Agency Information Collection Activities; Proposed Collection; Comment Request; Food Safety; Federal-State Food Regulatory Program Standards

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) 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 revision of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection associated with FDA's Federal-State Food Regulatory Program Standards.

DATES:

Submit either electronic or written comments on the collection of information by July 13, 2021.

ADDRESSES:

You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 13, 2021. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of July 13, 2021. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is 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-2021-N-0341 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Food Safety; Federal-State Food Regulatory Program Standards.” 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:

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:

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 revision 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; Federal-State Food Regulatory Program Standards

OMB Control Number 0910-0760—Revision

This information collection supports implementation of FDA's Federal-State Regulatory Program Standards, part of our National Integrated Food Safety System (IFSS) Programs and Initiatives. For more information we invite you to visit our website at: https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/national-integrated-food-safety-system-ifss-programs-and-initiatives. In the United States, Federal and State governments work cooperatively to ensure the safety of food intended for both human and animal consumption. Part of this effort includes developing and maintaining uniform review criteria by which to assess food safety. FDA has established and maintains a number of program standards aimed at improving the safety evaluation for certain food products including manufactured foods and animal feed. Similarly, we are establishing regulatory program standards for eggs and have developed the “Eggs Regulatory Program Standards” (ERPS). The ERPS is intended for use by State and local regulatory officials and identifies ten elements we believe are essential to the effective regulatory assessment of egg safety. States are encouraged to build systems that are sustainable and implement plans corresponding to the IFSS.

In the course of their normal duties, State, local, Territorial, and Tribal governments collect information pertaining to compliance with the respective State, local, Territorial, and tribal food safety requirements within their jurisdictions. Although content and format of the information collected may vary, these activities are a usual and customary part of routine regulatory oversight. Respondents to the information collection are State, local, Territorial, Tribal, and Federal regulatory agencies participating in FDA's Voluntary National Retail Food Regulatory Program Standards (information collection currently approved under OMB control number 0910-0621). Consistent with the ERPS, respondents will submit the following information to FDA: (1) Program self-assessment; (2) risk factor study of the regulated industry; and (3) independent outside audit (verification audit).

The ERPS offers forms, worksheets, and templates to help respondents assess and meet the program elements identified and discussed. Respondents are not required to use the sample collection instruments included in the ERPS, however all data elements should be submitted to FDA and supporting documentation retained. The ERPS is not intended to address any performance appraisal processes that any State, local, Territorial, or tribal agency may use to evaluate its employees' performance. Funding opportunities are available to respondents who choose to implement the ERPS, however these opportunities are limited and contingent upon the availability of funds, and to those respondents who currently have an egg inspection contract with FDA and thus subject to auditing. A copy of the ERPS has been posted to FDA-2021-N-0341 and is available at https://www.regulations.gov.

We estimate the burden of the information collection as follows:

Based on our experience with similar information collection, we estimate an initial 10 respondents will participate in the ERPS, and assume an average of 500 hours is necessary for the attendant recordkeeping and submission of data elements to FDA. We expect participation in the ERPS to increase.