The eRulemaking Program

31/07/2024 | Press release | Distributed by Public on 31/07/2024 20:12

Agency Information Collection Activities; Proposals, Submissions, and Approvals: Food Safety and Nutrition Survey

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-3029]

Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Food Safety and Nutrition Survey

Agency

Food and Drug Administration, HHS.

Action

Notice.

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 reinstatement of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on a collection of information used to conduct a voluntary consumer survey entitled, "FDA Food Safety and Nutrition Survey."

Dates

Either electronic or written comments on the collection of information must be submitted by September 30, 2024.

Addresses

You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of September 30, 2024. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.

Electronic Submissions

Submit electronic comments in the following way:

Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.

  • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see "Written/Paper Submissions" and "Instructions").

Written/Paper Submissions

Submit written/paper submissions as follows:

Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

  • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in "Instructions."

Instructions: All submissions received must include the Docket No. FDA-2024-N-3029 for "Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Food Safety and Nutrition Survey." Received comments, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as "Confidential Submissions," publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

• Confidential Submissions-To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states "THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION." The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as "confidential." Any information marked as "confidential" will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the "Search" box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

For Further Information Contact

JonnaLynn Capezzuto, 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

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, including each proposed reinstatement of an existing 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.

Food Safety and Nutrition Survey

OMB Control Number 0910-0345-Reinstatement

Under section 1003(b)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(b)(2)), we are authorized to conduct research relating to foods and to conduct educational and public information programs relating to the safety of the nation's food supply. In the past, FDA has conducted two separate surveys, a Food Safety Survey and a Health and Diet Survey, to measure consumers' knowledge, attitudes, and beliefs about food safety and nutrition issues. These surveys have been conducted every 3 to 5 years since the 1980s. In the Federal Register of August 14, 2018 (83 FR 40293), we announced the combination of these two surveys, which will now be the FDA Food Safety and Nutrition Survey (FSANS). Data from FDA's food safety and nutrition surveys have been used to support rulemaking and educational campaigns and to measure progress toward Healthy People 2010, 2020, and 2030 food safety goals. The proposed 2024 FSANS will contain many of the same questions and topics as the previous surveys to facilitate measuring trends in food safety and diet knowledge, attitudes, and behaviors over time. The proposed survey will also be updated to explore emerging consumer food safety and nutrition topics and to expand understanding of previously asked topics.

The 2024 FSANS will be both a paper-and-pencil and web-based survey. Respondents will be contacted by postal mail, using an addressed-based sampling frame. Once contacted, respondents will be encouraged to take the survey online. A paper-and-pencil version of the survey will be mailed to those who do not initially take the web-based version of the survey. One randomly selected adult from each sampled household will be invited to participate in the survey using the Hagen-Collier method. (1) A total of 5,000 respondents will be surveyed. We will sample approximately 25,000 households to offset nonresponding households and ineligible addresses and achieve 5,000 adult respondents. Participation in the survey will be voluntary. Cognitive interviews and a pre-test will be conducted prior to fielding the survey.

Description of Respondents: Respondents to this collection of information are individuals who are adults, age 18 and older, drawn from the 50 states and the District of Columbia.

FDA estimates the burden of this collection of information as follows:

Table 1-Estimated Annual Reporting Burden  1
Activity Number of respondents Number of responses perrespondent Total annual responses Average burden per response Total hours
Cognitive interview screener 75 1 75 0.083 (5 minutes) 6
Cognitive interview 18 1 18 1 18
Pretest 100 1 100 0.33 (20 minutes) 33
Mail survey 5,000 1 5,000 0.33 (20 minutes) 1,650
Total 5,193 1,707
1  There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA's burden estimate is based on the Agency's prior experience with food safety and nutrition surveys. We will use a cognitive interview screener with 75 individuals to recruit prospective interview participants for a total of 18 individuals. We estimate that it will take each screener respondent approximately 5 minutes (0.083 hours) to complete the cognitive interview screener, for a total of 6 hours. We will conduct cognitive interviews with 18 participants. We estimate that it will take each participant approximately 1 hour to complete the interview, for a total of 18 hours. Prior to the administration of the surveys, the Agency plans to conduct a pretest to identify and resolve potential survey administration problems. The pretest will be conducted with 100 participants; we estimate that it will take each participant 20 minutes (0.33 hours) for the pretest for a total of 33 hours. We estimate that 5,000 eligible adults will participate in the survey with each taking 20 minutes (0.33 hours), for a total of 1,650 hours. Thus, the total estimated burden is 1,707 hours.

Dated: July 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-16832 Filed 7-30-24; 8:45 am]
BILLING CODE 4164-01-P

Footnotes

(1)  In this method, we randomly select a category based on gender and age (based on the gender-age composition of the household), and then take the adult in that selected category.