Outsourcing Facility Fee Rates for Fiscal Year 2020, 37311-37314 [2019-16253]

Download as PDF 37311 Federal Register / Vol. 84, No. 147 / Wednesday, July 31, 2019 / Notices Dated: July 26, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–16270 Filed 7–30–19; 8:45 am] BILLING CODE 4164–01–P Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm. 61075, Beltsville, MD 20705–4304, 240–402–4585. SUPPLEMENTARY INFORMATION: I. Background DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–0007] Outsourcing Facility Fee Rates for Fiscal Year 2020 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2020 rates for the establishment and re-inspection fees related to entities that compound human drugs and elect to register as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act authorizes FDA to assess and collect an annual establishment fee from outsourcing facilities, as well as a re-inspection fee for each re-inspection of an outsourcing facility. This document establishes the FY 2020 rates for the small business establishment fee ($5,599), the nonsmall business establishment fee ($18,288), and the re-inspection fee ($16,798) for outsourcing facilities; provides information on how the fees for FY 2020 were determined; and describes the payment procedures outsourcing facilities should follow. These fee rates are effective October 1, 2019, and will remain in effect through September 30, 2020. FOR FURTHER INFORMATION CONTACT: For more information on human drug compounding and outsourcing facility fees: Visit FDA’s website at: https:// www.fda.gov/Drugs/ GuidanceComplianceRegulatory Information/PharmacyCompounding/ default.htm. For questions relating to this notice: Melissa Hurley, Office of Financial SUMMARY: The Drug Quality and Security Act (DQSA) contains important provisions relating to the oversight of compounding human drugs. Title I of this law, the Compounding Quality Act, created a new section 503B in the FD&C Act (21 U.S.C. 353b). Under section 503B of the FD&C Act, a human drug compounder can become an ‘‘outsourcing facility.’’ Outsourcing facilities, as defined in section 503B(d)(4) of the FD&C Act, are facilities that meet all of the conditions described in section 503B(a), including registering with FDA as an outsourcing facility and paying an annual establishment fee. If the conditions of section 503B are met, a drug compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility is exempt from three sections of the FD&C Act: (1) Section 502(f)(1) (21 U.S.C. 352(f)(1)) concerning the labeling of drugs with adequate directions for use; (2) section 505 (21 U.S.C. 355) concerning the approval of human drug products under new drug applications (NDAs) or abbreviated new drug applications (ANDAs); and (3) section 582 (21 U.S.C. 360eee–1) concerning drug supply chain security requirements. Drugs compounded in outsourcing facilities are not exempt from the requirements of section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)) concerning current good manufacturing practice requirements for drugs. Section 744K of the FD&C Act (21 U.S.C. 379j–62) authorizes FDA to assess and collect the following fees associated with outsourcing facilities: (1) An annual establishment fee from each outsourcing facility and (2) a reinspection fee from each outsourcing facility subject to a re-inspection (see section 744K(a)(1) of the FD&C Act). Under statutorily defined conditions, a qualified applicant may pay a reduced small business establishment fee (see section 744K(c)(4) of the FD&C Act). FDA announced in the Federal Register of November 24, 2014 (79 FR 69856), the availability of a final guidance for industry entitled ‘‘Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act.’’ The guidance provides additional information on the annual fees for outsourcing facilities and adjustments required by law, reinspection fees, how to submit payment, the effect of failure to pay fees, and how to qualify as a small business to obtain a reduction of the annual establishment fee. This guidance can be accessed on FDA’s website at: https://www.fda.gov/ downloads/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/ UCM391102.pdf. II. Fees for FY 2020 A. Methodology for Calculating FY 2020 Adjustment Factors 1. Inflation Adjustment Factor Section 744K(c)(2) of the FD&C Act specifies the annual inflation adjustment for outsourcing facility fees. The inflation adjustment has two components: One based on FDA’s payroll costs and one based on FDA’s non-payroll costs for the first 3 of the 4 previous fiscal years. The payroll component of the annual inflation adjustment is calculated by taking the average change in FDA’s per-full time equivalent (FTE) personnel compensation and benefits (PC&B) in the first 3 of the 4 previous fiscal years (see section 744K(c)(2)(A)(ii) of the FD&C Act). FDA’s total annual spending on PC&B is divided by the total number of FTEs per fiscal year to determine the average PC&B per FTE. Table 1 summarizes the actual cost and FTE data for the specified fiscal years, and provides the percent change from the previous fiscal year and the average percent change over the first 3 of the 4 fiscal years preceding FY 2020. The 3-year average is 3.1175 percent. TABLE 1—FDA PC&BS EACH YEAR AND PERCENT CHANGE jbell on DSK3GLQ082PROD with NOTICES Fiscal year 2016 Total PC&B .............................................................................. Total FTE ................................................................................. PC&B per FTE ......................................................................... Percent change from previous year ........................................ Section 744K(c)(2)(A)(ii) of the FD&C Act specifies that this 3.1175 percent should be multiplied by the proportion VerDate Sep<11>2014 20:09 Jul 30, 2019 Jkt 247001 $2,414,728,159 16,381 $147,408 2.2474% 2017 $2,581,551,000 17,022 $151,660 2.8845% 2018 $2,690,678,000 17,023 $158,061 4.2206% of PC&B to total costs of an average FDA FTE for the same 3 fiscal years. PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 E:\FR\FM\31JYN1.SGM 31JYN1 3-year average .............................. .............................. .............................. 3.1175% 37312 Federal Register / Vol. 84, No. 147 / Wednesday, July 31, 2019 / Notices TABLE 2—FDA PC&BS AS A PERCENT OF FDA TOTAL COSTS OF AN AVERAGE FTE Fiscal year 2016 Total PC&B .............................................................................. Total Costs ............................................................................... PC&B Percent .......................................................................... The payroll adjustment is 3.1175 percent multiplied by 50.8064 percent, or 1.5839 percent. Section 744K(c)(2)(A)(iii) of the FD&C Act specifies that the portion of the inflation adjustment for non-payroll costs for FY 2020 is equal to the average annual percent change in the Consumer Price Index (CPI) for urban consumers $2,414,728,159 $4,666,236,000 51.7490% 2017 2018 $2,581,551,000 $5,104,580,000 50.5732% (U.S. City Average; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data, multiplied by the proportion of all non-PC&B costs to total costs of an average FDA FTE for the same period. Table 2 provides the summary data for the percent change in the specified $2,690,678,000 $5,370,935,000 50.0970% 3-year average .............................. .............................. 50.8064% CPI for U.S. cities. These data are published by the Bureau of Labor Statistics and can be found on its website: https://data.bls.gov/cgi-bin/ surveymost?cu. The data can be viewed by checking the box marked ‘‘U.S. All items, 1982–84=100—CUUR0000SA0’’ and then selecting ‘‘Retrieve Data.’’ TABLE 3—ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN U.S. CITY AVERAGE CPI Year 2016 jbell on DSK3GLQ082PROD with NOTICES Annual CPI ............................................................................... Annual Percent Change .......................................................... Section 744K(c)(2)(A)(iii) of the FD&C Act specifies that this 1.9448 percent should be multiplied by the proportion of all non-PC&B costs to total costs of an average FTE for the same 3 fiscal years. The proportion of all non-PC&B costs to total costs of an average FDA FTE for FYs 2016 to 2018 is 49.1936 percent (100 percent¥50.8064 percent = 49.1936 percent). Therefore, the nonpay adjustment is 1.9448 percent times 49.1936 percent, or 0.9567 percent. The PC&B component (1.5839 percent) is added to the non-PC&B component (0.9567 percent), for a total inflation adjustment of 2.5406 percent (rounded). Section 744K(c)(2)(A)(i) of the FD&C Act specifies that one is added to that figure, making the inflation adjustment 1.025406. Section 744K(c)(2)(B) of the FD&C Act provides for this inflation adjustment to be compounded after FY 2015. This factor for FY 2020 (2.5406 percent) is compounded by adding one to it, and then multiplying it by one plus the inflation adjustment factor for FY 2019 (9.2148 percent), as published in the Federal Register of August 1, 2018 (83 FR 37500 at 37502). The result of this multiplication of the inflation factors for the 5 years since FY 2015 (1.025406 × 1.092148) becomes the inflation adjustment for FY 2020. For FY 2020, the inflation adjustment is 11.9895 percent (rounded). We then add one, making the FY 2020 inflation adjustment factor 1.119895. 2. Small Business Adjustment Factor Section 744K(c)(3) of the FD&C Act specifies that in addition to the inflation VerDate Sep<11>2014 20:09 Jul 30, 2019 Jkt 247001 240.007 1.2615% 2017 245.120 2.1304% adjustment factor, the establishment fee for non-small businesses is to be further adjusted for a small business adjustment factor. Section 744K(c)(3)(B) of the FD&C Act provides that the small business adjustment factor is the adjustment to the establishment fee for non-small businesses that is necessary to achieve total fees equaling the amount that FDA would have collected if no entity qualified for the small business exception in section 744K(c)(4) of the FD&C Act. Additionally, section 744K(c)(5)(A) states that in establishing the small business adjustment factor for a fiscal year, FDA shall provide for the crediting of fees from the previous year to the next year if FDA overestimated the amount of the small business adjustment factor for such previous fiscal year. Therefore, to calculate the small business adjustment to the establishment fee for non-small businesses for FY 2020, FDA must estimate: (1) The number of outsourcing facilities that will pay the reduced fee for small businesses for FY 2020 and (2) the total fee revenue it would have collected if no entity had qualified for the small business exception (i.e., if each entity that registers as an outsourcing facility for FY 2020 were to pay the inflation-adjusted fee amount of $16,798). With respect to (1), FDA estimates that 14 entities will qualify for small business exceptions and will pay the reduced fee for FY 2020. With respect to (2), to estimate the total number of entities that will register as outsourcing facilities for FY 2020, FDA used data PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 2018 251.107 2.4425% 3-year average .............................. 1.9448% submitted by outsourcing facilities through the voluntary registration process, which began in December 2013. Accordingly, FDA estimates that 85 outsourcing facilities, including 14 small businesses, will be registered with FDA in FY 2020. If the projected 85 outsourcing facilities paid the full inflation-adjusted fee of $16,798, this would result in total revenue of $1,427,830 in FY 2020 ($16,798 × 85). However, 14 of the entities that are expected to register as outsourcing facilities for FY 2020 are projected to qualify for the small business exception and to pay one-third of the full fee ($5,599 × 14), totaling $78,386 instead of paying the full fee ($16,798 × 14), which would total $235,172. This would leave a potential shortfall of $156,786 ($235,172¥$78,386). Additionally, section 744K(c)(5)(A) of the FD&C Act states that in establishing the small business adjustment factor for a fiscal year, FDA shall provide for the crediting of fees from the previous year to the next year if FDA overestimated the amount of the small business adjustment factor for such previous fiscal year. FDA has determined that it is appropriate to credit excess fees collected from the last completed fiscal year, due to the inability to conclusively determine the amount of excess fees from the fiscal year that is in progress at the time this calculation is made. This crediting is done by comparing the small business adjustment factor for the last completed fiscal year, FY 2018 ($2,012), to what would have been the small business adjustment factor for FY E:\FR\FM\31JYN1.SGM 31JYN1 Federal Register / Vol. 84, No. 147 / Wednesday, July 31, 2019 / Notices 2018 ($1,262) if FDA had estimated perfectly. The calculation for what the small business adjustment would have been if FDA had estimated perfectly begins by determining the total target collections (15,000 × [inflation adjustment factor] × [number of registrants]). For the most recent complete fiscal year, FY 2018, this was $1,223,068 ($16,093 × 76). The actual FY 2018 revenue from the 76 total registrants (i.e., 68 registrants paying FY 2018 non-small business establishment fee and eight small business registrants) paying establishment fees is $1,137,236. $1,137,236 is calculated as follows: (FY 2018 Non-Small Business Establishment Fee adjusted for inflation only) × (total number of registrants in FY 2018 paying Non-Small Business Establishment Fee) + (FY 2018 Small Business Establishment Fee) × (total number of small business registrants in FY 2018 paying Small Business Establishment Fee). $16,093 × 68 + $5,364 × 8 = $1,137,236. This left a shortfall of $85,832 from the estimated total target collection amount ($1,223,068¥$1,137,236). $85,832 divided by the total number of registrants in FY 2018 paying Standard Establishment Fee (68) equals $1,262. The difference between the small business adjustment factor used in FY 2018 and the small business adjustment factor that would have been used had FDA estimated perfectly; is $749 ($2,012¥$1,262). The $749 (rounded to the nearest dollar) is then multiplied by the number of actual registrants who paid the standard fee for FY 2018 (68), which provides us a total excess collection of $50,963 in FY 2018. Therefore, to calculate the small business adjustment factor for FY 2020, FDA subtracts $50,963 from the projected shortfall of $156,786 for FY 2020 to arrive at the numerator for the small business adjustment amount, which equals $105,823. This number divided by 71 (the number of expected non-small businesses for FY 2020) is the small business adjustment amount for FY 2020, which is $1,490 (rounded to the nearest dollar). jbell on DSK3GLQ082PROD with NOTICES B. FY 2020 Rates for Small Business Establishment Fee, Non-Small Business Establishment Fee, and Re-Inspection Fee 1. Establishment Fee for Qualified Small Businesses 1 The amount of the establishment fee for a qualified small business is equal to 1 To qualify for a small business reduction of the FY 2020 establishment fee, entities had to submit their exception requests by April 30, 2019. See VerDate Sep<11>2014 20:09 Jul 30, 2019 Jkt 247001 $15,000 multiplied by the inflation adjustment factor for that fiscal year, divided by three (see section 744K(c)(4)(A) and (c)(1)(A) of the FD&C Act). The inflation adjustment factor for FY 2020 is 1.119895. See section II.A.1 for the methodology used to calculate the FY 2020 inflation adjustment factor. Therefore, the establishment fee for a qualified small business for FY 2020 is one third of $16,798, which equals $5,599 (rounded to the nearest dollar). 2. Establishment Fee for Non-Small Businesses Under section 744K(c) of the FD&C Act, the amount of the establishment fee for a non-small business is equal to $15,000 multiplied by the inflation adjustment factor for that fiscal year, plus the small business adjustment factor for that fiscal year, and plus or minus an adjustment factor to account for over- or under-collections due to the small business adjustment factor in the prior year. The inflation adjustment factor for FY 2020 is 1.119895. The small business adjustment amount for FY 2020 is $1,490. See section II.A.2 for the methodology used to calculate the small business adjustment factor for FY 2020. Therefore, the establishment fee for a non-small business for FY 2020 is $15,000 multiplied by 1.119895 plus $1,490, which equals $18,288 (rounded to the nearest dollar). 3. Re-Inspection Fee Section 744K(c)(1)(B) of the FD&C Act provides that the amount of the FY 2020 re-inspection fee is equal to $15,000, multiplied by the inflation adjustment factor for that fiscal year. The inflation adjustment factor for FY 2020 is 1.119895. Therefore, the re-inspection fee for FY 2020 is $15,000 multiplied by 1.119895, which equals $16,798 (rounded to the nearest dollar). There is no reduction in this fee for small businesses. C. Summary of FY 2020 Fee Rates TABLE 4—OUTSOURCING FACILITY FEES 37313 TABLE 4—OUTSOURCING FACILITY FEES—Continued Non-Small Business Establishment Fee ................................................ Re-inspection Fee ............................ 18,288 16,798 III. Fee Payment Options and Procedures A. Establishment Fee Once an entity submits registration information and FDA has determined that the information is complete, the entity will incur the annual establishment fee. FDA will send an invoice to the entity, via email to the email address indicated in the registration file, or via regular mail if email is not an option. The invoice will contain information regarding the obligation incurred, the amount owed, and payment procedures. A facility will not be registered as an outsourcing facility until it has paid the annual establishment fee under section 744K of the FD&C Act. Accordingly, it is important that facilities seeking to operate as outsourcing facilities pay all fees immediately upon receiving an invoice. If an entity does not pay the full invoiced amount within 15 calendar days after FDA issues the invoice, FDA will consider the submission of registration information to have been withdrawn and adjust the invoice to reflect that no fee is due. Outsourcing facilities that registered in FY 2019 and wish to maintain their status as an outsourcing facility in FY 2020 must register during the annual registration period that lasts from October 1, 2019, to December 31, 2019. Failure to register and complete payment by December 31, 2019, will result in a loss of status as an outsourcing facility on January 1, 2020. Entities should submit their registration information no later than December 10, 2019, to allow enough time for review of the registration information, invoicing, and payment of fees before the end of the registration period. B. Re-Inspection Fee FDA will issue invoices for each reinspection after the conclusion of the reQualified Small Business Establishment Fee ....................................... $5,599 inspection, via email to the email address indicated in the registration file or via regular mail if email is not an section 744K(c)(4)(B) of the FD&C Act. The time for requesting a small business exception for FY 2020 option. Invoices must be paid within 30 has now passed. An entity that wishes to request days. a small business exception for FY 2021 should consult section 744K(c)(4) of the FD&C Act and section III.D of FDA’s guidance for industry entitled ‘‘Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act,’’ which can be accessed on FDA’s website at https://www.fda.gov/downloads/drugs/ guidancecomplianceregulatoryinformation/ guidances/ucm391102.pdf. PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 C. Fee Payment Procedures 1. The preferred payment method is online using electronic check (Automated Clearing House (ACH) also known as eCheck) or credit card (Discover, VISA, MasterCard, American E:\FR\FM\31JYN1.SGM 31JYN1 37314 Federal Register / Vol. 84, No. 147 / Wednesday, July 31, 2019 / Notices Express). 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 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. 2. If paying with a paper check: Checks must be in U.S. currency from a U.S. bank and made payable to the Food and Drug Administration. Payments can be mailed to: Food and Drug Administration, P.O. Box 979033, St. Louis, MO 63197–9000. If a check is sent by a courier that requests a street address, the courier can deliver the check to: U.S. Bank, Attn: Government Lockbox 979033, 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 the U.S. Bank at 314–418–4013). 3. When paying by wire transfer, the invoice number must be included. Without the invoice number the payment may not be applied. Regarding re-inspection fees, if the payment amount is not applied, the invoice amount will be referred to collections. The originating financial institution may charge a wire transfer fee. If the financial institution charges a wire transfer fee, it is required that the outsourcing facility add that amount to the payment to ensure that the invoice is paid in full. Use the following account information when sending a wire transfer: U.S. Dept of the Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No. 75060099, Routing No. 021030004, SWIFT: FRNYUS33. If needed, FDA’s tax identification number is 53–0196965. Dated: July 25, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–16253 Filed 7–30–19; 8:45 am] jbell on DSK3GLQ082PROD with NOTICES BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–1203] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Information To Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 August 30, 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 0910–0661. Also include the FDA docket number found in brackets in the heading of this document. SUMMARY: 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. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Information To Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements OMB Control Number 0910–0661— Extension Under section 520(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(m)), as amended by section 3052 of the 21st Century Cures Act (Cures Act) (Pub. L. 114–255), FDA is authorized to exempt a humanitarian VerDate Sep<11>2014 20:09 Jul 30, 2019 Jkt 247001 PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 use device (HUD) from the effectiveness requirements in sections 514 and 515 of the FD&C Act (21 U.S.C. 360d and 360e) provided that the device: (1) Is designed to treat or diagnose a disease or condition that affects not more than 8,000 individuals in the United States; (2) would not be available to a person with such a disease or condition unless the exemption is granted and there is no comparable device, other than another HUD approved under this exemption, available to treat or diagnose the disease or condition; and (3) the device will not expose patients to an unreasonable or significant risk of illness or injury and the probable benefit to health from using the device outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment. HUDs approved under a humanitarian device exemption (HDE) cannot be sold for an amount that exceeds the costs of research and development, fabrication, and distribution of the device (i.e., for profit), except in narrow circumstances. Under section 520(m)(6)(A)(i) of the FD&C Act, a HUD approved under an HDE is eligible to be sold for profit if the device meets the following criteria: The device is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients or in a pediatric subpopulation, and such device is labeled for use in pediatric patients or in a pediatric subpopulation in which the disease or condition occurs; or the device is intended for the treatment or diagnosis of a disease or condition that does not occur in pediatric patients, or that occurs in pediatric patients in such numbers that the development of the device for such patients is impossible, highly impracticable, or unsafe. Section 520(m)(6)(A)(ii) of the FD&C Act, provides that the Secretary of Health and Human Services will determine the annual distribution number (ADN) for devices that meet the eligibility criteria to be permitted to be sold for profit. The Cures Act amended the FD&C Act definition of the ADN as the number of devices reasonably needed to treat, diagnose, or cure a population of 8,000 individuals in the United States. Section 520(m)(6)(A)(iii) of the FD&C Act provides that an HDE holder immediately notify the Agency if the number of such devices distributed during any calendar year exceeds the ADN. Section 520(m)(6)(C) of the FD&C Act provides that an HDE holder may petition to modify the ADN if additional information arises. E:\FR\FM\31JYN1.SGM 31JYN1

Agencies

[Federal Register Volume 84, Number 147 (Wednesday, July 31, 2019)]
[Notices]
[Pages 37311-37314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16253]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0007]


Outsourcing Facility Fee Rates for Fiscal Year 2020

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
fiscal year (FY) 2020 rates for the establishment and re-inspection 
fees related to entities that compound human drugs and elect to 
register as outsourcing facilities under the Federal Food, Drug, and 
Cosmetic Act (FD&C Act). The FD&C Act authorizes FDA to assess and 
collect an annual establishment fee from outsourcing facilities, as 
well as a re-inspection fee for each re-inspection of an outsourcing 
facility. This document establishes the FY 2020 rates for the small 
business establishment fee ($5,599), the non-small business 
establishment fee ($18,288), and the re-inspection fee ($16,798) for 
outsourcing facilities; provides information on how the fees for FY 
2020 were determined; and describes the payment procedures outsourcing 
facilities should follow. These fee rates are effective October 1, 
2019, and will remain in effect through September 30, 2020.

FOR FURTHER INFORMATION CONTACT: 
    For more information on human drug compounding and outsourcing 
facility fees: Visit FDA's website at: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/default.htm.
    For questions relating to this notice: Melissa Hurley, Office of 
Financial Management, Food and Drug Administration, 4041 Powder Mill 
Rd., Rm. 61075, Beltsville, MD 20705-4304, 240-402-4585.

SUPPLEMENTARY INFORMATION: 

I. Background

    The Drug Quality and Security Act (DQSA) contains important 
provisions relating to the oversight of compounding human drugs. Title 
I of this law, the Compounding Quality Act, created a new section 503B 
in the FD&C Act (21 U.S.C. 353b). Under section 503B of the FD&C Act, a 
human drug compounder can become an ``outsourcing facility.''
    Outsourcing facilities, as defined in section 503B(d)(4) of the 
FD&C Act, are facilities that meet all of the conditions described in 
section 503B(a), including registering with FDA as an outsourcing 
facility and paying an annual establishment fee. If the conditions of 
section 503B are met, a drug compounded by or under the direct 
supervision of a licensed pharmacist in an outsourcing facility is 
exempt from three sections of the FD&C Act: (1) Section 502(f)(1) (21 
U.S.C. 352(f)(1)) concerning the labeling of drugs with adequate 
directions for use; (2) section 505 (21 U.S.C. 355) concerning the 
approval of human drug products under new drug applications (NDAs) or 
abbreviated new drug applications (ANDAs); and (3) section 582 (21 
U.S.C. 360eee-1) concerning drug supply chain security requirements. 
Drugs compounded in outsourcing facilities are not exempt from the 
requirements of section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 
351(a)(2)(B)) concerning current good manufacturing practice 
requirements for drugs.
    Section 744K of the FD&C Act (21 U.S.C. 379j-62) authorizes FDA to 
assess and collect the following fees associated with outsourcing 
facilities: (1) An annual establishment fee from each outsourcing 
facility and (2) a re-inspection fee from each outsourcing facility 
subject to a re-inspection (see section 744K(a)(1) of the FD&C Act). 
Under statutorily defined conditions, a qualified applicant may pay a 
reduced small business establishment fee (see section 744K(c)(4) of the 
FD&C Act).
    FDA announced in the Federal Register of November 24, 2014 (79 FR 
69856), the availability of a final guidance for industry entitled 
``Fees for Human Drug Compounding Outsourcing Facilities Under Sections 
503B and 744K of the FD&C Act.'' The guidance provides additional 
information on the annual fees for outsourcing facilities and 
adjustments required by law, re-inspection fees, how to submit payment, 
the effect of failure to pay fees, and how to qualify as a small 
business to obtain a reduction of the annual establishment fee. This 
guidance can be accessed on FDA's website at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM391102.pdf.

II. Fees for FY 2020

A. Methodology for Calculating FY 2020 Adjustment Factors

1. Inflation Adjustment Factor
    Section 744K(c)(2) of the FD&C Act specifies the annual inflation 
adjustment for outsourcing facility fees. The inflation adjustment has 
two components: One based on FDA's payroll costs and one based on FDA's 
non-payroll costs for the first 3 of the 4 previous fiscal years. The 
payroll component of the annual inflation adjustment is calculated by 
taking the average change in FDA's per-full time equivalent (FTE) 
personnel compensation and benefits (PC&B) in the first 3 of the 4 
previous fiscal years (see section 744K(c)(2)(A)(ii) of the FD&C Act). 
FDA's total annual spending on PC&B is divided by the total number of 
FTEs per fiscal year to determine the average PC&B per FTE.
    Table 1 summarizes the actual cost and FTE data for the specified 
fiscal years, and provides the percent change from the previous fiscal 
year and the average percent change over the first 3 of the 4 fiscal 
years preceding FY 2020. The 3-year average is 3.1175 percent.

                                 Table 1--FDA PC&Bs Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
             Fiscal year                     2016               2017               2018          3-year average
----------------------------------------------------------------------------------------------------------------
Total PC&B..........................     $2,414,728,159     $2,581,551,000     $2,690,678,000  .................
Total FTE...........................             16,381             17,022             17,023  .................
PC&B per FTE........................           $147,408           $151,660           $158,061  .................
Percent change from previous year...            2.2474%            2.8845%            4.2206%            3.1175%
----------------------------------------------------------------------------------------------------------------

    Section 744K(c)(2)(A)(ii) of the FD&C Act specifies that this 
3.1175 percent should be multiplied by the proportion of PC&B to total 
costs of an average FDA FTE for the same 3 fiscal years.

[[Page 37312]]



                      Table 2--FDA PC&Bs as a Percent of FDA Total Costs of an Average FTE
----------------------------------------------------------------------------------------------------------------
             Fiscal year                     2016               2017               2018          3-year average
----------------------------------------------------------------------------------------------------------------
Total PC&B..........................     $2,414,728,159     $2,581,551,000     $2,690,678,000  .................
Total Costs.........................     $4,666,236,000     $5,104,580,000     $5,370,935,000  .................
PC&B Percent........................           51.7490%           50.5732%           50.0970%           50.8064%
----------------------------------------------------------------------------------------------------------------

    The payroll adjustment is 3.1175 percent multiplied by 50.8064 
percent, or 1.5839 percent.
    Section 744K(c)(2)(A)(iii) of the FD&C Act specifies that the 
portion of the inflation adjustment for non-payroll costs for FY 2020 
is equal to the average annual percent change in the Consumer Price 
Index (CPI) for urban consumers (U.S. City Average; Not Seasonally 
Adjusted; All items; Annual Index) for the first 3 years of the 
preceding 4 years of available data, multiplied by the proportion of 
all non-PC&B costs to total costs of an average FDA FTE for the same 
period.
    Table 2 provides the summary data for the percent change in the 
specified CPI for U.S. cities. These data are published by the Bureau 
of Labor Statistics and can be found on its website: https://data.bls.gov/cgi-bin/surveymost?cu. The data can be viewed by checking 
the box marked ``U.S. All items, 1982-84=100--CUUR0000SA0'' and then 
selecting ``Retrieve Data.''

                   Table 3--Annual and 3-Year Average Percent Change in U.S. City Average CPI
----------------------------------------------------------------------------------------------------------------
                Year                         2016               2017               2018          3-year average
----------------------------------------------------------------------------------------------------------------
Annual CPI..........................            240.007            245.120            251.107  .................
Annual Percent Change...............            1.2615%            2.1304%            2.4425%            1.9448%
----------------------------------------------------------------------------------------------------------------

    Section 744K(c)(2)(A)(iii) of the FD&C Act specifies that this 
1.9448 percent should be multiplied by the proportion of all non-PC&B 
costs to total costs of an average FTE for the same 3 fiscal years. The 
proportion of all non-PC&B costs to total costs of an average FDA FTE 
for FYs 2016 to 2018 is 49.1936 percent (100 percent-50.8064 percent = 
49.1936 percent). Therefore, the non-pay adjustment is 1.9448 percent 
times 49.1936 percent, or 0.9567 percent.
    The PC&B component (1.5839 percent) is added to the non-PC&B 
component (0.9567 percent), for a total inflation adjustment of 2.5406 
percent (rounded). Section 744K(c)(2)(A)(i) of the FD&C Act specifies 
that one is added to that figure, making the inflation adjustment 
1.025406.
    Section 744K(c)(2)(B) of the FD&C Act provides for this inflation 
adjustment to be compounded after FY 2015. This factor for FY 2020 
(2.5406 percent) is compounded by adding one to it, and then 
multiplying it by one plus the inflation adjustment factor for FY 2019 
(9.2148 percent), as published in the Federal Register of August 1, 
2018 (83 FR 37500 at 37502). The result of this multiplication of the 
inflation factors for the 5 years since FY 2015 (1.025406 x 1.092148) 
becomes the inflation adjustment for FY 2020. For FY 2020, the 
inflation adjustment is 11.9895 percent (rounded). We then add one, 
making the FY 2020 inflation adjustment factor 1.119895.
2. Small Business Adjustment Factor
    Section 744K(c)(3) of the FD&C Act specifies that in addition to 
the inflation adjustment factor, the establishment fee for non-small 
businesses is to be further adjusted for a small business adjustment 
factor. Section 744K(c)(3)(B) of the FD&C Act provides that the small 
business adjustment factor is the adjustment to the establishment fee 
for non-small businesses that is necessary to achieve total fees 
equaling the amount that FDA would have collected if no entity 
qualified for the small business exception in section 744K(c)(4) of the 
FD&C Act. Additionally, section 744K(c)(5)(A) states that in 
establishing the small business adjustment factor for a fiscal year, 
FDA shall provide for the crediting of fees from the previous year to 
the next year if FDA overestimated the amount of the small business 
adjustment factor for such previous fiscal year.
    Therefore, to calculate the small business adjustment to the 
establishment fee for non-small businesses for FY 2020, FDA must 
estimate: (1) The number of outsourcing facilities that will pay the 
reduced fee for small businesses for FY 2020 and (2) the total fee 
revenue it would have collected if no entity had qualified for the 
small business exception (i.e., if each entity that registers as an 
outsourcing facility for FY 2020 were to pay the inflation-adjusted fee 
amount of $16,798).
    With respect to (1), FDA estimates that 14 entities will qualify 
for small business exceptions and will pay the reduced fee for FY 2020. 
With respect to (2), to estimate the total number of entities that will 
register as outsourcing facilities for FY 2020, FDA used data submitted 
by outsourcing facilities through the voluntary registration process, 
which began in December 2013. Accordingly, FDA estimates that 85 
outsourcing facilities, including 14 small businesses, will be 
registered with FDA in FY 2020.
    If the projected 85 outsourcing facilities paid the full inflation-
adjusted fee of $16,798, this would result in total revenue of 
$1,427,830 in FY 2020 ($16,798 x 85). However, 14 of the entities that 
are expected to register as outsourcing facilities for FY 2020 are 
projected to qualify for the small business exception and to pay one-
third of the full fee ($5,599 x 14), totaling $78,386 instead of paying 
the full fee ($16,798 x 14), which would total $235,172. This would 
leave a potential shortfall of $156,786 ($235,172-$78,386).
    Additionally, section 744K(c)(5)(A) of the FD&C Act states that in 
establishing the small business adjustment factor for a fiscal year, 
FDA shall provide for the crediting of fees from the previous year to 
the next year if FDA overestimated the amount of the small business 
adjustment factor for such previous fiscal year. FDA has determined 
that it is appropriate to credit excess fees collected from the last 
completed fiscal year, due to the inability to conclusively determine 
the amount of excess fees from the fiscal year that is in progress at 
the time this calculation is made. This crediting is done by comparing 
the small business adjustment factor for the last completed fiscal 
year, FY 2018 ($2,012), to what would have been the small business 
adjustment factor for FY

[[Page 37313]]

2018 ($1,262) if FDA had estimated perfectly.
    The calculation for what the small business adjustment would have 
been if FDA had estimated perfectly begins by determining the total 
target collections (15,000 x [inflation adjustment factor] x [number of 
registrants]). For the most recent complete fiscal year, FY 2018, this 
was $1,223,068 ($16,093 x 76). The actual FY 2018 revenue from the 76 
total registrants (i.e., 68 registrants paying FY 2018 non-small 
business establishment fee and eight small business registrants) paying 
establishment fees is $1,137,236. $1,137,236 is calculated as follows: 
(FY 2018 Non-Small Business Establishment Fee adjusted for inflation 
only) x (total number of registrants in FY 2018 paying Non-Small 
Business Establishment Fee) + (FY 2018 Small Business Establishment 
Fee) x (total number of small business registrants in FY 2018 paying 
Small Business Establishment Fee). $16,093 x 68 + $5,364 x 8 = 
$1,137,236. This left a shortfall of $85,832 from the estimated total 
target collection amount ($1,223,068-$1,137,236). $85,832 divided by 
the total number of registrants in FY 2018 paying Standard 
Establishment Fee (68) equals $1,262.
    The difference between the small business adjustment factor used in 
FY 2018 and the small business adjustment factor that would have been 
used had FDA estimated perfectly; is $749 ($2,012-$1,262). The $749 
(rounded to the nearest dollar) is then multiplied by the number of 
actual registrants who paid the standard fee for FY 2018 (68), which 
provides us a total excess collection of $50,963 in FY 2018.
    Therefore, to calculate the small business adjustment factor for FY 
2020, FDA subtracts $50,963 from the projected shortfall of $156,786 
for FY 2020 to arrive at the numerator for the small business 
adjustment amount, which equals $105,823. This number divided by 71 
(the number of expected non-small businesses for FY 2020) is the small 
business adjustment amount for FY 2020, which is $1,490 (rounded to the 
nearest dollar).

B. FY 2020 Rates for Small Business Establishment Fee, Non-Small 
Business Establishment Fee, and Re-Inspection Fee

1. Establishment Fee for Qualified Small Businesses \1\
---------------------------------------------------------------------------

    \1\ To qualify for a small business reduction of the FY 2020 
establishment fee, entities had to submit their exception requests 
by April 30, 2019. See section 744K(c)(4)(B) of the FD&C Act. The 
time for requesting a small business exception for FY 2020 has now 
passed. An entity that wishes to request a small business exception 
for FY 2021 should consult section 744K(c)(4) of the FD&C Act and 
section III.D of FDA's guidance for industry entitled ``Fees for 
Human Drug Compounding Outsourcing Facilities Under Sections 503B 
and 744K of the FD&C Act,'' which can be accessed on FDA's website 
at https://www.fda.gov/downloads/drugs/
guidancecomplianceregulatoryinformation/guidances/ucm391102.pdf.
---------------------------------------------------------------------------

    The amount of the establishment fee for a qualified small business 
is equal to $15,000 multiplied by the inflation adjustment factor for 
that fiscal year, divided by three (see section 744K(c)(4)(A) and 
(c)(1)(A) of the FD&C Act). The inflation adjustment factor for FY 2020 
is 1.119895. See section II.A.1 for the methodology used to calculate 
the FY 2020 inflation adjustment factor. Therefore, the establishment 
fee for a qualified small business for FY 2020 is one third of $16,798, 
which equals $5,599 (rounded to the nearest dollar).
2. Establishment Fee for Non-Small Businesses
    Under section 744K(c) of the FD&C Act, the amount of the 
establishment fee for a non-small business is equal to $15,000 
multiplied by the inflation adjustment factor for that fiscal year, 
plus the small business adjustment factor for that fiscal year, and 
plus or minus an adjustment factor to account for over- or under-
collections due to the small business adjustment factor in the prior 
year. The inflation adjustment factor for FY 2020 is 1.119895. The 
small business adjustment amount for FY 2020 is $1,490. See section 
II.A.2 for the methodology used to calculate the small business 
adjustment factor for FY 2020. Therefore, the establishment fee for a 
non-small business for FY 2020 is $15,000 multiplied by 1.119895 plus 
$1,490, which equals $18,288 (rounded to the nearest dollar).
3. Re-Inspection Fee
    Section 744K(c)(1)(B) of the FD&C Act provides that the amount of 
the FY 2020 re-inspection fee is equal to $15,000, multiplied by the 
inflation adjustment factor for that fiscal year. The inflation 
adjustment factor for FY 2020 is 1.119895. Therefore, the re-inspection 
fee for FY 2020 is $15,000 multiplied by 1.119895, which equals $16,798 
(rounded to the nearest dollar). There is no reduction in this fee for 
small businesses.

C. Summary of FY 2020 Fee Rates

                   Table 4--Outsourcing Facility Fees
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Qualified Small Business Establishment Fee.....................   $5,599
Non-Small Business Establishment Fee...........................   18,288
Re-inspection Fee..............................................   16,798
------------------------------------------------------------------------

III. Fee Payment Options and Procedures

A. Establishment Fee

    Once an entity submits registration information and FDA has 
determined that the information is complete, the entity will incur the 
annual establishment fee. FDA will send an invoice to the entity, via 
email to the email address indicated in the registration file, or via 
regular mail if email is not an option. The invoice will contain 
information regarding the obligation incurred, the amount owed, and 
payment procedures. A facility will not be registered as an outsourcing 
facility until it has paid the annual establishment fee under section 
744K of the FD&C Act. Accordingly, it is important that facilities 
seeking to operate as outsourcing facilities pay all fees immediately 
upon receiving an invoice. If an entity does not pay the full invoiced 
amount within 15 calendar days after FDA issues the invoice, FDA will 
consider the submission of registration information to have been 
withdrawn and adjust the invoice to reflect that no fee is due.
    Outsourcing facilities that registered in FY 2019 and wish to 
maintain their status as an outsourcing facility in FY 2020 must 
register during the annual registration period that lasts from October 
1, 2019, to December 31, 2019. Failure to register and complete payment 
by December 31, 2019, will result in a loss of status as an outsourcing 
facility on January 1, 2020. Entities should submit their registration 
information no later than December 10, 2019, to allow enough time for 
review of the registration information, invoicing, and payment of fees 
before the end of the registration period.

B. Re-Inspection Fee

    FDA will issue invoices for each re-inspection after the conclusion 
of the re-inspection, via email to the email address indicated in the 
registration file or via regular mail if email is not an option. 
Invoices must be paid within 30 days.

C. Fee Payment Procedures

    1. The preferred payment method is online using electronic check 
(Automated Clearing House (ACH) also known as eCheck) or credit card 
(Discover, VISA, MasterCard, American

[[Page 37314]]

Express). 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 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.
    2. If paying with a paper check: Checks must be in U.S. currency 
from a U.S. bank and made payable to the Food and Drug Administration. 
Payments can be mailed to: Food and Drug Administration, P.O. Box 
979033, St. Louis, MO 63197-9000. If a check is sent by a courier that 
requests a street address, the courier can deliver the check to: U.S. 
Bank, Attn: Government Lockbox 979033, 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 
the U.S. Bank at 314-418-4013).
    3. When paying by wire transfer, the invoice number must be 
included. Without the invoice number the payment may not be applied. 
Regarding re-inspection fees, if the payment amount is not applied, the 
invoice amount will be referred to collections. The originating 
financial institution may charge a wire transfer fee. If the financial 
institution charges a wire transfer fee, it is required that the 
outsourcing facility add that amount to the payment to ensure that the 
invoice is paid in full. Use the following account information when 
sending a wire transfer: U.S. Dept of the Treasury, TREAS NYC, 33 
Liberty St., New York, NY 10045, Acct. No. 75060099, Routing No. 
021030004, SWIFT: FRNYUS33. If needed, FDA's tax identification number 
is 53-0196965.

    Dated: July 25, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16253 Filed 7-30-19; 8:45 am]
BILLING CODE 4164-01-P

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