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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2021-N-0584]
 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 
                        ( print page 38166)
                        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, 
                        *PRAStaff@fda.hhs.gov.*


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: Table 1—Estimated Annual Reporting Burden 1
Awardee activity
Number of
                             respondents
Number of
                             responses per respondent
Total annual
                             responses
Average
                             burden per 
                             response
Total hoursInitial Report
400
1
400
10
4,000Updated Reports
400
2
800
40
32,000Supplement or Followup Report (if applicable)
100
1
100
10
1,000Total




37,0001
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
 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. Table 2—Estimated Annual Recordkeeping Burden 1
Awardee activity
Number of 
                             recordkeepers
Records per 
                             recordkeeper
Total annual 
                             records
Average 
                             burden per  
                             recordkeeping
Total hoursRecords related to Initial Report
400
1
400
0.5 hour (30 minutes)
200Records related to Updated Reports
400
2
800
0.5 hour (30 minutes)
400Records related to Supplement or Followup Report (if applicable)
100
1
100
0.5 hour (30 minutes)
50Total




6501
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
 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, 
                    ( print page 38167)
                    but no less than 3 years, as recommended by FDA (table 2). Table 3—Estimated Annual Third-Party Disclosure Burden 1
Awardee activity
Number of 
                             respondents
Number of 
                             disclosures per  
                             respondent
Total annual 
                             disclosures
Average 
                             burden per  
                             disclosure
Total hoursCoordination with partnering entities related to Initial Report
300
2
600
8
4,800Coordination with partnering entities related to Updated Reports
300
4
1,200
8
9,600Coordination with partnering entities related to Supplement or Followup Report (if applicable)
100
2
200
8
1,600Total




16,0001
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
 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.


[FR Doc. 2022-13642 Filed 6-24-22; 8:45 am] BILLING CODE 4164-01-P