Prescription Drug User Fee Rates for Fiscal Year 2022; Correction, 17300 [2022-06427]

Download as PDF 17300 Federal Register / Vol. 87, No. 59 / Monday, March 28, 2022 / Notices ANNUAL BURDEN ESTIMATES Instrument Number of respondents (total over request period) Number of responses per respondent (total over request period) Average burden per response (in hours) Total burden (in hours) Total burden (in hours) Annual burden (in hours) Construction Worker Survey .................... 4,200 1 1 0.5 2,100 1,050 Estimated Total Annual Burden Hours: 1,050. Authority: Section 105(d)(2) of the Trafficking Victims Protection Act of 2000 (Pub. L. 106–386) [22 U.S.C. 7103]. Mary B. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2022–06415 Filed 3–25–22; 8:45 am] BILLING CODE 4184–47–P 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. 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 jspears on DSK121TN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:30 Mar 25, 2022 Jkt 256001 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 setaside $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 8to 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 61⁄2 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.’’ PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–0336] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Quantitative Research on a Voluntary Symbol Depicting the Nutrient Content Claim ‘‘Healthy’’ on Packaged Foods AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA). DATES: Submit written comments (including recommendations) on the collection of information by April 27, 2022. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https:// www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. The title of this information collection is ‘‘Quantitative Research on a Voluntary Symbol Depicting the Nutrient Content Claim ‘Healthy’ on Packaged Foods.’’ Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White SUMMARY: E:\FR\FM\28MRN1.SGM 28MRN1

Agencies

[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]


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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.

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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