[Federal Register Volume 87, Number 59 (Monday, March 28, 2022)]
[Notices]
[Page 17300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06427]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0709]


Prescription Drug User Fee Rates for Fiscal Year 2022; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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

SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
entitled ``Prescription Drug User Fee Rates for Fiscal Year 2022'' that 
appeared in the Federal Register of August 16, 2021. The document 
announced the Fiscal Year 2022 fee rates for the Prescription Drug User 
Fee Act. The document published with errors. The errors did not have an 
impact on the previously published user fee rates but are corrected in 
this document for clarity.

FOR FURTHER INFORMATION CONTACT: Misbah Tareen, Office of Financial 
Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm. 
61077A, Beltsville, MD 20705-4304, 301-796-3997.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 16, 2021 
(86 FR 45732), appearing on page 45736 in FR Doc. 2021-17505, the 
following corrections are made:
    1. In the second column, in the last sentence of the third 
paragraph under ``D. FY 2022 Statutory Fee Revenue Adjustments for 
Operating Reserve'', ``both user fee funds available for obligation 
$126,873,636 and funds that are considered unavailable due to a lack of 
appropriations $98,850,995'' is corrected to read ``user fee funds 
considered unavailable due to a lack of appropriations $78,850,995, 
additional fee funds that are available for obligation but set aside 
for future year refunds as a matter of prudent operations $20,000,000, 
and carryover net of unavailable funds and the set-aside 
$126,873,636.''
    2. The fourth footnote is corrected by removing the text and 
replacing it with: ``In recent PDUFA Annual Financial Reports, the 
category ``unavailable for use'' has been used to refer both to (1) fee 
funds that are considered unappropriated and (2) appropriated fee funds 
the Agency has maintained to provide for any refunds. FDA intends to 
discontinue use of the category ``unavailable for use'' in forthcoming 
reports to better reflect the difference between these line items and 
improve the clarity of its reporting. Although certain amounts have 
been maintained for future refunds as a matter of prudent operations, 
these amounts are considered appropriated and are available for 
obligation.''
    3. In the second column, in the fifth paragraph under ``D. FY 2022, 
Statutory Fee Revenue Adjustments for Operating Reserve'', sentences 4 
through 7 are corrected by removing the text and replacing it with 
``FDA has decided to make an available operating reserve adjustment 
that is intended to increase the amount of available funds to 
approximately 8 weeks by the end of FY 2022, representing the low end 
of the 8- to 10-week range while mitigating the impact on fee amounts. 
FDA estimates the cost of operations per week is $22,144,672. Before 
the operating adjustment, the estimated end of year FY 2022 available 
operating reserve is $145,677,240, which equates to about 6\1/2\ weeks 
of available operating reserves. Adding the FY 2022 operating reserve 
adjustment of $39,402,923 to this amount is expected to provide 
approximately 8 weeks of available operating reserve, or $185,080,162 
(including $20,000,000 in available fee funds maintained for any future 
refunds), and a total carryover of operating reserves (including 
unavailable funds) of $263,931,157.''

    Dated: March 21, 2022.
Andi Lipstein Fristedt,
Deputy Commissioner for Policy, Legislation, and International Affairs, 
U.S. Food and Drug Administration.
[FR Doc. 2022-06427 Filed 3-25-22; 8:45 am]
BILLING CODE 4164-01-P