Agricultural Biotechnology Program - APS Q&A __ Amendment 1 Cover Page and Attachment A.pdf

Amendment #1 to the Agricultural Biotechnology for Global Food Security Annual Program Statement (APS) (No. 7200AA20APS00003)

The purpose of this Amendment is to:

1. Post answers to the APS questions received by the deadline (Attachment A).

2. Post a revised APS (Attachment B).

NOTE: Some questions have been paraphrased for the purpose of not publishing any personally identifiable information (PII), Sensitive but Unclassified (SBU) information, or any specific Concept Note ideas.

Please ensure you review both the amended APS and amended Addendum #1 in addition to the Questions and Answers document for both the APS and Addendum #1.

Attachment A To Amendment #1

Questions and Answers Document

The Agricultural Biotechnology for Global Food Security Annual Program

Statement (APS) (No. 7200AA20APS00003)

1. How is “Agricultural Biotechnology” defined? Are you looking specifically for transgenic approaches? Or other uses of biotechnology such as tissue culture and genomic-assisted breeding is also included?

a. For purposes of this opportunity, is the relevant working definition of Agricultural Biotechnology the one contained in Amendment #1 Annual Program Statement (provided at https://www.grants.gov/web/grants/view-opportunity.html?oppId=322 665)? If not, what definition applies?

b. Does the definition of agricultural biotechnology include synthetic biology?

USAID: Section A.1.a (“Definition of Agricultural Biotechnology Under This APS”) of the overarching APS contains the relevant working definition for activities to be developed under USAID’s Agricultural Biotechnology for Food Security program. This definition would therefore apply to activities to be developed under Addendum (#1) to the APS.

As stated in Section A.1.a of the APS, tissue culture and genomic-assisted breeding are excluded from the working definition of agricultural biotechnology established for the purposes of this APS, unless other elements of the proposed approach are consistent with the prioritized biotechnological approaches. “Synthetic Biology” is itself a broad term that may encompass a wide range of biotechnological approaches, so it is difficult to generalize, but to the extent that a prospective applicant believes they have a compelling application of synthetic biology to address food security priorities as outlined in the APS, and the approach is broadly consistent with the scope of “Agricultural Biotechnology” as described in Section A.1.a, then it would likely fall within the scope of this APS.

Note that Section A.1.a. of the APS has been amended for clarity, in response to several definitional questions raised in the Q&A for the both APS and Addendum #1. The amended text is provided below, for reference:

“a. Definition of Agricultural Biotechnology Under this APS Depending on the context, the term “Agricultural Biotechnology” can take on a range of different meanings, and may encompass a broad spectrum of technologies and approaches. To inform prospective applicants’ development of activities responsive to

Amendment #1 to Agricultural Biotechnology for Global Food Security Annual Program Statement (APS) - Attachment 1 https://www.grants.gov/web/grants/view-opportunity.html?oppId=322665 https://www.grants.gov/web/grants/view-opportunity.html?oppId=322665 this APS, and to minimize redundancy between approaches USAID already supports under other areas of its food security portfolio, USAID here indicates the subset of agricultural biotechnology approaches it is interested in supporting under this Program.

For the purposes of this APS, “Agricultural Biotechnology” refers to technologies used for the deliberate manipulation of an organism to introduce, remove, or modify one or more heritable characteristics of a product for agricultural use; and to overcome natural physiological reproductive or recombination barriers, with emphasis on in vitro nucleic acid techniques, including recombinant DNA or direct injection of nucleic acid into cells or organelles. Examples include, but are not limited to, “traditional” genetic engineering (GE) approaches (e.g., transgenic organisms, genetically modified organisms, living modified organisms, etc.). For the purposes of this APS, USAID is also interested in considering emerging approaches for gene editing and precision breeding (e.g., applications of CRISPR-Cas9, TALENs, zinc-finger nucleases, etc.), and will therefore also consider such technologies within the scope of the program. Under this broad working definition of agricultural biotechnology, USAID may consider all potential applications of agricultural biotechnology as a tool to achieve global food security objectives—ranging from crop improvement, livestock and veterinary applications, and agricultural pest and disease control, to food safety and processing, and beyond.

Note that, for the purposes of the APS, this definition of agricultural biotechnology specifically excludes technologies already commonly used in conventional breeding and selection, such as genomics- or marker-assisted breeding. It also excludes broader connotations of the term “agricultural biotechnology” as any application of biology to address agricultural challenges (such as rhizobial inoculants or tissue culture, for example). Though important in their own right, USAID supports such approaches under other Feed the Future programs, and therefore excludes them from this APS.”

2. Can you please specify which countries are in that category of “aligned countries?”

USAID: Detailed information regarding USAID Feed the Future Target Countries and how these countries were selected can be found by accessing the accompanied link (https://www.feedthefuture.gov/about/). In contrast, aligned countries are those countries which receive USAID assistance, but are outside USAID’s Feed the Future Target Countries list. Aligned countries can vary each year, and therefore further information regarding aligned countries will be provided during the co-creation process. As detailed in the Agricultural Biotechnology Annual Program Statement (APS) and accompanying Global Addendum, USAID programming may strategically engage additional countries or regions beyond those identified as Global Food Security Strategy (GFSS) target or aligned countries (See Section A.II.d of the APS and A.3.b of the Global Addendum). "

3. Should we look for collaborators in the targeted countries or the USAID program will find research institutions or collaborators for us.

Amendment #1 to Agricultural Biotechnology for Global Food Security Annual Program Statement (APS) - Attachment 1 https://www.feedthefuture.gov/about/

USAID: The Agricultural Biotechnology for Food Security Program welcomes applications from applicants who have identified/established collaborators in Target countries. However, interested applicants who have not established collaborators are encouraged to submit a Concept Note(s), as potential collaborators for promising applications can be identified during the co-creation process. For further information on Expectations Regarding Co-Creation, Collaboration and Communication, see Section B.III of the APS.

4. The collaborators should be College/University or National Agricultural Research Systems? What forms of collaboration or partnership are envisioned or required between activities supported by this program and USAID-supported Feed the Future Innovation Labs, including the Crop Innovation Lab?

USAID: Collaborators are not limited to College/University or National Agricultural Research Systems, and while collaborations with Feed the Future Innovation Labs are an excellent way to leverage and align complementary resources, there is not a specific requirement to collaborate with USAID Innovation Labs. Further information regarding collaborators can be found in Section B.I. of the APS.

5. If an activity is being funded under a grant funded by another Federal Agency (ie:USDA/NIFA grant), is it going to be considered redundant if we propose the same approach in a collaborative country?

USAID: Based on the information provided, these are considered two different activity objectives--though the USAID-funded activity should represent an efficient use of U.S.

Government resources to address international food-security priorities, rather than a duplicative funding stream to work already supported by another Agency. However, it is important to note the Agricultural Biotechnology Program for Food Security seeks to provide assistance for activities that engage multiple countries or regions, or that have a clear pathway to achieve widespread impact at a multi-country scale (See Section A.3.b of the Global Addendum). Note, an award issued by USAID would result in a standalone award with separate funding from an existing award from USAID or another government agency, and the funding must be treated as such.

6. Under section 1.II.c.3 on page 22 Can you provide an example of USAID programming expectations for an agricultural biotechnology project that may differentially impact men, women, boys, and girls differently? While biosafety policy is gender and age neutral, does this imply that applicants should generate analytics to measure potential impacts on gender and youth? Would it be expected that there will be proven impact in the 5 years project period or would research around how to get the impact be sufficient?

USAID: Information regarding gender equality, female and youth empowerment can be found in Section A.I.b and Section A.II.c.3 of the Agricultural Biotechnology Annual Program Statement (APS). As cited in section (A.I.b), additional information on integrating gender equality, female and youth empowerment into program design can Amendment #1 to Agricultural Biotechnology for Global Food Security Annual Program Statement (APS) -also be found by accessing the Global Food Security Strategy (GFSS) Technical Guidance Documents using the accompanying links:

Increased Gender Equality and Female Empowerment https://cg-281711fb-71ea-422c-b02c-ef79f539e9d2.s3.us-gov-west-1.amazonaws.co m/uploads/2018/03/GFSS_TechnicalGuidance_Gender.pdf Youth Empowerment https://cg-281711fb-71ea-422c-b02c-ef79f539e9d2.s3.us-gov-west-1.amazonaws.co m/uploads/2018/03/GFSS_TechnicalGuidance_Youth.pdf

7. Is Objective #2 (“enabling environment”) aimed primarily at issues surrounding the policy/regulatory environment or does it also include issues related to research on the physical enabling environment (i.e. ecological, natural resource or environmental constraints)?

USAID: Traditionally, the environmental aspect of Technical Objective 2 “enabling environment” has been considered one element of the informal and formal norms, traditions, customs, laws, regulations, policies, trade agreements, and infrastructure that must be in place in order for the products of agricultural biotechnology to be successfully developed and deployed. Section A.II.b.2 provides detailed information regarding “Key Elements for successful achievement of Objective 2.” We welcome for further review, Concept Notes which strongly demonstrate how research on the physical enabling environment is an effective approach to address Technical Objective 2.

8. Page 30. Font listed for the RFA is 12 pt Times New Roman but for the CN is listed as 11 pt without listing the type of font. Are we to use 11 pt Times New Roman for the CN?

USAID: Yes, Times New Roman (11 pt) font should be used for the Concept Note. The type and size for charts, tables, ect. should be the same (or slightly smaller if needed based on formatting).

9. On Page 26, Organizations that do not intend to apply for USAID support may still participate in the co-creation process. How is this accomplished? Who determines who will participate without a formal request for funds, or by virtue of being listed as a co-creation participant on a CN or as a sub-recipient?

USAID: This paragraph and associated language of the original Agricultural Biotechnology Annual Program Statement (APS) was intended to serve as an entry point solely for other donor organizations. Note this language has been amended to be taken out of the APS completely.

10. On Page 28, On the co-creation process, can an applicant propose a partner outside of the authorized geographical code?

Amendment #1 to Agricultural Biotechnology for Global Food Security Annual Program Statement (APS) - Attachment 1 https://cg-281711fb-71ea-422c-b02c-ef79f539e9d2.s3.us-gov-west-1.amazonaws.com/uploads/2018/03/GFSS_TechnicalGuidance_Gender.pdf https://cg-281711fb-71ea-422c-b02c-ef79f539e9d2.s3.us-gov-west-1.amazonaws.com/uploads/2018/03/GFSS_TechnicalGuidance_Gender.pdf https://cg-281711fb-71ea-422c-b02c-ef79f539e9d2.s3.us-gov-west-1.amazonaws.com/uploads/2018/03/GFSS_TechnicalGuidance_Youth.pdf https://cg-281711fb-71ea-422c-b02c-ef79f539e9d2.s3.us-gov-west-1.amazonaws.com/uploads/2018/03/GFSS_TechnicalGuidance_Youth.pdf

USAID: The geographic code for the procurement of commodities and services under this program is Code 937. This includes the United States, the recipient country, and developing countries other than advanced developing countries, but excludes any country that is a prohibited source (See Section B.4 of the Global Addendum #1).

However, partner selection will be further discussed during the interactive co-creation process.

11. Page 30, For the cost-schedule in excel; what is the prescribed paper size? Is it similar to Technical Application or any paper size will do?

USAID: Please note the cost-schedule is not a requirement for the initial Concept Note phase, and will be discussed further for strong Concept Notes selected to advance to the Request for Application (RFA) phase.

12. On Page 46, Instructions for performance reporting indicate that only an annual report is required but on pg. 48 the discussion of a final report mentions that it will replace the semi-annual report. Please clarify if reporting is semi annual or annual?

USAID: Reporting requirements will be determined during the award negotiation phase, but semi-annual reporting is typically required.

13. On Page 45, What is the extent of detail required for financial reporting by country? Is this an estimate or will financial transactions need be maintained by country?

USAID: Financial reporting requirements will be determined and further discussed during the award negotiation phase.

14. On Page 19, Intellectual property rights (IPR) (e.g. licensing) are referenced as part of the life cycle approach to product development. Can we assume that USAID intends IPR policies to be considered as one part of the enabling environment under Technical Objective 2? Licensing is mentioned but not IPR policy specifically.

USAID: To the extent that IPR is a critical constraint to the successful application of agricultural biotechnology to address food security challenges in a given partner country, it would be a relevant policy and capacity element within the enabling environment under Technical Objective 2.

Within the context of USAID’s procurement process, all intellectual property will be treated in accordance with ADS Chapter 318 and 2 CFR 200.448.

15. On Page 31, in Full Application Submission Procedures, in the case USAID system email does not generate proof of timely delivery in the form of system

Amendment #1 to Agricultural Biotechnology for Global Food Security Annual Program Statement (APS) -generated documentation of delivery receipt date and time, can the applicant use the sent delivery date and time as proof?

USAID: The applicant can use the sent delivery date and time as proof. Please keep in mind that any email address outside the agency will go through a security check and the email may be held in the system and will not be released to the mailbox until the check is complete. Therefore, we encourage all applicants to allow for timely security verification and not wait until the final minutes to submit Concept Notes or Full Applications.

16. On Page 32, Links to the Instructions for SF-424, SF-424A and SF-424B are not working.

a. Links to Application for Federal Assistance (SF-424), Budget Information and Assurances will bring you to SF-424 Family Forms. Is this the correct form? We noticed there are other types of forms (Individual Family, Mandatory Family, Short Organization family and R&R family).

USAID: USAID has not requested nor required any of the SF 424 series forms at this time. The forms listed in the APS that may be requested at the RFA or negotiations stage are the Application for Federal Assistance SF 424, Budget Information for Non-Construction Programs (SF 424A), and Assurances for Non-Construction Programs (424B). All forms can be found in PDF editable format on Grants.gov at the following link: https://www.grants.gov/forms/sf-424-family.html Note: The use of the word “family” on grants.gov is referring to the “SF 424 form series.”

For ex. SF 424, SF 424A, SF 424B, and SF 424D. In addition, these forms will be uploaded as an attachment in the APS related documents file on Grants.gov.

17. On Page 33, Are there substitutes for the Certificate of Compliance that provide similar assurance?

USAID: There are no substitutes for the certifications as they required for receiving a federal award from USAID. The AO will request certifications at the RFA or negotiation stage. This applies to both U.S. and Non-U.S. Organizations.

18. On Page 33, How do we receive confirmation we have successfully uploaded the documents?

USAID: The AO may request the Certifications, Assurances, Representations, and Other Statements of Recipient as part of the full application or during negotiations and will provide upload/verification instructions to the organization.

Please see the updated APS language.

19. Page 33, Is there a form for the Certificate, Assurances, Representation, and

Other Statements of the Recipient?

USAID: Please refer to the link directly in the APS:

https://www.usaid.gov/sites/default/files/documents/1868/303mav.pdf Amendment #1 to Agricultural Biotechnology for Global Food Security Annual Program Statement (APS) - Attachment 1 https://www.grants.gov/forms/sf-424-family.html https://www.usaid.gov/sites/default/files/documents/1868/303mav.pdf

USAID will upload this document as an attachment under the APS related documents file on Grants.gov as well.

20. On Page 33, How do we ensure we are in compliance?

USAID: Refer to the Certifications, Assurances, Representations, and Other Statements of Recipient documents as it details compliance.

21. On Page 34, What’s the differentiation in this document between a sub-recipient and consultant? Is a detailed budget required for both?

USAID: All sub-recipients and consultants shall be treated in accordance with 2 CFR

200.92. Typically, a subrecipient is considered an assistance agreement, while a consultancy would be considered a contractual agreement, however in accordance with the CFR definition in 2 CFR 200.92, they are all considered sub-awards.

Detailed budgets are required for both at the Full Application stage, however, the level of detail will depend on the situation, scale and what is being proposed. (Note that a detailed budget is not requested at the initial Concept Note phase.).

For example a high dollar value sub-award to an organization would require more information than a consultant you are hiring for five days of work.

22. On Pages 36 and 37, In the Dun and Bradstreet and SAM Requirement, we understand that all proposed subrecipients will need a valid DUNS number. Will they (the sub-recipients) also need to register in SAM and maintain active?

What about sub-contractors?

USAID:Per ADS 303, the USAID Agreement Officer(AO) must obtain certification from the applicant/recipient...that the subrecipient(s) does not have any active exclusions in the System for Award Management (SAM). Subcontractors are not required to register in SAM but must obtain a Unique Entity Identifier to be eligible to receive a sub-contract per FAR 52-204-7 and FAR 52-204-12.

23. On Page 38, Is branding and marking applicable to PIOs (Public International Organization)?

USAID: PIOs will be subject to branding and marking requirements only if USAID is the sole donor funding a specific program, activity, or project of a PIO, or in cases where other bilateral donors have received marking privileges. If either of these conditions exist, the PIO will be subject to the requirements set forth in ADS 320.3.3.1 Co-branding and Co-marking.

24. On Page 47, Will project work plans and annual reports be made publicly available on the DEC; can an exemption be considered?

USAID: Yes, annual or semi-annual reports will be made publicly available. Work plans do not get uploaded in the Development Experience Clearinghouse (DEC). Any exemptions will be made on a case by case basis. Refer to ADS Chapter 540 for details on all documents required to be uploaded in DEC.

25. On page 51, Concept Notes should not have intellectual property; however, one could consider that the entire CN itself is proprietary information. How will USAID protect the information contained in a CN during the co-creation process? Will CN’s be shared with other/all co-creation participants?

USAID: All participants invited to the co-creation will sign Non-Disclosure Agreements.

Likewise, the concept notes will not be shared with other co-creation participants without prior agreement from the CN authors.