCRIPTION

PART I – THE SCHEDULE PART II – CONTRACT CLAUSES

X A SOLICITATION/CONTRACT FORM 1 X I CONTRACT CLAUSES 29

X B SUPPLIES OR SERVICES AND PRICES/COSTS 2 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

X C DESCRIPTION/SPECS./WORK STATEMENT 3 X J LIST OF ATTACHMENTS 35

X D PACKAGING AND MARKING 8 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 9 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 10 X K OTHER STATEMENTS OF OFFERORS 36

X G CONTRACT ADMINISTRATION DATA 13 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 42

X H SPECIAL CONTRACT REQUIREMENTS 17 X M EVALUATION FACTORS FOR AWARD 47

OFFER (Must be fully completed by offeror)

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 calendar days unless a different period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52-232-8)

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

AMENDMENT NO. DATE AMENDMENT NO. DATE

CODE FACILITY 16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION

10 U.S.C. 2304(c)( ) 41 U.S.C. 253(c)( )

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

ITEM

24. ADMINISTERED BY (If other than Item 7) CODE 2536 25. PAYMENT WILL BE MADE BY CODE 434

Centers for Disease Control and Prevention

Acquisition and Assistance Branch 1

2920 Brandywine Road, MS E-15

Atlanta, GA 30341-5539

Centers for Disease Control and Prevention (FMO)

PO Box 15580 404-718-8100

Atlanta, GA 30333-0080

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

IMPORTANT -- Award will be made on this form, or on Standard Form 26, or by other authorized official written notice.

AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 33 (REV. 9-97)

PREVIOUS EDITION IS UNUSABLE Prescribed by GSA

FAR (48 CFR) 53.214©

K

Section B - Supplies Or Services And Prices/Costs

Period of Performance: September 29, 2017 through September 28, 2019

ITEM SUPPLIES / SERVICES QTY /

UNIT

UNIT PRICE EXTENDED

PRICE

0001 Multi-site Clinical Assessment (Non-Severable Services)

The Contractor shall provide services in accordance with the attached Statement of Work for the National Center for

Emerging and Zoonotic Infectious Diseases for Pediatric

Clinical Assessment of 300 patients.

24 Months

The Government anticipates a Firm Fixed Price multiple award requirement.

Section C - Description/Specification/Work Statement

STATEMENT OF WORK

MULTI-SITE CLINICAL ASSESSMENT OF PEDIATRIC MYALGIC

ENCEPHALOMYELLITIS/CHRONIC FATIGUE SYNDROME (ME/CFS)

Background

The National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) aims to prevent disease, disability, and death caused by a wide range of infectious diseases. NCEZID’s focus on diseases that have been around for many years, emerging diseases (those that are new or just recently identified), and zoonotic diseases (those spread from animals to people). NCEZID’s work is guided in part by a holistic "One Health" strategy, which recognizes the vital interconnectedness of microbes and the environment. Through a comprehensive approach involving many scientific disciplines, the government can attain better health for humans and animals and improve our environment.

In order to carry out our mission, the government may use many different tactics: providing leadership in public health, conducting exemplary science, strengthening preparedness efforts, establishing public health policy, sharing vital health information with the public, and building partnerships. Each of the center's seven divisions works with partners to protect and improve the public's health in the United States and worldwide.

Myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS) is a debilitating condition of unknown etiology and pathogenesis. ME/CFS is often thought of as a problem in adults, but it also affects children, including adolescents. In children, and particularly in adolescents, ME/CFS is more likely to develop after an acute flu-like or mononucleosis-like illness, but gradual onset of illness can occur across all age groups. Some symptoms of

ME/CFS in adolescents are similar to those in adults: disabling fatigue that substantially interferes with daily activities, sleep problems (such as unrefreshing sleep and a need to sleep more during the day), marked worsening of symptoms after physical or mental exertion, muscle and/or joint pain without redness or swelling, headaches, and impaired memory or concentration. Other symptoms that can be observed in both children and adults include sore throat, tender cervical and/or axillary lymph nodes, and headaches of new onset or severity. Until recently, diagnoses were made on the basis of ruling out other conditions that could explain most of these symptoms;

however, in 2015, an Institute of Medicine report proposed a new clinical case definition with specific symptoms and manifestations. In adolescents, diagnostic challenges are compounded by the processes of puberty, a time of hormonal fluctuation and social transition from childhood to adulthood that can contribute to problems with sleep and social adjustment.

More commonly than adults, children with ME/CFS report symptoms such as dizziness, light-headedness, abdominal pain, rash, fever and chills. ME/CFS may be more difficult to identify in children since the words they often use to describe their symptoms differ from those used by adults to describe their experiences of symptoms.

While there are some differences in ME/CFS illness in children compared with adults, similarities include that illness in both adults and children can be heterogeneous, meaning that the intensity of symptoms can vary and that there is no “classic” presentation of illness, as can occur with other childhood illnesses, including pertussis, for example. Therefore, measures to describe the heterogeneity in both child and adult populations are needed. Since

April 2012, the CDC has conducted a Multi-site Clinical Assessment of CFS in Adults (CDC IRB# 6286.0) to characterize adult patients with ME/CFS as identified in clinical practices of clinicians with expertise in ME/CFS.

The approach to the study of adolescents with ME/CFS was previously delineated and approved (Multi-site Clinical

Assessment of Chronic Fatigue Syndrome (CFS) in Children and Adolescents [CDC IRB# 6528]). Using this protocol, efforts to recruit adolescent patients through prior contract modification(s) are ongoing; this contract will supplement the sample sizes of adolescents as needed for currently planned descriptive analyses. The current study will focus on adolescents diagnosed with ME/CFS on the basis of clinical expertise and experience, and use the similar standardized approach to collect data on the key dimensions of the illness as employed in the Multi-site

Clinical Assessment of CFS in Adults (CDC IRB# 6286.0) and the Multi-site Clinical Assessment of Chronic Fatigue

Syndrome (CFS) in Children and Adolescents (CDC IRB# 6528). Such standardized data on all domains of

ME/CFS occurring among adolescents will inform further discussions of case definitions and provide information on potential ME/CFS sub-groups that could be evaluated for linkage to specific biologic measures.

There is also a need to improve the quality of care available to patients with ME/CFS. CDC’s continuing medical education initiatives for health care workers require best practices and evidence-based guidance for evaluating patients presenting with an unexplained fatiguing illness as well as for initial and ongoing management of patients with this condition. Consultation with clinical experts in ME/CFS and dialogue among these experts as part of this study will assist in building consensus in these areas.

Definition

Myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS) is a debilitating condition of unknown etiology and pathogenesis that can affect children, adolescents and adults.

Purpose

The purpose of this requirement is to examine the heterogeneity of the symptoms, manifestations, management, and responses to treatment among adolescents with ME/CFS following a diagnosis in the clinical practices of clinicians experienced with the identification and management of ME/CFS. Experienced clinicians will enroll patients whom they will or have diagnosed with ME/CFS based on their clinical expertise.

Scope of Work

As an independent organization, and not as an agent of the government, the contractor shall provide the government with clinical, functional, and epidemiological data using standardized approaches and perform a study employing the clinical expertise of the physicians caring for persons aged 10 – 17 years old with ME/CFS. The results will be used to characterize and describe the extent of the clinical and management heterogeneity within between participating clinical practices. The findings will facilitate the development of standardized approaches to the clinical diagnosis and management of ME/CFS among the persons aged between 10 and 17 years old, and will inform efforts to characterize further the similarities and differences in presentation of the patients of varied ages.

Ultimately, this study aims to improve measures of illness domains (questionnaires and biologic) and allow patients identified by case definitions and clinical judgment used in the clinical practices to be phenotypically sub-grouped in a way that allows the underlying biology to be discovered. In addition, to benefit needed ongoing and future research, this study will facilitate continued standardization, integration, and shared use of data pertaining to patients with ME/CFS.

Required activities include use of specific instruments and data collection forms for enrolled patients aged 10–17 years. Some of the instruments and forms listed below were employed for Multi-site Clinical Assessment of CFS in

Adults (CDC IRB# 6286.0) and the Multi-site Clinical Assessment of Chronic Fatigue Syndrome (CFS) in Children and Adolescents (CDC IRB# 6528). These protocols were designed to be compatible with routine clinical visits. The types of information collected as well as data collection forms and instruments may include at a minimum the following:

a. Basic vital sign measures

b. History of the present illness to include the time of onset and/or circumstances (acute infection, trauma, stress, etc.)

c. Standardized physical exam (as defined for this study through discussion and clinical protocol)

d. Medical history

e. Current medications. For example, any over-the-counter or non-prescription supplements

f. Multidimensional Fatigue Inventory (MFI-20)

g. Medical Outcomes Study 36-Item Short Form Health Survey (SF-36v2)

h. CDC Symptom Inventory (CDC-SI)

i. DePaul Pediatric Health Questionnaire (DPHQ)

j. Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Fatigue, Pain

k. Social Participation Form – School and Outside Activities

The overall target enrollment is 200 patients aged 10–17 years with ME/CFS and 100 healthy controls aged 10–17 years. The contractor shall either collaborate with or be qualified clinicians that have experience in diagnosing and managing ME/CFS. Contractors may apply with multiple clinical sites. For example, four (4) clinical sites have an average target enrollment per clinical site as 50 patients aged 10-17 years old with ME/CFS and 25 healthy controls aged 10-17 years old. Site targets might be adjusted depending on the number of clinical sites identified and proposed. For instance, a contractor with a large number of proposed clinical sites might have a lower enrollment per site; however, each practice site should have the capacity to enroll a minimum of 15 patients with ME/CFS. The contractor shall specify the maximum number of anticipated eligible patients for each patient group they would have the capacity to enroll.

Tasks to be Performed

The Contractor shall provide the following tasks:

1. Provide a copy in electronic format of clinical protocols for initial visits of patients being assessed for

ME/CFS. The documents submitted should be detailed and include the laboratory and other diagnostic tests performed, and the instruments and scoring algorithms and other clinical management tools.

2. Provide documentation of local Institutional Review Board (IRB) submissions.

3. Provide documentation of the initial local IRB approval

4. Provide documentation of the local IRB annual approval

5. Attend or designate the appropriate staff to attend an on-site meeting at the government facility or one or more conference calls, as necessary to “kick-off” the requirement activities.

6. Develop and submit a data management plan

7. Prepare for the study conduct and completion. The contractor shall provide and train staff to enroll patients, complete standardized physical exams as defined for this study through discussion and clinical protocol, collect data, check data quality, and transmit the data to the government. The training shall be in accordance with the study protocol, which shall be adapted from the prior pediatric protocol and developed collaboratively by the government, contractors, and designated clinicians.

The staff shall participate in the conference call(s) conducted with the government to train on the standardization of the data collection techniques and finalize the process implementation measures. The contractor shall provide:

a. Staff that is responsible for contacting eligible study subjects, obtaining informed consent, scheduling appointments, sending advance materials to patients, checking subjects into the clinic, reviewing all of the materials that participants submit to ensure completeness of information, and entering, managing, and submitting data.

b. Staff to abstract clinical records, administer physical exams, collect physical measurements, and review self-administered questionnaires with subjects.

c. A data manager is essential

d. Staff clinicians (e.g., psychologies, psychiatric social workers) or non-clinicians with documented experience in psychological assessment to interview patients regarding depression, substance abuse, anorexia, bulimia nervosa or other comorbidities.

e. Clinicians with both documented clinical training (e.g., MD, DO) and documented experience in diagnosing and managing patients with ME/CFS.

8. Enroll patients and collect the required information. The contractor, per clinical/practice site, shall ideally enroll 50 new or established patients with ME/CFS who have given informed consent for the data collection and sharing. The minimum enrollment per clinical/practice site is 15 patients with ME/CFS. In addition, 100 health controls matched by gender (minimum one control per two patients) shall be enrolled.

The contractor, or designated clinician, shall participate in monthly conference calls with the government.

a. The participants will receive a study number. The personal identifiers shall be stored separately and will only be accessible to the study coordinator at the participating site. The de-identified data shall be delivered to the government central data coordination site.

b. Permission should be sought from those that enrolled for future contact by the study site workers.

c. Assist in any government staff site visits (1 or 2 per awardee) to monitor the data collection and study implementation and perform random data checks.

d. Key all of the raw response data collected from paper forms into a database compatible with the data structure and dictionary standardized by the group and submit the electronic files of:

i. Medication history, the physical examination form including medical history,

ii. Laboratory test results,

iii. The questionnaires, and

iv. A spreadsheet containing the study numbers of the records with no personal identifier.

9. Final Study Report and Data Transfer. The contractor shall transfer the final data set and all of the required documentation to the government. The contractor (or designated clinician or staff) shall participate in conference calls with the contract awardees to summarize the study and discuss any issues or concerns and potential solutions for future studies.

Government Furnished Materials

The government will furnish the contractor with the standardized instruments as outlined for the Multi-site Clinical

Assessment of Chronic Fatigue Syndrome (CFS) in Children and Adolescents (CDC IRB# 6528), and if applicable, any additional tools that might be included in the study’s final clinical protocol. The final, detailed government IRB-approved clinical protocol will be provided for submission to local IRBs. A standardized approach for the data collection will reduce measurement errors that will result from use of different data collection instruments and will also facilitate characterization of the heterogeneity of the patients with ME/CFS. The government will also provide data storage for the final data sets at the government facility and secure File Transfer Protocol (FTP) website for transferring data.

Period of Performance

The estimated period of performance for this non-severable requirement is from September 29, 2017 through

September 28, 2019.

Minimum Qualifications

The contractor shall meet and/or exceed the minimum qualifications listed below.

a. Willing to collaborate with other contract holders and the government regarding this study and its conduct.

b. Willing to share current diagnosis criteria and tools as well as methods to determine exclusionary conditions in use at their clinic.

c. Willing to collect the data agreed upon by all contractors during the planning meeting or conference call held at the beginning of the contract as outlined in the Statement of Work and in subsequent protocol(s).

d. Commit to attending at least one planning meeting in person at the government facility in order to standardize protocols and determine methods for data integration and sharing. Depending on the availability of space at the government facility, the in person meeting may be substituted with a conference call.

e. Documented expertise in clinical diagnosis and management of ME/CFS and submit documentation pertaining to their clinical training, current medical licensures, and board certifications.

f. A description of their current patient population with ME/CFS in order to document feasibility of enrolling the required numbers of patients with ME/CFS.

g. Detail their plans for enrollment of required healthy patients.

h. A data management coordinator and data management plan to be submitted at the beginning of the study.

i. Curriculum vitae and credentials for all proposed clinicians and data managers are required.

References

1. Rangel L, Garralda ME, Levin M, Roberts H. The course of severe chronic fatigue syndrome in childhood. JR Soc Med 2000;93:129–134.

2. Carter BD, Edwards JF, William G, et al. Case control study of chronic fatigue in pediatric patients.

Pediatrics 1995;92:179–86.

3. Garralda M, Chalder T. Practitioner Review: Chronic fatigue syndrome in childhood. Journal of Child

Psychology and Psychiatry. 2005, Nov;46(11):1143–51.

4. Fukuda K, Straus SE, Hickie I, Sharpe MC, Dobbins JG, Komaroff AL; International Chronic Fatigue

Syndrome Study Group. The chronic fatigue syndrome: a comprehensive approach to its definition and study. Ann Intern Med 1994;121:953–959.

5. Carruthers BM, Jain AK, De Meirleir KL, Peterson DL, Klimas NG, Lerner AM, et al. Myalgic

Encephalomyelitis/chronic fatigue syndrome: clinical working case definition, diagnostic and treatment protocols. J Chronic Fatigue Syndr. 2003; 11: 7–115.

6. Carruthers BM, van de Sande MI, De Meirleir KL, Klimas NG, Broderick G, Mitchell T, et al.

Myalgic encephalomyelitis: International consensus criteria. J Intern Med. 2011; 270: 327-338.

7. Institute of Medicine. Beyond myalgic encephalomyelitis/chronic fatigue syndrome: redefining an illness. Washington, DC: The National Academies Press; 2015.

http://www.nationalacademies.org/hmd/ reports/2015/me-cfs.aspx

8. Farmer A, Fowler T, Scourfield J, & Thapar A. Prevalence of chronic disabling fatigue in children and adolescents. PJP. 2004; 184: 477–481.

9. Unger ER, Jin-Mann SL, Brimmer DJ, Lapp CW, Komaroff AL, Nath A, et al. CDC Grand Rounds:

Chronic Fatigue Syndrome—Advancing research and clinical education. MMWR Morb Mortal Wkly

Rep 2016;65:1434–1438.

10. Ian Hickie, Tracey Davenport, Suzanne D. Vernon, Rosane Nisenbaum, William C. Reeves, Dusan

Hadzi-Pavlovic, Andrew Lloyd, and the International Chronic Fatigue Syndrome Study Group. Are chronic fatigue and chronic fatigue syndrome valid clinical entities across countries and healthcare settings? Australian and New Zealand Journal of Psychiatry 2009; 43:25–35.

11. Light AR, Bateman L, Jo D, Hughen RW, Vanhaitsma TA, White AT, Light KC. Gene expression alterations at baseline and following moderate exercise in patients with Chronic Fatigue Syndrome and

Fibromyalgia Syndrome. J Intern Med. 2012 Jan;271(1):64–81. doi: 10.1111/j.1365-

2796.2011.02405.x. Epub 2011 Jul 13.

12. Department of Health and Human Services. Clinical Assessment of CFS—Solicitation number: 2011-

N-13483. Available at:

https://www.fbo.gov/index?s=opportunity&mode=form&id=16a2a858ddc024d0954ab38cea79960e&t ab=core&_cview=1 Updated: Aug 4, 2011. Accessed: Feb 6, 2017.

13. CDC. Multi-site clinical assessment of CFS. Available at: https://www.cdc.gov/cfs/programs/clinical-assessment/index.html Updated: April 8, 2013. Accessed: Feb 6, 2017.

https://www.fbo.gov/index?s=opportunity&mode=form&id=16a2a858ddc024d0954ab38cea79960e&tab=core&_cview=1 https://www.fbo.gov/index?s=opportunity&mode=form&id=16a2a858ddc024d0954ab38cea79960e&tab=core&_cview=1 https://www.cdc.gov/cfs/programs/clinical-assessment/index.html https://www.cdc.gov/cfs/programs/clinical-assessment/index.html

Section D - Packaging And Marking

There are no clauses/provisions included in this section.

Section E - Inspection And Acceptance

E.1 52.246-4 Inspection of Services -- Fixed-Price (Aug. 1996)

(a) Definition: “Services,” as used in this clause, includes services performed, workmanship, and material furnished or utilized in the performance of services.

(b) The Contractor shall provide and maintain an inspection system acceptable to the Government covering the services under this contract. Complete records of all inspection work performed by the Contractor shall be maintained and made available to the Government during contract performance and for as long afterwards as the contract requires.

(c) The Government has the right to inspect and test all services called for by the contract, to the extent practicable at all times and places during the term of the contract. The Government shall perform inspections and tests in a manner that will not unduly delay the work.

(d) If the Government performs inspections or tests on the premises of the Contractor or a subcontractor, the

Contractor shall furnish, and shall require subcontractors to furnish, at no increase in contract price, all reasonable facilities and assistance for the safe and convenient performance of these duties.

(e) If any of the services do not conform with contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, at no increase in contract amount. When the defects in services cannot be corrected by reperformance, the Government may --

(1) Require the Contractor to take necessary action to ensure that future performance conforms to contract requirements; and

(2) Reduce the contract price to reflect the reduced value of the services performed.

(f) If the Contractor fails to promptly perform the services again or to take the necessary action to ensure future performance in conformity with contract requirements, the Government may --

(1) By contract or otherwise, perform the services and charge to the Contractor any cost incurred by the

Government that is directly related to the performance of such service; or

(2) Terminate the contract for default.

(End of Clause)

Section F - Deliveries Or Performance

F.1 FAR 52.242-15 Stop-Work Order (Aug 1989)

(a) The Contracting Officer may, at any time, by written order to the Contractor, require the Contractor to stop all, or any part, of the work called for by this contract for a period of 90 days after the order is delivered to the Contractor, and for any further period to which the parties may agree. The order shall be specifically identified as a stop-work order issued under this clause. Upon receipt of the order, the Contractor shall immediately comply with its terms and take all reasonable steps to minimize the incurrence of costs allocable to the work covered by the order during the period of work stoppage. Within a period of 90 days after a stop-work is delivered to the Contractor, or within any extension of that period to which the parties shall have agreed, the Contracting Officer shall either –

(1) Cancel the stop-work order; or

(2) Terminate the work covered by the order as provided in the Default, or the Termination for Convenience of the

Government, clause of this contract.

(b) If a stop-work order issued under this clause is canceled or the period of the order or any extension thereof expires, the Contractor shall resume work. The Contracting Officer shall make an equitable adjustment in the delivery schedule or contract price, or both, and the contract shall be modified, in writing, accordingly, if –

(1) The stop-work order results in an increase in the time required for, or in the Contractor’s cost properly allocable to, the performance of any part of this contract; and

(2) The Contractor asserts its right to the adjustment within 30 days after the end of the period of work stoppage;

provided, that, if the Contracting Officer decides the facts justify the action, the Contracting Officer may receive and act upon the claim submitted at any time before final payment under this contract.

(c) If a stop-work order is not canceled and the work covered by the order is terminated for the convenience of the

Government, the Contracting Officer shall allow reasonable costs resulting from the stop-work order in arriving at the termination settlement.

(d) If a stop-work order is not canceled and the work covered by the order is terminated for default, the Contracting

Officer shall allow, by equitable adjustment or otherwise, reasonable costs resulting from the stop-work order.

F.2 Place(s) of Performance (Jul 1999)

The Contractor shall perform all work under this contract at: Contractor’s facility.

F.3 Period of Performance (Jul 1999)

The period of performance is 24 months.

The estimated period of performance is from September 29, 2017 through September 28, 2019.

F.4 Deliverable(s) Schedule (Jul 1999)

The Contractor shall deliver, within the time frames specified in the chart below:

Task

Number

Description Quantity or

Number of

Copies

Deliverable Due

Date

Delivered To

1 Clinical Protocols 1 protocol per clinical site

2 weeks after contract award

COR

2 Institutional Review Board (IRB) Documentation 1 Within 2 weeks after receipt of the study protocol from the government

COR

3 Initial Local IRB Approval(s) 1 per IRB COR

4 Local IRB Annual Approval(s) 1 electronic and 1 hard copy

No later than 3 months after receipt of the study protocol from the government

COR

6 Initial Draft of Data Management Plan 1 TBD COR

6 Final Data Management Plan 1 TBD COR

7 Study Preparation and Training Report 1 1 month of receipt of the study protocol from the government

COR

8 Raw Response Data for First Five (5) Enrollees Per Site 1 week of the data collection of the 5th enrollee at a clinical site

COR or designee

8 Upload Required Entered Data Sets and Documents Quarterly COR

8 Summary of Annual Enrollment Report 1 Annually COR

8 Spreadsheet Containing De-Identified Enrollees’ Study

Numbers

1 Annually COR

9 Final Data Set and All Required Documentation 1 1 month of the data collection of the last enrollee

COR

9 Draft Comprehensive Contractor-Specific Study Report 1 Within 2 months of the data collection of the last enrollee

COR

9 Final Comprehensive Contractor-Specific Study Report 1 At the end of the study

COR

Deliverable for Task 7

The study preparation and training report including a list of the study staff and their respective responsibilities shall be submitted to the Contracting Officer’s Representative (COR) within one month of receipt of study protocol from the government.

Deliverable for Task 8

When data collection and entry for the first five (5) subjects at a site are complete, transfer the raw response data and entered data to the government for the data validation and procedure quality control purpose. The transfer should occur within one (1) week of the data collection of the fifth (5th) enrollee at a clinical site.

Upload the entered data to the dedicated government secured FTP server quarterly.

Prepare a one single-spaced, typewritten copy of a summary of yearly enrollment report and provide the documentation to the Contracting Officer’s Representative or designee on an annual basis.

Provide a spreadsheet annually containing the enrollees’ study numbers with no personal identifiers.

Deliverable for Task 9

Submit the final data set and all of the required documentation within one (1) month of the data collection of the last enrollee.

Prepare one single-spaced, typewritten copy of a comprehensive, contractor-specific study report in a draft form for review and comment by the government within two (2) months of the data collection of the last enrollee.

Submit the final comprehensive contractor-specific study report and present to the other contract awardees and the government at the end of the study.

Section G - Contract Administration Data

G.1 Contract Communications/Correspondence (Jul 1999)

The Contractor shall identify all correspondence, reports, and other data pertinent to this contract by imprinting thereon the contract number from Page 1 of the contract.

G.2 Contracting Officer Representative (COR)

a) A Contracting Officer Representative (COR) will be assigned to the contract. A COR will be assigned to each contract issued under the contract. The Contracting Officer will provide under separate cover the duties and responsibilities of the COR. The COR is not authorized to alter the requirements of this contract or contract without written approval of the Contracting Officer. The COR is not authorized to obligate any funds.

b) Performance of the work hereunder shall be subject to the technical directions of the designated COR for this contract.

c) As used herein, technical directions are directions to the Contractor which fill in details, suggests possible lines of inquiry, or otherwise completes the general scope of work set forth herein. These technical directions must be within the general scope of work, and may not alter the scope of work or cause changes of such a nature as to justify an adjustment in the stated contract price/cost, or any stated limitation thereof. In the event that the Contractor feels that full implementation of any of these directions may exceed the scope of the contract, he or she shall notify the originator of the technical direction and the

Contracting Officer in a letter separate of any required report(s) within two (2) weeks of the date of receipt of the technical direction and no action shall be taken pursuant to the direction. If the Contractor fails to provide the required notification within the said two (2) week period that any technical direction exceeds the scope of the contract, then it shall be deemed for purposes of this contract that the technical direction was within the scope. No technical direction, nor its fulfillment, shall alter or abrogate the rights and obligations fixed in this contract.

d) The Government COR is not authorized to change any of the terms and conditions of this contract.

Changes shall be made only by the Contracting Officer by properly written modification(s) to the contract.

e) The Government will provide the Contractor with a copy of the delegation memorandum for the COR.

Any changes in COR delegation will be made by the Contracting Officer in writing with a copy being furnished to the Contractor.

G.3 Contracting Officer (Jul 1999)

(a) The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions, or other stipulations of this contract.

(b) No information, other than that which may be contained in an authorized modification to this contract, duly issued by the Contracting Officer, which may be received from any person employed by the United States

Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract.

G.4 Subcontracting Program Reports (May 1998)

(a) The Contractor shall submit the reports listed below in accordance with the instructions and within the time periods specified on the report forms:

(1) Standard Form 294, Subcontracting Report for Individual Contracts.

(2) Standard Form 295, Summary Subcontract Report.

(b) In addition to the reporting information specified on the report forms, the Contractor shall provide, in the

“Remarks” block on each Standard Form 294 submitted, a narrative of the progress made in fulfilling the small business and small disadvantaged business subcontracting goals contained in its approved plan.

(c) The Contractor shall report to the Contracting Officer any difficulties encountered in achieving the goals and shall describe the action being taken to overcome the difficulties.

G.5 CDCAG001 – Invoice Submission (Mar 2006)

(a) The Contractor shall submit the original contract invoice/voucher to the shown below:

The Centers for Disease Control and Prevention

Financial Management Office (FMO)

P.O. Box 15580

Atlanta, GA 3033

Or – The Contractor may submit the original invoice/voucher via facsimile or email:

Fax: 404-638-5324

Email: FMOAPINV@CDC.GOV

NOTE: Submit to only one (1) of the above locations.

(b) The contractor shall submit 2 copies of the invoice/voucher to the cognizant contracting office previously identified in this contract. These invoices/voucher copies shall be addressed to the attention of the Contracting

Officer.

(c) The Contractor is , is not required to submit a copy of each invoice directly to the Project Officer concurrently with submission to the Contracting Officer.

(d) In accordance with 5 CFR part 1315 (Prompt Payment), CDC's Financial Management Office is the designated billing office for the purpose of determining the payment due date under FAR 32.904.

(e) The Contractor shall include (as a minimum) the following information on each invoice:

(1) Contractor’s Name & Address

(2) Contractor’s Tax Identification Number (TIN)

(3) Purchase Order/Contract Number and Task Order Number, if Appropriate

(4) Invoice Number

(5) Invoice Date mailto:FMOAPINV@CDC.GOV

(6) Contract Line Item Number and Description of Item

(7) Quantity

(8) Unit Price & Extended Amount for each line item

(9) Shipping and Payment Terms

(10) Total Amount of Invoice

(11) Name, title and telephone number of person to be notified in the event of a defective invoice

(12) Payment Address, if different from the information in (c)(1).

(13) DUNS + 4 Number

G.6 CDC42.0002 Evaluation of Contractor Performance Utilizing CPARS (April 2013)

In accordance with FAR 42.15, the Centers for Disease Control and Prevention (CDC) will review and evaluate contract performance. FAR 42.1502 and 42.1503 requires agencies to prepare evaluations of contractor performance and submit them to the Past Performance Information Retrieval System (PPIRS). The CDC utilizes the

Department of Defense (DOD) web-based Contractor Performance Assessment Reporting System (CPARS) to prepare and report these contractor performance evaluations. All information contained in these assessments may be used by the Government, within the limitations of FAR 42.15, for future source selections in accordance with FAR

15.304 where past performance is an evaluation factor.

The CPARS system requires a contractor representative to be assigned so that the contractor has appropriate input into the performance evaluation process. The CPARS contractor representative will be given access to CPARS and will be given the opportunity to concur or not-concur with performance evaluations before the evaluations are complete. The CPARS contractor representative will also have the opportunity to add comments to performance evaluations.

The assessment is not subject to the Disputes clause of the contract, nor is it subject to appeal beyond the review and comment procedures described in the guides on the CPARS website. Refer to: www.cpars.gov for details and additional information related to CPARS, CPARS user access, how contract performance assessments are conducted, and how Contractors participate. Access and training for all persons responsible for the preparation and review of performance assessments is also available at the CPARS website.

G.7 CDC37.0001 Non-Personal Services (April 2013)

a) Personal services shall not be performed under this contract. Although the Government may provide sporadic or occasional instructions within the scope of the contract, the Contractor is responsible for control and supervision of its employees. If the Contractor (including its employees) believes any Government action or communication has been given that would create a personal services relationship between the

Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.

b) The contractor shall comply with, and ensure their employees and subcontractors comply with, CDC Policy titled “Identification of Contractors' Employees and Safeguarding Government Information.” No

Contractor employee shall hold him or herself out to be a Government employee, agent, or representative.

No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the

Government. In all communications with third parties in connection with this contract, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work. . The contractor is limited to performing the services identified in the contract statement http://www.cpars.gov/ of work and shall not interpret any communication with anyone as a permissible change in contract scope or as authorization to perform work not described in the contract. All contract changes will be incorporated by a modification signed by the Contracting Officer.

c) The Contractor shall ensure that all of its employees and subcontractor employees working on this contract are informed of the substance of this clause. The Contractor agrees that this is a non-personal services contract; and that for all the purposes of the contract, the Contractor is not, nor shall it hold itself out to be an agent or partner of, or joint venture with, the Government. The Contractor shall notify its employees that they shall neither supervise nor accept supervision from Government employees. The substance of this clause shall be included in all subcontracts at any tier.

d) Nothing in this clause shall limit the Government's rights in any way under any other provision of the contract, including those related to the Government's right to inspect and accept or reject the services performed under this contract.

G.8 Electronic Subcontracting Reporting System (eSRS) (Dec 2005)

The contractor shall register with the Electronic Subcontracts Reporting System (eSRS) for the submission of its

Individual Subcontract Report (SF 294) and the Annual Summary Reports (SF 295). Before registering in eSRS, the contractor information must be correct in Central Contractor Registration database. The eSRS is a world wide web-based application available at: http://www.esrs.gov. The eSRS website provides training and instruction for data submission.

G.9 Payment by Electronic Funds Transfer (Dec 2005)

(a) The Government shall use electronic funds transfer to the maximum extent possible when making payments under this contract. FAR 52.232-33, Payment by Electronic Funds Transfer – Central Contractor Registration, in

Section I, requires the contractor to designate in writing a financial institution for receipt of electronic funds transfer payments.

(b) In addition to Central Contractor Registration, the contractor shall make the designation by submitting the form titled “ACH Vendor/Miscellaneous Payment Enrollment Form” to the address indicated below. Note: The form is either attached to this contract (see Section J, List of Attachments) or may be obtained by contacting the Contracting

Officer or the CDC Financial Management Office at (404) 498-4050.

(c) In cases where the contractor has previously provided such designation, i.e., pursuant to a prior contract/order, and been enrolled in the program, the form is not required unless the designated financial institution has changed.

(d) The completed form shall be mailed after award, but no later than 14 calendar days before an invoice is submitted, to the following address:

The Centers for Disease Control and Prevention

Financial Management Office (FMO)

P.O. Box 15580

Atlanta, GA 30333

Or – Fax copy to: 404-638-5342 http://www.esrs.gov/

Section H - Special Contract Requirements

H.1 HHSAR 352.203-70 Anti-Lobbying (Mar 2012)

Pursuant to the current HHS annual appropriations act, Public Law 112-74, except for normal and recognized executive-legislative relationships, the Contractor shall not use any HHS contract funds for:

a) Publicity or propaganda purposes;

b) the preparation, distribution, or use of any kit, pamphlet, booklet, publication, electronic communication, radio, television or video presentation designed to support or defeat the enactment of legislation before the Congress or any State or local legislature or legislative body, except in presentation to the Congress or any State or local legislature itself; or designed to support or defeat any proposed or pending regulation, administrative action, or order issued by the executive branch of any State or local ·government, except in presentation to the executive branch of any State or local government itself; or

c) Payment of salary or expenses of the Contractor, or any agent acting for the Contractor, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or Executive order proposed or pending before the Congress or any State government, State legislature or local legislature or legislative body, other than for normal and recognized executive-legislative relationships or participation by an agency or officer of a State, local or tribal government in policymaking and administrative processes within the executive branch of that government.

The prohibitions in subsections (a), (b) and (c) above shall include any activity to advocate or promote any proposed, pending or future Federal, State or local tax increase, or any proposed, pending, or future requirement for, or restriction on, any legal consumer product, including its sale or marketing, including, but not limited to, the advocacy or promotion of gun control.

(End of clause)

H.2 Health Information Technology (Jan 2012)

Executive Order 13410: Promoting Quality and Efficient Health Care in Federal Government Administered or

Sponsored Health Care Programs promotes efficient delivery of quality health care through the use of health information technology, transparency regarding health care quality and price, and incentives to promote the widespread adoption of health information technology and quality of care. To support this objective the awardee shall adhere to the following interoperability standards and requirements. For purposes of this contract clause, interoperability is defined as the ability of two or more systems or components to exchange information and to use the information that has been exchanged.

The Health Information Technology Clause (January 2012) shall be inserted in Section H of all contracts that involve (1) the exchange of public health data between public health entities, CDC, and other federal agencies, or (2) the exchange of public health data within the clinical setting, such as hospitals and providers, or any combination of

(1) and (2), and covers both situations. The inclusion of this clause is a Contracting Officer decision made with the advice and in coordination with the appropriate program officials from the requesting office.

Interoperability of Health Information Technology

This section of the clause applies to contracts that involve the exchange of public health data between public health entities, CDC, and other federal agencies. This supports the development and use of interoperable information systems for public health functions such as biosurveillance, situational awareness, laboratory science, or environmental health.

In addition to complying with HHS Standards for Security Configurations (HHSAR Clause 352.239-70), HHS Standards for Encryption Language (HHSAR Clause 352.239-71) and Federal Laws, Regulations and

Standards related to IT Security (HHSAR Clause 352.239-72), the awardee is required to meet recognized interoperability standards as follows:

The awardee shall use nationally adopted Public Health Information Network (PHIN) standards

(www.cdc.gov/phin) at the time of the system implementation, acquisition, or upgrade, in all relevant information technology systems supported, in whole or in part, through this contract. Where no PHIN standards exist, the awardee shall utilize recognized standards established by the Office of the National

Coordinator for Health Information Technology (ONC) as described in their Nationwide Health

Information Network (NwHIN) standards (www.hhs.gov/healthit/standards/background).

The awardee shall use PHIN policies, standards, practices, and services in the research and implementation of efficient and effective public health information systems, to facilitate interoperability (the ability of two or more systems or components to exchange information and to use the information that has been exchanged) with public health organizations and networks, including NwHIN.

Where the awardee supports or participates in health information or data exchange with disparate entities, the awardee must have an architecture that is compatible with the architecture of PHIN, where appropriate.

If PHIN standards do not exist, the awardee shall refer to NwHIN standards

(www.hhs.gov/healthit/standards/background).

(Continued on the following page)

Public Health Data within Clinical Healthcare

This section of the clause applies to contracts that involve the exchange of public health data within the clinical setting, such as hospitals and providers. This supports the exchange of public health information, including laboratory exchange data, between public health entities and healthcare systems.

The awardee shall use health IT investments, such as electronic health records (EHRs), personalized health records, and network components through which they operate and share information, that are certified by a recognized certification board and/or validated and tested with PHIN (www.cdc.gov/phin) or NwHIN

(http://healthit.hhs.gov/portal/server.pt?open=512&objID=1153&mode=2) certification to ensure a minimum level of interoperability or compatibility of health IT products.

The awardee may use services available from the Agency for Healthcare Research and Quality (AHRQ) at www.healthit.ahrq.gov. This link provides technical assistance, identifies challenges to health IT adoption and use, and identifies solutions and best practices that have the potential to transform clinical practice through the best and most effective use of IT.

Where feasible, the awardee shall collaborate with other healthcare entities, local quality…