BAA_2017-Q-66210_Questions_and_Responses.pdf

BAA 2016-N-66210

Questions and Responses – January 17, 2017

Question

No.

Question: Response:

1 Is the approximate average award of “under $300,000”, as quoted on page 22 of the RFP, the total available for this area of interest? Or would it be $300,000 annually for the duration of the project? And, does it include direct and indirect costs?

We greatly appreciate any guidance you can provide.

The amount listed on page 22 is anticipated to cover up to the 36 month follow up. Depending upon the specific proposal submitted by interested parties, relevant timeframes and funding levels are subject to change. Direct and Indirect costs are included.

2 The FBO notice lists the relevant NAICS code as 923210.

On the SBA’s Size Standard table, they state “Small business size standards are not established for this Sector.

Establishments in the Public Administration Sector are

Federal, state, and local government agencies which administer and oversee government programs and activities that are not performed by private establishments.” Does this mean that only federal, state and local government agencies are eligible to apply for this solicitation? If not, please consider NAICS code 541712, which was used on a previous

BAA for the Zika response.

All types of organizations are eligible to respond.

3 Area of Interest #2: If the offeror’s proposed solution includes a survey or data collection effort for more than 9 non-federal respondents, would there be access to an emergency OMB-PRA approval? Or should the offeror plan for a typical OMB-PRA package response time of 9-12 months.

There is no blanket Zika related emergency approval. There are provisions in the PRA for emergency processing. Emergency processing is only to be used to respond to circumstances that could not be foreseen and when the use of regular procedures would result in significant harm to the public or the program. For many Zika related activities, the CDC has been able to secure emergency processing however, as stated previously, there is no blanket approval.

4 Part IV: Concept Paper Submission, #10 (page 17): For the listing of organizations in our response, is to be only organizations and subcontracts that we have already engaged or can it be a list of partner organizations we would like to engage in the project?

Lists may include organizations you would like to work with

5 It is our understanding that we can submit a separate concept paper for each of the four activities under Area of Interest #3.

Please confirm whether this understanding is correct.

It is possible to submit separate concept papers for each of the four activities. However, the Government considers the four activities complementary and is interested in reviewing concepts incorporating as many of the activities as feasible.

6 The stated funding ceiling for Area of Interest #3 is

<$300,000.

a) Is $300k the funding ceiling for each or all of the four activities under Area of Interest #3?

The funding ceiling of $300,000 is for all four of the proposed activities under Area of Interest #3. Depending upon the specific proposal submitted by interested parties, relevant timeframes and funding levels are subject to change. Direct and Indirect costs are included.

b) Is $300k the funding ceiling for each year or for the entire period of performance?

The $300,000 funding ceiling is for the entire period of performance.

7 Regarding the timeline, will CDC be able to secure expedited or emergency OMB review for data collection activities (e.g., surveys, focus groups, interviews)? How long should we expect OMB review to take?

There is no blanket Zika related emergency approval. There are provisions in the PRA for emergency processing. Emergency processing is only to be used to respond to circumstances that could not be foreseen and when the use of regular procedures would result in significant harm to the public or the program. For many Zika related activities, the CDC has been able to secure emergency processing however, as stated previously, there is no blanket approval.

8 Does CDC have an expected period of performance for each activity, e.g., Activity 3.1=12 months or Activity 3.4=48 months?

The offeror should propose the timeline which they believe is appropriate for the tasks to be performed.

9 The BAA states that the CDC is interested in additional

M&E activities “such as” the activities listed as 3.1 to 3.4. a)

Is CDC only interested in these specific M&E activities, or would you like proposals for other M&E activities as well?

b) If CDC welcomes other ideas, would you be interested in assessing knowledge, attitudes, and behaviors towards contraception for reproductive age women, including those who do not access Z-CAN services? If so, does CDC have plans to field BRFSS with the preconception health/family planning module at one or more points in time?

At this time, we are primarily interested in the specific activities listed in 3.1-3.4. However, offerors are allowed to submit other pertinent ideas.

10 The BAA describes a variety of activities already planned or underway to monitor and evaluate Z-CAN, including patient and physician surveys. How do you envision the new contractor(s) collaborating with and integrating with the ongoing monitoring and evaluation work? For example, would the patient and physician surveys requested in the

BAA be able to piggy back on those already underway, or should we expect that they would be stand-alone activities?

The physician survey (activity 3.2) would be a stand-alone activity, as the sample would be broader than the physicians curently included in the Z-CAN program. The patient surveys (activities 3..3 and 3.4) would be extensions of the current activities, and the new contractor(s) would be expected to collaborate with the current activities underway.

11 In particular, the BAA says that activities already planned will be assessing contraceptive patterns, contraceptive continuation rates, and pregnancy rates among Z-CAN patients, and requests 6- and 12-month follow-up surveys to assess these same measures. Should we assume that the baseline data collection will have already been conducted, and the contractor will be using the same sample to conduct the follow-up surveys? If so, could you provide an indication of what the baseline sample size will be? Could you describe the planned methodology for enrollment in the study and data collection?

Yes, the baseline data collection will have already been conducted and the sample defined. The baseline number is anticipated to be

3200 women, but could be more or less depending on enrollment in the Z-CAN program. The 6 and 12 month surveys will begin under the current activities, but will need to be completed under the new

BAA. Sample size is difficult to estimate at this point and will depend on program enrollment and response rates, but we anticipate that 1200 surveys may be needed.

12 Regarding Activity 3.1, are Z-CAN providers billing private and public third-parties for any portion of contraceptive care or are all services provided free of charge, regardless of client insurance status?

All services provided through Z-CAN are free of charge, regardless of client insurance status.

13 Regarding Activity 3.2, is there an existing population frame of all OB-GYNs in Puerto Rico or does CDC expect the contractor to develop the frame?

An existing population frame of all OB-GYNs in Puerto Rico exists, but may need updating and confirmation.

14 Regarding Activity 3.3, for the 6- and 12-month followup surveys of Z-CAN patients: Does CDC envision that the patients surveyed at 12 months are the same ones interviewed at 6 months or that patients interviewed at 6 months are the same ones interviewed at baseline? If CDC envisions a cross-sectional patient survey, what patient contact information and demographic information will be made available so that RTI can select a representative sample? During patient intake, are

Z-CAN patients consenting to being contacted for evaluation purposes or will the contractor be required to perform this task?

Patients are initially surveyed at 2 weeks and this 2-week sample will be the sample for both the 6 and 12 month surveys. During the initial Z-CAN visit, patients are notified that they will be contacted for follow-up surveys and have the option to opt out of contact.

However, patients will need to be separately consented electronically for each survey.

15 Regarding Activity 3.4, what does CDC anticipate to be the final size of the Z-CAN client population?

While the Z-CAN program numbers may change, at this point the

CDC anticipates about 2000 LARC users would be available for 24 and 26 months follow-up.

16 It is our understanding that the Z-CAN program will end in

Summer 2017. Will any program components, such as provider support or patient education, continue beyond that date? Should the M&E proposal be focused on activities and patient interactions that occur prior to that date only?

While the Z-CAN program is currently intended to end in summer

2017, the M&E activities will continue past this date as follow up with all patients over 12 months and patients with LARC methods at

24 and 36 months. It is not anticipated at this time that any program components will continue beyond summer 2017, with the exception that Z-CAN providers are obligated to remove LARC methods at any time.

17 How was the sample size determined? It is expected that approximately 4500 live born infants will be delivered to mothers enrolled in ZEN. Based on an estimated 10%

Zika virus infection rate during pregnancy for ZEN mothers, we expect that 450 of these babies will be born to Zika-infected mothers.

All of those infants would be followed from age 6 months to 5 years.

Due to resource constraints, the decision was to select a comparison cohort that was the same size as the exposed cohort, from the entire population of unexposed infants (approximately 4050 infants).

18 How does CDC see their partners on the ZEN initiative being involved in the Area 1a cohort study?

The final outcome of the BAA process is a contractual relationship.

19 Is it possible to include assessments for potential confounders in the protocol? Examples might be heavy metal exposure or non-Zika infections.

Yes

20 Section 3.4 refers to “Z-CAN providers.” To date, how many providers (by specialty, if known) have been trained as part of the Z-CAN program implementation?

Currently, 150 providers have been trained and are participating in the Z-CAN program; almost all are obstetricians/gynecologists.

21 The Z-CAN program is the result of a laudable partnership among many entities. Is it possible to share which contractor(s), if any, are performing the work described as, “Public health monitoring activities are currently planned and will begin to evaluate the implementation and impact of Z-

CAN, including focus groups…, online surveys of Z-CAN patients, and semi-structured, individual interviews and one surveys of Z-CAN physicians and clinic staff” on page 12 of the BAA?

Total Solutions, Inc. is currently assisting the CDC with activities related to ZCAN

22 Has the organization/entity that is currently performing the public health monitoring activities related to Z-CAN (focus groups, online surveys, interviews) applied for or already obtained Office of Management and Budget (OMB) approval, and if so, would the work by the contractor for

Area of Interest #3 (3.2-3.4) fall under the same OMB approval?

CDC has applied for OMB approval for the current activities. Activities under 3.3 and 3.4 would need to be submitted for approval as an amendment to the existing OMB approval.

Activity 3.2 would need a separate OMB submission.