90 FR 122 pgs. 27625-27628 - Agency Information Collection Activities; Proposed Collection; Comment Request; Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and Issue Certifications
Type: NOTICEVolume: 90Number: 122Pages: 27625 - 27628
Pages: 27625, 27626, 27627, 27628Docket number: [Docket No. FDA-2024-N-5579]
FR document: [FR Doc. 2025-11962 Filed 6-26-25; 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-2024-N-5579]
Agency Information Collection Activities; Proposed Collection; Comment Request; Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and Issue Certifications
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
[top] 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
DATES:
Either electronic or written comments on the collection of information must be submitted by August 26, 2025.
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 August 26, 2025. 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-5579 for "Agency Information Collection Activities; Proposed Collection; Comment Request; Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and Issue Certifications." 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:
Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, 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.
Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and Issue Certifications-21 CFR Part 1, Subpart M
OMB Control Number 0910-0750-Extension
[top] This information collection supports FDA's Accredited Third-Party Certification Program (also referred to as the third-party food program or TPP), administered under section 808 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384d), and codified in 21 CFR part 1, subpart M (21
Under TPP, accreditation bodies (ABs) apply to FDA for recognition. Recognized ABs accredit third-party certification bodies (CBs) under the program, except in limited circumstances. The accredited CBs conduct food safety audits and issue food or facility certifications to eligible foreign entities. Section 808(c)(2)(B) of the FD&C Act specifies that FDA uses certifications issued by accredited CBs under TPP in deciding whether to admit certain imported food (both food for human and food for animals) into the United States that we have determined poses a food safety risk under section 801(q) of the FD&C Act (21 U.S.C. 381(q)) and in deciding whether an importer is eligible to participate in a program for expedited review and entry under section 806 of the FD&C Act (21 U.S.C. 384b). Under TPP, FDA may grant recognition of an AB for up to 5 years from the date of recognition. There are current AB participants that are recognized through fiscal year 2027 or 2028 and will need to submit renewal of recognition applications to continue their participation. Specific requirements and procedures are found in 21 CFR part 1, subpart M.
There are approximately 200,000 foreign food (both food for human and food for animals) exporters who offer their food products for import into the United States. These foreign food exporters include approximately 130,000 food production facilities and approximately 71,000 farms. A proportion of these foreign food exporters may offer food subject to mandatory certification requirements under section 801(q)(3) of the FD&C Act. In that case, to continue importing food products into the United States, eligible entities must either obtain certification from a CB accredited under TPP, or obtain certification from a foreign government designated by FDA. We assume in any given year, 75 foreign food exporters will be subject to requirements in section 801(q) of the FD&C Act.
Use of accredited CBs and food and facility certifications issued under TPP helps reduce the number of redundant audits necessary to assess compliance with food safety requirements of the FD&C Act and applicable regulations. We have developed Forms FDA 3997 and FDA 3997a to enable respondents to submit required data elements using FDA's Unified Registration Listing System (FURLS), an electronic portal (Forms FDA 3997 for ABs and 3997a for CBs) that enables respondents to complete data fields and provide information to FDA electronically. The AB and CB portals provide a standardized format for entering information, prompting respondents for input, and facilitating FDA's review of the submittal. Respondents are subject to user fees for application, renewal, and annual fees, as set forth in 21 CFR 1.700 through 1.725. The user fee rates are calculated each fiscal year and published in the Federal Register before the start of a new fiscal year. Electronic portal instructions and user fee information may be accessed at https://www.fda.gov/food/importing-food-products-united-states/accredited-third-party-certification-program.
Respondents to the collection of information are the accredited CBs that conduct audits and issue certifications to eligible entities, the ABs and CBs seeking to participate in TPP, and the recognized ABs and accredited CBs complying with the TPP requirements. An accredited CB is a foreign government, agency of a foreign government, foreign cooperative, or any other third party that a recognized AB (or, in the case of direct accreditation, FDA) has determined meets the applicable requirements of TPP and is accredited to conduct food safety audits and to issue food or facility certifications to eligible entities. An AB is an authority, such as a private third-party, foreign government, or foreign agency, that performs accreditation of CBs. A recognized AB is an AB that FDA has determined meets the applicable requirements of TPP and is authorized to accredit CBs under TPP.
We estimate the burden of the information collection as follows:
| 21 CFR part 1; subpart M | Number of respondents | Number of responses per respondent? 2 | Total annual responses | Average burden per response? 2 | Total hours |
|---|---|---|---|---|---|
| AB applications, applications for renewals, notifications, and revocations | 25 | 11.36 | 284 | 3.18 | 903 |
| CB certifications, regulatory audits and assessments, notifications | 208 | 147.30 | 30,638 | 0.25 (15 minutes) | 7,660 |
| CB applications for direct accreditation & renewal | 1 | 1 | 1 | 90 | 90 |
| Total | 30,923 | 8,653 | |||
| 1 ?There are no capital costs or operating and maintenance costs associated with annual reporting. | |||||
| 2 ?Figures rounded to nearest 1/100th as calculated based on total number of records and hours. | |||||
[top]
| 21 CFR part 1; subpart M | Number of recordkeepers | Number of records per recordkeeper? 2 | Total annual records | Average burden per recordkeeping? 2 | Total hours |
|---|---|---|---|---|---|
| AB documenting procedures for accreditation; maintaining applicable records | 25 | 426.56 | 10,664 | 0.25 (15 minutes) | 2,666 |
| AB establishing and updating public list of CBs | 25 | 1 | 25 | 52.8 | 1,320 |
| CB documenting certification procedures; maintaining applicable records (audits, certifications, serious risks) | 208 | 113.04 | 23,512 | 0.35 (~20 minutes) | 8,229 |
| CB establishing and updating public list of eligible entities | 208 | 1.31 | 273 | 44.19 | 12,064 |
| Contract modification | 7 | 9 | 63 | 2 | 126 |
| Total | 34,537 | 24,405 | |||
| 1 ?There are no capital or operating and maintenance costs associated with the annual recordkeeping burden. | |||||
| 2 ?Figures rounded to the nearest 1/100th as calculated based on total number of records and hours. | |||||
Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate.
Dated: June 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-11962 Filed 6-26-25; 8:45 am]
BILLING CODE 4164-01-P