AMEND_5_-_1-19-23_0005.pdf

OMB No.: 0990-0115

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

PAGE

OF PAGES

2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

1/19/2023

4. REQUISITION/PURCHASE

REQ. NO.

5. PROJECT NO. (if applicable)

6. ISSUED BY CODE

7. ADMINISTERED BY (If other than Item 5) CODE

National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development Contracts Management Branch 6710B Rockledge Drive

BETHESDA MD 20892

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

TO ALL POTENTIAL OFFERORS

9A. AMENDMENT OF SOLICITATION

NO.

RFP 75N94022R00003

X

9B. DATED (SEE ITEM 11)

12/12/2022

10A. MODIFICATION OF

CONTRACT/ORDER NO.

CODE

FACILITY CODE

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

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

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 __1___ copy of the amendment in your business proposal; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram 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 telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (if required)

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

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

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO FAR 52.243-2. THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

ORDER NO. IN ITEM 10A.

B.THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b) and Contract ARTICLE B.4.

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

D.OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor __ is not, X is required to sign this document and return 1 copy in your business proposal to the issuing office.

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

PURPOSE: To amend RFP 75N94022R00003, entitled, “International and Domestic Pediatric and Maternal HIV and Other High Priority Infectious Diseases Data Coordinating Center.” This amendment also answers questions received regarding the

RFP.

DUE DATE: February 22, 2023, 4:00 PM Local Time (Eastern Standard Time (EST) (Unchanged).

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 (Type or print)

16A. NAME AND TITLE OF CONTRACTING OFFICER

Elizabeth Osinski NICHD Contracts Management Branch, NIH

15B. CONTRACTOR/OFFEROR

BY ______________________________________________

(Signature of person authorized to sign)

15C. DATE SIGNED

16B. UNITED STATES OF AMERICA

BY ________________________________________

(Signature of Contracting Officer)

16C.DATE

SIGNED

RFP-NIH-NICHD-75N94022R00003

AMENDMENT NO.: 005 CONTINUATION PAGE Page 2 of 7

A. As a result of this amendment, RFP No. 75N94022R00003, is revised as follows:

1. Add the following to Attachment 9. Offerors shall only provide letters of commitment for the seven NICHD clinical sites only. The contact information of the Business and Technical Representatives are listed below and in the Revised Attachment 8 in Amendment 2. Only seven sites will be participating in the Protocols 2024 (Task Order 3) and Protocol 2040 (Task Order 2).

These seven NICHD clinical sites are as follows:

IMPAACT 2040

(1) Jacobi Medical Center Bronx, CRS ID 5013, CITY Bronx, NY, USA andrew.wiznia@nychhc.org;

dwyerr1@nychhc.org

(2) University of Southern California LA CRS ID 5048 CITY Los Angeles, CA, USA akovacs@usc.edu;

ddavidov@usc.edu

(3) Johns Hopkins University, Baltimore CRS ID 5092, CITY Baltimore, MD, USA ageorg10@jhmi.edu Vpack1@jhmi.edu

IMPAACT 2024

(4) Chiangrai Prachanukroh Hospital, CRS ID 5116, CITY Chiang Rai, Thailand gonzague.jourdain@phpt.org nitima.chaiboonruang@phpt.org

(5) MU-JHU Care Limited CRS, CRS ID 5126, CITY Kampala, UGANDA cnakabiito@mujhu.org apdasal@mujhu.org

(6) Siriraj Hospital Mahidol University CRS CRS ID 5115, CITY Bangkok, Thailand kulkanya.cho@mahidol.ac.th watchareeped@gmail.com

(7) Kenya Medical Research Institute - Walter Reed Project Clinical Research Center CRS ID 5121,CITY Kericho, Kenya

Fredrick.sawe@usamru-k.org kdavis@hjf.org https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5013&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641335924%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=%2FO93GmPV5O9Iu9BPIn5D1A9eD3oiGLO6qhDimvu7Zic%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5013&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641492141%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=O3RdHpcIlOFLW8OJjFlJA5gfTWsTIYN%2Bphxb%2FgioQ%2F0%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5013&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641492141%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=O3RdHpcIlOFLW8OJjFlJA5gfTWsTIYN%2Bphxb%2FgioQ%2F0%3D&reserved=0 mailto:andrew.wiznia@nychhc.org mailto:dwyerr1@nychhc.org https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5048&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641492141%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=N86sWrO8suXyz0GDzdk8bc%2BJ5opfECktb2AujgOqsVM%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5048&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641492141%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=N86sWrO8suXyz0GDzdk8bc%2BJ5opfECktb2AujgOqsVM%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5048&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641492141%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=N86sWrO8suXyz0GDzdk8bc%2BJ5opfECktb2AujgOqsVM%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5048&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641492141%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=N86sWrO8suXyz0GDzdk8bc%2BJ5opfECktb2AujgOqsVM%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5048&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641492141%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=N86sWrO8suXyz0GDzdk8bc%2BJ5opfECktb2AujgOqsVM%3D&reserved=0 mailto:akovacs@usc.edu mailto:ddavidov@usc.edu https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5092&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641492141%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=8jbztftmIGL7gAOPTtCoezZQkSRmVO5c4lxwFh%2FS%2Fw0%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5092&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641492141%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=8jbztftmIGL7gAOPTtCoezZQkSRmVO5c4lxwFh%2FS%2Fw0%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5092&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641492141%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=8jbztftmIGL7gAOPTtCoezZQkSRmVO5c4lxwFh%2FS%2Fw0%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5092&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641648352%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=pT4SuJKu7PU6xnpzBLIpM3h2nMpiSItXzLHY0%2FmTqog%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5092&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641648352%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=pT4SuJKu7PU6xnpzBLIpM3h2nMpiSItXzLHY0%2FmTqog%3D&reserved=0 mailto:ageorg10@jhmi.edu mailto:Vpack1@jhmi.edu https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5116&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641648352%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=xAS%2FQKjofeUsMmEYDPX%2B06w7z%2BwvmF40ksR2IOjIAq0%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5116&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641648352%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=xAS%2FQKjofeUsMmEYDPX%2B06w7z%2BwvmF40ksR2IOjIAq0%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5116&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641648352%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=xAS%2FQKjofeUsMmEYDPX%2B06w7z%2BwvmF40ksR2IOjIAq0%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5116&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641648352%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=xAS%2FQKjofeUsMmEYDPX%2B06w7z%2BwvmF40ksR2IOjIAq0%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5116&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641648352%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=xAS%2FQKjofeUsMmEYDPX%2B06w7z%2BwvmF40ksR2IOjIAq0%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5116&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641648352%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=xAS%2FQKjofeUsMmEYDPX%2B06w7z%2BwvmF40ksR2IOjIAq0%3D&reserved=0 mailto:gonzague.jourdain@phpt.org mailto:nitima.chaiboonruang@phpt.org https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5126-0&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641648352%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=QYcmHgq1DEyI43GQoTB6G9%2F740lZkEz0YollRUU5spo%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5126-0&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641648352%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=QYcmHgq1DEyI43GQoTB6G9%2F740lZkEz0YollRUU5spo%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5126-0&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641648352%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=QYcmHgq1DEyI43GQoTB6G9%2F740lZkEz0YollRUU5spo%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5126-0&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641648352%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=QYcmHgq1DEyI43GQoTB6G9%2F740lZkEz0YollRUU5spo%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5126-0&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641648352%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=QYcmHgq1DEyI43GQoTB6G9%2F740lZkEz0YollRUU5spo%3D&reserved=0 mailto:cnakabiito@mujhu.org mailto:apdasal@mujhu.org https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5115&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641804579%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=lUj3xHcq0477IflaSlTw4AdfGT8C9RK%2BSvIBwrz7M5k%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5115&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641804579%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=lUj3xHcq0477IflaSlTw4AdfGT8C9RK%2BSvIBwrz7M5k%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5115&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641804579%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=lUj3xHcq0477IflaSlTw4AdfGT8C9RK%2BSvIBwrz7M5k%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5115&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641804579%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=lUj3xHcq0477IflaSlTw4AdfGT8C9RK%2BSvIBwrz7M5k%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5115&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641804579%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=lUj3xHcq0477IflaSlTw4AdfGT8C9RK%2BSvIBwrz7M5k%3D&reserved=0 mailto:kulkanya.cho@mahidol.ac.th mailto:watchareeped@gmail.com https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5121&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641804579%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=1%2BZmtZnuUTMRiey3g1pP3wR8gPBDQ%2FTfILzyY9t2V98%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5121&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641804579%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=1%2BZmtZnuUTMRiey3g1pP3wR8gPBDQ%2FTfILzyY9t2V98%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5121&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641804579%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=1%2BZmtZnuUTMRiey3g1pP3wR8gPBDQ%2FTfILzyY9t2V98%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5121&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641804579%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=1%2BZmtZnuUTMRiey3g1pP3wR8gPBDQ%2FTfILzyY9t2V98%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5121&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641804579%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=1%2BZmtZnuUTMRiey3g1pP3wR8gPBDQ%2FTfILzyY9t2V98%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.impaactnetwork.org%2Fabout%2Fsites%2F5121&data=05%7C01%7Cosinskie%40mail.nih.gov%7Ca3d8b2b22b9d4895e07908daf991fcaf%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638096702641804579%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=1%2BZmtZnuUTMRiey3g1pP3wR8gPBDQ%2FTfILzyY9t2V98%3D&reserved=0 mailto:Fredrick.sawe@usamru-k.org mailto:kdavis@hjf.org

AMENDMENT NO.: 005 CONTINUATION PAGE Page 3 of 7

2. Revised Attachment 9 in Amendment 2 dated 1-12-23, Travel Uniform Assumptions, is revised to correct the following administrative error for travel to the IMPAACT meeting. The cost for the 125 domestic investigators is estimated at $1,200 each and not $12,000 each for a total of $150,000.

3. Revised Attachment 9 - Additional Proposal Information and Instructions and Attachment 1, Packaging and Delivery of Proposals, the charts for the limitations on the Technical proposal are replaced with the following chart in order to exempt the Letters of Commitment obtained from subcontractors.

4. Organization of Technical Proposal and PAGE LIMITS:

Offerors are requested to write their Technical Proposal in four (4) parts:

TECHNICAL PROPOSAL BUSINESS PROPOSAL

The offeror must submit one (1) electronic PDF file for the Technical Proposal with the following sections included:

Offerors are requested to write their Technical Proposal in four

(4) parts:

First Part - shall address the IDIQ Contract Statement of Work and shall not exceed 30 single spaced pages. Parts 2 through 4 - (separate parts of the Technical Proposal) shall address Task Orders Nos. 1, 2, and 3 and shall not exceed 20 single spaced pages each. PROPOSAL PAGE LIMITS exclude resumes. Also excluded from the page limits are: Summary of Related Activities, Table of Contents, Proposal Cover Sheet, Technical Proposal Direct Cost Summary Sheet, Resumes, Bibliography/ References, Human Subjects Separate File, and Section 508 Template and Letters of Commitment from Subcontractors.

The Human Subjects Separate File in the Technical Proposal does not have a page limit. The Data Sharing Plan may be in Summary Form in the 30-page technical proposal and the Summary is not excluded from the page limits. If an offeror elects to provide a more expanded data sharing plan, the expanded plan can be an Appendix and is excluded from the page limits.

Pages that exceed the page limit requirements will not be read, evaluated, or considered for review. Issues that need to be addressed in Task Order 1, Task 2 and Task 3, which have already been detailed in Technical Proposal in response to the IDIQ Contract Statement of Work, should be referenced in the second, third, and fourth parts of your technical proposal rather than repeating passages.

The offeror must submit one (1) electronic PDF file for the Business Proposal* with the following sections included:

1. Task Order 1 – “Support Services for HIV Network Tasks”

2. Task Order 2 – IMPAACT Protocol – 2040

3. Task Order 3 – IMPAACT Protocol 2024

In addition, the Offerors must include the Excel Spreadsheet with the Breakdowns of the Proposed Estimated Costs.

*It should be noted that the IDIQ does not require a business proposal.

There are no page limits in the Business Proposal. Past Performance is included in the Business Proposal.

AMENDMENT NO.: 005 CONTINUATION PAGE Page 4 of 7

B. This Amendment provides answers to questions received regarding this RFP. Please note that individual questions may have been combined or reworded. The responses are provided for information only as guidance to potential offerors and do not supersede any terms of the RFP, and do not revise or become part of this RFP.

Solicitation Section Reference Question Attachment 4; Task Order 1 Statement of Work;

III. Technical Requirement #7.c-e (page 4 of Attachment 4):

Requirements 7.c., 7.d., and 7.e., specific the following:

c. Provide for timely and accurate data collection, data entry, data quality assurance, retrieval of source documentation, and generation of data and safety monitoring reports.

d. Provide training for staff of subcontracted NICHD clinical and laboratory centers in data management procedures.

e. Provide for data input, editing, electronic data storage, database management, data retrieval, and statistical analysis using well-documented database management and statistical computer software programs.

1. For Task Order 1, should the Contractor assume, we will provide the clinical data management/EDC system and associated costs for the 3 IMPAACT protocols in Year 1, 4 additional IMPAACT protocols in Year 2 (cumulative total of 7), and 4 additional IMPAACT protocols in Years 3-7 (cumulative total of 11)? Or alternatively, will Frontier Science provide the clinical data management/EDC system and the Contractor will need to work collaboratively with the IMPAACT SDMC (Harvard/Frontier) to securely transmit/transfer, integrate, analyze, and report on the clinical, safety, and lab data?

ANSWER: Frontier Science will provide the clinical data management/EDC system and the Contractor will need to work collaboratively with the IMPAACT SDMC (Harvard/Frontier) to securely transmit/transfer, integrate, analyze, and report on the clinical, safety, and lab data. The Offeror will not provide the clinical data management/EDC system.

Attachment 9 – B. Travel Uniform Assumptions

1. IMPAACT meeting 125 domestic investigators X $12,000 each = $150,000

2. Please confirm if the $12,000 per investigator should actually be $1,200 (125 X $1,200 = $150,000). If it is $1,200 per attendee, the estimated travel provided by the government cost looks low for a 3-day meeting. Please confirm.

ANSWER: This was an error. The correct amount is $1,200 per investigator X 125 or $150,000. This has been corrected in Section A above in this amendment. The Government is not changing the uniform assumption for this travel.

Task Order 1 - 3. Will the government provide facilities for the annual International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) meeting? Should offerors include the cost of meeting facilities in their proposal for the IMPAACT annual meetings?

AMENDMENT NO.: 005 CONTINUATION PAGE Page 5 of 7

Solicitation Section Reference Question ANSWER: No, the cost of the facility is provided through the IMPAACT network. It is not a part of the uniform assumption costs and should not be costed in your proposal.

Task Order 1 4. What is the location of the annual International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) meeting? Does it take place in the Washington D.C. metropolitan area each year?

ANSWER: YES, Washington, D.C.

RFP Page 136, Small Business Subcontracting Plan

5. Please clarify whether offerors need to submit a separate Small Business Subcontracting Plan for each task order if the estimated amount of each task order is over $750k? Is a single Small Business Subcontracting Plan under Task Order 1 sufficient to meet the requirement?

ANSWER: The Offeror only needs to submit one Small Business Subcontracting Plan based on the ceiling of the IDIQ. The offeror may use the three task orders, as typical task orders, to calculate the subcontracting percentages for the IDIQ goals.

Task Order 1 6. Can the government provide uniform subcontracting cost assumptions for clinical sites under Task Order 1? ANSWER: The Contractor can use the clinical site total subcontracting assumptions in Attachment 9 of Amendment 2 to this RFP.

Page 48, Independent Assessment 7. Will the government reimburse the contractor/subcontractor for the cost of independent, third-party system security and privacy controls validation?

ANSWER: Independent assessment is not needed. NICHD will conduct the independent assessment.

Page 5 of Amendment 4 states that offerors must contact the sites to request letters of commitment from the NICHD sites identified on the IMPAACT website and that the NICHD sites are identified on the IMPAACT website by CRS IDs in the “5xxx” format.

8. Have these sites been informed that they should expect outreach from all possible offerors requesting these letters of commitment?

ANSWER: The seven sites that will be participating in protocols 2040 and 2024 have been informed that offerors will be requesting letters of commitment. The offerors are only required to obtain letters of commitment from these seven clinical sites. This change is amended in the RFP in Section A above. These seven sites are named in the amended Section A.

AMENDMENT NO.: 005 CONTINUATION PAGE Page 6 of 7

Solicitation Section Reference Question

9. As we would expect that all offerors will need to disclose their legal name to the sites during this outreach, is there any concern that the sites will then be privy via the outreach to all possible offeror(s) they may eventually be subcontractor to prior to award?

ANSWER: The sites were informed that this is a competitive solicitation and were requested to maintain the confidentiality of the names of offerors requesting Letters of Commitment and to not disclose or discuss this information with any other parties.

10. Is the expectation that these letters of commitment would be included by each offeror as an appendix to the technical proposal and this does not affect page count?

ANSWER: Yes, these letters are exempted from the page limit. See amended Section A of this amendment.

11. If we do not receive the signed commitment letters from all sites by the proposal due date of 22Feb23 at 4 pm US Eastern Time, shall we provide these as they are received on a rolling basis?

ANSWER: No, we cannot accept any letters after the RFP due date. Offerors must submit the proposals and any documentation or revisions so as to reach the Government office electronically by the date and time specified in the solicitation.

12. Does NICHD need to review the template commitment letter before this is sent to the sites?

ANSWER: No, offerors should send their own template letter to the sites.

13. If the sites come back during this outreach process with general questions or questions specific to the IMPAACT protocol they will be working on, to whom should we direct them?

ANSWER: Site questions regarding specific protocols are answered through the IMPAACT network. General questions may be directed to the Contracting Officer.

14. IMPAACT 2024 website states that site selection was completed in August 2022 and 14 ex-US sites were selected. Of the 14 sites selected, only 4 have a four-digit CRS ID starting

AMENDMENT NO.: 005 CONTINUATION PAGE Page 7 of 7

Solicitation Section Reference Question with the digit “5”. Is the offeror only to contact those 4 sites or all 14 sites? (Please note that the site list provided as Attachment 8 in the RFP does not match the site list on the IMPAACT 2024 website).

ANSWER: We have listed the seven sites for these two protocols in Section A of this amendment.

15. IMPAACT 2040 website states that site selection was completed in November 2022 and 4 sites each were selected in the US and in South Africa. Of the 8 sites selected, only 3 (all in the US) have a four-digit CRS ID starting with the digit “5”. Is the offeror only to contact those 3 sites or all 8 sites? (Please note that the site list provided as Attachment 8 in the RFP does not match the site list on the IMPAACT 2040 website).

ANSWER: We have listed the seven clinical NICHD sites selected by IMPAACT for these two protocols in Section A of this amendment. Offerors are asked for commitment letters only from those seven NICHD sites. Attachment 8 provides the complete list of 24 NICHD clinical research sites that currently participate in the IMPAACT network.