Federal Register / Vol. 85, No. 249 / Tuesday, December 29, 2020 / Notices 85645 

also manages all data collected on youth 

served in the URM program. 

C. The Unaccompanied Alien 

Children’s Programs is directly 

responsible in providing care and 

services to unaccompanied alien 

children who are referred to ORR for 

care pending immigration status, or 

identified as victims of trafficking. The 

Unaccompanied Alien Children’s 

Program consists of the Division of 

Unaccompanied Alien Children’s 

Operations, the Division of Planning 

and Logistics, and the Division of 

Unaccompanied Alien Children’s 

Health. The Program maintains 

statistical information and data on each 

child and any actions concerning the 

child while the child is under the 

Director’s care. The Unaccompanied 

Alien Children’s Programs includes 

compliance teams who conducts 

oversight of allegations of abuse, 

monitoring and inspections of facilities, 

and placement locations in which 

unaccompanied alien children reside. 

Unaccompanied Alien Children 

Program staff ensures that services are 

administered in a manner that supports 

child welfare standards of care and 

services and complete regular 

monitoring of service provision. The 

Deputy Director reports directly to the 

Director of ORR. 

The Director of the Division of 

Unaccompanied Alien Children’s 

Operations implements intake and 

placement decisions for all 

unaccompanied alien children. The 

Division supports specialized care 

through grants and contracts. The 

Division ensures consideration of the 

child’s best interest in care and custody 

decisions. The Division coordinates all 

decisions related to sponsor 

reunification, background checks, home 

assessments, follow-up services, 

medical assessment and treatment, and 

repatriation. The Division administers 

the pro bono legal services and child 

advocate programs, and compiles a 

state-by-state list of professionals or 

entities qualified to provide the children 

with a guardian and attorney 

representational services. The Division 

also supports grants for services 

provided to children after their release 

from ORR care. 

The Director leads the Division of 

Planning and Logistics and oversees the 

development of a comprehensive 

strategic plan to ensure that the 

Unaccompanied Alien Children 

Programs is able to anticipate and meet 

capacity needs. The Planning and 

Logistic Division will lead a continuous 

improvement plan. The Division 

prepares plans for temporary increases 

in shelter capacity and staffing, as well 

as temporary changes in ORR staffing to 

support continued Unaccompanied 

Children Program operations. The 

Division leads coordination with other 

federal agencies and work with other 

Unaccompanied Alien Children’s 

divisions to support influx response. If 

ORR experiences an influx in referrals 

of unaccompanied children, the team 

leads influx response operations and 

logistics. 

The Director of the Division of 

Unaccompanied Alien Children’s 

Health oversees the provision of health 

and medical services to unaccompanied 

children in ORR care. The Division 

reviews and approves orders for 

complex medical procedures and 

reviews test results for certain medical 

ailments. The Division also ensures 

reporting of public health information to 

the appropriate public health 

authorities. 

III. Continuation of Policy. Except as 

inconsistent with this reorganization, all 

statements of policy and interpretations 

with respect to organizational 

components affected by this notice 

within ACF, heretofore issued and in 

effect on this date of this reorganization 

are continued in full force and effect. 

IV. Delegation of Authority. All 

delegations and re-delegations of 

authority made to officials and 

employees of affected organizational 

components will continue in them or 

their successors pending further redelegations, provided they are 

consistent with this reorganization. 

V. Funds, Personnel, and Equipment. 

Transfer of organizations and functions 

affected by this reorganization shall be 

accompanied in each instance by direct 

and support funds, positions, personnel, 

records, equipment, supplies, and other 

resources. 

This reorganization will be effective 

upon date of signature. 

Delegation of Authority. Directives or 

orders by the Assistant Secretary of the 

Administration of Children and 

Families, all delegations and 

redelegations of authority made to 

officials and employees of affected 

organizational components will 

continue in them or their successors 

pending further redelegations, provided 

they are consistent with this 

reorganization. 

(Authority: 44 U.S.C. 3101.) 

Dated: December 1, 2020. 

Megan E. Steel, 

Office of the Executive Secretariat, 

Administration for Children and Families. 

[FR Doc. 2020–28706 Filed 12–28–20; 8:45 am] 

BILLING CODE 4184–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2012–N–0197; FDA– 

2017–N–1095; FDA–2011–N–0424; FDA– 

2017–N–2021 and FDA–2010–N–0493] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approvals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of information collections that have 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

following is a list of FDA information 

collections recently approved by OMB 

under section 3507 of the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507). 

The OMB control number and 

expiration date of OMB approval for 

each information collection are shown 

in table 1. Copies of the supporting 

statements for the information 

collections are available on the internet 

at https://www.reginfo.gov/public/do/ 

PRAMain. An Agency may not conduct 

or sponsor, and a person is not required 

to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB 

Title of collection OMB 

control No. 

Date approval 

expires 

Shortages Data Collection ....................................................................................................................................... 0910–0491 05/31/2021 

Electronic Submission of Allegations of Regulatory Misconduct Associated with Medical Devices ...................... 0910–0769 11/30/2023 


KHAMMOND on DSKJM1Z7X2PROD with NOTICES
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