| Page Range | 53271-53273 | |
| FR Document | 2018-22953 |
[Federal Register Volume 83, Number 204 (Monday, October 22, 2018)] [Notices] [Pages 53271-53273] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-22953] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0143] 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 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 requirements associated with our Foreign Supplier Verification Programs (FSVP) for Food Importers. DATES: Submit either electronic or written comments on the collection of information by December 21, 2018. 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 December 21, 2018. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 21, 2018. 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-2011-N-0143 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. 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.thefederalregister.org/fdsys/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. 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, [email protected]. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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 [[Page 53272]] 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 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 the requirements we have developed Agency guidance, which is available at: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm253380.htm. We estimate the burden of the information collection is as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR section Number of responses per Total annual Average burden per response Total hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- 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 56,800 157 8,917,600 0.02 (1.2 minutes)....................... 178,352 Border Protection 1.509(c), 1.511(c), 1.512(b)(2). ---------------------------------------------------------------------------------------------------------- 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\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Information collection activity; 21 CFR Number of records per Total annual Average burden per recordkeeping Total hours section recordkeepers recordkeeper records -------------------------------------------------------------------------------------------------------------------------------------------------------- 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; 11,701 1 11,701 4........................................ 46,804 1.505(a)(2), 1.511(c)(1). Approval of suppliers; 1.505(b), 8,191 1 8,191 12....................................... 98,292 1.512(c)(1)(iii). Reevaluation of food and foreign 11,701 365 4,270,865 0.25 (15 minutes)........................ 1,067,716 supplier; 1.505(c), 1.512(c)(1)(ii)(A). Confirm or change requirements of foreign 2,340 1 2,340 2........................................ 4,680 supplier verification activity; 1.505(c), 1.512(c)(1)(ii)(A). Review of other entities assessments; 3,510 1 3,510 1.2...................................... 4,212 1.505(d), 1.512(c)(1)(iii). Written procedures for use of approved 11,701 1 11,701 8........................................ 93,608 foreign suppliers; 1.506(a)(1), 1.511(c)(2), 1.512(c)(3)(i). Review of written procedures; 11,701 1 11,701 1........................................ 11,701 1.506(a)(2), 1.511(c)(2)(ii), 1.512(c)(3)(ii). [[Page 53273]] Written procedures for conducting 11,701 1 11,701 2........................................ 23,402 verification activities; 1.506(b), 1.511(c)(3). Determination and documentation of 11,701 4 46,804 3.25..................................... 152,113 appropriate supplier verification activities; 1.506(d)(1)-(2), 1.511(c)(5)(i). Review of appropriate supplier 11,701 2 23,402 0.33 (20 minutes)........................ 7,723 verification activities determined by another entity; 1.506(d)(3), 1.511(c)(5)(iii). Conduct/review audits; 1.506(e)(1)(i), 11,701 2 23,402 3........................................ 70,206 1.511(c)(4)(ii)(A). Conduct periodic sampling/testing; 11,701 2 23,402 1........................................ 23,402 1.506(e)(1)(ii), 1.511(c)(4)(ii)(B). Review records; 1.506(e)(1)(iii), 11,701 2 23,402 1.6...................................... 37,443 1.511(c)(4)(ii)(C). Document your review of supplier 11,701 6 70,206 0.25 (15 minutes)........................ 17,552 verification activity records; 1.506(e)(3), 1.511(c)(4)(iii). 1.507(a)(1).............................. 11,701 3.17 37,092 1.25..................................... 46,365 Written assurances; 1.507(a)(2), 11,701 8.72 102,038 0.50 (30 minutes)........................ 51,019 1.507(a)(3), and 1.507(a)(4). Disclosures that accompany assurances; 102,038 1 102,038 0.50 (30 minutes)........................ 51,019 1.507(a)(2), 1.507(a)(3), and 1.507(a)(4). Document assurances from customers; 36,522 2.8 102,262 0.25 (15 minutes)........................ 25,566 1.507(c). Document corrective actions; 1.508(a) and 2,340 1 2,340 2........................................ 4,680 1.512(b)(4). Investigate and determine FSVP adequacy; 2,340 1 2,340 5........................................ 11,700 1.508(b), 1.511(c)(1). ---------------------------------------------------------------------------------------------------------- Subtotal for FSVP Recordkeeping .............. .............. 4,984,046 ......................................... 1,917,186 Itemized Above. ========================================================================================================== Written assurances for food produced 11,701 2.88 33,699 2.25..................................... 75,823 under dietary supplement current good manufacturing practices; 1.511(b). Document very small importer/certain 50,450 1 50,450 1........................................ 50,450 small foreign supplier status; 1.512(b)(1). Written assurances associated with very small 50,450 2.8 141,260 2.25..................................... 317,835 importer/certain small foreign supplier 1.512(b)(3). ---------------------------------------------------------------------------------------------------------- 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: October 16, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-22953 Filed 10-19-18; 8:45 am] BILLING CODE 4164-01-P
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on the collection of information by December 21, 2018. | |
| 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, [email protected] | |
| FR Citation | 83 FR 53271 |