85646 Federal Register / Vol. 85, No. 249 / Tuesday, December 29, 2020 / Notices 

1Although under section 744M(c)(4)(A) of the 

FD&C Act, FDA was to publish this notice not later 

than the second Monday in May of 2020, we note 

that under section 744M(f)(1) of the FD&C Act, 

OMUFA fees ‘‘shall be collected and available for 

obligation only to the extent and in the amount 

provided in advance in appropriations Acts’’. An 

appropriation of FY 2021 OMUFA fees was 

provided under section 123 of the Continuing 

Appropriations Act, 2021, Division A of Public Law 

116–159 (October 1, 2020). 

2Under OMUFA, a Tier 1 OMOR is defined as 

any OMOR which 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. 

TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB—Continued 

Title of collection OMB 

control No. 

Date approval 

expires 

Temporary Marketing Permit Applications .............................................................................................................. 0910–0133 12/31/2023 

Channels of Trade Policy for Commodities with Residues of Pesticide Chemicals for Which Tolerances Have 

Been Revoked, Suspended, or Modified by the EPA ......................................................................................... 0910–0562 12/31/2023 

Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe 

and Effective and Not Misbranded ...................................................................................................................... 0910–0688 12/31/2023 

Dated: December 21, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–28608 Filed 12–28–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–2246] 

Fee Rates Under the Over-the-Counter 

Monograph Drug User Fee Program for 

Fiscal Year 2021 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

fee rates under the Over-the-Counter 

(OTC) Monograph Drug user fee 

program for fiscal year (FY) 2021. On 

March 27, 2020, a new section was 

added to the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) by the 

Coronavirus Aid, Relief, and Economic 

Security Act, which authorizes FDA to 

assess and collect user fees from 

qualifying manufacturers of OTC 

monograph drugs and submitters of 

OTC monograph order requests. FDA 

refers to the OTC Monograph Drug user 

fee program as ‘‘OMUFA’’ throughout 

this document. This notice establishes 

the OMUFA fee rates for FY 2021. 

FOR FURTHER INFORMATION CONTACT: 

David Haas, Office of Financial 

Management, Food and Drug 

Administration, 4041 Powder Mill Rd., 

Rm. 61075, Beltsville, MD 20705–4304, 

240–402–4585. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 744M of the FD&C Act (21 

U.S.C. 379j–72) 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 which 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 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). The Agency 

refers to such facility as Monograph 

Drug Facility (MDF); 

• 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). 

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 are due 45 days 

after the date of publication 1 of this 

notice (see section 744M(a)(1)(D)(i) of 

the FD&C Act). As discussed below, 

OTC monograph drug facilities are 

exempt from FY 2021 facility fees if 

they had ceased OTC monograph drug 

activities, and updated their registration 

with FDA to that effect, prior to 

December 31, 2019 (see section 

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

In addition to facility fees, the Agency 

will assess and collect fees from 

submitters of OMORs, except for 

OMORs which 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.2

For FY 2021, the OMUFA fee rates are 

as follows: Tier 1 OMOR fees 

($500,000), Tier 2 OMOR fees 

($100,000), MDF facility fees ($14,060), 

and CMO facility fees ($9,373). These 

fees are effective as of October 1, 2020, 

and will remain in effect through 

September 30, 2021. This document 

describes the calculations used to set 

the OMUFA facility fees and OMOR fees 

for FY 2021. 

II. Facility Fee Revenue Amount for FY 

2021 

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 amount for FY 2021 is 

$8,000,000 (see section 744M(b)(3)(A) of 

the FD&C Act). 

B. Fee Revenue Adjustment for Inflation 

Under OMUFA, the annual base 

revenue amount for facility fees is 

adjusted for inflation for FY 2022 and 

each subsequent FY (see section 


KHAMMOND on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 85, No. 249 / Tuesday, December 29, 2020 / Notices 85647 

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

the adjustment for inflation does not 

apply until FY 2022, the FY 2021 

facility fee revenue is not subject to an 

inflation adjustment by FDA. 

C. Fee Revenue Adjustment for 

Additional Direct Cost 

Under OMUFA, $14,000,000 is added 

to the facility fee revenues for FY 2021 

to account for additional direct costs 

(see section 744M(c)(3)(A) of the FD&C 

Act). 

D. Fee Revenue Adjustment for 

Operating Reserve 

Under OMUFA, FDA may further 

increase the FY 2021 facility fee revenue 

and fees if such an adjustment is 

necessary in order to provide up to 3 

weeks of operating reserves of carryover 

user fees for OTC monograph drug 

activities (see section 744M(c)(2)(A) of 

the FD&C Act). However, under the 

statute, if the carryover balance exceeds 

10 weeks of operating reserves, FDA is 

required to decrease 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). 

FDA is applying the operating reserve 

adjustment to increase the FY 2021 

facility fee revenue and fees to enable 

the Agency to maintain 3 weeks of 

operating reserves of carryover user fees. 

To determine the 3-week operating 

reserve amount, the FY 2021 annual 

base revenue adjusted for additional 

direct costs (i.e., $8,000,000 + 

$14,000,000 = $22,000,000), is divided 

by 52, and then multiplied by 3. The 3- 

week operating reserve amount for FY 

2021 is $1,269,231. 

As a result of the above calculations, 

the final FY 2021 OMUFA target facility 

fee revenue is $23,269,000 (rounded to 

the nearest thousand dollars). 

III. Determination of FY 2021 OMOR 

Fees 

Under OMUFA, the FY 2021 Tier 1 

OMOR fee is $500,000 and the Tier 2 

OMOR fee is $100,000 (see section 

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

Act, respectively). 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 requestor 

has submitted the appropriate OMOR 

fee following receipt of the OMOR and 

the fee. 

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 2021, facility fee rates are 

being established to generate a total 

target revenue amount equal to 

$23,269,000 (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 

2021. FDA took into consideration that 

the CMO facility fee is equal to twothirds of the amount of the MDF facility 

fee (see section 744M(a)(1)(B)(ii) of the 

FD&C Act). 

B. Estimate of the Number of Qualifying 

Facilities and Setting the Facility Fees 

For FY 2021, FDA utilized the 

Agency’s Electronic Drug Registration 

and Listing System (eDRLS) to estimate 

the number of qualifying MDF or CMO 

facilities that engage in the 

manufacturing or processing of the 

finished dosage form of an OTC 

monograph drug. In setting the FY 2021 

facility fees, FDA considers the feequalifying population of OTC 

monograph drug facilities to be the 

population of establishments coded in 

eDRLS with the business operation 

qualifier of ‘‘manufactures human overthe-counter drug products produced 

under a monograph’’ or ‘‘contract 

manufacturing for human over-thecounter drug products produced under 

a monograph’’ and indicating at least 

one of the following business 

operations: Finished dosage form 

manufacture, label, manufacture, pack, 

relabel, or repack. FDA estimated this 

population through December 30, 2020, 

based on information provided by 

facilities in eDRLS during the first three 

calendar quarters of 2020. 

Those facilities that only manufacture 

the active pharmaceutical ingredient (or 

API) 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 considered an 

OTC monograph drug facility if its only 

manufacturing or processing activities 

are one or more of the following: (a) 

Production of clinical research supplies; 

(b) testing; or (c) 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). In 

addition, as noted above, certain OTC 

monograph drug facilities are exempt 

from facility fees. Under the statute, a 

facility fee will not be assessed if the 

identified OTC monograph drug facility: 

(1) Has ceased all activities related to 

OTC monograph drugs prior to 

December 31 of the year immediately 

preceding the applicable fiscal year; and 

(2) has updated its eDRLS registration to 

reflect that change (see section 

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

the applicable fiscal year for fee-setting 

under this notice is FY 2021, the year 

immediately preceding the applicable 

fiscal year is FY 2020. December of FY 

2020 is December 2019. Thus, a FY 2021 

facility fee will not be assessed with 

respect to an OTC monograph drug 

facility that, prior to December 31, 2019, 

had ceased all activities related to OTC 

monograph drugs and updated its 

eDRLS registration to that effect. 

FDA considered a number of factors 

that could affect collection of the target 

revenue, including that FY 2021 is the 

first year of this new user fee program 

and uncertainties related to the effects 

of the COVID–19 public health 

emergency. In estimating the total 

number of fee-paying facilities, the 

Agency made certain assumptions, 

including that: 

(1) Facilities using expired Structured 

Product Labeling (SPL) codes in eDRLS 

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 do not include OTC 

monograph drugs but instead indicate 

such products as OTC drug products 

under an approved drug application or 

OTC animal drug products) are not 

engaged in manufacturing or processing 

the finished dosage form of an OTC 

monograph drug; and 


KHAMMOND on DSKJM1Z7X2PROD with NOTICES
85648 Federal Register / Vol. 85, No. 249 / Tuesday, December 29, 2020 / Notices 

(4) Facilities that registered but do not 

have an active OTC monograph drug 

product listing associated in their 

registration profile are not 

manufacturing or processing such drug 

products. 

Each establishment paying the facility 

fee is counted as one fee-paying unit. 

The total estimate of fee-paying units is 

further analyzed to determine the 

number of respective MDF and CMO 

fee-paying units. 

Based on the data obtained from 

eDRLS, FDA estimates there will be 

1,712 fee-paying units. The Agency 

estimates that 90 percent (1,712 × .90 = 

1,541, rounded) will incur the MDF fee 

and 10 percent (1,712 × .10 = 171, 

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 (1,541) 

and a value of 2⁄3 to each CMO (171 × 2⁄3 = 114) for a full facility equivalent of 

1,655 (rounded). The target fee revenue 

of $23,269,000 is then divided by 1,655 

for an MDF fee of $14,060 and a CMO 

fee of $9,373. 

V. Fee Schedule for FY 2021 

The fee rates for FY 2021 are 

displayed in table 1. 

TABLE 1—FEE SCHEDULE FOR FY 

2021 

Fee category FY 2021 fee 

rates 

OMOR: 

Tier 1 ................................. $500,000 

Tier 2 ................................. 100,000 

Facility Fees: 

MDF .................................. 14,060 

CMO .................................. 9,373 

VI. Fee Payment Options and 

Procedures 

The new fee rates are effective 

October 1, 2020, through September 30, 

2021. 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 application 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. 

Dated: December 22, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–28714 Filed 12–28–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; Information Collection 

Request Title: DATA 2000 Waiver 

Training Payment Program Application 

for Payment, OMB No. 0906–xxxx— 

New 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with of the 

Paperwork Reduction Act of 1995, 

HRSA has submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. OMB may act on 

HRSA’s ICR only after the 30 day 

comment period for this Notice has 

closed. 

DATES: Comments on this ICR should be 

received no later than January 28, 2021. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under Review—Open for 

Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email Lisa 

Wright-Solomon, the HRSA Information 

Collection Clearance Officer at 

paperwork@hrsa.gov or call (301) 443– 

1984. 

SUPPLEMENTARY INFORMATION: 

Information Collection Request Title: 

DATA 2000 Waiver Training Payment 

Program Application for Payment, OMB 

No. 0906–xxxx—New. 

Abstract: The Substance Use— 

Disorder Prevention that Promotes 

Opioid Recovery and Treatment for 

Patients and Communities Act (Pub. L. 

115–271), section 6083, amended the 

Social Security Act (subsections 

1834(o)(3) and 1833(bb)), authorizing 

the Secretary to pay Federally Qualified 

Health Centers (FQHC) and Rural Health 

Clinics (RHC) the average cost of 


KHAMMOND on DSKJM1Z7X2PROD with NOTICES