# Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Pilot Survey To Develop Standardized Reporting Forms for Federally Funded Public Health Projects
**AGENCY:**
Food and Drug Administration, HHS.
**ACTION:**
Notice.
**SUMMARY:**
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
**DATES:**
Submit written comments (including recommendations) on the collection of information by July 27, 2022.
**ADDRESSES:**
To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to *https://www.reginfo.gov/public/do/PRAMain.* Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. The title of this information collection is Pilot Survey to Develop Standardized Reporting Forms for Federally Funded Public Health Projects. Also include the FDA docket number found in brackets in the heading of this document.
**FOR FURTHER INFORMATION CONTACT:**
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, *[email protected].*
**SUPPLEMENTARY INFORMATION:**
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
**Pilot Survey To Develop Standardized Reporting Forms for Federally Funded Public Health Projects**
**OMB Control Number 0910-NEW**
This information collection supports federally funded public health projects administered by the Agency's Office of Regulatory Affairs (ORA). As part of FDA's efforts to protect the public health, we work collaboratively with State partners to enhance oversight of FDA-regulated products. Consistent with applicable regulations pertaining to federally funded programs, we currently collect information related to an awardee's progress in completing agreed-upon performance metrics 3 to 4 times a year during the reporting period. Respondents to the information collection are recipients of FDA-funded projects who submit required information to FDA in free text and narrative form via portable document format. To increase our efficiency in evaluating program effectiveness and return-on-investment (ROI)/return-on-value (ROV) for the federally funded projects that we administer, we intend to develop and establish the use of digital forms that contain standardized questions to capture data elements necessary to measure/track ROI/ROV. We believe the use of standardized forms will reduce the time required by awardees in completing and submitting progress reports.
As part of the pilot, respondents will complete an initial report and progress/performance reports, which include data fields to identify the award project and contact person and directs specific questions to respondents regarding project and progress updates. Based on public feedback, we hope to revise the reports, tailoring for project specificity and purpose, to include, but not limited to, improvements, such as drop-down menu selections and potential common response indicators that will reduce time for respondents and allow us to more quickly process information and determine impacts at the Agency level. As information will be requested of actively funded projects, it may become necessary to request additional information for a particular project to complete the performance evaluation(s) in a timely manner. To ensure data is sufficient, on a case-by-case basis, FDA anticipates a need for followup questionnaire(s) to supplement the progress reports as instruments of collection are developed and fine-tuned through this effort.
In the *Federal Register* of July 29, 2021 (86 FR 40853), we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
We estimate the burden of the information collection as follows:
| Awardee activity | Number of | Number of | Total annual | Average | Total hours |
| --- | --- | --- | --- | --- | --- |
| Initial Report | 400 | 1 | 400 | 10 | 4,000 |
| Updated Reports | 400 | 2 | 800 | 40 | 32,000 |
| Supplement or Followup Report (if applicable) | 100 | 1 | 100 | 10 | 1,000 |
| Total | | | | | 37,000 |
We estimate that 400 respondents will participate under this pilot project and will submit an average of 3 to 4 reports within a single budget year (table 1). To ensure adequate reporting will be achieved over the course of this pilot, the option for a supplement or followup report is included in the estimated reporting burden; however, the need for these reports will be determined on a case-by-case basis with the FDA project manager.
| Awardee activity | Number of | Records per | Total annual | Average | Total hours |
| --- | --- | --- | --- | --- | --- |
| Records related to Initial Report | 400 | 1 | 400 | 0.5 hour (30 minutes) | 200 |
| Records related to Updated Reports | 400 | 2 | 800 | 0.5 hour (30 minutes) | 400 |
| Records related to Supplement or Followup Report (if applicable) | 100 | 1 | 100 | 0.5 hour (30 minutes) | 50 |
| Total | | | | | 650 |
Recordkeeping activities include storing and maintaining records related to submitting a request to participate in the project and compiling reports. Respondents should use current record retention capabilities for electronic or paper storage to achieve these activities. We assume it will take 0.5 hour/year to ensure the documents related to submitting a request to participate in the program are retained properly according to their existing recordkeeping policies, but no less than 3 years, as recommended by FDA (table 2).
| Awardee activity | Number of | Number of | Total annual | Average | Total hours |
| --- | --- | --- | --- | --- | --- |
| Coordination with partnering entities related to Initial Report | 300 | 2 | 600 | 8 | 4,800 |
| Coordination with partnering entities related to Updated Reports | 300 | 4 | 1,200 | 8 | 9,600 |
| Coordination with partnering entities related to Supplement or Followup Report (if applicable) | 100 | 2 | 200 | 8 | 1,600 |
| Total | | | | | 16,000 |
For those pilot projects that involve a participant composed of partnering entities in the program, FDA is taking into consideration the time that partnering entities will spend coordinating with each other in a pilot project. We estimate that 300 respondents will work with their respective partnering entities and the average number of partnering entities will be 2. We assume each respondent will spend 8 hours coordinating with each partnering entity on each response for this pilot. We estimate that seven respondents will need to coordinate with an average of two partnering entities to create updated reports and the final report to submit to FDA (table 3).
Dated: June 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.