Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Foreign Supplier Verification Programs for Food Importers

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0143]

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Foreign Supplier Verification Programs for Food Importers

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

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.

DATES:

Fax written comments on the collection of information by March 28, 2019.

ADDRESSES:

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

oira_submission@omb.eop.gov.

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.

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.

SUPPLEMENTARY 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:

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

Total

299,067

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

Total

2,361,294

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.

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