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