80 FR 46028 - Prescription Drug User 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 Range		46028-46032
FR Document		2015-18914

The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2016. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Amendments of 2012 (PDUFA V), authorizes FDA to collect user fees for certain applications for the review of human drug and biological products, on establishments where the products are made, and on such products. This notice establishes the fee rates for FY 2016.

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

[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Notices]
[Pages 46028-46032]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-18914]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Prescription Drug User Fee Rates for Fiscal Year 2016

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the rates
for prescription drug user fees for fiscal year (FY) 2016. The Federal
Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the
Prescription Drug User Fee Amendments of 2012 (PDUFA V), authorizes FDA
to collect user fees for certain applications for the review of human
drug and biological products, on establishments where the products are
made, and on such products. This notice establishes the fee rates for
FY 2016.

FOR FURTHER INFORMATION CONTACT: Robert J. Marcarelli, Office of
Financial Management, Food and Drug Administration, 8455 Colesville
Rd., COLE-14202F, Silver Spring, MD 20993-0002, 301-796-7223.

SUPPLEMENTARY INFORMATION:

I. Background

Sections 735 and 736 of the FD&C Act (21 U.S.C. 379g and 379h,
respectively) establish three different kinds of user fees. Fees are
assessed on the following: (1) Certain types of applications and
supplements for the review of human drug and biological products; (2)
certain establishments where such products are made; and (3) certain
products (section 736(a) of the FD&C Act). When certain conditions are
met, FDA may waive or reduce fees (section 736(d) of the FD&C Act).
For FY 2013 through FY 2017, the base revenue amounts for the total
revenues from all PDUFA fees are established by PDUFA V. The base
revenue amount for FY 2013, which became the base amount for the
remaining 4 FYs of PDUFA V, is $718,669,000, as published in the
Federal Register of August 1, 2012 (77 FR 45639). The FY 2013 base
revenue amount is further adjusted each year after FY 2013 for
inflation and workload. Fees for applications, establishments, and
products are to be established each year by FDA so that revenues from
each category will provide one-third of the total revenue to be
collected each year.
This document provides fee rates for FY 2016 for an application
requiring

[[Page 46029]]

clinical data ($2,374,200), for an application not requiring clinical
data or a supplement requiring clinical data ($1,187,100), for an
establishment ($585,200), and for a product ($114,450). These fees are
effective on October 1, 2015, and will remain in effect through
September 30, 2016. For applications and supplements that are submitted
on or after October 1, 2015, the new fee schedule must be used.
Invoices for establishment and product fees for FY 2016 will be issued
in August 2015 using the new fee schedule.

II. Fee Revenue Amount for FY 2016

The base revenue amount for FY 2016 is $718,669,000 prior to
adjustments for inflation and workload (see section 736(c)(1) and
(c)(2) of the FD&C Act).

A. FY 2016 Statutory Fee Revenue Adjustments for Inflation

PDUFA V specifies that the $718,669,000 is to be further adjusted
for inflation increases for FY 2016 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 1 plus the average annual percent change in the cost of all PC&B
paid per full-time equivalent (FTE) position at FDA for the first 3 of
the preceding 4 FYs, multiplied by the proportion of PC&B costs to
total FDA costs of 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 that 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 3 of the 4 FYs preceding FY
2016. The 3-year average is 2.2328 percent.

Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Changes
----------------------------------------------------------------------------------------------------------------
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%
----------------------------------------------------------------------------------------------------------------

The statute specifies that this 2.2328 percent should be multiplied
by the proportion of PC&B costs to total FDA costs of the process for
the review of human drug applications. Table 2 shows the PC&B and the
total obligations for the process for the review of human drug
applications for 3 FYs.

Table 2--PC&B as a Percent of Fee Revenues Spent on the Process for the Review of Human Drug Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fiscal year 2012 2013 2014 3-Year average
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total PC&B.......................................... $592,642,252 $568,206,210 $585,260,720 .......................
Total Costs......................................... $1,032,419,218 $966,169,007 $1,077,263,695 .......................
PC&B Percent........................................ 57.4033% 58.8102% 54.3285% 56.8473%
--------------------------------------------------------------------------------------------------------------------------------------------------------

The payroll adjustment is 2.2328 percent from table 1 multiplied by
56.8473 percent (or 1.2693 percent).
The statute specifies that the portion of the inflation adjustment
for non-payroll costs is the average annual percent change that
occurred in the Consumer Price Index (CPI) for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; 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 costs other than
PC&B costs to total costs of the process for the review of human drug
applications for the first 3 years of the preceding 4 FYs (see section
736(c)(1)(C) of the FD&C Act). Table 3 provides the summary data for
the percent changes in the specified CPI for the Washington-Baltimore
area. The data are published by the Bureau of Labor Statistics and can
be found on their Web site at http://data.bls.gov/cgi-bin/surveymost?cu
by checking the box marked ``Washington-Baltimore All Items, November
1996=100--CUURA311SA0'' and then clicking on the ``Retrieve Data''
button.

Table 3--Annual and 3-Year Average Percent Change in CPI for Washington-Baltimore Area
--------------------------------------------------------------------------------------------------------------------------------------------------------
Year 2012 2013 2014 3-Year average
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual CPI.......................................... 150.212 152.500 154.847 .......................
Annual Percent Change............................... 2.2024% 1.5232% 1.5390% 1.7549%
--------------------------------------------------------------------------------------------------------------------------------------------------------

To calculate the inflation adjustment for non-payroll costs, we
multiply the 1.7549 percent by the proportion of all costs other than
PC&B to total costs of the process for the review of human drug
applications obligated. Since 56.8473 percent was obligated for PC&B as
shown in table 2, 43.1527 percent is the portion of costs other than
PC&B (100 percent minus 56.8473 percent equals 43.1527 percent). The
non-payroll adjustment is 1.7549 percent times 43.1527 percent, or
0.7573 percent.
Next, we add the payroll adjustment (1.2693 percent) to the non-
payroll adjustment (0.7573 percent), for a total inflation adjustment
of 2.0266 percent (rounded) for FY 2016.
PDUFA V provides for this inflation adjustment to be compounded
after FY 2013 (see section 736(c)(1) of the FD&C Act). This factor for
FY 2016 (2.0266 percent) is compounded by adding 1

[[Page 46030]]

and then multiplying by 1 plus the compound inflation adjustment factor
for FY 2015 (4.327 percent), as published in the Federal Register of
August 1, 2014 (79 FR 44807 at 44809), which equals to 1.064414
(rounded) (1.020266 times 1.04327) for FY 2016. We then multiply the
base revenue amount for FY 2016 ($718,669,000) by 1.064414, yielding an
inflation-adjusted amount of $764,961,345.

B. FY 2016 Statutory Fee Revenue Adjustments for Workload

The statute specifies that after the $718,669,000 has been adjusted
for inflation, the inflation-adjusted amount shall be further adjusted
for workload (see section 736(c)(2) of the FD&C Act).
To calculate the FY 2016 workload adjustment, FDA calculated the
average number of each of the four types of applications specified in
the workload adjustment provision: (1) Human drug applications; (2)
active commercial investigational new drug applications (INDs)
(applications that have at least one submission during the previous 12
months); (3) efficacy supplements; and (4) manufacturing supplements
received over the 3-year period that ended on June 30, 2012 (base
years), and the average number of each of these types of applications
over the most recent 3 year period that ended June 30, 2015.
The calculations are summarized in table 4. The 3-year averages for
each application category are provided in column 1 (``3-Year Average
Base Years 2010-2012'') and column 2 (``3-Year Average 2013-2015'').
Column 3 reflects the percent change in workload from column 1 to
column 2. Column 4 shows the weighting factor for each type of
application, estimating how much of the total FDA drug review workload
was accounted for by each type of application in the table during the
most recent 3 years. Column 5 is the weighted percent change in each
category of workload. This was derived by multiplying the weighting
factor in each line in column 4 by the percent change from the base
years in column 3. The sum of the values in column 5 is added,
reflecting an increase in workload of 11.31 percent (rounded) for FY
2016 when compared to the base years.

Table 4--Workload Adjuster Calculation for FY 2016
----------------------------------------------------------------------------------------------------------------
Column 1 Column 2 Column 3 Column 4 Column 5
-------------------------------------------------------------------------------
Application type 3-Year 3-Year Percent change Weighting
average base average 2013- (column 1 to factor Weighted
years 2010- 2015 column 2) (percent) percent change
---------------------------------------2012---------------------------------------------------------------------
New Drug Applications/Biologics 124.3 148.3 19.3081 38.9 7.51
License Applications...........
Active Commercial INDs.......... 6830.0 7375.3 7.9839 39.2 3.13
Efficacy Supplements............ 136.3 175.0 28.3933 6.0 1.69
Manufacturing Supplements....... 2548.3 2386.7 -6.3415 16.0 -1.01
FY 2016 Workload Adjuster....... .............. .............. .............. .............. 11.31
----------------------------------------------------------------------------------------------------------------

Table 5 shows the calculation of the revenue amount for FY 2016.
The $718,669,000 subject to adjustment on Line 1 is multiplied by the
inflation adjustment factor of 1.064414, resulting in the inflation-
adjusted amount on Line 3, $764,961,345. That amount is then multiplied
by one plus the workload adjustment of 11.31 percent, resulting in the
inflation and workload adjusted amount of $851,481,000 on Line 5,
rounded to the nearest thousand dollars.

Table 5--PDUFA Revenue Amount for FY 2016, Summary Calculation
------------------------------------------------------------------------

------------------------------------------------------------------------
FY 2013 Revenue Amount and Base $718,669,000 Line 1.
Subsequent FYs as published in
the Federal Register of August 1,
2012 (77 FR 45639) (Rounded to
nearest thousand dollars).
Inflation Adjustment Factor for FY 1.064414 Line 2.
2016 (1 plus 6.4414 percent).
Inflation Adjusted Amount......... $764,961,345 Line 3.
Workload Adjustment Factor for FY 1.1131 Line 4.
2016 (1 plus 11.31 percent).
Inflation and Workload Adjusted $851,481,000 Line 5.
Amount (Rounded to nearest
thousand dollars).
------------------------------------------------------------------------

PDUFA specifies that one-third of the total fee revenue is to be
derived from application fees, one-third from establishment fees, and
one-third from product fees (see section 736(b)(2) of the FD&C Act).
Accordingly, one-third of the total revenue amount ($851,481,000), or a
total of $283,827,000, is the amount of fee revenue that will be
derived from each of these fee categories: Application Fees,
Establishment Fees, and Product Fees.

III. Application Fee Calculations

A. Application Fee Revenues and Application Fees

Application fees will be set to generate one-third of the total fee
revenue amount, or $283,827,000 in FY 2016.

B. Estimate of the Number of Fee-Paying Applications and Setting the
Application Fees

For FY 2013 through FY 2017, FDA will estimate the total number of
fee-paying full application equivalents (FAEs) it expects to receive
the next FY by averaging the number of fee-paying FAEs received in the
3 most recently completed FYs. Beginning with FY 2016, prior year FAE
totals will be updated annually to reflect refunds and waivers
processed after the close of the FY.
In estimating the number of fee-paying FAEs, a full application
requiring clinical data counts as one FAE. An application not requiring
clinical data counts as one-half of an FAE, as does a supplement
requiring clinical data. An application that is withdrawn, or refused
for filing, counts as one-fourth of an FAE if the applicant initially
paid a full application fee, or one-eighth of an FAE if the applicant
initially paid one-half of the full application fee amount.
As table 6 shows, the average number of fee-paying FAEs received
annually in the most recent 3-year period is 119.545 FAEs. FDA will set
fees for FY 2016 based on this estimate as the number of

[[Page 46031]]

full application equivalents that will pay fees.

Table 6--Fee-Paying FAE 3-Year Average
----------------------------------------------------------------------------------------------------------------
FY 2012 2013 2014 3-Year average
----------------------------------------------------------------------------------------------------------------
Fee-Paying FAEs................................. 120.375 109.510 128.750 119.545
----------------------------------------------------------------------------------------------------------------
Beginning with FY 2016, prior year FAE totals will be updated annually to reflect refunds and waivers processed
after the close of the FY.

The FY 2016 application fee is estimated by dividing the average
number of full applications that paid fees over the latest 3 years,
119.545, into the fee revenue amount to be derived from application
fees in FY 2016, $283,827,000. The result, rounded to the nearest
hundred dollars, is a fee of $2,374,200 per full application requiring
clinical data, and $1,187,100 per application not requiring clinical
data or per supplement requiring clinical data.

IV. Fee Calculations for Establishment and Product Fees

A. Establishment Fees

At the beginning of FY 2015, the establishment fee was based on an
estimate that 509 establishments would be subject to and would pay
fees. By the end of FY 2015, FDA estimates that 516 establishments will
have been billed for establishment fees, before all decisions on
requests for waivers or reductions are made. FDA estimates that a total
of 15 establishment fee waivers or reductions will be made for FY 2015.
In addition, FDA estimates that another 16 full establishment fees will
be exempted this year based on the orphan drug exemption in section
736(k) of the FD&C Act. Subtracting 31 establishments (15 waivers, plus
the estimated 16 establishments under the orphan exemption) from 516
leaves a net of 485 fee-paying establishments. FDA will use 485 to
estimate the FY 2016 establishments paying fees. The fee per
establishment is determined by dividing the adjusted total fee revenue
to be derived from establishments ($283,827,000) by the estimated 485
establishments, for an establishment fee rate for FY 2016 of $585,200
(rounded to the nearest hundred dollars).

B. Product Fees

At the beginning of FY 2015, the product fee was based on an
estimate that 2,434 products would be subject to and would pay product
fees. By the end of FY 2015, FDA estimates that 2,554 products will
have been billed for product fees, before all decisions on requests for
waivers, reductions, or exemptions are made. FDA assumes that there
will be 39 waivers and reductions granted. In addition, FDA estimates
that another 35 product fees will be exempted this year based on the
orphan drug exemption in section 736(k) of the FD&C Act. FDA estimates
that 2,480 products will qualify for and pay product fees in FY 2015,
after allowing for an estimated 74 waivers and reductions, including
the orphan drug products, and will use this number for its FY 2016
estimate. The FY 2016 product fee rate is determined by dividing the
adjusted total fee revenue to be derived from product fees
($283,827,000) by the estimated 2,480 products for a FY 2016 product
fee of $114,450 (rounded to the nearest ten dollars).

V. Fee Schedule for FY 2016

The fee rates for FY 2016 are displayed in table 7:

Table 7--Fee Schedule for FY 2016
------------------------------------------------------------------------
Fee rates for
Fee category FY 2016
------------------------------------------------------------------------
Applications:
Requiring clinical data............................. $2,374,200
Not requiring clinical data......................... 1,187,100
Supplements requiring clinical data................. 1,187,100
Establishments.......................................... 585,200
Products................................................ 114,450
------------------------------------------------------------------------

VI. Fee Payment Options and Procedures

A. Application Fees

The appropriate application fee established in the new fee schedule
must be paid for any application or supplement subject to fees under
PDUFA that is received on or after October 1, 2015. Payment must be
made in U.S. currency by check, bank draft, or U.S. postal money order
payable to the order of the Food and Drug Administration. Please
include the user fee identification (ID) number on your check, bank
draft, or postal money order. Your payment can be mailed to: Food and
Drug Administration, P.O. Box 979107, St. Louis, MO 63197-9000.
If checks are to be sent by a courier that requests a street
address, the courier can deliver the checks to: U.S. Bank, Attention:
Government Lockbox 979107, 1005 Convention Plaza, St. Louis, MO 63101.
(Note: This U.S. Bank address is for courier delivery only. Contact the
U.S. Bank at 314-418-4013 if you have any questions concerning courier
delivery.)
Please make sure that the FDA post office box number (P.O. Box
979107) is written on the check, bank draft, or postal money order.
Wire transfer payment may also be used. Please reference your
unique user fee ID number when completing your transfer. The
originating financial institution may charge a wire transfer fee.
Please ask your financial institution about the fee and add it to your
payment to ensure that your fee is fully paid. The account information
for wire transfers is as follows: New York Federal Reserve Bank, U.S.
Department of the Treasury, TREAS NYC, 33 Liberty St., New York, NY
10045, Acct. No.: 75060099, Routing No.: 021030004, SWIFT: FRNYUS33,
Beneficiary: FDA, 8455 Colesville Rd., 14th Floor, Silver Spring, MD
20993-0002.

[[Page 46032]]

Application fees can also be paid online with an electronic check
(ACH). FDA has partnered with the U.S. Department of the Treasury to
use Pay.gov, a Web-based payment application, for online electronic
payment. The Pay.gov feature is available on the FDA Web site after the
user fee ID number is generated.
The tax identification number of FDA is 53-0196965.

B. Establishment and Product Fees

FDA will issue invoices for establishment and product fees for FY
2016 under the new fee schedule in August 2015. Payment will be due on
October 1, 2015. FDA will issue invoices in November 2016 for any
products and establishments subject to fees for FY 2016 that qualify
for fee assessments after the August 2015 billing.

Dated: July 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18914 Filed 7-31-15; 8:45 am]
BILLING CODE 4164-01-P

46028 Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices

makes it possible to evaluate the after this document publishes in the DEPARTMENT OF HEALTH AND
effectiveness of some process changes Federal Register.) HUMAN SERVICES
and intervention strategies in reducing 1. FDA and Health Canada, ‘‘Joint Food and
the risk of listeriosis. Drug Administration/Health Canada— Food and Drug Administration
ADDRESSES: See the SUPPLEMENTARY Santé Canada Quantitative Assessment [Docket No. FDA–2015–N–0007]
INFORMATION section for electronic of the Risk of Listeriosis from Soft-
access to the QRA and related Ripened Cheese Consumption in the Prescription Drug User Fee Rates for
documents. United States and Canada: Interpretative Fiscal Year 2016
Summary,’’ 2015. Accessible at http://
FOR FURTHER INFORMATION CONTACT: www.fda.gov/Food/FoodScience AGENCY: Food and Drug Administration,
Sherri Dennis, Center for Food Safety Research/RiskSafetyAssessment/ HHS.
and Applied Nutrition (HFS–005), Food default.htm and http://www.fda.gov/ ACTION: Notice.
and Drug Administration, 5100 Paint ScienceResearch/SpecialTopics/Peer
Branch Pkwy., College Park, MD 20740, ReviewofScientificInformationand SUMMARY: The Food and Drug
240–402–1914. Assessments/ucm079120.htm. Administration (FDA) is announcing the
SUPPLEMENTARY INFORMATION: 2. FDA and Health Canada, ‘‘Joint Food and rates for prescription drug user fees for
Drug Administration/Health Canada— fiscal year (FY) 2016. The Federal Food,
I. Background Santé Canada Quantitative Assessment Drug, and Cosmetic Act (the FD&C Act),
In the Federal Register of February of the Risk of Listeriosis from Soft- as amended by the Prescription Drug
11, 2013 (78 FR 9701), we made Ripened Cheese Consumption in the User Fee Amendments of 2012 (PDUFA
United States and Canada: Technical V), authorizes FDA to collect user fees
available a document entitled ‘‘Draft
Report,’’ 2015. Accessible at http:// for certain applications for the review of
Joint Food and Drug Administration/ www.fda.gov/Food/FoodScience
Health Canada—Santé Canada human drug and biological products, on
Research/RiskSafetyAssessment/ establishments where the products are
Quantitative Assessment of the Risk of default.htm and http://www.fda.gov/
Listeriosis From Soft-Ripened Cheese made, and on such products. This
ScienceResearch/SpecialTopics/Peer
Consumption in the United States and ReviewofScientificInformationand
notice establishes the fee rates for FY
Canada.’’ We gave interested parties an Assessments/ucm079120.htm. 2016.
opportunity to submit comments by 3. FDA and Health Canada, ‘‘Joint Food and FOR FURTHER INFORMATION CONTACT:
April 29, 2013, for us to consider on the Drug Administration/Health Canada— Robert J. Marcarelli, Office of Financial
approach used, the assumptions made, Santé Canada Quantitative Assessment Management, Food and Drug
the modeling techniques, the data used, of the Risk of Listeriosis from Soft- Administration, 8455 Colesville Rd.,
and the clarity and the transparency of Ripened Cheese Consumption in the COLE–14202F, Silver Spring, MD
United States and Canada: Technical
the QRA documentation. We received 20993–0002, 301–796–7223.
Report Appendices,’’ 2015. Accessible at
nearly 100 comments on the draft QRA http://www.fda.gov/Food/FoodScience SUPPLEMENTARY INFORMATION:
and have revised the QRA where Research/RiskSafetyAssessment/
appropriate (See Refs. 1 to 5). I. Background
default.htm and http://www.fda.gov/
Elsewhere in this issue of the Federal ScienceResearch/SpecialTopics/Peer Sections 735 and 736 of the FD&C Act
Register, we are issuing a notice ReviewofScientificInformationand (21 U.S.C. 379g and 379h, respectively)
requesting comments and scientific data Assessments/ucm079120.htm. establish three different kinds of user
and information that would assist us in 4. FDA and Health Canada, ‘‘Joint Food and fees. Fees are assessed on the following:
understanding potential intervention Drug Administration/Health Canada— (1) Certain types of applications and
measures to reduce the risk of foodborne Santé Canada Quantitative Assessment supplements for the review of human
illness from consumption of cheeses of the Risk of Listeriosis from Soft- drug and biological products; (2) certain
manufactured from unpasteurized milk. Ripened Cheese Consumption in the establishments where such products are
United States and Canada: Risk made; and (3) certain products (section
II. Electronic Access Assessment Model,’’ 2015. Accessible at
736(a) of the FD&C Act). When certain
http://www.fda.gov/Food/
The QRA and related documents are conditions are met, FDA may waive or
FoodScienceResearch/
available electronically on the FDA Web RiskSafetyAssessment/default.htm and reduce fees (section 736(d) of the FD&C
site at http://www.fda.gov/Food/Food http://www.fda.gov/ScienceResearch/ Act).
ScienceResearch/RiskSafety SpecialTopics/PeerReviewofScientific For FY 2013 through FY 2017, the
Assessment/default.htm, http:// InformationandAssessments/ base revenue amounts for the total
www.fda.gov/ScienceResearch/Special ucm079120.htm. revenues from all PDUFA fees are
Topics/PeerReviewofScientific 5. Joint FDA/Health Canada Quantitative established by PDUFA V. The base
InformationandAssessments/ Assessment of the Risk of Listeriosis revenue amount for FY 2013, which
ucm079120.htm, and http:// from Soft-Ripened Cheese Consumption became the base amount for the
www.regulations.gov. in the United States and Canada: Replies remaining 4 FYs of PDUFA V, is
to Public Comments, 2015. Accessible at $718,669,000, as published in the
III. References http://www.fda.gov/Food/ Federal Register of August 1, 2012 (77
The following references have been FoodScienceResearch/
FR 45639). The FY 2013 base revenue
RiskSafetyAssessment/default.htm and
placed on display in the Division of amount is further adjusted each year
http://www.fda.gov/ScienceResearch/
Dockets Management (see ADDRESSES) SpecialTopics/PeerReviewofScientific after FY 2013 for inflation and
mstockstill on DSK4VPTVN1PROD with NOTICES

and may be seen by interested persons InformationandAssessments/ workload. Fees for applications,
between 9 a.m. and 4 p.m., Monday ucm079120.htm. establishments, and products are to be
through Friday, and are available established each year by FDA so that
Dated: July 29, 2015.
electronically at http:// revenues from each category will
www.regulations.gov. (FDA has verified Leslie Kux,
provide one-third of the total revenue to
the Web site addresses in this reference Associate Commissioner for Policy. be collected each year.
section, but we are not responsible for [FR Doc. 2015–18960 Filed 7–31–15; 8:45 am] This document provides fee rates for
any subsequent changes to the Web sites BILLING CODE 4164–01–P FY 2016 for an application requiring

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46032 Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices

Application fees can also be paid transfusion and transplantation, information that FDA recommends to be
online with an electronic check (ACH). whether testing is for a single locus or used in designing and conducting
FDA has partnered with the U.S. for multiple loci simultaneously, for studies for validation of nucleic acid-
Department of the Treasury to use which the premarket submission to FDA based HLA test kits and preparing a
Pay.gov, a Web-based payment will be a 510(k). The guidance 510(k) submission.
application, for online electronic announced in this notice finalizes the In the Federal Register of November
payment. The Pay.gov feature is draft guidance of the same title dated 20, 2013 (78 FR 69693), FDA announced
available on the FDA Web site after the November 2013. the availability of the draft guidance of
user fee ID number is generated. DATES: Submit either electronic or the same title dated November 2013.
The tax identification number of FDA written comments on Agency guidances FDA received several comments on the
is 53–0196965. at any time. draft guidance and those comments
ADDRESSES: Submit written requests for
were considered as the guidance was
B. Establishment and Product Fees
single copies of the guidance to the finalized. In addition, editorial changes
FDA will issue invoices for were made for purposes of clarity and
establishment and product fees for FY Office of Communication, Outreach, and
accuracy. The guidance announced in
2016 under the new fee schedule in Development, Center for Biologics
this notice finalizes the draft guidance
August 2015. Payment will be due on Evaluation and Research (CBER), Food
dated November 2013.
October 1, 2015. FDA will issue and Drug Administration, 10903 New The guidance is being issued
invoices in November 2016 for any Hampshire Ave., Bldg. 71, Rm. 3128, consistent with FDA’s good guidance
products and establishments subject to Silver Spring, MD 20993–0002. Send practices regulation (21 CFR 10.115).
fees for FY 2016 that qualify for fee one self-addressed adhesive label to The guidance represents the current
assessments after the August 2015 assist the office in processing your thinking of FDA on premarket
billing. requests. The guidance may also be notification (510(k)) submissions for
obtained by mail by calling CBER at 1– nucleic acid-based HLA test kits used
Dated: July 28, 2015.
800–835–4709 or 240–402–7800. See for matching of donors and recipients in
Leslie Kux, the SUPPLEMENTARY INFORMATION section
Associate Commissioner for Policy. transfusion and transplantation. It does
for electronic access to the guidance not establish any rights for any person
[FR Doc. 2015–18914 Filed 7–31–15; 8:45 am] document. and is not binding on FDA or the public.
BILLING CODE 4164–01–P Submit electronic comments on the You can use an alternative approach if
guidance to http://www.regulations.gov. it satisfies the requirements of the
Submit written comments to the applicable statutes and regulations.
DEPARTMENT OF HEALTH AND Division of Dockets Management (HFA–
HUMAN SERVICES 305), Food and Drug Administration, II. Paperwork Reduction Act of 1995
5630 Fishers Lane, Rm. 1061, Rockville, This guidance refers to previously
Food and Drug Administration MD 20852. approved collections of information
[Docket No. FDA–2013–D–1358] FOR FURTHER INFORMATION CONTACT: found in FDA regulations. These
Valerie A. Butler, Center for Biologics collections of information are subject to
Recommendations for Premarket Evaluation and Research, Food and review by the Office of Management and
Notification (510(k)) Submissions for Drug Administration, 10903 New Budget (OMB) under the Paperwork
Nucleic Acid-Based Human Leukocyte Hampshire Ave., Bldg. 71, Rm. 7301, Reduction Act of 1995 (44 U.S.C. 3501–
Antigen Test Kits Used for Matching of Silver Spring, MD 20993–0002, 240– 3520). The collections of information in
Donors and Recipients in Transfusion 402–7911. 21 CFR part 807, subpart E have been
and Transplantation; Guidance for
SUPPLEMENTARY INFORMATION: approved under OMB control number
Industry; Availability
0910–0120; the collections of
I. Background
AGENCY: Food and Drug Administration, information in 21 CFR part 809 have
HHS. FDA is announcing the availability of been approved under OMB control
ACTION: Notice. a document entitled ‘‘Recommendations number 0910–0485; the collections of
for Premarket Notification (510(k)) information in 21 CFR part 812 have
SUMMARY: The Food and Drug Submissions for Nucleic Acid-Based been approved under OMB control
Administration (FDA or Agency) is Human Leukocyte Antigen Test Kits numbers 0910–0078 and 0910–0582; the
announcing the availability of a Used for Matching of Donors and collections of information in 21 CFR
document entitled ‘‘Recommendations Recipients in Transfusion and part 820 have been approved under
for Premarket Notification (510(k)) Transplantation; Guidance for OMB control number 0910–0073; the
Submissions for Nucleic Acid-Based Industry.’’ The guidance provides collections of information in 21 CFR
Human Leukocyte Antigen (HLA) Test recommendations to submitters and part 56 have been approved under OMB
Kits Used for Matching of Donors and FDA reviewers in preparing and control number 0910–0130; and the
Recipients in Transfusion and reviewing 510(k) submissions for IVD collections of information in 21 CFR
Transplantation; Guidance for device test kits, specifically for nucleic part 50 have been approved under OMB
Industry.’’ The guidance document acid-based HLA test kits used for the control number 0910–0586.
provides recommendations to matching of donors and recipients in
submitters and FDA reviewers in transfusion and transplantation, III. Comments
mstockstill on DSK4VPTVN1PROD with NOTICES

preparing and reviewing premarket whether testing is for a single locus or Interested persons may submit either
notification submissions (hereafter for multiple loci simultaneously. The electronic comments regarding this
referred to as ‘‘510(k) submission’’ or guidance includes detailed information document to http://www.regulations.gov
‘‘510(k)’’) for HLA in vitro diagnostic on the types of studies FDA or written comments to the Division of
(IVD) device test kits. The guidance recommends for validation of HLA test Dockets Management (see ADDRESSES). It
applies specifically to nucleic acid- kits submitted as 510(k)s. More is only necessary to send one set of
based HLA test kits used for the specifically, the guidance document comments. Identify comments with the
matching of donors and recipients in addresses the types of studies and other docket number found in brackets in the

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Document Created: 2018-02-23 10:51:41
Document Modified: 2018-02-23 10:51:41

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Contact		Robert J. Marcarelli, Office of Financial Management, Food and Drug Administration, 8455 Colesville Rd., COLE-14202F, Silver Spring, MD 20993-0002, 301-796-7223.
FR Citation		80 FR 46028

80 FR 46028 - Prescription Drug User Fee Rates for Fiscal Year 2016

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration