81 FR 67356 - Fee for Using a Tropical Disease Priority Review Voucher in Fiscal Year 2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 190 (September 30, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 190 (September 30, 2016)
| Page Range | 67356-67358 | |
| FR Document | 2016-23623 |
[Federal Register Volume 81, Number 190 (Friday, September 30, 2016)] [Notices] [Pages 67356-67358] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-23623] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0007] Fee for Using a Tropical Disease Priority Review Voucher in Fiscal Year 2017 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) is announcing the fee rates for using a tropical disease priority review voucher for fiscal year (FY) 2017. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect priority review user fees for certain applications for approval of drug or biological products when those applications use a tropical disease priority review voucher awarded by the Secretary of Health and Human Services. These vouchers are awarded to the sponsors of certain tropical disease product applications, submitted after September 27, 2007, upon FDA approval of such applications. The amount of the fee submitted to FDA with applications using a tropical disease priority review voucher 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 in the review of an application that is not subject to priority review in the previous fiscal year. This notice establishes the tropical disease priority review fee rate for FY 2017. 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 1102 of FDAAA (Pub. L. 110-85) added section 524 to the FD&C Act (21 U.S.C. 360n). In section 524, Congress encouraged development of new drug and biological products for prevention and treatment of certain tropical diseases by offering additional incentives for obtaining FDA approval [[Page 67357]] of such products. Under section 524, the sponsor of an eligible human drug application submitted after September 27, 2007, for a tropical disease (as defined in section 524(a)(3) of the FD&C Act), shall receive a priority review voucher upon approval of the tropical disease product application. The recipient of a tropical disease priority review voucher may either use the voucher with a future submission to FDA under section 505(b)(1) of the FD&C Act (21 U.S.C. 355(b)(1)) or section 351 of the Public Health Service Act (42 U.S.C. 262), 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 upon the type of application. Information regarding the PDUFA goals is available at: http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf. The applicant that uses a priority review voucher is entitled to a priority review but must pay FDA a priority review user fee in addition to any other fee required by PDUFA. FDA published draft guidance on its Web site about how this tropical disease priority review voucher program operates (available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080599.pdf). This notice establishes the tropical disease priority review fee rate for FY 2017 as $2,706,000 and outlines FDA's process for implementing the collection of the priority review user fees. This rate is effective on October 1, 2016, and will remain in effect through September 30, 2017, for applications submitted with a tropical disease priority review voucher. The payment of this priority review user fee is required in addition to the payment of any other fee that would normally apply to such an application under PDUFA before FDA will consider the application complete and acceptable for filing. II. Tropical Disease Priority Review User Fee for FY 2017 FDA interprets section 524(c)(2) of the FD&C Act as requiring that FDA determine the amount of the tropical disease priority review user fee 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 will receive a standard review. Under the PDUFA goals letter, FDA 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. As interpreted by FDA, section 524(c)(2) of the FD&C Act requires that the fee amount should be based on the difference between the average cost incurred by the Agency in the review of a human drug application subject to a 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. FDA is setting fees for FY 2017, and the previous fiscal year is FY 2016. However, the FY 2016 submission cohort has not been closed out yet, and the cost data for FY 2016 are not complete. The latest year for which FDA has complete cost data is FY 2015. 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 does publish each year are: (1) New drug applications (NDAs) for a new molecular entity (NME) with clinical data and (2) biologics license applications (BLAs). The worksheets for standard costs for FY 2015, show a standard cost (rounded to the nearest thousand dollars) of $5,251,000 for a NME NDA and $5,055,000 for a BLA. Based on these standard costs, the total cost to review the 56 applications in these two categories in FY 2015 (32 NME NDAs with clinical data and 24 BLAs) was $289,352,000. (Note: These numbers exclude the President's Emergency Plan for AIDS Relief NDAs; no investigational new drug review costs are included in this amount.) 25 of these applications (18 NDAs and 7 BLAs) received priority review, which would mean that the remaining 31 received standard reviews. Because a priority review compresses a review 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 2015 figures, the costs of a priority and standard review are estimated using the following formula: (25 [alpha] x 1.67) + (31 [alpha]) = $289,352,000 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 $3,977,000 (rounded to the nearest thousand dollars) and the cost of a priority review for NME NDAs and BLAs is 1.67 times that amount, or $6,642,000 (rounded to the nearest thousand dollars). The difference between these two cost estimates, or $2,665,000, represents the incremental cost of conducting a priority review rather than a standard review. For the FY 2017 fee, FDA will need to adjust the FY 2015 incremental cost by the average amount by which FDA's average costs increased in the three years prior to FY 2016, to adjust the FY 2015 amount for cost increases in FY 2016. That adjustment, published in the Federal Register on July 28, 2016 (see 81 FR 49674 at 49676), setting FY 2017 PDUFA fees, is 1.5468 percent for the most recent year, not compounded. Increasing the FY 2015 incremental priority review cost of $2,665,000 by 1.5468 percent results in an estimated cost of $2,706,000 (rounded to the nearest thousand dollars). This is the [[Page 67358]] tropical disease priority review user fee amount for FY 2017 that must be submitted with a priority review voucher for a human drug application in FY 2017, in addition to any PDUFA fee that is required for such an application. III. Fee Schedule for FY 2017 The fee rate for FY 2017 is set out in Table 1: Table 1--Tropical Disease Priority Review Schedule for FY 2017 ------------------------------------------------------------------------ Fee rate for FY Fee category 2017 ------------------------------------------------------------------------ Application submitted with a tropical disease priority $2,706,000 review voucher in addition to the normal PDUFA fee.... ------------------------------------------------------------------------ IV. Implementation of Tropical Disease Priority Review User Fee Under section 524(c)(4)(A) of the FD&C Act, the priority review user fee is due upon submission of a human drug application for which the priority review voucher is used. Section 524(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, FDA may not grant a waiver, exemption, reduction, or refund of any fees due and payable under this section of the FD&C Act and FDA may not collect priority review voucher fees ``except to the extent provided in advance in appropriation Acts.'' Section 524(c)(4)(C) and 524(c)(5)(B). Beginning with FDA's appropriation for FY 2009, the annual appropriation language states specifically that ``priority review user fees authorized by 21 U.S.C. 360n (section 524 of the FD&C Act) may be credited to this account, to remain available until expended.'' (Pub. L. 111-8, Section 5, Division A, Title VI). The tropical disease priority review fee established in the new fee schedule must be paid for any application that is received on or after October 1, 2016, and submitted with a priority review voucher. This fee must be paid in addition to any other fee due under PDUFA. 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. Once you search for your invoice, click ``Pay Now'' to be redirected to Pay.gov. Note that electronic payment options are based on the balance due. Payments must be drawn on U.S bank accounts. 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 user fee identification (ID) number should be included on the check, followed by the words ``Tropical Disease Priority Review.'' Payments can be 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. The tax identification number of FDA is 53- 0196965. If paying by wire transfer, 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 include it with your payment to ensure that your fee is fully paid. 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. Paying by credit card (Discover, VISA, MasterCard, American Express) is available for balances less than $25,000. If the balance exceeds this amount, only the ACH option is available. Payments must be drawn on U.S. credit cards. V. Reference The following reference is on display in the Division of Dockets Management (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 26, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-23623 Filed 9-29-16; 8:45 am] BILLING CODE 4164-01-P
![67356 Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Notices
support programs to use federally- its chapter in a Caseworker’s Guide to Respondents: State agencies
approved forms in intergovernmental Processing Cases with Foreign administering a child support program
IV–D cases unless a country has Reciprocating Countries. under title IV–D of the Social Security
provided alternative forms as a part of Act.
ANNUAL BURDEN ESTIMATES
Number of Average
Number of responses burden Total burden
Instrument respondents per hours per hours
respondent response
Annex I: Transmittal form under Article 12(2) ................................................. 54 46 1 2,484
Annex II: Acknowledgment form under Article 12(3) ....................................... 54 93 .5 2,511
Annex A: Application for Recognition and Enforcement, including restricted
information on the applicant ......................................................................... 54 19 .5 513
Annex A: Abstract of Decision ......................................................................... 54 5 1 270
Annex A: Statement of Enforceability of Decision ........................................... 54 19 0.17 174
Annex A: Statement of Proper Notice ............................................................. 54 5 .5 135
Annex A: Status of Application Report ............................................................ 54 37 .33 659
Annex B: Application for Enforcement of a Decision Made or Recognized in
the Requested State, including restricted information on the applicant ...... 54 19 .5 513
Annex B: Status of Application Report, Article 12 ........................................... 54 37 .33 659
Annex C: Application for Establishment of a Decision, including restricted
information on the Applicant ........................................................................ 54 5 .5 135
Annex C: Status of Application Report—Article 12 ......................................... 54 9 .33 160
Annex D: Application for Modification of a Decision, including Restricted In-
formation on the Applicant ........................................................................... 54 5 .5 135
Annex D: Status of Application Report—Article 12 ......................................... 54 9 .33 160
Annex E: Financial Circumstances Form ........................................................ 54 46 2 4,968
Estimated Total Annual Burden Hours ..................................................... ........................ ........................ ........................ 13,478
In compliance with the requirements Consideration will be given to awarded by the Secretary of Health and
of Section 506(c)(2)(A) of the Paperwork comments and suggestions submitted Human Services. These vouchers are
Reduction Act of 1995, the within 60 days of this publication. awarded to the sponsors of certain
Administration for Children and tropical disease product applications,
Robert Sargis,
Families is soliciting public comment submitted after September 27, 2007,
on the specific aspects of the Reports Clearance Officer. upon FDA approval of such
information collection described above. [FR Doc. 2016–23722 Filed 9–29–16; 8:45 am] applications. The amount of the fee
Copies of the proposed collection of BILLING CODE 4184–01–P submitted to FDA with applications
information can be obtained and using a tropical disease priority review
comments may be forwarded by writing voucher is determined each fiscal year
to the Administration for Children and DEPARTMENT OF HEALTH AND based on the difference between the
Families, Office of Planning, Research HUMAN SERVICES average cost incurred by FDA in the
and Evaluation, 370 L’Enfant Food and Drug Administration review of a human drug application
Promenade SW., Washington, DC 20447, subject to priority review in the
Attn: ACF Reports Clearance Officer. [Docket No. FDA–2016–N–0007] previous fiscal year, and the average
Email address: infocollection@ cost incurred in the review of an
acf.hhs.gov. All requests should be Fee for Using a Tropical Disease application that is not subject to priority
identified by the title of the information Priority Review Voucher in Fiscal Year review in the previous fiscal year. This
collection. 2017 notice establishes the tropical disease
The Department specifically requests AGENCY: Food and Drug Administration, priority review fee rate for FY 2017.
comments on: (a) Whether the proposed HHS. FOR FURTHER INFORMATION CONTACT:
collection of information is necessary ACTION: Notice. Robert J. Marcarelli, Office of Financial
for the proper performance of the Management, Food and Drug
functions of the agency, including SUMMARY: The Food and Drug Administration, 8455 Colesville Rd.,
whether the information shall have Administration (FDA or the Agency) is COLE–14202F, Silver Spring, MD
practical utility; (b) the accuracy of the announcing the fee rates for using a 20993–0002, 301–796–7223.
agency’s estimate of the burden of the tropical disease priority review voucher SUPPLEMENTARY INFORMATION:
proposed collection of information; (c) for fiscal year (FY) 2017. The Federal
the quality, utility, and clarity of the Food, Drug, and Cosmetic Act (the I. Background
information to be collected; and (d) FD&C Act), as amended by the Food and Section 1102 of FDAAA (Pub. L. 110–
mstockstill on DSK3G9T082PROD with NOTICES
ways to minimize the burden Drug Administration Amendments Act 85) added section 524 to the FD&C Act
information to be collected; and (d) of 2007 (FDAAA), authorizes FDA to (21 U.S.C. 360n). In section 524,
ways to minimize the burden of the determine and collect priority review Congress encouraged development of
collection of information on user fees for certain applications for new drug and biological products for
respondents, including through the use approval of drug or biological products prevention and treatment of certain
of automated collection techniques or when those applications use a tropical tropical diseases by offering additional
other forms of information technology. disease priority review voucher incentives for obtaining FDA approval
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![67358 Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Notices
tropical disease priority review user fee User Fees Payment Portal at https:// 1. Ridley, D.B., H.G. Grabowski, and J.L. Moe,
amount for FY 2017 that must be userfees.fda.gov/pay. Once you search ‘‘Developing Drugs for Developing
submitted with a priority review for your invoice, click ‘‘Pay Now’’ to be Countries,’’ Health Affairs, vol. 25, no. 2,
pp. 313–324, 2006.
voucher for a human drug application in redirected to Pay.gov. Note that
FY 2017, in addition to any PDUFA fee electronic payment options are based on Dated: September 26, 2016.
that is required for such an application. the balance due. Payments must be Leslie Kux,
drawn on U.S bank accounts. Associate Commissioner for Policy.
III. Fee Schedule for FY 2017 FDA has partnered with the U.S. [FR Doc. 2016–23623 Filed 9–29–16; 8:45 am]
The fee rate for FY 2017 is set out in Department of the Treasury to use BILLING CODE 4164–01–P
Table 1: Pay.gov, a Web-based payment
application, for online electronic
TABLE 1—TROPICAL DISEASE PRI- payment. The Pay.gov feature is DEPARTMENT OF HEALTH AND
ORITY REVIEW SCHEDULE FOR FY available on the FDA Web site after the HUMAN SERVICES
2017 user fee ID number is generated.
The user fee identification (ID) Food and Drug Administration
Fee rate for number should be included on the
Fee category [Docket No. FDA–2016–N–2836]
FY 2017 check, followed by the words ‘‘Tropical
Disease Priority Review.’’ Payments can Agency Information Collection
Application submitted with a be mailed to: Food and Drug
tropical disease priority re- Activities; Proposed Collection;
view voucher in addition to
Administration, P.O. Box 979107, St. Comment Request; Donor Risk
the normal PDUFA fee ..... $2,706,000 Louis, MO 63197–9000. Assessment Questionnaire for the
If checks are sent by a courier that Food and Drug Administration/National
requests a street address, the courier can Heart, Lung, and Blood Institute-
IV. Implementation of Tropical Disease
deliver the checks to: U.S. Bank, Sponsored Transfusion-Transmissible
Priority Review User Fee
Attention: Government Lockbox 979107, Infections Monitoring System—Risk
Under section 524(c)(4)(A) of the 1005 Convention Plaza, St. Louis, MO
FD&C Act, the priority review user fee Factor Elicitation
63101. (Note: This U.S. Bank address is
is due upon submission of a human for courier delivery only. If you have AGENCY: Food and Drug Administration,
drug application for which the priority any questions concerning courier HHS.
review voucher is used. Section delivery contact the U.S. Bank at 314– ACTION: Notice.
524(c)(4)(B) of the FD&C Act specifies 418–4013. This telephone number is
that the application will be considered only for questions about courier SUMMARY: The Food and Drug
incomplete if the priority review user delivery.) The FDA post office box Administration (FDA) is announcing an
fee and all other applicable user fees are number (P.O. Box 979107) must be opportunity for public comment on the
not paid in accordance with FDA written on the check. The tax proposed collection of certain
payment procedures. In addition, FDA identification number of FDA is 53– information by the Agency. Under the
may not grant a waiver, exemption, 0196965. Paperwork Reduction Act of 1995 (the
reduction, or refund of any fees due and If paying by wire transfer, please PRA), Federal Agencies are required to
payable under this section of the FD&C reference your unique user fee ID publish notice in the Federal Register
Act and FDA may not collect priority number when completing your transfer. concerning each proposed collection of
review voucher fees ‘‘except to the The originating financial institution information and to allow 60 days for
extent provided in advance in may charge a wire transfer fee. Please public comment in response to the
appropriation Acts.’’ Section ask your financial institution about the notice. This notice solicits comments on
524(c)(4)(C) and 524(c)(5)(B). Beginning fee and include it with your payment to an information collection request
with FDA’s appropriation for FY 2009, ensure that your fee is fully paid. The regarding risk factors associated with
the annual appropriation language states account information is as follows: U.S. transfusion-transmissible infections
specifically that ‘‘priority review user Dept. of Treasury, TREAS NYC, 33 (TTI) in blood donors.
fees authorized by 21 U.S.C. 360n Liberty St., New York, NY 10045, DATES: Submit either electronic or
(section 524 of the FD&C Act) may be Account Number: 75060099, Routing written comments on the collection of
credited to this account, to remain Number: 021030004, SWIFT: information by November 29, 2016.
available until expended.’’ (Pub. L. 111– FRNYUS33, Beneficiary: FDA, 8455 ADDRESSES: You may submit comments
8, Section 5, Division A, Title VI). Colesville Rd., 14th Floor, Silver Spring, as follows:
The tropical disease priority review MD 20993–0002.
fee established in the new fee schedule Paying by credit card (Discover, VISA, Electronic Submissions
must be paid for any application that is MasterCard, American Express) is Submit electronic comments in the
received on or after October 1, 2016, and available for balances less than $25,000. following way:
submitted with a priority review If the balance exceeds this amount, only • Federal eRulemaking Portal: http://
voucher. This fee must be paid in the ACH option is available. Payments www.regulations.gov. Follow the
addition to any other fee due under must be drawn on U.S. credit cards. instructions for submitting comments.
PDUFA. Payment must be made in U.S. Comments submitted electronically,
currency by electronic check, check, V. Reference including attachments, to http://
bank draft, wire transfer, credit card, or The following reference is on display www.regulations.gov will be posted to
mstockstill on DSK3G9T082PROD with NOTICES
U.S. postal money order payable to the in the Division of Dockets Management the docket unchanged. Because your
order of the Food and Drug (HFA–305), Food and Drug comment will be made public, you are
Administration. The preferred payment Administration, 5630 Fishers Lane, Rm. solely responsible for ensuring that your
method is online using electronic check 1061, Rockville, MD 20852, and is comment does not include any
(Automated Clearing House (ACH) also available for viewing by interested confidential information that you or a
known as eCheck). Secure electronic persons between 9 a.m. and 4 p.m., third party may not wish to be posted,
payments can be submitted using the Monday through Friday. such as medical information, your or
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Document Created: 2018-02-09 13:33:43
Document Modified: 2018-02-09 13:33:43
| 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 | 81 FR 67356 |
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