83 FR 48437 - Fee for Using a Tropical Disease Priority Review Voucher in Fiscal Year 2019
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 186 (September 25, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 186 (September 25, 2018)
| Page Range | 48437-48439 | |
| FR Document | 2018-20772 |
[Federal Register Volume 83, Number 186 (Tuesday, September 25, 2018)] [Notices] [Pages 48437-48439] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-20772] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-0007] Fee for Using a Tropical 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 rates for using a tropical 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 Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect priority review user fees for certain applications for review of drug or biological products when those applications use a tropical disease priority review voucher. These vouchers are awarded to the applicants 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 to review a human drug application designated as 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 2019. 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 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 tropical diseases by offering additional incentives for obtaining FDA approval of such products. Under section 524, the applicant 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 (assuming other criteria are met). 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(a) 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: https://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 website about how this tropical disease priority review voucher program operates (available at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080599.pdf). This notice establishes the tropical disease priority review fee rate for FY 2019 as $2,457,140 and outlines FDA's process for implementing the collection of the priority review user fees. This rate is effective on October 1, 2018, and will remain in effect through September 30, 2019, 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 2019 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 receives a standard review. Under the [[Page 48438]] 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 2019, and the previous fiscal year is FY 2018. However, the FY 2018 submission cohort has not been closed out yet, and 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 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 2017 show a standard cost 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 review costs are included in this amount.) Of these applications 33 (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 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 2017 figures, the costs of a priority and standard review 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 FY 2019 PDUFA fees, 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 tropical 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--Tropical Disease Priority Review Schedule for FY 2019 ------------------------------------------------------------------------ Fee rate for FY Fee category 2019 ------------------------------------------------------------------------ Application submitted with a tropical disease priority $2,457,140 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.) 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, 2018, 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 website after the user fee identification (ID) number is generated. If paying with a paper check, the user fee 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 [[Page 48439]] 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. V. Reference The following reference is on display with 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. Dated: September 19, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-20772 Filed 9-24-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 186 / Tuesday, September 25, 2018 / Notices 48437
Transparency and Communication for Act), as amended by the Food and Drug 6 months after the receipt or filing date,
NME (New Molecular Entity) NDAs and Administration Amendments Act of depending upon the type of application.
Original BLAs, and risk evaluation and 2007 (FDAAA), authorizes FDA to Information regarding the PDUFA goals
mitigation strategies. determine and collect priority review is available at: https://www.fda.gov/
In addition, the draft guidance has user fees for certain applications for downloads/forindustry/userfees/
been consolidated to focus on the review of drug or biological products prescriptiondruguserfee/
fundamental values and operational when those applications use a tropical ucm511438.pdf.
principles that serve as the foundation disease priority review voucher. These The applicant that uses a priority
for the GRMPs. Details of the review vouchers are awarded to the applicants review voucher is entitled to a priority
process are covered in other documents of certain tropical disease product review but must pay FDA a priority
referenced by this guidance. applications, submitted after September review user fee in addition to any other
Fundamental values and operational 27, 2007, upon FDA approval of such fee required by PDUFA. FDA published
principles should remain relatively applications. The amount of the fee guidance on its website about how this
constant over time, while processes submitted to FDA with applications tropical disease priority review voucher
must be able to adapt and respond to using a tropical disease priority review program operates (available at: https://
scientific advances in product voucher is determined each fiscal year www.fda.gov/downloads/Drugs/
development and evolving public health based on the difference between the GuidanceComplianceRegulatory
needs. average cost incurred by FDA to review Information/Guidances/
This draft guidance is being issued a human drug application designated as ucm080599.pdf).
consistent with FDA’s good guidance priority review in the previous fiscal This notice establishes the tropical
practices regulation (21 CFR 10.115). year and the average cost incurred in the disease priority review fee rate for FY
The draft guidance, when finalized, will review of an application that is not 2019 as $2,457,140 and outlines FDA’s
represent the current thinking of FDA subject to priority review in the process for implementing the collection
on GRMPs for NDAs and BLAs. It does previous fiscal year. This notice of the priority review user fees. This rate
not establish any rights for any person establishes the tropical disease priority is effective on October 1, 2018, and will
and is not binding on FDA or the public. review fee rate for FY 2019. remain in effect through September 30,
You can use an alternative approach if 2019, for applications submitted with a
FOR FURTHER INFORMATION CONTACT:
it satisfies the requirements of the tropical disease priority review voucher.
Lola Olajide, Office of Financial The payment of this priority review user
applicable statutes and regulations. This Management, Food and Drug
guidance is not subject to Executive fee is required in addition to the
Administration, 8455 Colesville Rd., payment of any other fee that would
Order 12866. COLE–14541B, Silver Spring, MD normally apply to such an application
II. Electronic Access 20993–0002, 240–402–4244. under PDUFA before FDA will consider
Persons with access to the internet SUPPLEMENTARY INFORMATION: the application complete and acceptable
may obtain the draft guidance at https:// I. Background for filing.
www.fda.gov/Drugs/Guidance
Section 1102 of FDAAA (Pub. L. 110– II. Tropical Disease Priority Review
ComplianceRegulatoryInformation/
85) added section 524 to the FD&C Act User Fee for FY 2019
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/ (21 U.S.C. 360n). In section 524, FDA interprets section 524(c)(2) of the
GuidanceComplianceRegulatory Congress encouraged development of FD&C Act as requiring that FDA
Information/default.htm, or https:// new drug and biological products for determine the amount of the tropical
www.regulations.gov. prevention and treatment of tropical disease priority review user fee each
diseases by offering additional fiscal year based on the difference
Dated: September 19, 2018.
incentives for obtaining FDA approval between the average cost incurred by
Leslie Kux, of such products. Under section 524, the FDA in the review of a human drug
Associate Commissioner for Policy. applicant of an eligible human drug application subject to priority review in
[FR Doc. 2018–20789 Filed 9–24–18; 8:45 am] application submitted after September the previous fiscal year and the average
BILLING CODE 4164–01–P 27, 2007, for a tropical disease (as cost incurred by FDA in the review of
defined in section 524(a)(3) of the FD&C a human drug application that is not
Act) shall receive a priority review subject to priority review in the
DEPARTMENT OF HEALTH AND voucher upon approval of the tropical previous fiscal year.
HUMAN SERVICES disease product application (assuming A priority review is a review
other criteria are met). The recipient of conducted with a PDUFA goal date of 6
Food and Drug Administration
a tropical disease priority review months after the receipt or filing date,
[Docket No. FDA–2018–N–0007] voucher may either use the voucher depending on the type of application.
with a future submission to FDA under Under the PDUFA goals letter, FDA has
Fee for Using a Tropical Disease section 505(b)(1) of the FD&C Act (21 committed to reviewing and acting on
Priority Review Voucher in Fiscal Year U.S.C. 355(b)(1)) or section 351(a) of the 90 percent of the applications granted
2019 Public Health Service Act (42 U.S.C. priority review status within this
AGENCY: Food and Drug Administration, 262), or transfer (including by sale) the expedited timeframe. Normally, an
HHS. voucher to another party. The voucher application for a human drug or
ACTION: Notice. may be transferred (including by sale) biological product will qualify for
daltland on DSKBBV9HB2PROD with NOTICES
repeatedly until it ultimately is used for priority review if the product is
SUMMARY: The Food and Drug a human drug application submitted to intended to treat a serious condition
Administration (FDA or the Agency) is FDA under section 505(b)(1) of the and, if approved, would provide a
announcing the fee rates for using a FD&C Act or section 351(a) of the Public significant improvement in safety or
tropical disease priority review voucher Health Service Act. A priority review is effectiveness. An application that does
for fiscal year (FY) 2019. The Federal a review conducted with a Prescription not receive a priority designation
Food, Drug, and Cosmetic Act (FD&C Drug User Fee Act (PDUFA) goal date of receives a standard review. Under the
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![Federal Register / Vol. 83, No. 186 / Tuesday, September 25, 2018 / Notices 48439
mailed to: Food and Drug DEPARTMENT OF HEALTH AND anyone else’s Social Security number, or
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Louis, MO 63197–9000. as a manufacturing process. Please note
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deliver the checks to: U.S. Bank,
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Attention: Government Lockbox 979107, posted on https://www.regulations.gov.
When Determining Substantial
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Equivalence in Premarket Notifications
63101. (Note: This U.S. Bank address is with confidential information that you
(510(k)) With Different Technological
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any questions concerning courier and Food and Drug Administration public, submit the comment as a
delivery, contact the U.S. Bank at 314– Staff; Availability written/paper submission and in the
418–4013. (This telephone number is manner detailed (see ‘‘Written/Paper
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written on the check. If needed, FDA’s Submit written/paper submissions as
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tax identification number is 53– Administration (FDA or Agency) is • Mail/Hand Delivery/Courier (for
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reference your unique user fee ID to Consider When Determining Drug Administration, 5630 Fishers
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The originating financial institution Notifications (510(k)) with Different • For written/paper comments
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amount to the payment to ensure that benefit-risk profile of a device in information submitted, marked and
the invoice is paid in full. The account comparison to a predicate device in a identified, as confidential, if submitted
510(k) when the device has the same as detailed in ‘‘Instructions.’’
information is as follows: U.S. Dept. of
intended use as the predicate device, Instructions: All submissions received
Treasury, TREAS NYC, 33 Liberty St.,
and different technological must include the Docket No. FDA–
New York, NY 10045, Account Number:
characteristics that do not raise different 2014–D–0900 for ‘‘Benefit-Risk Factors
75060099, Routing Number: 021030004, questions of safety and effectiveness. to Consider When Determining
SWIFT: FRNYUS33. This guidance can be helpful in Substantial Equivalence in Premarket
V. Reference situations when there is an increase in Notifications (510(k)) with Different
risk and increase or equivalent benefit, Technological Characteristics.’’
The following reference is on display or a decrease in benefit and a decrease Received comments will be placed in
with the Dockets Management Staff or equivalent risk when comparing a the docket and, except for those
(HFA–305), Food and Drug new device to a predicate device. FDA submitted as ‘‘Confidential
Administration, 5630 Fishers Lane, Rm. developed this guidance to improve the Submissions,’’ publicly viewable at
1061, Rockville, MD 20852, and is predictability, consistency, and https://www.regulations.gov or at the
available for viewing by interested transparency of the 510(k) premarket Dockets Management Staff between 9
persons between 9 a.m. and 4 p.m., review process. a.m. and 4 p.m., Monday through
Monday through Friday; it is not DATES: The announcement of the Friday.
available electronically at https:// guidance is published in the Federal • Confidential Submissions—To
www.regulations.gov as this reference is Register on September 25, 2018. submit a comment with confidential
copyright protected. FDA has verified ADDRESSES: You may submit either information that you do not wish to be
the website address, as of the date this electronic or written comments on made publicly available, submit your
document publishes in the Federal Agency guidances at any time as comments only as a written/paper
follows: submission. You should submit two
Register, but websites are subject to
copies total. One copy will include the
change over time. Electronic Submissions information you claim to be confidential
1. Ridley, D.B., H.G. Grabowski, and J.L. Moe, Submit electronic comments in the with a heading or cover note that states
‘‘Developing Drugs for Developing following way: ‘‘THIS DOCUMENT CONTAINS
Countries,’’ Health Affairs, vol. 25, no. 2, • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
pp. 313–324, 2006, available at: https:// https://www.regulations.gov. Follow the Agency will review this copy, including
faculty.fuqua.duke.edu/∼willm/HSM_ instructions for submitting comments. the claimed confidential information, in
RA/Documents/HA2006_Ridley_ Comments submitted electronically, its consideration of comments. The
Vouchers.pdf. including attachments, to https:// second copy, which will have the
Dated: September 19, 2018. www.regulations.gov will be posted to claimed confidential information
daltland on DSKBBV9HB2PROD with NOTICES
Leslie Kux, the docket unchanged. Because your redacted/blacked out, will be available
comment will be made public, you are for public viewing and posted on
Associate Commissioner for Policy.
solely responsible for ensuring that your https://www.regulations.gov. Submit
[FR Doc. 2018–20772 Filed 9–24–18; 8:45 am]
comment does not include any both copies to the Dockets Management
BILLING CODE 4164–01–P confidential information that you or a Staff. If you do not wish your name and
third party may not wish to be posted, contact information to be made publicly
such as medical information, your or available, you can provide this
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Document Created: 2018-09-25 00:22:03
Document Modified: 2018-09-25 00:22:03
| 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 | Lola Olajide, Office of Financial Management, Food and Drug Administration, 8455 Colesville Rd., COLE-14541B, Silver Spring, MD 20993-0002, 240-402-4244. | |
| FR Citation | 83 FR 48437 |
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