83_FR_49014 83 FR 48826 - Fee for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2019

83 FR 48826 - Fee for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2019

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 188 (September 27, 2018)

Page Range48826-48829
FR Document2018-21033

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) 2019. The Federal Food, Drug, and Cosmetic Act (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 applicants 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 to review of a human drug application designated as 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 2019 and outlines the payment procedures for such fees.

Federal Register, Volume 83 Issue 188 (Thursday, September 27, 2018) 
[Federal Register Volume 83, Number 188 (Thursday, September 27, 2018)]
[Notices]
[Pages 48826-48829]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-21033]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0007]


Fee for Using a Rare Pediatric Disease Priority Review Voucher in 
Fiscal Year 2019

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

[[Page 48827]]

pediatric disease priority review voucher for fiscal year (FY) 2019. 
The Federal Food, Drug, and Cosmetic Act (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 
applicants 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 to review of a human drug application 
designated as 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 2019 and outlines the 
payment procedures for such fees.

FOR FURTHER INFORMATION CONTACT: Lola Olajide, Office of Financial 
Management, Food and Drug Administration, 8455 Colesville Rd., COLE-
14541B, Silver Spring, MD 20993-0002, 240-402-4244.

SUPPLEMENTARY INFORMATION:

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 applicant 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 2019 at $2,457,140 and outlines FDA's procedures for 
payment of rare pediatric disease priority review user fees. This rate 
is effective on October 1, 2018, and will remain in effect through 
September 30, 2019.

II. Rare Pediatric Priority Review User Fee for FY 2019

    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 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 receives 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 2019, which is to be based on standard 
cost data from the previous fiscal year, FY 2018. However, the FY 2018 
submission cohort has not been closed out yet, thus the cost data for 
FY 2018 are not complete. The latest year for which FDA has complete 
cost data is FY 2017. 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 website 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 2017 show standard costs of 
$5,340,560 for an NME NDA, and $4,596,936 for a BLA. Based on these 
standard costs, the total cost to review the 57 applications in these 
two categories in FY 2017 (31 NME NDAs with clinical data and 26 BLAs) 
was $285,077,688. (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.) Thirty-three of these 
applications (20 NDAs and 13 BLAs) received priority review, which 
would mean that the remaining 24 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 / 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 2017 figures, the costs of a 
priority and standard review

[[Page 48828]]

are estimated using the following formula:

(33 [alpha] x 1.67) + (24[alpha]) = $285,077,688

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 
$3,603,561 (rounded to the nearest dollar) and the cost of a priority 
review for NME NDAs and BLAs is 1.67 times that amount, or $6,017,946 
(rounded to the nearest dollar). The difference between these two cost 
estimates, or $2,414,386, represents the incremental cost of conducting 
a priority review rather than a standard review.
    For the FY 2019 fee, FDA will need to adjust the FY 2017 
incremental cost by the average amount by which FDA's average costs 
increased in the 3 years prior to FY 2018, to adjust the FY 2017 amount 
for cost increases in FY 2018. That adjustment, published in the 
Federal Register on August 1, 2018 (83 FR 37504), setting the FY 2019 
PDUFA fee, is 1.7708 percent for the most recent year, not compounded. 
Increasing the FY 2017 incremental priority review cost of 2,414,386 by 
1.7708 percent (or 0.017708) results in an estimated cost of $2,457,140 
(rounded to the nearest dollar). This is the rare pediatric disease 
priority review user fee amount for FY 2019 that must be submitted with 
a priority review voucher for a human drug application in FY 2019, in 
addition to any PDUFA fee that is required for such an application.

III. Fee Schedule for FY 2019

    The fee rate for FY 2019 is set out in table 1:

  Table 1--Rare Pediatric Disease Priority Review Schedule for FY 2019
------------------------------------------------------------------------
                                                         Fee rate for FY
                      Fee category                             2019
------------------------------------------------------------------------
Application submitted with a rare pediatric disease          $2,457,140
 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.
    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, 2018. 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 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.

V. Reference

    The following reference is on display at 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; it is not 
available electronically at https://www.regulations.gov as this 
reference is copyright protected. FDA has verified the website address, 
as of the date this document publishes in the Federal Register, but 
websites are subject to change over time.

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, available at: https://faculty.fuqua.duke.edu/~willm/
HSM_RA/Documents/HA2006_Ridley_Vouchers.pdf.


[[Page 48829]]


    Dated: September 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21033 Filed 9-26-18; 8:45 am]
 BILLING CODE 4164-01-P

48826 Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices such as medical information, your or information on the cover sheet and not effectively and quickly as possible. FDA anyone else’s Social Security number, or in the body of your comments and you seeks comment on this draft guidance, confidential business information, such must identify this information as including scope of the term ‘‘retail as a manufacturing process. Please note ‘‘confidential.’’ Any information marked consignee’’ as used in this document, that if you include your name, contact as ‘‘confidential’’ will not be disclosed the situations where providing retail information, or other information that except in accordance with 21 CFR 10.20 consignee lists would be of the most use identifies you in the body of your and other applicable disclosure law. For to consumers to identify recalled food in comments, that information will be more information about FDA’s posting their possession, and additional posted on https://www.regulations.gov. of comments to public dockets, see 80 information that would be of the most • If you want to submit a comment FR 56469, September 18, 2015, or access use to consumers to help them identify with confidential information that you the information at: https://www.gpo.gov/ recalled food in their possession. do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015- This draft guidance is being issued public, submit the comment as a 23389.pdf. consistent with FDA’s good guidance written/paper submission and in the Docket: For access to the docket to practices regulation (21 CFR 10.115). manner detailed (see ‘‘Written/Paper read background documents or the The draft guidance, when finalized, will Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments represent the current thinking of FDA Written/Paper Submissions received, go to https:// regarding publicizing retail consignees www.regulations.gov and insert the to effectuate certain food recalls. It does Submit written/paper submissions as docket number, found in brackets in the not establish any rights for any person follows: heading of this document, into the and is not binding on FDA or the public. • Mail/Hand Delivery/Courier (for You can use an alternative approach if ‘‘Search’’ box and follow the prompts written/paper submissions): Dockets it satisfies the requirements of the and/or go to the Dockets Management Management Staff (HFA–305), Food and applicable statutes and regulations. This Staff, 5630 Fishers Lane, Rm. 1061, Drug Administration, 5630 Fishers draft guidance is not subject to Rockville, MD 20852. Lane, Rm. 1061, Rockville, MD 20852. Executive Order 12866. • For written/paper comments You may submit comments on any submitted to the Dockets Management guidance at any time (see 21 CFR II. Paperwork Reduction Act of 1995 Staff, FDA will post your comment, as 10.115(g)(5)). Submit written requests for single This draft guidance refers to well as any attachments, except for previously approved collections of information submitted, marked and copies of the draft guidance to the Office of Strategic Planning and Operational information found in FDA regulations. identified, as confidential, if submitted These collections of information are as detailed in ‘‘Instructions.’’ Policy, Office of Regulatory Affairs, Food and Drug Administration, 12420 subject to review by the Office of Instructions: All submissions received Management and Budget (OMB) under must include the Docket No. FDA– Parklawn Dr., Element Building, Rockville, MD 20857. Send one self- the Paperwork Reduction Act of 1995 2018–D–1752 for ‘‘Public Availability of (44 U.S.C. 3501–3520). Any collections Lists of Retail Consignees to Effectuate addressed adhesive label to assist that office in processing your requests. See of information under 21 CFR 7.46, 7.49, Certain Human and Animal Food 7.53, 7.55, and 7.59 have been approved Recalls; Draft Guidance for Industry and the SUPPLEMENTARY INFORMATION section for electronic access to the draft under OMB control number 0910–0249. FDA Staff.’’ Received comments will be placed in the docket and, except for guidance document. III. Electronic Access those submitted as ‘‘Confidential FOR FURTHER INFORMATION CONTACT: Persons with access to the internet Submissions,’’ publicly viewable at Chris Henderson, Office of Regulatory may obtain the draft guidance at either https://www.regulations.gov or at the Affairs, Division of Operational Policy, https://www.fda.gov/Safety/Recalls/ Dockets Management Staff between 9 Food and Drug Administration, 12420 default.htm or https:// a.m. and 4 p.m., Monday through Parklawn Dr., Rockville, MD 20857, www.regulations.gov. Friday. 240–402–8186, Christopher.henderson@ Dated: September 21, 2018. • Confidential Submissions—To fda.hhs.gov. submit a comment with confidential Leslie Kux, SUPPLEMENTARY INFORMATION: information that you do not wish to be Associate Commissioner for Policy. made publicly available, submit your I. Background [FR Doc. 2018–21042 Filed 9–26–18; 8:45 am] comments only as a written/paper FDA is announcing the availability of BILLING CODE 4164–01–P submission. You should submit two a draft guidance for industry and FDA copies total. One copy will include the staff entitled ‘‘Public Availability of information you claim to be confidential Lists of Retail Consignees to Effectuate DEPARTMENT OF HEALTH AND with a heading or cover note that states Certain Human and Animal Food HUMAN SERVICES ‘‘THIS DOCUMENT CONTAINS Recalls.’’ The draft guidance, when Food and Drug Administration CONFIDENTIAL INFORMATION.’’ The finalized, establishes guidance for Agency will review this copy, including industry and FDA staff on how and [Docket No. FDA–2018–N–0007] the claimed confidential information, in when FDA intends to publicize retail its consideration of comments. The consignees that may have received Fee for Using a Rare Pediatric Disease second copy, which will have the recalled foods. FDA’s goal is to Priority Review Voucher in Fiscal Year claimed confidential information publicize retail consignee lists for these 2019 daltland on DSKBBV9HB2PROD with NOTICES redacted/blacked out, will be available food recalls, especially those that are AGENCY: Food and Drug Administration, for public viewing and posted on likely to be classified as Class I recalls, HHS. https://www.regulations.gov. Submit where providing this additional ACTION: Notice. both copies to the Dockets Management information will be of the most use to Staff. If you do not wish your name and consumers to help them identify SUMMARY: The Food and Drug contact information to be made publicly recalled food and to determine whether Administration (FDA or the Agency) is available, you can provide this that food is in their possession as announcing the fee rate for using a rare VerDate Sep<11>2014 17:20 Sep 26, 2018 Jkt 244001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\27SEN1.SGM 27SEN1

Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices 48827 pediatric disease priority review transferred (including by sale) receives a standard review. Under the voucher for fiscal year (FY) 2019. The repeatedly until it ultimately is used for PDUFA goals letter, FDA has committed Federal Food, Drug, and Cosmetic Act a human drug application submitted to to reviewing and acting on 90 percent of (FD&C Act), as amended by the Food FDA under section 505(b)(1) of the standard applications within 10 months and Drug Administration Safety and FD&C Act or section 351(a) of the Public of the receipt or filing date depending Innovation Act (FDASIA), authorizes Health Service Act. A priority review is on the type of application. A priority FDA to determine and collect rare a review conducted with a Prescription review involves a more intensive level pediatric disease priority review user Drug User Fee Act (PDUFA) goal date of of effort and a higher level of resources fees for certain applications for review 6 months after the receipt or filing date, than a standard review. of human drug or biological products depending on the type of application. FDA is setting a fee for FY 2019, when those applications use a rare Information regarding PDUFA goals is which is to be based on standard cost pediatric disease priority review available at https://www.fda.gov/ data from the previous fiscal year, FY voucher. These vouchers are awarded to downloads/forindustry/userfees/ 2018. However, the FY 2018 submission the applicants of rare pediatric disease prescriptiondruguserfee/ cohort has not been closed out yet, thus product applications that meet all of the ucm511438.pdf. the cost data for FY 2018 are not requirements of this program and that The applicant that uses a rare complete. The latest year for which FDA are submitted 90 days or more after July pediatric disease priority review has complete cost data is FY 2017. 9, 2012, upon FDA approval of such voucher is entitled to a priority review Furthermore, because FDA has never applications. The amount of the fee for of its eligible human drug application, tracked the cost of reviewing using a rare pediatric disease priority but must pay FDA a rare pediatric applications that get priority review as review voucher is determined each FY, disease priority review user fee in a separate cost subset, FDA estimated based on the difference between the addition to any user fee required by this cost based on other data that the average cost incurred by FDA to review PDUFA for the application. Information Agency has tracked. FDA uses data that of a human drug application designated regarding the rare pediatric disease the Agency estimates and publishes on as priority review in the previous FY priority review voucher program is its website each year—standard costs for and the average cost incurred in the available at: https://www.fda.gov/Drugs/ review. FDA does not publish a review of an application that is not DevelopmentApprovalProcess/ standard cost for ‘‘the review of a subject to priority review in the DevelopmentResources/ human drug application subject to previous FY. This notice establishes the ucm375479.htm. priority review in the previous fiscal rare pediatric disease priority review fee This notice establishes the rare year.’’ However, we expect all such rate for FY 2019 and outlines the pediatric disease priority review fee rate applications would contain clinical for FY 2019 at $2,457,140 and outlines payment procedures for such fees. data. The standard cost application FDA’s procedures for payment of rare FOR FURTHER INFORMATION CONTACT: Lola pediatric disease priority review user categories with clinical data that FDA Olajide, Office of Financial fees. This rate is effective on October 1, publishes each year are: (1) New drug Management, Food and Drug 2018, and will remain in effect through applications (NDAs) for a new Administration, 8455 Colesville Rd., September 30, 2019. molecular entity (NME) with clinical COLE–14541B, Silver Spring, MD data and (2) biologics license 20993–0002, 240–402–4244. II. Rare Pediatric Priority Review User applications (BLAs). SUPPLEMENTARY INFORMATION: Fee for FY 2019 The standard cost worksheets for FY Under section 529(c)(2) of the FD&C 2017 show standard costs of $5,340,560 I. Background Act, the amount of the rare pediatric for an NME NDA, and $4,596,936 for a Section 908 of FDASIA (Pub. L. 112– disease priority review user fee is BLA. Based on these standard costs, the 144) added section 529 to the FD&C Act determined each fiscal year based on the total cost to review the 57 applications (21 U.S.C. 360ff). In section 529 of the difference between the average cost in these two categories in FY 2017 (31 FD&C Act, Congress encouraged incurred by FDA in the review of a NME NDAs with clinical data and 26 development of new human drugs and human drug application subject to BLAs) was $285,077,688. (Note: These biological products for prevention and priority review in the previous fiscal numbers exclude the President’s treatment of certain rare pediatric year, and the average cost incurred by Emergency Plan for AIDS Relief NDAs; diseases by offering additional FDA in the review of a human drug no investigational new drug (IND) incentives for obtaining FDA approval application that is not subject to priority review costs are included in this of such products. Under section 529 of review in the previous fiscal year. amount.) Thirty-three of these the FD&C Act, the applicant of an A priority review is a review applications (20 NDAs and 13 BLAs) eligible human drug application conducted with a PDUFA goal date of 6 received priority review, which would submitted 90 days or more after July 9, months after the receipt or filing date, mean that the remaining 24 received 2012, for a rare pediatric disease (as depending on the type of application. standard reviews. Because a priority defined in section 529(a)(3)) shall Under the PDUFA goals letter, FDA has review compresses a review schedule receive a priority review voucher upon committed to reviewing and acting on that ordinarily takes 10 months into 6 approval of the rare pediatric disease 90 percent of the applications granted months, FDA estimates that a multiplier product application. The recipient of a priority review status within this of 1.67 (10 months ÷ 6 months) should rare pediatric disease priority review expedited timeframe. Normally, an be applied to non-priority review costs voucher may either use the voucher for application for a human drug or in estimating the effort and cost of a daltland on DSKBBV9HB2PROD with NOTICES a future human drug application biological product will qualify for priority review as compared to a submitted to FDA under section priority review if the product is standard review. This multiplier is 505(b)(1) of the FD&C Act (21 U.S.C. intended to treat a serious condition consistent with published research on 355(b)(1)) or section 351(a) of the Public and, if approved, would provide a this subject which supports a priority Health Service Act (42 U.S.C. 262(a)), or significant improvement in safety or review multiplier in the range of 1.48 to transfer (including by sale) the voucher effectiveness. An application that does 2.35 (Ref. 1). Using FY 2017 figures, the to another party. The voucher may be not receive a priority designation costs of a priority and standard review VerDate Sep<11>2014 17:20 Sep 26, 2018 Jkt 244001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\27SEN1.SGM 27SEN1

48828 Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices are estimated using the following $2,414,386, represents the incremental cost of 2,414,386 by 1.7708 percent (or formula: cost of conducting a priority review 0.017708) results in an estimated cost of (33 a × 1.67) + (24a) = $285,077,688 rather than a standard review. $2,457,140 (rounded to the nearest For the FY 2019 fee, FDA will need dollar). This is the rare pediatric disease where ‘‘a’’ is the cost of a standard to adjust the FY 2017 incremental cost priority review user fee amount for FY review and ‘‘a times 1.67’’ is the cost of by the average amount by which FDA’s 2019 that must be submitted with a a priority review. Using this formula, average costs increased in the 3 years priority review voucher for a human the cost of a standard review for NME prior to FY 2018, to adjust the FY 2017 drug application in FY 2019, in addition NDAs and BLAs is calculated to be amount for cost increases in FY 2018. to any PDUFA fee that is required for $3,603,561 (rounded to the nearest That adjustment, published in the dollar) and the cost of a priority review such an application. Federal Register on August 1, 2018 (83 for NME NDAs and BLAs is 1.67 times FR 37504), setting the FY 2019 PDUFA III. Fee Schedule for FY 2019 that amount, or $6,017,946 (rounded to fee, is 1.7708 percent for the most recent the nearest dollar). The difference year, not compounded. Increasing the The fee rate for FY 2019 is set out in between these two cost estimates, or FY 2017 incremental priority review table 1: TABLE 1—RARE PEDIATRIC DISEASE PRIORITY REVIEW SCHEDULE FOR FY 2019 Fee rate for Fee category FY 2019 Application submitted with a rare pediatric disease priority review voucher in addition to the normal PDUFA fee .......................... $2,457,140 IV. Implementation of Rare Pediatric FDA’s normal procedures for timely 418–4013. This telephone number is Disease Priority Review User Fee payment of the PDUFA fee for the only for questions about courier Under section 529(c)(4)(A) of the human drug application. delivery.) The FDA post office box FD&C Act, the priority review user fee Payment must be made in U.S. number (P.O. Box 979107) must be is due (i.e., the obligation to pay the fee currency by electronic check, check, written on the check. If needed, FDA’s is incurred) when a sponsor notifies bank draft, wire transfer, credit card, or tax identification number is 53– FDA of its intent to use the voucher. U.S. postal money order payable to the 0196965. Section 529(c)(4)(B) of the FD&C Act order of the Food and Drug If paying by wire transfer, please specifies that the application will be Administration. The preferred payment reference your invoice number when considered incomplete if the priority method is online using electronic check completing your transfer. The review user fee and all other applicable (Automated Clearing House (ACH) also originating financial institution may user fees are not paid in accordance known as eCheck). Secure electronic charge a wire transfer fee. If the with FDA payment procedures. In payments can be submitted using the financial institution charges a wire addition, section 529(c)(4)(C) specifies User Fees Payment Portal at https:// transfer fee it is required to add that that FDA may not grant a waiver, userfees.fda.gov/pay. (Note: only full amount to the payment to ensure that exemption, reduction, or refund of any payments are accepted. No partial the invoice is paid in full. The account fees due and payable under this section payments can be made online.) Once information is as follows: U.S. Dept. of of the FD&C Act. you search for your invoice, select ‘‘Pay Treasury, TREAS NYC, 33 Liberty St., The rare pediatric disease priority Now’’ to be redirected to Pay.gov. Note New York, NY 10045, Account Number: review fee established in the new fee that electronic payment options are 75060099, Routing Number: 021030004, schedule must be paid for any based on the balance due. Payment by SWIFT: FRNYUS33. application that is received on or after credit card is available for balances that October 1, 2018. In order to comply are less than $25,000. If the balance V. Reference with this requirement, the sponsor must exceeds this amount, only the ACH notify FDA 90 days prior to submission option is available. Payments must be The following reference is on display of the human drug application that is made using U.S bank accounts as well at the Dockets Management Staff (HFA– the subject of a priority review voucher as U.S. credit cards. 305), Food and Drug Administration, of an intent to submit the human drug If paying with a paper check the 5630 Fishers Lane, Rm. 1061, Rockville, application, including the date on invoice number should be included on MD 20852) and is available for viewing which the sponsor intends to submit the the check, followed by the words ‘‘Rare by interested persons between 9 a.m. application. Pediatric Disease Priority Review.’’ All and 4 p.m., Monday through Friday; it Upon receipt of this notification, FDA paper checks must be in U.S. currency is not available electronically at https:// will issue an invoice to the sponsor who from a U.S. bank made payable and www.regulations.gov as this reference is has incurred a rare pediatric disease mailed to: Food and Drug copyright protected. FDA has verified priority review voucher fee. The invoice Administration, P.O. Box 979107, St. the website address, as of the date this will include instructions on how to pay Louis, MO 63197–9000. document publishes in the Federal the fee via wire transfer or check. If checks are sent by a courier that Register, but websites are subject to As noted in section II, if a sponsor requests a street address, the courier can change over time. daltland on DSKBBV9HB2PROD with NOTICES uses a rare pediatric disease priority deliver the checks to: U.S. Bank, 1. Ridley, D.B., H.G. Grabowski, and J.L. Moe, review voucher for a human drug Attention: Government Lockbox 979107, ‘‘Developing Drugs for Developing application, the sponsor would incur 1005 Convention Plaza, St. Louis, MO Countries,’’ Health Affairs, vol. 25, no. 2, the rare pediatric disease priority review 63101. (Note: This U.S. Bank address is pp. 313–324, 2006, available at: https:// voucher fee in addition to any PDUFA for courier delivery only. If you have faculty.fuqua.duke.edu/∼willm/HSM_ fee that is required for the application. any questions concerning courier RA/Documents/HA2006_Ridley_ The sponsor would need to follow delivery contact the U.S. Bank at 314– Vouchers.pdf. VerDate Sep<11>2014 17:20 Sep 26, 2018 Jkt 244001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\27SEN1.SGM 27SEN1

Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices 48829 Dated: September 20, 2018. that if you include your name, contact of comments to public dockets, see 80 Leslie Kux, information, or other information that FR 56469, September 18, 2015, or access Associate Commissioner for Policy. identifies you in the body of your the information at: https://www.gpo.gov/ [FR Doc. 2018–21033 Filed 9–26–18; 8:45 am] application, that information will be fdsys/pkg/FR-2015-09-18/pdf/2015- BILLING CODE 4164–01–P posted on https://www.regulations.gov. 23389.pdf. • If you want to submit an Docket: For access to the docket, go to application with confidential https://www.regulations.gov and insert DEPARTMENT OF HEALTH AND information that you do not wish to be the docket number, found in brackets in HUMAN SERVICES made available to the public, submit the the heading of this document, into the application as a written/paper ‘‘Search’’ box and follow the prompts Food and Drug Administration submission and in the manner detailed and/or go to the Dockets Management [Docket No. FDA–2009–N–0329] (see ‘‘Written/Paper Submissions’’ and Staff, 5630 Fishers Lane, Rm. 1061, ‘‘Instructions’’). Rockville, MD 20852 between 9 a.m. Dilip Patel; Denial of Hearing; Final Written/Paper Submissions and 4 p.m., Monday through Friday. Debarment Order Publicly available submissions may be Submit written/paper submissions as seen in the docket. AGENCY: Food and Drug Administration, follows: • Mail/Hand Delivery/Courier (for FOR FURTHER INFORMATION CONTACT: HHS. written/paper submissions): Dockets Rachael Vieder Linowes, Office of ACTION: Notice. Management Staff (HFA–305), Food and Scientific Integrity, Food and Drug SUMMARY: The Food and Drug Drug Administration, 5630 Fishers Administration, 10903 New Hampshire Administration (FDA or Agency) is Lane, Rm. 1061, Rockville, MD 20852. Ave., Bldg. 1, Rm. 4206, Silver Spring, denying a request for a hearing • For a written/paper application MD 20993, 240–402–5931. submitted by Dilip Patel and is issuing submitted to the Dockets Management SUPPLEMENTARY INFORMATION: an order under the Federal Food, Drug, Staff, FDA will post your application, as and Cosmetic Act (FD&C Act) debarring I. Background well as any attachments, except for Patel for 5 years from providing services information submitted, marked and Section 306(b)(2)(B)(i)(II) of the FD&C in any capacity to a person that has an identified, as confidential, if submitted Act (21 U.S.C. 335a(b)(2)(B)(i)(II)) approved or pending drug product as detailed in ‘‘Instructions.’’ permits FDA to debar an individual if it application. FDA bases this order on a Instructions: Your application must finds: (1) That the individual has been finding that Patel was convicted of a include the Docket No. FDA–2009–N– convicted of a conspiracy to commit a conspiracy to commit a felony under 0329. An application will be placed in felony under Federal law for conduct Federal law for conduct relating to the the docket and, unless submitted as relating to the regulation of any drug regulation of a drug product under the ‘‘Confidential Submissions,’’ publicly product under the FD&C Act and (2) FD&C Act and that the conduct viewable at https://www.regulations.gov that the type of conduct which served underlying the conviction undermines or at the Dockets Management Staff as the basis for the conviction the process for the regulation of drugs. between 9 a.m. and 4 p.m., Monday undermines the process for the In determining the appropriateness and through Friday. regulation of drugs. period of Patel’s debarment, FDA • Confidential Submissions—To On April 24, 2007, Patel pled guilty considered the relevant factors listed in submit an application with confidential to one count of conspiracy to distribute the FD&C Act. Patel failed to file with information that you do not wish to be misbranded and adulterated drugs, in the Agency information and analyses made publicly available, submit your violation of 18 U.S.C. 371. On December sufficient to create a basis for a hearing application only as a written/paper 9, 2010, the U.S. District Court for the concerning this action. submission. You should submit two District of New Jersey entered the DATES: The order is applicable copies total. One copy will include the conviction, sentenced Patel to 2 years of September 27, 2018. information you claim to be confidential probation, and imposed a $3,000 fine. ADDRESSES: Any application for with a heading or cover note that states Patel’s conviction stemmed from his termination of debarment by Patel under ‘‘THIS DOCUMENT CONTAINS employment at Able Laboratories, Inc. section 306(d) of the FD&C Act CONFIDENTIAL INFORMATION.’’ The (Able), where he was a Supervisor of (application) may be submitted as Agency will review this copy, including Analytical Control and later a Quality follows: the claimed confidential information, in Control Manager in the Quality Control its consideration of your application. Department. Patel and his co- Electronic Submissions The second copy, which will have the conspirators conspired and agreed with • Federal eRulemaking Portal: claimed confidential information others to cause the introduction of https://www.regulations.gov. Follow the redacted/blacked out, will be available misbranded and adulterated drugs into instructions for submitting comments. for public viewing and posted on interstate commerce with an intent to An application submitted electronically, https://www.regulations.gov. Submit defraud and mislead the United States, including attachments, to https:// both copies to the Dockets Management in violation of sections 301(a) and www.regulations.gov will be posted to Staff. If you do not wish your name and 303(a)(2) of the FD&C Act (21 U.S.C. the docket unchanged. Because your contact information to be made publicly 331(a) and 333(a)(2)). Specifically, application will be made public, you are available, you can provide this according to the criminal information to solely responsible for ensuring that your information on the cover sheet and not which he pled guilty, Patel supervised daltland on DSKBBV9HB2PROD with NOTICES application does not include any in the body of your application and you the falsification and manipulation of confidential information that you or a must identify this information as assay test results for atenolol, a third party may not wish to be posted, ‘‘confidential.’’ Any information marked prescription medication for cardiac such as medical information, your or as ‘‘confidential’’ will not be disclosed conditions, and he directed a anyone else’s Social Security number, or except in accordance with 21 CFR 10.20 subordinate chemist to falsify and confidential business information, such and other applicable disclosure law. For manipulate dissolution test results for as a manufacturing process. Please note more information about FDA’s posting methylphenidate hydrochloride VerDate Sep<11>2014 17:20 Sep 26, 2018 Jkt 244001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\27SEN1.SGM 27SEN1


Document Created: 2018-09-27 01:04:57
Document Modified: 2018-09-27 01:04:57
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.
ContactLola Olajide, Office of Financial Management, Food and Drug Administration, 8455 Colesville Rd., COLE- 14541B, Silver Spring, MD 20993-0002, 240-402-4244.
FR Citation83 FR 48826 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR