Rules and Regulations. Notice

Agency: Food and Drug Administration, HHS
Action: Notice
Citation: FR Doc. 2021-16192 · Docket No. FDA-2021-N-0584

Summary

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with a pilot survey to develop standardized reporting forms for capturing performance data for federally funded public health projects.

Dates

Submit either electronic or written comments on the collection of information by September 27, 2021.

Supplementary Information

Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. 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 performance 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 (pdf). 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. 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 hours Initial Report 400 1 400 10 4,000 Progress Reports 400 2 800 40 32,000 Supplement or Followup Report (if applicable) 100 1 100 10 1,000 Total 37,000 1 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 Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours Records related to Initial Report 400 1 400 0.5 hour (30 minutes) 200 Records related to Progress 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 1 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, 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 hours Coordination with partnering entities related to Initial Report 300 2 600 8 4,800 Coordination with partnering entities related to Progress 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 1 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 progress reports and the final report to submit to FDA (table 3). Dated: July 26, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021-16192 Filed 7-28-21; 8:45 am]