Amendment 0001_executed.pdf

(x)

75N91023Q00142 x x

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

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

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

x

NCI

Bethesda, MD 20892-7511 National Cancer Institute National Institutes of Health

NCI-EXEC

Bethesda, MD 20892-7511 National Cancer Institute National Institutes of Health

02/15/2024

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

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

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

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

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

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

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

PAGE OF PAGES

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

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

02/15/2024

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

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

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

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

ORDER NO. IN ITEM 10A.

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

The purpose of this amendment is to extend the quote submission due date and to respond to questions regarding Solicitation No. 75N91023Q00142.

Quoters are required to acknowledge each Solicitation Amendment by including each Standard

Form 30 (SF-30) with Block 8 completed and signed by your organization's signature authority and submitted with your quote.

PROPOSAL SUBMISSION DUE DATE: FEBRUARY 23, 2024, 5:00 PM EST (CHANGED)

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

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

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

ANGELA M. MOORE

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

Previous edition unusable

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

02/15/2024

1x

Solicitation # 75N91023Q00142 Amendment 1 1

QUESTIONS AND ANSWERS ON SOLICITATION # 75N91023Q00142

1. Tumor sites included to define ovarian cancer includes not just code for ovary. Please confirm, if the broader defini�on of the cancer is to be used and also whether in the data tables we submit with the proposal, we should include the broader defini�on.

Response: Yes, the broader defini�on specified on page II-5 of the dra� Data Acquisi�on Manual (DAM) (primary site C56.9 (ovary), C48.1 (specified parts of peritoneum), C48.2 (peritoneum,NOS), or C57.0 (fallopian tube)) is to be used and should be the basis for submited data tables.

2. For ovarian cancer, one of the inclusion criteria is requiring Grade 2 – 4. However, grade for this cancer are measured as either Low/High or 1-3 scale. Which grades relevant to these two scales should be excluded during sample selec�on?

Response: High-grade ovarian cancers are those with grade “high” (if high vs. low is specified) or grade 2 or 3 (if a numerical grade is specified)

3. The below listed objec�ves in RFQ_Final are not listed in the [Data Acquisi�on Manual] (DAM).

Please clarify if these should be included as study objec�ves.

• #10: Assess the incidence of cancer recurrence and metastasis following ini�al diagnosis.

#11: Describe medical record documenta�on of pa�ent financial impacts due to the COVID-

19 pandemic poten�ally affec�ng cancer care.

Response: Cancer recurrence and metastasis following ini�al diagnosis refers to item B-25 of the dra� DAM Prostate Cancer Data Set (page IV-45) and item B-14 of the dra� DAM Ovarian Cancer Data Set (page V-24). Both items are labeled as “METASTASIS OR LOCAL RECURRENCE AFTER DIAGNOSIS”. Pa�ent financial impacts due to the COVID-19 pandemic refers to the item A-16 of the dra� DAM Common Data Set, “IMPACT OF COVID-19 PANDEMIC ON FINANCES/INSURANCE” (page

III-32)

4. Please can you clarify whether this POC study will be star�ng during the next Task Order period, i.e., on or a�er May 1, 2024?

Response: This is not a task order to an exis�ng contract. This acquisi�on will result in a purchase order with a dura�on of 12 months. The an�cipated award date will be on or around April 30, 2024.

5. Due to compe�ng priori�es as well as staff shortages within our agency, we will not be in a posi�on to submit an accurate budget by the current deadline for the submission of the quotes (2/20/2024).

Will it be acceptable to provide an es�mated budget with our quote, and provide an updated accurate budget at a later date?

Response: Ini�al Quotes should be considered final in nature because the Government reserves the right to award without discussions per Solicita�on Sec�on VI. Basis for Award and Evalua�on.

Solicitation # 75N91023Q00142 Amendment 1 2

That Sec�on states “The Government intends to evaluate the quote and award Firm-Fixed-Price Purchase Order(s) for non-severable services without discussions with the quoter. Therefore, the quoter’s initial quote should contain the quoter’s best terms from a price and technical standpoint.

However, the Government reserves the right to request quote revisions that seek additional price discounts, request revisions to the technical quote or clarify aspects of the quote. The Government may reject the quote if such action is in the Government’s interest and waive informalities and minor irregularities in the received quote. In the event quote revisions are requested, the Government will not necessarily be seeking revisions from all quoters.”

6. We respec�ully request an extension to the deadline for submi�ng the technical and business quotes in response to this RFQ. [TEXT DELETED] We would be extremely grateful if you would consider an extension to the deadline of at least 2 weeks.

Response: The deadline for submission of quotes has been extended to February 23, 2024 5:00PM

EST.

7. What is the es�mated start date of the period of performance? This informa�on is essen�al for our budget planning.

Response: The an�cipated award date will be on or around April 30, 2024.

8. In reference to the table characterizing number of pa�ents available by race/ethnicity and age for diagnosis year 2021 (Atachment 7, page 2): The race/ethnicity categories in the table are not mutually exclusive. The categories are Non-Hispanic White, Non-Hispanic Black, Hispanic, Asian/Pacific Islander, and American Indian/Alaska Na�ve. Should Asian/Pacific Islander and American Indian/Alaska Na�ve popula�ons be categorized as non-Hispanic?

Response: Yes, pa�ents included in POC are first iden�fied as Hispanic vs. non-Hispanic. Then, among non-Hispanic individuals, pa�ents are characterized based on race as indicated in the medical record. This includes Non-Hispanic White, Non-Hispanic Black, Non-Hispanic Asian/Pacific Islander, and Non-Hispanic American Indian/Alaska Na�ve.