36C24E26R0007 0002.docx

5. PROJECT NUMBER (if applicable)

CODE

7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

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:

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

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ 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 ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

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.

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

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

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.

15A. NAME AND TITLE OF SIGNER

16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

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

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer) 240E None 00240E Veterans Health Administration Regional Procurement Office East Building 32 Suite 1A1111 1010 Delafield Road Pittsburgh

PA

15215-1802 00240E Veterans Health Administration Regional Procurement Office East Building 32 Suite 1A1111 1010 Delafield Road Pittsburgh

PA

15215-1802 To all Offerors/Bidders

36C24E26R0007

X X X ** HOUR & DATE for Receipt of Offers is EXTENDED to: 06-11-2026 10:00 am EDT X The purpose of this amendment is to provide answers to offeror questions and add other information.

The proposal due date has been extended until June 11, 2026.

Michael D. Haydo Contracting Officer

PCOE14L3-67579

Post Answers to Offeror Questions, add information to the solicitation and extend the proposal due date to 6/11/2026.

Answers to Offeror Questions.

Responses in Bold Type.

The correct solicitation # is 36C24E26R0007

Corrected Attachment 2 to Central IRB Support Services and attached to amendment P00001.

Incorrect attachment uploaded. Correct Attachment 1 added to amendment P00001.

The space between the heading Section B and B.1 should be blank. Consider N/A removed from that area. No other information will be added to the area. Invoice submission is outlined in section C.11.

The base contract will have no funding nor associated unit amounts. Task orders will be awarded from the price list with line items based on VA needs at the time of each award.

Level of effort not required.

IRB Coordinator duties are equal to the IRB Manager.

ORPP&E reorganized into EPROS to account the Research Enterprise Transformation. The scope difference is narrower due to the change in the Research organization from 2021 to 2026.

The contractor is expected to use VAIRRS/IRBNet and/or any successor software and will have access provided by the government as well as training in detailed workflow instructions.

Frequency is expected to be the same, attendance only for meetings with an item on the agenda.

Total of 20 per year.

(a) “Transition in/Transition out” activities will no be funded separately. (b) Minimal coordination from both government and incumbent. (c) Depends on award and performance start date of the new contract. The estimate is a minimum of 30 days.

VAAR Clause 852.237-75 is hereby added to this solicitation and will be included in the contract award.

Telework is the primary work mode for all contract staff.

Travel is not anticipated, but possible. Travel pricing information added to price list.

GFE will be provided, one laptop per contractor. Onboarding timeline varies by location, contractor timeliness of completion documents, etc. Three weeks is normal. Issues beyond either sides’ control should be able to be address mutually.

TIER 1 NACI Background Investigation is the requirement.

No contractor side C&A package, FISMA SSP or PIA is a required deliverable.

Key personnel resumes may be submitted as appendices and will not count against the page limitations.

Only the proposing company’s name shall be redacted in all forms including resumes. Other employer info on resumes is fine. Any format is acceptable, if the vendor name and any other company identifying information is not visible.

(a) No, only those surveys received before the solicitation closing date/time. (b) Offerors may submit other past performance information in the appropriate volume, but the surveys are separate.

Any relevant past performance within any point over the last five years. Active or complete.

Any IRB experience the offeror feels may be relevant to the solicitation specifications may be used. The correlation between other than federally-operated may be pointed out in the offer. Key personnel experience is a specific area under Evaluation Factor 2.

Volumes I, II, and III when combined are significantly less important than price.

The adjectival ratings will not be published with the solicitation. The government’s strategy is internal and used for evaluation purposes.

(a) 25 MB is the maximum email/attachment size accepted by the VA gateway. Multiple emails is the only current option. It is suggested that the first email in the string outline the information to be sent in subsequent emails. (b) Yes, the government will provide email acknowledgement.

FAR 52.217-9 is used to exercise regular option periods (i.e. Base period, option period 1, etc.) and will not be part of the awarded contract. FAR 52.217-8 is used as a short-term extension, typically for up to six months to allow time for a new contract award and will be in the final contract.

Section E.9 is hereby changed to “Options. The base contract ordering period is expected to be five (5) year with only option information as outlined in FAR 52.217-8.”

(a) Offerors should propose escalated hourly rates across all years.

The SOW states that contract services will primarily occur at the contractor’s facilities. The Wage Determination for the VA requesting office is hereby added to the solicitation by attachment but will be updated on award based on the selected contractor’s location.

VA requesting office address: 1800 G NW Street, Washington, DC, 20006.

Yes, with the limitations stated in 852.219-75 (a)(i).

Contract support is only for Panels 1 and 2 at this time. Numbers provided are only for panels 1 and 2. Current contractor headcount is 6 IRB Coordinator/Managers, and 1 Program Manager, managing approximately 45% of total packages.

Examples of prior periods:

FY24

New Study submissions

18 PI

99 LSI

1086 Amendments 1234 Continuing review 342 Reportable Events 51 Convened meetings

FY25

30 PI

122 LSI

1098 Amendments 1117 Continuing review 257 Reportable Events 50 Convened meetings

SOP, rosters, assignments and tracking aids will be provided by the government to the awardee for use during the contract period.

(a) The expected turnaround time is three (3) days or less from request. (b) Only one offeror code is required for the prime.

Is this the correct PPQ for this opportunity? If not, please provide the correct form.

Corrected form attached to amendment P00001.

Current processes only rely on occasional contractor support of the toll-free line. Approximately 6 calls a month are logged. Historically, contractors have logged approximately between 3 to 6 in the past 4 years.

Staggered 8 hour days, the specific schedule will be worked out to between contract staff and VA Administrators.

There may be considerable variation in complexity and scope and it would be impossible to predict how many of which would need to be reviewed in any one year.

Front matter sections like cover, cover letter, TOC, acronyms, and appendices are commonly excluded from the Technical Proposal page count. Was this meant to say excluding cover pages, etc. or are these sections indeed included in the overall 50-page limit for Volume II?

See attached document: WD 15-4281.