14888 Federal Register / Vol. 87, No. 51 / Wednesday, March 16, 2022 / Notices 

1Under section 744M(a)(1) of the FD&C Act, 

‘‘Each person that owns a facility identified as an 

OTC monograph drug facility on December 31 of 

the fiscal year or at any time during the preceding 

12-month period shall be assessed an annual fee for 

each such facility’’. For purposes of FY 2022 facility 

fees, that time period is January 1, 2021, through 

December 31, 2021. 

2Assuming that, as we anticipate, the FY 2022 fee 

appropriation will occur prior to June 1, 2022. 

Under section 744M(a)(1)(D)(ii), the FY 2022 

facility fees are due on the later of (1) the first 

business day of June 2022 (i.e., June 1, 2022) or (2) 

the first business day after the enactment of an 

appropriations Act providing for the collection and 

obligation of FY 2022 OMUFA fees. 

3The term ‘‘hand sanitizer’’ commonly refers to 

consumer antiseptic rubs. However, because the 

Health and Human Services (HHS) notice published 

January 12, 2021, referred to ‘‘persons that entered 

the over-the-counter drug market to supply hand 

sanitizer products in response to the COVID–19 

Public Health Emergency’’ (86 FR 2420,https:// 

www.federalregister.gov/documents/2021/01/12/ 

2021–00237/notice-that-persons-that-entered-theover-the-counter-drug-market-to-supply-handsanitizer-during), we are using the same 

terminology—‘‘hand sanitizer products’’—to refer to 

OTC monograph drug products intended for use 

(without water) as antiseptic hand rubs or antiseptic 

hand wipes by consumers or healthcare personnel. 

4See HHS Federal Register notice of January 12, 

2021, 86 FR 2420, https://www.federalregister.gov/ 

documents/2021/01/12/2021-00237/notice-thatpersons-that-entered-the-over-the-counter-drugmarket-to-supply-hand-sanitizer-during. 

5Under OMUFA, a Tier 1 OMOR is defined as 

any OMOR that is not a Tier 2 OMOR (see section 

744L(8) of the FD&C Act). Tier 2 OMORs are 

detailed in section 744L(9) of the FD&C Act. 

6These OMUFA fees are for FY 2022, per section 

744M(a) of the FD&C Act. 

[FR Doc. 2022–05459 Filed 3–14–22; 4:15 pm] 

BILLING CODE 4120–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0284] 

Over-the-Counter Monograph Drug 

User Fee Rates for Fiscal Year 2022 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the fee rates under the overthe-counter (OTC) monograph drug user 

fee program (OMUFA) for fiscal year 

(FY) 2022. The Federal Food, Drug, and 

Cosmetic Act (FD&C Act) authorizes 

FDA to assess and collect user fees from 

qualifying manufacturers of OTC 

monograph drugs and submitters of 

OTC monograph order requests. This 

notice publishes the OMUFA fee rates 

for FY 2022. 

FOR FURTHER INFORMATION CONTACT: 

David Haas, Office of Financial 

Management, Food and Drug 

Administration, 4041 Powder Mill Rd., 

Rm. 61075, Beltsville, MD 20705–4304, 

240–402–9845. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 744M of the FD&C Act (21 

U.S.C. 379j–72), as added by the 

Coronavirus Aid, Relief, and Economic 

Security Act (CARES Act), authorizes 

FDA to assess and collect: (1) Facility 

fees from qualifying owners of OTC 

monograph drug facilities and (2) fees 

from submitters of qualifying OTC 

monograph order requests. These fees 

are to support FDA’s OTC monograph 

drug activities, which are detailed in 

section 744L(6) of the FD&C Act (21 

U.S.C. 379j–71(6)) and include various 

FDA activities associated with OTC 

monograph drugs and inspection of 

facilities associated with such products. 

For OMUFA purposes: 

• An OTC monograph drug is a 

nonprescription drug without an 

approved new drug application that is 

governed by the provisions of section 

505G of the FD&C Act (21 U.S.C. 355h) 

(see section 744L(5) of the FD&C Act); 

• An OTC monograph drug facility 

(MDF) is a foreign or domestic business 

or other entity that, in addition to 

meeting other criteria, is engaged in 

manufacturing or processing the 

finished dosage form of an OTC 

monograph drug (see section 744L(10) 

of the FD&C Act); 

• A contract manufacturing 

organization (CMO) facility is an OTC 

monograph drug facility where neither 

the owner nor any affiliate of the owner 

or facility sells the OTC monograph 

drug produced at such facility directly 

to wholesalers, retailers, or consumers 

in the United States (see section 744L(2) 

of the FD&C Act); and 

• An OTC monograph order request 

(OMOR) is a request for an 

administrative order, with respect to an 

OTC monograph drug, which is 

submitted under section 505G(b)(5) of 

the FD&C Act (see section 744L(7) of the 

FD&C Act). 

Under section 744M(a)(1)(A) of the 

FD&C Act, a facility fee for FY 2022 

shall be assessed with respect to each 

facility that is identified as an OTC 

monograph drug facility during the feeliable period from January 1, 2021, 

through December 31, 2021.1 Consistent 

with the statute, FDA will assess and 

collect facility fees with respect to the 

two types of OTC monograph drug 

facilities—MDF and CMO facilities. A 

full facility fee will be assessed to each 

qualifying person that owns a facility 

identified as an MDF (see section 

744M(a)(1)(A) of the FD&C Act), and a 

reduced facility fee of two-thirds will be 

assessed to each qualifying person that 

owns a facility identified as a CMO 

facility (see section 744M(a)(1)(B)(ii) of 

the FD&C Act). The facility fees for FY 

2022 are due on June 1, 2022 (see 

section 744M(a)(1)(D)(ii) of the FD&C 

Act).2

As discussed in greater detail below: 

• OTC monograph drug facilities are 

exempt from FY 2022 facility fees if 

they had ceased OTC monograph drug 

activities, and updated their registration 

with FDA to that effect, prior to 

December 31, 2020 (see section 

744M(a)(1)(B)(i) of the FD&C Act). 

• Entities that registered with FDA 

during the Coronavirus Disease 2019 

(COVID–19) pandemic whose sole 

activity with respect to OTC monograph 

drugs during the pandemic consists (or 

had consisted) of manufacturing OTC 

hand sanitizer products 3 are not 

identified as OTC monograph drug 

facilities subject to OMUFA facility 

fees.4

In addition to facility fees, the Agency 

is authorized to assess and collect fees 

from submitters of OMORs, except for 

OMORs that request certain safetyrelated changes (as discussed below). 

There are two levels of OMOR fees, 

based on whether the OMOR at issue is 

a Tier 1 or Tier 2 OMOR.5

For FY 2022, the OMUFA fee rates 

are: Tier 1 OMOR fees ($507,021), Tier 

2 OMOR fees ($101,404), MDF facility 

fees ($24,178), and CMO facility fees 

($16,119). These fees are effective for 

the period from October 1, 2021, 

through September 30, 2022.6 This 

document is issued pursuant to sections 

744M(a)(4) and 744M(c)(4)(B) of the 

FD&C Act and describes the calculations 

used to set the OMUFA facility fees and 

OMOR fees for FY 2022 in accordance 

with the directives in the statute. 

II. Facility Fee Revenue Amount for FY 

2022 

A. Base Fee Revenue Amount 

Under OMUFA, FDA sets annual 

facility fees to generate the total facility 

fee revenues for each fiscal year 

established by section 744M(b) of the 

FD&C Act. The yearly base revenue 

amount is the starting point for setting 

annual facility fee rates. The base 

revenue for FY 2022 is the dollar 

amount of the total revenue amount for 

the previous fiscal year, without certain 

adjustments made for that previous 

year, and is $8,000,000 (see section 

744M(b)(3)(B) of the FD&C Act). 

B. Fee Revenue Adjustment for Inflation 

Under OMUFA, the annual base 

revenue amount for facility fees is 


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adjusted for inflation for FY 2022 and 

each subsequent fiscal year (see section 

744M(c)(1) of the FD&C Act). That 

provision states that the dollar amount 

of the inflation adjustment is equal to 

the product of the annual base revenue 

for the fiscal year and the inflation 

adjustment percentage. For each of FYs 

2022 and 2023, the inflation adjustment 

percentage is equal to the average 

annual percent change that occurred in 

the Consumer Price Index (CPI) for 

urban consumers (WashingtonBaltimore, DC-MD-VA-WV; Not 

Seasonally Adjusted; All items; Annual 

Index) for the first 3 years of the 

preceding 4 years of available data 

(section 744M(c)(1)(C) of the FD&C Act). 

As a result of a geographical revision 

made by the Bureau of Labor and 

Statistics in January 2018, the 

‘‘Washington, DC-Baltimore’’ index was 

discontinued and replaced with two 

separate indices (i.e., the ‘‘WashingtonArlington-Alexandria’’ and ‘‘BaltimoreColumbia-Towson’’ indices). To 

continue applying a CPI that best 

reflects the geographic region in which 

FDA is located and that provides the 

most current data available, the 

‘‘Washington-Arlington-Alexandria’’ 

index is used in calculating the inflation 

adjustment percentage. Table 1 provides 

the summary data for the percent 

changes in the specified CPI for the 

Washington-Arlington-Alexandria area. 

The data are published by the Bureau of 

Labor Statistics and can be found on its 

website at: https://data.bls.gov/pdq/ 

SurveyOutputServlet?data_

tool=dropmap&series_

id=CUURS35ASA0,CUUSS35ASA0. 

TABLE 1—ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN CPI FOR WASHINGTON-ARLINGTON-ALEXANDRIA AREA

Year 2018 2019 2020 3-year 

average 

Annual CPI ....................................................................................................... 261.445 264.777 267.157 ........................

Annual Percent Change .................................................................................. 2.0389% 1.2745% 0.8989% 1.4041% 

Pursuant to the statute, the FY 2022 

base revenue of $8,000,000 is increased 

by 1.4041 percent, yielding an inflation 

adjusted base revenue amount of 

$8,112,328 for FY 2022 (see section 

744M(c)(1)(A)). 

C. Additional Dollar Amounts 

The inflation adjusted revenue 

amount of $8,112,328 is increased by an 

additional dollar amount of $7,000,000 

as specified in the statute (see section 

744M(b)(2)(E) of the FD&C Act). This 

yields an adjusted fee revenue subtotal 

of $15,112,328. 

D. Fee Revenue Adjustment for 

Additional Direct Cost 

Fee revenue is further adjusted for 

additional direct costs as specified in 

the statute. In FY 2022, $7,000,000 is 

added to the facility fee revenues to 

account for additional direct costs (see 

section 744M(c)(3)(B) of the FD&C Act). 

Adding the additional direct costs 

amount of $7,000,000 to $15,112,328 

yields an additional direct cost adjusted 

fee revenue of $22,112,328. 

E. Fee Revenue Adjustment for 

Operating Reserve 

Under OMUFA, FDA may further 

increase the FY 2022 facility fee revenue 

and fees if such an adjustment is 

necessary to provide up to 7 weeks of 

operating reserves of carryover user fees 

for OTC monograph drug activities (see 

section 744M(c)(2)(B) of the FD&C Act). 

Accordingly, in setting fees for FY 2022, 

the Agency must estimate its carryover 

for FY 2022, to ensure the Agency has 

sufficient carryover to continue its OTC 

monograph drug activities, as required 

under the statute, including an 

operating reserve to mitigate certain 

financial risks, such as under 

collections, unanticipated surges in 

program costs, or a lapse in 

appropriations. Under the statute, if 

FDA has carryover for OTC monograph 

drug activities that would exceed 10 

weeks of such operating reserves, FDA 

is required to decrease FY 2022 fee 

revenues and fees to provide for not 

more than 10 weeks of operating 

reserves of carryover user fees (see 

section 744M(c)(2)(C) of the FD&C Act). 

As described below, a fee revenue 

adjustment for the FY 2022 operating 

reserve is necessary to ensure that FDA 

has sufficient resources to maintain its 

authorized OTC monograph drug 

activities. 

Per the statute, OMUFA facility fees 

are not due until the third quarter of 

each fiscal year (i.e., June 1). To address 

this timing of facility fee collections for 

late in the fiscal year, the Agency must 

set aside additional carryover, beyond 

that for an operating reserve, to sustain 

the Agency’s OTC monograph drug 

activities until the facility fees for the 

subsequent fiscal year are due and 

payable on June 1, 2023. Thus, the 

Agency will require FY 2022 carryover 

sufficient to cover payroll and operating 

expenses for the first 8 months (i.e., 35 

weeks rounded) of the following fiscal 

year (i.e., October 1, 2022, to May 31, 

2023). To determine the carryover 

needed, the Agency starts with the 

additional direct cost adjusted fee 

revenue of $22,112,328 (calculated in 

section D), divides it by 52 to yield a 

weekly operating amount of $425,237, 

and then multiplies the weekly 

operating amount by 35. Based on this 

calculation, FDA requires $14,883,298 

to support the program until the FY 

2023 fees are due. After running 

analyses on the projected collections 

and obligations for FY 2022, FDA 

estimates the FY 2022 carryover to be 

$13,107,260 which is $1,776,038 lower 

than the total required to support the 

program through the 35-week period 

(i.e., $14,883,298). 

Therefore, FDA is applying an 

operating reserve adjustment for FY 

2022 in the amount of $1,776,038, 

equating to approximately 4 weeks of 

program costs, to increase the FY 2022 

facility fee revenue and fees to enable 

the Agency to sustain program 

operations through the 35-week period 

of FY 2023. As a result of the above 

calculations, the final FY 2022 OMUFA 

target facility fee revenue is $23,888,000 

(rounded to the nearest thousand 

dollars). 

III. Determination of FY 2022 OMOR 

Fees 

Under OMUFA, the FY 2022 Tier 1 

OMOR fee is $507,021 and the Tier 2 

OMOR fee is $101,404 (see section 

744M(a)(2)(A)(i) and (ii) of the FD&C 

Act, respectively) including an 

adjustment for inflation. OMOR fees are 

not included in the OMUFA target 

revenue calculation, which is based on 

the facility fees (see section 744M(b)(1) 

of the FD&C Act). 

An OMOR fee is generally assessed to 

each person who submits an OMOR (see 

section 744M(a)(2)(A) of the FD&C Act). 

OMOR fees are due on the date of the 

submission of the OMOR (see section 

744M(a)(2)(B) of the FD&C Act). The 

payor should submit the OMOR fee that 

applies to the type of OMOR they are 

submitting (i.e., Tier 1 or Tier 2). FDA 

will determine whether the appropriate 

OMOR fee has been submitted following 

receipt of the OMOR and the fee. 


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14890 Federal Register / Vol. 87, No. 51 / Wednesday, March 16, 2022 / Notices 

7OTC monograph drug facilities had selected in 

the eDRLS the business operation qualifiers of 

‘‘manufactures human over-the-counter drug 

products produced under a monograph’’ or 

‘‘contract manufacturing for human over-thecounter drug products produced under a 

monograph’’ and indicated at least one of the 

following business operations: finished dosage form 

manufacture, label, manufacture, pack, relabel, or 

repack. 

8Under section 744M(a)(1) of the FD&C Act, 

‘‘Each person that owns a facility identified as an 

OTC monograph drug facility on December 31 of 

the fiscal year or at any time during the preceding 

12-month period shall be assessed an annual fee for 

each such facility’’ (emphasis added). 

9See 86 FR 2420, https://www.federalregister.gov/ 

documents/2021/01/12/2021-00237/notice-thatpersons-that-entered-the-over-the-counter-drugmarket-to-supply-hand-sanitizer-during. 

10See 86 FR 16223, https://

www.federalregister.gov/documents/2021/03/26/ 

2021-06361/fee-rates-under-the-over-the-countermonograph-drug-user-fee-program-for-fiscal-year2021. 

11See https://www.phe.gov/emergency/news/ 

healthactions/phe/Pages/2019-nCoV.aspx. 

An OMOR fee will not be assessed if 

the OMOR seeks to make certain safety 

changes with respect to an OTC 

monograph drug. Specifically, no fee 

will be assessed if FDA finds that the 

OMOR seeks to change the drug facts 

labeling of an OTC monograph drug in 

a way that would add to or strengthen: 

(1) A contraindication, warning, or 

precaution; (2) a statement about risk 

associated with misuse or abuse; or (3) 

an instruction about dosage and 

administration that is intended to 

increase the safe use of the OTC 

monograph drug (see section 

744M(a)(2)(C) of the FD&C Act). 

IV. Facility Fee Calculations 

A. Facility Fee Revenues and Fees 

For FY 2022, facility fee rates are 

being established to generate a total 

target revenue amount, as determined 

under the statute, equal to $23,888,000 

(rounded to the nearest thousand 

dollars). FDA used the methodology 

described below to determine the 

appropriate number of MDF and CMO 

facilities to be used in setting the 

OMUFA facility fees for FY 2022. FDA 

took into consideration that the CMO 

facility fee is equal to two-thirds of the 

amount of the MDF facility fee (see 

section 744M(a)(1)(B)(ii) of the FD&C 

Act). 

B. Calculating the Number of Qualifying 

Facilities and Setting the Facility Fees 

For FY 2022, FDA utilized data 

consisting of the number of facilities 

that were registered in FDA’s electronic 

Drug Registration and Listing System 

(eDRLS) to manufacture human OTC 

products produced under a monograph 7

during the FY 2021 fee-liable period 

(i.e., January 1, 2020, through December 

31, 2020) and the number of facilities 

that paid FY 2021 OMUFA fees, as the 

primary sources for estimating the 

number of each facility fee type (i.e., 

MDF and CMO). In addition, the Agency 

considered data provided by firms 

regarding their operation as MDFs and 

CMOs during FY 2021—i.e., October 1, 

2020, through September 30, 2021— 

when they were submitting OTC 

Monograph User Fee Cover Sheets to 

pay the FY 2021 fee. These data helped 

FDA estimate the number of firms 

operating as MDF and CMO facilities 

during the FY 2022 fee-liable period 

(i.e., January 1, 2021, through December 

31, 2021) 8 and thus informed FDA’s 

calculation of the number and ratio of 

MDF and CMO facilities used in 

determining the FY 2022 fee rates. 

FDA’s review of data also reflected 

input received during the first three 

quarters of the FY 2022 fee-liable period 

from facilities whose manufacturing or 

processing practices meet the definition 

of fee-eligible OTC monograph drug 

facilities, to help capture those facilities 

that are in the market and intend to 

remain in the market for FY 2022. 

Those facilities that only manufacture 

the active pharmaceutical ingredient of 

an OTC monograph drug do not meet 

the definition of an OTC monograph 

drug facility (see section 

744L(10)(A)(i)(II)) of the FD&C Act). 

Likewise, a facility is not an OTC 

monograph drug facility if its only 

manufacturing or processing activities 

are one or more of the following: (1) 

Production of clinical research supplies; 

(2) testing; or (3) placement of outer 

packaging on packages containing 

multiple products, for such purposes as 

creating multipacks, when each 

monograph drug product contained 

within the overpackaging is already in 

a final packaged form prior to placement 

in the outer overpackaging (see section 

744L(10)(A)(iii) of the FD&C Act). 

Consistent with the January 12, 2021, 

HHS Federal Register Notice 9 and 

FDA’s subsequent March 26, 2021, 

Federal Register Notice publishing FY 

2021 OMUFA fees,10 facilities are not 

identified as an ‘‘OTC monograph drug 

facility’’ and will not be assessed a FY 

2022 OMUFA facility fee if they: (1) 

Were not registered with FDA as OTC 

drug manufacturers prior to the HHS 

declaration of the COVID–19 public 

health emergency on January 27, 

2020 11; (2) registered with FDA on or 

after the declaration of the COVID–19 

public health emergency; and (3) 

registered for the sole purpose of 

producing hand sanitizer products 

during the COVID–19 public health 

emergency. We note, however, that 

under the FD&C Act, whether an entity 

is subject to OMUFA fees has no bearing 

on whether the entity or the entity’s 

products are subject to other 

requirements under the FD&C Act. FDA 

will continue to use its regulatory 

compliance and enforcement tools to 

protect consumers, including from 

potentially dangerous or subpotent hand 

sanitizers. 

In undertaking the statutorily directed 

fee calculations, the Agency also made 

certain assumptions, including that: (1) 

Facilities using expired Structured 

Product Labeling (SPL) codes in eDRLS, 

that did not reregister for calendar year 

(CY) 2022, were no longer 

manufacturing and marketing OTC 

monograph drugs; (2) facilities that have 

deregistered in eDRLS have exited the 

market; (3) facilities that FDA believes 

registered incorrectly as OTC 

monograph drug facilities (for example, 

because the associated drug listings for 

these facilities did not include OTC 

monograph drugs but instead indicated 

such products as OTC drug products 

under an approved drug application or 

OTC animal drug products) were not 

engaged in manufacturing or processing 

the finished dosage form of an OTC 

monograph drug; (4) facilities that 

registered but did not have an active 

OTC monograph drug product listing 

associated in their registration profile 

were not manufacturing or processing 

such drug products; and (5) facilities 

that, at the close of FY 2021, remain on 

the arrears list for failure to satisfy the 

FY 2021 facility fee are likely to be 

placed on the FY 2022 arrears list as 

well. 

Based on the above-referenced factors 

and assumptions, FDA estimates there 

will be 1,118 OMUFA fee-paying units. 

The Agency estimates that 65 percent 

(1,118 × 0.65 = 727, rounded) will incur 

the MDF fee and 35 percent (1,118 × 

0.35 = 391, rounded) will incur the 

CMO fee. 

To determine the number of full feepaying equivalents (the denominator) to 

be used in setting the OMUFA fees, FDA 

assigns a value of 1 to each MDF (727) 

and a value of 2⁄3 to each CMO (391 × 2⁄3 = 261) for a full facility equivalent of 

988 (rounded). The target fee revenue of 

$23,888,000 is then divided by 988 for 

an MDF fee of $24,178 and a CMO fee 

of $16,119. 

V. Fee Schedule for FY 2022 

The fee rates for FY 2022 are 

displayed in table 1. 


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Federal Register / Vol. 87, No. 51 / Wednesday, March 16, 2022 / Notices 14891 

TABLE 1—FEE SCHEDULE FOR FY 

2022 

Fee category FY 2022 

fee rates 

OMOR: 

Tier 1 ....................................... $507,021 

Tier 2 ....................................... 101,404 

Facility Fees: 

MDF ........................................ 24,178 

CMO ........................................ 16,119 

VI. Fee Payment Options and 

Procedures 

The new fee rates are for the period 

from October 1, 2021, through 

September 30, 2022. To pay the OMOR, 

MDF, and CMO fees, complete an OTC 

Monograph User Fee Cover Sheet, 

available at: https://userfees.fda.gov/ 

OA_HTML/omufaCAcdLogin.jsp. A user 

fee identification (ID) number will be 

generated. Payment must be made in 

U.S. currency by electronic check or 

wire transfer, payable to the order of the 

Food and Drug Administration. The 

preferred payment method is online 

using electronic check (Automated 

Clearing House (ACH) also known as 

eCheck) or credit card for payments 

under $25,000 (Discover, VISA, 

MasterCard, American Express). 

FDA has partnered with the U.S. 

Department of the Treasury to use 

Pay.gov, a web-based payment 

application, for online electronic 

payment. The Pay.gov feature is 

available on the FDA website after 

completing the OTC Monograph User 

Fee Cover Sheet and generating the user 

fee ID number. Secure electronic 

payments can be submitted using the 

User Fees Payment Portal at https://

userfees.fda.gov/pay (Note: Only full 

payments are accepted. No partial 

payments can be made online). Once an 

invoice is located, ‘‘Pay Now’’ should be 

selected to be redirected to Pay.gov. 

Electronic payment options are based on 

the balance due. Payment by credit card 

is available for balances that are less 

than $25,000. If the balance exceeds this 

amount, only the ACH option is 

available. Payments must be made using 

U.S. bank accounts as well as U.S. credit 

cards. 

For payments made by wire transfer, 

include the unique user fee ID number 

to ensure that the payment is applied to 

the correct fee(s). Without the unique 

user fee ID number, the payment may 

not be applied, which could result in 

FDA not filing an OMOR request, for 

example, and other penalties. The 

originating financial institution may 

charge a wire transfer fee. Applicable 

wire transfer fees must be included with 

payment to ensure fees are fully paid. 

Questions about wire transfer fees 

should be addressed to the financial 

institution. The account information for 

wire transfers is as follows: U.S. 

Department of the Treasury, TREAS 

NYC, 33 Liberty St., New York, NY 

10045, Acct. No.: 75060099, Routing 

No.: 021030004, SWIFT: FRNYUS33. If 

needed, FDA’s tax identification 

number is 53–0196965. 

If you are assessed an FY 2022 

OMUFA facility fee and believe your 

facility is not an OTC monograph drug 

facility as described in this notice, 

please contact CDERCollections@

fda.hhs.gov. 

Dated: March 9, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–05542 Filed 3–14–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–N–1593] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Medical Device 

Accessories 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on medical device 

accessory requests. 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 16, 2022. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before May 16, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of May 16, 2022. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2016–N–1593 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Medical 

Device Accessories.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 


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