Needs and Challenges in Personal Protective Equipment (PPE) Use for Underserved User Populations; Extension of Comment Period, 45732 [2021-17485]
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Federal Register / Vol. 86, No. 155 / Monday, August 16, 2021 / Notices
special review process. In addition, the
Federal Travel Regulation (FTR) allows
for actual expense reimbursement as
provided in §§ 301–11.300 through 301–
11.306.
For FY 2022, all current non-standard
area (NSA) maximum lodging allowance
rates will remain at FY 2021 levels. The
standard lodging rate will also remain
unchanged at $96. The M&IE
reimbursement rates were revised for FY
2022; they were last revised in FY 2019.
The M&IE NSA tiers are revised from
$56–$76 to $59–$79, and the standard
M&IE rate is revised from $55 to $59.
Notices published periodically in the
Federal Register now constitute the
only notification of revisions in CONUS
per diem reimbursement rates to
agencies, other than the changes posted
on the GSA website.
Krystal J. Brumfield,
Associate Administrator, Office of
Government-wide Policy.
N.
Katherine Yoon, Ph.D., National
Institute for Occupational Safety and
Health Centers for Disease Control and
Prevention Email Address: NYoon@
cdc.gov, Phone number: 412–386–6752
[non-toll-free number].
SUPPLEMENTARY INFORMATION: NIOSH
published a notice and request for
information in the Federal Register on
June 24, 2021 (86 FR 33296) regarding
the Needs and Challenges in Personal
Protective Equipment (PPE) Use for
Underserved User Populations. This
notice announces the extension of the
comment period until October 15, 2021.
FOR FURTHER INFORMATION CONTACT:
Frank J. Hearl,
Chief of Staff, National Institute for
Occupational Safety and Health, Centers for
Disease Control and Prevention.
[FR Doc. 2021–17485 Filed 8–13–21; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2021–17491 Filed 8–13–21; 8:45 am]
BILLING CODE 6820–14–P
Food and Drug Administration
[Docket No. FDA–2021–N–0709]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Prescription Drug User Fee Rates for
Fiscal Year 2022
Centers for Disease Control and
Prevention
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
Needs and Challenges in Personal
Protective Equipment (PPE) Use for
Underserved User Populations;
Extension of Comment Period
National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS).
ACTION: Extension of comment period.
AGENCY:
On June 24, 2021, NIOSH
opened a notice to request information
on the Needs and Challenges in
Personal Protective Equipment (PPE)
Use for Underserved User Populations.
Written comments were to be received
by August 23, 2021. NIOSH is extending
the public comment period to October
15, 2021.
DATES: The comment period for the
document published on June 24, 2021
(86 FR 33296), is extended. Comments
must be received by October 15, 2021.
ADDRESSES: Interested parties should
submit information to: NIOSH, Attn:
Sherri Diana, National Institute for
Occupational Safety and Health, NIOSH
Docket Office, 1090 Tusculum Avenue,
MS C–34, Cincinnati, Ohio 45226–1998,
Email address: ppeconcerns@cdc.gov.
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:21 Aug 13, 2021
Jkt 253001
The Food and Drug
Administration (FDA) is announcing the
rates for prescription drug user fees for
fiscal year (FY) 2022. The Federal Food,
Drug, and Cosmetic Act (FD&C Act), as
amended by the Prescription Drug User
Fee Amendments of 2017 (PDUFA VI),
authorizes FDA to collect application
fees for certain applications for the
review of human drug and biological
products, and prescription drug
program fees for certain approved
products. This notice establishes the fee
rates for FY 2022.
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:
SUMMARY:
I. Background
Sections 735 and 736 of the FD&C Act
(21 U.S.C. 379g and 379h, respectively)
establish two different kinds of user
fees. Fees are assessed as follows: (1)
Application fees are assessed on certain
types of applications for the review of
human drug and biological products
and (2) prescription drug program fees
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
are assessed on certain approved
products (section 736(a) of the FD&C
Act). When specific conditions are met,
FDA may waive or reduce fees (section
736(d) of the FD&C Act) or exempt
certain prescription drug products from
fees (section 736(k) of the FD&C Act).
For FY 2018 through FY 2022, the
base revenue amounts for the total
revenues from all PDUFA fees are
established by PDUFA VI. The base
revenue amount for FY 2022 is
$1,098,077,960. The FY 2022 base
revenue amount is adjusted for inflation
and for the resource capacity needs for
the process for the review of human
drug applications (the capacity planning
adjustment (CPA)). An additional dollar
amount specified in the statute (see
section 736(b)(1)(F) of the FD&C Act) is
then added to provide for additional
full-time equivalent (FTE) positions to
support PDUFA VI initiatives. The FY
2022 revenue amount may be adjusted
further, if necessary, to provide for
sufficient operating reserves of
carryover user fees. Finally, the amount
is adjusted to provide for additional
direct costs to fund PDUFA VI
initiatives. Fee amounts are to be
established each year so that revenues
from application fees provide 20 percent
of the total revenue, and prescription
drug program fees provide 80 percent of
the total revenue.
This document provides fee rates for
FY 2022 for an application requiring
clinical data ($3,117,218), for an
application not requiring clinical data
($1,558,609), and for the prescription
drug program fee ($369,413). These fees
are effective on October 1, 2021, and
will remain in effect through September
30, 2022. For applications that are
submitted on or after October 1, 2021,
the new fee schedule must be used.
II. Fee Revenue Amount for FY 2022
The base revenue amount for FY 2022
is $1,098,077,960 prior to adjustments
for inflation, capacity planning,
additional FTE, operating reserve, and
additional direct costs (see section
736(b)(1) of the FD&C Act).
A. FY 2022 Statutory Fee Revenue
Adjustments for Inflation
PDUFA VI specifies that the
$1,098,077,960 is to be adjusted for
inflation increases for FY 2022 using
two separate adjustments—one for
personnel compensation and benefits
(PC&B) and one for non-PC&B costs (see
section 736(c)(1) of the FD&C Act).
The component of the inflation
adjustment for payroll costs shall be one
plus the average annual percent change
in the cost of all PC&B paid per FTE
positions at FDA for the first 3 of the
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[Federal Register Volume 86, Number 155 (Monday, August 16, 2021)]
[Notices]
[Page 45732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17485]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Needs and Challenges in Personal Protective Equipment (PPE) Use
for Underserved User Populations; Extension of Comment Period
AGENCY: National Institute for Occupational Safety and Health (NIOSH)
of the Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Extension of comment period.
-----------------------------------------------------------------------
SUMMARY: On June 24, 2021, NIOSH opened a notice to request information
on the Needs and Challenges in Personal Protective Equipment (PPE) Use
for Underserved User Populations. Written comments were to be received
by August 23, 2021. NIOSH is extending the public comment period to
October 15, 2021.
DATES: The comment period for the document published on June 24, 2021
(86 FR 33296), is extended. Comments must be received by October 15,
2021.
ADDRESSES: Interested parties should submit information to: NIOSH,
Attn: Sherri Diana, National Institute for Occupational Safety and
Health, NIOSH Docket Office, 1090 Tusculum Avenue, MS C-34, Cincinnati,
Ohio 45226-1998, Email address: [email protected].
FOR FURTHER INFORMATION CONTACT: N. Katherine Yoon, Ph.D., National
Institute for Occupational Safety and Health Centers for Disease
Control and Prevention Email Address: [email protected], Phone number: 412-
386-6752 [non-toll-free number].
SUPPLEMENTARY INFORMATION: NIOSH published a notice and request for
information in the Federal Register on June 24, 2021 (86 FR 33296)
regarding the Needs and Challenges in Personal Protective Equipment
(PPE) Use for Underserved User Populations. This notice announces the
extension of the comment period until October 15, 2021.
Frank J. Hearl,
Chief of Staff, National Institute for Occupational Safety and Health,
Centers for Disease Control and Prevention.
[FR Doc. 2021-17485 Filed 8-13-21; 8:45 am]
BILLING CODE 4163-18-P
