RFQ 75D301-26-Q-95343.pdf

REQUEST FOR QUOTATIONS

(THIS IS NOT AN ORDER)

THIS RFQ X IS IS NOT A SMALL BUSINESS SET-ASIDE.

PAGE OF PAGES

1 73

1. REQUEST NO.

75D301-26-Q-95343

2. DATE ISSUED

9/10/2026

3. REQUISITION/PURCHASE REQUEST NO.

0HJAAQBE-2026-95343

4. CERT. FOR NAT. DEF.

UNDER BDSA REG. 2

AND/OR DMS REG. 1

RATING

5a. ISSUED BY Centers for Disease Control and Prevention

Chamblee Campus Building 108, MS S108-4

4770 Buford Hwy

Atlanta GA 303413717

6. DELIVERY BY (Date)

5b. FOR INFORMATION CALL (No collect calls) X

NAME TELEPHONE NUMBER

AREA CODE NUMBER

H. Dale Bish (404) 498-1312

8. TO: 9. DESTINATION

a. NAME b. COMPANY a. NAME OF CONSIGNEE

c. STREET ADDRESS b. STREET ADDRESS

c. CITY

d. CITY e. STATE f. ZIP CODE d. STATE e. ZIP CODE

10. PLEASE FURNISH QUOTATIONS TO

THE ISSUING OFFICE IN BLOCK 5a ON OR BEFORE CLOSE OF BUSINESS (Date)

09/17/2026 10 AM ET

IMPORTANT: This is a request for information, and quotations furnished are not offers. If you are unable to quote, please so indicate on this form and return it. This request does not commit the Government to pay any costs incurred in the preparation of the submission of this quotation or to contract for supplies or services.

Supplies are of domestic origin unless otherwise indicated by quoter. Any representations and/or certifications attached to this Request for Quotations must be completed by the quoter.

11. SCHEDULE (Include applicable Federal, State and local taxes)

ITEM NO.

(a)

SUPPLIES/SERVICES

(b)

QUANTITY

(c)

UNIT

(d)

UNIT PRICE

(e)

AMOUNT

(f)

Project Title:

Facilitating Research, Programmatic, and

Operational Support of the National

Amyotrophic Lateral Sclerosis’ (ALS)

Biorepository in support of the ALS Registry

Act

Questions, Quotes, and All Communication is to be with H. Dale Bish at uwo8@cdc.gov.

12. DISCOUNT FOR PROMPT PAYMENT

a. 10 CALENDAR DAYS

b. 20 CALENDAR DAYS

c. 30 CALENDAR DAYS

d. CALENDAR DAYS

NUMBER PERCENTAGE

NOTE: Additional provisions and representations are are not attached.

13. NAME AND ADDRESS OF QUOTER 14. SIGNATURE OF PERSON AUTHORIZED TO

SIGN QUOTATION

15. DATE OF

QUOTATION

a. NAME OF QUOTER

b. STREET ADDRESS 16. SIGNER

a. NAME (Type or print) b. TELEPHONE

c. COUNTY AREA CODE

d. CITY e. STATE f. ZIP CODE c. TITLE (Type or print) NUMBER

AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 18 (REV. 6-95)

Previous edition not usable Prescribed by GSA FAR (48 CFR) 53.215-1(a)

7. DELIVERY

FOB

DESTINATION

OTHER

(See Schedule) mailto:uwo8@cdc.gov

Section B - Supplies Or Services and Prices/Costs

Base Period / Year 1

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

0001 Facilitating Research, Programmatic, and Operational

Support of the National

Amyotrophic Lateral Sclerosis’

(ALS) Biorepository in support of the ALS Registry Act

Firm Fixed Price

Severable Services

Payment Terms:

Monthly Payments in Arrears

Period of Performance:

09/28/2026 – 09/27/2027

1 Job $ $

0002 Non-Conference Travel

All travel shall be conducted in accordance with Federal Travel

Regulations.

Direct Reimbursement

09/28/2026 – 06/27/2027

1 Job $7,500.00

Estimate

$7,500.00

Not-to-Exceed

Option Period 1 / Year 2

1001 Facilitating Research, Programmatic, and Operational

Support of the National

Amyotrophic Lateral Sclerosis’

09/28/2027 – 09/27/2028

1002 Non-Conference Travel

09/28/2027 – 06/27/2028

1 Job $7,500.00 $7,500.00

Option Period 2 / Year 3

2001 Facilitating Research, Programmatic, and Operational

Support of the National

Amyotrophic Lateral Sclerosis’

09/28/2028 – 09/27/2029

2002 Non-Conference Travel

09/28/2028 – 06/27/2029

Option Period 3 / Year 4

3001 Facilitating Research, Programmatic, and Operational

Support of the National

Amyotrophic Lateral Sclerosis’

09/28/2029 – 09/27/2030

3002 Non-Conference Travel

09/28/2029 – 06/27/2030

Option Period 4 / Year 5

4001 Facilitating Research, Programmatic, and Operational

Support of the National

Amyotrophic Lateral Sclerosis’

09/28/2030 – 09/27/2031

4002 Non-Conference Travel

09/28/2030 – 06/27/2031

1 Job $7,500.00 $7,500.00

4003 Optional Task 9

Contract Transition

09/28/2030 – 09/27/2031

1 Job

Section C - Performance Work Statement

Project Title: Facilitating Research and Programmatic and Operational Support of the National

Amyotrophic Lateral Sclerosis’ (ALS) Biorepository in support of the ALS Registry Act

SECTION 1 – BACKGROUND

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.

The National ALS Registry estimates there are 30,000 patients living with ALS at any given time. This number is expected to increase as the population ages. The Registry also has modules to help identify potential risk factors for ALS, funds investigator initiated R01 grants, connects patients with clinical trials and epidemiological studies, and uses 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.

SECTION 2 – PURPOSE/OBJECTIVE

The purpose of this contract is to maintain and continue a national biorepository of specimens for the purpose of facilitating research from persons with ALS. These samples would encompass both premortem and/or postmortem samples.

ATSDR is particularly interested in samples such as blood, urine, saliva, hair, and nails, in addition to port-mortem specimens such as bone, muscle, skin, whole brains, spinal cords, and cerebrospinal fluid (CSF). Note, these specimens are subject to change. Collected samples (already collected and future collections) may be used by researchers for the purpose of creating cell lines (only for research purpose; no commercial gain), identifying diagnostic or prognostic biomarkers, and extracting genomic information (e.g., genotype, variants, whole genome/exome sequences, ribonucleic acid or RNA sequences). 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 logistical support for the operation, facilitation, collection, maintenance, transport, cataloging, and ongoing analyses as directed by ATSDR of sample supply and demand of an existing biorepository of specimens from persons with ALS enrolled in the National ALS Registry as well as other comparable repositories to complement and augment the National ALS Biorepository, when directed. These activities are subject to change at the direction of ATSDR.

SECTION 3 – SCOPE OF WORK

The successful Contractor shall provide assistance support to a biorepository (internal and/or external) based on the existing protocol which was created by subject matter experts in registries, surveillance, and/or neurological diseases.

Internal is defined as the National ALS Biorepository, a facet of the National ALS Registry and its internal CDC partners and/or laboratories. External refers to an existing biorepository or collection of

ALS samples or partners and entities that are not directly connected with the National ALS Biorepository.

Samples such as blood, urine, saliva, hair, and nails, in addition to post-mortem specimens such as whole brains, spinal cords, and CSF have been and may be collected, stored, and disseminated to qualified researchers requesting biospecimens for their approved studies as directed by the government.

SECTION 4 – TASKS TO BE PERFORMED

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 award) 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 below.

The Contractor shall be responsible for the following:

1. The Contractor shall maintain and support an Office of Management and Budget and Institutional Review

Board (OMB/IRB) approved biorepository linked to persons with ALS who are enrolled in the National

ALS Registry or another comparable tissue repository, according to the specifications below:

Biorepository Biospecimen collection:

a. Biospecimens shall be collected from up to 150 National ALS Registry enrollees per year from a patient’s home or designated location such as a physician’s office or clinic. The collection number is subject to change as directed by ATSDR.

b. For each biospecimen collected, the collection may include up to 70 ml blood, nail clippings, hair clippings and urine. Blood tubes will be considered for: 1 tube Whole-Blood (Metal Free), 1 tube

Whole-blood, 1 tube EDTA for DNA, 1 tube plasma, 1 tube serum, 2 tubes for RNA, and 1 tube (with

CPT) for peripheral blood mononuclear cells. Saliva will be collected only if blood draw is unsuccessful and if person with ALS requests it in lieu of blood sample. The specimens collected are subject to change as directed by ATSDR.

c. These collected tubes will be sent to the CDC for processing, storage, and dissemination. Blood or saliva will be processed and stored in an appropriate facility(ies) in a way that will enable future analysis of DNA, RNA, chemicals and other small molecules, and other biofluid analytes.

d. Biospecimens stored internally to CDC will follow CDC/ATSDR retention schedule guidance to determine the period of storage of samples and any data/records procured from samples.

e. Biospecimens stored externally to CDC will be stored for a period of time determined by the contract award.

i. Any data procured and stored externally to CDC during the period of contract award are also subject to CDC/ATSDR retention schedule guidance, which will be provided to the

Contractor as needed.

f. Biospecimens will be transferred to a facility designated by COR at the end of the contract period, if applicable.

2. Biospecimens (premortem) that will be collected prospectively, the Contractor shall arrange for the collection, transport, and storage to a designated CDC facility. New samples collected may also come from and not necessarily be collected by the vendor and its subcontractors from other existing biorepositories which have an ALS research focus. 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.

3. The Contractor shall maintain an error free system for matching biospecimens IDs to those of National

ALS Registry participants so that specimens and epidemiological data are linked and will coordinate with internal CDC laboratory group.

a. This coordination will include the intake of samples, storing, and dissemination of samples to researchers. All Samples shall be categorized and cataloged in numerical sequence.

b. This task may necessitate the communication with the internal CDC laboratory and biorepository group and also the use of biospecimen inventory platform internal to CDC for obtaining information on sample accession, identification and maintenance of sample (inventory) to fulfill tasks outlined in the document.

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

5. Contractor shall ensure the accuracy of data transmitted to the Government and shall retain and provide all raw data and documents related to the data, when requested by the Government.

6. Since premortem samples will be stored at CBR, the contractor does not need to identify a separate repository for specimens.

7. The Contractor shall provide the COR with quality assessment/quality control analysis/protocols of all sub-contractors’ procedures for all sample collections when requested.

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

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

In performing this contract, the contractor shall:

Task 1: IRB & OMB Support

Support the National ALS Registry with relevant IRB and OMB-PRA package materials. The contractor shall prepare, deliver, be familiar with, and have knowledge of all necessary internal/external clearances documents (e-

Clearance, IRB, OMB), as needed.

Task 2: Participation Recruitment

Select and recruit participants enrollees, with input from Registry staff, in the National ALS Registry or another comparable tissue repository. The contractor shall use an appropriate sampling scheme for choosing enrollees with input from Registry staff, so that samples are as nationally representative when possible.

Task 3: Consent and Scheduling Collection

Conduct informed consent in accordance with an established ALS protocols and schedule collections.

Task 4: Conduct Collection and Logistics

Conduct collections and facilitate the logistics for enrollees to be sampled according to a geographically representative sampling scheme or as directed by ATSDR. The contractor shall provide all materials or receive from a designated and approved facility (e.g., CDC’s Division of Laboratory Sciences) needed for the collections. The work will be performed all the while ensuring the security of Personally Identifiable Information of the enrollees from any materials involved during the process Biospecimen or biofluid shall be collected in metal-free container or as directed by the Government to ensure sample integrity or to prevent contamination. All ALS samples shall be categorized, and cataloged in numerical sequence.

Task 5: Facilitation and Logistics of Sample Processing and Storage at

CDC Laboratory and Biorepository

Ensure biofluid and biospecimen collected from the patient are properly received by the CDC sample processing laboratory, accessioned, and transferred to CDC Biorepository for long-term storage and dissemination. The specimens and quantities below are currently in our inventory.

National ALS Biorepository Specimen Inventory as of 12/01/2025 (Subject to Change)

SAMPLE TYPE

REQUESTED

TEMPERATURE

CONTAINER

TYPE

CONTAINER

SIZE

SAMPLE VOLUME

SIZE_ML TOTAL NUMBER

BUFFY COAT -80 deg C Cryovial 2.5 ml 0.1 - 1.0 ml 261

DNA -80 deg C Cryovial 2.5 ml 0.001 - 0.250 ml 25236

DNA STOCK -80 deg C Cryovial 2.5 ml 0.001 - 0.55 ml 2486

UNDILUTED DNA

STOCK -80 deg C Cryovial 2.5 ml 0.001 - 0.200 ml 672

GENOTYPE -80 deg C Cryovial 2.5 ml 0.003 - 1.5 ml 263

ORAGENE -80 deg C Cryovial 2.0 ml 2.0 ml 1

PAXGENE -80 deg C Cryovial 2.5 ml 2.0 ml 25

PLASMA -80 deg C Cryovial 2.5 ml 0.1 - 1.8 ml 5556

RBC -80 deg C Cryovial 2.5 ml 0.1 - 1.9 ml 4610

RNA -80 deg C Cryovial 2.5 ml 0.1 - 1.6 ml 10809

SERUM -80 deg C Cryovial 2.5 ml 0.1 - 1.3 ml 8376

CDC U -80 deg C Cryovial 2.5 ml 1.6 - 1.8 ml 1215

URINE -80 deg C Cryovial 2.5 ml 1.8 ml 9386

URINE 2 -80 deg C Falcon tube 15 ml 0.2 - 15.0 ml 3852

URINE+PRESERVATIVE -80 deg C Cryovial 5 ml 0.8 - 4.5 ml 687

WHOLE BLOOD -80 deg C Cryovial 2.5 ml 0.1 - 2.0 ml 3099

HAIR -80 deg C Glass vial 20.0 ml strands 241

NAILS -80 deg C Cryovial 2.0 ml clips 268

PBMC -196 deg C Cryovial 2.5 ml 0.05 - 0.50 ml 9137

FIBROBLASTS -196 deg C Cryovial 2.5 ml 1.0 - 1.50 ml 701

TOTAL 86881

Abbreviations: DNA, deoxyribonucleic acid; RNA, ribonucleic acid; RBC, red blood cells; PBMC, peripheral blood mononuclear cells

Task 6: Specimen Request Process

Support ATSDR in the ALS Specimen Request Process by implementing an existing approved plan for releasing specimens to qualified scientists/researchers. The Government anticipates up to 25 requests per year.

i. Upon receipt of biorepository researcher request/application, the Contractor shall assess feasibility of biospecimen support and communicate the feasibility status to the Government.

ii. The Contractor shall work with research review committee member (s) identified by the

Registry as subject matter expert (internal and/or external) for the evaluation of biorepository application for scientific merit and relevancy to ALS research.

iii. Upon approval of the sample request application, the Contractor will work with involved parties (e.g., CDC Biorepository, researcher, data provider) and acquire necessary documentation to fulfill the task.

Task 7: Marketing Plan and Specimen Supply/Demand

The contractor shall develop and implement an approved plan to market availability of specimens in the National

ALS Biorepository to scientists/researchers, domestically and internationally. The contractor shall also conduct an analysis of the types of specimens that may be requested and collected as well as documentation of specimens distributed throughout the year.

Task 8: Development of Publications

Support development of publications related to the National ALS Registry/Biorepository. Should scientific publications be developed based on the work, the contractor shall comply with ATSDR and CDC requirements for pre-submission review, co-authorship, and clearance of scientific documents.

OPTIONAL Task 9: Contract Transition

a) The contractor shall develop a written plan, 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.

b) For any specimen samples stored externally to CDC during the contract period, obtain disposition instructions from the Government regarding specimen samples and other related data.

c) Conduct 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 within 6 months of date of exercise of this option or by September 30, 2030, whichever occurs earlier. In the event of transition, any specimens and samples stored externally to CDC during the contract period will be shipped/transferred to the specified location as instructed by the COR with no loss of sample integrity. All ALS samples shall be categorized, cataloged, and shipped in numerical sequence.

The exact location of samples where this transition plan may apply will be released to the contractor upon award.

SECTION 5 – GOVERNMENT FURNISHED PROPERTY

Contractors will not require logical or physical access to any of our CDC facilities or information systems except for onsite meetings, unless the Government deems necessary to carry out the tasks outlined in this document.

Biorepository coordinator may need approval and access to ELIMS which is an internal CDC specimen inventory platform to identify sample ids and counts that meets researchers request.

SECTION 6 – PLACE OF PERFORMANCE AND CONTRACT SUPPORT HOURS

All work shall be conducted off-site at the contractor’s facility and during normal business hours, subject to change.

SECTION 7 – TRAVEL

Contractors shall travel to in person or virtual conference or meetings as requested by the government and includes:

• Site visits of subcontractors to ensure satisfactory progress and performance.

• Conferences such as the annual Society for Neuroscience (SFN) where the vendor shall provide shipping and logistical support of a booth.

Travel will be in accordance with / and not to exceed the Federal Travel Regulation rates. Travel costs need to be approved in advance by the COR. The contractor shall be required to provide their travel policy to the

Government for review. Contractor can attend meetings and/or conference in person or virtual.

Travel does include conferences. Conference Approval Management Systems (CAMS) approval is required in advance of any travel for conferences. If the need for conference travel occurs, the contract will be modified to separately add funding.

SECTION 8 – DELIVERABLES/REPORTING SCHEDULE

https://easi.cdc.gov/Modules

Please submit electronically to the Contracting Officer’s Representative (COR) with a duplicate copy to

Contracting Officer (CO).

Task Deliverable Quantity/Format Due Date Deliver

To

1 Provide biorepository logistical support ensuring proper collection, transport, and release of specimens as well as data collection/release. Collect up to 150 specimens a year, or as directed by the

Government.

N/A Recurring in

Nature

COR

2 Establishment of subcontract with external designated blood collection service vendor

1 90 days after award

COR

3 Relevant IRB and OMBPRA package materials completed with support

N/A Recurring in

Nature

COR

4 Plan for documentation of changes to Quality

Assessment/Quality

Control (QA/QC) QA/QC procedures or reports for sample processing and storage may be obtained from internal CDC laboratory/biorepository, or on their web.

Procedures in the future collection, compared to what was applied to previously collected samples.

All samples 90 days after award

COR

• Catalog of biorepository participants with minimal demographics information (e.g., sex), as deemed permissible.

• Summary of inventory of samples which includes total number of participants contributing to each sample type and number of aliquots for each sample type.

• Update to external research studies using

Biorepository samples.

• Analysis of supply/demand for samples, and cost recovery Report. Documentation of potential change in QA/QC is necessary since entity processing and storing samples is the only variable for this contract, while the inventory and primary contractor may stay the same.

1 Monthly COR

6 Marketing Plan 1 NLT 90 days after award

COR

7 Storage facility audit report 1 NLT 90 days after award

COR

8 Specimen Demand Report 1 NLT 90 days after award

COR

9 Sample distribution list that catalogs each sample released to the researcher/institution and a summary table

1 Quarterly COR

Task Deliverable Quantity/Format Due Date Deliver

To

10 Meeting minutes/summary 1 NLT 10 days after meeting

COR

11 Monthly Progress Report 1 Within 5 days of invoice submission

COR

SUBSECTION A – PERFORMANCE MATRIX

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.

PERFORMANCE

OBJECTIVE

STANDARD PERFORMANCE

THRESHOLD

ACCEPTABLE

QUALITY LEVELS

(AQLs)

METHOD OF

SURVEILLANCE

Qualified personnel staffed

All requirements shall be staff by qualified personnel

All requirements are staffed by qualified personnel

Observation and

Monthly review completed by the

COR

Excellence in

Contract

Management

Maintains high levels of quality assurance, reliability, timeliness, and completeness of task.

Issues are identified, addressed and resolved by the contractor causing little to no disruption to the

Government or the requirement

Observation and

Monthly meetings with

ATSDR staff and

COR

Prepare and

Deliver all

Internal and

External clearance

Documents

Complies with procedural requirements; and demonstrates high quality writing skills, fully edited, timely and accurate.

IRB and OMB packages are accurate and free of errors.

Observation and

Review by COR and ATSDR staff

Develop an appropriate sampling scheme for choosing enrollees

Timely, accurate, and comprehensive submission of sampling scheme

Must be free of all bias and subjective to review by the Government

Review by COR and ATSDR staff

Specimens

Collected, Transported, and

Disseminated

Specimens are collected, categorized, cataloged, transported with minimal adverse events, and specimen quality is maintained through collecting, shipping

The specimens are transported, kept and stored at a constant temperature and the integrity of the sample is

Observation and

Review by the

COR of monthly progress reports, and/or any other specimen report provided such as the Lab Facility

PERFORMANCE

OBJECTIVE

STANDARD PERFORMANCE

THRESHOLD

ACCEPTABLE

QUALITY LEVELS

(AQLs)

METHOD OF

SURVEILLANCE

and dissemination.

preserved.

All incoming and outgoing specimens are documented accurately. Must coordinate/communicate with CDC Biorepository and/or shipment coordination hub for international/domestic sample shipment.

Audit Report.

Programmatic

Support and reporting requirements

Support is responsive to attendees and reflects an understanding of the project’s requirements, standards, and techniques.

(1) Reports are complete, timely and accurate.

(2) Reports comply with

PWS and

Federal regulations

(3) Timely submission

Observation and review of monthly reports and monthly meetings

SECTION 9 – ADDITIONAL REQUIREMENTS

A. Information Security and Privacy Compliance

Standard-1: Procurements Requiring Information Security and/or Physical Access Security

1. Baseline Security Requirements

a. Applicability. The requirements herein apply whether the entire contract or modification

(hereafter "contract"), or portion thereof, includes either or all of the followings. No contractor will be permitted to access or operate CDC infrastructure or systems overseas unless prior approval is received from CDC CISO.

i. Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information.

ii. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor) will operate a federal system and information technology containing data that supports the CDC mission. In addition to the Federal Acquisition Regulation (FAR)

Subpart 2.1 definition of "information technology" (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

b. Safeguarding Information and Information Systems. All government information and information systems must be protected in accordance with HHS/CDC policies and level of risk. At a minimum, the Contractor (and/or any subcontractor) must:

i. Protect the:

▪ Confidentiality, which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information;

▪ Integrity, which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and

▪ Availability, which means ensuring timely and reliable access to and use of information.

ii. Categorize all information owned and/or collected/managed on behalf of CDC and information systems that store, process, and/or transmit HHS information in accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special

Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of

Information and Information Systems to Security Categories. Based on information provided by the ISSO, CISO, CDC CPO, or other representative, the impact level for each Security Objective (Confidentiality, Integrity, and Availability) and the Overall

Impact Level, which is the highest watermark of the three factors of the information or information system are the following:

▪ Confidentiality: [ ] Low [ x ] Moderate [ ] High

▪ Integrity: [ ] Low [ x ] Moderate [ ] High

▪ Availability: [ X ] Low [ ] Moderate [ ] High

▪ Overall Impact Level: [ ] Low [ x ] Moderate [ ] High

iii. Based on the agreed-upon level of impact, implement the necessary safeguards to protect all information systems and information collected and/or managed on behalf of CDC regardless of location or purpose.

iv. Report any discovered or unanticipated threats or hazards by either the agency or contractor, or if existing safeguards have ceased to function immediately after discovery, within one (1) hour or less, to the government representative(s).

v. Adopt and implement all applicable policies, procedures, controls, and standards required by the CDC Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain all applicable security and privacy policies by contacting the CO/COR or CDC security and/or privacy officials.

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/800-60-rev1/SP800-60_Vol2-Rev1.pdf

c. Privacy Act. Comply with the Privacy Act requirements (when applicable), and tailor FAR and

HHSAR clauses as needed.

d. Privacy Compliance. Comply with the E-Government Act of 2002, NIST SP 800-53, and applicable CDC privacy policies, and complete all the requirements below:

i. Per the Office of Management and Budget (OMB) Circular A-130, Personally

Identifiable Information (PII), is "information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual." Examples of PII include, but are not limited to the following: Social Security number, date and place of birth, mother's maiden name, biometric records, etc.

ii. To ensure that the public's personal information is protected in a manner commensurate with the privacy risks, CDC uses a privacy analysis process to assess the risks associated with CDC's collection and maintenance of PII and to ensure information is handled in accordance with applicable legal, regulatory, and policy requirements. PTAs analyze how information is handled in IT systems and electronic information collections and determines if the IT system or electronic information collection collects, disseminates, maintains, or disposes of PII. PIAs are used to assess the privacy risks of IT systems and electronic information collections that collect, disseminate, maintain, or dispose of PII about members of the public. PIAs also provide transparency into how CDC collects, disseminates, maintains, or disposes of the public's PII.

iii. The Contractor must support the agency with conducting a Privacy Threshold Analysis

(PTA) for the information system and/or information handled under this contract to determine whether or not PII is collected, disseminated, maintained, or disposed as part of the contract. The PTA will determine if a full Privacy Impact Assessment (PIA) needs to be completed.

▪ If the results of the PTA show that a full PIA is needed, the Contractor must support the agency with completing a PIA for the system or information within

60 days after completion of the PTA and in accordance with CDC policy and

OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E-

Government Act of 2002.

▪ The Contractor must support the agency in reviewing the PIA at least every three years throughout the system development lifecycle (SDLC)/information lifecycle, or when determined by the agency that a review is required based on a major change to the system, or when new types of PII are collected that introduces new or increased privacy risks, whichever comes first.

e. Controlled Unclassified Information (CUI). Executive Order 13556 defines CUI as

"information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information." The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 3 CFR, part 2002) when handling CUI. 32 C.F.R. 2002.4(aa) As implemented the term "handling" refers to "…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re-using, and disposing of the information." 81 Fed. Reg. 63323. The requirements below apply only to nonfederal systems that process, store, or transmit CUI, or that provide security protection for such components. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, must be:

i. Marked appropriately;

ii. Disclosed to authorized personnel on a Need-To-Know basis;

iii. Protected in accordance with NIST SP 800-53, Security and Privacy Controls for

Information Systems and Organizations applicable baseline if handled by a Contractor system operated on behalf of the agency, or NIST SP 800-171, Protecting Controlled

Unclassified Information in Nonfederal Information Systems and Organizations if handled by internal Contractor system; and

iv. Returned to HHS/CDC control, destroyed when no longer needed, or held until otherwise directed. Information and/or data must be disposed of in accordance with NIST SP 800-

88, Guidelines for Media Sanitization.

f. Protection of Sensitive Information. For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The

Contractor (and/or any subcontractor) must protect all government information that is or may be sensitive by securing it with a solution that is validated with current FIPS 140 validation certificate from the NIST CMVP.

g. Confidentiality and Nondisclosure of Information. Any information provided to the contractor

(and/or any subcontractor) by CDC or collected by the contractor on behalf of CDC must be used only for the purpose of carrying out the provisions of this contract and must not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of

Government records and must ensure that all work performed by its employees and subcontractors must be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any CDC records may be made available or disclosed must be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein.

The confidentiality, integrity, and availability of such information must be protected in accordance with HHS/CDC policies. Unauthorized disclosure of information will be subject to the HHS/CDC sanction policies and/or governed by the following laws and regulations:

i. 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records);

ii. 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and

iii. 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

h. Internet Protocol Version 6 (IPv6). All procurements using Internet Protocol must comply with

OMB Memorandum M-05-22, Transition Planning for Internet Protocol Version 6 (IPv6).

i. Information and Communications Technology (ICT). ICT products and services from prohibited entities/sources must not be used/acquired in compliance with Public Law 115-232, Section 889 Parts A and B, FAR 4.21, FAR 52.204.23, FAR 52.204.24, and FAR 52.204.25. The contractor (and/or any subcontractor) must notify the government if they identify prohibited ICT products and/or services are used during the contract performance.

j. Government Websites. All new and existing public-facing government websites must be securely configured with Hypertext Transfer Protocol Secure (HTTPS) using the most recent version of Transport Layer Security (TLS). In addition, HTTPS must enable HTTP Strict

Transport Security (HSTS) to instruct compliant browsers to always assume HTTPS to reduce the number of insecure redirects and protect against attacks that attempt to downgrade connections to plain HTTP. For internal-facing websites, HTTPS is not required, but it is highly recommended.

Consult HHS/CDC Policy for Internet and Email Security for additional information.

k. Contract Documentation. The Contractor must use provided templates, policies, forms and other agency documents specify which documents/forms will be provided to contractor] to comply with contract deliverables as appropriate.

l. Standard for Encryption. The Contractor (and/or any subcontractor) must:

i. Comply with the HHS Standard for Encryption of Computing Devices and Information to prevent unauthorized access to government information.

ii. Encrypt all sensitive federal data and information (i.e., PII, protected health information

[PHI], proprietary information, etc.) in transit (i.e., email, network connections, etc.) and at rest (i.e., servers, storage devices, mobile devices, backup media, etc.) with encryption solution that is validated with current FIPS 140 validation certificate from the NIST

CMVP.

iii. Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices meet and CDC Component-specific encryption standard requirements. Maintain a complete and current inventory of all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive government information (including PII).

iv. Verify that the encryption solutions in use have been validated under the Cryptographic

Module Validation Program to confirm compliance with current FIPS 140 validation certificate from the NIST CMVP. The Contractor must provide a written copy of the validation documentation to the COR.

v. Use the Key Management system on the CDC personal identification verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys http://csrc.nist.gov/publications/. Encryption keys must be provided to CSPO.

m. Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract must complete the CDC non-disclosure agreement, as applicable. Contractors (and/or subcontractors) must submit a copy of each signed and witnessed NDA to the Contracting Officer (CO) and/or CO

Representative (COR) prior to performing any work under this acquisition.

2. Training Requirements

a. Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract must complete the applicable CDC Contractor

Information Security Awareness, Privacy, and Records Management training (provided upon contract award) before performing any work under this contract. Thereafter, the employees must complete CDC Security Awareness, Privacy, and Records Management training at least annually, during the life of this contract. All provided training must be compliant with CDC training policies.

b. Role-based Training. All Contractor (and/or any subcontractor) employees with significant security responsibilities (as determined by the program manager) must complete role-based training annually commensurate with their role and responsibilities in accordance with HHS/CDC policy and the CDC Role-Based Training (RBT) of Personnel with Significant Security

Responsibilities.

c. Training Records. The Contractor (and/or any subcontractor) must maintain training records for all its employees working under this contract in accordance with CDC policy. A copy of the http://csrc.nist.gov/publications/ training records must be provided to the CO and/or COR within 30 days after contract award and annually thereafter or upon request.

3. Rules of Behavior

a. The Contractor (and/or any subcontractor) must ensure that all employees performing on the contract comply with CDC Implementation of the HHS Rules of Behavior for Use of HHS

Information Technology Resources.

b. All Contractor employees performing on the contract must read and adhere to the Rules of

Behavior before accessing agency data or other information, systems, and/or networks that store/process government information, initially at the beginning of the contract and at least annually thereafter, which may be done as part of annual CDC Information Security Awareness

Training. If the training is provided by the contractor, the signed ROB must be provided as a separate deliverable to the CO and/or COR per defined timelines above.

4. Incident Response

a. The Contractor (and/or any subcontractor) must respond to all alerts/Indicators of Compromise

(IOCs) provided by CDC Computer Security Incident Response Center (CSIRC) IRT teams within 24 hours, whether the response is positive or negative. In accordance with FISMA and

OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information

(PII)1, an incident is "an occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or

(2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies" and a privacy breach is "the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose." For additional information on the CDC breach response process, please see the CDC Standard for Responding to Breaches of Personally Identifiable Information

(PII).2"

b. Contracts with entities that collect, maintain, use, or operate Federal information or information systems on behalf of CDC must include in the following requirements:

i. The contractor shall cooperate with and exchange information with CDC officials, as deemed necessary by the CDC Breach Response Team, to report and manage of a suspected or confirmed breach.

ii. All contractors and subcontractors shall properly encrypt PII in accordance with OMB

Circular A-130 and other applicable policies, including CDC-specific policies, and comply with HHS-specific policies for protecting PII. To this end, all contractors and subcontractors shall protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract, with encryption solution that is validated with the current FIPS 140 validation certificate from the NIST CMVP.

iii. All contractors and subcontractors shall participate in regular training on how to identify and report a breach

1 Memorandum is available at: https://www.whitehouse.gov/wp-content/uploads/legacy_drupal_files/omb/memoranda/2017/m-17-12_0.pdf 2 Standard is available at: https://cdc.sharepoint.com/teams/OCIO-CSPO- PUBDOCS/Standards/CSPO%20Responding%20to%20Breaches%20of%20Personally%20Identifiable%20Informati on.pdf

iv. NOT notify affected individuals unless so instructed by the Contracting Officer or designated representative. If instructed by the Contracting Officer or representative, the

Contractor must send [CDC Component] approved notifications to affected individuals

[insert CDC Component Specific timeline, process, and format].

v. Report all suspected and confirmed information security and privacy incidents and breaches to the CSPO Incident Response Team (IRT) [CDC Component inserted contact information should be cited here], COR, CO, CDC CPO (or his or her designee), and other stakeholders, including breaches involving PII, in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay, no later than one (1) hour, and consistent with the applicable CDC Component and CDC policy and procedures, NIST standards and guidelines, as well as US-CERT notification guidelines. The types of information required in an incident report must include at a minimum: company and point of contact information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor must:

▪ Cooperate and exchange any information, as determined by the Agency, necessary to effectively manage or mitigate a suspected or confirmed breach;

▪ Not include any sensitive information in the subject or body of any reporting e-mail; and

▪ Encrypt sensitive information in attachments to email, media, etc.

vi. Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally

Identifiable Information, and CDC Component and CSPO privacy breach response policies when handling PII breaches.

vii. Provide full access and cooperate on all activities as determined by the Government to ensure an effective incident response, including providing all requested images, log files, and event information to facilitate rapid resolution of sensitive information incidents.

This may involve disconnecting the system processing, storing, or transmitting the sensitive information from the Internet or other networks or applying additional security controls. This may also involve physical access to contractor facilities during a breach/incident investigation [CDC Component insert timeline if required].

viii. All contractors and subcontractors shall be able to determine what Federal information was or could have been accessed and by whom, construct a timeline of user activity, determine methods and techniques used to access Federal information, and identify the initial attack vector.

ix. Cloud service providers shall use guidance provided in the FedRAMP Incident

Communications Procedures when deciding when to report directly to US-CERT first or notify CDC first.

x. Acknowledge that CDC will not interpret report of a breach, by itself, as conclusive evidence that the contractor or its subcontractor failed to provide adequate safeguards for

PII.

5. Position Sensitivity Designations

All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations

(CFR). The following position sensitivity designation levels apply to this solicitation/contract:

6. Homeland Security Presidential Directive (HSPD)-12

The Contractor (and/or any subcontractor) and its employees must comply with Homeland Security Presidential

Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors; OMB

M-05-24; OMB M-19-17; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and Contractors;

CDC HSPD-12 policy; and Executive Order 13467, Part 1 §1.2.

7. Roster

The Contractor (and/or any subcontractor) must submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster must be submitted to the COR and/or CO 30 days prior to the effective date of this contract. Any revisions to the roster as a result of staffing changes must be submitted immediately upon the 30 days change. The COR will notify the Contractor of the appropriate level of investigation required for each staff member.

If the employee is filling a new position, the Contractor must provide a position description and the Government will determine the appropriate suitability level.

8. Contract Initiation and Expiration

a. General Security Requirements. The Contractor (and/or any subcontractor) must comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, CDC Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. All information systems development or enhancement tasks supported by the contractor must follow the CDC EPLC framework and methodology and in accordance with the CDC Office of Financial Resources (OFR) Contract

Closeout Guide and HHS Closeout Guide: Contracts and Orders.

b. System Documentation. Contractors (and/or any subcontractors) must follow and adhere to CDC

System…