U.S. President's Emergency Plan for AIDS Relief Database Customer Survey to Industry and External Stakeholders (CDER)

OMB Control No: 0910-0360 Expiration Date: 10/31/2023

Paperwork Reduction Act Statement: According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0910-0360. The time required to complete this information collection is estimated to average 8 minutes per respondent, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden to PRAStaff@fda.hhs.gov.

The survey we are conducting is on behalf of the U.S. Food and Drug Administration.

U.S. President’s Emergency Plan for AIDS Relief Database Customer Survey to Industry and External Stakeholders

Intro:

In January 2020, FDA launched a new interactive PEPFAR (President's Emergency Plan for AIDS Relief) database that provides information to the public about approved and tentatively approved antiretroviral (ARV) drugs that are eligible for procurement under PEPFAR. The purpose of this survey is to capture feedback and insights from key stakeholders on various aspects of the database including:

o Current operability
o User-friendliness
o Ability to generate reports and data
o Areas of improvement

This survey should take 8 minutes to complete. All responses will be anonymized and aggregated upon review.  

Your participation/nonparticipation is completely voluntary, and your responses will not have an effect on your eligibility for receipt of any FDA services. In instances where respondent identity is needed (e.g., for follow-up of non-respondents), the information collection will be kept secure to the fullest extent allowed by law.”

We appreciate your participation in our survey to ensure a continued improvement of our services to the PEPFAR community.

1. What is your current organization or company affiliation?

2. Have you used the database before?

• Yes, frequently

• Yes, a few times

• Yes, once

• Never

(Survey Logic- If response is “Never” proceeds to question 3.(a), 4.(a), and Concluding note.

With any other answer of Q2, the respondent proceeds to question 3.(b), 4.(b), 5-11)

3. (a) Please share why you have not yet visited the PEPFAR Database.

3. (b) Which resources do you currently use to find or compare drug information for PEPFAR drugs or antiretrovirals in general? (Check All that Apply)

• Drugs@FDA

• FDA’s Electronic Orange Book

• FDA’s Online NDC Directory

• FDA’s PEPFAR Website

• Industry Website

• USAID Website

• Third Party Websites/Other

• Internal Records

• None of the above

4. (a) Which resources do you currently use to find or compare drug information for PEPFAR drugs or antiretrovirals in general? (Check All that Apply)

• Drugs@FDA

• FDA’s Electronic Orange Book

• FDA’s Online NDC Directory

• FDA’s PEPFAR Website

• Industry Website

• USAID Website

• Third Party Websites/Other

• Internal Records

• None of the above

(Survey participants who answered 4.a are routed to concluding note to end survey)

4.(b) If you selected USAID, PEPFAR, Industry, or Third-party website for the pervious question (Q3), please provide the specific website you use to find or compare drug information for PEPFAR drugs or antiretroviral in general.

If the above does not apply, please enter “N/A”.

(Respondents who answered 4.b. proceed with questions 5-11)

5. What, if anything, do you want to change about the formatting and functionality of the PEPFAR database? (Rank with the top position (#1) representing the most desired category. All presented categories do not need to be ranked.)

• Increase promotion and general awareness of the database

• Add more PEPFAR statistics

• Provide additional instructions (e.g., video instructions or FAQs)

• Change Data Category Names

• Add links to other FDA sites (E.g., Drugs@FDA)

• Add more file type downloads

• Add more data categories

• Improve mobile friendliness

• Improve database layout

• Enhance data visualizations (e.g., add more dashboards)

• Add more sorting options

• Improve search functionality

6. If you have suggestions about how to improve the PEPFAR Database, please provide your ideas below.

7. What categories of drug information do you most want to see added to the PEPFAR database? (Rank with the top position (#1) representing your most desired category. All presented categories do not need to be ranked.

• Application supplement information ((Listings of approved supplements and information regarding their contents) Information about ARVs outside of PEPFAR (e.g., PrEP drugs)

• Therapeutically equivalent products, when applicable

• Historical labeling

• Patent and exclusivity information, when applicable

8. Thinking specifically about PEPFAR ARVs, what drug information is the most difficult to find? What is the easiest to find?

9. Please rate your overall satisfaction with the PEPFAR Database in its current state on a scale from one to five.

(1=Not at all satisfied, 3=Neutral or somewhat satisfied, 5=Completely satisfied).

10. What single change to the database would most increase your satisfaction? (E.g., specific bug fix, address reoccurring challenge, etc.)

11. What other general comments do you have regarding the PEPFAR Database that were not addressed in this survey?

(Concluding note) Thank you for participating in our survey! If you wish to share more feedback, please email us at PEPFAR@fda.hhs.gov