87 FR 19 pgs. 4607-4609 - Agency Information Collection Activities; Proposed Collection; Comment Request; Foreign Supplier Verification Programs for Food Importers
Type: NOTICEVolume: 87Number: 19Pages: 4607 - 4609
Pages: 4607, 4608, 4609Docket number: [Docket No. FDA-2017-D-5225]
FR document: [FR Doc. 2022-01796 Filed 1-27-22; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
[top]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-5225]
Agency Information Collection Activities; Proposed Collection; Comment Request; Foreign Supplier Verification Programs for Food Importers
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 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 requirements associated with our Foreign Supplier Verification Programs for Food Importers.
DATES:
Submit either electronic or written comments on the collection of information by March 29, 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 29, 2022. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of March 29, 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-2017-D-5225 for "Agency Information Collection Activities; Proposed Collection; Comment Request; Foreign Supplier Verification Programs for Food Importers." 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.
[top] • 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
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 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.
Foreign Supplier Verification Programs (FSVP) for Food Importers-21 CFR Part 1, Subpart L
OMB Control Number 0910-0752-Extension
This information collection supports FDA regulations in 21 CFR part 1, subpart L (21 CFR 1.500 through 1.514), which help to implement section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384a). Section 805 authorizes the Agency's FSVP and establishes requirements applicable to imported food. Respondents to the information collection are importers, as defined in section 805(a)(1) of the FD&C Act. The regulations are intended to provide verification that imported food is produced in compliance with statutory requirements that include the implementation of appropriate risk-based preventive controls. The regulations also establish that importers of foods must develop, maintain, and follow an FSVP that provides adequate assurances a foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 of the FD&C Act (21 U.S.C. 350g) (regarding hazard analysis and risk-based preventive controls for certain foods) or 419 (21 U.S.C. 350h) (regarding standards for produce safety), if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 (21 U.S.C. 342) (regarding adulteration) and 403(w) (21 U.S.C. 343(w)) (if applicable) (regarding misbranding with respect to labeling for the presence of major food allergens) of the FD&C Act. The regulations also provide for certain exemptions. To assist respondents with understanding the requirements we have developed Agency guidance, available at: https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.
Specifically, regulations in 21 CFR 1.501 set forth the applicability of requirements for FSVP, while regulations in sections 1.502 through 1.508, prescribe specific activities for developing, maintaining, and following an FSVP; as well as for evaluating compliance and for identifying and correcting hazards. Finally, regulations in section 1.509 identify required data elements applicable to food products offered for importation into the United States, while regulations in 1.510 govern required records, providing that records be made available to FDA upon request and that records be maintained electronically. On May 10, 2021, FDA launched the FSVP Importer Portal for FSVP Records Submission as a means for importers to upload FSVP records electronically and submit them to the Agency, after receiving a request for records from FDA. The portal may be found at https://www.access.fda.gov/, and a user guide is available at https://www.fda.gov/media/148312/download.
We estimate the burden for the information collection as follows:
[top]
| 21 CFR section | Number of respondents | Number of responses per respondent | Total annual responses | Average burden per response | Total hours |
|---|---|---|---|---|---|
| Exemption for food for research; 1.501(c) | 36,360 | 40 | 1,454,400 | 0.083 (5 minutes) | 120,715 |
| Identifier for filing with U.S. Customs and Border Protection; 1.509 | 56,800 | 157 | 8,917,600 | 0.02 (1.2 minutes) | 178,352 |
| Total | 10,372,000 | 299,067 | |||
| 1 ?There are no capital costs or operating and maintenance costs associated with the information collection. | |||||
| Information collection activity; 21 CFR section | Number of recordkeepers | Number of records per recordkeeper | Total annual records | Average burden per recordkeeping | Total hours |
|---|---|---|---|---|---|
| Controls for low-acid canned foods; 1.502(b) | 2,443 | 4 | 9,772 | 1 | 9,772 |
| Hazard determinations, controls, and audits; 1.504, 1.506, 1.511 | 56,800 | 87.74 | 4,984,036 | 0.38 (23 minutes) | 1,917,174 |
| Written assurances for food produced under dietary supplement current good manufacturing practices; 1.511 | 11,701 | 2.88 | 33,664 | 2.25 | 75,744 |
| Document very small importer/certain small foreign supplier status; 1.512(b)(1) | 50,450 | 1 | 50,450 | 1 | 50,450 |
| Written assurances associated with very small importer/certain small foreign supplier; 1.512(b)(3) | 50,450 | 2.79 | 141,084 | 2.25 | 317,439 |
| Total | 5,219,006 | 2,370,579 | |||
| 1 ?There are no capital costs or operating and maintenance costs associated with the information collection. | |||||
| 2 ?Figures have been rounded to the nearest one hundredth. | |||||
Upon evaluation of the information collection, we are retaining the currently approved burden estimates.
Dated: January 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01796 Filed 1-27-22; 8:45 am]
BILLING CODE 4164-01-P