75N96025R00002 Amendment 0001.pdf

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 items 8 and 15, and returning or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT 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.

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

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

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

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended. is not extended.

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.

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

NUMBER IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

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

15C. DATE SIGNED

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

16C. DATE SIGNED

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

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

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

Previous edition unusable

NIEHS-OA

See Block 14 continuation on next page.

National Institutes of Health National Institute of Environmental Health Sciences Office of Acquisition 530 Davis Drive Durham, NC 27713

75N96025R0002

1 4

12/04/2024

11/21/2024

SF30, Block 14 Continuation Page

Amendment 0001:

The purpose of this amendment is to:

1) Reflect the following changes to the RFP (see Attachment “Amend 0001 - 75N96025R00002 QA Services RFP”):

a) Update Page 1 of the RFP for the offeror proposal due time and page number changes.

b) Remove text from Article B.3.

c) Update Article L.5 FAR Provision 52.204-7.

2) Respond and make edits related to questions received in response to the solicitation (included on next page).

All other terms and conditions remain the same.

Note: red font indicates additions, red strikethrough indicates deletions.

Attachments:

- Amend 0001 - 75N96025R00002 QA Services RFP

- Amend 0001 – Att2_Statement of Work

Responses to Pre-Proposal Inquiries:

RFP

Page #

Section Paragraph Question Response

ARTICLE L.3; II

FORMATTING

AND PAGE

LIMITATIONS;

Paragraph A.

Formatting for proposals

May offerors use 10-point font for tables and graphics in the Technical Proposal?

Yes.

L.4.A.1 Mandatory Criteria

e. Conformance to Section 508 Standards

The Mandatory Criteria for the Business Proposal states that “Organizations submitting proposals will be required to demonstrate compliance with the established EIT accessibility standards by preparing an HHS Section 508 Product Assessment Template….or HHS Conformance Checklist.”

To clarify, are offerors required to submit a 508 Product Assessment Template or HHS Conformance Checklist on the PDF of Business Proposal? If so, how are offerors to address the RFP attachments and forms required for the Business Proposal (listed below), which are not 508 compliant?

• Standard Form 33 (SF-33), and potentially solicitation amendment(s) (SF-30s)

• Attachment 3: Proposal Summary and Data Record NIH Form 2043

• Attachment 5: Section K - Representations, Certifications, and Other Statements

• Attachment 6: Summary of Related Activities

• Attachment 13: Disclosure of Lobbying Activities

• Attachment 15: Financial Report of Individual Project/Contract NIH Form 2706

See Attachment “Amend 0001 - 75N96025R00002 QA Services RFP” for changes relating to the 508 requirements at the following locations:

- Article C.2.b.3 is edited.

- HHSAR 352.239-78 Note after provision is removed.

- Section J, Attachment 4 removed.

- Section L.4.A.1.e removed.

- Article M.2 Conformance to Section 508 Standards is removed.

See Attachment "Amend 0001 - Att2_Statement of Work" - Section

1.6.4 HHS Section 508 and

Accessibility Standards has been deleted.

L.4.B.2 Technical Factors

(1) Factor 1 Experience

No page limitations were provided for Factor

1. However, Attachment 8 – Experience Form is two pages. Are offerors limited to 2 pages for each relevant contract (for a maximum total of 6 pages if submitting three contract examples)?

Factor 1 has no page limitations. The Experience Form can be expanded as needed.

61, 64

L.4.B.2 - (2) Factor 2, Program and Project Management

1. Management Plan and Approach, paragraph b.

A functional organization chart is requested for Factor 2 (p. 61) and Factor 3 (3.

Organizational Details, paragraph a. (p. 64)).

Please clarify if the organization chart should be provided in both sections.

See Attachment “Amend 0001 - 75N96025R00002 QA Services RFP” - Section L.4.B.2.(2)(i)1.b has been removed.

L.4.B.2 - (2) Factor 2, Program and Project Management

g. Summary of Corporate experience

g. Summary of Corporate experience asks offerors to summarize their experience “in the conduct and management of programs and projects of similar size, scope, and complexity.” Could the government clarify if this is the same information as requested for

(1) Factor 1 Experience (p. 61)?

See Attachment “Amend 0001 - 75N96025R00002 QA Services RFP” - Section L.4.B.2.(2)(i)1.g has been removed.

RFP

Page #

Section Paragraph Question Response

63, 64

L.4.B.2 - (2) Factor 2, Program and Project Management

1. Management Plan and Approach, paragraph i.

Both Factor 2 (p. 63) and Factor 3 (3.1.b (p.64)) ask that we “Include an approach to avoid real and perceived conflicts of interest for all staff, including subcontract(or)s/consultants”. Please clarify if this topic should be addressed in both sections.

See Attachment “Amend 0001 - 75N96025R00002 QA Services RFP” - Section L.4.B.2.(3)(i)1.b has been edited.

L.4.B.2 – (5) Factor 5, Environment – Facilities, Equipment, and Security

2. Equipment and Physical Resources, Policies, Procedures, and IT Processes, paragraph c.

Paragraph c. states that offerors “Provide a draft IT Security Plan for ensuring integrity and security of information” for the Technical Proposal. However, SOW Section 1.6.3 - IT Security Plan and Other IT Deliverables (SOW

p. 5) states than an IT Security Plan is “Not applicable to this contract because the contractor will use NIEHS resources.”

Please clarify if an IT Security Plan is required for the Technical Proposal.

See Attachment “Amend 0001 - 75N96025R00002 QA Services RFP” - Section L.4.B.2.(5)(i)2.c has been removed.

L.4.A. Business Proposal;

L.4.A.1 Mandatory Criteria

o. HHS

SECURITY AND

PRIVACY

LANGUGAGE

FOR

INFORMATION

AND IT

PROCUREMENTS

If a Draft IT Security Plan is required for the Technical Proposal, could the Government clarify what information is requested for Section o. HHS SECURITY AND PRIVACY

LANGUGAGE FOR INFORMATION AND

IT PROCUREMENTS of the Business Proposal? Is there any information requested for this Section that won’t be covered in a Draft IT Security Plan?

See Attachment “Amend 0001 - 75N96025R00002 QA Services RFP” Section L.4.A.1.o for edit/clarification.

1 Attachment 7

RO1: Toxicology Study Conducted by a Contract Research Organization

In the Sample Research Outlines (Attachment

7) for RO1 - Chronic Study for Audit of Pathology Tables, body weights and clinical observations are listed as study endpoints, but these are not relevant for a pathology table audit. Please clarify why they are listed.

Requirements remain as stated in the solicitation. Information is provided in the RO guidelines as an overview for study designs.