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
Federal Register / Vol. 85, No. 249 / Tuesday, December 29, 2020 / Notices 85649 

training to obtain DATA 2000 waivers 

for their physicians and practitioners to 

furnish opioid use disorder treatment 

services. To receive payment, FQHCs 

and RHCs must submit a formal 

application. 

In order to be eligible for payment, as 

well as to provide HRSA with 

information necessary for validation and 

issuance of accurate payments, the form 

requires that FQHCs and RHCs provide 

information identifying the submitting 

organization and the number of 

practitioners who have completed 

training and obtained a DATA 2000 

waiver. The form requires the 

submitting FQHC or RHC to include 

information regarding each claimed 

practitioner’s name, physician or 

practitioner type (e.g., physician, 

physician assistant, nurse practitioner, 

certified nurse midwife, clinical nurse 

specialist, certified registered nurse, or 

anesthetist), National Provider Identifier 

number, Drug Enforcement 

Administration number, state medical 

license number, length of training, date 

the training was completed, date of 

waiver attainment, and DATA 2000 

waiver number. Additionally, the form 

requires signature of an attestation 

statement certifying that (1) each 

practitioner for which the entity is 

seeking payment under the application 

is employed by or working under 

contract for this facility; (2) it is the first 

time the entity is seeking payment on 

behalf of the listed practitioner(s); (3) 

the entity is eligible to seek payment 

under 42 U.S.C. 1395m(o)(3) or 42 

U.S.C. 1395l(bb); (4) each practitioner is 

furnishing opioid use disorder treatment 

services; and (5) that the statements 

herein are true, complete, and accurate 

to the best of the applicant’s knowledge. 

FQHCs and RHCs will need a System for 

Award Management account and a 

HRSA Electronic Handbooks account in 

order to apply (visit https://sam.gov/ 

SAM/ and https://grants.hrsa.gov/2010/ 

WebEPSExternal/Interface/ 

UserRegistration/Registration

Home.aspx?controlName=ContentTabs 

for more information on how to create 

an account). 

A 60-day notice published in the 

Federal Register on October 6, 2020, 

vol. 85, No. 194; pp. 63121–22. There 

were no public comments. 

Need and Proposed Use of the 

Information: The Substance Use— 

Disorder Prevention that Promotes 

Opioid Recovery and Treatment for 

Patients and Communities Act requires 

FQHCs and RHCs to submit to the 

Secretary an application for payment at 

such time, in such manner, and 

containing such information as 

specified by the Secretary in order to 

receive a payment under section 6083. 

This form allows FQHCs and RHCs to 

apply for such payments based on the 

average cost of training to obtain DATA 

2000 waivers, as determined by the 

Secretary, for their physicians and 

practitioners to furnish opioid use 

disorder treatment services. HRSA 

intends to validate and pay $3,000 per 

eligible provider submitted on the form 

by FQHCs and RHCs. The form also 

provides HRSA with the requisite data 

to validate qualifying DATA 2000 

waiver possessions for the purpose of 

ensuring accurate payments to FQHCs 

and RHCs. 

The following changes were made 

since the publication of the 60 Day 

notice. The number of respondents, total 

respondents, and total burden hours 

were updated to reflect administrative 

costs in the agency’s spend plan. The 

figures assume a $3,000 payment for 

each DATA 2000 waiver and $750,000 

in administrative costs, thereby leaving 

$7,250,000 in funds available for 

payment to FQHCs and RHCs. Language 

was added in the ‘‘Need and Proposed 

Use of the Information’’ section to signal 

to stakeholders that HRSA intends to 

validate and pay $3,000 per eligible 

provider submitted on the form by 

FQHCs and RHCs. Additionally, 

language was added in the ‘‘Abstract’’ 

section notifying FQHCs and RHCs that 

they will need a System for Award 

Management account and a HRSA 

Electronic Handbooks account in order 

to apply. 

Likely Respondents: Only FQHC and 

RHC are eligible to apply. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total 

burden 

hours 

DATA 2000 Waiver Training Payment Program Application 

for Payment ...................................................................... 2,416 1 2,416 0.5 1,208 

Total .............................................................................. 2, 416 ........................ 2,416 ........................ 1,208 

HRSA specifically requests comments 

on (1) the necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions, (2) the accuracy of the 

estimated burden, (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

Amy P. McNulty, 

Deputy Director, Executive Secretariat. 

[FR Doc. 2020–28767 Filed 12–28–20; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–New] 

Agency Information Collection 

Request; 30-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 


KHAMMOND on DSKJM1Z7X2PROD with NOTICES