RFP 2012-N-14270.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 63

2. CONTRACT NO.

3. SOLICITATION NO.

2012-N-14270

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

04/25/12

6. REQUISITION/PURCHASE

NO.

000HCCLE-2012-44112

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

Centers for Disease Control and Prevention

Acquisition and Assistance Field Branch V

P O Box 18070 - 626 Cochrans Mill Road

Pittsburgh PA 15236-0070

See Item 7

Approved as to Form and Legality: _____________________________

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

SOLICITATION

9. Sealed offers in original and four (4) copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in CDC AAFB-V 626 Cochrans Mill Road B-140 2 nd

Floor until 3:30PM local time 05/25/2012

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 25

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 30

X D PACKAGING AND MARKING 7 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 8 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 9 X K OTHER STATEMENTS OF OFFERORS 31

X G CONTRACT ADMINISTRATION DATA 11 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 35

X H SPECIAL CONTRACT REQUIREMENTS 16 X M EVALUATION FACTORS FOR AWARD 47

OFFER (Must be fully completed by offeror)

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

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

13. DISCOUNT FOR PROMPT PAYMENT

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

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

AMENDMENT NO. DATE AMENDMENT NO. DATE

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

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT

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

21. ACCOUNTING AND APPROPRIATION

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

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

ITEM

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

Centers for Disease Control and Prevention

Acquisition and Assistance Field Branch V

P O Box 18070 - 626 Cochrans Mill Road

Pittsburgh PA 15236-0070

Centers for Disease Control and Prevention

Financial Management Office - 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

0001 Respiratory Protective Devices - On-Site

Compliance Audit Assistance in

Accordance with the Enclosed Statement of Work

Maximum

Value

$1,200,000.00 $1,200,000.00

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 $1,200,000.00 over a period of five years.

Section C - Description/Specification/Work Statement

The services contemplated under this contract are considered to be a Critical Function to inherently governmental work as defined by the Office of Federal Procurement Policy in OFPP letter 11-01 and by HHS in Acquisition

Policy Memorandum 2012-01.

C.1 Statement of Work (Jul 1999)

Introduction/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 2-4 above).

Objective

The objective of the services provided under this contract is to create a pool of validated quality auditing firms familiar with the National Institute for Occupational Safety and Health (NIOSH) regulatory requirements. 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 skill will be validated. Training and audit skills will be validated by a NIOSH representative accompanying the contract auditor and participating in several audits. Subsequently, the contract auditors will act as authorized NIOSH representatives in planning, conducting, and reporting on on-site audits in accordance with 42 CFR 84, approved quality system documents, NIOSH Audit Checklist and Standard Operating Procedures (SOP) for Conducting On-Site Compliance

Audits. The contract auditors shall conduct U.S. and international on-site compliance audits, defined within the specific task orders, generated from the most current audit schedule.

A NIOSH representative may accompany the contractor at any time participating as an audit team member and to monitor the contractor’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.

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

Personal Protective Technology Laboratory (NPPTL), Technology Evaluation Branch is mandated by Congress to review respiratory protective devices for approval. Currently, the Technology Evaluation Branch monitors over

8000 approvals and over 80 approval holders worldwide (covering 19 countries). The regulations which are used to certify these respiratory protective devices are 42 CFR 84, which includes quality assurance and minimum respirator performance requirements. NIOSH conducts on-site compliance audits to verify continued compliance with the regulations after approval has been granted.

Scope and Requirements

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.

The contractor and its auditors will:

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

2. write acceptable draft audit announcement letters for official distribution by NIOSH,

3. review approval holder quality documentation and respirator-specific requirements provided by NIOSH in preparation for the audit,

4. travel to and conduct the on-site quality system compliance audits,

5. write acceptable draft audit reports for official distribution by NIOSH, and

6. provide clarification and answer questions about audits as requested.

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 staff and practices. Current NIOSH practice is that a site audit can be accomplished by one auditor in one or two full work 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 man days for each audit will be determined by NIOSH and included in each task order.

This work will require each lead auditor to visit NIOSH in Pittsburgh, Pennsylvania to meet employees associated with the audit program, obtain training on NIOSH-specific requirements, evaluate audit skills, and discuss any specific/unique audit requirements. To maintain qualification after the initial visit, auditors must make a return visit to NIOSH within two years of their most recent visit. The requirement for these additional visits may be reduced at the discretion of NIOSH. Task orders will be issued as required for training visits.

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 Exhibit 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.

Award of Specific Tasks

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 regions. The current geographic groupings are listed below.

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.

The evaluation criteria for the competitive award of task orders will include the following categories. The criteria are listed in descending order of importance.

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. NIOSH evaluation or training needs

8. Price

Award will be made based primarily on technical merit, with price used for selection among proposals of comparable quality. NIOSH staff will accompany some audits to evaluate auditor performance. Each contractor in the pool will be guaranteed award of task orders totaling a minimum of $2,500.00.

The current geographic regions are:

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

Other

This contract will not require routine access to Government facilities or information technology systems by the

Contractor.

This contract will require access by the Contractor to information obtained from the Government or by reason of audits, examinations, investigations, or other reviews made by the Contractor, where information concerns or relates to trade secrets, processes, operations, style of work, or apparatus of any person, firm, partnership, corporation, or association being audited, examined, or otherwise reviewed under this contract (collectively, “Confidential

Information”). As a condition of this contract, the Contractor promises not to publish, divulge, disclose, or make known such Confidential Information in any manner or to any extent to any party other than NIOSH.

Notwithstanding this promise, nothing contained herein shall prohibit the Contractor from providing, divulging, or otherwise disclosing Confidential Information to its independent contractors or subcontractors in connection with the services provided by the Contractor under this contract. Such independent contractors and subcontractors of the

Contractor shall agree to be bound by the provisions of the contractor’s Subcontracting Agreement, the provisions of which prohibit such independent contractors and subcontractors from providing, divulging, or otherwise disclosing

Confidential Information to any third parties.

The Contractor agrees that failure of it or its independent contractors or subcontractors to abide by the clause pertaining to Confidential Information will be sufficient grounds to terminate the Contractor for default.

The Contractor further agrees that it, its employees, and its independent contractors or subcontractors will execute a confidentiality agreement upon request with any person, firm, partnership, corporation, or association being audited, examined, or otherwise reviewed. Such agreement shall be in the form of the attached Attachment A without substantive changes.

This contract does not involve the acquisition of information technology products or services.

Travel

Auditors will travel to approval holders’ locations to conduct the on-site portion of the audit. These may be located within or outside the United States. 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.

References

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 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 Project

Officer) 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 Microsoft Word 2007, for example Word

2007 document (.docx), Word 97-2003 document (.doc), OpenDocument Text (.odt), and Rich Text Format (.rtf).

Delivery shall be made to the Contracting Officer’s Technical Representative (COTR). Delivery of additional copies may be requested to the Contracting Officer or others designated by the COTR.

(c) Delivery of Reports

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

Contracting Officer Technical Representative shall be addressed as follows:

NIOSH – National Personal Protective Technology Laboratory, PO Box 18070, 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 (Dec 2005)

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

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

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

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

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

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

The Centers for Disease Control and Prevention

Financial Management Office (FMO)

P.O. Box 15580

Atlanta, GA 30333

Or – Fax copy to: 404-638-5342

G.2 Invoice Submission - Part 1 (Mar 2006)

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

The Centers for Disease Control and Prevention

Financial Management Office (FMO)

P.O. Box 15580

Atlanta, GA 3033

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

Fax: 404-638-5324

Email: FMOAPINV@CDC.GOV

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

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

Officer.

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

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

mailto:FMOAPINV@CDC.GOV

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

(1) Contractor’s Name & Address

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

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

(4) Invoice Number

(5) Invoice Date

(6) Contract Line Item Number and Description of Item

(7) Quantity

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

(9) Shipping and Payment Terms

(10) Total Amount of Invoice

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

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

(13) DUNS + 4 Number

G.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 $1,200,000.00. 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

Contract payments shall be made on a task or individual audit sub-task basis as work progresses in the task or individual audit award amounts. Partial payment is authorized after the completion of each audit report in accordance with the following schedule. Ten (10) percent of a task or audit value may be made upon submission the

Audit Intent Correspondence, twenty-five (25) percent upon submission of a Draft Audit Announcement Letter and

Audit Plan, and sixty-five (65) percent upon submission of the Draft Audit Report for final payment.

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 Contracting Officers Technical Representative (COTR) Technical Guidance (Sep 2009)

Performance of the work hereunder shall be subject to the technical directions of the designated COTR 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 feels that full implementation of any of these directions may exceed the scope of the contract, he or she shall notify the originator of the technical direction and the Contracting Officer in a letter separate of any required report(s) within two (2) weeks of the date of receipt of the technical direction and no action shall be taken pursuant to the direction.

If the Contractor fails to provide the required notification within the said two (2) week period that any technical direction exceeds the scope of the contract, then it shall be deemed for purposes of this contract that the technical direction was within the scope. No technical direction, nor its fulfillment, shall alter or abrogate the rights and obligations fixed in this contract.

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

The Government will provide the Contractor with a copy of the delegation memorandum for the COTR. Any changes in COTR delegation will be made by the Contracting Officer in writing with a copy being furnished to the

Contractor.

G.7 Technical Monitoring (Jul 1999)

(a) Performance of the work under this contract shall be subject to the technical monitoring of the Contracting

Officer Technical Representative (COTR). The term “Technical Monitoring” is defined to include, without limitation, the following:

(1) Technical directions to the Contractor which redirect the contract effort, shift work emphasis between work areas or tasks, require pursuit of certain lines of inquiry, fill in details or otherwise serve to accomplish contractual scope of work.

(2) Providing information to the Contractor for assistance in the interpretation of drawings, specifications or technical portions of the work description.

(3) Review and, where required by the contract, approve of technical reports, drawings, specifications and technical information to be delivered by the Contractor to the Government under the contract.

(b) Technical direction must be within the general scope of work stated in the contract. The COTR does not have the authority to and may not issue any technical direction which (I) constitutes an assignment of additional work outside the general scope of the contract; (ii) constitutes a change as defined in the contract clause entitled

“Changes”; (iii) in any manner causes an increase or decrease in the total contract cost, the fixed fee or the time required for contract performance; or (iv) changes any of the express terms, conditions, or specifications of the contract.

(c) All technical directions shall be issued in writing by the COTR or shall be confirmed by him/her in writing within five (5) working days after issuance.

(d) The Contractor shall proceed promptly with the performance of technical directions duly issued by the COTR in the manner prescribed by this article and within his/her authority under the provisions of this clause.

(e) If, in the opinion of the Contractor, any instruction or direction issued by the COTR is within one of the categories as defined in (b)(3)(i) through (iv) above, the Contractor shall not proceed but shall notify the Contracting

Officer in writing within five (5) working days after the receipt of any such instruction or direction and shall request the Contracting Officer to modify the contract accordingly. Upon receiving such notification from the Contractor, the Contracting Officer shall issue an appropriate contract modification or advise the Contractor in writing that, in his/her opinion, the technical direction is within the scope of this clause and does not constitute a change under the

Changes clause of the contract. The Contractor shall thereupon proceed immediately with the direction given. A failure of the parties to agree upon the nature of the instructions or direction or upon the contract action to be taken with respect thereto shall be subject to the provisions of the contract clause entitled “Disputes”.

G.8 Evaluation of Contractor Performance (Service) (Jan 2000)

(a) Purpose

In accordance with FAR 42.1502, the Contractor's performance will be periodically evaluated by the Government, in order to provide current information for source selection purposes. These evaluations will therefore be marked

“Source Selection Information.”

(b) Performance Evaluation Period

The Contractor's performance will be evaluated at least annually.

(c) Evaluators

The performance evaluation will be completed jointly by the Project officer and the Contracting officer.

(d) Performance Evaluation Factors

The contractor's performance will be evaluated in accordance with the attachment listed in Section J titled

Performance Evaluation Report.

(e) Contractor Review

A copy of the evaluation will be provided to the contractor as soon as practicable after completion of the evaluation.

The contractor shall submit comments, rebutting statements, or additional information to the Contracting Officer within 30 calendar days after receipt of the evaluation.

(f) Resolving Disagreements Between the Government and the Contractor

Disagreements between the parties regarding the evaluation will be reviewed at a level above the Contracting

Officer. The ultimate conclusion on the performance evaluation is a decision of the contracting agency. Copies of the evaluation, contractor's response, and review comments, if any, will be retained as part of the evaluation.

(g) Release of Contractor Performance Evaluation Information

The completed evaluation will not be released to other than Government personnel and the contractor whose performance is being evaluated. Disclosure of such information could cause harm both to the commercial interest of the Government and to the competitive position of the contractor being evaluated as well as impede the efficiency of

Government operations.

(h) Source Selection Information

Departments and agencies may share past performance information with other Government departments and agencies when requested to support future award decisions. The information may be provided through interview and/or by sending the evaluation and comment document to the requesting source selection official.

(i) Retention Period

The agency will retain past performance information for a maximum period of three years after completion of contract performance for the purpose of providing source selection information for future contract awards.

G.9 Contract Communications/Correspondence (Jul 1999)

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

Section H - Special Contract Requirements

H.1 Conflict of Interest

A potential conflict of interest exists between any contractor which provides services to the respiratory manufacturing industry and is retained as a NIOSH auditing firm. All bidders must disclose any potential conflicts of interest which might arise as a result of being an awardee of this contract. Mechanisms to eliminate these conflicts must be documented in the solicitation response. NIOSH will evaluate if these mechanisms are effective.

A contractor may be selected which services the respirator manufacturing industry if NIOSH determines that there are adequate controls in place to prevent conflicts of interest. However, specific potential conflicts must be disclosed when bidding on any specific task order. A contractor may be determined to be ineligible for specific task orders, based on conflicts with specific companies, as determined by NIOSH. If this situation arises, the contractor can bid, without bias, on subsequent task orders in which no conflict of interest exists.

H.2 Confidentiality Agreement

The Contractor promises not to publish, divulge, disclose or make known in any manner or to any extent, not authorized by law, to any party other than NIOSH, any information coming to the contractor and obtained in the course of this contract by reason of audits, examinations, investigations or other reviews made by the contractor, where information concerns or relates to trade secrets, processes, operations, style of work, or apparatus of any person, firm, partnership, corporation, or association being audited, examined, or otherwise reviewed under this contract (collectively, "Confidential Information"). Notwithstanding this promise, nothing contained herein shall prohibit the Contractor from providing, divulging or otherwise disclosing Confidential Information to its independent contractors or subcontractors in connection with the services provided by the contractor under this contract. Such independent contractors and subcontractors of the Contractor shall agree to be bound by the provisions of the contractor's Subcontracting Agreement, the provisions of which prohibit such independent contractors and subcontractors from providing, divulging or otherwise disclosing Confidential Information to any third parties.

The Contractor agrees that failure to abide by this confidentiality clause will be sufficient grounds to terminate the contractor for default.

The Contractor further agrees to execute a confidentiality agreement, without substantive changes to the form of the confidentiality agreement annexed as Exhibit "A" hereto, with any person, firm, partnership, corporation, or association being audited, examined or otherwise reviewed.

H.3 Issuance of Task Orders

a. Although the Contractor may not be required to conduct all of the tasks set forth in this Statement of

Work, the Contractor shall be capable of providing the staff necessary to conduct the required work. The timing, magnitude, and scope of each requirement cannot be predicted until the Government determines the specific work to be performed. The Contractor should expect a fluctuating workload throughout the performance period of this contract and will provide the technical, professional, managerial, and clerical support required to complete the task order successfully. The technical monitor, project officer or designee may accompany the Contractor to each site for the purpose of monitoring the Contractor's startup activities and may elect to remain at the site to monitor Contractor activities.

b. Single Award Contract

Performance hereunder shall be accomplished by task orders issued under this contract in accordance with the following procedures:

As the Government identifies specific requirements for work to be performed under this contract, a Task Order

Request Package (TORP) will be generated to cover individual projects. The TORP will include a statement of work and an independent cost estimate. The Contractor will be provided with a copy of the statement of work and will be requested to prepare and submit both a technical and cost proposal for accomplishing the proposed effort.

Based on this proposal, the Government and the Contractor will negotiate an estimated cost and fixed fee to perform the work. Once agreement is reached on all aspects of the work, the Government will issue a task order to the

Contractor. Failure to reach agreement on an individual task order shall be considered a dispute and handled according to the provision of the contract in Section I, FAR 52.233-1 "Disputes" (July 2002).

c. Multiple Award Contracts

Performance hereunder shall be accomplished by task orders issued under this contract in accordance with the following procedures:

As the Government identifies specific requirements for work to be performed under this contract, a Task

Order Request Package (TORP) will be generated to cover individual projects. The TORP will include a statement of work, evaluation criteria, and an independent cost estimate. Should the Government's estimate for a TORP exceed $3,000.00, each Contractor will receive a copy of the TORP, excluding the Government cost estimate. All Contractors will then have not more than 10 working days to furnish a proposal in writing or in an oral/written combination to the contracting office addressing the technical, cost, and past performance criteria furnished with the statement of work. The Government will evaluate all proposals received and make award of a task order to that firm whose proposal represents the best value to the Government.

H. 4 HHSAR 352.242-70 Key Personnel (January 2006)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request

(including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the contractor or Government.

(End of clause)

H.5 Key Personnel Listing

Personnel Title

H.6 Prohibition on the Use of Appropriated Funds for Lobbying Activities (Jul 1999)

The contractor is hereby notified of the restrictions on the use of Department of Health and Human Service's funding for lobbying of Federal, State and Local legislative bodies.

Section 1352 of Title 10, United Stated Code (Public Law 101-121, effective 12/23/89), among other things, prohibits a recipient (and their subcontractors) of a Federal contract, grant, loan, or cooperative agreement from using appropriated funds (other than profits from a federal contract) to pay any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with any of the following covered Federal actions; the awarding of any Federal contract; the making of any Federal grant; the making of any Federal loan; the entering into of any cooperative agreement; or the modification of any Federal contract, grant, loan, or cooperative agreement. For additional information of prohibitions against lobbying activities, see FAR Subpart 3.8 and FAR Clause 52.203-12.

In addition, the current Department of Health and Human Services Appropriations Act provides that no part of any appropriation contained in this Act shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support, or defeat legislation pending before the Congress, or any State or Local legislature except in presentation to the Congress, or any State or Local legislative body itself.

The current Department of Health and Human Services Appropriations Act also provides that no part of any appropriation contained in this Act shall be used to pay the salary or expenses of any contract or grant recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress, or any State or Local legislature.

H.7 Smoke Free Environment (Jul 1999)

In compliance with Department of Health and Human Services (DHHS) regulations, all contractor personnel performing work within CDC/ATSDR facilities shall observe the CDC/ATSDR smoke-free working environment policy at all times. This policy prohibits smoking in all CDC/ATSDR buildings and in front of buildings which are open to the public. This policy is also applicable to contractor personnel who do not work full-time within

CDC/ATSDR facilities, but are attending meetings within CDC/ATSDR facilities.

H.8 Year 2000 Compliance (Jul 1999)

Unless elsewhere exempted, information technology (if any) to be acquired under this contract/purchase order, which will be required to perform date/time processing involving dates subsequent to December 31, 1999, shall be

Year 2000 compliant as defined in Federal Acquisition Regulation Part 39.002.

H.9 Identification of Data (May 1998)

The Contractor shall identify the technical data delivered to the Government as required by this contract with the number of the contract and the name and address of the Contractor or subcontractor that generated the data.

H.10 Representations, Certifications and Other Statements of Offerors (Jul 1999)

The Representations, Certifications and Other Statements of Offerors submitted by dated are hereby incorporated by reference, with the same force and effect as if they were given in full text.

H.11 Incorporation of Technical Proposal (May 1998)

The Contractor’s technical proposal, including all revisions thereto, submitted in response to RFP 2012-N-14270 is hereby incorporated into the contract by reference. The Contractor shall perform the work substantially as set forth in the technical proposal. Any revisions to the technical proposal that would significantly alter the technical approach must be approved in writing by the Contracting Officer. In the event of a conflict between Section C, Statement of Work, and the Contractor’s technical proposal, Section C will take precedence.

H.12 Review and Comment (May 1998)

All materials developed or information of whatever nature resulting from work performed under this contract shall be submitted to the Project Officer for review and comment prior to publication or dissemination.

H.13 Conference Disclaimer and Use of Logos (Apr 2006)

The views expressed in written conference materials or publications and by speakers and moderators at HHS-sponsored conferences do not necessarily reflect the official policies of the Department of Health and Human

Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S.

Government.

H.14 Government Property (Feb 2012)

(a) Government-Furnished Property (GFP). In accordance with the terms of FAR 52.245-1, Government Property, the Government reserves the right to supply the Contractor, as Government-furnished property, any additional supplies, equipment, and materials determined by the Contracting Officer to be necessary and in the best interest of the Government.

(b) Contractor-Acquired Property (CAP). The Contractor must receive written consent from the Contracting

Officer prior to purchase of any CAP not expressly identified in the contract, and as defined in FAR 52.245-1.

(c) Accountable and Sensitive Government Property. The Government will provide property labels and other identification for contractor-acquired Government property that is considered Accountable as defined in the HHS

Logistics Management Manual (LMM) or considered Sensitive as defined in

CDC's Sensitive Items List

(d) The contractor shall be responsible for the control and accountable record keeping of any Government property used in the performance of this contract predominately outside the confines of a Government controlled workspace in accordance with HHS LMM Appendix Q, HHS Contracting Guide for Contract of Government Property.

(e) The Chief of the Logistics Management Branch, PGO, Centers for Disease Control and Prevention (CDC), is hereby designated as the Property Administrator for this contract. The Contractor shall identify each item of equipment furnished by the Government to the Contractor or acquired by the Contractor using contract funds, with a suitable decal, tag, or other marking, as prescribed by the Property Administrator, and shall follow the guidance set forth in Appendix Q, HHS Contracting Guide for Contract of Government Property.

H.15 HHSAR 352.239-70 Standard for Security Configurations (Oct 2009)

a) The Contractor shall configure its computers that contain HHS data with the applicable Federal Desktop Core

Configuration (FDCC) (see http://nvd.nist.gov/fdcc/index.cfm) and ensure that its computers have and maintain the latest operating system patch level and anti-virus software level.

Note: FDCC is applicable to all computing systems using Windows XP

TM

and Windows Vista

TM

, including desktops and laptops--regardless of function--but not including servers.

http://www.hhs.gov/hhsmanuals/logisticsmanual/LMM.pdf http://www.hhs.gov/hhsmanuals/logisticsmanual/LMM.pdf http://pgo.cdc.gov/pgo/webcache/content/DocsRepository/Logistics/REVISED_SENSITVE_ITEM_10042010.xlsx http://www.hhs.gov/hhsmanuals/logisticsmanual/Appendix%20Q_HHS%20Contracting%20Guide.pdf http://www.hhs.gov/hhsmanuals/logisticsmanual/Appendix%20Q_HHS%20Contracting%20Guide.pdf

(b) The Contractor shall apply approved security configurations to information technology (IT) that is used to process information on behalf of HHS. The following security configuration requirements apply:

Approved security configurations are identified in NIST checklists (http://web.nvd.nist.gov/view/ncp/repository) or contained in a DoD DISA security technical implementation guide or security checklist http://iase.disa.mil/stigs/index.html. If CDC specific security configuration requirements are later determined to apply, they will be provided subsequent to contract award and incorporated by contract modification.

Note: The Contracting Officer shall specify applicable security configuration requirements in solicitations and contracts based on information provided by the Project Officer, who shall consult with the OPDIV/STAFFDIV

Chief Information Security Officer.

(c) The Contractor shall ensure IT applications operated on behalf of HHS are fully functional and operate correctly on systems configured in accordance with the above configuration requirements. The Contractor shall use Security

Content Automation Protocol (SCAP)-validated tools with FDCC Scanner capability to ensure its products operate correctly with FDCC configurations and do not alter FDCC settings--see http://nvd.nist.gov/validation.cfm. The

Contractor shall test applicable product versions with all relevant and current updates and patches installed. The

Contractor shall ensure currently supported versions of information technology products meet the latest FDCC major version and subsequent major versions.

(d) The Contractor shall ensure IT applications designed for end users run in the standard user context without requiring elevated administrative privileges.

(e) The Contractor shall ensure hardware and software installation, operation, maintenance, update, and patching will not alter the configuration settings or requirements specified above.

(f) The Contractor shall (1) include Federal Information Processing Standard (FIPS) 201-compliant (see http://csrc.nist.gov/publications/fips/fips201-1/FIPS-201-1-chng1.pdf), Homeland Security Presidential Directive 12

(HSPD-12) card readers with the purchase of servers, desktops, and laptops; and (2) comply with FAR Subpart

4.13, Personal Identity Verification.

(g) The Contractor shall ensure that its subcontractors (at all tiers) which perform work under this contract comply with the requirements contained in this clause.

H.16 HHSAR 352.239-71 Standard for Encryption Language (Oct 2009)

(a) The Contractor shall use Federal Information Processing Standard (FIPS) 140-2-compliant encryption (Security

Requirements for Cryptographic Module, as amended) to protect all instances of HHS sensitive information during storage and transmission. (Note: The Government has determined that HHS information under this contract is considered ``sensitive'' in accordance with FIPS 199,…