Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by March 28, 2019.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to email@example.com. All comments should be identified with the OMB control number 0910-0752. Also include the FDA docket number found in brackets in the heading of this document.
Start Further Info
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, 301-796-3794, PRAStaff@fda.hhs.gov.
End Further Info
Start Supplemental Information
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Foreign Supplier Verification Programs (FSVP) for Food Importers
OMB Control Number 0910-0752—Extension
This information collection supports FDA regulations at 21 CFR part 1, subpart L—Foreign Supplier Verification Programs for Food Importers, as well as associated guidance. As amended by the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), the Federal Food, Drug, and Cosmetic Act (FD&C Act) enables the Agency to better protect the public health by helping to ensure the safety and security of the food supply. The regulations are intended to help ensure that food imported into the United States is produced in compliance with specific processes and procedures, including reasonably appropriate risk-based preventive controls. The regulations establish that importers of foods must develop, maintain, and follow an FSVP that provides adequate assurances that 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 regulatory requirements, we have developed Agency guidance, which is available at: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm253380.htm.
In the Federal Register of October 22, 2018 (83 FR 53271), we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
We estimate the burden for the information collection as follows:Start Printed Page 6153
Table 1—Estimated Annual Reporting Burden 1
|21 CFR section(s)||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|
|DUNS number for filing with U.S. Customs and Border Protection 1.509, 1.511, 1.512||56,800||157||8,917,600||0.02 (1.2 minutes)||178,352|
|1 There are no capital costs or operating and maintenance costs associated with this collection of information.|
Table 2—Estimated Annual Recordkeeping Burden 1
|Information collection activity; 21 CFR section(s)||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|
|FSVP Recordkeeping, including hazard determination, written procedures, reevaluation; audits; and corrective actions:|
|Determine and document hazards; 1.504(a)||11,701||1||11,701||3.5||40,954|
|Review hazard analysis; 1.504(d)||11,701||7||81,907||0.33 (20 minutes)||27,029|
|Evaluation of food and foreign supplier; 1.505(a)(2), 1.511(c)(1)||11,701||1||11,701||4||46,804|
|Approval of suppliers; 1.505(b), 1.512(c)(1)(iii)||8,191||1||8,191||12||928,292|
|Reevaluation of food and foreign supplier; 1.505(c), 1.512(c)(1)(ii)(A)||11,701||365||4,270,865||0.25 (15 minutes)||1,067,716|
|Confirm or change requirements of foreign supplier verification activity; 1.505(c), 1.512(c)(1)(ii)(A)||2,340||1||2,340||2||4,680|
|Review of other entities assessments; 1.505(d), 1.512(c)(1)(iii)||3,510||1||3,510||1.2||4,212|
|Written procedures for use of approved foreign suppliers; 1.506(a)(1), 1.511(c)(2), 1.512(c)(3)(i)||11,701||1||11,701||8||93,608|
|Review of written procedures; 1.506(a)(2), 1.511(c)(2)(ii), 1.512(c)(3)(ii)||11,701||1||11,701||1||11,701|
|Written procedures for conducting verification activities; 1.506(b), 1.511(c)(3)||11,701||1||11,701||2||23,402|
|Determination and documentation of appropriate supplier verification activities; 1.506(d)(1)-(2) 1.511(c)(5)(i)||11,701||4||46,804||3.25||152,113|
|Review of appropriate supplier verification activities determined by another entity; 1.506(d)(3) 1.511(c)(5)(iii)||11,701||2||23,402||0.33 (20 minutes)||7,723|
|Conduct/review audits; 1.506(e)(1)(i), 1.511(c)(4)(ii)(A)||11,701||2||23,402||3||70,206|
|Conduct periodic sampling/testing; 1.506(e)(1)(ii), 1.511(c)(4)(ii)(B)||11,701||2||23,402||1||23,402|
|Review records; 1.506(e)(1)(iii), 1.511(c)(4)(ii)(C)||11,701||2||23,402||1.6||37,443|
|Document your review of supplier verification activity records; 1.506(e)(3), 1.511(c)(4)(iii)||11,701||6||70,206||0.25 (15 minutes)||17,552|
|Document hazard controls; 1.507(a)(1)||11,701||3.17||37,092||1.25||46,365|
|Written assurances; 1.507(a)(2), (a)(3), and (a)(4)||11,701||8.72||102,038||0.50 (30 minutes)||51,019|
|Disclosures that accompany assurances; 1.507(a)(2), (a)(3), and (a)(4)||102,038||1||102,038||0.50 (30 minutes)||51,019|
|Document assurances from customers; 1.507(c)||36,522||2.8||102,262||0.25 (15 minutes)||25,566|
|Document corrective actions; 1.508(a), 1.512(b)(4)||2,340||1||2,340||2||4,680|
|Investigate and determine FSVP adequacy; 1.508(b), 1.511(c)(1)||2,340||1||2,340||5||11,700|
|Subtotal for FSVP Recordkeeping Itemized Above||4,984,046||1,917,186|
|Written assurances for food produced under dietary supplement current good manufacturing practices; 1.511(b)||11,701||2.88||33,699||2.25||75,823|
|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||2.8||141,260||2.25||317,835|
|Start Printed Page 6154|
|1 There are no capital costs or operating and maintenance costs associated with the information collection.|
We are retaining the currently approved burden estimates. The FSVP requirements became effective May 30, 2017, and we continue to evaluate associated burden.
End Supplemental Information
Dated: February 21, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03282 Filed 2-25-19; 8:45 am]
BILLING CODE 4164-01-P