Fee for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2018, 45291-45293 [2017-20798]
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Federal Register / Vol. 82, No. 187 / Thursday, September 28, 2017 / Notices
45291
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses
per
respondent
Average
burden
hours per
response
Total burden
hours
CCDF QPR ......................................................................................................
56
1
60.0
3,360
Estimated Total Annual Burden
Hours: 3,360 hours.
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proposed collection may be obtained by
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Planning, Research and Evaluation, 330
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address: infocollection@acf.hhs.gov.
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Therefore, a comment is best assured of
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Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
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Reports Clearance Officer.
[FR Doc. 2017–20765 Filed 9–27–17; 8:45 am]
BILLING CODE 4184–43–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0007]
Fee for Using a Rare Pediatric Disease
Priority Review Voucher in Fiscal Year
2018
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
announcing the fee rate for using a rare
pediatric disease priority review
voucher for fiscal year (FY) 2018. The
Federal Food, Drug, and Cosmetic Act
(the FD&C Act), as amended by the Food
and Drug Administration Safety and
Innovation Act (FDASIA), authorizes
FDA to determine and collect rare
pediatric disease priority review user
SUMMARY:
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fees for certain applications for review
of human drug or biological products
when those applications use a rare
pediatric disease priority review
voucher. These vouchers are awarded to
the sponsors of rare pediatric disease
product applications that meet all of the
requirements of this program and that
are submitted 90 days or more after July
9, 2012, upon FDA approval of such
applications. The amount of the fee for
using a rare pediatric disease priority
review voucher is determined each FY,
based on the difference between the
average cost incurred by FDA in the
review of a human drug application
subject to priority review in the
previous FY and the average cost
incurred in the review of an application
that is not subject to priority review in
the previous FY. This notice establishes
the rare pediatric disease priority review
fee rate for FY 2018 and outlines the
payment procedures for such fees.
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
Section 908 of FDASIA (Pub. L. 112–
144) added section 529 to the FD&C Act
(21 U.S.C. 360ff). In section 529 of the
FD&C Act, Congress encouraged
development of new human drugs and
biological products for prevention and
treatment of certain rare pediatric
diseases by offering additional
incentives for obtaining FDA approval
of such products. Under section 529 of
the FD&C Act, the sponsor of an eligible
human drug application submitted 90
days or more after July 9, 2012, for a rare
pediatric disease (as defined in section
529(a)(3)) shall receive a priority review
voucher upon approval of the rare
pediatric disease product application.
The recipient of a rare pediatric disease
priority review voucher may either use
the voucher for a future human drug
application submitted to FDA under
section 505(b)(1) of the FD&C Act (21
U.S.C. 355(b)(1)) or section 351(a) of the
Public Health Service Act (42 U.S.C.
262(a)), or transfer (including by sale)
the voucher to another party. The
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
voucher may be transferred (including
by sale) repeatedly until it ultimately is
used for a human drug application
submitted to FDA under section
505(b)(1) of the FD&C Act or section
351(a) of the Public Health Service Act.
A priority review is a review conducted
with a Prescription Drug User Fee Act
(PDUFA) goal date of 6 months after the
receipt or filing date, depending on the
type of application. Information
regarding PDUFA goals is available at
https://www.fda.gov/downloads/
forindustry/userfees/prescriptiondrug
userfee/ucm511438.pdf.
The applicant that uses a rare
pediatric disease priority review
voucher is entitled to a priority review
of its eligible human drug application,
but must pay FDA a rare pediatric
disease priority review user fee in
addition to any user fee required by
PDUFA for the application. Information
regarding the rare pediatric disease
priority review voucher program is
available at: https://www.fda.gov/Drugs/
DevelopmentApprovalProcess/
DevelopmentResources/
ucm375479.htm.
This notice establishes the rare
pediatric disease priority review fee rate
for FY 2018 at $2,830,579 and outlines
FDA’s procedures for payment of rare
pediatric disease priority review user
fees. This rate is effective on October 1,
2017, and will remain in effect through
September 30, 2018.
II. Rare Pediatric Priority Review User
Fee for FY 2018
Under section 529(c)(2) of the FD&C
Act, the amount of the rare pediatric
disease priority review user fee is
determined each fiscal year based on the
difference between the average cost
incurred by FDA in the review of a
human drug application subject to
priority review in the previous fiscal
year, and the average cost incurred by
FDA in the review of a human drug
application that is not subject to priority
review in the previous fiscal year.
A priority review is a review
conducted with a PDUFA goal date of 6
months after the receipt or filing date,
depending on the type of application.
Under the PDUFA goals letter, FDA has
committed to reviewing and acting on
90 percent of the applications granted
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Federal Register / Vol. 82, No. 187 / Thursday, September 28, 2017 / Notices
priority review status within this
expedited timeframe. Normally, an
application for a human drug or
biological product will qualify for
priority review if the product is
intended to treat a serious condition
and, if approved, would provide a
significant improvement in safety or
effectiveness. An application that does
not receive a priority designation will
receive a standard review. Under the
PDUFA goals letter, FDA has committed
to reviewing and acting on 90 percent of
standard applications within 10 months
of the receipt or filing date depending
on the type of application. A priority
review involves a more intensive level
of effort and a higher level of resources
than a standard review.
FDA is setting a fee for FY 2018,
which is to be based on standard cost
data from the previous fiscal year, FY
2017. However, the FY 2017 submission
cohort has not been closed out yet, thus
the cost data for FY 2017 are not
complete. The latest year for which FDA
has complete cost data is FY 2016.
Furthermore, because FDA has never
tracked the cost of reviewing
applications that get priority review as
a separate cost subset, FDA estimated
this cost based on other data that the
Agency has tracked. FDA uses data that
the Agency estimates and publishes on
its Web site each year—standard costs
for review. FDA does not publish a
standard cost for ‘‘the review of a
human drug application subject to
priority review in the previous fiscal
year.’’ However, we expect all such
applications would contain clinical
data. The standard cost application
categories with clinical data that FDA
publishes each year are: (1) New drug
applications (NDAs) for a new
molecular entity (NME) with clinical
data and (2) biologics license
applications (BLAs).
The standard cost worksheets for FY
2016 show standard costs (rounded to
the nearest hundred dollars) of
$5,929,100 for an NME NDA, and
$4,887,100 for a BLA. Based on these
standard costs, the total cost to review
the 49 applications in these two
categories in FY 2016 (27 NME NDAs
with clinical data and 22 BLAs) was
$267,601,900. (Note: These numbers
exclude the President’s Emergency Plan
for AIDS Relief NDAs; no
investigational new drug (IND) review
costs are included in this amount.) 23 of
these applications (14 NDAs and 9
BLAs) received priority review, which
would mean that the remaining 26
received standard reviews. Because a
priority review compresses a review
schedule that ordinarily takes 10
months into 6 months, FDA estimates
that a multiplier of 1.67 (10 months
divided by 6 months) should be applied
to non-priority review costs in
estimating the effort and cost of a
priority review as compared to a
standard review. This multiplier is
consistent with published research on
this subject which supports a priority
review multiplier in the range of 1.48 to
2.35 (Ref. 1). Using FY 2016 figures, the
costs of a priority and standard review
are estimated using the following
formula:
(23 a × 1.67) + (26 a) = $267,601,900
where ‘‘a’’ is the cost of a standard
review and ‘‘a times 1.67’’ is the cost of
a priority review. Using this formula,
the cost of a standard review for NME
NDAs and BLAs is calculated to be
$4,154,664 (rounded to the nearest
dollar) and the cost of a priority review
for NME NDAs and BLAs is 1.67 times
that amount, or $6,938,289 (rounded to
the nearest dollar). The difference
between these two cost estimates, or
$2,783,625, represents the incremental
cost of conducting a priority review
rather than a standard review.
For the FY 2018 fee, FDA will need
to adjust the FY 2016 incremental cost
by the average amount by which FDA’s
average costs increased in the 3 years
prior to FY 2017, to adjust the FY 2016
amount for cost increases in FY 2017.
That adjustment, published in the
Federal Register on September 14, 2017
(82 FR 43244), setting the FY 2018
PDUFA fee, is 1.6868 percent for the
most recent year, not compounded.
Increasing the FY 2016 incremental
priority review cost of $2,783,625 by
1.6868 percent (or 0.016868) results in
an estimated cost of $2,830,579
(rounded to the nearest dollar). This is
the rare pediatric disease priority review
user fee amount for FY 2018 that must
be submitted with a priority review
voucher for a human drug application in
FY 2018, in addition to any PDUFA fee
that is required for such an application.
III. Fee Schedule for FY 2018
The fee rate for FY 2018 is set out in
Table 1:
TABLE 1—RARE PEDIATRIC DISEASE PRIORITY REVIEW SCHEDULE FOR FY 2018
Fee category
Fee rate for
FY 2018
Application submitted with a rare pediatric disease priority review voucher in addition to the normal PDUFA fee ..........................
$2,830,579
IV. Implementation of Rare Pediatric
Disease Priority Review User Fee
Under section 529(c)(4)(A) of the
FD&C Act, the priority review user fee
is due (i.e. the obligation to pay the fee
is incurred) when a sponsor notifies
FDA of its intent to use the voucher.
Section 529(c)(4)(B) of the FD&C Act
specifies that the application will be
considered incomplete if the priority
review user fee and all other applicable
user fees are not paid in accordance
with FDA payment procedures. In
addition, section 529(c)(4)(C) specifies
that FDA may not grant a waiver,
exemption, reduction, or refund of any
fees due and payable under this section
of the FD&C Act. Beginning with FDA’s
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appropriation for FY 2015, the annual
appropriation language states
specifically that ‘‘priority review user
fees authorized by 21 U.S.C. 360n [i.e.,
section 524 of the FD&C Act] and 360ff
[i.e., section 529 of the FD&C Act] shall
be credited to this account, to remain
available until expended.’’ (Pub. L. 113–
235, Section 5, Division A, Title VI).
The rare pediatric disease priority
review fee established in the new fee
schedule must be paid for any
application that is received on or after
October 1, 2017. In order to comply
with this requirement, the sponsor must
notify FDA 90 days prior to submission
of the human drug application that is
the subject of a priority review voucher
PO 00000
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Fmt 4703
Sfmt 4703
of an intent to submit the human drug
application, including the date on
which the sponsor intends to submit the
application.
Upon receipt of this notification, FDA
will issue an invoice to the sponsor who
has incurred a rare pediatric disease
priority review voucher fee. The invoice
will include instructions on how to pay
the fee via wire transfer or check.
As noted in section II, if a sponsor
uses a rare pediatric disease priority
review voucher for a human drug
application, the sponsor would incur
the rare pediatric disease priority review
voucher fee in addition to any PDUFA
fee that is required for the application.
The sponsor would need to follow
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Federal Register / Vol. 82, No. 187 / Thursday, September 28, 2017 / Notices
FDA’s normal procedures for timely
payment of the PDUFA fee for the
human drug application.
Payment must be made in U.S.
currency by electronic check, check,
bank draft, wire transfer, credit card, or
U.S. postal money order payable to the
order of the Food and Drug
Administration. The preferred payment
method is online using electronic check
(Automated Clearing House (ACH) also
known as eCheck). 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, select ‘‘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 that
are less than $25,000. If the balance
exceeds this amount, only the ACH
option is available. Payments must be
made using U.S bank accounts as well
as U.S. credit cards.
If paying with a paper check the
invoice number should be included on
the check, followed by the words ‘‘Rare
Pediatric Disease Priority Review.’’ All
paper checks must be in U.S. currency
from a U.S. bank made payable and
mailed to: Food and Drug
Administration, P.O. Box 979107, St.
Louis, MO 63197–9000.
If checks are 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. If you have
any questions concerning courier
delivery contact the U.S. Bank at 314–
418–4013. This telephone number is
only for questions about courier
delivery). The FDA post office box
number (P.O. Box 979107) must be
written on the check. If needed, FDA’s
tax identification number is 53–
0196965.
If paying by wire transfer, please
reference your invoice number when
completing your transfer. The
originating financial institution may
charge a wire transfer fee. If the
financial institution charges a wire
transfer fee it is required to add that
amount to the payment to ensure that
the invoice is paid in full. The account
information is as follows: U.S. Dept. of
Treasury, TREAS NYC, 33 Liberty St.,
New York, NY 10045, Account Number:
75060099, Routing Number: 021030004,
SWIFT: FRNYUS33, Beneficiary: FDA,
8455 Colesville Rd., 14th Floor, Silver
Spring, MD 20993–0002.
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V. Reference
The following reference is on display
in the Dockets Management Staff (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852, and is available for viewing
by interested persons between 9 a.m.
and 4 p.m., Monday through Friday.
1. Ridley, D.B., H.G. Grabowski, and J.L. Moe,
‘‘Developing Drugs for Developing
Countries,’’ Health Affairs, vol. 25, no. 2,
pp. 313–324, 2006.
Dated: September 22, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–20798 Filed 9–27–17; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1119]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food Canning
Establishment Registration, Process
Filing, and Recordkeeping for Acidified
Foods and Thermally Processed LowAcid Foods in Hermetically Sealed
Containers
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by October 30,
2017.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0037. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00038
Fmt 4703
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
I. Background
Food Canning Establishment
Registration, Process Filing, and
Recordkeeping for Acidified Foods and
Thermally Processed Low-Acid Foods
in Hermetically Sealed Containers 21
CFR 108.25 and 108.35, and Parts 113
and 114
OMB Control Number 0910–0037—
Extension
BILLING CODE 4164–01–P
AGENCY:
45293
Sfmt 4703
Section 402 of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 342) deems a food to be
adulterated, in part, if the food bears or
contains any poisonous or deleterious
substance that may render it injurious to
health. Section 301(a) of the FD&C Act
(21 U.S.C. 331(a)) prohibits the
introduction or delivery for introduction
into interstate commerce of adulterated
food. Under section 404 of the FD&C
Act (21 U.S.C. 344), our regulations
require registration of food processing
establishments, filing of process or other
data, and maintenance of processing
and production records for acidified
foods and thermally processed low-acid
foods in hermetically sealed containers.
These requirements are intended to
ensure safe manufacturing, processing,
and packing procedures, and to permit
us to verify that these procedures are
being followed. Improperly processed
low-acid foods present life-threatening
hazards if contaminated with foodborne
microorganisms, especially Clostridium
botulinum. The spores of C. botulinum
need to be destroyed or inhibited to
avoid production of the deadly toxin
that causes botulism. This is
accomplished with good manufacturing
procedures, which must include the use
of adequate heat processes or other
means of preservation.
To protect the public health, our
regulations require that each firm that
manufactures, processes, or packs
acidified foods or thermally processed
low-acid foods in hermetically sealed
containers for introduction into
interstate commerce register the
establishment with us using Form FDA
2541 (§§ 108.25(c)(1) and 108.35(c)(2)
(21 CFR 108.25(c)(1) and 108.35(c)(2)).
In addition to registering the plant, each
firm is required to provide data on the
processes used to produce these foods,
using Forms FDA 2541d, FDA 2541e,
E:\FR\FM\28SEN1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 187 (Thursday, September 28, 2017)]
[Notices]
[Pages 45291-45293]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20798]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0007]
Fee for Using a Rare Pediatric Disease Priority Review Voucher in
Fiscal Year 2018
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the fee rate for using a rare pediatric disease priority
review voucher for fiscal year (FY) 2018. The Federal Food, Drug, and
Cosmetic Act (the FD&C Act), as amended by the Food and Drug
Administration Safety and Innovation Act (FDASIA), authorizes FDA to
determine and collect rare pediatric disease priority review user fees
for certain applications for review of human drug or biological
products when those applications use a rare pediatric disease priority
review voucher. These vouchers are awarded to the sponsors of rare
pediatric disease product applications that meet all of the
requirements of this program and that are submitted 90 days or more
after July 9, 2012, upon FDA approval of such applications. The amount
of the fee for using a rare pediatric disease priority review voucher
is determined each FY, based on the difference between the average cost
incurred by FDA in the review of a human drug application subject to
priority review in the previous FY and the average cost incurred in the
review of an application that is not subject to priority review in the
previous FY. This notice establishes the rare pediatric disease
priority review fee rate for FY 2018 and outlines the payment
procedures for such fees.
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
Section 908 of FDASIA (Pub. L. 112-144) added section 529 to the
FD&C Act (21 U.S.C. 360ff). In section 529 of the FD&C Act, Congress
encouraged development of new human drugs and biological products for
prevention and treatment of certain rare pediatric diseases by offering
additional incentives for obtaining FDA approval of such products.
Under section 529 of the FD&C Act, the sponsor of an eligible human
drug application submitted 90 days or more after July 9, 2012, for a
rare pediatric disease (as defined in section 529(a)(3)) shall receive
a priority review voucher upon approval of the rare pediatric disease
product application. The recipient of a rare pediatric disease priority
review voucher may either use the voucher for a future human drug
application submitted to FDA under section 505(b)(1) of the FD&C Act
(21 U.S.C. 355(b)(1)) or section 351(a) of the Public Health Service
Act (42 U.S.C. 262(a)), or transfer (including by sale) the voucher to
another party. The voucher may be transferred (including by sale)
repeatedly until it ultimately is used for a human drug application
submitted to FDA under section 505(b)(1) of the FD&C Act or section
351(a) of the Public Health Service Act. A priority review is a review
conducted with a Prescription Drug User Fee Act (PDUFA) goal date of 6
months after the receipt or filing date, depending on the type of
application. Information regarding PDUFA goals is available at https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm511438.pdf.
The applicant that uses a rare pediatric disease priority review
voucher is entitled to a priority review of its eligible human drug
application, but must pay FDA a rare pediatric disease priority review
user fee in addition to any user fee required by PDUFA for the
application. Information regarding the rare pediatric disease priority
review voucher program is available at: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm375479.htm.
This notice establishes the rare pediatric disease priority review
fee rate for FY 2018 at $2,830,579 and outlines FDA's procedures for
payment of rare pediatric disease priority review user fees. This rate
is effective on October 1, 2017, and will remain in effect through
September 30, 2018.
II. Rare Pediatric Priority Review User Fee for FY 2018
Under section 529(c)(2) of the FD&C Act, the amount of the rare
pediatric disease priority review user fee is determined each fiscal
year based on the difference between the average cost incurred by FDA
in the review of a human drug application subject to priority review in
the previous fiscal year, and the average cost incurred by FDA in the
review of a human drug application that is not subject to priority
review in the previous fiscal year.
A priority review is a review conducted with a PDUFA goal date of 6
months after the receipt or filing date, depending on the type of
application. Under the PDUFA goals letter, FDA has committed to
reviewing and acting on 90 percent of the applications granted
[[Page 45292]]
priority review status within this expedited timeframe. Normally, an
application for a human drug or biological product will qualify for
priority review if the product is intended to treat a serious condition
and, if approved, would provide a significant improvement in safety or
effectiveness. An application that does not receive a priority
designation will receive a standard review. Under the PDUFA goals
letter, FDA has committed to reviewing and acting on 90 percent of
standard applications within 10 months of the receipt or filing date
depending on the type of application. A priority review involves a more
intensive level of effort and a higher level of resources than a
standard review.
FDA is setting a fee for FY 2018, which is to be based on standard
cost data from the previous fiscal year, FY 2017. However, the FY 2017
submission cohort has not been closed out yet, thus the cost data for
FY 2017 are not complete. The latest year for which FDA has complete
cost data is FY 2016. Furthermore, because FDA has never tracked the
cost of reviewing applications that get priority review as a separate
cost subset, FDA estimated this cost based on other data that the
Agency has tracked. FDA uses data that the Agency estimates and
publishes on its Web site each year--standard costs for review. FDA
does not publish a standard cost for ``the review of a human drug
application subject to priority review in the previous fiscal year.''
However, we expect all such applications would contain clinical data.
The standard cost application categories with clinical data that FDA
publishes each year are: (1) New drug applications (NDAs) for a new
molecular entity (NME) with clinical data and (2) biologics license
applications (BLAs).
The standard cost worksheets for FY 2016 show standard costs
(rounded to the nearest hundred dollars) of $5,929,100 for an NME NDA,
and $4,887,100 for a BLA. Based on these standard costs, the total cost
to review the 49 applications in these two categories in FY 2016 (27
NME NDAs with clinical data and 22 BLAs) was $267,601,900. (Note: These
numbers exclude the President's Emergency Plan for AIDS Relief NDAs; no
investigational new drug (IND) review costs are included in this
amount.) 23 of these applications (14 NDAs and 9 BLAs) received
priority review, which would mean that the remaining 26 received
standard reviews. Because a priority review compresses a review
schedule that ordinarily takes 10 months into 6 months, FDA estimates
that a multiplier of 1.67 (10 months divided by 6 months) should be
applied to non-priority review costs in estimating the effort and cost
of a priority review as compared to a standard review. This multiplier
is consistent with published research on this subject which supports a
priority review multiplier in the range of 1.48 to 2.35 (Ref. 1). Using
FY 2016 figures, the costs of a priority and standard review are
estimated using the following formula:
(23 [alpha] x 1.67) + (26 [alpha]) = $267,601,900
where ``[alpha]'' is the cost of a standard review and ``[alpha] times
1.67'' is the cost of a priority review. Using this formula, the cost
of a standard review for NME NDAs and BLAs is calculated to be
$4,154,664 (rounded to the nearest dollar) and the cost of a priority
review for NME NDAs and BLAs is 1.67 times that amount, or $6,938,289
(rounded to the nearest dollar). The difference between these two cost
estimates, or $2,783,625, represents the incremental cost of conducting
a priority review rather than a standard review.
For the FY 2018 fee, FDA will need to adjust the FY 2016
incremental cost by the average amount by which FDA's average costs
increased in the 3 years prior to FY 2017, to adjust the FY 2016 amount
for cost increases in FY 2017. That adjustment, published in the
Federal Register on September 14, 2017 (82 FR 43244), setting the FY
2018 PDUFA fee, is 1.6868 percent for the most recent year, not
compounded. Increasing the FY 2016 incremental priority review cost of
$2,783,625 by 1.6868 percent (or 0.016868) results in an estimated cost
of $2,830,579 (rounded to the nearest dollar). This is the rare
pediatric disease priority review user fee amount for FY 2018 that must
be submitted with a priority review voucher for a human drug
application in FY 2018, in addition to any PDUFA fee that is required
for such an application.
III. Fee Schedule for FY 2018
The fee rate for FY 2018 is set out in Table 1:
Table 1--Rare Pediatric Disease Priority Review Schedule for FY 2018
------------------------------------------------------------------------
Fee rate for FY
Fee category 2018
------------------------------------------------------------------------
Application submitted with a rare pediatric disease $2,830,579
priority review voucher in addition to the normal
PDUFA fee.............................................
------------------------------------------------------------------------
IV. Implementation of Rare Pediatric Disease Priority Review User Fee
Under section 529(c)(4)(A) of the FD&C Act, the priority review
user fee is due (i.e. the obligation to pay the fee is incurred) when a
sponsor notifies FDA of its intent to use the voucher. Section
529(c)(4)(B) of the FD&C Act specifies that the application will be
considered incomplete if the priority review user fee and all other
applicable user fees are not paid in accordance with FDA payment
procedures. In addition, section 529(c)(4)(C) specifies that FDA may
not grant a waiver, exemption, reduction, or refund of any fees due and
payable under this section of the FD&C Act. Beginning with FDA's
appropriation for FY 2015, the annual appropriation language states
specifically that ``priority review user fees authorized by 21 U.S.C.
360n [i.e., section 524 of the FD&C Act] and 360ff [i.e., section 529
of the FD&C Act] shall be credited to this account, to remain available
until expended.'' (Pub. L. 113-235, Section 5, Division A, Title VI).
The rare pediatric disease priority review fee established in the
new fee schedule must be paid for any application that is received on
or after October 1, 2017. In order to comply with this requirement, the
sponsor must notify FDA 90 days prior to submission of the human drug
application that is the subject of a priority review voucher of an
intent to submit the human drug application, including the date on
which the sponsor intends to submit the application.
Upon receipt of this notification, FDA will issue an invoice to the
sponsor who has incurred a rare pediatric disease priority review
voucher fee. The invoice will include instructions on how to pay the
fee via wire transfer or check.
As noted in section II, if a sponsor uses a rare pediatric disease
priority review voucher for a human drug application, the sponsor would
incur the rare pediatric disease priority review voucher fee in
addition to any PDUFA fee that is required for the application. The
sponsor would need to follow
[[Page 45293]]
FDA's normal procedures for timely payment of the PDUFA fee for the
human drug application.
Payment must be made in U.S. currency by electronic check, check,
bank draft, wire transfer, credit card, or U.S. postal money order
payable to the order of the Food and Drug Administration. The preferred
payment method is online using electronic check (Automated Clearing
House (ACH) also known as eCheck). 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, select
``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 that are less than $25,000. If the balance
exceeds this amount, only the ACH option is available. Payments must be
made using U.S bank accounts as well as U.S. credit cards.
If paying with a paper check the invoice number should be included
on the check, followed by the words ``Rare Pediatric Disease Priority
Review.'' All paper checks must be in U.S. currency from a U.S. bank
made payable and mailed to: Food and Drug Administration, P.O. Box
979107, St. Louis, MO 63197-9000.
If checks are 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. If you have any
questions concerning courier delivery contact the U.S. Bank at 314-418-
4013. This telephone number is only for questions about courier
delivery). The FDA post office box number (P.O. Box 979107) must be
written on the check. If needed, FDA's tax identification number is 53-
0196965.
If paying by wire transfer, please reference your invoice number
when completing your transfer. The originating financial institution
may charge a wire transfer fee. If the financial institution charges a
wire transfer fee it is required to add that amount to the payment to
ensure that the invoice is paid in full. The account information is as
follows: U.S. Dept. of Treasury, TREAS NYC, 33 Liberty St., New York,
NY 10045, Account Number: 75060099, Routing Number: 021030004, SWIFT:
FRNYUS33, Beneficiary: FDA, 8455 Colesville Rd., 14th Floor, Silver
Spring, MD 20993-0002.
V. Reference
The following reference is on display in the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Ridley, D.B., H.G. Grabowski, and J.L. Moe, ``Developing Drugs
for Developing Countries,'' Health Affairs, vol. 25, no. 2, pp. 313-
324, 2006.
Dated: September 22, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20798 Filed 9-27-17; 8:45 am]
BILLING CODE 4164-01-P
