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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices proposed participants, and an indication of the approximate time requested to make their presentation on or before September 15, 2021. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by September 16, 2021.
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FR Doc. 202116356 Filed 73021; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2021N0659

Medical Device User Fee Rates for Fiscal Year 2022
AGENCY:

Food and Drug Administration,
HHS.
khammond on DSKJM1Z7X2PROD with NOTICES

ACTION:

Notice.

The Food and Drug Administration FDA is announcing the fee rates and payment procedures for medical device user fees for fiscal year FY 2022. The Federal Food, Drug, and
SUMMARY:

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Cosmetic Act FD&C Act, as amended by the Medical Device User Fee Amendments of 2017 MDUFA IV, authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2022, which apply from October 1, 2021, through September 30, 2022, and provides information on how the fees for FY 2022 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.
FOR FURTHER INFORMATION CONTACT:
For information on Medical Device User Fees: https www.fda.gov/
industry/fda-user-fee-programs/
medical-device-user-fee-amendmentsmdufa.
For questions relating to the MDUFA
Small Business Program, please visit the Center for Devices and Radiological Healths website: https www.fda.gov/
medical-devices/premarketsubmissions/reduced-medical-deviceuser-fees-small-business-determinationsbd-program.
For questions relating to this notice:
Andrew Bank, Office of Financial Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm. 62019A, Beltsville, MD 20705, 301
7960292.
SUPPLEMENTARY INFORMATION:

by FDA during FY 2022 is $329,000.
From this starting point, this document establishes FY 2022 fee rates for certain types of submissions, and for periodic reporting, by applying criteria specified in the FD&C Act.

I. Background
MDUFA specifies that the $213,687,660 is to be adjusted for inflation increases for FY 2022 using two separate adjustmentsone for payroll costs and one for non-payroll costs see 21 U.S.C. 379jc2. The base inflation adjustment for FY 2022 is the sum of one plus the two separate adjustments and is compounded as specified in the statute see 21 U.S.C.
379jc2C and 379jc2B.

Section 738 of the FD&C Act 21
U.S.C. 379j establishes fees for certain medical device applications, submissions, supplements, notices, and requests for simplicity, this document refers to these collectively as submissions or applications; for periodic reporting on class III devices;
and for the registration of certain establishments. Under statutorily defined conditions, a qualified applicant may receive a fee waiver or may pay a lower small business fee see 21 U.S.C. 379jd and e.
Under the FD&C Act, the fee rate for each type of submission is set at a specified percentage of the standard fee for a premarket application a premarket application is a premarket approval application PMA, a product development protocol PDP, or a biologics license application BLA.
The FD&C Act specifies the base fee for a premarket application for each year from FY 2018 through FY 2022; the base fee for a premarket application received
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The FD&C Act specifies the base fee for establishment registration for each year from FY 2018 through FY 2022; the base fee for an establishment registration in FY 2022 is $4,978. There is no reduction in the registration fee for small businesses. Each establishment that is registered or is required to register with the Secretary of Health and Human Services under section 510
of the FD&C Act 21 U.S.C. 360 because such establishment is engaged in the manufacture, preparation, propagation, compounding, or processing of a device is required to pay the annual fee for establishment registration.
II. Revenue Amount for FY 2022
The total revenue amount for FY 2022
is $213,687,660, as set forth in the statute prior to the inflation adjustment see 21 U.S.C. 379jb3. MDUFA
directs FDA to use the yearly total revenue amount as a starting point to set the standard fee rates for each fee type.
The fee calculations for FY 2022 are described in this document.
Inflation Adjustment
The component of the inflation adjustment for payroll costs is the average annual percent change in the cost of all personnel compensation and benefits PC&B paid per full-time equivalent position FTE at FDA for the first 3 of the 4 preceding FYs, multiplied by 0.60, or 60 percent see 21
U.S.C. 379jc2C.
Table 1 summarizes the actual cost and FTE data for the specified FYs, and provides the percent change from the previous FY and the average percent change over the first 3 of the 4 FYs preceding FY 2022. The 3-year average is 2.7383 percent rounded.

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