2022-00559. Agency Information Collection Activities; Proposed Collection; Comment Request; Manufactured 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 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 the information collection provisions of the Manufactured Food Regulatory Program Standards.

DATES:

Submit either electronic or written comments on the collection of information by March 14, 2022.

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 March 14, 2022. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of March 14, 2022. 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-2010-N-0414 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Manufactured 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:

Rachel Showalter, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399, [e-mail].

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 extension 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.

Manufactured Food Regulatory Program Standards

OMB Control Number 0910-0601—Extension

This information collection supports FDA's “Manufactured Food Regulatory Program Standards” (2019) ( https://www.fda.gov/​media/​131392/​download ). We recommend that States use these program standards as the framework to design and manage their manufactured food programs. There are 44 State programs currently enrolled in the Manufactured Food Regulatory Program Standards (MFRPS) under cooperative agreements.

The goal of the MFRPS is to implement a nationally integrated, risk-based, food safety system focused on protecting public health. The MFRPS establish a uniform basis for measuring and improving the performance of prevention, intervention, and response activities of manufactured food regulatory programs in the United States. The development and implementation of the standards will help Federal and State programs better direct their regulatory activities toward reducing foodborne illness. For more information we invite you to visit our website at: https://www.fda.gov/​federal-state-local-tribal-and-territorial-officials/​regulatory-program-standards/​manufactured-food-regulatory-program-standards-mfrps.

FDA recommends that a State program enrolled in the MFRPS use the worksheets and forms contained in the standards; however, alternate forms that are equivalent may be used. The State program maintains documentation (guidance, procedures, documents, and forms) required by the 10 standards, which must be current and fit for use. In the first year of implementing the program standards, the State program conducts a baseline self-assessment of the documentation to determine if it meets the elements of each standard. The State program must participate in additional verification audits in subsequent years. After 5 years, FDA will conduct a comprehensive program audit of the documentation. As part of the program audit, the auditor reviews the records and supporting documents required by the criteria in each standard to determine if the self-assessment and improvement plan accurately reflect the State program's level of conformance with each of the standards. If the State program fails to meet all program elements and documentation requirements of a standard, it develops a strategic plan which includes the following: (1) The individual element of documentation requirement of the standard that was not met, (2) improvements needed to meet the program element or documentation requirement of the standard, and (3) projected completion dates for each task.

Description of Respondents: Respondents are State Departments of Agriculture or Health enrolled in the MFRPS (State Governments).

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

Table 1—Estimated Annual Reporting Burden  ¹

Type of respondent; activity	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
State Governments; Development and reporting of data consistent with MFRPS	44	1	44	569	25,036
1  There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2—Estimated Annual Recordkeeping Burden  ¹

Type of respondent; activity	Number of recordkeepers	Number of records per recordkeeper	Total annual records	Average burden per recordkeeping	Total hours
State Governments; Maintenance of data records consistent with MFRPS	44	10	440	40	17,600
1  There are no capital costs or operating and maintenance costs associated with this collection of information.

We have adjusted the number of respondents to the information collection to reflect the enrollment of an additional State since our last evaluation.

Dated: January 6, 2022.

Lauren K. Roth,

Associate Commissioner for Policy.