75A50121R00012 Amendment 1.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

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offerse above is extended. is not 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 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 RESULT IN REJECTION OF YOUR OFFER.

ASPR-BARDA

Amendment 1 to RFP 75A50121R00012. Attachment to the Amendment include Questions and Answers.

ASPR-BARDA

200 Independence Ave., S.W.

Room 640 -G Washington D.C. 20201

75A50121R00012

06/24/2021

06/02/2021

1 3

Jeffrey Brown

06/24/2021

# Contractor Questions BARDA Answers

The instruction said that the laboratories with GLP capabilities are eligible. We do not have a GLP status, but we perform GLP-like studies. In the past, we have performed studies for BARDA as a subcontractor for chlorine gas inhalation project. Currently, we are awarded as a subcontractor for BARDA as well. I am wondering, if we are eligible for this RFP?

Mandatory Qualification Criteria “e. GLP Capabilities” applies to Offerors proposing to “Group A” or qualified for task orders related to pulmonary agents, cyanide, opioids, toxic industrial chemicals (TICs), and other potential chemical agents of concern by inhalation ingestion and topical routes. The mandatory criteria specifies the Offeror must have completed at least one (1) GLP study in the last 3 years. Proposals unable to demonstrate compliance with this mandatory qualification criteria will not be distributed for evaluation and will not be considered for award.

In the RFP, it was mentioned that BARDA is interested in pig model of phosphene inhalation. Conscious ovine models of acute lung injury is extensively used in our lab. Is ovine model of phosphene is acceptable or it has to be pig model. Can you also identify the duration (acute, chronic [hrs or days]) of the study.

Yes. The sample RTOR is for example purposes only. The pig is not required.

Offerors are encouraged to consider specific animal species/strain based on their facility capabilities, which includes experience and scientific judgement as to the most appropriate study species. The suggested study duration is discussed in the sample RTOR.

Can you please also let me know where i can find the instruction on the proposal writing (pages, fonds, structure etc). Instructions to Offerors begins on page 63 of the RFP.

The sample RTOR is presented as a SOW. To my understanding, the response to a SOW should address exactly what is being asked for, whereas the response to a SOO leaves more room for initiative. However, the note at the end of paragraph 2 states ‘Offerors are encouraged to consider approaches and specific animal species or strains based on their facility capabilities to simplify workflow, manage study size, and eliminate biases’, which appears to offer more degrees of freedom. My specific question is: is it allowed to offer another animal species than the pig for this model development?

Yes. The sample RTOR is for example purposes only. The pig is not required.

Offerors are encouraged to consider specific animal species/strain based on their facility capabilities, which includes experience and scientific judgement as to the most appropriate study species.

The pig is not further specified; can this be any type of pig, for instance a mini-pig or a Yorkshire pig?

Yes. The sample RTOR is for example purposes only. The pig is not required.

Offerors are encouraged to consider specific animal species/strain based on their facility capabilities, which includes experience and scientific judgement as to the most appropriate study species.

CHEM IDIQ 75A50121R00012 - Q&As

In Attachment 1 – Statement of Work: Background - Task Order Title:

Development of a Pig Model of Pulmonary Phosgene Exposure Injury (p. 122) of the RFP, it states, “The study design should also propose methods for evaluating promising therapeutics in this model. The development of the model should be carried out under well controlled conditions but will not need to meet the criteria for good laboratory practice (GLP) regulations. “This language seems to be contradicted elsewhere, that suggests that a GLP designation is required for work funded under this title. Can you confirm that the passage on p. 122 is correct, and strict GLP criteria are NOT required for these proposed models? Our University has experience conducting GLP studies in animal models at our facilities however one of the models we are considering for this is not GLP but is a well-controlled.

The sample RTOR is for example purposes only, and although this particular example does not require meeting criteria for GLP, it is mandatory to have conducted a GLP study within the last three years to qualify as a performer in Group A. Mandatory Qualification Criteria “e. GLP Capabilities” applies to Offerors proposing to “Group A” or qualified for task orders related to pulmonary agents, cyanide, opioids, toxic industrial chemicals (TICs), and other potential chemical agents of concern by inhalation ingestion and topical routes. The mandatory criteria specifies the Offeror must have completed at least one (1) GLP study in the last 3 years. Proposals unable to demonstrate compliance with this mandatory qualification criteria will not be distributed for evaluation and will not be considered for award.

The RFP discusses a swine (pig) model for the studies of phosgene inhalation.

Would other large-animal models, including ovine (sheep) be considered?

Yes. The sample RTOR is for example purposes only. The pig is not required.

Offerors are encouraged to consider specific animal species/strain based on their facility capabilities, which includes experience and scientific judgement as to the most appropriate study species.