Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2022, 40571-40574 [2021-16056]

Download as PDF khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices days after FDA grants the sponsor’s request for a BPD meeting for that product or upon the date of submission by the sponsor of an IND describing an investigation that FDA determines is intended to support a biosimilar biological product application for that product. The application fee for a biosimilar biological product is due upon submission of the application (see section 744H(a)(2)(C) of the FD&C Act). To make a payment of the initial BPD, reactivation, or application fee, complete the Biosimilar User Fee Cover Sheet, available on FDA’s website (https://www.fda.gov/bsufa) and generate a user fee identification (ID) number. Payment must be made in U.S. currency by electronic check, check, bank draft, U.S. postal money order, or wire transfer. The preferred payment method is online using electronic check (Automated Clearing House (ACH) also known as eCheck) or credit card (Discover, VISA, MasterCard, American Express). FDA has partnered with the U.S. Department of the Treasury to use Pay.gov, a web-based payment application, for online electronic payment. The Pay.gov feature is available on the FDA website after the user fee ID number is generated. Secure electronic payments can be submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay (Note: Only full payments are accepted. No partial payments can be made online). Once you search for your invoice, click ‘‘Pay Now’’ to be redirected to Pay.gov. Electronic payment options are based on the balance due. Payment by credit card is available for balances that are less than $25,000. If the balance exceeds this amount, only the ACH option is available. Payments must be made using U.S. bank accounts as well as U.S. credit cards. If a check, bank draft, or postal money order is submitted, make it payable to the order of the Food and Drug Administration and include the user fee ID number to ensure that the payment is applied to the correct fee(s). Payments can be mailed to: Food and Drug Administration, P.O. Box 979108, St. Louis, MO 63197–9000. If a check, bank draft, or money order is to be sent by a courier that requests a street address, the courier should deliver your payment to: U.S. Bank, Attention: Government Lockbox 979108, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank address is for courier delivery only. If you have any questions concerning courier delivery, contact U.S. Bank at 314–418–4013. This telephone number is only for questions about courier delivery.) Please make VerDate Sep<11>2014 17:16 Jul 27, 2021 Jkt 253001 sure that the FDA post office box number (P.O. Box 979108) and ID number is written on the check, bank draft, or postal money order. For payments made by wire transfer, include the unique user fee ID number to ensure that the payment is applied to the correct fee(s). Without the unique user fee ID number, the payment may not be applied. The originating financial institution may charge a wire transfer fee. Include applicable wire transfer fees with payment to ensure fees are fully paid. Questions about wire transfer fees should be addressed to the financial institution. The following account information should be used to send payments by wire transfer: U.S. Department of the Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No.: 75060099, Routing No.: 021030004, SWIFT: FRNYUS33. FDA’s tax identification number is 53– 0196965. B. Annual BPD and Program Fees FDA will issue invoices with payment instructions for FY 2022 annual BPD and program fees under the new fee schedule in August 2021. Payment will be due on October 1, 2021. If sponsors join the BPD program after the annual BPD invoices have been issued in August 2021, FDA will issue invoices in December 2021 to firms subject to fees for FY 2022 that qualify for the annual BPD fee after the August 2021 billing. FDA will issue invoices in December 2021 for any annual program fees for FY 2022 that qualify for fee assessments and were not issued in August 2021. Dated: July 23, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–16084 Filed 7–27–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–0701] Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2022 Food and Drug Administration, Health and Human Services (HHS). ACTION: Notice. AGENCY: The Food and Drug Administration (FDA or Agency) is announcing the fiscal year (FY) 2022 fee rates for certain domestic and foreign SUMMARY: PO 00000 Frm 00128 Fmt 4703 Sfmt 4703 40571 facility reinspections, failures to comply with a recall order, and importer reinspections that are authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). These fees are effective on October 1, 2021, and will remain in effect through September 30, 2022. FOR FURTHER INFORMATION CONTACT: Jimmy Carlton, Office of Management, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857,240–888– 1556,jimmy.carlton@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background Section 107 of FSMA (Pub. L. 111– 353) added section 743 to the FD&C Act (21 U.S.C. 379j–31) to provide FDA with the authority to assess and collect fees from, in part: (1) The responsible party for each domestic facility and the U.S. agent for each foreign facility subject to a reinspection, to cover reinspectionrelated costs; (2) the responsible party for a domestic facility and an importer who does not comply with a recall order, to cover food 1 recall activities associated with such order; and (3) each importer subject to a reinspection to cover reinspection-related costs (sections 743(a)(1)(A), (B), and (D) of the FD&C Act). Section 743 of the FD&C Act directs FDA to establish fees for each of these activities based on an estimate of 100 percent of the costs of each activity for each year (sections 743(b)(2)(A)(i), (ii), and (iv)), and these fees must be made available solely to pay for the costs of each activity for which the fee was incurred (section 743(b)(3)). These fees are effective on October 1, 2021, and will remain in effect through September 30, 2022. Section 743(b)(2)(B)(iii) of the FD&C Act directs FDA to develop a proposed set of guidelines in consideration of the burden of fee amounts on small businesses. As a first step in developing these guidelines, FDA invited public comment on the potential impact of the fees authorized by section 743 of the FD&C Act on small businesses (76 FR 45818, August 1, 2011). The comment period for this request ended November 30, 2011. As stated in FDA’s September 2011 ‘‘Guidance for Industry: Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act,’’ (https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents/ guidance-industry-implementation-fee1 The term ‘‘food’’ for purposes of this document has the same meaning as such term in section 201(f) of the FD&C Act (21 U.S.C. 321(f)). E:\FR\FM\28JYN1.SGM 28JYN1 40572 Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices provisions-section-107-fda-food-safetymodernization-act), because FDA recognizes that for small businesses the full cost recovery of FDA reinspection or recall oversight could impose severe economic hardship, FDA intends to consider reducing certain fees for those firms. FDA does not intend to issue invoices for reinspection or recall order fees until FDA publishes a guidance document outlining the process through which firms may request a reduction in fees. In addition, as stated in the September 2011 Guidance, FDA is in the process of considering various issues associated with the assessment and collection of importer reinspection fees. The fee rates set forth in this notice will be used to determine any importer reinspection fees assessed in FY 2022. II. Estimating the Average Cost of a Supported Direct FDA Work Hour for FY 2022 FDA is required to estimate 100 percent of its costs for each activity in order to establish fee rates for FY 2022. In each year, the costs of salary (or personnel compensation) and benefits for FDA employees account for between 50 and 60 percent of the funds available to, and used by, FDA. Almost all of the remaining funds (operating funds) available to FDA are used to support FDA employees for paying rent, travel, utility, information technology (IT), and other operating costs. khammond on DSKJM1Z7X2PROD with NOTICES A. Estimating the Full Cost per Direct Work Hour in FY 2022 Full-time Equivalent (FTE) reflects the total number of regular straight-time hours—not including overtime or holiday hours—worked by employees, divided by the number of compensable hours applicable to each fiscal year. Annual leave, sick leave, compensatory time off, and other approved leave categories are considered ‘‘hours worked’’ for purposes of defining FTE employment. In general, the starting point for estimating the full cost per direct work hour is to estimate the cost of an FTE or paid staff year. Calculating an Agency-wide total cost per FTE requires three primary cost elements: Payroll, non-payroll, and rent. We have used an average of past year cost elements to predict the FY 2022 cost. The FY 2022 FDA-wide average cost for payroll (salaries and benefits) is $171,228; non-payroll—including equipment, supplies, IT, general and administrative overhead—is $101,625; and rent, including cost allocation analysis and adjustments for other rent VerDate Sep<11>2014 17:16 Jul 27, 2021 Jkt 253001 and rent-related costs, is $23,597 per paid staff year, excluding travel costs. Summing the average cost of an FTE for payroll, non-payroll, and rent, brings the FY 2022 average fully supported cost to $296,450 per FTE, excluding travel costs. FDA will use this base unit fee in determining the hourly fee rate for reinspection and recall order fees for FY 2022 prior to including domestic or foreign travel costs as applicable for the activity. To calculate an hourly rate, FDA must divide the FY 2022 average fully supported cost of $296,450 per FTE by the average number of supported direct FDA work hours in FY 2020—the last fiscal year for which data are available. See table 1. TABLE 1—SUPPORTED DIRECT FDA WORK HOURS IN A PAID STAFF YEAR IN FY 2020 Total number of hours in a paid staff year ... Less: 10 paid holidays ........................................ 20 days of annual leave ............................ 10 days of sick leave ................................. 12.5 days of training .................................. 26.5 days of general administration .......... 26.5 days of travel ..................................... 2 hours of meetings per week ................... 2,080 ¥80 ¥160 ¥80 ¥100 ¥184 ¥212 ¥104 Net Supported Direct FDA Work Hours Available for Assignments ..................... 1,160 Dividing the average fully supported FTE cost in FY 2022 ($296,450) by the total number of supported direct work hours available for assignment in FY 2022 (1,160) results in an average fully supported cost of $256 (rounded to the nearest dollar), excluding inspection travel costs, per supported direct work hour in FY 2022. B. Adjusting FY 2020 Travel Costs for Inflation To Estimate FY 2022 Travel Costs To adjust the hourly rate for FY 2022, FDA must estimate the cost of inflation in each year for FY 2021 and FY 2022. FDA uses the method prescribed for estimating inflationary costs under the Prescription Drug User Fee Act (PDUFA) provisions of the FD&C Act (section 736(c)(1) (21 U.S.C. 379h(c)(1)), the statutory method for inflation adjustment in the FD&C Act that FDA has used consistently. FDA previously determined the FY 2021 inflation rate to be 1.3493 percent; this rate was published in the FY 2021 PDUFA user fee rates notice in the Federal Register (August 3, 2020, 85 FR 46651). Utilizing the method set forth in section 736(c)(1) of the FD&C Act, FDA has calculated an inflation rate of 1.3493 percent for FY 2021 and 2.2013 percent for FY 2022, and FDA intends to use these inflation PO 00000 Frm 00129 Fmt 4703 Sfmt 4703 rates to make inflation adjustments for FY 2022 for several of its user fee programs; the derivation of this rate will be published in the Federal Register in the FY 2022 notice for the PDUFA user fee rates. The average fully supported cost per supported direct FDA work hour, excluding travel costs, of $256 already takes into account inflation as the calculation above is based on FY 2022 predicted costs. FDA will use this base unit fee in determining the hourly fee rate for reinspection and recall order fees for FY 2022 prior to including domestic or foreign travel costs as applicable for the activity. In FY 2020, FDA’s Office of Regulatory Affairs (ORA) spent a total of $3,831,758 for domestic regulatory inspection travel costs and General Services Administration Vehicle costs related to FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine (CVM) field activities programs. The total ORA domestic travel costs spent is then divided by the 4,399 CFSAN and CVM domestic inspections, which averages a total of $871 per inspection. These inspections average 42.65 hours per inspection. Dividing $871 per inspection by 42.65 hours per inspection results in a total and an additional cost of $20 (rounded to the nearest dollar) per hour spent for domestic inspection travel costs in FY 2020. To adjust for the $20 per hour additional domestic cost inflation increases for FY 2021 and FY 2022, FDA must multiply the FY 2021 PDUFA inflation rate adjustor (1.013493) times the FY 2022 PDUFA inflation rate adjustor (1.022013) times the $20 additional domestic cost, which results in an estimated cost of $21 (rounded to the nearest dollar) per paid hour in addition to $256 for a total of $277 per paid hour ($256 plus $21) for each direct hour of work requiring domestic inspection travel. FDA will use these rates in charging fees in FY 2022 when domestic travel is required. In FY 2020, ORA spent a total of $1,449,058 on 171 foreign inspection trips related to FDA’s CFSAN and CVM field activities programs, which averaged a total of $8,474 per foreign inspection trip. These trips averaged 3 weeks (or 120 paid hours) per trip. Dividing $8,474 per trip by 120 hours per trip results in a total and an additional cost of $71 (rounded to the nearest dollar) per paid hour spent for foreign inspection travel costs in FY 2020. To adjust $71 for inflationary increases in FY 2021 and FY 2022, FDA must multiply it by the same inflation factors mentioned previously in this E:\FR\FM\28JYN1.SGM 28JYN1 Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices would consider non-compliance to be materially related to a food safety requirement of the FD&C Act. Under section 743(a)(1)(A) of the FD&C Act, FDA is directed to assess and collect fees from ‘‘the responsible party for each domestic facility (as defined in section 415(b) (21 U.S.C. 350d(b))) and the United States agent for each foreign facility subject to a reinspection’’ to TABLE 2—FSMA FEE SCHEDULE FOR cover reinspection-related costs. Section 743(a)(2)(A)(i) of the FD&C FY 2022 Act defines the term ‘‘reinspection’’ with respect to domestic facilities as ‘‘1 Fee rates for Fee category or more inspections conducted under FY 2022 section 704 subsequent to an inspection Hourly rate if domestic travel conducted under such provision which is required ......................... $277 identified non-compliance materially Hourly rate if foreign travel is related to a food safety requirement of required ............................. 330 th[e] Act, specifically to determine whether compliance has been achieved III. Fees for Reinspections of Domestic to the Secretary’s satisfaction.’’ or Foreign Facilities Under Section The FD&C Act does not contain a 743(a)(1)(A) definition of ‘‘reinspection’’ specific to foreign facilities. In order to give A. What will cause this fee to be meaning to the language in section assessed? 743(a)(1)(A) of the FD&C Act to collect The fee will be assessed for a fees from the U.S. agent of a foreign reinspection conducted under section facility subject to a reinspection, the 704 of the FD&C Act (21 U.S.C. 374) to Agency is using the following definition determine whether corrective actions of ‘‘reinspection’’ for purposes of have been implemented and are assessing and collecting fees under effective and compliance has been section 743(a)(1)(A), with respect to a achieved to the Secretary of Health and foreign facility, ‘‘1 or more inspections Human Services’ (the Secretary) (and, conducted by officers or employees duly by delegation, FDA’s) satisfaction at a designated by the Secretary subsequent facility that manufactures, processes, to such an inspection which identified packs, or holds food for consumption non-compliance materially related to a necessitated as a result of a previous food safety requirement of the FD&C inspection (also conducted under Act, specifically to determine whether section 704) of this facility, which had compliance has been achieved to the a final classification of Official Action Secretary’s (and, by delegation, FDA’s) Indicated (OAI) conducted by or on satisfaction.’’ behalf of FDA, when FDA determined This definition allows FDA to fulfill the non-compliance was materially the mandate to assess and collect fees related to food safety requirements of from the U.S. agent of a foreign facility the FD&C Act. FDA considers such non- in the event that an inspection reveals compliance to include non-compliance non-compliance materially related to a with a statutory or regulatory food safety requirement of the FD&C requirement under section 402 of the Act, causing one or more subsequent FD&C Act (21 U.S.C. 342) and section inspections to determine whether 403(w) of the FD&C Act (21 U.S.C. compliance has been achieved to the 343(w)). However, FDA does not Secretary’s (and, by delegation, FDA’s) consider non-compliance that is satisfaction. By requiring the initial materially related to a food safety inspection to be conducted by officers requirement to include circumstances or employees duly designated by the where the non-compliance is of a Secretary, the definition ensures that a technical nature and not food safety foreign facility would be subject to fees related (e.g., failure to comply with a only in the event that FDA, or an entity food standard or incorrect font size on designated to act on its behalf, has made a food label). Determining when nonthe requisite identification at an initial compliance, other than under sections inspection of non-compliance materially 402 and 403(w) of the FD&C Act, is related to a food safety requirement of materially related to a food safety the FD&C Act. The definition of requirement of the FD&C Act may ‘‘reinspection-related costs’’ in section depend on the facts of a particular 743(a)(2)(B) of the FD&C Act relates to situation. FDA intends to issue guidance both a domestic facility reinspection to provide additional information about and a foreign facility reinspection, as the circumstances under which FDA described in section 743(a)(1)(A). khammond on DSKJM1Z7X2PROD with NOTICES document (1.013493 and 1.022013), which results in an estimated cost of $74 (rounded to the nearest dollar) per paid hour in addition to $256 for a total of $330 per paid hour ($256 plus $74) for each direct hour of work requiring foreign inspection travel. FDA will use these rates in charging fees in FY 2022 when foreign travel is required. VerDate Sep<11>2014 17:16 Jul 27, 2021 Jkt 253001 PO 00000 Frm 00130 Fmt 4703 Sfmt 4703 40573 B. Who will be responsible for paying this fee? The FD&C Act states that this fee is to be paid by the responsible party for each domestic facility (as defined in section 415(b) of the FD&C Act) and by the U.S. agent for each foreign facility (section 743(a)(1)(A) of the FD&C Act). This is the party to whom FDA will send the invoice for any fees that are assessed under this section. C. How much will this fee be? The fee is based on the number of direct hours spent on such reinspections, including time spent conducting the physical surveillance and/or compliance reinspection at the facility, or whatever components of such an inspection are deemed necessary, making preparations and arrangements for the reinspection, traveling to and from the facility, preparing any reports, analyzing any samples or examining any labels if required, and performing other activities as part of the OAI reinspection until the facility is again determined to be in compliance. The direct hours spent on each such reinspection will be billed at the appropriate hourly rate shown in table 2 of this document. IV. Fees for Non-Compliance With a Recall Order Under Section 743(a)(1)(B) A. What will cause this fee to be assessed? The fee will be assessed for not complying with a recall order under section 423(d) (21 U.S.C. 350l(d)) or section 412(f) of the FD&C Act (21 U.S.C. 350a(f)) to cover food recall activities associated with such order performed by the Secretary (and by delegation, FDA) (section 743(a)(1)(B) of the FD&C Act). Non-compliance may include the following: (1) Not initiating a recall as ordered by FDA; (2) not conducting the recall in the manner specified by FDA in the recall order; or (3) not providing FDA with requested information regarding the recall, as ordered by FDA. B. Who will be responsible for paying this fee? Section 743(a)(1)(B) of the FD&C Act states that the fee is to be paid by the responsible party for a domestic facility (as defined in section 415(b) of the FD&C Act) and an importer who does not comply with a recall order under section 423 or under section 412(f) of the FD&C Act. In other words, the party paying the fee would be the party that received the recall order. E:\FR\FM\28JYN1.SGM 28JYN1 40574 Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices C. How much will this fee be? The fee is based on the number of direct hours spent on taking action in response to the firm’s failure to comply with a recall order. Types of activities could include conducting recall audit checks, reviewing periodic status reports, analyzing the status reports and the results of the audit checks, conducting inspections, traveling to and from locations, and monitoring product disposition. The direct hours spent on each such recall will be billed at the appropriate hourly rate shown in table 2 of this document. V. How must the fees be paid? An invoice will be sent to the responsible party for paying the fee after FDA completes the work on which the invoice is based. Payment must be made within 30 days of the invoice date in U.S. currency by check, bank draft, or U.S. postal money order payable to the order of the Food and Drug Administration. Detailed payment information will be included with the invoice when it is issued. VI. What are the consequences of not paying these fees? Under section 743(e)(2) of the FD&C Act, any fee that is not paid within 30 days after it is due shall be treated as a claim of the U.S. Government subject to provisions of subchapter II of chapter 37 of title 31, United States Code. Dated: July 20, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–16056 Filed 7–27–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2007–D–0369] Product-Specific Guidance for Olodaterol Hydrochloride; Tiotropium Bromide; Draft Guidance for Industry; Availability Food and Drug Administration, HHS. khammond on DSKJM1Z7X2PROD with NOTICES ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Draft Guidance for Olodaterol Hydrochloride; Tiotropium Bromide.’’ The draft guidance, when finalized, will provide product-specific recommendations on, SUMMARY: VerDate Sep<11>2014 17:16 Jul 27, 2021 Jkt 253001 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 Food and Drug Administration AGENCY: among other things, the information and data needed to demonstrate bioequivalence (BE) to support abbreviated new drug applications (ANDAs) for olodaterol hydrochloride; tiotropium bromide inhalation spray. DATES: Submit either electronic or written comments on the draft guidance by September 27, 2021 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: 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– 2007–D–0369 for ‘‘Draft Guidance for Olodaterol Hydrochloride; Tiotropium Bromide.’’ Received comments will be placed in the docket and, except for PO 00000 Frm 00131 Fmt 4703 Sfmt 4703 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-201509-18/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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. E:\FR\FM\28JYN1.SGM 28JYN1

Agencies

[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40571-40574]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16056]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0701]


Food Safety Modernization Act Domestic and Foreign Facility 
Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal 
Year 2022

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the fiscal year (FY) 2022 fee rates for certain domestic and foreign 
facility reinspections, failures to comply with a recall order, and 
importer reinspections that are authorized by the Federal Food, Drug, 
and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety 
Modernization Act (FSMA). These fees are effective on October 1, 2021, 
and will remain in effect through September 30, 2022.

FOR FURTHER INFORMATION CONTACT: Jimmy Carlton, Office of Management, 
Office of Regulatory Affairs, Food and Drug Administration, 12420 
Parklawn Dr., Rockville, MD 20857,240-888-
1556,[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 107 of FSMA (Pub. L. 111-353) added section 743 to the FD&C 
Act (21 U.S.C. 379j-31) to provide FDA with the authority to assess and 
collect fees from, in part: (1) The responsible party for each domestic 
facility and the U.S. agent for each foreign facility subject to a 
reinspection, to cover reinspection-related costs; (2) the responsible 
party for a domestic facility and an importer who does not comply with 
a recall order, to cover food \1\ recall activities associated with 
such order; and (3) each importer subject to a reinspection to cover 
reinspection-related costs (sections 743(a)(1)(A), (B), and (D) of the 
FD&C Act). Section 743 of the FD&C Act directs FDA to establish fees 
for each of these activities based on an estimate of 100 percent of the 
costs of each activity for each year (sections 743(b)(2)(A)(i), (ii), 
and (iv)), and these fees must be made available solely to pay for the 
costs of each activity for which the fee was incurred (section 
743(b)(3)). These fees are effective on October 1, 2021, and will 
remain in effect through September 30, 2022. Section 743(b)(2)(B)(iii) 
of the FD&C Act directs FDA to develop a proposed set of guidelines in 
consideration of the burden of fee amounts on small businesses. As a 
first step in developing these guidelines, FDA invited public comment 
on the potential impact of the fees authorized by section 743 of the 
FD&C Act on small businesses (76 FR 45818, August 1, 2011). The comment 
period for this request ended November 30, 2011. As stated in FDA's 
September 2011 ``Guidance for Industry: Implementation of the Fee 
Provisions of Section 107 of the FDA Food Safety Modernization Act,'' 
(https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/guidance-industry-implementation-fee-

[[Page 40572]]

provisions-section-107-fda-food-safety-modernization-act), because FDA 
recognizes that for small businesses the full cost recovery of FDA 
reinspection or recall oversight could impose severe economic hardship, 
FDA intends to consider reducing certain fees for those firms. FDA does 
not intend to issue invoices for reinspection or recall order fees 
until FDA publishes a guidance document outlining the process through 
which firms may request a reduction in fees.
---------------------------------------------------------------------------

    \1\ The term ``food'' for purposes of this document has the same 
meaning as such term in section 201(f) of the FD&C Act (21 U.S.C. 
321(f)).
---------------------------------------------------------------------------

    In addition, as stated in the September 2011 Guidance, FDA is in 
the process of considering various issues associated with the 
assessment and collection of importer reinspection fees. The fee rates 
set forth in this notice will be used to determine any importer 
reinspection fees assessed in FY 2022.

II. Estimating the Average Cost of a Supported Direct FDA Work Hour for 
FY 2022

    FDA is required to estimate 100 percent of its costs for each 
activity in order to establish fee rates for FY 2022. In each year, the 
costs of salary (or personnel compensation) and benefits for FDA 
employees account for between 50 and 60 percent of the funds available 
to, and used by, FDA. Almost all of the remaining funds (operating 
funds) available to FDA are used to support FDA employees for paying 
rent, travel, utility, information technology (IT), and other operating 
costs.

A. Estimating the Full Cost per Direct Work Hour in FY 2022

    Full-time Equivalent (FTE) reflects the total number of regular 
straight-time hours--not including overtime or holiday hours--worked by 
employees, divided by the number of compensable hours applicable to 
each fiscal year. Annual leave, sick leave, compensatory time off, and 
other approved leave categories are considered ``hours worked'' for 
purposes of defining FTE employment.
    In general, the starting point for estimating the full cost per 
direct work hour is to estimate the cost of an FTE or paid staff year. 
Calculating an Agency-wide total cost per FTE requires three primary 
cost elements: Payroll, non-payroll, and rent.
    We have used an average of past year cost elements to predict the 
FY 2022 cost. The FY 2022 FDA-wide average cost for payroll (salaries 
and benefits) is $171,228; non-payroll--including equipment, supplies, 
IT, general and administrative overhead--is $101,625; and rent, 
including cost allocation analysis and adjustments for other rent and 
rent-related costs, is $23,597 per paid staff year, excluding travel 
costs.
    Summing the average cost of an FTE for payroll, non-payroll, and 
rent, brings the FY 2022 average fully supported cost to $296,450 per 
FTE, excluding travel costs. FDA will use this base unit fee in 
determining the hourly fee rate for reinspection and recall order fees 
for FY 2022 prior to including domestic or foreign travel costs as 
applicable for the activity.
    To calculate an hourly rate, FDA must divide the FY 2022 average 
fully supported cost of $296,450 per FTE by the average number of 
supported direct FDA work hours in FY 2020--the last fiscal year for 
which data are available. See table 1.

Table 1--Supported Direct FDA Work Hours in a Paid Staff Year in FY 2020
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Total number of hours in a paid staff year......................   2,080
Less:
  10 paid holidays..............................................     -80
  20 days of annual leave.......................................    -160
  10 days of sick leave.........................................     -80
  12.5 days of training.........................................    -100
  26.5 days of general administration...........................    -184
  26.5 days of travel...........................................    -212
  2 hours of meetings per week..................................    -104
                                                                 -------
  Net Supported Direct FDA Work Hours Available for Assignments.   1,160
------------------------------------------------------------------------

    Dividing the average fully supported FTE cost in FY 2022 ($296,450) 
by the total number of supported direct work hours available for 
assignment in FY 2022 (1,160) results in an average fully supported 
cost of $256 (rounded to the nearest dollar), excluding inspection 
travel costs, per supported direct work hour in FY 2022.

B. Adjusting FY 2020 Travel Costs for Inflation To Estimate FY 2022 
Travel Costs

    To adjust the hourly rate for FY 2022, FDA must estimate the cost 
of inflation in each year for FY 2021 and FY 2022. FDA uses the method 
prescribed for estimating inflationary costs under the Prescription 
Drug User Fee Act (PDUFA) provisions of the FD&C Act (section 736(c)(1) 
(21 U.S.C. 379h(c)(1)), the statutory method for inflation adjustment 
in the FD&C Act that FDA has used consistently. FDA previously 
determined the FY 2021 inflation rate to be 1.3493 percent; this rate 
was published in the FY 2021 PDUFA user fee rates notice in the Federal 
Register (August 3, 2020, 85 FR 46651). Utilizing the method set forth 
in section 736(c)(1) of the FD&C Act, FDA has calculated an inflation 
rate of 1.3493 percent for FY 2021 and 2.2013 percent for FY 2022, and 
FDA intends to use these inflation rates to make inflation adjustments 
for FY 2022 for several of its user fee programs; the derivation of 
this rate will be published in the Federal Register in the FY 2022 
notice for the PDUFA user fee rates.
    The average fully supported cost per supported direct FDA work 
hour, excluding travel costs, of $256 already takes into account 
inflation as the calculation above is based on FY 2022 predicted costs. 
FDA will use this base unit fee in determining the hourly fee rate for 
reinspection and recall order fees for FY 2022 prior to including 
domestic or foreign travel costs as applicable for the activity. In FY 
2020, FDA's Office of Regulatory Affairs (ORA) spent a total of 
$3,831,758 for domestic regulatory inspection travel costs and General 
Services Administration Vehicle costs related to FDA's Center for Food 
Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine 
(CVM) field activities programs. The total ORA domestic travel costs 
spent is then divided by the 4,399 CFSAN and CVM domestic inspections, 
which averages a total of $871 per inspection. These inspections 
average 42.65 hours per inspection. Dividing $871 per inspection by 
42.65 hours per inspection results in a total and an additional cost of 
$20 (rounded to the nearest dollar) per hour spent for domestic 
inspection travel costs in FY 2020. To adjust for the $20 per hour 
additional domestic cost inflation increases for FY 2021 and FY 2022, 
FDA must multiply the FY 2021 PDUFA inflation rate adjustor (1.013493) 
times the FY 2022 PDUFA inflation rate adjustor (1.022013) times the 
$20 additional domestic cost, which results in an estimated cost of $21 
(rounded to the nearest dollar) per paid hour in addition to $256 for a 
total of $277 per paid hour ($256 plus $21) for each direct hour of 
work requiring domestic inspection travel. FDA will use these rates in 
charging fees in FY 2022 when domestic travel is required.
    In FY 2020, ORA spent a total of $1,449,058 on 171 foreign 
inspection trips related to FDA's CFSAN and CVM field activities 
programs, which averaged a total of $8,474 per foreign inspection trip. 
These trips averaged 3 weeks (or 120 paid hours) per trip. Dividing 
$8,474 per trip by 120 hours per trip results in a total and an 
additional cost of $71 (rounded to the nearest dollar) per paid hour 
spent for foreign inspection travel costs in FY 2020. To adjust $71 for 
inflationary increases in FY 2021 and FY 2022, FDA must multiply it by 
the same inflation factors mentioned previously in this

[[Page 40573]]

document (1.013493 and 1.022013), which results in an estimated cost of 
$74 (rounded to the nearest dollar) per paid hour in addition to $256 
for a total of $330 per paid hour ($256 plus $74) for each direct hour 
of work requiring foreign inspection travel. FDA will use these rates 
in charging fees in FY 2022 when foreign travel is required.

                 Table 2--FSMA Fee Schedule for FY 2022
------------------------------------------------------------------------
                                                           Fee rates for
                      Fee category                            FY 2022
------------------------------------------------------------------------
Hourly rate if domestic travel is required..............            $277
Hourly rate if foreign travel is required...............             330
------------------------------------------------------------------------

III. Fees for Reinspections of Domestic or Foreign Facilities Under 
Section 743(a)(1)(A)

A. What will cause this fee to be assessed?

    The fee will be assessed for a reinspection conducted under section 
704 of the FD&C Act (21 U.S.C. 374) to determine whether corrective 
actions have been implemented and are effective and compliance has been 
achieved to the Secretary of Health and Human Services' (the Secretary) 
(and, by delegation, FDA's) satisfaction at a facility that 
manufactures, processes, packs, or holds food for consumption 
necessitated as a result of a previous inspection (also conducted under 
section 704) of this facility, which had a final classification of 
Official Action Indicated (OAI) conducted by or on behalf of FDA, when 
FDA determined the non-compliance was materially related to food safety 
requirements of the FD&C Act. FDA considers such non-compliance to 
include non-compliance with a statutory or regulatory requirement under 
section 402 of the FD&C Act (21 U.S.C. 342) and section 403(w) of the 
FD&C Act (21 U.S.C. 343(w)). However, FDA does not consider non-
compliance that is materially related to a food safety requirement to 
include circumstances where the non-compliance is of a technical nature 
and not food safety related (e.g., failure to comply with a food 
standard or incorrect font size on a food label). Determining when non-
compliance, other than under sections 402 and 403(w) of the FD&C Act, 
is materially related to a food safety requirement of the FD&C Act may 
depend on the facts of a particular situation. FDA intends to issue 
guidance to provide additional information about the circumstances 
under which FDA would consider non-compliance to be materially related 
to a food safety requirement of the FD&C Act.
    Under section 743(a)(1)(A) of the FD&C Act, FDA is directed to 
assess and collect fees from ``the responsible party for each domestic 
facility (as defined in section 415(b) (21 U.S.C. 350d(b))) and the 
United States agent for each foreign facility subject to a 
reinspection'' to cover reinspection-related costs.
    Section 743(a)(2)(A)(i) of the FD&C Act defines the term 
``reinspection'' with respect to domestic facilities as ``1 or more 
inspections conducted under section 704 subsequent to an inspection 
conducted under such provision which identified non-compliance 
materially related to a food safety requirement of th[e] Act, 
specifically to determine whether compliance has been achieved to the 
Secretary's satisfaction.''
    The FD&C Act does not contain a definition of ``reinspection'' 
specific to foreign facilities. In order to give meaning to the 
language in section 743(a)(1)(A) of the FD&C Act to collect fees from 
the U.S. agent of a foreign facility subject to a reinspection, the 
Agency is using the following definition of ``reinspection'' for 
purposes of assessing and collecting fees under section 743(a)(1)(A), 
with respect to a foreign facility, ``1 or more inspections conducted 
by officers or employees duly designated by the Secretary subsequent to 
such an inspection which identified non-compliance materially related 
to a food safety requirement of the FD&C Act, specifically to determine 
whether compliance has been achieved to the Secretary's (and, by 
delegation, FDA's) satisfaction.''
    This definition allows FDA to fulfill the mandate to assess and 
collect fees from the U.S. agent of a foreign facility in the event 
that an inspection reveals non-compliance materially related to a food 
safety requirement of the FD&C Act, causing one or more subsequent 
inspections to determine whether compliance has been achieved to the 
Secretary's (and, by delegation, FDA's) satisfaction. By requiring the 
initial inspection to be conducted by officers or employees duly 
designated by the Secretary, the definition ensures that a foreign 
facility would be subject to fees only in the event that FDA, or an 
entity designated to act on its behalf, has made the requisite 
identification at an initial inspection of non-compliance materially 
related to a food safety requirement of the FD&C Act. The definition of 
``reinspection-related costs'' in section 743(a)(2)(B) of the FD&C Act 
relates to both a domestic facility reinspection and a foreign facility 
reinspection, as described in section 743(a)(1)(A).

B. Who will be responsible for paying this fee?

    The FD&C Act states that this fee is to be paid by the responsible 
party for each domestic facility (as defined in section 415(b) of the 
FD&C Act) and by the U.S. agent for each foreign facility (section 
743(a)(1)(A) of the FD&C Act). This is the party to whom FDA will send 
the invoice for any fees that are assessed under this section.

C. How much will this fee be?

    The fee is based on the number of direct hours spent on such 
reinspections, including time spent conducting the physical 
surveillance and/or compliance reinspection at the facility, or 
whatever components of such an inspection are deemed necessary, making 
preparations and arrangements for the reinspection, traveling to and 
from the facility, preparing any reports, analyzing any samples or 
examining any labels if required, and performing other activities as 
part of the OAI reinspection until the facility is again determined to 
be in compliance. The direct hours spent on each such reinspection will 
be billed at the appropriate hourly rate shown in table 2 of this 
document.

IV. Fees for Non-Compliance With a Recall Order Under Section 
743(a)(1)(B)

A. What will cause this fee to be assessed?

    The fee will be assessed for not complying with a recall order 
under section 423(d) (21 U.S.C. 350l(d)) or section 412(f) of the FD&C 
Act (21 U.S.C. 350a(f)) to cover food recall activities associated with 
such order performed by the Secretary (and by delegation, FDA) (section 
743(a)(1)(B) of the FD&C Act). Non-compliance may include the 
following: (1) Not initiating a recall as ordered by FDA; (2) not 
conducting the recall in the manner specified by FDA in the recall 
order; or (3) not providing FDA with requested information regarding 
the recall, as ordered by FDA.

B. Who will be responsible for paying this fee?

    Section 743(a)(1)(B) of the FD&C Act states that the fee is to be 
paid by the responsible party for a domestic facility (as defined in 
section 415(b) of the FD&C Act) and an importer who does not comply 
with a recall order under section 423 or under section 412(f) of the 
FD&C Act. In other words, the party paying the fee would be the party 
that received the recall order.

[[Page 40574]]

C. How much will this fee be?

    The fee is based on the number of direct hours spent on taking 
action in response to the firm's failure to comply with a recall order. 
Types of activities could include conducting recall audit checks, 
reviewing periodic status reports, analyzing the status reports and the 
results of the audit checks, conducting inspections, traveling to and 
from locations, and monitoring product disposition. The direct hours 
spent on each such recall will be billed at the appropriate hourly rate 
shown in table 2 of this document.

V. How must the fees be paid?

    An invoice will be sent to the responsible party for paying the fee 
after FDA completes the work on which the invoice is based. Payment 
must be made within 30 days of the invoice date in U.S. currency by 
check, bank draft, or U.S. postal money order payable to the order of 
the Food and Drug Administration. Detailed payment information will be 
included with the invoice when it is issued.

VI. What are the consequences of not paying these fees?

    Under section 743(e)(2) of the FD&C Act, any fee that is not paid 
within 30 days after it is due shall be treated as a claim of the U.S. 
Government subject to provisions of subchapter II of chapter 37 of 
title 31, United States Code.

    Dated: July 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16056 Filed 7-27-21; 8:45 am]
BILLING CODE 4164-01-P