82 FR 45296 - Fee for Using a Tropical Disease Priority Review Voucher in Fiscal Year 2018
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 187 (September 28, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 187 (September 28, 2017)
| Page Range | 45296-45298 | |
| FR Document | 2017-20799 |
[Federal Register Volume 82, Number 187 (Thursday, September 28, 2017)] [Notices] [Pages 45296-45298] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-20799] [[Page 45296]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-0007] Fee for Using a Tropical 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 rates for using a tropical 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 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 2018. 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 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/ucm511438.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 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 2018 as $2,830,579 and outlines FDA's process for implementing the collection of the priority review user fees. This rate is effective on October 1, 2017, and will remain in effect through September 30, 2018, 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 2018 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. FDA is setting fees for FY 2018, and the previous fiscal year is FY 2017. However, the FY 2017 submission cohort has not been closed out yet, and 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 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 2016, show a standard cost (rounded to the nearest hundred dollars) of $5,929,100 for a 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 [[Page 45297]] investigational new drug review costs are included in this amount.) Twenty-three 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 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 July 28, 2016 (see 81 FR 49674 at 49676), setting FY 2018 PDUFA fees, 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 tropical 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--Tropical Disease Priority Review Schedule for FY 2018 ------------------------------------------------------------------------ Fee rate for FY Fee category 2018 ------------------------------------------------------------------------ Application submitted with a tropical disease priority $2,830,579 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 section 524 of the FD&C Act (see section 524(c)(4)(C)) and FDA may not collect priority review voucher fees ``except to the extent provided in advance in appropriation Acts.'' (Section 524(c)(5)(B) of the FD&C Act.) 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 [i.e., 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, 2017, and submitted with a priority review voucher. This fee must be paid in addition to any other fee due under PDUFA. Payment should 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 should be made using U.S bank accounts as well as U.S. credit cards. 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. If paying with a paper check the user fee identification (ID) number should be included on the check, followed by the words ``Tropical Disease Priority Review.'' All paper checks should 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 unique user fee ID 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, [[Page 45298]] 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. 2017-20799 Filed 9-27-17; 8:45 am] BILLING CODE 4164-01-P
![45296 Federal Register / Vol. 82, No. 187 / Thursday, September 28, 2017 / Notices
DEPARTMENT OF HEALTH AND defined in section 524(a)(3) of the FD&C a human drug application that is not
HUMAN SERVICES Act), shall receive a priority review subject to priority review in the
voucher upon approval of the tropical previous fiscal year.
Food and Drug Administration disease product application. The A priority review is a review
[Docket No. FDA–2017–N–0007] recipient of a tropical disease priority conducted with a PDUFA goal date of 6
review voucher may either use the months after the receipt or filing date,
Fee for Using a Tropical Disease voucher with a future submission to depending on the type of application.
Priority Review Voucher in Fiscal Year FDA under section 505(b)(1) of the Under the PDUFA goals letter, FDA has
2018 FD&C Act (21 U.S.C. 355(b)(1)) or committed to reviewing and acting on
section 351 of the Public Health Service 90 percent of the applications granted
AGENCY: Food and Drug Administration, Act (42 U.S.C. 262), or transfer priority review status within this
HHS. (including by sale) the voucher to expedited timeframe. Normally, an
ACTION: Notice. another party. The voucher may be application for a human drug or
transferred (including by sale) biological product will qualify for
SUMMARY: The Food and Drug
repeatedly until it ultimately is used for priority review if the product is
Administration (FDA or the Agency) is
a human drug application submitted to intended to treat a serious condition
announcing the fee rates for using a
FDA under section 505(b)(1) of the and, if approved, would provide a
tropical disease priority review voucher
FD&C Act or section 351(a) of the Public significant improvement in safety or
for fiscal year (FY) 2018. The Federal
Health Service Act. A priority review is effectiveness. An application that does
Food, Drug, and Cosmetic Act (the
a review conducted with a Prescription not receive a priority designation will
FD&C Act), as amended by the Food and
Drug User Fee Act (PDUFA) goal date of receive a standard review. Under the
Drug Administration Amendments Act
6 months after the receipt or filing date, PDUFA goals letter, FDA committed to
of 2007 (FDAAA), authorizes FDA to
depending upon the type of application. reviewing and acting on 90 percent of
determine and collect priority review
Information regarding the PDUFA goals standard applications within 10 months
user fees for certain applications for
is available at: http://www.fda.gov/ of the receipt or filing date, depending
approval of drug or biological products
downloads/forindustry/userfees/ on the type of application. A priority
when those applications use a tropical
prescriptiondruguserfee/ review involves a more intensive level
disease priority review voucher
ucm511438.pdf. of effort and a higher level of resources
awarded by the Secretary of Health and
The applicant that uses a priority than a standard review.
Human Services. These vouchers are FDA is setting fees for FY 2018, and
review voucher is entitled to a priority
awarded to the sponsors of certain the previous fiscal year is FY 2017.
review but must pay FDA a priority
tropical disease product applications, However, the FY 2017 submission
review user fee in addition to any other
submitted after September 27, 2007, fee required by PDUFA. FDA published cohort has not been closed out yet, and
upon FDA approval of such guidance on its Web site about how this the cost data for FY 2017 are not
applications. The amount of the fee tropical disease priority review voucher complete. The latest year for which FDA
submitted to FDA with applications program operates (available at: http:// has complete cost data is FY 2016.
using a tropical disease priority review www.fda.gov/downloads/Drugs/ Furthermore, because FDA has never
voucher is determined each fiscal year GuidanceComplianceRegulatory tracked the cost of reviewing
based on the difference between the Information/Guidances/ applications that get priority review as
average cost incurred by FDA in the ucm080599.pdf). a separate cost subset, FDA estimated
review of a human drug application This notice establishes the tropical this cost based on other data that the
subject to priority review in the disease priority review fee rate for FY Agency has tracked. FDA uses data that
previous fiscal year, and the average 2018 as $2,830,579 and outlines FDA’s the Agency estimates and publishes on
cost incurred in the review of an process for implementing the collection its Web site each year—standard costs
application that is not subject to priority of the priority review user fees. This rate for review. FDA does not publish a
review in the previous fiscal year. This is effective on October 1, 2017, and will standard cost for ‘‘the review of a
notice establishes the tropical disease remain in effect through September 30, human drug application subject to
priority review fee rate for FY 2018. 2018, for applications submitted with a priority review in the previous fiscal
FOR FURTHER INFORMATION CONTACT: tropical disease priority review voucher. year.’’ However, we expect all such
Robert J. Marcarelli, Office of Financial The payment of this priority review user applications would contain clinical
Management, Food and Drug fee is required in addition to the data. The standard cost application
Administration, 8455 Colesville Rd., payment of any other fee that would categories with clinical data that FDA
COLE–14202F, Silver Spring, MD normally apply to such an application does publish each year are: (1) New
20993–0002, 301–796–7223. under PDUFA before FDA will consider drug applications (NDAs) for a new
SUPPLEMENTARY INFORMATION: the application complete and acceptable molecular entity (NME) with clinical
for filing. data and (2) biologics license
I. Background applications (BLAs).
Section 1102 of FDAAA (Pub. L. 110– II. Tropical Disease Priority Review The worksheets for standard costs for
85) added section 524 to the FD&C Act User Fee for FY 2018 FY 2016, show a standard cost (rounded
(21 U.S.C. 360n). In section 524, FDA interprets section 524(c)(2) of the to the nearest hundred dollars) of
Congress encouraged development of FD&C Act as requiring that FDA $5,929,100 for a NME NDA and
new drug and biological products for determine the amount of the tropical $4,887,100 for a BLA. Based on these
prevention and treatment of certain disease priority review user fee each standard costs, the total cost to review
tropical diseases by offering additional fiscal year based on the difference the 49 applications in these two
incentives for obtaining FDA approval between the average cost incurred by categories in FY 2016 (27 NME NDAs
of such products. Under section 524, the FDA in the review of a human drug with clinical data and 22 BLAs) was
sponsor of an eligible human drug application subject to priority review in $267,601,900. (Note: These numbers
application submitted after September the previous fiscal year, and the average exclude the President’s Emergency Plan
27, 2007, for a tropical disease (as cost incurred by FDA in the review of for AIDS Relief NDAs; no
VerDate Sep<11>2014 18:44 Sep 27, 2017 Jkt 241001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\28SEN1.SGM 28SEN1](https://thefederalregister.org/doc/82_FR_45483/page/1.svg)
![Federal Register / Vol. 82, No. 187 / Thursday, September 28, 2017 / Notices 45297
investigational new drug review costs (23 a × 1.67) + (26 a) = $267,601,900 That adjustment, published in the
are included in this amount.) Twenty- where ‘‘a’’ is the cost of a standard Federal Register on July 28, 2016 (see
three of these applications (14 NDAs review and ‘‘a times 1.67’’ is the cost of 81 FR 49674 at 49676), setting FY 2018
and 9 BLAs) received priority review, a priority review. Using this formula, PDUFA fees, is 1.6868 percent for the
which would mean that the remaining the cost of a standard review for NME most recent year, not compounded.
26 received standard reviews. Because a NDAs and BLAs is calculated to be Increasing the FY 2016 incremental
priority review compresses a review that $4,154,664 (rounded to the nearest priority review cost of $2,783,625 by
ordinarily takes 10 months into 6 dollar) and the cost of a priority review 1.6868 percent (or 0.016868) results in
months, FDA estimates that a multiplier for NME NDAs and BLAs is 1.67 times an estimated cost of $2,830,579
of 1.67 (10 months divided by 6 months) that amount, or $6,938,289 (rounded to (rounded to the nearest dollar). This is
should be applied to non-priority the nearest dollar). The difference
the tropical disease priority review user
review costs in estimating the effort and between these two cost estimates, or
fee amount for FY 2018 that must be
cost of a priority review as compared to $2,783,625, represents the incremental
a standard review. This multiplier is submitted with a priority review
cost of conducting a priority review
consistent with published research on voucher for a human drug application in
rather than a standard review.
this subject which supports a priority For the FY 2018 fee, FDA will need FY 2018, in addition to any PDUFA fee
review multiplier in the range of 1.48 to to adjust the FY 2016 incremental cost that is required for such an application.
2.35 (Ref. 1). Using FY 2016 figures, the by the average amount by which FDA’s III. Fee Schedule for FY 2018
costs of a priority and standard review average costs increased in the 3 years
are estimated using the following prior to FY 2017, to adjust the FY 2016 The fee rate for FY 2018 is set out in
formula: amount for cost increases in FY 2017. table 1:
TABLE 1—TROPICAL DISEASE PRIORITY REVIEW SCHEDULE FOR FY 2018
Fee rate for
Fee category FY 2018
Application submitted with a tropical disease priority review voucher in addition to the normal PDUFA fee .................................... $2,830,579
IV. Implementation of Tropical Disease U.S. currency by electronic check, Administration, P.O. Box 979107, St.
Priority Review User Fee check, bank draft, wire transfer, credit Louis, MO 63197–9000.
card, or U.S. postal money order If checks are sent by a courier that
Under section 524(c)(4)(A) of the payable to the order of the Food and requests a street address, the courier can
FD&C Act, the priority review user fee Drug Administration. The preferred deliver the checks to: U.S. Bank,
is due upon submission of a human payment method is online using Attention: Government Lockbox 979107,
drug application for which the priority electronic check (Automated Clearing 1005 Convention Plaza, St. Louis, MO
review voucher is used. Section 63101. (Note: This U.S. Bank address is
House (ACH) also known as eCheck).
524(c)(4)(B) of the FD&C Act specifies for courier delivery only.) If you have
Secure electronic payments can be
that the application will be considered any questions concerning courier
submitted using the User Fees Payment
incomplete if the priority review user delivery, contact the U.S. Bank at 314–
Portal at https://userfees.fda.gov/pay.
fee and all other applicable user fees are 418–4013. (This telephone number is
(NOTE: Only full payments are accepted.
not paid in accordance with FDA only for questions about courier
No partial payments can be made
payment procedures. In addition, FDA delivery). The FDA post office box
online). Once you search for your
may not grant a waiver, exemption, number (P.O. Box 979107) must be
invoice, select ‘‘Pay Now’’ to be
reduction, or refund of any fees due and written on the check. If needed, FDA’s
redirected to Pay.gov. Note that
payable under section 524 of the FD&C tax identification number is 53–
Act (see section 524(c)(4)(C)) and FDA electronic payment options are based on
the balance due. Payment by credit card 0196965.
may not collect priority review voucher If paying by wire transfer, please
fees ‘‘except to the extent provided in is available for balances that are less
than $25,000. If the balance exceeds this reference your unique user fee ID
advance in appropriation Acts.’’ number when completing your transfer.
(Section 524(c)(5)(B) of the FD&C Act.) amount, only the ACH option is
available. Payments should be made The originating financial institution
Beginning with FDA’s appropriation for may charge a wire transfer fee. If the
FY 2009, the annual appropriation using U.S bank accounts as well as U.S.
credit cards. financial institution charges a wire
language states specifically that transfer fee, it is required to add that
‘‘priority review user fees authorized by FDA has partnered with the U.S. amount to the payment to ensure that
21 U.S.C. 360n [i.e., section 524 of the Department of the Treasury to use the invoice is paid in full. The account
FD&C Act] may be credited to this Pay.gov, a web-based payment information is as follows: U.S. Dept. of
account, to remain available until application, for online electronic Treasury, TREAS NYC, 33 Liberty St.,
expended.’’ (Pub. L. 111–8, Section 5, payment. The Pay.gov feature is New York, NY 10045, Account Number:
Division A, Title VI). available on the FDA Web site after the 75060099, Routing Number: 021030004,
The tropical disease priority review user fee ID number is generated. SWIFT: FRNYUS33, Beneficiary: FDA,
fee established in the new fee schedule If paying with a paper check the user 8455 Colesville Rd., 14th Floor, Silver
must be paid for any application that is fee identification (ID) number should be Spring, MD 20993–0002.
received on or after October 1, 2017, and included on the check, followed by the
submitted with a priority review words ‘‘Tropical Disease Priority V. Reference
voucher. This fee must be paid in Review.’’ All paper checks should be in The following reference is on display
addition to any other fee due under U.S. currency from a U.S. bank made in the Dockets Management Staff (HFA–
PDUFA. Payment should be made in payable and mailed to: Food and Drug 305), Food and Drug Administration,
VerDate Sep<11>2014 18:44 Sep 27, 2017 Jkt 241001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\28SEN1.SGM 28SEN1](https://thefederalregister.org/doc/82_FR_45483/page/2.svg)
![45298 Federal Register / Vol. 82, No. 187 / Thursday, September 28, 2017 / Notices
5630 Fishers Lane, Rm. 1061, Rockville, upcoming vacancies effective with this the panels listed in the table in this
MD 20852, and is available for viewing notice. document.
by interested persons between 9 a.m. DATES: Any industry organization I. Medical Devices Advisory Committee
and 4 p.m., Monday through Friday. interested in participating in the
1. Ridley, D.B., H.G. Grabowski, and J.L. Moe, selection of an appropriate nonvoting The Committee reviews and evaluates
‘‘Developing Drugs for Developing member to represent industry interests data on the safety and effectiveness of
Countries,’’ Health Affairs, vol. 25, no. 2, must send a letter stating that interest to marketed and investigational devices
pp. 313–324, 2006. the FDA by October 30, 2017 (see and makes recommendations for their
Dated: September 22, 2017. sections I and II of this document for regulation. The panels engage in a
further details). Concurrently, number of activities to fulfill the
Anna K. Abram,
nomination materials for prospective functions the Federal Food, Drug, and
Deputy Commissioner for Policy, Planning,
candidates should be sent to FDA by Cosmetic Act (the FD&C Act) envisions
Legislation, and Analysis.
October 30, 2017. for device advisory panels. With the
[FR Doc. 2017–20799 Filed 9–27–17; 8:45 am]
ADDRESSES: All statements of interest exception of the Medical Devices
BILLING CODE 4164–01–P
from industry organizations interested Dispute Resolution Panel, each panel,
in participating in the selection process according to its specialty area, advises
of nonvoting industry representative the Commissioner of Food and Drugs
DEPARTMENT OF HEALTH AND
nomination should be sent to Margaret (the Commissioner) regarding
HUMAN SERVICES
Ames (see FOR FURTHER INFORMATION recommended classification or
Food and Drug Administration CONTACT). All nominations for reclassification of devices into one of
nonvoting industry representatives three regulatory categories; advises on
should be submitted electronically by any possible risks to health associated
[Docket No. FDA–2017–N–0001]
accessing the FDA Advisory Committee with the use of devices; advises on
Request for Nominations on Public Membership Nomination Portal: https:// formulation of product development
Advisory Panels of the Medical www.accessdata.fda.gov/scripts/FACT protocols; reviews premarket approval
Devices Advisory Committee RSPortal/FACTRS/index.cfm or by mail applications for medical devices;
to Advisory Committee Oversight and reviews guidelines and guidance
AGENCY: Food and Drug Administration, Management Staff, Food and Drug documents; recommends exemption of
HHS. Administration, 10903 New Hampshire certain devices from the application of
ACTION: Notice. Ave., Bldg. 32, Rm. 5103, Silver Spring, portions of the FD&C Act; advises on the
MD 20993–0002. Information about necessity to ban a device; and responds
SUMMARY: The Food and Drug becoming a member of an FDA advisory to requests from the agency to review
Administration (FDA) is requesting that committee can also be obtained by and make recommendations on specific
any industry organizations interested in visiting FDA’s Web site at https:// issues or problems concerning the safety
participating in the selection of www.fda.gov/AdvisoryCommittees/ and effectiveness of devices. With the
nonvoting industry representatives to default.htm. exception of the Medical Devices
serve on certain panels of the Medical Dispute Resolution Panel, each panel,
Devices Advisory Committee (MDAC or FOR FURTHER INFORMATION CONTACT: according to its specialty area, may also
Committee) in the Center for Devices Margaret Ames, Division of Workforce make appropriate recommendations to
and Radiological Health (CDRH) notify Management, Center for Devices and the Commissioner on issues relating to
FDA in writing. FDA is also requesting Radiological Health, Food and Drug the design of clinical studies regarding
nominations for nonvoting industry Administration, 10903 New Hampshire the safety and effectiveness of marketed
representatives to serve on certain Ave., Bldg. 66, Rm. 5264, Silver Spring, and investigational devices. The
device panels of the MDAC in the MD 20993, 301–796–5960, Fax: 301– Committee also provides
CDRH. A nominee may either be self- 847–8505, email: margaret.ames@ recommendations to the Commissioner
nominated or nominated by an fda.hhs.gov. or designee on complexity
organization to serve as a nonvoting SUPPLEMENTARY INFORMATION: The categorization of in vitro diagnostics
industry representative. Nominations Agency is requesting nominations for under the Clinical Laboratory
will be accepted for current and nonvoting industry representatives to Improvement Amendments of 1988.
Panels Function
Circulatory System Devices Panel Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational de-
vices for use in the circulatory and vascular systems and makes appropriate recommendations to the
Commissioner of Food and Drugs.
Clinical Chemistry and Clinical Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational in
Toxicology Devices Panel. vitro devices for use in clinical laboratory medicine including clinical toxicology, clinical chemistry, endo-
crinology, and oncology and makes appropriate recommendations to the Commissioner of Food and
Drugs.
Gastroenterology and Urology De- Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational gas-
vices Panel. troenterology, urology, and nephrology devices and makes appropriate recommendations to the Com-
missioner of Food and Drugs.
General Hospital and Personal Use Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational gen-
Devices Panel. eral hospital, infection control, and personal use devices and makes appropriate recommendations to the
Commissioner of Food and Drugs.
Obstetrics and Gynecology Devices Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational de-
Panel. vices for use in obstetrics and gynecology and makes appropriate recommendations to the Commis-
sioner of Food and Drugs.
VerDate Sep<11>2014 18:44 Sep 27, 2017 Jkt 241001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\28SEN1.SGM 28SEN1](https://thefederalregister.org/doc/82_FR_45483/page/3.svg)
Document Created: 2017-09-28 01:32:34
Document Modified: 2017-09-28 01:32:34
| 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 | 82 FR 45296 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR