80_FR_46155 80 FR 46007 - Outsourcing Facility Fee Rates for Fiscal Year 2016

80 FR 46007 - Outsourcing Facility Fee Rates for Fiscal Year 2016

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 148 (August 3, 2015)

Page Range46007-46010
FR Document2015-18916

The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2016 rates for the establishment and reinspection fees related to human drug compounding outsourcing facilities (outsourcing facilities) that elect to register 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 that have elected to register, as well as a reinspection fee for each reinspection of an outsourcing facility. This document establishes the FY 2016 rates for the small business establishment fee ($5,203), the non-small business establishment fee ($16,465), and the reinspection fee ($15,610) for outsourcing facilities; provides information on how the fees for FY 2016 were determined; and describes the payment procedures outsourcing facilities should follow.

Federal Register, Volume 80 Issue 148 (Monday, August 3, 2015) 
[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Notices]
[Pages 46007-46010]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-18916]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0007]


Outsourcing Facility Fee Rates for Fiscal Year 2016

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) 2016 rates for the establishment and reinspection fees 
related to human drug compounding outsourcing facilities (outsourcing 
facilities) that elect to register 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 that 
have elected to register, as well as a reinspection fee for each 
reinspection of an outsourcing facility. This document establishes the 
FY 2016 rates for the small business establishment fee ($5,203), the 
non-small business establishment fee ($16,465), and the reinspection 
fee ($15,610) for outsourcing facilities; provides information on how 
the fees for FY 2016 were determined; and describes the payment 
procedures outsourcing facilities should follow.

FOR FURTHER INFORMATION CONTACT: 
    For information on pharmacy compounding and pharmacy compounding 
user fees: Visit FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/default.htm.
    For questions relating to this notice: Rachel Richter, Office of 
Financial Management, Food and Drug Administration, 8455 Colesville 
Rd., COLE-14216, Silver Spring, MD 20933-0002, 301-796-7111.

SUPPLEMENTARY INFORMATION: 

I. Background

    On November 27, 2013, President Obama signed the Drug Quality and 
Security Act (DQSA), legislation that contains important provisions 
relating to the oversight of compounding of human drugs. Title I of 
this law, the Compounding Quality Act, creates 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 these conditions 
are satisfied, a drug compounded by or under the direct supervision of 
a licensed pharmacist in an outsourcing facility is exempt from two 
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 and 
(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). 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 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 that elect to register under section 503B of the FD&C Act: 
(1) An annual establishment fee from each outsourcing facility and (2) 
a reinspection fee from each outsourcing facility subject to a 
reinspection (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 registered outsourcing facilities 
and adjustments required by law, reinspection fees, how to submit 
payment, the effect of failure to pay fees,

[[Page 46008]]

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 Web 
site at http://wcms.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM391102.pdf.

II. Fees for FY 2016 \1\
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    \1\ FY 2016 runs from October 1, 2015, through September 30, 
2016.
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A. FY 2016 Rates for Small Business Establishment Fee, Non-Small 
Business Establishment Fee, and Reinspection Fee

1. Establishment Fee for Qualified Small Businesses \2\
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    \2\ To qualify for a small business reduction of the FY 2016 
establishment fee, entities had to submit their exception requests 
by April 30, 2015. See section 744K(c)(4)(B) of the FD&C Act. 
Although the time for requesting a small business exception for FY 
2016 has now passed, an entity that wishes to request a small 
business exception for FY 2017 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 Web site at http://wcms.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM391102.pdf.
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    The amount of the establishment fee for a qualified small business 
fee 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 2016 
is 1.040646. See section II.B.1 for the methodology used to calculate 
the FY 2016 inflation adjustment factor. Therefore, the establishment 
fee for a qualified small business for FY 2016 is one third of $15,610, 
which, rounded to the nearest dollar, equals $5,203.
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 fee 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 2016 is 1.040646. The 
small business adjustment amount for FY 2016 is $855. See section 
II.B.2 for the methodology used to calculate the small business 
adjustment factor for FY 2016. Therefore, the establishment fee for a 
non-small business for FY 2016 is $15,000 multiplied by 1.040646 plus 
$855, which equals $16,465.3.
3. Reinspection Fee
    Section 744K(c)(1)(B) of the FD&C Act provides that the amount of 
the FY 2016 reinspection fee is equal to $15,000, multiplied by the 
inflation adjustment factor for that fiscal year. The inflation 
adjustment factor for FY 2016 is 1.040646. Therefore, the reinspection 
fee for FY 2016 is $15,000 multiplied by 1.040646, which equals 
$15,610. There is no reduction in this fee for small businesses.

B. Methodology for Calculating FY 2016 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-pay costs for the first three of the four previous fiscal years. 
The payroll component of the annual inflation adjustment is calculated 
by taking the average change in the FDA's per-full time equivalent 
(FTE) personnel compensation and benefits (PC&B) in the first three of 
the four 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 three of the four 
fiscal years preceding FY 2016. The 3-year average is 2.2328 percent.

                                Table 1--FDA PC&B's Each Year and Percent Change
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             Fiscal year                     2012               2013               2014          3-Year average
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Total PC&B..........................     $1,824,703,000     $1,927,703,000     $2,054,937,000  .................
Total FTE...........................             13,382             13,974             14,555  .................
PC&B per FTE........................           $136,355           $137,949           $141,184  .................
Percent change from previous year...            3.1843%            1.1690%            2.3451%            2.2328%
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    Section 744K(c)(2)(A)(ii) of the FD&C Act specifies that this 
2.2328 percent should be multiplied by the proportion of PC&B to total 
costs of an average FTE of FDA for the same three fiscal years.

                      Table 2--FDA PC&B's as a Percent of FDA Total Costs of an Average FTE
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             Fiscal year                     2012               2013               2014          3-Year average
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Total PC&B..........................     $1,824,703,000     $1,927,703,000     $2,054,937,000  .................
Total Costs.........................     $3,550,496,000     $4,151,343,000      4,298,476,000  .................
PC&B Percent........................           51.3929%           46.4356%           47.8062%           48.5449%
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    The payroll adjustment is 2.2328 percent multiplied by 48.5449 
percent, or 1.0839 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 2016 
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 FTE of the FDA for the 
same period.

[[Page 46009]]

    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 Web site at http://data.bls.gov/cgi-bin/surveymost?cu by checking the box marked ``U.S. 
All items, 1982-84 = 100 - CUUR0000SA0'' and then clicking on the 
``Retrieve Data'' button.

                   Table 3--Annual and 3-Year Average Percent Change in U.S. City Average CPI
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                Year                         2012               2013               2014          3-Year average
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Annual CPI..........................            229.594            232.957            236.736  .................
Annual Percent Change...............            2.0694%            1.4648%            1.6222%            1.7188%
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    Section 744K(c)(2)(A)(iii) of the FD&C Act specifies that this 
1.7188 percent should be multiplied by the proportion of all non-PC&B 
costs to total costs of an average FTE for the same three fiscal years. 
The proportion of all non-PC&B costs to total costs of an average FTE 
of FDA for FYs 2012 to 2014 is 51.4551 percent (100 percent - 48.5449 
percent = 51.4551 percent). Therefore, the non-pay adjustment is 1.7188 
percent times 51.4551 percent, or 0.8844 percent.
    The PC&B component (1.0839 percent) is added to the non-PC&B 
component (0.8844 percent), for a total inflation adjustment of 1.9683 
percent (rounded), and then one is added, making the inflation 
adjustment 1.019683.
    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 2016 
(1.9683 percent) is compounded by adding one to it, and then 
multiplying it by one plus the inflation adjustment factor for FY 2015 
(2.0558 percent), as published in the Federal Register of August 1, 
2014 (79 FR 44805). The result of this multiplication of the inflation 
factors for the 1 year since FY 2015 (1.019683 x 1.020558) becomes the 
inflation adjustment for FY 2016. For FY 2016, the inflation adjustment 
is 4.0646 percent (rounded). We then add one, making the FY 2016 
inflation adjustment factor 1.040646.
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 2016, FDA must 
estimate: (1) The number of outsourcing facilities that will pay the 
reduced fee for small businesses for FY 2016 and (2) the total fee 
revenue it would have collected if no entity had qualified for the 
small business exception (i.e., if each outsourcing facility that 
registers for FY 2016 were to pay the inflation-adjusted fee amount of 
$15,610).
    With respect to (1), FDA estimates that eight entities will qualify 
for small business exceptions and will pay the reduced fee for FY 2016. 
With respect to (2), to estimate the total number of outsourcing 
facilities that will register for FY 2016, FDA used data submitted by 
outsourcing facilities through the voluntary registration process, 
which began in December 2013. Accordingly, FDA estimates that 55 
outsourcing facilities, including 8 small businesses, will register 
with FDA in FY 2016.
    If the projected 55 outsourcing facilities paid the full inflation-
adjusted fee of $15,610, this would result in total revenue of $858,550 
in FY 2016 ($15,610 x 55). However, because 8 of the outsourcing 
facilities expected to register for FY 2016 are estimated to qualify 
for the small business exception and will pay one-third of the full fee 
($5,203 x 8), totaling $41,624 instead of paying the full fee ($15,610 
x 8), which totals $124,880. This would leave a shortfall of $83,256 
($124,880 - $41,624).
    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. For each year, total 
target collections are calculated as (15,000 x [inflation adjustment 
factor] x [number of registrants]). This would have been $887,864 for 
FY 2015 ($15,308 x 58). However, because FDA did not have the exact 
number of registrants and had to rely on estimates of the number of 
small businesses and non-small businesses that would register in FY 
2015, FDA's FY 2015 small business adjustment factor resulted in excess 
collections of $43,094 ($930,958 - $887,864) as of June 30, 2015.\3\
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    \3\ If FDA receives additional excess collections for FY 2015 
after June 30, 2015, then FDA will credit this amount when it 
establishes the small business adjustment factor for FY 2017.
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    Therefore, to calculate the small business adjustment factor for FY 
2016, FDA subtracts the $43,094 overage from FY 2015 from the $83,256 
projected shortfall for FY 2016 to arrive at the numerator for the 
small business adjustment amount, which equals $40,162. This number 
divided by 47 (the number of expected non-small businesses for FY 2016) 
is the small business adjustment amount for FY 2016, which is $855. 
Therefore, the establishment fee for a non-small business for FY 2016 
is $15,000 multiplied by 1.040646 plus $855, which equals $16,465.

C. Summary of FY 2016 Fee Rates

                   Table 4--Outsourcing Facility Fees
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Qualified Small Business Establishment Fee..............          $5,203
Non-Small Business Establishment Fee....................          16,465
Reinspection Fee........................................          15,610
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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

[[Page 46010]]

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 deemed 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 registered 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 2015 and wish to 
maintain their status as an outsourcing facility in FY 2016 must 
register during the annual registration period that lasts from October 
1, 2015, to December 31, 2015. Failure to register and complete payment 
by December 31, 2015, will result in a loss of status as an outsourcing 
facility on January 1, 2016. Entities should submit their registration 
information no later than December 10, 2015, to allow enough time for 
review of the registration information, invoicing, and payment of fees 
before the end of the registration period.

B. Reinspection 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

    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. Once you search for your invoice, click ``Pay 
Now'' to be redirected to Pay.gov. Note that electronic payment options 
are based on the balance due. Payment by credit card is available for 
balances less than $50,000. If the balance exceeds this amount, only 
the ACH option is available. Payments must be drawn on 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 
956733, St. Louis, MO 63195-6733. 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 956733, 1005 Convention Plaza, St. 
Louis, MO 63101. (Note: This U.S. Bank address is for courier delivery 
only; do not send mail to this address.)
    3. If paying with a wire transfer: 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, 
Beneficiary: FDA, 8455 Colesville Rd., Silver Spring, MD 20993. The 
originating financial institution may charge a wire transfer fee. An 
outsourcing facility should ask its financial institution about the fee 
and add it to the payment to ensure that the order is fully paid. The 
tax identification number of FDA is 53-0196965.

    Dated: July 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18916 Filed 7-31-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices 46007 The application or supplement fee for product fees under the new fee schedule Management, Food and Drug a biosimilar biological product is due in August 2015. Payment instructions Administration, 8455 Colesville Rd., upon submission of the application or will be included in the invoices. COLE–14216, Silver Spring, MD 20933– supplement. Payment will be due on October 1, 2015. 0002, 301–796–7111. To make a payment of the initial BPD, If sponsors join the BPD program after SUPPLEMENTARY INFORMATION: reactivation, supplement, or application the annual BPD invoices have been fee, complete the Biosimilar User Fee issued in August 2015, FDA will issue I. Background Cover Sheet, available on FDA’s Web invoices in November 2015 to firms On November 27, 2013, President site (http://www.fda.gov/bsufa) and subject to fees for FY 2016 that qualify Obama signed the Drug Quality and generate a user fee identification (ID) for the annual BPD fee after the August Security Act (DQSA), legislation that number. Payment must be made in U.S. 2015 billing. FDA will issue invoices in contains important provisions relating currency by electronic check, check, November 2016 for any annual products to the oversight of compounding of bank draft, U.S. postal money order, or and establishments subject to fees for human drugs. Title I of this law, the wire transfer. FY 2016 that qualify for fee assessments Compounding Quality Act, creates a FDA has partnered with the U.S. after the August 2015 billing. new section 503B in the FD&C Act (21 Department of the Treasury to use Dated: July 28, 2015. U.S.C. 353b). Under section 503B of the Pay.gov, a Web-based payment FD&C Act, a human drug compounder Leslie Kux, application, for online electronic can become an ‘‘outsourcing facility.’’ payment. The Pay.gov feature is Associate Commissioner for Policy. Outsourcing facilities, as defined in available on FDA’s Web site after [FR Doc. 2015–18908 Filed 7–31–15; 8:45 am] section 503B(d)(4) of the FD&C Act, are completing the Biosimilar User Fee BILLING CODE 4164–01–P facilities that meet all of the conditions Cover Sheet and generating the user fee described in section 503B(a), including ID number. registering with FDA as an outsourcing Please include the user fee ID number DEPARTMENT OF HEALTH AND facility and paying an annual on your check, bank draft, or postal HUMAN SERVICES establishment fee. If these conditions money order, and make it payable to the are satisfied, a drug compounded by or Food and Drug Administration Food and Drug Administration. Your under the direct supervision of a payment can be mailed to: Food and [Docket No. FDA–2015–N–0007] licensed pharmacist in an outsourcing Drug Administration, P.O. Box 979108, facility is exempt from two sections of St. Louis, MO 63197–9000. If you prefer Outsourcing Facility Fee Rates for the FD&C Act: (1) Section 502(f)(1) (21 to send a check by a courier such as Fiscal Year 2016 U.S.C. 352(f)(1)) concerning the labeling Federal Express or United Parcel AGENCY: Food and Drug Administration, of drugs with adequate directions for Service, the courier may deliver the HHS. use and (2) section 505 (21 U.S.C. 355) check and printed copy of the cover ACTION: Notice. concerning the approval of human drug sheet to: U.S. Bank, Attention: products under new drug applications Government Lockbox 979108, 1005 SUMMARY: The Food and Drug (NDAs) or abbreviated new drug Convention Plaza, St. Louis, MO 63101. Administration (FDA) is announcing the applications (ANDAs). Drugs (Note: This U.S. Bank address is for fiscal year (FY) 2016 rates for the compounded in outsourcing facilities courier delivery only. Contact U.S. Bank establishment and reinspection fees are not exempt from the requirements of at 314–418–4013 if you have any related to human drug compounding section 501(a)(2)(B) of the FD&C Act (21 questions concerning courier delivery.) outsourcing facilities (outsourcing U.S.C. 351(a)(2)(B)) concerning current Please make sure that the FDA post facilities) that elect to register under the good manufacturing practice for drugs. office box number (P.O. Box 979108) is Federal Food, Drug, and Cosmetic Act Section 744K of the FD&C Act (21 written on the check, bank draft, or (the FD&C Act). The FD&C Act U.S.C. 379j–62) authorizes FDA to postal money order. authorizes FDA to assess and collect an assess and collect the following fees If paying by wire transfer, please annual establishment fee from associated with outsourcing facilities reference your unique user fee ID outsourcing facilities that have elected that elect to register under section 503B number when completing your transfer. to register, as well as a reinspection fee of the FD&C Act: (1) An annual The originating financial institution for each reinspection of an outsourcing establishment fee from each outsourcing may charge a wire transfer fee. Please facility. This document establishes the facility and (2) a reinspection fee from ask your financial institution about the FY 2016 rates for the small business each outsourcing facility subject to a fee and include it with your payment to establishment fee ($5,203), the non- reinspection (see section 744K(a)(1) of ensure that your fee is fully paid. The small business establishment fee the FD&C Act). Under statutorily account information is as follows: New ($16,465), and the reinspection fee defined conditions, a qualified York Federal Reserve Bank, U.S. ($15,610) for outsourcing facilities; applicant may pay a reduced small Department of Treasury, TREAS NYC, provides information on how the fees business establishment fee (see section 33 Liberty St., New York, NY 10045, for FY 2016 were determined; and 744K(c)(4) of the FD&C Act). Acct. No.: 75060099, Routing No.: describes the payment procedures FDA announced in the Federal 021030004, SWIFT: FRNYUS33, outsourcing facilities should follow. Register of November 24, 2014 (79 FR Beneficiary: FDA, 8455 Colesville Rd., FOR FURTHER INFORMATION CONTACT: 69856), the availability of a final Silver Spring, MD 20993–0002. For information on pharmacy guidance for industry entitled ‘‘Fees for mstockstill on DSK4VPTVN1PROD with NOTICES The tax identification number of FDA compounding and pharmacy Human Drug Compounding Outsourcing is 53–0196965. compounding user fees: Visit FDA’s Facilities Under Sections 503B and Web site at http://www.fda.gov/Drugs/ 744K of the FD&C Act.’’ The guidance B. Annual BPD, Establishment, and GuidanceComplianceRegulatory provides additional information on the Product Fees Information/PharmacyCompounding/ annual fees for registered outsourcing FDA will issue invoices for annual default.htm. facilities and adjustments required by BPD, biosimilar biological product For questions relating to this notice: law, reinspection fees, how to submit establishment, and biosimilar biological Rachel Richter, Office of Financial payment, the effect of failure to pay fees, VerDate Sep<11>2014 18:35 Jul 31, 2015 Jkt 235001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 E:\FR\FM\03AUN1.SGM 03AUN1

46008 Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices and how to qualify as a small business 2. Establishment Fee for Non-Small is no reduction in this fee for small to obtain a reduction of the annual Businesses businesses. establishment fee. This guidance can be Under section 744K(c) of the FD&C B. Methodology for Calculating FY 2016 accessed on FDA’s Web site at http:// Act, the amount of the establishment fee Adjustment Factors wcms.fda.gov/downloads/Drugs/ for a non-small business fee is equal to GuidanceComplianceRegulatory 1. Inflation Adjustment Factor $15,000 multiplied by the inflation Information/Guidances/UCM391102. adjustment factor for that fiscal year, Section 744K(c)(2) of the FD&C Act pdf. plus the small business adjustment specifies the annual inflation factor for that fiscal year, and plus or adjustment for outsourcing facility fees. II. Fees for FY 2016 1 minus an adjustment factor to account The inflation adjustment has two A. FY 2016 Rates for Small Business for over- or under-collections due to the components: One based on FDA’s Establishment Fee, Non-Small Business small business adjustment factor in the payroll costs and one based on FDA’s Establishment Fee, and Reinspection prior year. The inflation adjustment non-pay costs for the first three of the Fee factor for FY 2016 is 1.040646. The four previous fiscal years. The payroll small business adjustment amount for component of the annual inflation 1. Establishment Fee for Qualified Small FY 2016 is $855. See section II.B.2 for adjustment is calculated by taking the Businesses 2 the methodology used to calculate the average change in the FDA’s per-full small business adjustment factor for FY time equivalent (FTE) personnel The amount of the establishment fee 2016. Therefore, the establishment fee compensation and benefits (PC&B) in for a qualified small business fee is for a non-small business for FY 2016 is the first three of the four previous fiscal equal to $15,000 multiplied by the years (see section 744K(c)(2)(A)(ii) of $15,000 multiplied by 1.040646 plus inflation adjustment factor for that fiscal $855, which equals $16,465.3. the FD&C Act). FDA’s total annual year, divided by three (see section spending on PC&B is divided by the 744K(c)(4)(A) and (c)(1)(A) of the FD&C 3. Reinspection Fee total number of FTEs per fiscal year to Act). The inflation adjustment factor for Section 744K(c)(1)(B) of the FD&C Act determine the average PC&B per FTE. FY 2016 is 1.040646. See section II.B.1 provides that the amount of the FY 2016 Table 1 summarizes the actual cost for the methodology used to calculate reinspection fee is equal to $15,000, and FTE data for the specified fiscal the FY 2016 inflation adjustment factor. multiplied by the inflation adjustment years, and provides the percent change Therefore, the establishment fee for a factor for that fiscal year. The inflation from the previous fiscal year and the qualified small business for FY 2016 is adjustment factor for FY 2016 is average percent change over the first one third of $15,610, which, rounded to 1.040646. Therefore, the reinspection three of the four fiscal years preceding the nearest dollar, equals $5,203. fee for FY 2016 is $15,000 multiplied by FY 2016. The 3-year average is 2.2328 1.040646, which equals $15,610. There percent. TABLE 1—FDA PC&B’S EACH YEAR AND PERCENT CHANGE Fiscal year 2012 2013 2014 3-Year average Total PC&B .............................................................................. $1,824,703,000 $1,927,703,000 $2,054,937,000 .............................. Total FTE ................................................................................. 13,382 13,974 14,555 .............................. PC&B per FTE ......................................................................... $136,355 $137,949 $141,184 .............................. Percent change from previous year ........................................ 3.1843% 1.1690% 2.3451% 2.2328% Section 744K(c)(2)(A)(ii) of the FD&C of PC&B to total costs of an average FTE Act specifies that this 2.2328 percent of FDA for the same three fiscal years. should be multiplied by the proportion TABLE 2—FDA PC&B’S AS A PERCENT OF FDA TOTAL COSTS OF AN AVERAGE FTE Fiscal year 2012 2013 2014 3-Year average Total PC&B .............................................................................. $1,824,703,000 $1,927,703,000 $2,054,937,000 .............................. Total Costs ............................................................................... $3,550,496,000 $4,151,343,000 4,298,476,000 .............................. PC&B Percent .......................................................................... 51.3929% 46.4356% 47.8062% 48.5449% The payroll adjustment is 2.2328 costs for FY 2016 is equal to the average the first 3 years of the preceding 4 years percent multiplied by 48.5449 percent, annual percent change in the Consumer of available data, multiplied by the or 1.0839 percent. Price Index (CPI) for urban consumers proportion of all non-PC&B costs to total Section 744K(c)(2)(A)(iii) of the FD&C (U.S. City Average; Not Seasonally costs of an average FTE of the FDA for mstockstill on DSK4VPTVN1PROD with NOTICES Act specifies that the portion of the Adjusted; All items; Annual Index) for the same period. inflation adjustment for non-payroll 1 FY 2016 runs from October 1, 2015, through time for requesting a small business exception for Outsourcing Facilities Under Sections 503B and September 30, 2016. FY 2016 has now passed, an entity that wishes to 744K of the FD&C Act,’’ which can be accessed on 2 To qualify for a small business reduction of the request a small business exception for FY 2017 FDA’s Web site at http://wcms.fda.gov/downloads/ FY 2016 establishment fee, entities had to submit should consult section 744K(c)(4) of the FD&C Act Drugs/GuidanceComplianceRegulatoryInformation/ their exception requests by April 30, 2015. See and section III.D of FDA’s guidance for industry Guidances/UCM391102.pdf. section 744K(c)(4)(B) of the FD&C Act. Although the entitled ‘‘Fees for Human Drug Compounding VerDate Sep<11>2014 18:35 Jul 31, 2015 Jkt 235001 PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 E:\FR\FM\03AUN1.SGM 03AUN1

Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices 46009 Table 2 provides the summary data Statistics and can be found on its Web ¥ CUUR0000SA0’’ and then clicking on for the percent change in the specified site at http://data.bls.gov/cgi-bin/ the ‘‘Retrieve Data’’ button. CPI for U.S. cities. These data are surveymost?cu by checking the box published by the Bureau of Labor marked ‘‘U.S. All items, 1982–84 = 100 TABLE 3—ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN U.S. CITY AVERAGE CPI 3-Year Year 2012 2013 2014 average Annual CPI ............................................................................... 229.594 232.957 236.736 .............................. Annual Percent Change .......................................................... 2.0694% 1.4648% 1.6222% 1.7188% Section 744K(c)(2)(A)(iii) of the FD&C the small business adjustment factor for fiscal year. For each year, total target Act specifies that this 1.7188 percent a fiscal year, FDA shall provide for the collections are calculated as (15,000 × should be multiplied by the proportion crediting of fees from the previous year [inflation adjustment factor] × [number of all non-PC&B costs to total costs of an to the next year if FDA overestimated of registrants]). This would have been average FTE for the same three fiscal the amount of the small business $887,864 for FY 2015 ($15,308 × 58). years. The proportion of all non-PC&B adjustment factor for such previous However, because FDA did not have the costs to total costs of an average FTE of fiscal year. exact number of registrants and had to FDA for FYs 2012 to 2014 is 51.4551 Therefore, to calculate the small rely on estimates of the number of small percent (100 percent ¥ 48.5449 percent business adjustment to the businesses and non-small businesses = 51.4551 percent). Therefore, the non- establishment fee for non-small that would register in FY 2015, FDA’s pay adjustment is 1.7188 percent times businesses for FY 2016, FDA must FY 2015 small business adjustment 51.4551 percent, or 0.8844 percent. estimate: (1) The number of outsourcing factor resulted in excess collections of The PC&B component (1.0839 facilities that will pay the reduced fee $43,094 ($930,958 ¥ $887,864) as of percent) is added to the non-PC&B for small businesses for FY 2016 and (2) June 30, 2015.3 component (0.8844 percent), for a total the total fee revenue it would have Therefore, to calculate the small inflation adjustment of 1.9683 percent collected if no entity had qualified for business adjustment factor for FY 2016, (rounded), and then one is added, the small business exception (i.e., if FDA subtracts the $43,094 overage from making the inflation adjustment each outsourcing facility that registers FY 2015 from the $83,256 projected 1.019683. for FY 2016 were to pay the inflation- shortfall for FY 2016 to arrive at the Section 744K(c)(2)(B) of the FD&C Act adjusted fee amount of $15,610). numerator for the small business provides for this inflation adjustment to With respect to (1), FDA estimates adjustment amount, which equals be compounded after FY 2015. This that eight entities will qualify for small $40,162. This number divided by 47 factor for FY 2016 (1.9683 percent) is business exceptions and will pay the (the number of expected non-small compounded by adding one to it, and reduced fee for FY 2016. With respect businesses for FY 2016) is the small then multiplying it by one plus the to (2), to estimate the total number of business adjustment amount for FY inflation adjustment factor for FY 2015 outsourcing facilities that will register 2016, which is $855. Therefore, the (2.0558 percent), as published in the for FY 2016, FDA used data submitted establishment fee for a non-small Federal Register of August 1, 2014 (79 by outsourcing facilities through the business for FY 2016 is $15,000 FR 44805). The result of this voluntary registration process, which multiplied by 1.040646 plus $855, multiplication of the inflation factors for began in December 2013. Accordingly, which equals $16,465. the 1 year since FY 2015 (1.019683 × FDA estimates that 55 outsourcing C. Summary of FY 2016 Fee Rates 1.020558) becomes the inflation facilities, including 8 small businesses, adjustment for FY 2016. For FY 2016, will register with FDA in FY 2016. TABLE 4—OUTSOURCING FACILITY the inflation adjustment is 4.0646 If the projected 55 outsourcing FEES percent (rounded). We then add one, facilities paid the full inflation-adjusted making the FY 2016 inflation fee of $15,610, this would result in total Qualified Small Business Es- adjustment factor 1.040646. revenue of $858,550 in FY 2016 tablishment Fee ................ $5,203 ($15,610 × 55). However, because 8 of Non-Small Business Estab- 2. Small Business Adjustment Factor the outsourcing facilities expected to lishment Fee ..................... 16,465 Section 744K(c)(3) of the FD&C Act register for FY 2016 are estimated to Reinspection Fee .................. 15,610 specifies that in addition to the inflation qualify for the small business exception adjustment factor, the establishment fee and will pay one-third of the full fee III. Fee Payment Options and for non-small businesses is to be further ($5,203 × 8), totaling $41,624 instead of Procedures adjusted for a small business adjustment paying the full fee ($15,610 × 8), which A. Establishment Fee factor. Section 744K(c)(3)(B) of the totals $124,880. This would leave a FD&C Act provides that the small shortfall of $83,256 ($124,880 ¥ Once an entity submits registration business adjustment factor is the $41,624). information and FDA has determined that the information is complete, the mstockstill on DSK4VPTVN1PROD with NOTICES adjustment to the establishment fee for Additionally, section 744K(c)(5)(A) of non-small businesses that is necessary the FD&C Act states that in establishing entity will incur the annual to achieve total fees equaling the the small business adjustment factor for establishment fee. FDA will send an amount that FDA would have collected a fiscal year, FDA shall provide for the invoice to the entity, via email to the if no entity qualified for the small crediting of fees from the previous year 3 If FDA receives additional excess collections for business exception in section 744K(c)(4) to the next year if FDA overestimated FY 2015 after June 30, 2015, then FDA will credit of the FD&C Act. Additionally, section the amount of the small business this amount when it establishes the small business 744K(c)(5)(A) states that in establishing adjustment factor for such previous adjustment factor for FY 2017. VerDate Sep<11>2014 18:35 Jul 31, 2015 Jkt 235001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\03AUN1.SGM 03AUN1

46010 Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices email address indicated in the Food and Drug Administration. Date and Time: The public workshop registration file, or via regular mail if Payments can be mailed to: Food and will be held on September 28, 2015, email is not an option. The invoice will Drug Administration, P.O. Box 956733, from 8 a.m. to 5 p.m. contain information regarding the St. Louis, MO 63195–6733. If a check is Location: The public workshop will obligation incurred, the amount owed, sent by a courier that requests a street be held at FDA White Oak Campus, and payment procedures. A facility will address, the courier can deliver the 10903 New Hampshire Ave., Building not be deemed registered as an check to: U.S. Bank, Attn: Government 31 Conference Center, the Great Room outsourcing facility until it has paid the Lockbox 956733, 1005 Convention (Rm. 1503), Silver Spring, MD 20993. annual establishment fee under section Plaza, St. Louis, MO 63101. (Note: This Entrance for the public meeting 744K of the FD&C Act. Accordingly, it U.S. Bank address is for courier delivery participants (non-FDA employees) is is important that facilities seeking to only; do not send mail to this address.) through Building 1 where routine operate as registered outsourcing 3. If paying with a wire transfer: Use security check procedures will be facilities pay all fees immediately upon the following account information when performed. For parking and security receiving an invoice. If an entity does sending a wire transfer: New York information, please refer to http:// not pay the full invoiced amount within Federal Reserve Bank, U.S. Dept of www.fda.gov/AboutFDA/ 15 calendar days after FDA issues the Treasury, TREAS NYC, 33 Liberty St., WorkingatFDA/BuildingsandFacilities/ invoice, FDA will consider the New York, NY 10045, Acct. No. WhiteOakCampusInformation/ submission of registration information 75060099, Routing No. 021030004, ucm241740.htm. to have been withdrawn and adjust the SWIFT: FRNYUS33, Beneficiary: FDA, Contact Person: Steven Gitterman, invoice to reflect that no fee is due. 8455 Colesville Rd., Silver Spring, MD Food and Drug Administration, Center Outsourcing facilities that registered 20993. The originating financial for Devices and Radiological Health, in FY 2015 and wish to maintain their institution may charge a wire transfer Bldg. 66, Rm. 5518, 10903 New status as an outsourcing facility in FY fee. An outsourcing facility should ask Hampshire Ave., Silver Spring, MD 2016 must register during the annual its financial institution about the fee 20993–0002, 301–796–6694, FAX: 301– registration period that lasts from and add it to the payment to ensure that 847–2512, email: steven.gitterman@ October 1, 2015, to December 31, 2015. the order is fully paid. The tax fda.hhs.gov. Failure to register and complete Registration: Registration is free and identification number of FDA is 53– payment by December 31, 2015, will available on a first-come, first-served 0196965. result in a loss of status as an basis. Persons interested in attending outsourcing facility on January 1, 2016. Dated: July 28, 2015. this public workshop must register Entities should submit their registration Leslie Kux, online by 4 p.m. September 18, 2015. information no later than December 10, Associate Commissioner for Policy. Early registration is recommended 2015, to allow enough time for review [FR Doc. 2015–18916 Filed 7–31–15; 8:45 am] because facilities are limited and, of the registration information, BILLING CODE 4164–01–P therefore, FDA may limit the number of invoicing, and payment of fees before participants from each organization. If the end of the registration period. time and space permits, onsite DEPARTMENT OF HEALTH AND registration on the day of the public B. Reinspection Fee HUMAN SERVICES workshop will be provided beginning at FDA will issue invoices for each 7 a.m. (EDT). reinspection after the conclusion of the Food and Drug Administration If you need special accommodations reinspection, via email to the email due to a disability, please contact Susan [Docket No. FDA–2015–N–2372] address indicated in the registration file Monahan, Center for Devices and or via regular mail if email is not an Promoting Semantic Interoperability of Radiological Health, Food and Drug option. Invoices must be paid within 30 Laboratory Data; Public Workshop; Administration, 10903 New Hampshire days. Request for Comments Ave., Bldg. 32, Rm. 5231, Silver Spring, MD 20993–0002, 301–796–5661, email: C. Fee Payment Procedures AGENCY: Food and Drug Administration, susan.monahan@fda.hhs.gov no later 1. The preferred payment method is HHS. than 4 p.m. on September 14, 2015. online using electronic check ACTION: Notice of public workshop; To register for the public workshop, (Automated Clearing House (ACH) also request for comments. please visit FDA’s Medical Devices known as eCheck) or credit card News & Events—Workshops & (Discover, VISA, MasterCard, American The Food and Drug Administration Conferences calendar at http:// Express). Secure electronic payments (FDA), the Centers for Disease Control www.fda.gov/MedicalDevices/ can be submitted using the User Fees and Prevention (CDC), and the National NewsEvents/WorkshopsConferences/ Payment Portal at https:// Library of Medicine (NLM) of the default.htm. (Select this public userfees.fda.gov/pay. Once you search National Institutes of Health are workshop from the posted events list.) for your invoice, click ‘‘Pay Now’’ to be announcing the following public Please provide complete contact redirected to Pay.gov. Note that workshop entitled ‘‘FDA/CDC/NLM information for each attendee, including electronic payment options are based on Workshop on Promoting Semantic name, title and affiliation, address, the balance due. Payment by credit card Interoperability of Laboratory Data.’’ email, and telephone number. Those is available for balances less than The purpose of this workshop is to without Internet access should contact mstockstill on DSK4VPTVN1PROD with NOTICES $50,000. If the balance exceeds this receive and discuss input from Susan Monahan to register. Registrants amount, only the ACH option is stakeholders regarding proposed will receive confirmation after they have available. Payments must be drawn on approaches to promoting the semantic been accepted. You will be notified if U.S. bank accounts as well as U.S. credit interoperability of laboratory data you are on a waiting list. cards. between in vitro diagnostic devices and Streaming Webcast of the Public 2. If paying with a paper check: database systems, including laboratory Workshop: This public workshop will Checks must be in U.S. currency from information systems and electronic also be Webcast. Persons interested in a U.S. bank and made payable to the health records. viewing the Webcast must register VerDate Sep<11>2014 18:35 Jul 31, 2015 Jkt 235001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\03AUN1.SGM 03AUN1


Document Created: 2018-02-23 10:51:52
Document Modified: 2018-02-23 10:51:52
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactFor information on pharmacy compounding and pharmacy compounding user fees: Visit FDA's Web site at http://www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ default.htm.
FR Citation80 FR 46007 
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