Outsourcing Facility Fee Rates for Fiscal Year 2019, 37500-37504 [2018-16416]

Download as PDF 37500 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Notices Subject standard Standard and summary Summary—Transportation Standards ................ The proposed transportation standards focus broadly on the applicant having a reliable, legal, and safe mode of transportation for a child in foster care to attend appointments, visitation, and meetings. We also propose that only adults in the home be permitted to transport children in foster care and only those having a driving record in good standing. We specifically avoid proposing standards that could impact a foster parent based on geographic location and income. For example, some states require foster parents to have their own vehicle. However, applicants in states with a high urban population may not have access to or need a vehicle. Rather, they rely upon public transportation. G. Training: a. Applicants must complete pre-licensing training on the following topics: legal rights, roles, responsibilities and expectations of foster parents; agency structure, purpose, policies, and services; laws and regulations; the impact of childhood trauma; managing child behaviors; first aid (including cardiopulmonary resuscitation (CPR) for the ages of the children in placement) and medication administration; and the importance of maintaining meaningful connections between the child and parents, including regular visitation. Foster parents must participate in ongoing training to receive instruction to support their parental roles and ensure the parent is up to date with agency requirements. Further, this training may also include child-specific training and/or may address issues relevant to the general population of children in foster care. The proposed training standards include both pre-licensing and ongoing training and include mandatory training topics. The purpose of the pre-licensing training standards is to provide information to applicants so they can make an informed decision about their commitment to foster a child. In addition, the pre-service training is to prepare the applicant to be licensed as a foster parent. This includes training on the reasonable and prudent parent standard per section 471(a)(24) of the Act. The ongoing training is to ensure the parent receives ongoing instruction to support their parental roles and remain up to date on policies, requirements, and services. Therefore, there are no mandatory topics, as these depend on agency priorities and specific individual needs. H. Foster Parent Assurances: Applicants must agree to comply with their roles and responsibilities as discussed with the title IV–E agency once a child is placed in their care. The title IV–E agency must require assurances including: a. Applicants will not use corporal or degrading punishment b. Applicants will not use any illegal substances, abuse alcohol by consuming it in excess amounts, or abuse legal prescription and/or nonprescription drugs by consuming them in excess amounts or using them contrary to as indicated. b. Applicants and their guests will not smoke in the family foster home, in any vehicle used to transport the child, or in the presence of the child in foster care. c. Applicants will adhere to the title IV–E agency’s reasonable and prudent parent standard per section 472(c)(1)(A)(ii)(I) of the Act. There are four proposed foster parent assurances are broadly written to apply across title IV– E jurisdictions which cover corporal punishment, alcohol and drug use, the reasonable and prudent parent standard and smoking. Assurances help potential foster family to have a clear understanding of expectations prior to approval as a foster home, cover behaviors which cannot be verified as part of the home study and typically are expectations after a home is licensed. Title IV–E agencies may wish to develop additional assurances as appropriate to their jurisdiction. Training ............................................................... Summary—Training ............................................ Foster Parent Assurances .................................. Summary—Foster Parent Assurances ............... Dated: July 24, 2018. Steven Wagner, Acting Assistant Secretary for Children and Families. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2018–16380 Filed 7–31–18; 8:45 am] [Docket No. FDA–2017–N–0007] BILLING CODE 4148–25–P Food and Drug Administration Outsourcing Facility Fee Rates for Fiscal Year 2019 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2019 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 (the FD&C Act). The FD&C Act authorizes FDA to assess and collect an annual establishment fee from outsourcing sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: 2 Task Force on Sudden Infant Death Syndrome. ‘‘SIDS and Other Sleep-Related Infant Deaths: Updated 2016 Recommendations for a Safe Infant Sleeping Environment.’’ Pediatrics, 138, no. 5 (2016): 1, https://pediatrics.aappublications.org/ content/138/5/e20162938. 3 Ibid., 2–4. VerDate Sep<11>2014 20:07 Jul 31, 2018 Jkt 244001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 facilities, as well as a re-inspection fee for each re-inspection of an outsourcing facility. This document establishes the FY 2019 rates for the small business establishment fee ($5,461), the nonsmall business establishment fee ($18,375), and the re-inspection fee ($16,382) for outsourcing facilities; provides information on how the fees for FY 2019 were determined; and describes the payment procedures outsourcing facilities should follow. These fee rates are effective October 1, 2018, and will remain in effect through September 30, 2019. For more information on human drug compounding and outsourcing facility fees: Visit FDAs website at: https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ PharmacyCompounding/default.htm. FOR FURTHER INFORMATION CONTACT: E:\FR\FM\01AUN1.SGM 01AUN1 37501 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Notices For questions relating to this notice: Melissa Hurley, Office of Financial Management, Food and Drug Administration, 8455 Colesville Rd., COLE–14202J, Silver Spring, MD 20993–0002, 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 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 2019 A. Methodology for Calculating FY 2019 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 2019. The 3-year average is 2.4152 percent. TABLE 1—FDA PC&BS EACH YEAR AND PERCENT CHANGE Fiscal year 2015 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 2.4152 percent should be multiplied by the proportion 2016 $2,232,304,000 15,484 $144,168 2.1136% 2017 $2,414,728,159 16,381 $147,408 2.2474% $2,581,551,000 17,022 $151,660 2.8845% 3-year average ................................ ................................ ................................ 2.4152% of PC&B to total costs of an average FDA FTE for the same 3 fiscal years. TABLE 2—FDA PC&BS AS A PERCENT OF FDA TOTAL COSTS OF AN AVERAGE FTE Fiscal year 2015 sradovich on DSK3GMQ082PROD with NOTICES Total PC&B ...................................................................... Total Costs ....................................................................... PC&B Percent .................................................................. The payroll adjustment is 2.4152 percent multiplied by 50.6043 percent, or 1.2222 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 2019 is equal to the average annual percent change in the Consumer VerDate Sep<11>2014 20:07 Jul 31, 2018 Jkt 244001 2016 $2,232,304,000 $4,510,565,000 49.4906% $2,414,728,159 $4,666,236,000 51.7490% 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. PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 2017 $2,581,551,000 $5,104,580,000 50.5732% 3-year average ................................ ................................ 50.6043% 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 E:\FR\FM\01AUN1.SGM 01AUN1 37502 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Notices 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 2015 Annual CPI ....................................................................... Annual Percent Change .................................................. sradovich on DSK3GMQ082PROD with NOTICES Section 744K(c)(2)(A)(iii) of the FD&C Act specifies that this 1.1702 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 2015 to 2017 is 49.3957 percent (100 percent ¥ 50.6043 percent = 49.3957 percent). Therefore, the nonpay adjustment is 1.1702 percent times 49.3957 percent, or 0.5780 percent. The PC&B component (1.2222 percent) is added to the non-PC&B component (0.5780 percent), for a total inflation adjustment of 1.8002 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 1.018002. 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 2019 (1.8002 percent) is compounded by adding one to it, and then multiplying it by one plus the inflation adjustment factor for FY 2018 (7.2835 percent), as published in the Federal Register of August 2, 2017 (82 FR 35962 at 35965). The result of this multiplication of the inflation factors for the 4 years since FY 2015 (1.018002 × 1.072835) becomes the inflation adjustment for FY 2019. For FY 2019, the inflation adjustment is 9.2148 percent (rounded). We then add one, making the FY 2019 inflation adjustment factor 1.092148. 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 VerDate Sep<11>2014 20:07 Jul 31, 2018 Jkt 244001 2016 237.017 0.1187% 240.007 1.2615% 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 2019, FDA must estimate: (1) The number of outsourcing facilities that will pay the reduced fee for small businesses for FY 2019 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 2019 were to pay the inflation-adjusted fee amount of $16,382). With respect to (1), FDA estimates that 14 entities will qualify for small business exceptions and will pay the reduced fee for FY 2019. With respect to (2), to estimate the total number of entities that will register as outsourcing facilities for FY 2019, FDA used data submitted by outsourcing facilities through the voluntary registration process, which began in December 2013. Accordingly, FDA estimates that 82 outsourcing facilities, including 14 small businesses, will be registered with FDA in FY 2019. If the projected 82 outsourcing facilities paid the full inflation-adjusted fee of $16,382, this would result in total revenue of $1,343,324 in FY 2019 ($16,382 × 82). However, 14 of the entities that are expected to register as outsourcing facilities for FY 2019 are projected to qualify for the small business exception and to pay one-third of the full fee ($5,461 × 14), totaling $76,454 instead of paying the full fee ($16,382 × 14), which would total $229,348. This would leave a potential shortfall of $152,894 ($229,348 ¥ $76,454). 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 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 2017 245.120 2.1304% 3-year average ................................ 1.1702% 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 2017 ($1,137), to what would have been the small business adjustment factor for FY 2017 ($892) 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 2017, this was $1,219,449 ($15,837 × 77). The actual FY 2017 revenue from the 77 total registrants (i.e., 71 registrants paying FY 2017 non-small business establishment fee and six small business registrants) paying establishment fees is $1,156,101. $1,156,101 is calculated as follows: (FY 2017 Non-Small Business Establishment Fee adjusted for inflation only) × (total number of registrants in FY 2017 paying Non-Small Business Establishment Fee) + (FY 2017 Small Business Establishment Fee) × (total number of small business registrants in FY 2017 paying Small Business Establishment Fee). $15,837 × 71 + $5,279 × 6 = $1,156,101. This left a shortfall of $63,348 from the estimated total target collection amount ($1,219,449 ¥ $1,156,101). $63,348 divided by the total number of registrants in FY 2017 paying Standard Establishment Fee (71) equals $892. The difference between the small business adjustment factor used in FY 2017 and the small business adjustment factor that would have been used had FDA estimated perfectly; is $245 ($1,137 ¥ $892). The $245 (rounded to the nearest dollar) is then multiplied by the number of actual registrants who paid the standard fee for FY 2017 (71), which provides us a total excess collection of $17,380 in FY 2017. Therefore, to calculate the small business adjustment factor for FY 2019, FDA subtracts $17,380 from the projected shortfall of $152,894 for FY 2019 to arrive at the numerator for the E:\FR\FM\01AUN1.SGM 01AUN1 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Notices small business adjustment amount, which equals $135,514. This number divided by 68 (the number of expected non-small businesses for FY 2019) is the small business adjustment amount for FY 2019, which is $1,993 (rounded to the nearest dollar). B. FY 2019 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 $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 2019 is 1.092148. See section II.A.1 for the methodology used to calculate the FY 2019 inflation adjustment factor. Therefore, the establishment fee for a qualified small business for FY 2019 is one third of $16,382, which equals $5,461 (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 2019 is 1.092148. The small business adjustment amount for FY 2019 is $1,993. See section II.A.2 for the methodology used to calculate the small business adjustment factor for FY 2019. Therefore, the establishment fee for a non-small business for FY 2019 is $15,000 multiplied by 1.092148 plus $1,993, which equals $18,375 (rounded to the nearest dollar). sradovich on DSK3GMQ082PROD with NOTICES 3. Re-Inspection Fee Section 744K(c)(1)(B) of the FD&C Act provides that the amount of the FY 2019 1 To qualify for a small business reduction of the FY 2019 establishment fee, entities had to submit their exception requests by April 30, 2018. See section 744K(c)(4)(B) of the FD&C Act. The time for requesting a small business exception for FY 2019 has now passed. An entity that wishes to request a small business exception for FY 2020 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. VerDate Sep<11>2014 20:07 Jul 31, 2018 Jkt 244001 re-inspection fee is equal to $15,000, multiplied by the inflation adjustment factor for that fiscal year. The inflation adjustment factor for FY 2019 is 1.092148. Therefore, the re-inspection fee for FY 2019 is $15,000 multiplied by 1.092148, which equals $16,382 (rounded to the nearest dollar). There is no reduction in this fee for small businesses. 37503 B. Re-Inspection Fee FDA will issue invoices for each reinspection after the conclusion of the reinspection, 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 C. Summary of FY 2019 Fee Rates 1. The preferred payment method is online using electronic check TABLE 4—OUTSOURCING FACILITY (Automated Clearing House (ACH) also FEES known as eCheck) or credit card (Discover, VISA, MasterCard, American Express). Secure electronic payments Qualified Small Business Establishment Fee ....................................... $5,461 can be submitted using the User Fees Non-Small Business Establishment Payment Portal at https:// Fee ................................................ 18,375 userfees.fda.gov/pay. (Note: only full Re-inspection Fee ............................ 16,382 payments are accepted. No partial payments can be made online.) Once III. Fee Payment Options and you search for your invoice, click ‘‘Pay Procedures Now’’ to be redirected to Pay.gov. Electronic payment options are based on A. Establishment Fee the balance due. Payment by credit card is available for balances less than Once an entity submits registration $25,000. If the balance exceeds this information and FDA has determined amount, only the ACH option is that the information is complete, the available. Payments must be made using entity will incur the annual U.S bank accounts as well as U.S. credit establishment fee. FDA will send an cards. invoice to the entity, via email to the email address indicated in the 2. If paying with a paper check: registration file, or via regular mail if Checks must be in U.S. currency from email is not an option. The invoice will a U.S. bank and made payable to the contain information regarding the Food and Drug Administration. obligation incurred, the amount owed, Payments can be mailed to: Food and and payment procedures. A facility will Drug Administration, P.O. Box 979033, not be registered as an outsourcing St. Louis, MO 63197–9000. If a check is facility until it has paid the annual sent by a courier that requests a street establishment fee under section 744K of address, the courier can deliver the the FD&C Act. Accordingly, it is check to: U.S. Bank, Attn: Government important that facilities seeking to Lockbox 979033, 1005 Convention operate as outsourcing facilities pay all Plaza, St. Louis, MO 63101. (Note: This fees immediately upon receiving an U.S. Bank address is for courier delivery invoice. If an entity does not pay the full only. If you have any questions invoiced amount within 15 calendar concerning courier delivery, contact the days after FDA issues the invoice, FDA U.S. Bank at 314–418–4013). will consider the submission of 3. When paying by wire transfer, the registration information to have been invoice number must be included. withdrawn and adjust the invoice to Without the invoice number the reflect that no fee is due. payment may not be applied. Regarding Outsourcing facilities that registered re-inspection fees, if the payment in FY 2018 and wish to maintain their amount is not applied, the invoice status as an outsourcing facility in FY amount will be referred to collections. 2019 must register during the annual The originating financial institution registration period that lasts from may charge a wire transfer fee. If the October 1, 2018, to December 31, 2018. financial institution charges a wire Failure to register and complete transfer fee, it is required that the payment by December 31, 2018, will outsourcing facility add that amount to result in a loss of status as an the payment to ensure that the invoice outsourcing facility on January 1, 2019. is paid in full. Use the following Entities should submit their registration account information when sending a information no later than December 10, wire transfer: New York Federal Reserve 2018, to allow enough time for review Bank, U.S. Dept of Treasury, TREAS of the registration information, NYC, 33 Liberty St., New York, NY invoicing, and payment of fees before 10045, Acct. No. 75060099, Routing No. the end of the registration period. 021030004, SWIFT: FRNYUS33. If PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\01AUN1.SGM 01AUN1 37504 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Notices needed, FDA’s tax identification number is 53–0196965. Dated: July 26, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–16416 Filed 7–31–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–0007] Prescription Drug User Fee Rates for Fiscal Year 2019 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2019. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Prescription Drug User Fee Amendments of 2017 (PDUFA VI), authorizes FDA to collect application fees for certain applications for the review of human drug and biological products, and prescription drug program fees for certain approved products. This notice establishes the fee rates for FY 2019. FOR FURTHER INFORMATION CONTACT: Lola Olajide, Office of Financial Management, Food and Drug Administration, 8455 Colesville Rd., COLE–14541B, Silver Spring, MD 20993–0002, 240–402–4244. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background Sections 735 and 736 of the FD&C Act (21 U.S.C. 379g and 379h, respectively) establish two different kinds of user fees. Fees are assessed as follows: (1) Application fees are assessed on certain types of applications for the review of human drug and biological products; and (2) prescription drug program fees are assessed on certain approved products (section 736(a) of the FD&C Act). When specific conditions are met, FDA may waive or reduce fees (section 736(d) of the FD&C Act). For FY 2018 through FY 2022, the base revenue amounts for the total revenues from all PDUFA fees are established by PDUFA VI. The base revenue amount for FY 2019 is $935,903,507. The FY 2019 base revenue amount is adjusted for inflation and for the resource capacity needs for the process for the review of human drug applications (the capacity planning adjustment). An additional dollar amount specified in the statute (see section 736(b)(1)(F) of the FD&C Act) is then added to provide for additional full-time equivalent (FTE) positions to support PDUFA VI initiatives. The FY 2019 revenue amount may be adjusted further, if necessary, to provide for sufficient operating reserves of carryover user fees. Finally, the amount is adjusted to provide for additional direct costs to fund PDUFA VI initiatives. Fee amounts are to be established each year so that revenues from application fees provide 20 percent of the total revenue, and prescription drug program fees provide 80 percent of the total revenue. This document provides fee rates for FY 2019 for an application requiring clinical data ($2,588,478), for an application not requiring clinical data ($1,294,239), and for the prescription drug program fee ($309,915). These fees are effective on October 1, 2018, and will remain in effect through September 30, 2019. For applications that are submitted on or after October 1, 2018, the new fee schedule must be used. II. Fee Revenue Amount for FY 2019 The base revenue amount for FY 2019 is $935,903,507 prior to adjustments for inflation, capacity planning, additional FTE, operating reserve, and additional direct costs (see section 736(b)(1) of the FD&C Act). A. FY 2018 Statutory Fee Revenue Adjustments for Inflation PDUFA VI specifies that the $935,903,507 is to be adjusted for inflation increases for FY 2019 using two separate adjustments—one for personnel compensation and benefits (PC&B) and one for non-PC&B costs (see section 736(c)(1) of the FD&C Act). The component of the inflation adjustment for payroll costs shall be one plus the average annual percent change in the cost of all PC&B paid per FTE positions at FDA for the first 3 of the preceding 4 FYs, multiplied by the proportion of PC&B costs to total FDA costs of the process for the review of human drug applications for the first 3 of the preceding 4 FYs (see section 736(c)(1)(A) and (c)(1)(B) of the FD&C Act). Table 1 summarizes the actual cost and FTE data for the specified FYs and provides the percent changes from the previous FYs and the average percent changes over the first three of the four FYs preceding FY 2019. The 3-year average is 2.4152 percent. TABLE 1—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGES Fiscal year 2015 sradovich on DSK3GMQ082PROD with NOTICES $2,414,728,159 16,381 $147,408 $2,581,551,000 17,022 $151,660 ........................................ ........................................ ........................................ 2.1136 The statute specifies that this 2.4152 percent be multiplied by the proportion of PC&B costs to the total FDA costs of 2017 $2,232,304,000 15,484 $144,168 Total PC&B ...................................... Total FTE ......................................... PC&B per FTE ................................. Percent Change From Previous Year .............................................. 2016 2.2474 2.8845 2.4152 the process for the review of human drug applications. Table 2 shows the PC&B and the total obligations for the 3-year average process for the review of human drug applications for the first three of the preceding four FYs. TABLE 2—PC&B AS A PERCENT OF TOTAL COST OF THE PROCESS FOR THE REVIEW OF HUMAN DRUG APPLICATIONS Fiscal year 2015 Total PC&B ...................................... Total Costs ....................................... PC&B Percent .................................. VerDate Sep<11>2014 20:07 Jul 31, 2018 Jkt 244001 2016 2017 $615,483,892 $1,127,664,528 54.5804 $652,508,273 $1,157,817,695 56.3567 $711,016,627 $1,206,657,269 58.9245 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\01AUN1.SGM 01AUN1 3-year average ........................................ ........................................ 56.6205

Agencies

[Federal Register Volume 83, Number 148 (Wednesday, August 1, 2018)]
[Notices]
[Pages 37500-37504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16416]


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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 2019

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
fiscal year (FY) 2019 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 (the 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 2019 rates for the small 
business establishment fee ($5,461), the non-small business 
establishment fee ($18,375), and the re-inspection fee ($16,382) for 
outsourcing facilities; provides information on how the fees for FY 
2019 were determined; and describes the payment procedures outsourcing 
facilities should follow. These fee rates are effective October 1, 
2018, and will remain in effect through September 30, 2019.

FOR FURTHER INFORMATION CONTACT: For more information on human drug 
compounding and outsourcing facility fees: Visit FDAs website at: 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/default.htm.

[[Page 37501]]

    For questions relating to this notice: Melissa Hurley, Office of 
Financial Management, Food and Drug Administration, 8455 Colesville 
Rd., COLE-14202J, Silver Spring, MD 20993-0002, 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 2019

A. Methodology for Calculating FY 2019 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 2019. The 3-year average is 2.4152 percent.

                                 Table 1--FDA PC&Bs Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
           Fiscal year                   2015                2016                2017           3-year average
----------------------------------------------------------------------------------------------------------------
Total PC&B......................      $2,232,304,000      $2,414,728,159      $2,581,551,000  ..................
Total FTE.......................              15,484              16,381              17,022  ..................
PC&B per FTE....................            $144,168            $147,408            $151,660  ..................
Percent change from previous                 2.1136%             2.2474%             2.8845%             2.4152%
 year...........................
----------------------------------------------------------------------------------------------------------------

    Section 744K(c)(2)(A)(ii) of the FD&C Act specifies that this 
2.4152 percent should be multiplied by the proportion of PC&B to total 
costs of an average FDA FTE for the same 3 fiscal years.

                      Table 2--FDA PC&Bs as a Percent of FDA Total Costs of an Average FTE
----------------------------------------------------------------------------------------------------------------
           Fiscal year                   2015                2016                2017           3-year average
----------------------------------------------------------------------------------------------------------------
Total PC&B......................      $2,232,304,000      $2,414,728,159      $2,581,551,000  ..................
Total Costs.....................      $4,510,565,000      $4,666,236,000      $5,104,580,000  ..................
PC&B Percent....................            49.4906%            51.7490%            50.5732%            50.6043%
----------------------------------------------------------------------------------------------------------------

    The payroll adjustment is 2.4152 percent multiplied by 50.6043 
percent, or 1.2222 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 2019 
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

[[Page 37502]]

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                       2015                2016                2017           3-year average
----------------------------------------------------------------------------------------------------------------
Annual CPI......................             237.017             240.007             245.120  ..................
Annual Percent Change...........             0.1187%             1.2615%             2.1304%             1.1702%
----------------------------------------------------------------------------------------------------------------

    Section 744K(c)(2)(A)(iii) of the FD&C Act specifies that this 
1.1702 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 2015 to 2017 is 49.3957 percent (100 percent - 50.6043 percent 
= 49.3957 percent). Therefore, the non-pay adjustment is 1.1702 percent 
times 49.3957 percent, or 0.5780 percent.
    The PC&B component (1.2222 percent) is added to the non-PC&B 
component (0.5780 percent), for a total inflation adjustment of 1.8002 
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 
1.018002.
    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 2019 
(1.8002 percent) is compounded by adding one to it, and then 
multiplying it by one plus the inflation adjustment factor for FY 2018 
(7.2835 percent), as published in the Federal Register of August 2, 
2017 (82 FR 35962 at 35965). The result of this multiplication of the 
inflation factors for the 4 years since FY 2015 (1.018002 x 1.072835) 
becomes the inflation adjustment for FY 2019. For FY 2019, the 
inflation adjustment is 9.2148 percent (rounded). We then add one, 
making the FY 2019 inflation adjustment factor 1.092148.
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 2019, FDA must 
estimate: (1) The number of outsourcing facilities that will pay the 
reduced fee for small businesses for FY 2019 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 2019 were to pay the inflation-adjusted fee 
amount of $16,382).
    With respect to (1), FDA estimates that 14 entities will qualify 
for small business exceptions and will pay the reduced fee for FY 2019. 
With respect to (2), to estimate the total number of entities that will 
register as outsourcing facilities for FY 2019, FDA used data submitted 
by outsourcing facilities through the voluntary registration process, 
which began in December 2013. Accordingly, FDA estimates that 82 
outsourcing facilities, including 14 small businesses, will be 
registered with FDA in FY 2019.
    If the projected 82 outsourcing facilities paid the full inflation-
adjusted fee of $16,382, this would result in total revenue of 
$1,343,324 in FY 2019 ($16,382 x 82). However, 14 of the entities that 
are expected to register as outsourcing facilities for FY 2019 are 
projected to qualify for the small business exception and to pay one-
third of the full fee ($5,461 x 14), totaling $76,454 instead of paying 
the full fee ($16,382 x 14), which would total $229,348. This would 
leave a potential shortfall of $152,894 ($229,348 - $76,454).
    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 2017 ($1,137), to what would have been the small business 
adjustment factor for FY 2017 ($892) 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 2017, this 
was $1,219,449 ($15,837 x 77). The actual FY 2017 revenue from the 77 
total registrants (i.e., 71 registrants paying FY 2017 non-small 
business establishment fee and six small business registrants) paying 
establishment fees is $1,156,101. $1,156,101 is calculated as follows: 
(FY 2017 Non-Small Business Establishment Fee adjusted for inflation 
only) x (total number of registrants in FY 2017 paying Non-Small 
Business Establishment Fee) + (FY 2017 Small Business Establishment 
Fee) x (total number of small business registrants in FY 2017 paying 
Small Business Establishment Fee). $15,837 x 71 + $5,279 x 6 = 
$1,156,101. This left a shortfall of $63,348 from the estimated total 
target collection amount ($1,219,449 - $1,156,101). $63,348 divided by 
the total number of registrants in FY 2017 paying Standard 
Establishment Fee (71) equals $892.
    The difference between the small business adjustment factor used in 
FY 2017 and the small business adjustment factor that would have been 
used had FDA estimated perfectly; is $245 ($1,137 - $892). The $245 
(rounded to the nearest dollar) is then multiplied by the number of 
actual registrants who paid the standard fee for FY 2017 (71), which 
provides us a total excess collection of $17,380 in FY 2017.
    Therefore, to calculate the small business adjustment factor for FY 
2019, FDA subtracts $17,380 from the projected shortfall of $152,894 
for FY 2019 to arrive at the numerator for the

[[Page 37503]]

small business adjustment amount, which equals $135,514. This number 
divided by 68 (the number of expected non-small businesses for FY 2019) 
is the small business adjustment amount for FY 2019, which is $1,993 
(rounded to the nearest dollar).

B. FY 2019 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 2019 
establishment fee, entities had to submit their exception requests 
by April 30, 2018. See section 744K(c)(4)(B) of the FD&C Act. The 
time for requesting a small business exception for FY 2019 has now 
passed. An entity that wishes to request a small business exception 
for FY 2020 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 2019 
is 1.092148. See section II.A.1 for the methodology used to calculate 
the FY 2019 inflation adjustment factor. Therefore, the establishment 
fee for a qualified small business for FY 2019 is one third of $16,382, 
which equals $5,461 (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 2019 is 1.092148. The 
small business adjustment amount for FY 2019 is $1,993. See section 
II.A.2 for the methodology used to calculate the small business 
adjustment factor for FY 2019. Therefore, the establishment fee for a 
non-small business for FY 2019 is $15,000 multiplied by 1.092148 plus 
$1,993, which equals $18,375 (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 2019 re-inspection fee is equal to $15,000, multiplied by the 
inflation adjustment factor for that fiscal year. The inflation 
adjustment factor for FY 2019 is 1.092148. Therefore, the re-inspection 
fee for FY 2019 is $15,000 multiplied by 1.092148, which equals $16,382 
(rounded to the nearest dollar). There is no reduction in this fee for 
small businesses.

C. Summary of FY 2019 Fee Rates

                   Table 4--Outsourcing Facility Fees
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Qualified Small Business Establishment Fee.....................   $5,461
Non-Small Business Establishment Fee...........................   18,375
Re-inspection Fee..............................................   16,382
------------------------------------------------------------------------

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 2018 and wish to 
maintain their status as an outsourcing facility in FY 2019 must 
register during the annual registration period that lasts from October 
1, 2018, to December 31, 2018. Failure to register and complete payment 
by December 31, 2018, will result in a loss of status as an outsourcing 
facility on January 1, 2019. Entities should submit their registration 
information no later than December 10, 2018, 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 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: New York Federal Reserve Bank, U.S. Dept of 
Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No. 
75060099, Routing No. 021030004, SWIFT: FRNYUS33. If

[[Page 37504]]

needed, FDA's tax identification number is 53-0196965.

    Dated: July 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16416 Filed 7-31-18; 8:45 am]
 BILLING CODE 4164-01-P

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