attachment_1_changed_pages_only.pdf

(BEST) Initiative: Development of New and Innovative Methods for Automated Reporting for CBER- Regulated Biological Products

Solicitation Number: FDA-18-223-SOL-1196210 Amendment 1

B. Government Closures: When the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings, for other than firm fixed price contracts, the contractor will not be reimbursed when the government facility is closed for the above reasons.

F.4. PLACE OF PERFORMANCE

Most of the work shouldwill be performed at the contractor’s facility, to include maximizing technology to minimize travel elsewhere, however, note Paragraph G.8 Travel Costs should travel be required. However, the Government requires all personnel listed as Key Personnel (Section G.5) to be located within a reasonable commutable distance from the FDA White Oak Campus in Silver Spring, MD for items that require occasional onsite support. There will be no travel reimbursement for key personnel when work is performed at FDA’s White Oak Campus in Silver Spring, MD.

F.5. AAM 2018.06-005 Macro Functionality Disabled

Be advised that FDA does not accept documents which contain the use of macros.

Document submissions required throughout the award period(s) shall not have macro enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

F.6. FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): https://www.acquisition.gov/?q=browsefar

52.242-15 Stop-Work Order (AUG 1989)

This area is intentionally left blank.

Solicitation Number: FDA-18-223-SOL-1196210 Amendment 1 categories, rates and descriptions will be negotiated on a case-by-case basis. The additional categories, rates and descriptions quoted, upon determination by the Government that they are necessary for performance and are both fair and reasonable, will be incorporated by modification into the Section B Labor Rate Tables of this contract.

G.7. CONTRACTOR PERFORMANCE ASSESSMENT REPORT

In accordance with Federal Acquisition Regulation (FAR) 42.15, FDA will complete annual and final contractor performance evaluations. Annual evaluations will be prepared to coincide with the anniversary date of the contract. Additional interim performance evaluations may be prepared at Contracting Officer discretion, as necessary. Final performance evaluations will be completed upon contract expiration.

FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final contractor performance evaluations. CPARS is a secure Internet website located at http://www.cpars.csd.disa.mil/cparsmain.htm. FDA will register the contractor in CPARS upon receipt of the name and email address of two

(2) individuals who will be responsible for serving as the Contractor’s primary and alternate CPARS contacts. Once FDA registers the contractor in CPARS, the Contractor will receive an automated CPARS email message which contains User IDs and instructions for creating a password.

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contact will receive an email instructing them to logon to CPARS in order to review the performance evaluation. The Contractor has 30 days from the date of performance evaluation issuance in which to review the evaluation. If the Contractor is in agreement with the performance evaluation outcome, the evaluation becomes final.

Should the Contractor be in disagreement with the performance evaluation outcome, rebuttal comments must be submitted via the CPARS within 30 days from date the evaluation was issued by the FDA. Any disagreement between the Contracting Officer and the Contractor will be referred to a contracting official one level above the Contracting Officer, whose decision will be final.

Copies of each performance evaluation and contractor responses, if any, will be retained as part of the official contract file and will be used to support future award decisions. Evaluations will also be stored for a 3-year period in the Past Performance Information Retrieval System (PPIRS) at https://www.ppirs.gov/.

Contractors may obtain CPARS training material and register for on-line training at http://www.cpars.gov/allapps/cpcbtdlf.htm . There is no fee for registration or use of the

CPARS.

G.8. TRAVEL COSTS AND OTHER DIRECT COSTS

Solicitation Number: FDA-18-223-SOL-1196210 Amendment 1

Travel and ODC costs/pricing shall be included in each of the offeror’s overall task order pricing, noting however, that (1) costs for travel within the area of Washington, D.C. (i.e., the District of Columbia; Alexandria, Fairfax, and Falls Church Cities, Va,; Arlington, Fairfax, Loudon, and Prince Williams Counties, Va,; and Charles, Montgomery, and Prince Georges Counties, Md.) will not be allowed nor reimbursed, (2) travel costs shall be limited to that authorized by FAR 31.205-46, (3) no fee/profit, overhead, or G&A will be allowed/paid, (4) all travel outside of the Washington, D.C area . Any Contractor travel required by the Government in support of this contract shall be authorized and requested in advance (minimum of 30 calendar days) by the COR, and (5) the Contractor will be responsible for making all required travel arrangements for its personnel and in accordance with Federal Travel Regulations (FAR) 31.205-46. There is no routine travel anticipated other than meetings at the FDA campus under this requirement. If at a future date the Government does require one or more contractor employees to travel (training, conferences, etc.) the travel line item will be modified and the Contractor will be responsible for making all required travel arrangements for Contractor’s personnel.

When requested by the COR, the Contractor shall perform travel outside the Contractor’s normal commuting area. Costs for such travel are considered to be allowable based upon Federal Government per diem rates permitted by the General Services Administration (GSA), Federal Travel Regulations (FTRs) applicable to Federal Government employees and Contractors. The Contractor is referred to http://www.gsa.gov to “Travel on Government Business,” scroll down to “Federal Travel Regulations.”

Contractor will be reimbursed only for actual travel costs incurred. No additional profit, G&A or fee of any kind will be allowed on the direct travel reimbursement.

G.9. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in FDA funded programs is encouraged to report such matters to the HHS Inspector General’s Office in writing or on the Inspector General’s Hotline. The toll-free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be handled confidentially. The email address is HHStips@oig.hhs.gov and the mailing address is:

Office of Inspector General Department of Health and Human Services Attn: HOTLINE 330 Independence Avenue, S.W.

Washington, D.C. 20201

G.10. PROPERTY, EQUIPMENT, SUPPLIES, FACILITIES, PERSONNEL AND

SERVICES

Solicitation Number: FDA-18-223-SOL-1196210 Amendment 1

SECTION I: SOLICITATION PROVISIONS AND CONTRACT CLAUSES

I.1. FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE. (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address(es): https://www.acquisition.gov/?q=browsefar HHS Acquisition Regulation (HHSAR): https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html.

FAR

CLAUSE

NO.

TITLE AND DATE

52.202-1 Definitions (NOV 2013)

52.203-3 Gratuities (APR 1984)

52.203-5 Covenant Against Contingent Fees

(MAY 2014)

52.203-6 Restrictions on Subcontractor Sales to the Government (SEPT 2006)

52.203-7 Anti-Kickback Procedures (MAY 2014)

52.203-8 Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity

(MAY 2014)

52.203-10 Price or Fee Adjustment for Illegal or Improper Activity (MAY 2014)

52.203-12 Limitation on Payments to Influence Certain Federal Transactions (OCT 2010)

52.203-13 Contractor Code of Business Ethics and Conduct (OCT 2015)

52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017)

52.204-4 Printed or Copied Double-Sided on Recycled Paper (MAY 2011)

52.204-9 Personal Identity Verification of Contractor Personnel (Jan 2011)

52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards (OCT 2016)

52.204-15 Service Contract Reporting Requirements for Indefinite-Delivery Contracts. (OCT 2016)

52.204-16 Commercial and Government Entity Code Reporting. (JUL 2016)

52.204-18 Commercial and Government Entity Code Maintenance. (Jul 2016)

Solicitation Number: FDA-18-223-SOL-1196210 Amendment 1

52.225-13 Restrictions on Certain Foreign Purchases (JUN 2008)

52.225-25 Prohibition on Contracting with Entities Engaging in Sanctioned Activities Relating to Iran— Representation and Certification (OCT 2015)

52.227-1 Authorization and Consent (DEC 2007)

52.227-2 Notice and Assistance Regarding Patent and Copyright Infringement (DEC 2007)

52.227-11 Patent Rights – Ownership by the Contractor (MAY 2014)

52.227-14 Rights in Data - General (MAY 2014)

52.227-17 Rights in Data - Special Works (DEC 2007)

52.232-7 Payments under Time-and-Materials and Labor-Hour Contracts (AUG 2012)

52.232-9 Limitation on Withholding of Payments (APR 1984)

52.232-17 Interest (MAY 2014)

52.232-18 Availability of Funds (APR 1984)

52.232-23 Assignment of Claims (MAY 2014)

52.232-25 Prompt Payment (JAN 2017)

52.232-33 Payment by Electronic Funds Transfer – System for Award Management

52.232-39 Unenforceability of Unauthorized Obligations (JUL 2013)

52.232-40 Providing Accelerated Payments to Small Business Subcontractors (JUL 2013)

52.233-1 Disputes (MAY 2014) Alternate I (Dec 1991).

52.233-3 Protest after Award. (AUG 1996)

52.233-4 Applicable Law for Breach of Contract Claim. (OCT 2004)

52.237-2 Protection of Government Buildings, Equipment, and Vegetation (APR 1984)

52.237-3 Continuity of Services (JAN 1991)

52.242-13 Bankruptcy (JUL 1995)

52.243-3 Changes – Time-and-Materials or Labor-Hours (SEPT 2000)

52.244-2 Subcontracts (OCT 2010)

52.244-5 Competition in Subcontracting (DEC 1996)

52.244-6 Subcontracts for Commercial Items (NOV 2017)

52.246-25 Limitation of Liability – Services (FEB 1997)

52.248-1 Value Engineering (OCT 2010)

52.249-2 Termination for Convenience of the Government (Fixed-Price) (APR 2012)

52.249-6 Termination (Cost-Reimbursement) (May 2004) Alternate IV (Sept 1996).

52.249-8 Default (Fixed-Price Supply and Service) (APR 1984)

52.249-14 Excusable Delays (APR 1984)

Solicitation Number: FDA-18-223-SOL-1196210 Amendment 1 information on current or past performance is not available will not be evaluated favorably or unfavorably but rated neutral. Favorable past performance is considered higher than neutral past performance.

The Government will evaluate past performance as a risk assessment, not as an evaluation factor.

The Government will assess the relative performance risks associated with each offer.

Performance risks are those associated with an Offeror’s likelihood of success in performing the acquisition requirements as indicated by that Offeror’s record of past performance.

M.7. PRICE EVALUATION FACTORS

Price will be a non-scored factor. Offerors are expected to establish a reasonable price relationship between all price elements listed in Section B. An evaluation of the Offeror's price proposal maywill be made to determine if proposed prices are realistic for the work to be performed, reflect a clear understanding of the requirements, and are consistent with the technical proposal. Reasonableness determinations maywill be made by determining if competition exists (comparing proposed prices with other offers received), by comparing proposed prices with established commercial or GSA price schedules, and/or by comparing proposed prices with the Independent Government Cost Estimate

(IGCE).

Base IDIQ Price Evaluation o Total Evaluated Price – This value is the sum of the pricing in section B.3.1. The Government will evaluate ordering periods 1 through 5 by adding together the total proposed price for each period to reach a grand total evaluated price.

o FAR 52.217-8. The Government will evaluate as if the extension of service clause is exercised (maximum 6 months), it will be on the exact same rates and terms, other than length of performance, as the Ordering Period 5 rates being extended.

Task Order Award Price EvaluaitonEvaluation:

o The Task Order 0001 labor mix and materials/Travel/ODCs, to ensure they are realistic for the proposed technical response and compared among competing offers for the task order award.

M.8. SMALL BUSINESS SUBCONTRACTING PLAN

The Small Business Subcontracting Plan is not part of the best value trade-off decision but rather if the Government and offeror can negotiate an acceptable plan. The plan is