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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 30111.300 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: 4123866752
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. 202117485 Filed 81321; 8:45 am BILLING CODE 416318P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

FR Doc. 202117491 Filed 81321; 8:45 am BILLING CODE 682014P

Food and Drug Administration Docket No. FDA2021N0709

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 C34, Cincinnati, Ohio 452261998, Email address: ppeconcerns@cdc.gov.

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SUMMARY:

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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, 3017963997.
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
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are assessed on certain approved products section 736a of the FD&C
Act. When specific conditions are met, FDA may waive or reduce fees section 736d of the FD&C Act or exempt certain prescription drug products from fees section 736k 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 736b1F 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 736b1 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 adjustmentsone for personnel compensation and benefits PC&B and one for non-PC&B costs see section 736c1 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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