Solicitation - Amendment 1 Package 08.21.2023.pdf

DEPARTMENT OF HEALTH & HUMAN SERVICES

Health Resources and Services Administration Office of Acquisitions Management and Policy 5600 Fishers Lane, Room 14W26B Rockville, MD 20857

Subject: Combined Synopsis/Solicitation for Solicitation #75R60223Q00073 Amendment 1– Newborn Screening Information Center

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with the format in subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation;

proposals are being requested and a written solicitation will not be issued.

A Request for Quotation (RFQ), Solicitation #75R60223Q000073, is for the requirement is to develop new materials and maintain current educational materials in English and Spanish for a central clearinghouse of Newborn Screening (NBS) information that is located at https://newbornscreening.hrsa.gov/ and https://newbornscreening.hrsa.gov/es.

Health Resources and Services Administration (HRSA) intends to solicit, negotiate (if necessary), and award a Firm Fixed Price contract will be awarded utilizing the System for Award Management (SAM.GOV) under the NAICS (NAICS) Code of 541990 – All other Professional Scientific and Technical Services. This requirement is not set-aside. Small Business Size Standard is $19,500,000.00.

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2023-04.

The anticipated period of performance will be for one (1) base year with a four (4) year option periods for a total of five (5) years or 60 months. The place of performance will primarily be at the contractor’s facility.

FAR 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services, applies to this acquisition.

Offerors shall include a completed copy of the provision FAR 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services, with their offer. Offerors shall include a confirmation of receipt of any amendments to this solicitation. Failure to submit a confirmation could result in the offer being determined non-responsive.

FAR 52.212-4, Contract Terms and Conditions-Commercial Products and Commercial Services, applies to this acquisition.

FAR 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Products and Commercial Services, applies to this acquisition.

Questions may be submitted requesting clarification for this requirement via email. Any clarifying information issued by the Government will be provided to al prospective offerors. All https://newbornscreening.hrsa.gov/es questions must be submitted no later than August 11, 2023, at 16:00 pm (ET) via email to Ms.

Shawn Horton at SHorton@hrsa.gov with a courtesy copy to Ms. Helen Wesley at HWesley@hrsa.gov. Questions received after the due date and time will not be considered. No Exceptions.

Quotes shall be prepared in accordance with Attachment B entitled Instructions, Conditions, and Notices to Offerors, see attached. This RFQ does not commit the Government to pay any costs for the preparation and submission of a proposal nor does it commit the Government to make an award. It is also brought to your attention that the Contracting Officer is the only individual who can legally commit the Government to expenditure of public funds in connection with this proposed acquisition.

Quotes must include a contact name, phone number and email address as well as your company name and complete address, including street, city, county, state, zip code, Tax Identification Number (TIN), and Unique Entity ID (UEI). The TIN must match the name of the offeror to whom the payments will be made. Please note that FAR 52.204-7 System for Award Management (Oct 2018) applies to this acquisition.

Quotes must be submitted no later than August 29, 2023, at 10:00 am (ET) via email to Ms.

Shawn Horton at SHorton@hrsa.gov and a courtesy copy to Ms. Helen Wesley at HWesley@hrsa.gov.

By submission of a quote, the offeror acknowledges the requirement that a prospective awardee shall be registered in the SAM database prior to award, during performance, and through final payment of any contract, resulting from this solicitation. If not registered in the SAM database within the time prescribed by the Contracting Officer, the Contracting Officer may proceed to award to the next otherwise successful registered offeror. The System for Award Management (SAM) requires any prospective awardee to have a Unique Identifier (UEI) Number and be registered in the SAM database prior to award, during performance, and through final payment of any award resulting from this solicitation.

If you are not registered in the SAM, you may obtain information on registration and annual confirmation requirements via the internet at beta.sam.gov or by calling 1-866-606-8220.

If you do not have a UEI number, please contact Dun and Bradstreet by calling Dun and Bradstreet at 1-866-705-5711 or via the Internet at http://www.dnb.com.

Requests for additional information concerning this combined synopsis/solicitation should only be referred to via email to Ms. Shawn Horton at SHorton@hrsa.gov.

Attachments:

Attachment A – Statement of Work Attachment B – Instructions, Conditions and Notices to Offerors mailto:SHorton@hrsa.gov mailto:HWesley@hrsa.gov

FEDERAL ACQUISITION REGULATION (FAR) CLAUSES INCORPORATED BY

REFERENCE

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/ https://www.acquisition.gov/hhsar

52.202-1 Definitions JUN 2020 52.203-3 Gratuities APR 1984 52.203-6 Restrictions on Subcontractor Sales to the Government--Alternate I NOV 2021 52.203-11 Certification and Disclosure Regarding Payments to Influence Certain

Federal Transactions

SEP 2007

52.203-12 Limitation on Payments to Influence Certain Federal Transactions JUN 2020 52.204-7 System for Award Management OCT 2018 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards JUN 2020 52.204-13 System for Award Management Maintenance OCT 2018 52.204-14 Service Contract Reporting Requirements OCT 2016 52.204-16 Commercial and Government Entity Code Reporting AUG 2020 52.204-17 Ownership or Control of Offeror AUG 2020 52.204-18 Commercial and Government Entity Code Maintenance AUG 2020 52.204-20 Predecessor of Offeror AUG 2020 52.204-23 Prohibition on Contracting for Hardware, Software, and Services

Developed or Provided by Kaspersky Lab and Other Covered Entities

NOV 2021

52.204-25 Prohibition of Contracting for Certain Telecomunications and Video Surveillance Services or Equipment

NOV 2021

52.204-26 Covered Telecommunications Equipment or Services--Representation OCT 2020 52.204-27 Prohibition on a ByteDance Covered Application JUN 2023 52.209-6 Protecting the Government’s Interest When Subcontracting with

Contractors Debarred, Suspended, or Proposed for Debarment

NOV 2021

52.209-7 Information Regarding Responsibility Matters OCT 2018 52.209-9 Updates of Publicly Available Information Regarding Responsibility

Matters

OCT 2018

52.209-10 Prohibition on Contracting with Inverted Domestic Corporations NOV 2015 52.212-1 Instructions to Offerors—Commercial Products and Commercial Services NOV 2021 52.212-3 Offeror Representations and Certifications—Commercial Products and

Commercial Services

DEC 2022

52.212-4 Contract Terms and Conditions—Commercial Products and Commercial Services

DEC 2022

52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Products and Commercial Services

JUN 2023

52.217-4 Evaluation of Options Exercised at Time of Contract Award JUN 1988 52.217-5 Evaluation of Options JUL 1990 52.217-8 Option to Extend Services NOV 1999 52.217-9 Option to Extend the Term of the Contract MAR 2000 52.219-4 Notice of Price Evaluation Preference for HUBZone Small Business

Concerns

OCT 2022

https://www.acquisition.gov/ https://www.acquisition.gov/ https://www.acquisition.gov/hhsar

52.219-8 Utilization of Small Business Concerns OCT 2022 52.219-9 Small Business Subcontracting Plan OCT 2022 52.219-16 Liquidated Damages - Subcontracting Plan SEP 2021 52.219-28 Post-Award Small Business Program Rerepresentation OCT 2022 52.222-3 Convict Labor JUNE 2003 52.222-21 Prohibition of Segregated Facilities APR 2015 52.222-22 Previous Contracts and Compliance Reports FEB 1999 52.222-25 Affirmative Action Compliance APR 1984 52.222-26 Equal Opportunity SEP 2016 52.222-35 Equal Opportunity for Veterans JUN 2020 52.222-36 Equal Opportunity for Workers with Disabilities JUN 2020 52.222-37 Employment Reports on Veterans JUN 2020 52.222-40 Notification of Employee Rights Under the National Labor Relations Act DEC 2010 52.222-41 Service Contract Labor Standards AUG 2018 52.222-42 Statement of Equivalent Rates for Federal Hires MAY 2014 52.222-43 Fair Labor Standards Act and Service Contract Labor Standards—Price

Adjustment (Multiple Year and Option Contracts)

AUG 2018

52.222-50 Combating Trafficking in Persons NOV 2021 52.222-54 Employment Eligibility Verification MAY 2022 52.222-55 Minimum Wages Under Executive Order 13658 JAN 2022 52.222-62 Paid Sick Leave Under Executive Order 13706 JAN 2022 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving JUN 2020 52.223-22 Public Disclosure of Greenhouse Gas Emissions and Reduction Goals—

Representation

DEC 2016

52.229-11 Tax on Certain Foreign Procurements—Notice and Representation. JUN 2020 52.229-12 Tax on Certain Foreign Procurements FEB 2021 52.232-33 Payment by Electronic Funds Transfer—System for Award Management OCT 2018 52.232-39 Unenforceability of Unauthorized Obligations JUN 2013 52.232-40 Providing Accelerated Payments to Small Business Subcontractors NOV 2021 52.233-3 Protest after Award AUG 1996 52.233-4 Applicable Law for Breach of Contract Claim OCT 2004 52.242-5 Payments to Small Business Subcontractors JAN 2017

FAR CLAUSES INCORPORATED BY FULL TEXT

52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

The Offeror shall not complete the representation at paragraph (d)(1) of this provision if the Offeror has represented that it "does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument" in paragraph (c)(1) in the provision at 52.204-26, Covered Telecommunications Equipment or Services—Representation, or in paragraph (v)(2)(i) of the provision at 52.212-3, Offeror Representations and Certifications- Commercial Products or Commercial Services. The Offeror shall not complete the representation in paragraph (d)(2) of this provision if the Offeror has represented that it "does not use covered telecommunications equipment or services, or any equipment, system, or service that uses https://www.acquisition.gov/far/52.204-26#FAR_52_204_26 https://www.acquisition.gov/far/52.212-3#FAR_52_212_3 covered telecommunications equipment or services" in paragraph (c)(2) of the provision at 52.204-26, or in paragraph (v)(2)(ii) of the provision at 52.212-3.

(a) Definitions. As used in this provision—

Backhaul, covered telecommunications equipment or services, critical technology, interconnection arrangements, reasonable inquiry, roaming, and substantial or essential component have the meanings provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Prohibition.

(1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. Nothing in the prohibition shall be construed to—

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(2) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115-232) prohibits the head of an executive agency on or after August 13, 2020, from entering into a contract or extending or renewing a contract with an entity that uses any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. This prohibition applies to the use of covered telecommunications equipment or services, regardless of whether that use is in performance of work under a Federal contract.

Nothing in the prohibition shall be construed to—

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

https://www.acquisition.gov/far/52.204-26#FAR_52_204_26 https://www.acquisition.gov/far/52.212-3#FAR_52_212_3 https://www.acquisition.gov/far/52.204-25#FAR_52_204_25

(c) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM) ( https://www.sam.gov) for entities excluded from receiving federal awards for "covered telecommunications equipment or services".

(d) Representation. The Offeror represents that—

(1) It □ will, □ will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation. The Offeror shall provide the additional disclosure information required at paragraph (e)(1) of this section if the Offeror responds "will" in paragraph (d)(1) of this section; and

(2) After conducting a reasonable inquiry, for purposes of this representation, the Offeror represents that—

It □ does, □ does not use covered telecommunications equipment or services, or use any equipment, system, or service that uses covered telecommunications equipment or services.

The Offeror shall provide the additional disclosure information required at paragraph (e)(2) of this section if the Offeror responds "does" in paragraph (d)(2) of this section.

(e) Disclosures.

(1) Disclosure for the representation in paragraph (d)(1) of this provision. If the Offeror has responded "will" in the representation in paragraph (d)(1) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment—

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the original equipment manufacturer (OEM) or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number;

and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(ii) For covered services—

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or https://www.sam.gov/

(B) If not associated with maintenance, the Product Service Code (PSC) of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(2) Disclosure for the representation in paragraph (d)(2) of this provision. If the Offeror has responded "does" in the representation in paragraph (d)(2) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment—

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the OEM or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number;

and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(ii) For covered services—

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the PSC of the service being provided;

and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(End of provision)

52.212-2 Evaluation—Commercial Products and Commercial Services (Nov 2021)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. Offers will be evaluated in accordance to Attachment B – Instructions, Conditions, and Notices to Offerors.

Technical and past performance, when combined, are significantly more important than Price.

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of provision)

HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR)

CONTRACT CLAUSES INCORPORATED BY REFERENCE:

352.203-70 Anti-Lobbying December 18, 2015 352.222-70 Contractor Cooperation in Equal Employment Opportunity

Investigations December 18, 2015

352.224-71 Confidential Information December 18, 2015

HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR)

CONTRACT CLAUSES INCORPORATED BY FULL TEXT:

352.239-73 Electronic Information and Technology Accessibility Notice (December 18, 2015)

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at https://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be https://www.hhs.gov/web/508 accessed at https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.

(c) The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-74, Electronic and Information Technology Accessibility.

In order to facilitate the Government’s determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and document—in detail—whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS website https://www.hhs.gov/web/508.

In order to facilitate the Government’s determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(End of provision)

352.239-74 Electronic and Information Technology Accessibility (December 18, 2015)

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all electronic and information technology (EIT) supplies and services developed, acquired, or maintained under this contract or order must comply with the “Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194.

Information about Section 508 is available at https://www.hhs.gov/web/508. The complete text of Section 508 Final Provisions can be accessed at https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.

(b) The Section 508 accessibility standards applicable to this contract or order are identified in the Statement of Work or Specification or Performance Work Statement. The contractor must provide any necessary updates to the submitted HHS Product Assessment Template(s) at the end of each contract or order exceeding the simplified acquisition threshold (see FAR 2.101) when https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html#352.239-74 https://www.hhs.gov/web/508 the contract or order duration is one year or less. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) The Section 508 accessibility standards applicable to this contract are:

Web Content Accessibility Guidelines (WCAG) 2.0 Success Criteria, Level A and AA Chapter 3: Functional Performance Criteria (FPC) Chapter 4: Hardware (If Applicable) Chapter 5: Software Chapter 6: Support Documentation and Services

(d) In the event of a modification(s) to this contract or order, which adds new EIT supplies or services or revises the type of, or specifications for, supplies or services, the Contracting Officer may require that the contractor submit a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards.

Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found under Section 508 policy on the HHS website:

(https://www.hhs.gov/web/508). If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(e) If this is an Indefinite Delivery contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include EIT supplies or services will define the specifications and accessibility standards for the order. In those cases, the Contractor may be required to provide a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found at https://www.hhs.gov/web/508. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(End of clause)

(x)

75R60223Q00073 x x

1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE

RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR

OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

x

Rockville MD 20857

OAMP

5600 Fishers Lane, Room 14W26B Management and Policy Office of Acquisition

HHS/HRSA/OO/OAMP

Rockville MD 20857

OAMP

5600 Fishers Lane, Rm 14W26B Management and Policy Office of Acquisition

HHS/HRSA/OO/OAMP

08/21/20230001

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

7. ADMINISTERED BY (If other than Item 6)CODE 6. ISSUED BY

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

08/03/2023

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

E. IMPORTANT: Contractor is not is required to sign this document and return __________________ copies to the issuing office.

ORDER NO. IN ITEM 10A.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

Title: Newborn Screening Information Center

Unique ID: MCHB62 C 4669

Award Type: Firm Fixed Price (FFP)

The purpose of this amendment is to 1) respond to questions submitted, and 2) adjust the due date to submit proposals to no later than 10am EST on August 29, 2023.

Attachments:

Attachment A - Statement of Work

Attachment B - Instructions, Conditions, and Notices to Offerors

Solicitation Questions and Responses

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

Previous edition unusable

Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .

Attachment A

STATEMENT OF WORK

August 21, 2023

Project Title: Content Development for the Newborn Screening Information Center

(MCHB62 C 4669)

I. BACKGROUND

The Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), is the primary federal agency for improving access to health care for the tens of millions of Americans who, for a variety of reasons, are medically underserved or face barriers to needed care. HRSA’s mission is to improve health and achieve health equity through access to quality services, a skilled health workforce and innovative programs.

Newborn Screening (NBS) is a successful public health program implemented at the state level that saves and/or improves the lives of thousands of babies each year in the United States. Four million newborns each year are screened for conditions that are included on state’s NBS panels as recommended by the HHS Secretary. These conditions may not be apparent at birth but require early intervention and treatment. Early detection mitigates brain and organ damage, may attenuate disease severity, and prevent life-threatening complications associated with these conditions. MCHB has administered various NBS and other heritable disorders programs, which were authorized by the Newborn Screening Saves Lives Act of 2007 (P.L. 110-204) and reauthorized by the Newborn Screening Saves Lives Reauthorization Act of 2014 (P.L. 113- 240). These programs collectively aim to enhance, improve, or expand the ability of states and local public health agencies to provide screening, counseling, and health care services to newborns and children having or at risk for having heritable disorders.

The Maternal and Child Health Bureau of HRSA is providing this contract in support of the Newborn Screening Saves Lives Reauthorization Act of 2015 (Public Health Service Act § 1112 (42 U.S.C. 300b-11)). The statute requires HRSA to establish and maintain a central clearinghouse of current educational and family support and services information, materials, resources, research, and data on NBS. The Newborn Screening Information Center (NBSIC) is a trusted resources for NBS and is an objective, impartial website.

The HRSA Office of Communications (OC), within the Office of the Administrator, directs all web and social media outreach efforts of the agency. This includes creating, publishing, managing, deleting, maintaining, and ensuring Section 508 compliance, usability and plain-language writing of the content for www.hrsa.gov and its sub-domains to host content developed through this requirement. The HRSA OC team will be uploading the content to https://newbornscreening.hrsa.gov/ and https://newbornscreening.hrsa.gov/es.

The purpose of the NBSIC website is to:

http://www.hrsa.gov/ https://newbornscreening.hrsa.gov/ o Enable parents and family members of newborns, health professionals, industry representatives, and other members of the public to increase their awareness, knowledge and understanding of NBS.

o Increase awareness, knowledge, and understanding of NBS for expectant individuals and families.

Per the legislation, the NBSIC website shall:

1. Be available on the Internet.

2. Include an interactive forum.

3. Be updated on a regular basis, but not less than quarterly.

4. Provide the following:

a. links to Government-sponsored, non-profit, and other Internet websites of laboratories that have demonstrated expertise in NBS that supply research-based information on NBS tests currently available throughout the United States.

b. information about newborn conditions and screening services available in each State from laboratories certified under the Clinical Laboratory Improvement Amendments, including information about supplemental screening that is available but not required, in the State where the infant is born.

c. current research on both treatable and not-yet treatable conditions for which NBS tests are available.

d. the availability of Federal funding for newborn and child screening for heritable disorders including grants authorized under the Newborn Screening Saves Lives Reauthorization Act of 2014; and

e. other relevant information as determined appropriate by the Secretary and HRSA.

II. PURPOSE/GENERAL DESCRIPTION

The purpose of this contract is to develop new materials and maintain current educational materials in English and Spanish for a central clearinghouse of NBS information that is located at https://newbornscreening.hrsa.gov/ and https://newbornscreening.hrsa.gov/es.

III. PERIOD OF PERFORMANCE / PLACE OF PERFORMANCE

The period of performance shall be for one base year and four (4) option years.

The place of performance will primarily be at the contractor’s facility.

Federal Holidays

• New Year’s Day January 1

• Martin Luther King’s Birthday 3rd Monday in January

• Washington’s Birthday 3rd Monday in February

• Memorial Day last Monday in May

• Juneteenth National Independence Day June 19 https://newbornscreening.hrsa.gov/

• Independence Day July 4

• Labor Day 1st Monday in September

• Columbus Day 2nd Monday in October

• Veterans’ Day November 11

• Thanksgiving Day 4th Thursday in November

• Christmas Day December 25

Federal law (5 U.S.C. 6103) establishes the public holidays listed in these pages for Federal employees. Please note that most Federal employees work on a Monday through Friday schedule. For these employees, when a holiday falls on a nonwork day -- Saturday or Sunday --the holiday usually is observed on Monday (if the holiday falls on Sunday) or Friday (if the holiday falls on Saturday).

IV. TASKS

Task 1 - Records Management Training

The Contractor shall:

1.1 Records and Information Regulation Guidelines: In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

1.2 Records and Information Management: The contractor shall manage and maintain Federal records and/or information, including electronic records and/or information, ensuing from this contract in accordance with all applicable records management laws and regulations, including but not limited to the Federal Records Act (44 U.S.C.

Chapters. 21, 29, 31, 33); 36 CFR § 1236.20 What are appropriate record keeping systems for electronic records? & 1236.22 What are the additional requirements for managing electronic mail records? https://www.ecfr.gov/current/title-36/part-1236;

NARA Bulletin 2013-02, August 29, 2013, Guidance on a New Approach to Managing Email Records (https://www.archives.gov/records-mgmt/bulletins/2013/2013-02.html);

and NARA Bulletin 2010-05 September 08, 2010 (http://www.archives.gov/records-mgmt/bulletins/2010/2010-05.html), Guidance on Managing Records in Cloud Computing Environments.

Managing the records includes, maintaining records to retain functionality and integrity throughout the records' full lifecycle including: (1) maintenance of links between records and metadata, and (2) categorization of records to manage retention and disposal, either https://www.ecfr.gov/current/title-36/part-1236 https://www.archives.gov/records-mgmt/bulletins/2013/2013-02.html http://www.archives.gov/records-mgmt/bulletins/2010/2010-05.html http://www.archives.gov/records-mgmt/bulletins/2010/2010-05.html through transfer of permanent records to NARA or deletion of temporary records in accordance with NARA-approved retention schedules.

1.3 Records Management Training: The contractor (and/or subcontractor) shall ensure that all employees having access to (1) Federal information or a Federal information system, or (2) personally identifiable information (PII), complete the HHS Records Management Training before performing work under this contract, and thereafter completing the annual refresher training during the life of the contract. The training is located at https://humancapital.learning.hhs.gov/courses/2022recordsmanagement/01_index.html . At the end of the Records Management training, please send the "Certificate of Completion" to the Contracting Officer Representative (COR) of the contract. The listing of completed training shall be included in the first progress report. Any revisions to this listing as a result of staffing changes shall be submitted with next required progress report.

Task 2: Kickoff Meeting

The Contractor shall:

2.1 Meet with the Contracting Officer’s Representative (COR) and other HRSA staff invited by the COR within two (2) weeks of Effective Date of Contract (EDOC) using a web-based meeting platform (such as WebEx or Zoom) to introduce key task participants and their roles in the project, discuss the draft work plan and timeline for all phases of the project, scope of work, schedule of deliverables, priorities, and identify any potential challenges.

2.2 Electronically submit via email a draft meeting agenda and any materials within five (5) business days of EDOC to the COR. The draft agenda and materials will be reviewed by the COR prior to the meeting.

2.3 Take meeting minutes and electronically submit to the COR within three (3) business days after the Kickoff Meeting. The meeting minutes shall reflect any changes to the project timeline and include a list of anticipated deadlines reflecting all agreed upon outcomes of the discussion.

2.4 Revise the meeting minutes as directed by the COR and electronically submit the revised meeting minutes to the COR within two (2) business days after receipt of comments from the COR.

Task 3: Project Management

Task 3.1 – Monthly Meetings

The Contractor Shall:

a. Meet with the COR and other members as indicated by the COR monthly using a web-https://humancapital.learning.hhs.gov/courses/2022recordsmanagement/01_index.html based meeting platform (such as WebEx or Zoom) to discuss the status of contract and other pertinent issues. These meetings shall include the following discussion items:

• Progress on activities that have occurred since the EDOC or date of last call, including problems encountered and potential future problems, solutions or steps taken to resolve challenges, actual and possible delays in deliverables, etc.;

• Progress and plans for upcoming activities, for review and acceptance by the COR;

• Technical direction based on any questions or problems the contractor has to achieve the desired outcomes on the project plan.

b. Develop an agenda for the meeting and electronically submit to the COR in Microsoft Outlook for review and acceptance no less than three (3) business days before each meeting.

c. Take meeting minutes of each meeting and electronically submit the draft minutes to the

COR within two (2) business days of each meeting. The minutes shall include a list of any decisions made during the meeting and action items due by the COR and the Contractor until the next meeting.

Task 3.2 – Quarterly Meetings

The Contractor Shall:

a. Each quarter, conduct quarterly meetings using a web-based meeting platform (such as

WebEx or Zoom) with the COR and designated HRSA staff, including management, project officers of other grants related to NBS, the HRSA website team, and other members as indicated by the COR. The meeting will discuss new updates to the NBSIC website since the last quarterly meeting, challenges, and resolutions to complex task assignments, allow for HRSA staff feedback, and follow-up action items.

b. Develop an agenda for the meeting and electronically submit to the COR in Microsoft

Outlook for review and acceptance no less than three (3) business days before each

c. Take meeting minutes of each meeting and electronically submit the draft minutes to the

COR in Microsoft Word within two (2) business days of each meeting. The minutes shall include a list of any decisions made during the meeting and action items due by the COR and the Contractor until the next meeting.

Task 3.3 – Quarterly Progress Report

Electronically submit a quarterly progress report to the COR outlining activities and issues affecting contract performance. The quarterly report shall be submitted five (5) business days after the end of each quarter. Specifically provide the following in the quarterly progress report:

• Status of Work – In a narrative and table, highlight the status of activities by task, including any significant events, trends, or problems that occurred along with suggestions for resolution and/or recommendations for improving performance.

• Planned Activities for Next Three Months – Include a discussion of the work to be performed, by task, during the subsequent month and estimated completion date of each task.

Task 4: Work Plan

4.1 Submit a revised work plan that was submitted in the proposal to the COR twenty (20) business days after the kickoff meeting. The revised workplan will refine priorities for inclusion in the work plan; to incorporate HRSA’s input; and reflect discussions from the project kickoff meeting. The revised work plan shall include updated objectives and deliverables associated with timelines and milestones.

4.2 The work plan shall be updated annually within one-month after the start of each exercised option period.

4.3 Complete all activities from the technical work plan within five (5) business days before the end of each period of performance.

Task 5: Development of Web Content for the NBSIC Websites

The Contractor Shall:

5.1 Provide expertise and update content on the following topics related to NBS: newborn and child medical/genetic conditions including presenting phenotype, diagnosis, treatment, genetic etiology and implications for family members; family education;

screening practices; laboratories methods; public health impact; information technology;

health education; medical home; health literacy; cultural competency and patient/family-centered care experts that have served the needs of diverse populations and stakeholders.

5.2 Content shall be submitted to the COR in the Quarterly Updates of Content for the Newborn Screening Information Center for the following:

a. Update all currently posted pages on the website with updated information.

b. Contact the states on a yearly basis to confirm the information for the state NBS panels. Review quarterly the 56 state and territories website pages to confirm what is on the NBSIC website is the same as the state pages for NBS panels.

c. Provide updated information, as needed, on conditions on the RUSP or other conditions for parents and caregivers. This shall include information on the NBS test, follow up needed to establish a diagnosis, clinical history, management and treatment and services needed by the family.

d. Provide maps or other graphics that show national information on NBS (average of 5 maps of the US and the territories [e.g., number of conditions screened in each state and territory)

e. Provide fact sheets, education tools, infographics, etc. from other groups that are vetted by the contractor (average of 10 items total per year) that will be useful to the stakeholders.

f. Develop emerging NBS and genetics issues summaries (average of 2 pages each year).

g. Develop summaries that highlight challenges faced by parents, caregivers, and other stakeholders in the newborn screening community (average of 5 pages each year) and, if appropriate, solutions or mechanisms to address those challenges.

h. Provide latest NBS technologies information about supplemental screening that is available but not required, in each State (1 page).

5.3 All content must be vetted by NBS experts, as identified by the contractor, and approved by the COR to include that the latest information on the NBSIC website is up to date.

5.4 Incorporate recommendations from HRSA to develop accurate, up-to-date web page content that executes on the findings from the evaluation of the site and the ability to reach the intended audience. The recommendations provided by HRSA are from reviewing the NBSIC website to evaluate the content and the usability of the website.

Information will be forthcoming from HRSA of strategies to operationalize the website to maximize its reach and impact.

5.5 Provide one-page summaries, if requested (up to 6 pages per year) and links to:

• authoritative and/or evidence-based information.

• community training initiatives.

• health care provider educational materials.

• NBS best practices and guidelines.

• information and tools that promote culturally sensitive education and decision-making regarding NBS for heritable disorders; and

• quality indicators to measure performance of NBSs, such as false-positive rates and other quality indicators.

a) The draft summary shall be submitted 35 business days after the request need from an email from the COR.

b) The final 508 compliant summary in a PDF document shall be submitted to the COR within ten (10) business days after receipt of comments from COR.

5.6 Coordinate with the HRSA grantees for the Family Engagement and Leadership in Systems of Care, the NBS Excel, NBS Propel, and other HHS grantees as identified by the COR, to identify educational needs. The contractor will not recreate items but will provide emphasis and/or links to established materials.

5.7 Provide links to the COR, quarterly, for websites and other sources of credible information regarding NBS, including Government-sponsored, nonprofit, advocacy, NBS laboratories, and other online websites that have demonstrated expertise in NBS, and that supply research-based information on NBS tests currently available throughout the United States.

5.8 Participate in the steering committees that guide the activities of the project awardee for the Family Engagement and Leadership in Systems of Care and the NBS Excel Program.

The COR will provide dates for the steering committees to the Contractor when dates become available. The contractor shall attend two (2) in-person, two-day Steering Committee meeting each year in Washington D.C.

5.9 Vet all non-government websites using the vetting strategy approved by HRSA at the kickoff meeting. See sample guideline https://medlineplus.gov/criteria.html.