45732 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. 

[FR Doc. 2021–17491 Filed 8–13–21; 8:45 am] 

BILLING CODE 6820–14–P 

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: ppeconcerns@cdc.gov. 

FOR FURTHER INFORMATION CONTACT: 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. 

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 

Food and Drug Administration 

[Docket No. FDA–2021–N–0709] 

Prescription Drug User Fee Rates for 

Fiscal Year 2022 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: 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: 

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 

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 


lotter on DSK11XQN23PROD with NOTICES1