Requirements Document june 17 2026 final.pdf

July 17, 2026

STATEMENT OF WORK

PART 1: DESCRIPTION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information. This announcement constitutes the only solicitation; a proposal is being requested, and a written solicitation will not be issued. The North American Industrial Classification System (NAICS) code for this procurement is 541620, size standard $15 million. The Government contemplates a firm fixed price purchase order for this solicitation. This requirement is other than a full and open competition. (sole source).

PART 2: SUPPLIES /SERVICES AND PRICES

2.1 Brief Description of Supplies or Services

The U.S. Food and Drug Administration (FDA) requires the completion of an Environmental Assessment or the preparation of an Environmental Impact Statement for sunscreen active ingredients, zinc oxide (ZnO) and titanium dioxide (TiO2), to amend the over-the-counter (OTC) monograph for sunscreen drug products for OTC use. The work was started on Contract GS-00F- 194CA/75F40120F8430 (labor hour contract) with Johnson Mirmiran & Thompson, Inc. (JMT) but not completed by the contract’s ending period of performance date of February 28, 2026.

PART 3: STATEMENT OF WORK

3.1 Background

The OTC drug review process was established to evaluate the safety and effectiveness of OTC drug products marketed in the United States. This process has been modified over time, most recently on March 27, 2020, when Congress enacted the Coronavirus Aid, Relief, and Economic Security (CARES) Act, which modified section 505G of the Federal Food, Drug and Cosmetic Act (FD&C Act). Among other things, the CARES Act required FDA to issue a proposed order addressing sunscreens, which was issued September 24, 2021.1 FDA expects that a final sunscreen order will establish revised conditions for marketing a sunscreen product without the prior approval of an NDA, and that among the conditions addressed will be the permissibility of including certain active ingredients in sunscreen products marketed without an NDA.

1 86 FR 53322 (Sept. 27, 2021); FDA Proposed Order OCT000008 Amending Over-the-Counter (OTC) Monograph M020: Sunscreen Drug Products for OTC Human Use, https://www.accessdata.fda.gov/drugsatfda_docs/omuf/Order/Proposed%20Administrative%20Order%20OTC0000 08_Amending%20M020_Sunscreen_Signed24Sept2021.pdf.

https://www.accessdata.fda.gov/drugsatfda_docs/omuf/Order/Proposed%20Administrative%20Order%20OTC000008_Amending%20M020_Sunscreen_Signed24Sept2021.pdf https://www.accessdata.fda.gov/drugsatfda_docs/omuf/Order/Proposed%20Administrative%20Order%20OTC000008_Amending%20M020_Sunscreen_Signed24Sept2021.pdf

In the proposed order FDA proposed that, of the 16 currently marketed sunscreen active ingredients, two ingredients, ZnO and TiO2, are generally recognized as safe and effective (GRASE) for use in sunscreens because there is sufficient safety data supporting their use, and two ingredients, aminobenzoic acid (PABA) and trolamine salicylate, are not GRASE for use in sunscreens because of data demonstrating safety issues relating to these ingredients. FDA also proposed that the remaining 12 ingredients are not GRASE because there is insufficient safety data to support a positive GRASE determination. These ingredients are: cinoxate, dioxybenzone, padimate O, sulisobenzone, oxybenzone, octinoxate, avobenzone, ensulizole, homosalate, meradimate, octisalate, and octocrylene. FDA has asked industry and other interested parties to submit additional clinical and non-clinical safety data that is needed to finalize a GRASE determination on these 12 ingredients.

Before engaging in a major federal action, the National Environmental Policy Act (NEPA) requires federal agencies to consider the potential environmental consequences of proposed actions, and any reasonable alternatives.2 To comply with NEPA, agencies will prepare documentation of the analysis they conduct in a categorical exclusion (CE), an environmental assessment (EA) accompanied by a finding of no significant impact (FONSI), or an environmental impact statement (EIS) accompanied by a record of decision (ROD) before taking action on the proposal. FDA will prepare an EIS when data or information in an environmental assessment or otherwise available to the agency leads to a finding that the proposed agency action may significantly affect the quality of the human environment. This environmental NEPA analysis is separate and apart from FDA’s action to finalize the proposed sunscreen OTC monograph order related to active ingredients ZnO and TiO2, which will decide the permissibility of marketing these active ingredients in sunscreen products without an NDA, under the FD&C Act.

FDA began its NEPA analysis for the proposed order in 2020, and entered into contract #GS- 00F-194CA75F40120F80430 with Johnson Mirmiran & Thompson, Inc. (JMT) on August 28, 2020, for the development of an EIS under NEPA to support a final sunscreen order or orders.

Under that contract and modifications, JMT was required to: (a) develop and prepare a draft and, if necessary, a final EIS for two (2) sunscreen active ingredients, oxybenzone and octinoxate; (b) develop and prepare a draft and final EA for sunscreen active ingredients, ZnO and TiO2; and (c) if FDA exercised certain options, develop and prepare a draft and final EA or EIS for some or all of the following six (6) active ingredients: avobenzone, ensulizole, homosalate, meradimate, octocrylene, and octisalate. On May 13, 2021, FDA published a Notice of Intent to prepare an EIS for the sunscreen active ingredients, oxybenzone and octinoxate. .

Throughout that contract period JMT prepared draft documents related to the EIS, but at FDA’s request, JMT focused most of its time preparing draft documents relating to the EA on ZnO and TiO2. Due to circumstances beyond JMT’s control, including changing legal standards under NEPA, the EA on ZnO and TiO2 was not completed. At the close of the contract, FDA agreed that the deliverables completed to date were acceptable and satisfactory, but the scope of the contract remained incomplete due to external regulatory complexities and shifting priorities rather than contractor performance issues. FDA continues to work on the proposed sunscreen order and needs to complete this EA regarding ZnO and TiO2prior to issuing a final order on

2 42 U.S.C. § 4321 et seq.; 21 CFR Part 25.

these ingredients. We agree that the scientific environmental analysis in the drafted documents is technically sound, but there are revisions and edits that need to be made before the documents are finalized and published.

JMT’s scientific expertise to assess environmental issues, and the fact that the work described in this SOW is a reasonable extension of the work previously conducted by JMT, supports the continued use of this contractor in completing this NEPA analysis.

3.2 Objectives

The objective of this contract is to prepare and document an appropriate level of environmental review under NEPA, applicable regulations and guidance, prior to issuing the final Sunscreen OTC Monograph Order regarding ZnO and TiO2. Specifically, the intent is to finalize the EA on ZnO and TiO2 including appendices or, if necessary, to exercise an option under this contract to prepare and finalize an EIS for these active ingredients.

3.3 Scope of Work

The Contractor shall perform the necessary tasks, functions, activities, and preparation of deliverables incident to the performance of the NEPA work as described below relating to active ingredients ZnO and TiO2. This scope of work outlines the tasks to be performed by the Contractor to assist FDA in completing certain NEPA analysis for the proposed sunscreen order, and in documenting the analyses in an EA or EIS, and the appropriate decision documents – a FONSI and/or a Record of Decision (ROD), respectively. The Contractor shall provide assistance to FDA throughout the EA or EIS process, as described below. FDA shall provide guidance to the Contractor in the preparation of the EAor EIS.

The drafted EA and five appendices, A. Baseline Environmental Exposures, B. Ecotoxicity Profile for Zinc Oxide, C. Ecotoxicity Profile for Titanium Dioxide, D. National and State Population Characteristics and E. Consumption and Load Analyses, shall be revised, edited and prepared for publication on the sunscreen OTC Monograph webpage.

These technical appendices support the environmental analysis, and contractor should confirm the appendices and text are consistent. We anticipate the work will include the following types of activities:

3.4 Tasks

3.4.1 General Requirements

1. The Contractor shall establish and maintain computer-based systems to enter, track, and retrieve internal revisions of text; manage a comprehensive, nonproprietary distribution list of interested and affected parties (developed and provided by FDA initially); and create and maintain the files that will eventually constitute the completed NEPA Administrative Record (AR). Such records shall be maintained throughout the completion of the EA or EIS, consistent with FDA’s AR guidance and procedures.

Within one (1) week of completion of a document representing final Agency action (ROD or FONSI), or within one (1) week of other FDA action indicating completion or termination of this contract, the Contractor shall deliver all materials considered to be part of the AR in an electronic format to the Contracting Officer’s Representative (COR).

2. The Contractor shall participate in regular meetings and monthly special progress review meetings, as requested by the COR. The Contractor shall participate in the FDA review sessions of the revised draft EA and supporting documents, or, if appropriate, the revised draft EIS and supporting documents. FDA shall determine the frequency and location of meetings, which will be specified by the COR. When deemed appropriate by FDA, meetings will be held via teleconferencing.

3. The Contractor shall support public involvement activities where appropriate. This may include support for discussions with Native American Tribes, Federal, State, or local governments, and other interested parties, during document preparation or finalization.

4. The Contractor shall support the COR’s interactions with cooperating agencies during document preparation or finalization.

5. The Contractor shall prepare and transmit monthly updates and an annual progress report.

3.4.2 Task 1 Revise and finalize draft EA on ZnO and TiO2 (clin 1)

1. The contractor shall prepare a revised draft EA on ZnO and TiO2, including revisions to the five appendices identified above, where appropriate. This shall include corrections, revisions, addition and deletions based on comments from FDA that have not been incorporated into the document.

The following is provided to give the contractor an understanding of the level of work FDA is requesting in the review and revision of these documents:

• Conduct brief literature search for any major updates of the science that could change the results

• Ensure all FDA comments have been addressed

• Edit text for readability for the public and to the extent possible use plain language

• Confirm that the technical analysis in Appendices is consistent with the text

• Ensure that document is consistent with the most recent changes to NEPA, including statutory page limitations

• Ensure there is adequate discussion for incomplete or unavailable information

• Confirm modeling assumptions and conclusions regarding potential exposure

• Confirm analysis of nationwide exposure to sunscreens as compared to isolated geographic regions

• Confirm that nano and non-nano categories are separated, combined, and assessed as appropriate

• Address cultural issues to be consistent with recent NEPA changes, including recent Executive Orders

• Confirm whether using two separate approaches are needed for Alternatives B and C

– most likely scenario is that ZnO and TiO2 will be used in the same volume before and after final order; second scenario included in Appendix A, assumes that only sunscreen products containing ZnO and TiO2 will be marketed.

2. The EA for ZnO and TiO2 shall be finalized when FDA determines which action to take regarding this NEPA analysis, either issuing a FONSI or preparing an EIS.

3.4.4 Optional Task: EIS for ZnO and TiO2 (clin 2)

The following tasks will be prepared or implemented:

1. Initial Preliminary Draft

The Contractor shall prepare an initial preliminary draft EIS (Summary, Chapters, Appendices) based in part on the research and scientific analysis presented in the final or draft EA on ZnO and TiO2. FDA and contractor shall determine if additional scientific research is needed for the EIS.

Contractor shall determine whether a separate EIS shall be prepared for each active ingredient in consultation with FDA. The document shall include appropriate text and graphic material to allow full understanding of the analysis and methodologies used and their results. The document shall be written in a style that is readily understandable by the public. The Contractor shall compile, track, answer and resolve internal review comments on the initial preliminary draft EIS, including validation reviews, and shall then revise the initial preliminary draft EIS. The COR shall provide a distribution list, and the Contractor shall provide an electronic copy of the initial preliminary draft EIS for purposes of FDA and, if appropriate, cooperating agency internal review.

The EIS shall describe the purpose and need for agency action, the proposed action, the No Action and other reasonable NEPA alternatives, and analyze the potential environmental impacts associated with the proposed projects, in a cumulative impacts section. The preferred alternative shall be identified and analyzed in the EIS, and FDA’s decision shall be announced and documented in the EIS ROD.

As part of the analysis for the EIS, the Contractor shall work with FDA to identify any actions that could be taken to mitigate, reduce, avoid, eliminate, or compensate for the environmental impacts of the proposed action or an alternative. If the analyses indicate the potential for such action, the Contractor shall identify the action for the COR to consider incorporating into the proposed action or alternatives.

2. Revised Preliminary Draft

The Contractor shall prepare a revised preliminary draft EIS that includes corrections, revisions, additions, and deletions based on comments received from FDA on the first preliminary draft EIS. The Contractor shall compile, track, answer and resolve internal review comments on this revised preliminary draft EIS, including validation reviews. The Contractor shall provide an electronic copy of the revised preliminary draft EIS for distribution within FDA.

3. Concurrence Draft

FDA shall be responsible for obtaining concurrence from applicable regulatory agencies associated with the provisions of the final order (e.g., Environmental Protection Agency, National Oceanic and Atmospheric Administration, Fish and Wildlife Services). FDA shall post the draft EIS in the designated docket along with reference documents or links to the reference documents.

If necessary, the Contractor shall prepare a concurrence version of the draft EIS that includes corrections, revisions, additions, and deletions based on the comments received on the revised preliminary draft EIS.

4. Draft EIS Including Public Comment

The Contractor shall provide support to FDA if it decides to seek public comment or hold a public meeting to discuss this EIS. The anticipated level of meeting support from the Contractor includes, but is not necessarily limited to:

• Establishing the meeting location and facility (including making facility reservations) and providing publicity, setup, registration, security, handout copying and distribution. Contractor will also provide a webcast of the public meeting and other audio visual and computer support as required. The Contractor shall also assist in preparing written instructions for all key hearing personnel, including opening and closing statements, assist with preparing presentation materials; and provide takedown support for the meeting.

• Developing, reviewing, finalizing and distributing meeting fact sheets, mailings, and advertisements.

• If FDA determines public comments should be requested, the Contractor shall categorize and collate comments received. The Contractor shall assist FDA in developing draft responses to all comments for incorporation into a Comment Response Document as part of the final EIS and shall identify and prepare necessary revisions to the draft EIS, or conduct further analyses based on those comments, as necessary.

5. Final EIS

The Contractor shall prepare a final EIS by drafting an initial preliminary final EIS, including supporting appendices, and providing an opportunity for FDA to comment on the documents, and then preparing the final EIS. Such documents shall include corrections, revisions, additions, and deletions based on comments received on the initial preliminary final EIS documents. The

COR shall provide a distribution list, and the Contractor shall distribute an electronic copy of these documents for purposes of FDA review.

A. Initial preliminary final EIS and final EIS

The Contractor shall prepare an initial preliminary final EIS that includes corrections, revisions, additions, and deletions based on comments received on the revised preliminary draft EIS and public comment. The COR shall provide a distribution list, and the Contractor shall distribute an electronic copy of the initial preliminary final EIS for purposes of FDA review. The Contractor shall also provide support to FDA to solicit and address internal review comments on this document. The Contractor shall compile, track, answer and resolve review comments on the initial preliminary final EIS, including validation reviews, and incorporate such changes into the EIS. The Contractor shall provide an electronic copy of the final EIS for distribution within

FDA.

The Contractor shall be responsible for preparing an FDA-approved final EIS, along with links to underlying reference documents. FDA will post the final EIS in the docket, along with reference documents, or links for reference documents, and FDA may post the final EIS on its FDA.gov website. As appropriate, interested parties and stakeholders should be notified when the posting becomes available. If requested, the Contractor shall provide and assist FDA in the distribution of the final EIS. The COR shall provide a distribution list in addition to approving the Contractor-provided distribution list for dissemination of the link to the final EIS.

B. Record of Decision

NEPA requires that if an EIS is completed, that FDA prepare a ROD that states the decision, identifies and discusses alternatives considered by the agency, states whether all practical means to avoid or minimize environmental harm have been adopted, and, if not, why not, and summarizes the program for monitoring and enforcing the practical means adopted to avoid or minimize the environmental harm. (21 CFR 25.43).

3.4.6 Task 3 Project Files and Administrative Record (Clin 1)

The Contractor shall compile project files and the administrative record (AR) file for the EA on ZnO and TiO2 or if appropriate, an EIS for ZnO and TiO2 in electronic format following completion of the final EA or EIS. The Contractor shall deliver the completed project and AR files to the location designated by the COR within one (1) month from the publication date of the FDA EA for ZnO and TiO2, or, if appropriate, the EIS for ZnO and TiO2.

3.5 Deliverables Schedule

Table 1 summarizes the duration/timeframes and deliverables that the Contractor shall submit to the COR, in accordance with the identified tasks. The table also summarizes the associated FDA actions and response times.

Table 1 Summary of Deliverables

Task Deliverable

Weeks After Contract

Award/Option Exercise

Contractor revise and finalize draft EA

Contractor and FDA meet for kick-off Day 1 Contractor revise draft EA 4 weeks

FDA review and comment +4 weeks (at wk8)

Contractor finalize EA, appendices at wk10

FDA coordinate publication EA and FONSI with final sunscreen order at wk12

Optional Task: EIS

Contractor provide Initial Preliminary Draft EIS and FDA post Notice of Intent*

6 weeks

FDA review and comment 4 weeks Contractor provide Revised Preliminary Draft EIS and responses to comments on Initial Preliminary Draft EIS

4 weeks

Contractor draft summary of public comments and responses to public comments, if necessary

2 weeks

Contractor prepare Initial Preliminary Final EIS 4 weeks FDA review and comment 4 weeks Contractor prepare Revised Preliminary Final EIS and responses to comments on Initial Preliminary Final EIS

2 weeks

FDA final review and comments 2 weeks Contractor provide Final EIS 2 weeks

FDA coordinate publication of EIS and ROD with final sunscreen order

2 weeks

Administrative Record

Create AR file share site (clin1) at wk2 Monthly updated AR index (Collection, Compilation, Organization of Records, AR Reviews)

Monthly

Final AR (electronic copy in pdf and Word, Final Records Creation) at wk52

*Task 2 depends on implementation of an option in section 3.2, Objectives.

3.6 Period of Performance

The period of performance of this contract shall consist of base and option periods as follows:

Base Period of Performance: one (1) year following award of contract (to be specified on award of contract). September 1, 2026, to August 31, 2027

3.7 Place of Performance

The place of performance for this requirement is the Contractor’s site.

DELIVERY LOCATION:

White Oak Campus; Building 1 The US Food and Drug Administration Attn: Shila Ndeh 10903 New Hampshire Avenue Silver Spring, MD 20993

Unless otherwise specified, deliveries shall be made to the Delivery Point specified above, Monday through Friday (excluding Federal Holidays, see OPM List of Federal Holidays) between the hours of 8:30 a.m. and 5:30 p.m. EASTERN TIME only.

Supplies or services scheduled for delivery on a Federal holiday shall be made on the next business day.

3.8 Government Furnished Property

No government furnished property.

3.9 Special Considerations

If necessary, FDA will be responsible for obtaining concurrence from applicable regulatory agencies associated with NEPA (e.g., Environmental Protection Agency, National Oceanic and Atmospheric Administration, Fish and Wildlife Services).

The EA, or, if appropriate, the EIS will describe the purpose and need for agency action, the proposed action, the No Action and other reasonable NEPA alternatives, and analyze the potential environmental impacts associated with the proposed sunscreen OTC monograph order, and any reasonably foreseeable past, present, and future actions. The preferred alternative will be identified and analyzed in the EA or if appropriate in the EIS, and FDA’s decision will be announced and documented in the FONSI or ROD, as appropriate.

3.10 Alternatives

A No Action Alternative in this EA or EIS will be analyzed to serve as a basis for comparison with the action alternatives. For the purpose of this analysis, FDA assumes at least two (2) reasonable NEPA action alternatives will be provided.

https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/#url=2020 https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/#url=2020

Alternative provisions will be discussed and evaluated in the EA or EIS, along with the No Action Alternative. Potentially, the analysis will be revised by FDA and provided again to the Contractor. It is the Contractor’s responsibility to use the existing, available data and information that they gather and are provided to conduct an adequate analysis of the alternatives to the Agency’s action and the environmental impacts associated with that action.

3.11 Packing, Marking and Shipping

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and contractor name.

The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

The Contractor shall scan all electronic deliverables for viruses before submitting to the FDA.

3.12 Key Personnel

The individuals listed below are identified as Key Personnel and are subject to the terms of HHSAR 352.237-75.

List of Key Personnel Title Refer to IGCE for Proposed Rates Program Director Project Manager Social Scientist II Scientist II Scientist I Technical Writer Administrative Support

The Contractor shall ensure that all personnel are adequately trained, possess the requisite experience, and are otherwise fully qualified to provide the high level of support required by this Statement of Work prior to being assigned to this task order. If any personnel are found to not be able to perform the tasks listed in the Statement of Work, Contract Specialist shall reserve the ability, at any time, to ask the Contractor to find adequate replacements within a reasonable timeframe.

3.13 Monthly Progress Reports

The Contractor shall submit progress reports to the COR and Contract Specialist. These reports shall be prepared monthly and submitted by the 15th of the month following the reporting period.

Each progress report shall contain concise statements covering the activities relevant to the contract, including:

(a) A clear account of the work performed under each task during the report period.

(b) An outline of the work to be accomplished during the next report period.

(c) A description of any problem encountered or anticipated that will affect the completion of any work within the time and fiscal constraints set, together with recommended solutions to such problems; or a statement that no problems were encountered.

(d) A chart showing current and cumulative expenditures versus planned expenditures.

The monthly progress reports shall be delivered via email to the Contract Specialist (CS) and the Contracting Officer’s Representative (COR) at the following email addresses:

COR: Shila.Ndeh@fda.hhs.gov CS: howard.yablon@fda.hhs.gov

3.14 Organizational Conflicts of Interest

The Contractor warrants that, to the best of its knowledge and belief, and except as otherwise disclosed to the Contracting Officer, he or she does not have any actual or potential conflict of interests pertaining to the subject contract, as defined in Federal Acquisition Regulation (FAR) Subpart 9.5.

The Contractor agrees that, if after award he or she discovers an organizational conflict of interest with respect to this contract, he or she shall make an immediate and full disclosure in writing to the Contracting Officer.

The Government reserves the right to exercise any remedy available at law or equity, including termination of the contract for cause or convenience, should the Government determine that remedial action is necessary to address any identified actual or potential conflicts of interests.

3.15 Contractor Performance Requirements

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) to execute annual and final Contractor performance evaluations. CPARS is a secure Internet website located at http://www.cpars.gov/. 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.

http://www.cpars.gov/

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contact will receive an email instructing them to logon to CPARS to review the performance evaluation.

The Contractor has 15 days from the date of performance evaluation issuance in which to review the evaluation. If the Contractor agrees with the performance evaluation outcome, the evaluation becomes final. Should the Contractor disagree with the performance evaluation outcome, rebuttal comments must be submitted via the CPARS within 15 days from date the evaluation was issued by 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.

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.

3.16 Confidentiality

It is not the intent of FDA to provide Contractor with confidential commercial or financial information during the implementation of this contract; however, if such information is delivered to Contractor, Contractor agrees to maintain such information confidentially. Contractor agrees to maintain all materials, including but not limited to, documents, notes, records of meetings, etc., confidentially, and agrees to prevent such disclosure of information to the public.

Specifically, the Contractor agrees to maintain confidentially any trade secret information or business confidential commercial or financial information, considered to be privileged or confidential, it may receive during execution and through completion of this contract. All such information shall be maintained in a manner that allows FDA to comply with applicable laws and regulations concerning confidential business information and concerning the protection of personal files subject to confidential treatment under the Privacy Act.

With respect to the need for the Contractor to provide information to the public or to the public dockets established for purposes of this NEPA review, Contractor shall maintain all draft documents confidentially, until FDA agrees in writing that such document is ready for public dissemination, display or availability.

Contractors shall require employees working on this contract to commit to protect FDA information that is non-public and shall sign Form FDA 3398, including Addendum to Form 3398 Non-Disclosure Agreement for this contract acknowledging their commitment to maintaining the confidentiality of this information. Signed documentation shall be sent to the COR and Contract Specialist.

3.18 352.227-70 Publications and Publicity. (December 18, 2015)

(a) Unless otherwise specified in this contract, the Contractor may publish the results of its work under this contract, provided that such publication is consistent with the terms of the http://www.cpars.gov/allapps/cpcbtdlf.htm

Non-disclosure Agreement described in paragraph 3.16. The Contractor shall promptly send a copy of each article submitted for publication to the Contracting Officer’s Representative.

The Contractor shall also inform the Contracting Officer’s Representative when the article or other publication is published and furnish a copy of it as finally published.

(b) Unless authorized in writing by the Contracting Officer, the Contractor shall not display the HHS logo including Operating Division or Staff Division logos on any publications.

(c) The Contractor shall not reference the product(s) or service(s) awarded under this contract in commercial advertising, as defined in FAR 31.205-1, in any manner which states or implies HHS approval or endorsement of the product(s) or service(s) provided.

(d) The contractor shall include this clause, including this section (d) in all subcontracts where the subcontractor may propose publishing the results of its work under the subcontract.

3.19 508 Requirements

§ 1194.22 Web-based intranet and internet information and applications.

(a) A text equivalent for every non-text element shall be provided (e.g., via “alt”, “longdesc”, or in element content).

(b) Equivalent alternatives for any multimedia presentation shall be synchronized with the presentation.

(c) Web pages shall be designed so that all information conveyed with color is also available without color, for example from context or markup.

(d) Documents shall be organized so they are readable without requiring an associated style sheet.

(e) Redundant text links shall be provided for each active region of a server-side image map.

(f) Client-side image maps shall be provided instead of server-side image maps except where the regions cannot be defined with an available geometric shape.

(g) Row and column headers shall be identified for data tables.

(h) Markup shall be used to associate data cells and header cells for data tables that have two or more logical levels of row or column headers.

(i) Frames shall be titled with text that facilitates frame identification and navigation.

(j) Pages shall be designed to avoid causing the screen to flicker with a frequency greater than 2 Hz and lower than 55 Hz.

(k) A text-only page, with equivalent information or functionality, shall be provided to make a web site comply with the provisions of this part, when compliance cannot be accomplished in any other way. The content of the text-only page shall be updated whenever the primary page changes.

(l) When pages utilize scripting languages to display content, or to create interface elements, the information provided by the script shall be identified with functional text that can be read by assistive technology.

(m) When a web page requires that an applet, plug-in or other application be present on the client system to interpret page content, the page must provide a link to a plug-in or applet that complies with §1194.21(a) through (l).

(n) When electronic forms are designed to be completed on-line, the form shall allow people using assistive technology to access the information, field elements, and functionality required for completion and submission of the form, including all directions and cues.

(o) A method shall be provided that permits users to skip repetitive navigation links.

(p) When a timed response is required, the user shall be alerted and given sufficient time to indicate more time is required.

Note to §1194.22: 1. The Board interprets paragraphs (a) through (k) of this section as consistent with the following priority 1 Checkpoints of the Web Content Accessibility Guidelines 1.0 (WCAG 1.0) (May 5, 1999) published by the Web Accessibility Initiative of the World Wide Web Consortium:

Section 1194.22 Paragraph WCAG 1.0 Checkpoint

(a) 1.1

(b) 1.4

(c) 2.1

(d) 6.1

(e) 1.2

(f) 9.1

(g) 5.1

Section 1194.22 Paragraph WCAG 1.0 Checkpoint

(h) 5.2

(i) 12.1

(j) 7.1

(k) 11.4

2. Paragraphs (l), (m), (n), (o), and (p) of this section are different from WCAG 1.0. Web pages that conform to WCAG 1.0, level A (i.e., all priority 1 checkpoints) must also meet paragraphs (l), (m), (n), (o), and (p) of this section to comply with this section. WCAG 1.0 is available at http://www.w3.org/TR/1999/WAI-WEBCONTENT-19990505.

PART 4: INSPECTION AND ACCEPTANCE

The COR will perform inspection and acceptance of services and required reporting to be provided.

1. Inspection and acceptance will be performed at: the delivery location identified in section

3.7.

Acceptance is communicated in writing unless otherwise indicated in writing by the Contracting Officer or COR within 30 days of receipt.

2. Satisfactory performance of this contract shall be deemed to occur upon acceptance of all services and required reporting noted in the Statement of Work.

PART 5: CONTRACT ADMINISTRATION DATA

5.1 Contract Specialist

The contact information for the Contracting Specialist is:

Department of Health and Human Services Food & Drug Administration, OAGS Attn: Howard S. Yablon http://www.w3.org/TR/1999/WAI-WEBCONTENT-19990505

11601 Landsdown Street , 13th Floor North Bethesda, MD howard.yablon@fda.hhs.gov Phone: (240)-402-7630

5.2 Contracting Officer

The contact information for the Contracting Officer is:

Department of Health and Human Services Food & Drug Administration, OAGS Attn: Howard S. Yablon 11601 Landsdown Street, 13th Floor North Bethesda, MD howard.yablon@fda.hhs.gov Phone: (240) - 402-7630

5.3 Contracting Officer Representative (COR)

The following COR(s) will represent the Government for the purpose of this order:

Shila Ndeh (301 796- 8347 Shila.Ndeh@fda.hhs.gov

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Government may unilaterally change its COR designation.

5.4 Invoice Submission

352.232-71 Electronic Submission of Payment Requests As prescribed in HHSAR 332.7002, insert the following clause:

ELECTRONIC SUBMISSION OF PAYMENT REQUESTS [(APR 2026) (RFO

DEVIATION)]

(a) Definitions. As used in this clause – Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable payment clause included in this contract.

(b) [Submission instructions.] Except as provided in paragraph (c) of this clause, the Contractor must submit payment requests electronically using the Department of Treasury mailto:howard.yablon@fda.hhs.gov mailto:howard.yablon@fda.hhs.gov mailto:Shila.Ndeh@fda.hhs.gov

Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) [Alternate submission procedures.] The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) [Submission of alternate payment procedures authorization.] If alternate payment procedures are authorized, the Contractor must include a copy of the Contracting Officer's written authorization with each payment request.

(End of clause)

FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022) a.All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury's Invoice Processing Platform System (IPP).

http://www.ipp.gov/vendors/index.htm b.Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is:

https://www.ipp.gov c.

1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4. If your company is already registered to use IPP, you will not be required to re-register.

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

• Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

• Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)-show rate, base and total amount;

• Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

• Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

• Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

• Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

• Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted (2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order (c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827- ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

52.222-90 Addressing DEI Discrimination by Federal Contractors.

ADDRESSING DEI DISCRIMINATION BY FEDERAL CONTRACTORS (APRIL 2026)

(a) Definitions. As used in this clause—

Program participation means membership or participation in, or access or admission to: training, mentoring, or leadership development programs; educational opportunities; clubs;

associations; or similar opportunities that are sponsored or established by the contractor or subcontractor.

Racially discriminatory diversity, equity, and inclusion (DEI) activities means disparate treatment based on race or ethnicity in the recruitment, employment (e.g., hiring, promotions), contracting (e.g., vendor agreements), program participation, or allocation or deployment of an entity's resources.

(b) In connection with the performance of work under this contract, the Contractor agrees as follows:

(1) The Contractor will not engage in any racially discriminatory DEI activities;

(2) The Contractor will furnish all information and reports, including providing access to books, records, and accounts, as required by the Contracting Officer, for purposes of ascertaining compliance with this clause;

(3) In the event of the Contractor's or a subcontractor's noncompliance with this clause, this contract may be canceled, terminated, or suspended in whole or in part, and the Contractor or subcontractor may be declared ineligible for further Government contracts;

(4) The Contractor will report any subcontractor's known or reasonably knowable conduct that may violate this clause to the Contracting Officer and take any appropriate remedial actions directed by the Contracting Officer; and

(5) The Contractor will inform the Contracting Officer if a subcontractor sues the Contractor and the suit puts at issue, in any way, the validity of this clause.

(6) The Contractor recognizes that compliance with the requirements of this clause are material to the Government's payment decisions for purposes of 31 U.S.C. 3729(b)(4).

(c) The Contractor must include the substance of this clause, including this paragraph (c), in subcontracts at any tier, including those for commercial products and commercial services, except those where the place of delivery or performance is outside the United States.

(End of clause)

PART 6 – FAR CLAUSES

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 shall make their full text available. Also, the full text of a clause may be accessed electronically at:

www.acquisition.gov/far/index.html

52.227-14 RIGHTS IN DATA-GENERAL (MAY 2014)

http://www.acquisition.gov/far/index.html