2015-N-17148_Solicitation_ALS_Full_Biorepository_FFP.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 83

2. CONTRACT NO.

3. SOLICITATION NO.

2015-N-17148

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

06/01/2015

6. REQUISITION/PURCHASE

NO.

000HJAAN-2015-81471

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

Centers for Disease Control and Prevention Acquisitioin and Assistance Branch 2/Team 1 2920 Brandywine Road, MS-K69 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 5 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 Section L.10-5 until 11AM EST local time July 20, 2015

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.

THIS IS A TOTAL SMALL BUSINESS SET- ASIDE

10. FOR INFORMATION

CALL:

A. NAME

Betty Vannoy

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(770) 488-2891

C. E-MAIL ADDRESS

Bbv9@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 44

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

X C DESCRIPTION/SPECS./WORK STATEMENT 6 X J LIST OF ATTACHMENTS 52

X D PACKAGING AND MARKING 19 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 20 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 21 X K OTHER STATEMENTS OF OFFERORS 53

X G CONTRACT ADMINISTRATION DATA 24 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 62

X H SPECIAL CONTRACT REQUIREMENTS 30 X M EVALUATION FACTORS FOR AWARD 78

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 90 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

Same as Block 7

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

BASE PERIOD: September 10, 2015 through September 9, 2016

ITEM SUPPLIES / SERVICES QTY/UNIT UNIT PRICE EXTENDED PRICE

0001 Professional Services for the project entitled, “Establishing a Biorepository of

Amyotrophic Lateral Sclerosis (ALS)

Specimens to Complement the National ALS

Registry,” in accordance with the

Performance Work Statement as set forth in Section C.

Inspection/Acceptance: Destination

FOB: Destination

Performance Period:

September 10, 2015 through September 09, 1 JOB $___________ $_____________

OPTION PERIOD 1: September 10, 2016 through September 09, 2017

ITEM SUPPLIES / SERVICES QTY//UNIT UNIT PRICE EXTENDED PRICE

0002 Professional Services for the project entitled, “Establishing a Biorepository of

Amyotrophic Lateral Sclerosis (ALS)

Specimens to Complement the National ALS

Registry,” in accordance with the

September 10, 2016 through September 09, 1JOB $__________ $_________________

OPTION PERIOD 2: September 10, 2017 through September 09, 2018

0003 Professional Services for the project entitled, “Establishing a Biorepository of

Amyotrophic Lateral Sclerosis (ALS)

Specimens to Complement the National ALS

Registry,” in accordance with the

September 10, 2017 through September 09, 1 JOB $__________ $_________________

OPTION PERIOD 3: September 10, 2018 through September 09, 2019

0004 Professional Services for the project entitled, “Establishing a Biorepository of

Amyotrophic Lateral Sclerosis (ALS)

Specimens to Complement the National ALS

Registry,” in accordance with the

September 10, 2018 through September 09, OPTION PERIOD 4: September 10, 2019 through September 09, 2020

0005 Professional Services for the project entitled, “Establishing a Biorepository of

Amyotrophic Lateral Sclerosis (ALS)

Specimens to Complement the National ALS

Registry,” in accordance with the

September 10, 2019 through September 09, B.2 Total Contract Value (including all options):

CLIN PERIOD EXTENDED PRICE

0001 Base

0002 Option 1

0003 Option 2

0004 Option 3

0005 Option 4

TOTAL

B.3 General

This is a competitive total small business set-aside procurement. This acquisition is being competed in accordance with FAR Part 15 - Contracting by Negotiation. The NAICS Code is 541712, Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology), with a small business size standard of 500 employees.

B.4 FAR 52.216-1 Type of Contract (Apr 1984)

The Government contemplates an award of a Fixed Price Performance Based Service award resulting from this solicitation.

(End of Provision)

B.5 Performance-Based Preference

Pursuant to FAR 37.102(a) (1), the Contracting Officer will use performance-based acquisition methods to the maximum extent practicable. Pursuant to FAR 37.102(a)(2), a firm-fixed price performance-based contract will be awarded.

B.6 Lines of Accounting:

To Be Determined (TBD)

B.7 Service Definition (Check One)

Non-Severable Service -- BASE PERIOD

Severable Service – OPTION PERIODS, if exercised

B.8 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 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.

(End of Clause)

Section C - Description/Specification/ Work Statement

Title of Project: Establishing a Biorepository of Amyotrophic Lateral Sclerosis (ALS) Specimens to

Complement the National ALS Registry

C.1 Background and Need – The ALS Registry Act (H.R. 2295) was passed on October 16, 2008. The

ALS Registry Act amends the Public Health Service Act to require the Secretary of DHHS, acting through the Director of CDC/ATSDR, to (1) develop a system to collect data on amyotrophic lateral sclerosis (ALS); and (2) establish a national registry for the collection and storage of ALS data.

In October, 2010, ATSDR officially launched the National ALS Registry. The purpose of the ALS

Registry is to better describe the incidence and prevalence of ALS in the United States; examine factors, such as environmental and occupational, that might be associated with the disease; better outline key demographic factors (such as age, race or ethnicity, gender, and family history of individuals who are diagnosed with the disease) associated with the disease; and facilitate examination of the connection between ALS and other motor neuron disorders that can be confused with ALS, misdiagnosed as ALS, and in some cases progress to ALS.

In July 2014, ATSDR released its first National ALS Registry report. During October 19, 2010–

December 31, 2011, a total of 12,187 persons meeting the surveillance case definition of ALS were identified by the Registry, for a prevalence of 3.9 cases of ALS per 100,000 persons in the U.S. general population. In addition to tracking new ALS cases, ATSDR is now engaging in a series of activities to further enhance the National ALS Registry. Examples already underway include launching new survey modules to help identify potential risk factors for ALS and using comprehensive surveillance activities in select states and large metropolitan areas to help test the completeness of the Registry.

Because little is known about the role genetics plays in ALS, ATSDR conducted a pilot study to determine the feasibility of establishing a biorepository of samples from persons with ALS. Samples from approximately 330 patients have been collected, including blood, urine, hair, and nails samples, as well as post-mortem specimens from up to 30 patients, such as whole brains, spinal cords, and cerebrospinal fluid. The findings of that pilot study indeed support the creation of a biorepository.

C.2 Project Objective – The purpose of this contract is to establish an ongoing biorepository of specimens from persons with ALS enrolled in the National ALS Registry.

ATSDR is particularly interested in samples such as blood, urine, saliva, hair, and nails, in addition to post-mortem specimens, such as bone, muscle, skin, whole brains, spinal cords, and cerebrospinal fluid.

Collected samples (already collected via the pilot effort and future collections) may be used for the purposes such as genetic analysis creating cell lines or other analyses requested by CDC/ATSDR. While there are other biorepositories currently in existence that contain specimens from persons with ALS, these biorepositories are often limited and target select groups (e.g., military veterans with ALS). Additionally, these biorepositories do not necessarily collect epidemiological/risk factor data from the patients who contribute specimens (e.g., occupational, residential, and military history). Submission of specimens for this biorepository would be open to all persons with ALS enrolled in the congressionally mandated

National ALS Registry. The ability to connect the biological material to information about risk factors and data about medical treatment will make the biorepository unique and especially valuable to ALS researchers.

This contract will provide funding for the creation, operation, maintenance, cataloging, and ongoing analysis of sample supply and demand of a biorepository of specimens from persons with ALS enrolled in the National ALS Registry.

C.3 Scope of Work – To provide technical assistance support to create a biorepository based on the protocol developed from the pilot study mentioned above, which was created by a group of experts in registries, surveillance, and/or neurological diseases. Samples such as blood, urine, saliva hair, and nails, in addition to post-mortem specimens, such as whole brains, spinal cords, and cerebrospinal fluid (CSF) will be collected, stored, and disseminated to qualified researchers requesting biospecimens.

C.4 Work Requirements/Tasks

The Contractor shall perform the work requirements/tasks as described in Section C and in conformance with all other terms, conditions, and sections of the contract, whether printed in full text or incorporated by reference into the contract.

The contractor shall, as an independent organization and not as part of the Government, furnish all necessary services, facilities, equipment, qualified personnel, and material (except for those to be furnished by the ATSDR as specified elsewhere in this RFP) to perform the services required by the

Performance Work Statement (PWS) as set forth below. The Contractor shall use its best efforts to optimize achievement of the Performance Requirements and Performance Standards listed in Section

C.14.

BASE PERIOD and OPTION PERIODS, IF EXERCISED, UNLESS SPECIFIED ELSEWHERE:

(See Chart on page 12)

C.5 General Requirement:

The Contractor shall be responsible for the following:

1. The Contractor shall establish an OMB/IRB approved biorepository linked to persons with ALS who are enrolled in the National ALS Registry, according to the specifications below:

Biorepository Biospecimen collection

a. Biospecimens will be collected from 300–500 ALS Registry enrollees per year. Previously collected samples from the pilot study will undergo RNA extraction (up to 1200 samples) and DNA extraction (up to 175 samples). This DNA and RNA analysis will also apply for future collections.

b. For each biospecimen collected, the collection will include up to 70 ml blood and up to 40–

50ml urine, nail clippings, hair clippings. Blood tubes will be considered for: 1 tube EDTA for DNA, 1 tube plasma, 1 tube serum, 1 tube for RNA, and 1 tube for the creation of cell lines. Saliva will be collected only if blood draw is unsuccessful and if PALS requests it in lieu of blood sample.

c. Plasma and serum will be processed and stored in an appropriate facility in a way that will enable future analysis of DNA, RNA, chemicals, and metals.

d. Biospecimens will be stored for a period of time determined by the COR

e. Biospecimens will be transferred to a facility designated by COR at the end of the contract period.

2. The Contractor shall use the existing specimens already collected through the pilot program as the foundation for this Biorepository. This will entail working with the pilot Contractor to coordinate, gain access to, and transfer the existing retrospective samples to an appropriate facility.

Biorepository Post-Mortem Specimen collection

a. Post-mortem biospecimens will be collected from 12–30 ALS Registry enrollees per year.

Previously collected samples from the pilot study will undergo RNA extraction and DNA extraction. This DNA and RNA analysis will also apply for future collections

b. Post-mortem biospecimens collected will include whole brain and spinal cords, cerebrospinal fluid (CSF), bone, muscle, and skin.

c. Brain and spinal cord tissue will be processed and stored in an appropriate facility according to the sample protocol and procedures of the VA ALS Registry Brain Banking Program

(http://www.research.va.gov/programs/tissue_banking/als/).

d. Brain and spinal cord tissues will be subject to a standard post-mortem pathology analysis and CSF will be collected in a standardized way if specified by CDC.

e. Post-mortem tissue samples will be stored for a period of time determined by the COR.

f. Post-mortem tissue samples will be transferred to a facility designated by COR at the end of the contract period

3. In addition to biospecimens that will be collected prospectively, the Contractor shall receive, store, and maintain the samples collected from the pilot study mentioned above as well as all new samples collected. In addition, the Contractor with input from the government shall determine adequate storage supply/demand of specimens. This may include obtaining new consent forms from existing participants and facilitating the necessary and appropriate IRB approvals.

4. The Contractor shall develop a system for matching biospecimens IDs to those of National ALS

Registry participants so that specimens and epidemiological data are linked.

5. The Contractor shall guarantee the security of Personal Identifiable Information (PII) during the custody chain. The Contractor will transfer all PII to the Government prior to the end of the contract.

6. The Contractor shall work closely with the Veterans Administration (VA) to determine how Registry enrollees with military experience can become part of the VA’s Brain Banking program. PALS with no military experience will be handled by the National ALS Registry’s biorepository.

7. The Contractor shall identify an appropriate facility(ies) for the storage of the repository specimens.

The facility(ies) shall be Good Laboratory Practices (GLP) compliant and certified. COR acceptance of the facility(ies) is required.

8. The Contractor shall provide the COR with quality assessment/quality control analysis procedures for all sample collections.

9. The Contractor shall determine specimen demand for sample requests as well as plan to market and promote the repository.

10. The contractor shall determine a cost-recovery mechanism for the storage and dissemination of samples.

http://www.research.va.gov/programs/tissue_banking/als/

11. Should scientific publications be developed based on this work, the contractor shall comply with

ATSDR and CDC requirements for pre-submission review, possible co-authorship, and clearance of scientific documents.

C.6 Technical Requirements –

In addition to the General Requirements, the following are specific tasks to this project.

In performing this contract, the contractor shall:

Task 1: Prepare protocol as described in Sections C.5 and C. 11

Provide ATSDR with a draft protocol for establishing a biorepository in accordance with the schedule.

This protocol shall include, but not be limited to, describing the Contractor’s plans to (1) ensure the confidentiality of the National ALS data; (2) ensure the confidentiality of the lab samples; (3) details as to how “allocate” and determine “appropriateness” of scientists’ requests for access to the data; (4) long term storage of samples and results; (5) final ownership of the information and samples; (6) appropriate protocols for handling non-ALS insignificant findings in the lab samples; (7) maintenance; (8) disposition of data and other information used in the work performed under the contract. The Contractor should use the protocol developed during the pilot as a foundation for the permanent protocol developed under this contract.

Task 2: Prepare, deliver, and be familiar with and have knowledge of all necessary internal/external clearances documents (e.g., clinical exemption, amendments, IT security certification and accreditation process (C&A), IRB, OMB).

Prepare and assist ATSDR with revising existing IRB documents to address release of data from the

National ALS Registry to an outside party (Contractor), and if necessary, revise existing C&A systems documents for the National ALS Registry.

Task 3: Develop an appropriate sampling scheme for choosing enrollees, so that samples are as nationally representative as possible, determine specimen demand for sample requests as well as plan to market and promote the repository, and determine a cost-recovery mechanism for the storage and dissemination of samples.

Task 4: Contact interested enrollees to schedule sampling.

Task 5: Facilitate the logistics for enrollees to be sampled.

Task 6: Identify a primary storage facility for all samples received.

Task 7: Identify a method for allocating samples to appropriate scientists/researchers and facilitate distribution of specimens, from review of request until potential cost recovery procedures.

Task 8: Devise an ATSDR approved plan for releasing specimens to qualified scientists/researchers, including those specimens obtained from the pilot study.

Task 9: Conduct Monthly Conference Calls.

During the project the Contractor shall hold, at a minimum, a monthly conference call with the COR to discuss the performance and financial status of the project. The contractor shall submit an agenda, and any materials to be used for discussion, five working days in advance of the meetings. The participants in the meetings will include the COR and other Agency staff as deemed appropriate by the COR, the Project

Director, and relevant project staff as selected by the Contractor with the COR’s acceptance. There will be core staff that will attend these meetings and additional staff will be asked to participate on an as needed basis. Progress will be reviewed, milestones discussed, problems examined, solutions explored, and short-range and long-range plans made. Action items and minutes resulting from this meeting shall be prepared by the Contractor and submitted electronically to the COR within ten days after completion of the meeting. If corrections are necessary, revised replacement minutes shall be submitted within two

(2) days after receipt of the COR’s comments.

The contractor shall keep minutes of all monthly conference call meetings, and any other decision making meetings with the COR. The minutes shall include the contract number, project director, a list of attendees, a description of the issues discussed, action items, assignments and due dates.

Task 10: Contract Transition

Develop a written plan prior to the contract completion date, subject to COR approval, to ensure the orderly transfer of all contract-generated data, documents and other materials to the

Government and/or a successor contractor.

For the specimen samples, obtain disposition instructions from the COR regarding specimen samples and other related data.

Effect a smooth transfer of all databases, data/information and other files, documents, and materials required under the contract to the Government and/or the successor contractor.

C.7 Reporting Schedule

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

A. Work Plan

The Contractor shall submit an electronic copy of the Work Plan to the COR for acceptance. The time of submittal shall be within one week after the effective date of the task order, unless otherwise directed by the Contracting Officer. The Work Plan shall consist of the following:

(i) A narrative statement reflecting the methods and technical approach to be used by the

Contractor in achieving the objectives and requirements set forth in the task order.

(ii) A program schedule (milestones, tasks, activities, events) in adequate detail to provide reasonable measurement of the technical accomplishments which can be summarized to the cost reporting level of the Performance Work Statement (PWS).

(iii) The contractor shall address any anticipated copyright requests, and any claims of

"Limited Rights" or "Restricted Rights".

Revisions to Work Plan: The Contractor shall submit revisions to the Work Plan described above:

(i) when required by the Performance Work Statement; and

(ii) when directed by the COR pursuant to the Change clause; and

(iii) whenever the task order requirements are changed by appropriate modification. The

Contractor may submit recommended revisions to the Work Plan when the Contractor believes such revision is deemed desirable for optimum achievement of task order objectives. Every revision to the Work Plan shall be approved by the Contracting Officer prior to implementation by the Contractor.

B. Draft Final Manuscript

Submit a Final Manuscript to ATSDR outlining the methods, problems and solutions, as well as the biorepository data which are complete and free of errors in accordance with the PWS.

C. Final Manuscript

Submit a publication ready Final Manuscript to ATSDR complete and free of errors in accordance with the PWS. The final manuscript will be submitted in accordance with SECTION

F.3, DELIVERIES of this contract.

D. Monthly Reports

Monthly Progress Report detailing current status of each project/site under the contract shall be written. The report shall be narrative in form and shall include a summary of progress toward completion project/site, any changes in the procedures used, and problems encountered to date, including the Contractor's assessment of specific impact of such problems on estimated costs and scheduled date of completion. In addition, the report shall include the following information:

1. New Employees who have or will have access to HHS/CDC Information systems or data:

Provide the name, position title, e-mail address, and phone number of the new employee. Provide the name, position title and suitability level held by the former incumbent. If the employee is filling a new position, provide a description of the position and the Government will determine the appropriate security level.

2. Departing Employees: 1) Provide the name, position title, and security clearance level held by or pending for the individual when a Contractor/Subcontractor employee terminates work under this contract. All documentation shall be made available to the COR and/or Contracting Officer upon request.

3. Any changes in the completion dates as outlined in the original time schedules.

4. Monthly Progress Reports shall be single-spaced pages with details for each work assignment covered by the report and shall be due on the 1st Friday of every month. The contractor shall send one copy of the report to the COR and the Contracting Officer (CO).

Tasks Summary Recap:

Task No. Task Description BASE OPTION 1 OPTION 2 OPTION 3 OPTION 4

GENERAL REQUIREMENT

Sec. C.5 General Requirement X X X X X

TECHNICAL REQUIREMENT

1 Prepare protocol and amendments X

2 OMB/IRB Packages X

2 IT security C&A and revisions X X X X X

3 Sampling scheme for enrollees and revisions, if applicable.

X X X X X

4 Contact enrollees X X X X X

5 Logistics for enrollees to be sampled.

X X X X X

6 Identify a primary storage facility X

7 Identify a method for allocating samples

X X X X X

8 An approved plan for releasing specimens and amendments, if applicable.

X X X X X

9 Conduct Monthly Conference

Calls

X X X X X

10 Contract Transition X

Section

C.7

Work Plan X

Section

C.7

Submit monthly progress reports X X X X X

Section

C.7

Draft/Final manuscripts X

Section E Quality Control Plan X

C.8 Special Considerations –

A. INFORMATION TECHNOLOGY (IT) SECURITY

Contractor performance and resulting deliverables must adhere to all federal, HHS, and/or CDC IT security policies and procedures.

Based upon the scope of this contract, adherence to the following HHSAR IT Security clauses is required:

352.239-70 Standard for Security Configurations http://www.gpo.gov/fdsys/pkg/CFR-2011-title48-vol4/xml/CFR-2011-title48-vol4-sec352-239-70.xml) 352.239-71 Standard for Encryption Language (http://www.gpo.gov/fdsys/pkg/CFR-2011-title48-vol4/xml/CFR-2011-title48-vol4-sec352-239-71.xml); Note per OMB and CDC requirements, any/all portable media (CD, DVD, USB drives, etc.) and mobile devices (laptops, tablets, etc.)

used for administration and data collection/transfer must be encrypted. (this applies even if the information is not sensitive or otherwise protected)

352.239-72 Security Requirements for Federal Information Technology Resources

(http://www.gpo.gov/fdsys/pkg/CFR-2011-title48-vol4/xml/CFR-2011-title48-vol4-sec352-239-http://www.gpo.gov/fdsys/pkg/CFR-2011-title48-vol4/xml/CFR-2011-title48-vol4-sec352-239-70.xml http://www.gpo.gov/fdsys/pkg/CFR-2011-title48-vol4/xml/CFR-2011-title48-vol4-sec352-239-70.xml http://www.gpo.gov/fdsys/pkg/CFR-2011-title48-vol4/xml/CFR-2011-title48-vol4-sec352-239-71.xml http://www.gpo.gov/fdsys/pkg/CFR-2011-title48-vol4/xml/CFR-2011-title48-vol4-sec352-239-71.xml http://www.gpo.gov/fdsys/pkg/CFR-2011-title48-vol4/xml/CFR-2011-title48-vol4-sec352-239-72.xml

72.xml). Note contractor must support security authorization process as required by CDC in accordance with this HHS FAR Section.

Development or implementation of any federal information system1 or any electronic data collection effort conducted in the performance of this contract will be required to complete

Security Authorization (also known as “C&A”) prior to operation resulting in an Authority of

Operate (ATO) from CDC. The contractor shall be required to complete all security documentation and materials necessary to obtain and maintain an ATO. The contractor shall comply with all applicable HHS, CDC, FISMA, HIPPA, NIST, and other federal policies and regulations in the performance of the security requirements.

All information systems developed, implemented, or maintained in support of this contract must adhere to the security controls outlined in the National Institute of Standards and Technology (NIST) Special

Publication 800-53, Recommended Security Controls for Federal Information Systems and Organizations

(as of the date of the SOW review, the current version can be found at http://csrc.nist.gov/publications/PubsSPs.html) and NIST 800-53A, Guide for Assessing the Security

Controls in Federal Information Systems and Organizations.

A. The Contractor must follow the guidance available from NIST and other recognized sources, including:

NIST Special Publication 800-60, Guide for Mapping Types of Information and Information Systems to Security Categories Vol. 1 (http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol1-Rev1.pdf) and Vol. 2 (http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf).

NIST Special Publication 800-63, Electronic Authentication Guideline (http://csrc.nist.gov/publications/nistpubs/800-63/SP800-63V1_0_2.pdf)

B. SOCIAL MEDIA AND OTHER THIRD-PARTY WEBSITE USAGE

Use of any and all third-party2 / social media3 sites must be approved in advance, and comply with HHS and CDC policies, procedures and best practices (including security and privacy) such as those found at:

http://www.hhs.gov/web/socialmedia/ and http://www.cdc.gov/SocialMedia/Tools/guidelines/. Contractor will submit necessary documentation, in cooperation with the Project Officer, to obtain approval through designated CDC Social Media governance, as well as Information Security and Privacy Officers.

1 Defining federal information systems:

- “Federal Information System” [40 U.S.C., Sec. 11331]: An information system used or operated by an executive agency, by a contractor of an executive agency, or by another organization on behalf of an executive agency.

- “Information System” [44 U.S.C., Sec. 3502]: A discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information.

2 Third-party websites are Internet-based commercial and other non-CDC information services that offer information gathering, storage and processing services, without the usual contracting mechanisms. Examples include SurveyMonkey, Discovery Cast and Google collaboration sites.

3 "Social media are various activities that integrate technology, social interaction, and content creation. Social media uses many technologies and forms, such as blogs, wikis, photo and video sharing, podcasts, social networking, mash-ups, and virtual worlds." U.S. General Administration (GSA) http://www.gpo.gov/fdsys/pkg/CFR-2011-title48-vol4/xml/CFR-2011-title48-vol4-sec352-239-72.xml http://csrc.nist.gov/publications/PubsSPs.html http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol1-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol1-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-63/SP800-63V1_0_2.pdf http://www.hhs.gov/web/socialmedia/ http://www.cdc.gov/SocialMedia/Tools/guidelines/ http://www.gsa.gov/graphics/staffoffices/socialmediapolicy.pdf

C. CAPITAL PLANNING AND INVESTMENT CONTROL/PROJECT MANAGEMENT

The Clinger-Cohen Act (CCA2) legislatively mandates the prudent management of IT investments.

Capital Planning and Investment Control (CPIC) is a continuous and integrated process for managing the risks and returns of information technology (IT) investments. The CPIC process fully integrates with the

CDC’s overall budget, finance, acquisition, strategic planning, enterprise architecture, security, and other relevant processes. CPIC also aligns with DHHS Enterprise Performance Life Cycle (EPLC) framework and is used for all IT related decisions.

The contractor will follow the EPLC framework which will provide a standard structure for planning, managing, and overseeing IT projects over their entire life cycle. The framework consists of ten life cycle phases. Within each phase, activities, responsibilities, reviews and deliverables are defined. Templates for the deliverables are available to the contractor after award. Exit criteria are established for each phase and

Stage Gate reviews are conducted through CDC’s IT Governance process to ensure that the project’s management quality, soundness, and technical feasibility remain adequate and the project is ready to move forward to the next phase. All IT projects in support of this task must adhere to the EPLC requirements and pass each State Gate as appropriate. More information about EPLC can be found at http://www.hhs.gov/ocio/eplc/.

D. MOBILE APPLICATION DEVELOPMENT

All mobile applications must comply with CDC-related technical and security standards, processes and procedures as stated in the IT Security section of the RFTOP. In addition, the following considerations should be addressed in the proposal:

The target platform(s) for the mobile application (e.g. iPhone, iPad, Android, Blackberry)

Approach to 508 compatibility for the platform of choice If the mobile application will be made available in a related platform’s online store (e.g. iTunes, Android Market), the process for making it available in a desired store will be managed by and through CDC, resulting in a CDC branded mobile application. The contractor will also be responsible for ensuring the mobile application complies with all standards and specifications for the desired store.

E. WEB TECHNOLOLGY AND SECTION 508 COMPLIANCE

The contractor must follow CDC development standards and use the CDC web template package. The

CDC Secure Web Application Coding Guidelines and CDC Template Package can be provided by the

CDC Project Officer.

All IT development must adhere to Section 508 of the 1986 addition to the Rehabilitation Act of 1973.

Three regulations address the requirements detailed in Section 508:

The Section 508 technical and functional standards are codified at 36 CFR Part 1194 and may be accessed through the Access Board’s Web site at http://www.access-board.gov

The Federal Acquisition Regulation (FAR) Part 39.2 requires that agency acquisitions of

Electronic and Information Technology (EIT) comply with the Access Board’s standards. The entire FAR is found at Chapter 1 of the Code of Federal Register (CFR) Title 48, located at http://www.acquisition.gov. The FAR rule implementing Section 508 can be found at http://www.section508.gov.

The HHS Acquisition Regulation (HHSAR) which can be found at http://www.hhs.gov/policies/hhsar/ http://www.hhs.gov/ocio/eplc/ http://intranet.cdc.gov/ociso/pandp/documents/CDC_Secure_Web_App_Coding_Guidelines.pdf http://knowledgeshare.cdc.gov/08._Web_Development/CDC.gov_Internet_Templates http://www.access-board.gov/ http://www.acquisition.gov/ http://www.section508.gov/ http://www.hhs.gov/policies/hhsar/

F. SECTION 508:

This language is applicable to Statements of Work (SOW) or Performance Work Statements (PWS) generated by the Department of Health and Human Services (HHS) that require a contractor or consultant to (1) produce content in any format that could be placed on a Department-owned or Department-funded

Web site; or (2) write, create or produce any communications materials intended for public or internal use; to include reports, documents, charts, posters, presentations (such as Microsoft PowerPoint) or video material that could be placed on a Department-owned or Department-funded Web site.

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase electronic and information technologies (EIT) that meet specific accessibility standards. This law helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services.

Regardless of format, all Web content or communications materials produced for publication on or delivery via HHS Web sites - including text, audio or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors1) or consultants responsible for preparing or posting content intended for use on an HHS-funded or HHS-managed Web site must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in HHS or CDC policy or standards documents. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW or PWS, shall be the responsibility of the contractor or consultant retained to produce the Web-suitable content or communications material.

The following Section 508 provisions apply to the content or communications material identified in this

SOW or PWS: 36 CFR 1194.21, .22. .31 and .41. Acceptance checklists for various file formats are available at http://www.hhs.gov/web/508/.

I. Since the Biorepository of Amyotrophic Lateral Selerosis (ALS) Specimens to Complement the National

ALS Registry is an ongoing data capture and future procurements will be necessary, all programs, data, documentation, specifications and materials needed to perform these tasks will be provided to the

Government. This will ensure that all future procurements are competitive and in the best interest and value to the government.

J. Any external publications(s) being considered by the Contractor related to this project, the Contractor shall obtain the necessary clearances by the COR prior to being submitted to a journal.

K. The Privacy Act of 1974 applies under System of Records Notice 09-19-0001 Records of Persons

Exposed or Potentially Exposed to Toxic or Hazardous Substances. Adequate administrative, operational, and technical security controls must be implemented to prevent unauthorized access to or disclosure of any personally identifiable information (PII) that will be accessed by the contractor. Electronic transfers of PII via Internet or portable media must utilize FIPS 140-2 compliant encryption.

L. The Government has unlimited rights to all documents/material or other products produced under this contract. All documents, materials or other products, to include the source codes of any software, produced under this contract shall be Government owned and are the property of the Government with all rights and privileges of ownership/copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the contractor without written permission from the Contracting http://www.hhs.gov/web/508/

Officer. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights.

C.9 Government Furnished Property – Not applicable – Contractors will not require logical or physical access to any of our CDC facilities or information systems.

C.10 References – The data generated by this acquisition shall be used in the acquisition.

Federal Section 508 Laws and Guideline http://www.access-board.gov/508.htm

Federal Information Security Management Act of 2002 (FISMA).

http://csrc.nist.gov/groups/SMA/fisma/index.html

The Privacy Act of 1974 - adequate administrative, operational, and technical security controls must be implemented to prevent unauthorized access to or disclosure of any personally identifiable information (PII) that will be accessed by the contractor http://www.hhs.gov/foia/privacy/index.html

Paperwork Reduction Act (PRA) http://www.hhs.gov/ocio/policy/collection/index.html

E-Government Act of 2002 http://www.archives.gov/about/laws/egov-act-section-207.html

CDC Information Technology Guidelines

(May be made available by the COR upon request, after execution of a CDC/HHS Non-disclosure

Agreement)

CDC Web Template Guidelines http://www.cdc.gov/healthcommunication/ToolsTemplates

CDC Social Media Guidelines http://www.cdc.gov/SocialMedia/Tools/guidelines/index.html

Other guidelines as produced and sanctioned by the CDC.gov web Council and the CDC Social

Media Council http://www.cdc.gov/healthcommunication/index.html

Office of Management and Budget (OMB), National Institute of Standards and Technology

(NIST), and General Accounting Office (GAO) policies that can be primarily found at or through the Federal CIO Council website at http://cio.gov

NCEH/ATSDR Information Resources Governance Board

See CDC/HHS Enterprise Performance Life Cycle {EPLC} http://www2a.cdc.gov/cdcup/library/other/eplc.htm

NOTE: Copies of relevant non–public CDC internal information security and privacy guidance can be made available upon execution and submission of an appropriate non-disclosure form to the supporting

Information System Security Officer, via the Contracting Officer.

http://www.access-board.gov/508.htm http://csrc.nist.gov/groups/SMA/fisma/index.html http://www.hhs.gov/foia/privacy/index.html http://www.hhs.gov/ocio/policy/collection/index.html http://www.archives.gov/about/laws/egov-act-section-207.html http://www.cdc.gov/healthcommunication/ToolsTemplates http://www.cdc.gov/SocialMedia/Tools/guidelines/index.html http://www.cdc.gov/healthcommunication/index.html http://cio.gov/ http://www2a.cdc.gov/cdcup/library/other/eplc.htm

C.11 Invoice Submission

Invoices will be handled in accordance with FAR 52.232.32, Performance Based Payments, see Section

C.14 for more details.

C.12 Government Quality Assurance

Quality assurance will be performed by the Government during the contract at regular intervals. Methods may include visual survey and review of Contractor quality control documents. Deduction for work may include rework at no cost to the Government or Government acceptance with price reduction.

C.13 Quality Control

The contractor shall develop a quality control plan that provides details of how quality control will be addressed for all major deliverables and tasks. The plan shall detail how they shall monitor and control the services provided in terms of: timeliness, accuracy, relevance, accessibility, cost-effectiveness, technical requirements and contract provisions.

This plan shall identify which quality standards are relevant to the project and determine how to satisfy them. The contractor will apply the quality control activities identified in the plan and monitor specific project results to determine whether they comply with relevant quality standards. The contractor will identify ways to eliminate causes of unsatisfactory performance. At a minimum this plan shall address:

* Overall project quality control including any proposed evaluations addressing efforts to reduce errors, data collection specialist, abstractor and monitoring, training and retraining of staff, change control process, planning for cyclical changes in staffing and workload.

* Identification of major data quality indicators that require weekly monitoring during data collection (missing data, response rate)

* Data capture instrument change - question development, programming, if needed, testing and evaluation

* Version control for documentation, forms, and memos, and design changes

* A check list of items to be verified for all data deliverables (is the number of records correct, has benchmarking been completed and if so, what were the results of the benchmarking), has the documentation and cover memo been checked for accuracy)

* Adequate and timely documentation to assure repeatability of all data capture activities

* The development and maintenance of decision logs and procedural manuals for all data coding, data entry, data collection, data editing, data abstraction, and verification activities

* Setting up a structure in which responses to ATSDR Peer Reviews within one month of receipt.

* Supervisor related QC activities

C.14 Schedule of Milestones for Performance-Based Payments:

In accordance with FAR 52.232.32, Performance Based Payments (April 2012), upon successful completion of an event, the Contractor may request performance based payments. The determination of eligibility for receipt of payment will be made by the Contracting Officer upon written certification from the COR that the performance milestone has been met. It is anticipated that the completion date for each event will vary and eligibility for payment could occur sooner or later depending upon the time of completion of the designated event. Milestone payments are subject to the terms of FAR 52.232-32 incorporated in Section I of the contract.

The Government has provided a proposed milestone payment schedule and a proposed payment percentage based on the government’s determination of the key events outlined in the PWS. However, the Contractor is invited, but not required, to propose an alternative milestone payment schedule for this contract along with its proposed payment percentage allocations for each scheduled payment based upon the offeror’s understanding of the key events outlined in the PWS. The milestone payment schedule may be negotiated between the parties. However, if both parties cannot agree, the Contracting Officer has the final determination as to the milestone payment schedule that will be included in the contract award.

PERFORMANCE PERIOD: 12 MONTHS (BASE PERIOD ONLY)

GOVERNMENT-PROPOSED

MILESTONE EVENT

PAYMENT %*

CONTRACTOR-PROPOSED

MILESTONE EVENT

PAYMENT %*

Draft Protocol

IRB/OMB Packages

Quality Control Plan/Work Plan

Biospecimens collected from 300-500 registry enrollees per year

Post-Mortem biospecimens 12-30 ALS registry enrollees per year

Draft/Final Manuscripts __%

Transition Plan __%

Total Total

*Milestone event payments may be allocated on a periodic basis as long as a completed event is associated with that payment.

***The milestone payment schedule for the options, if exercised, will be determined at time of award.

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 and

Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

Section E - Inspection And Acceptance

E.1 FAR 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…