83 FR 48617 - Fee for Using a Material Threat Medical Countermeasure Priority Review Voucher in Fiscal Year 2019
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 187 (September 26, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 187 (September 26, 2018)
| Page Range | 48617-48619 | |
| FR Document | 2018-20910 |
[Federal Register Volume 83, Number 187 (Wednesday, September 26, 2018)] [Notices] [Pages 48617-48619] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-20910] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-0007] Fee for Using a Material Threat Medical Countermeasure Priority Review Voucher in Fiscal Year 2019 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a material threat medical countermeasure (MCM) priority review voucher for fiscal year (FY) 2019. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to determine and collect material threat MCM priority review user fees for certain applications for review of human drug products when those applications use a material threat MCM priority review voucher. These vouchers are awarded to the applicants of material threat MCM applications that meet all of the requirements of this program upon FDA approval of such applications. The amount of the fee for using a material threat MCM priority review voucher is determined each FY based on the difference between the average cost incurred by FDA to review of a human drug application designated as priority review in the previous FY, and the average cost incurred in the review of an application that is not subject to priority review in the previous FY. This notice establishes the material threat MCM priority review fee rate for FY 2019 and outlines the payment procedures for such fees. FOR FURTHER INFORMATION CONTACT: Lola Olajide, Office of Financial Management, Food and Drug Administration, 8455 Colesville Rd., COLE- 14541B, Silver Spring, MD 20993-0002, 240-402-4244. SUPPLEMENTARY INFORMATION: I. Background Section 3086 of the Cures Act (Pub. L. 114-255) added section 565A to the FD&C Act (21 U.S.C. 360bbb-4a). In section 565A of the FD&C Act, Congress encouraged development of material threat MCMs by offering additional incentives for obtaining FDA approval of such products. Under section 565A of the FD&C Act, the applicant of an eligible material threat MCM application (as defined in section 565A(a)(4)) shall receive a priority review voucher upon approval of the [[Page 48618]] material threat MCM application. The recipient of a material threat MCM priority review voucher may either use the voucher for a future human drug application submitted to FDA under section 505(b)(1) of the FD&C Act (21 U.S.C. 355(b)(1)) or section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)), or transfer (including by sale) the voucher to another party. The voucher may be transferred (including by sale) repeatedly until it ultimately is used for a human drug application submitted to FDA under section 505(b)(1) of the FD&C Act or section 351(a) of the Public Health Service Act. A priority review is a review conducted with a Prescription Drug User Fee Act (PDUFA) goal date of 6 months after the receipt or filing date, depending on the type of application. Information regarding PDUFA goals is available at https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm511438.pdf. The applicant that uses a material threat MCM priority review voucher is entitled to a priority review of its eligible human drug application, but must pay FDA a material threat MCM priority review user fee in addition to any user fee required by PDUFA for the application. Information regarding the material threat MCM priority review voucher program is available at: https://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMLegalRegulatoryandPolicyFramework/ucm566498.htm. This notice establishes the material threat MCM priority review fee rate for FY 2019 at $2,457,140 and outlines FDA's procedures for payment of material threat MCM priority review user fees. This rate is effective on October 1, 2018, and will remain in effect through September 30, 2019. II. Material Threat Medical Countermeasure Priority Review User Fee for FY 2019 FDA interprets section 565A(c)(2) of the FD&C Act as requiring that FDA determine the amount of the material threat MCM 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 product will qualify for priority review if the product is intended to treat a serious condition and, if approved, would provide a significant improvement in safety or effectiveness. An application that does not receive a priority designation receives a standard review. Under the PDUFA goals letter, FDA has committed to reviewing and acting on 90 percent of standard applications within 10 months of the receipt or filing date, depending on the type of application. A priority review involves a more intensive level of effort and a higher level of resources than a standard review. As interpreted by FDA, section 565A 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 the Agency in the review of a human drug application not subject to a priority review in the previous fiscal year. FDA is setting a fee for FY 2019, which is to be based on standard cost data from the previous fiscal year, FY 2018. However, the FY 2018 submission cohort has not been closed out yet, thus the cost data for FY 2018 are not complete. The latest year for which FDA has complete cost data is FY 2017. Furthermore, because FDA has never tracked the cost of reviewing applications that get priority review as a separate cost subset, FDA estimated this cost based on other data that the Agency has tracked. FDA uses data that the Agency estimates and publishes on its website each year--standard costs for review. FDA does not publish a standard cost for ``the review of a human drug application subject to priority review in the previous fiscal year.'' However, we expect all such applications would contain clinical data. The standard cost application categories with clinical data that FDA publishes each year are: (1) New drug applications (NDAs) for a new molecular entity (NME) with clinical data and (2) biologics license applications (BLAs). The standard cost worksheets for FY 2017 show standard costs of $5,340,560 for an NME NDA, and $4,596,936 for a BLA. Based on these standard costs, the total cost to review the 57 applications in these two categories in FY 2017 (31 NME NDAs with clinical data and 26 BLAs) was $285,077,688. (Note: These numbers exclude the President's Emergency Plan for AIDS Relief NDAs; no investigational new drug review costs are included in this amount.) Thirty-three of these applications (20 NDAs and 13 BLAs) received priority review, which would mean that the remaining 24 received standard reviews. Because a priority review compresses a review schedule that ordinarily takes 10 months into 6 months, FDA estimates that a multiplier of 1.67 (10 months / 6 months) should be applied to non-priority review costs in estimating the effort and cost of a priority review as compared to a standard review. This multiplier is consistent with published research on this subject that 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 (see 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 material threat MCM 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: [[Page 48619]] Table 1--Material Threat Medical Countermeasure Priority Review Schedule for FY 2019 ------------------------------------------------------------------------ Fee rate for FY Fee category 2019 ------------------------------------------------------------------------ Application submitted with a material threat MCM $2,457,140 priority review voucher in addition to the normal PDUFA fee............................................. ------------------------------------------------------------------------ IV. Implementation of Material Threat Medical Countermeasure Priority Review User Fee Under section 565A(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 565A(c)(4)(B) of the FD&C Act specifies that the application will be considered incomplete if the priority review user fee and all other applicable user fees are not paid in accordance with FDA payment procedures. In addition, section 565A(c)(4)(C) specifies that FDA may not grant a waiver, exemption, reduction, or refund of any fees due and payable under this section of the FD&C Act. The material threat MCM 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 must be made in U.S. currency by electronic check, check, bank draft, wire transfer, credit card, or U.S. postal money order payable to the order of the Food and Drug Administration. The preferred payment method is online using electronic check (Automated Clearing House (ACH) also known as eCheck). Secure electronic payments can be submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay. (Note: Only full payments are accepted. No partial payments can be made online.) Once you search for your invoice, select ``Pay Now'' to be redirected to https://www.pay.gov/public/home. Note that electronic payment options are based on the balance due. Payment by credit card is available for balances that are less than $25,000. If the balance exceeds this amount, only the ACH option is available. Payments must be made using U.S. bank accounts as well as U.S. credit cards. 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 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 ``Material Threat Medical Countermeasure Priority Review.'' All paper checks must be in U.S. currency from a U.S. bank made payable and mailed to: Food and Drug Administration, P.O. Box 979107, St. Louis, MO 63197-9000. If checks are sent by a courier that requests a street address, the courier can deliver the checks to: U.S. Bank, Attention: Government Lockbox 979107, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank address is for courier delivery only. If you have any questions concerning courier delivery, contact the U.S. Bank at 314- 418-4013. This telephone number is only for questions about courier delivery). The FDA post office box number (P.O. Box 979107) must be written on the check. If needed, FDA's tax identification number is 53- 0196965. If paying by wire transfer, please reference your 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 at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852) and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is not available electronically at https://www.regulations.gov as this reference is copyright protected. FDA has verified the website address, as of the date this document publishes in the Federal Register, but websites are subject to change over time. 1. Ridley, D.B., H.G. Grabowski, and J.L. Moe, ``Developing Drugs for Developing Countries,'' Health Affairs, vol. 25, no. 2, pp. 313- 324, 2006, available at: https://faculty.fuqua.duke.edu/~willm/ HSM_RA/Documents/HA2006_Ridley_Vouchers.pdf. Dated: September 20, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-20910 Filed 9-25-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices 48617
and other applicable disclosure law. For orally or in writing, on issues pending DEPARTMENT OF HEALTH AND
more information about FDA’s posting before the committees. All electronic HUMAN SERVICES
of comments to public dockets, see 80 and written submissions submitted to
FR 56469, September 18, 2015, or access the Docket (see ADDRESSES) on or before Food and Drug Administration
the information at: https://www.gpo.gov/ October 18, 2018, will be provided to [Docket No. FDA–2018–N–0007]
fdsys/pkg/FR-2015-09-18/pdf/2015- the committees. Oral presentations from
23389.pdf. the public will be scheduled between Fee for Using a Material Threat Medical
Docket: For access to the docket to approximately 1 p.m. and 2 p.m. Those Countermeasure Priority Review
read background documents or the individuals interested in making formal Voucher in Fiscal Year 2019
electronic and written/paper comments oral presentations should notify the
received, go to https:// AGENCY: Food and Drug Administration,
contact person and submit a brief HHS.
www.regulations.gov and insert the
statement of the general nature of the ACTION: Notice.
docket number, found in brackets in the
evidence or arguments they wish to
heading of this document, into the SUMMARY: The Food and Drug
‘‘Search’’ box and follow the prompts present, the names and addresses of
proposed participants, and an Administration (FDA or the Agency) is
and/or go to the Dockets Management announcing the fee rate for using a
Staff, 5630 Fishers Lane, Rm. 1061, indication of the approximate time
requested to make their presentation on material threat medical countermeasure
Rockville, MD 20852. (MCM) priority review voucher for fiscal
FOR FURTHER INFORMATION CONTACT:
or before October 10, 2018. Time
allotted for each presentation may be year (FY) 2019. The Federal Food, Drug,
Kalyani Bhatt, Center for Drug and Cosmetic Act (the FD&C Act), as
Evaluation and Research, Food and limited. If the number of registrants
amended by the 21st Century Cures Act
Drug Administration, 10903 New requesting to speak is greater than can (Cures Act), authorizes FDA to
Hampshire Ave., Bldg. 31, Rm. 2417, be reasonably accommodated during the determine and collect material threat
Silver Spring, MD 20993–0002, 301– scheduled open public hearing session, MCM priority review user fees for
796–9001, Fax: 301–847–8533, email: FDA may conduct a lottery to determine certain applications for review of
kalyani.bhatt@fda.hhs.gov, or FDA the speakers for the scheduled open human drug products when those
Advisory Committee Information Line, public hearing session. The contact applications use a material threat MCM
1–800–741–8138 (301–443–0572 in the person will notify interested persons priority review voucher. These vouchers
Washington, DC area). A notice in the regarding their request to speak by are awarded to the applicants of
Federal Register about last minute October 11, 2018. material threat MCM applications that
modifications that impact a previously Persons attending FDA’s advisory meet all of the requirements of this
announced advisory committee meeting committee meetings are advised that the program upon FDA approval of such
cannot always be published quickly Agency is not responsible for providing applications. The amount of the fee for
enough to provide timely notice. using a material threat MCM priority
access to electrical outlets.
Therefore, you should always check review voucher is determined each FY
FDA’s website at https://-www.fda.gov/ For press inquiries, please contact the based on the difference between the
Advisory-Committees/default.htm and Office of Media Affairs at fdaoma@ average cost incurred by FDA to review
scroll down to the appropriate advisory fda.hhs.gov or 301–796–4540. of a human drug application designated
committee meeting link, or call the FDA welcomes the attendance of the as priority review in the previous FY,
advisory committee information line to public at its advisory committee and the average cost incurred in the
learn about possible modifications meetings and will make every effort to review of an application that is not
before coming to the meeting. accommodate persons with disabilities. subject to priority review in the
SUPPLEMENTARY INFORMATION: If you require special accommodations previous FY. This notice establishes the
Agenda: The committees will discuss due to a disability, please contact material threat MCM priority review fee
the efficacy, safety, and benefit-risk Kalyani Bhatt (see FOR FURTHER rate for FY 2019 and outlines the
profile of new drug application (NDA) INFORMATION CONTACT) at least 7 days in
payment procedures for such fees.
211371, brexanolone 5 mg/mL advance of the meeting. FOR FURTHER INFORMATION CONTACT: Lola
intravenous injection, submitted by Olajide, Office of Financial
Sage Therapeutics, for the proposed FDA is committed to the orderly Management, Food and Drug
indication of postpartum depression. conduct of its advisory committee Administration, 8455 Colesville Rd.,
FDA intends to make background meetings. Please visit our website at COLE–14541B, Silver Spring, MD
material available to the public no later https://www.fda.gov/Advisory 20993–0002, 240–402–4244.
than 2 business days before the meeting. Committees/AboutAdvisoryCommittees/ SUPPLEMENTARY INFORMATION:
If FDA is unable to post the background ucm111462.htm for procedures on
material on its website prior to the public conduct during advisory I. Background
meeting, the background material will committee meetings. Section 3086 of the Cures Act (Pub. L.
be made publicly available at the Notice of this meeting is given under 114–255) added section 565A to the
location of the advisory committee the Federal Advisory Committee Act (5 FD&C Act (21 U.S.C. 360bbb–4a). In
meeting, and the background material U.S.C. app. 2). section 565A of the FD&C Act, Congress
will be posted on FDA’s website after encouraged development of material
the meeting. Background material is Dated: September 20, 2018. threat MCMs by offering additional
daltland on DSKBBV9HB2PROD with NOTICES
available at https://www.fda.gov/ Leslie Kux, incentives for obtaining FDA approval
AdvisoryCommittees/Calendar/ Associate Commissioner for Policy. of such products. Under section 565A of
default.htm. Scroll down to the [FR Doc. 2018–20908 Filed 9–25–18; 8:45 am] the FD&C Act, the applicant of an
appropriate advisory committee meeting BILLING CODE 4164–01–P
eligible material threat MCM
link. application (as defined in section
Procedure: Interested persons may 565A(a)(4)) shall receive a priority
present data, information, or views, review voucher upon approval of the
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![Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices 48619
TABLE 1—MATERIAL THREAT MEDICAL COUNTERMEASURE PRIORITY REVIEW SCHEDULE FOR FY 2019
Fee rate for
Fee category FY 2019
Application submitted with a material threat MCM priority review voucher in addition to the normal PDUFA fee ............................ $2,457,140
IV. Implementation of Material Threat If paying with a paper check, the user RA/Documents/HA2006_Ridley_
Medical Countermeasure Priority fee identification (ID) number should be Vouchers.pdf.
Review User Fee included on the check, followed by the Dated: September 20, 2018.
words ‘‘Material Threat Medical Leslie Kux,
Under section 565A(c)(4)(A) of the Countermeasure Priority Review.’’ All Associate Commissioner for Policy.
FD&C Act, the priority review user fee paper checks must be in U.S. currency [FR Doc. 2018–20910 Filed 9–25–18; 8:45 am]
is due upon submission of a human from a U.S. bank made payable and
BILLING CODE 4164–01–P
drug application for which the priority mailed to: Food and Drug
review voucher is used. Section Administration, P.O. Box 979107, St.
565A(c)(4)(B) of the FD&C Act specifies Louis, MO 63197–9000. DEPARTMENT OF HEALTH AND
that the application will be considered If checks are sent by a courier that HUMAN SERVICES
incomplete if the priority review user requests a street address, the courier can
fee and all other applicable user fees are deliver the checks to: U.S. Bank, Food and Drug Administration
not paid in accordance with FDA Attention: Government Lockbox 979107,
payment procedures. In addition, [Docket No. FDA–2014–D–2138]
1005 Convention Plaza, St. Louis, MO
section 565A(c)(4)(C) specifies that FDA 63101. (Note: This U.S. Bank address is Agency Information Collection
may not grant a waiver, exemption, for courier delivery only. If you have Activities; Submission for Office of
reduction, or refund of any fees due and any questions concerning courier Management and Budget Review;
payable under this section of the FD&C delivery, contact the U.S. Bank at 314– Comment Request; Guidance for
Act. 418–4013. This telephone number is Industry: Adverse Event Reporting for
The material threat MCM priority only for questions about courier Outsourcing Facilities Under Section
review fee established in the new fee delivery). The FDA post office box 503B of the Federal Food, Drug, and
schedule must be paid for any number (P.O. Box 979107) must be Cosmetic Act
application that is received on or after written on the check. If needed, FDA’s
October 1, 2018, and submitted with a tax identification number is 53– AGENCY: Food and Drug Administration,
priority review voucher. This fee must 0196965. HHS.
be paid in addition to any other fee due If paying by wire transfer, please ACTION: Notice.
under PDUFA. Payment must be made reference your unique user fee ID
number when completing your transfer. SUMMARY: The Food and Drug
in U.S. currency by electronic check, Administration (FDA) is announcing
check, bank draft, wire transfer, credit The originating financial institution
may charge a wire transfer fee. If the that a proposed collection of
card, or U.S. postal money order information has been submitted to the
payable to the order of the Food and financial institution charges a wire
transfer fee, it is required to add that Office of Management and Budget
Drug Administration. The preferred (OMB) for review and clearance under
payment method is online using amount to the payment to ensure that
the invoice is paid in full. The account the Paperwork Reduction Act of 1995.
electronic check (Automated Clearing
information is as follows: U.S. Dept. of DATES: Fax written comments on the
House (ACH) also known as eCheck).
Secure electronic payments can be Treasury, TREAS NYC, 33 Liberty St., collection of information by October 26,
submitted using the User Fees Payment New York, NY 10045, Account Number: 2018.
Portal at https://userfees.fda.gov/pay. 75060099, Routing Number: 021030004, ADDRESSES: To ensure that comments on
(Note: Only full payments are accepted. SWIFT: FRNYUS33. the information collection are received,
No partial payments can be made OMB recommends that written
V. Reference
online.) Once you search for your comments be faxed to the Office of
The following reference is on display Information and Regulatory Affairs,
invoice, select ‘‘Pay Now’’ to be
at the Dockets Management Staff (HFA– OMB, Attn: FDA Desk Officer, Fax: 202–
redirected to https://www.pay.gov/
305), Food and Drug Administration, 395–7285, or emailed to oira_
public/home. Note that electronic
5630 Fishers Lane, Rm. 1061, Rockville, submission@omb.eop.gov. All
payment options are based on the
MD 20852) and is available for viewing comments should be identified with the
balance due. Payment by credit card is
by interested persons between 9 a.m. OMB control number 0910–0800. Also
available for balances that are less than
and 4 p.m., Monday through Friday; it include the FDA docket number found
$25,000. If the balance exceeds this
is not available electronically at https:// in brackets in the heading of this
amount, only the ACH option is
www.regulations.gov as this reference is document.
available. Payments must be made using
copyright protected. FDA has verified
U.S. bank accounts as well as U.S. credit FOR FURTHER INFORMATION CONTACT:
the website address, as of the date this
cards. Domini Bean, Office of Operations,
document publishes in the Federal
daltland on DSKBBV9HB2PROD with NOTICES
FDA has partnered with the U.S. Food and Drug Administration, Three
Register, but websites are subject to
Department of the Treasury to use White Flint North, 10A–12M, 11601
change over time.
Pay.gov, a web-based payment Landsdown St., North Bethesda, MD
1. Ridley, D.B., H.G. Grabowski, and J.L. Moe, 20852, 301–796–5733, PRAStaff@
application, for online electronic ‘‘Developing Drugs for Developing
payment. The Pay.gov feature is fda.hhs.gov.
Countries,’’ Health Affairs, vol. 25, no. 2,
available on the FDA website after the pp. 313–324, 2006, available at: https:// SUPPLEMENTARY INFORMATION: In
user fee ID number is generated. faculty.fuqua.duke.edu/∼willm/HSM_ compliance with 44 U.S.C. 3507, FDA
VerDate Sep<11>2014 19:21 Sep 25, 2018 Jkt 244001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\26SEN1.SGM 26SEN1](https://thefederalregister.org/doc/83_FR_48804/page/3.svg)
Document Created: 2018-09-26 00:47:14
Document Modified: 2018-09-26 00:47:14
| 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 48617 |
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