RFP_2018-N-67794.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 67

2. CONTRACT NO.

3. SOLICITATION NO.

2018-N-67794

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

05/04/2018

6. REQUISITION/PURCHASE

NO.

000HCCLH-2018-20368

7. ISSUED BY CODE 436 8. ADDRESS OFFER TO (If other than Item 7)

Centers for Disease Control and Prevention/OCOO OFR / Office of Acquisition Services - Branch 4 626 Cochrans Mill Road

Pittsburgh PA 15236-3611

Same as Item 7 - May be submtted by electronic mail to JCarolan@CDC.GOV, to Facsimile Number

412-386-6429, or in print to the address in Block

7. ISSUED BY.

Approved as to Form and Legality: _____________________________

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

SOLICITATION

9. Sealed offers in original copy 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 CDC OAS Br-4 626 Cochrans Mill Road B-140 2nd Floor until 03:00PM local time 06/04/2018

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

10. FOR INFORMATION

CALL:

A. NAME

John J. Carolan

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(412) 386-6430

C. E-MAIL ADDRESS

JCarolan@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 27

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

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

X D PACKAGING AND MARKING 13 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 14 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 15 X OTHER STATEMENTS OF OFFERORS 36

X G CONTRACT ADMINISTRATION DATA 17 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 40

X H SPECIAL CONTRACT REQUIREMENTS 21 X M EVALUATION FACTORS FOR AWARD 53

OFFER (Must be fully completed by offeror)

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

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

13. DISCOUNT FOR PROMPT PAYMENT

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

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

AMENDMENT NO. DATE AMENDMENT NO. DATE

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

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT

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

21. ACCOUNTING AND APPROPRIATION

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

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

ITEM

24. ADMINISTERED BY (If other than Item 7) CODE 436 25. PAYMENT WILL BE MADE BY CODE 434

Centers for Disease Control and Prevention/OCOO OFR / Office of Acquisition Services - Branch 4 626 Cochrans Mill Road

Pittsburgh PA 15236-3611

Centers for Disease Control and Prevention

Office of Financial Resources - P O Box 15580

Atlanta GA 30333

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

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

SUPPLIES / SERVICES

QTY / UNIT

UNIT PRICE

EXTENDED PRICE

Respiratory Protective Devices –

On-Site Compliance Audit Assistance in Accordance with the Enclosed

Statement of Work

Maximum

Value

$1,894,000.00

$1,894,000.00

Not To Exceed

B.1 Description of Services

The Contractor shall furnish all labor, equipment, and materials required to accomplish the project entitled

“Respiratory Protective Devices - On-Site Compliance Audit Assistance.” This effort shall be performed in accordance with Section C, Description/Specifications/Work Statement.

B.2 Payment Schedule

Invoices may be submitted upon completion of each audit or task order. The invoice amounts for the audits or tasks shall be fixed.

B.3 Guaranteed Contract Minimum

The guaranteed minimum total task order awards for all contracts awarded is $2,500.00.

B.4 Maximum Amount

The maximum amount for all contracts awarded shall not exceed $1,894,000.00over a period of five years.

Section C - Description/Specification/Work Statement

Statement of Work

Title: Respiratory Protective Devices – On-Site Compliance Audit Assistance

SECTION 1 – BACKGROUND

Since the implementation of Title 42, Code of Federal Regulations, Part 84 (42 CFR 84) in 1995, NIOSH has conducted on-site compliance audits of respirator approval holders’ facilities. The purpose of these audits is to assess the approval holders’ conformance to the quality assurance requirements in Subpart E of 42 CFR 84 and to the approved quality control plans.

These audits consist of the following steps: 1) audit initiation, 2) audit planning, 3) on-site visit and assessment, 4) reporting of audit results, and 5) follow-up activities to correct nonconformances found or to revoke approval where necessary.

This contract is for audit services to perform audit planning, on-site visits, and reporting (steps 2 through 4 above).

SECTION 2 – PURPOSE

The Centers for Disease Control and Prevention (CDC), National Institute for Occupational Safety and Health

(NIOSH), National Personal Protective Technology Laboratory (NPPTL), is mandated by Congress to review respiratory protective devices for approval. Currently, NPPTL monitors over 8000 approvals and over 80 approval holders worldwide (covering 19 countries). The regulations, which are used to approve these respiratory protective devices, are found in 42 CFR 84, which includes quality assurance and minimum respirator performance requirements. NIOSH conducts on-site quality system audits to verify continued compliance with the regulations after approval has been granted.

The purpose of the services obtained under this contract is to create a pool of validated quality auditing firms familiar with the NIOSH regulatory requirements, under 42 CFR 84, for conducting on-site compliance audits. A

Firm-Fixed-Price (FFP), Indefinite-Delivery-Indefinite-Quantity (IDIQ) type service contract (with task orders) is anticipated.

Contractor staff will receive training on the specific NIOSH program requirements and existing audit skills will be validated. Training will be conducted by NIOSH staff, and will be offered as an online course via Skype, Envision, Adobe Connect, or other comparable online system. Audit skills will be validated by either a NIOSH representative witnessing the new contract auditor on an actual audit or by the experienced contractor providing evidence that the auditor has successfully conducted an actual audit. Subsequently, the contract auditors will act as authorized

NIOSH representatives in planning, conducting, and reporting the findings of on-site audits. On-site audits will be performed in accordance with 42 CFR 84, approved quality system documents, and the “NIOSH Audit Checklist and Standard Operating Procedures (SOP) for Conducting On-Site Compliance Audits”. The contract auditors shall conduct on-site compliance audits in the United States and internationally, as defined within the specific task orders, that will be generated from the most current audit schedule.

A NIOSH representative may accompany the contractor at any time, participating as an audit team member and monitoring the contractor auditor’s performance. Joint audits with the Mine Safety and Health Administration

(MSHA) may also be conducted for specific sites with joint NIOSH and MSHA approvals. A NIOSH representative may also accompany the contractor when past site audit results indicate recurring quality system issues with a specific site.

SECTION 3 – SCOPE OF WORK

It is anticipated that approximately 50 sites will be audited annually. These site locations are currently about 40% within the US and 60% outside the US. Manufacturing sites continue to be added and deleted in response to business requirements.

Approximately half of the sites are registered to ISO 9001:2008. The other sites have company-specific quality systems approved by NIOSH to the requirements of 42 CFR 84.

Each site audit must evaluate the manufacturer’s complete quality system with regard to NIOSH-approved products to a level of assurance provided by current NIOSH regulations and practices. Current NIOSH practice is that a site audit can be accomplished by one auditor in one or two full working days, depending on the size of the organization.

Additional resources may be assigned for sites with language, security, or unusual quality system issues. NIOSH auditors may be assigned to the audit team for both assistance and monitoring purposes. The number of on-site working days for each audit will be determined by NIOSH and included in each task order.

This work will require each auditor to obtain training on NIOSH-specific requirements. Initial training will be conducted upon award of the contract. To maintain qualification after the initial training, auditors must attend the training every two years. The requirement for additional training every two years may be reduced at the discretion of NIOSH.

All approval holder documentation and audit results are confidential. Each contractor must establish binding confidentiality agreements on any employee, auditor, or other audit team member (such as an interpreter) exposed to approval holder information. Any approval holder may request that individual audit team members execute a separate confidentiality agreement with the approval holder. All audit team members must be prepared and willing to execute such a standard confidentiality agreement in the form attached as Appendix A.

Contractors must be prepared, as requested, to return or destroy any documentation provided by NIOSH or approval holders once it is no longer needed for the provision of services under this contract.

It is anticipated that a pool of no more than three (3) contractors will be established based on evaluations of proposals received in response to the solicitation. Assignment of actual work will be done through competitive bids on specific task orders by contractors in the pool. These task orders will be to perform specific on-site compliance audits within one or more geographic region(s) as follows.

Region 1 – USA (New England)

Region 2 – USA (Mid Atlantic)

Region 3 – USA (Southern)

Region 4 – USA (Midwest)

Region 5 – USA (West)

Region 6 – Canada

Region 7 – Mexico

Region 8 – South America

Region 9 – UK

Region 10 – Europe

Region 11 – Australia/New Zealand

Region 12A – China

Region 12B – Taiwan

Region 12C – Other Asia (currently Singapore and India)

Region 13 – Japan/Korea

Region 14 – Africa (currently no sites in this region)

Region 15 – Middle East (currently no sites in this region)

Auditors will travel to approval holders’ locations to conduct the on-site portion of the audit. The Government will not make any travel arrangements for auditors; contractors will bear this responsibility. Travel costs will not be billed or paid separately; they must be anticipated by the contractor and included in the firm fixed price bid for each task order.

SECTION 4 – TASKS TO BE PERFORMED

The contractor and its auditors will:

1. Communicate with NIOSH personnel during all phases of the audit process.

2. Write acceptable Audit Announcement Letters for official distribution by NIOSH.

3. Write acceptable Audit Plans for official distribution by NIOSH.

4. Review approval holder quality documentation and respirator-specific requirements provided by NIOSH in preparation for the audit.

5. Travel to and conduct the on-site quality system compliance audits.

6. Write acceptable, well-written final reports ready for official distribution by NIOSH.

7. Provide insights and background on the acceptability of any corrective actions required by the audit, with final evaluation done by NIOSH personnel.

SECTION 5 – GOVERNMENT FURNISHED MATERIALS

NIOSH will provide the template for the Audit Announcement Letter, Audit Plan, and Audit Report. These files will be provided in Microsoft Word format (currently version 2016, .docx).

NIOSH will also provide all necessary quality documentation and respirator-specific requirements to conduct the on-site audit.

All documents provided by NIOSH will be uploaded to a secure file-transfer-protocol (SFTP) site. All bidders receiving an award under this contract will be provided the login information to access the SFTP site. The documents provided on the SFTP site shall be accessed via the site. At no time shall the awardee download or store these documents on personal or contractor owned computers.

SECTION 6 – PERIOD OF PERFORMANCE

The Period of Performance for this contract is TBD through TBD. Site-specific task orders, organized by region, will be awarded annually over this five-year period. All task orders will be subject to the availability of funds.

SECTION 7 – DELIVERABLES/REPORTING SCHEDULE

The following deliverables and reports will be furnished as part of this contract.

1. Audit Intent Correspondence: Electronic correspondence (e-mail) between the Contractor, Approval

Holder, and any other persons accompanying the site visit (such as language interpreters, NIOSH staff, or

MSHA staff) indicating agreement by all parties on the date(s) and location(s) of the site visit. Delivery is due 45 calendar days prior to the site visit date.

2. Audit Announcement Letter and Audit Plan: The Audit Announcement Letter and Audit Plan follow a standard NIOSH template format formally announcing the site visit date(s), location(s), and audit parameters. Delivery is due 30 calendar days prior to the site visit date.

3. Audit Report: The Audit Report will contain the findings from the site visit. The report will follow a standard NIOSH format. For each report section, evidence will be provided of conformance or nonconformance to requirements. Nonconformances will be written describing the required audit criteria and the evidence showing that it is not met. Delivery is due 14 calendar days after the site visit date.

Note: Audit Reports will be reviewed by the COR (or designee) for acceptance, and must contain all pertinent information to allow for proper review/processing by NIOSH staff. Information needed from

NIOSH staff to clarify any issues that prevent completion of the audit report should be addressed with

NIOSH prior to submitting report. Reports that are lacking the required information will be rejected and returned for additional response.

4. Post-Audit Clarification: Responses, generally via e-mail or telephone, answering questions from NIOSH staff on details or interpretation of audit evidence, occurrences during site visits, or the acceptability of corrective action undertaken by Approval Holders in response to a nonconformance. Delivery is due 3 business days after the NIOSH request.

Delivery of documents shall be made in an electronic format readable by Microsoft Word 2016, for example Word

2013-2016 document (.docx), Word 97-2003 document (.doc), OpenDocument Text (.odt), or Rich Text Format

(.rtf).

The deliverable documents will be transferred via the SFTP site described in Section 5. The awardee will notify the

Contracting Officer’s Representative (COR) and the NIOSH Records Room, via email, that the documents are ready to be accessed via the SFTP site. The COR will provide additional copies to others or the Contracting Officer as requested.

SECTION 8 – REFERENCE MATERIALS

Title 42, Code of Federal Regulations, Part 84. Currently available from the Government Printing Office at http://www.gpo.gov/fdsys/search/submitcitation.action?publication=CFR

ISO 9001:2008, Quality management systems - Requirements. Currently available commercially from the American

Society for Quality at http://asq.org/, the International Organization for Standardization http://www.iso.org/, and other national standards bodies.

ISO 19011:2002, Guidelines for quality and/or environmental management systems auditing. Currently available commercially from the American Society for Quality at http://asq.org/, the International Organization for

Standardization http://www.iso.org/, and other national standards bodies.

NIOSH certified equipment list: http://www.cdc.gov/niosh/npptl/topics/respirators/CEL/default.html

SECTION 9 – POINT OF CONTACT INFORMATION

The Point of Contact (POC) for this procurement

NIOSH/NPPTL

Attn: TBD

626 Cochrans Mill Road, M/S-B40

Pittsburgh, PA 15236-3611

E-mail Address:

Telephone Number

Preferred method of communication: Email or Phone

SECTION 10 – MINIMUM VENDOR QUALIFICATIONS AND LEVEL OF EFFORT

The contractor’s auditors must be competent to serve as an audit team leader for a quality system audit. Auditors must be knowledgeable of Quality System Standards (e.g., ISO 9001 or MIL-STD-1916) and auditing techniques.

They must also have experience leading quality system audits. The contractor must be able to demonstrate adequate mastery of spoken and written English.

SECTION 11 – EVALUATION FACTORS

It is anticipated that typical task orders will include three (3) to ten (10) sites for audit. Special circumstances may require non-typical task orders to be generated. Current practice is that most sites are to be audited on a two-year cycle. Some sites may be audited more or less frequently based on individual circumstances.

http://www.gpo.gov/fdsys/search/submitcitation.action?publication=CFR http://www.iso.org/ http://www.iso.org/ http://www.cdc.gov/niosh/npptl/topics/respirators/CEL/default.html

The evaluation criteria for the competitive award of task orders will include the following categories:

1. Past performance of contractor.

2. Past performance of proposed auditor(s).

3. Auditor qualifications.

4. Conflicts of interest.

5. Special skills required for task.

6. Prior experience with sites to be audited.

7. Price.

Award will be made to the responsible offeror submitting the proposal (Technical and Business) determined to be the most advantageous and present the best value to the Government as evaluated under the criteria described in this

Section. Award will be made based primarily on technical merit, with price used for selection among proposals of comparable quality. In the first year of the contract, NIOSH staff may accompany some or all of the audits conducted in the United States to evaluate auditor performance. Alternate evaluation regions may be chosen and announced in subsequent years.

A. BASELINE SECURITY REQUIREMENTS

1) Applicability. The requirements herein apply whether the entire contract or order (hereafter

“contract”), or portion thereof, includes either or both of the following:

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

b. 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 HHS 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.

2) Safeguarding Information and Information Systems. In accordance with the Federal Information

Processing Standards Publication (FIPS)199, Standards for Security Categorization of Federal

Information and Information Systems, the Contractor (and/or any subcontractor) shall:

a. Protect government information and information systems in order to ensure:

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.

b. Provide security for any Contractor systems, and information contained therein, connected to an HHS network or operated by the Contractor on behalf of HHS regardless of location. In addition, if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less, bring the situation to the attention of the other party.

c. Adopt and implement the policies, procedures, controls, and standards required by the HHS

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 the HHS

Information Security Program security requirements, outlined in the HHS Information Security and

Privacy Policy (IS2P), by contacting the CO/COR or emailing fisma@hhs.gov.

d. Comply with the Privacy Act requirements and tailor FAR clauses as needed.

3) Information Security Categorization. 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, Appendix C, and based on information provided by the ISSO, CISO, or other security representative, the risk level for each Security Objective and the Overall Risk Level, which is the highest watermark of the three factors

(Confidentiality, Integrity, and Availability) 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 Risk Level: [ ] Low [X] Moderate [ ] High

Based on information provided by the ISSO, Privacy Office, system/data owner, or other security or privacy representative, it has been determined that this solicitation/contract involves:

[X] No PII [ ] Yes PII

Personally Identifiable Information (PII). Per the Office of Management and Budget (OMB) Circular A-

130, “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.

PII Confidentiality Impact Level has been determined to be: [ ] Low [ ] Moderate [ ] High

4) Controlled Unclassified Information (CUI). CUI is defined 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. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, shall be:

a. marked appropriately;

b. disclosed to authorized personnel on a Need-To-Know basis;

c. protected in accordance with NIST SP 800-53, Security and Privacy Controls for Federal 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

d. returned to HHS control, destroyed when no longer needed, or held until otherwise directed.

Destruction of information and/or data shall be accomplished in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

5) 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) shall protect all government information that is or may be sensitive in 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 accordance with OMB Memorandum M-06-16, Protection of Sensitive Agency Information by securing it with a FIPS 140-2 validated solution.

6) Confidentiality and Nondisclosure of Information. Any information provided to the contractor (and/or any subcontractor) by HHS or collected by the contractor on behalf of HHS shall be used only for the purpose of carrying out the provisions of this contract and shall 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 shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each

Contractor employee or any of its subcontractors to whom any HHS records may be made available or disclosed shall 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 shall be protected in accordance with

HHS and CDC policies. Unauthorized disclosure of information will be subject to the HHS/CDC sanction policies and/or governed by the following laws and regulations:

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

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

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

7) Internet Protocol Version 6 (IPv6). All procurements using Internet Protocol shall comply with

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

8) 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 shall enable HTTP Strict Transport Security

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

9) Contract Documentation. The Contractor shall use provided templates, policies, forms and other agency documents to comply with contract deliverables as appropriate.

10) Standard for Encryption. The Contractor (and/or any subcontractor) shall:

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

11) Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract shall complete the

CDC non-disclosure agreement. A copy of each signed and witnessed NDA shall be submitted to the

Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

Training

1) Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract shall complete the applicable HHS/OpDiv Contractor

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

2) 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 policy and the

HHS Role-Based Training (RBT) of Personnel with Significant Security Responsibilities

Memorandum.

3) Training Records. The Contractor (and/or any subcontractor) shall maintain training records for all its employees working under this contract in accordance with HHS policy. A copy of the training records shall be provided to the CO and/or COR within 30 days after contract award and annually thereafter or upon request.

Rules of Behavior

1) The Contractor (and/or any subcontractor) shall ensure that all employees performing on the contract comply with the HHS Information Technology General Rules of Behavior, and CDC Implementation of the

HHS Rules of Behavior for Use of HHS Information Technology Resources.

2) All Contractor employees performing on the contract must read and adhere to the Rules of Behavior before accessing Department 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 OpDiv 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.

Incident Response

The Contractor (and/or any subcontractor) shall respond to all alerts/Indicators of Compromise (IOCs) provided by

CDC Computer Security Incident Response Team (CSIRT) within 24 hours, whether the response is positive or negative.

FISMA defines an incident as “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. The HHS

Policy for IT Security and Privacy Incident Reporting and Response further defines incidents as events involving cybersecurity and privacy threats, such as viruses, malicious user activity, loss of, unauthorized disclosure or destruction of data, and so on.

A privacy breach is a type of incident and is defined by Federal Information Security Modernization Act (FISMA) as 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. The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines a breach as “a suspected or confirmed incident involving PII” .

In the event of a suspected or confirmed incident or breach, the Contractor (and/or any subcontractor) shall:

1) Protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract so as to avoid a secondary sensitive information incident with FIPS 140-2 validated encryption.

2) NOT notify affected individuals unless so instructed by the Contracting Officer or designated representative. If so instructed by the Contracting Officer or representative, the Contractor shall send CDC approved notifications to affected individuals within 30 days.

3) Report all suspected and confirmed information security and privacy incidents and breaches to the CDC

Computer Security Incident Response Team (CSIRT) at 866-655-2245 and CSIRT@cdc.gov, COR, CO, OpDiv SOP (or his or her designee), and other stakeholders, including incidents 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 and HHS 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, contract information, impact classifications/threat vector, and the type of information compromised. In addition, the

Contractor shall:

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

b. not include any sensitive information in the subject or body of any reporting e-mail; and

c. encrypt sensitive information in attachments to email, media, etc.

4) Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable

Information, HHS and CDC incident response policies when handling PII breaches.

5) 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.

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:

[ ] Level 6C: Sensitive - High Risk

[ ] Level 5C: Sensitive -Moderate Risk

Homeland Security Presidential Directive (HSPD)-12

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

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

M-05-24; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and Contractors; HHS HSPD-12 policy; and Executive Order 13467, Part 1 §1.2.

Roster. The Contractor (and/or any subcontractor) shall 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 shall be submitted to the

COR and/or CO within 14 business days of the effective date of this contract. Any revisions to the roster as a result of staffing changes shall be submitted within 14 business days of the 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 shall provide a position description and the Government will determine the appropriate suitability level.

Contract Initiation and Expiration

1) Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) shall provide all required documentation to the CO and/or COR to certify that, at the government’s direction, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800-88, Guidelines for

Media Sanitization.

2) Notification. The Contractor (and/or any subcontractor) shall notify the CO and/or COR and system ISSO within 14 days before an employee stops working under this contract.

3) Contractor Responsibilities Upon Physical Completion of the Contract. The contractor (and/or any subcontractors) shall return all government information and IT resources (i.e., government information in non-government-owned systems, media, and backup systems) acquired during the term of this contract to the CO and/or COR. Additionally, the Contractor shall provide a certification that all government information has been properly sanitized and purged from Contractor-owned systems, including backup systems and media used during contract performance, in accordance with HHS and/or CDC policies.

4) The Contractor (and/or any subcontractor) shall perform and document the actions identified in the CDC

Contractor Employee Separation Checklist when an employee terminates work under this contract within 2 business days of the employee’s exit from the contract. All documentation shall be made available to the

CO and/or COR upon request.

Records Management and Retention

The Contractor (and/or any subcontractor) shall maintain all information in accordance with Executive Order 13556

-- Controlled Unclassified Information, National Archives and Records Administration (NARA) records retention policies and schedules and HHS/CDC policies and shall not dispose of any records unless authorized by HHS/CDC.

In the event that a contractor (and/or any subcontractor) accidentally disposes of or destroys a record without proper authorization, it shall be documented and reported as an incident in accordance with HHS/CDC policies.

Section D - Packaging And Marking

There are no clauses/provisions included in this section.

Section E - Inspection And Acceptance

FAR SOURCE TITLE AND DATE

52.246-16 Responsibility for Supplies (Apr 1984)

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

E.1 Inspection and Acceptance (Jul 1999)

Inspection and acceptance of the articles, services, and documentation called for herein shall be accomplished by the

Contracting Officer, or his duly authorized representative (who for the purposes of this contract shall be the

Contracting Officer’s Representative) at the destination of the articles, services or documentation.

(End of Clause)

Section F - Deliveries Or Performance

52.242-15 Stop-Work Order (Aug 1989)

F.1 Deliverable(s) Schedule (Jul 1999)

(a) Documentation

The following is a list of required documentation to be delivered to the Government as a part of contract performance.

Item No. Description No. of Copies Delivery Date

1 Audit Intent

Correspondence

One (1) Each 45 Calendar Days Prior to the Site Visit Date

2 Draft Audit

Announcement Letter and Audit Plan

One (1) Each 30 Calendar Days Prior to the Site Visit Date

3 Draft Audit Report One (1) Each 14 Calendar Days After the Site Visit Date

4 Post-Audit Clarification One (1) Each 3 Business Days After the NIOSH Request

(b) Report Content

1. Audit Intent Correspondence - Electronic correspondence (e-mail) between the Contractor, Approval

Holder, and any other persons accompanying the site visit (such as language interpreters or NIOSH monitors) indicating agreement by all parties on the date(s) and location(s) of the site visit. Delivery is due

45 calendar days prior to the site visit date.

2. Draft Audit Announcement Letter and Audit Plan - Documents following a standard NIOSH template format formally announcing the site visit date(s), location(s), and audit parameters. Delivery is due 30 calendar days prior to the site visit date.

3. Draft Audit Report - A report of the findings from the site visit, following a standard NIOSH format. For each report section, evidence will be provided of conformance or nonconformance to requirements.

Nonconformances will be written describing the required audit criteria and the evidence showing that it is not met. Delivery is due 14 calendar days after the site visit date.

4. Post-Audit Clarification - Responses, generally via e-mail or telephone, answering questions from NIOSH on details or interpretation of audit evidence, occurrences during site visits, or the acceptability of corrective action undertaken by Approval Holders in response to a nonconformance. Delivery is due 3 business days after the NIOSH request.

Delivery of documents shall be made in an electronic format readable by such as Microsoft Word or Microsoft

Excel for spreadsheets, for example. Delivery shall be made to the Contracting Officer’s Representative (COR).

Delivery of additional copies may be requested to the Contracting Officer or others designated by the COR.

(c) Delivery of Reports

Reports shall be delivered in accordance with the instructions in F.1. Items designated for delivery to the

Contracting Officer Representative shall be addressed as follows:

NIOSH – National Personal Protective Technology Laboratory, 626 Cochrans Mill Road, Pittsburgh, PA 15236-

Attn: TBD - TBD@cdc.gov

F.2 Period of Performance (Task/Delivery Order Contracts) (Jul 1999)

(a) Contract: The period of performance of this contract shall be from award through sixty (60) months. The effective date of the contract is shown on the face page of the contract.

(b) Task Orders: The time for completion for each task or delivery order shall be determined under each individual task or delivery order through the mutual agreement of the parties involved. Task/delivery orders under this contract may be awarded by the Contracting Officer at any time within the contract period. The actual performance of the work may extend beyond the contract period.

F.3 Place(s) of Performance (Jul 1999)

The Contractor shall perform all work under this contract as identified in the SOW and in each individual Task

Order.

Section G - Contract Administration Data

G.1 Payment by Electronic Funds Transfer

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

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

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

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

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

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

The Centers for Disease Control and Prevention

Office of Financial Management (OFR)

P.O. Box 15580

Atlanta, GA 30333

Or – Fax copy to: 404-638-5342

G.2 CDCA_G001 – Invoice Submission (Jul 2017)

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

The Centers for Disease Control and Prevention

Office of Financial Resources (OFR)

P.O. Box 15580

Atlanta, GA 3033

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

Fax: 404-638-5324

Email: FMOAPINV@CDC.GOV

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

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

(c) The Contractor is , is not required to submit a copy of each invoice directly to the Contracting

Officer’s Representative (COR) concurrently with submission to the Contracting Officer.

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

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

mailto:FMOAPINV@CDC.GOV

(1) Contractor’s Name & Address

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

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

(4) Invoice Number

(5) Invoice Date

(6) Contract Line Item Number and Description of Item

(7) Quantity

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

(9) Shipping and Payment Terms

(10) Total Amount of Invoice

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

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

(13) DUNS + 4 Number

(14) Electronic funds transfer (EFT) banking information

G.3 Payments/Payment Schedule

The total of the work to be performed by the Contractor under this contract, as the total of all contracts awarded, is a not to exceed firm fixed price at $1,894,000.00. Subject to the provisions of the clause entitled "52.232-1 Payments

(Apr 1984)” of Section I, payments shall be made for work accepted by the Government. All vouchers shall reflect itemized cumulative totals of billings to the date of that voucher.

G.4 Vouchers

Partial payments will be issued upon completion of a specific site audit within a task order. Under the partial payment terms, the contractor shall submit an invoice upon completion of one specific site audit within the task order. Payment will be authorized upon acceptance of the Site Audit Report.

The contractor also has the option to submit one invoice at the completion of the task order. Under these payment terms, the contractor will submit one invoice for all site audits conducted under a task order. Payment will be authorized upon acceptance of all Site Audit Reports associated with the task order.

G.5 Contracting Officer (Jul 1999)

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

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

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

G.6 CDC0_G008 Contracting Officer’s Representative (COR) (Jul 2017)

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

As used herein, technical directions are directions to the Contractor which fill in details, suggests possible lines of inquiry, or otherwise completes the general scope of work set forth herein. These technical directions must be within the general scope of work, and may not alter the scope of work or cause changes of such a nature as to justify an adjustment in the stated contract price/cost, or any stated limitation thereof.

In the event that the Contractor believes full implementation of any of these directions may exceed the scope of the contract, he or she shall notify the originator of the technical direction and the Contracting Officer, immediately or as soon as possible, in a letter or e-mail separate of any required report(s). No technical direction, nor its fulfillment, shall alter or abrogate the rights and obligations fixed in this contract.

The Government COR is not authorized to change any of the terms and conditions of this contract. Contract changes shall be made only by the Contracting Officer by properly written modification(s) to the contract.

The Government will provide the Contractor with a copy of the COR delegation memorandum upon request.

G.7 CDC42.0002 Evaluation of Contractor Performance Utilizing CPARS (Apr 2013)

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

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

15.304 where past performance is an evaluation factor.

The CPARS system requires a contractor representative to be assigned so that the contractor has appropriate input into the performance evaluation process.