Federal Register / Vol. 86, No. 160 / Monday, August 23, 2021 / Notices 47119 

SUPPLEMENTARY INFORMATION: Section 

505(j) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

355(j)) allows the submission of an 

ANDA to market a generic version of a 

previously approved drug product. To 

obtain approval, the ANDA applicant 

must show, among other things, that the 

generic drug product: (1) Has the same 

active ingredient(s), dosage form, route 

of administration, strength, conditions 

of use, and, with certain exceptions, 

labeling as the listed drug, which is a 

version of the drug that was previously 

approved and (2) is bioequivalent to the 

listed drug. ANDA applicants do not 

have to repeat the extensive clinical 

testing otherwise necessary to gain 

approval of a new drug application 

(NDA). 

Section 505(j)(7) of the FD&C Act 

requires FDA to publish a list of all 

approved drugs. FDA publishes this list 

as part of the ‘‘Approved Drug Products 

with Therapeutic Equivalence 

Evaluations,’’ which is known generally 

as the ‘‘Orange Book.’’ Under FDA 

regulations, drugs are removed from the 

list if the Agency withdraws or 

suspends approval of the drug’s NDA or 

ANDA for reasons of safety or 

effectiveness, or if FDA determines that 

the listed drug was withdrawn from sale 

for reasons of safety or effectiveness (21 

CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

ORTHO-CEPT (desogestrel-ethinyl 

estradiol) 21- and 28-day oral tablets, 

0.15 mg/0.03 mg, is the subject of NDA 

020301, held by Janssen 

Pharmaceuticals, Inc., and initially 

approved on December 14, 1992. 

ORTHO-CEPT is indicated for the 

prevention of pregnancy in women who 

elect to use oral contraceptives as a 

method of contraception. 

In a letter dated October 7, 2014, 

Janssen Pharmaceuticals, Inc., notified 

FDA that ORTHO-CEPT (desogestrelethinyl estradiol) 21- and 28-day oral 

tablets, 0.15 mg/0.03 mg, were being 

discontinued, and FDA moved the drug 

product to the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. 

Arnall Golden Gregory LLP submitted 

a citizen petition dated March 11, 2021 

(Docket No. FDA–2021–P–0292), under 

21 CFR 10.30, requesting that the 

Agency determine whether ORTHOCEPT (desogestrel-ethinyl estradiol) oral 

tablets, were withdrawn from sale for 

reasons of safety or effectiveness. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that ORTHO-CEPT 

(desogestrel-ethinyl estradiol) 21- and 

28-day oral tablets, 0.15 mg/0.03 mg, 

were not withdrawn for reasons of 

safety or effectiveness. The petitioner 

has identified no data or other 

information suggesting that ORTHOCEPT (desogestrel-ethinyl estradiol) 21- 

and 28-day oral tablets, 0.15 mg/0.03 

mg, were withdrawn for reasons of 

safety or effectiveness. We have 

carefully reviewed our files for records 

concerning the withdrawal of ORTHOCEPT (desogestrel-ethinyl estradiol) 21- 

and 28-day oral tablets, 0.15 mg/0.03 

mg, from sale. We have also 

independently evaluated relevant 

literature and data for possible 

postmarketing adverse events. We have 

found no information that would 

indicate that this drug product was 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list ORTHO-CEPT 

(desogestrel-ethinyl estradiol) 21- and 

28-day oral tablets, 0.15 mg/0.03 mg, in 

the ‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. FDA will not 

begin procedures to withdraw approval 

of approved ANDAs that refer to this 

drug product. Additional ANDAs for 

this drug product may also be approved 

by the Agency as long as they meet all 

other legal and regulatory requirements 

for the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: August 17, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–17990 Filed 8–20–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

[OMB No. 0906–XXXX] 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request Information 

Collection Request Title: COVID–19 

Provider Relief Programs Application 

and Attestation Portal, and Claims 

Reimbursement Submission Activities 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than October 22, 2021. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N136B, 5600 Fishers 

Lane, Rockville, MD 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Lisa Wright-Solomon, the HRSA 

Information Collection Clearance Officer 

at (301) 443–1984. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information request collection title for 

reference. 

Information Collection Request Title: 

COVID–19 Provider Relief Programs 

Application and Attestation Portal, and 

Claims Reimbursement Submission 

Activities, OMB No. 0906–XXXX. 

Abstract: HRSA administers the 

Provider Relief Programs (which 

includes the Provider Relief Fund (PRF), 

the American Rescue Plan Act Rural 

(ARPA–R) payments, the COVID–19 

Coverage Assistance Fund (CAF), and 

the COVID–19 Claims Reimbursement 

to Health Care Providers and Facilities 

for Testing, Treatment, and Vaccine 

Administration for the Uninsured 

(Uninsured Program or UIP). The 


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47120 Federal Register / Vol. 86, No. 160 / Monday, August 23, 2021 / Notices 

Provider Relief Programs disbursed, and 

are continuing to disburse, funds to 

eligible healthcare providers through 

two pathways: (1) Direct provider 

payments via the PRF and ARPA–R 

payments, and (2) claims 

reimbursement via the CAF and the UIP. 

This information collection includes 

four components: (1) The PRF and 

ARPA–R application portal; (2) the PRF 

and ARPA–R attestation portal; (3) the 

CAF application portal; and (4) the UIP 

application portal. To date, information 

for these programs has been collected 

under a Paperwork Reduction Act 

waiver executed pursuant to public 

health emergency authorities. HRSA is 

seeking comments regarding the CAF 

and the UIP for the first time. These 

information collections support 

administration of the Provider Relief 

Programs including the PRF, the 

Uninsured Program, and the CAF (funds 

for these three programs were 

appropriated under the Coronavirus 

Aid, Relief, and Economic Security Act 

(Pub. L. 116–136), Paycheck Protection 

Program and Health Care Enhancement 

Act (Pub. L. 116–139), Coronavirus 

Response and Relief Supplemental 

Appropriations Act (Division M of Pub. 

L. 116–260)), and the ARPA–R 

payments (funds were appropriated 

under the American Rescue Plan Act of 

2021, Pub. L. 117–2). 

Need and Proposed Use of the 

Information: Providers who apply for 

Provider Relief Programs (i.e., PRF, 

ARPA–R, CAF, and UIP payments) must 

apply for direct provider payments or 

claims reimbursement and attest to a set 

of Terms and Conditions to enable 

HRSA’s appropriate disbursement and 

oversight of recipients’ use of funds. 

Information collected will allow for 

(1) assessing if recipients have met 

statutory and programmatic 

requirements; (2) conducting audits; (3) 

gathering data required to calculate, 

disburse, and report on PRF, ARPA–R, 

CAF, and UIP payments; and (4) 

program evaluation. HRSA staff may 

also use information collected to 

identify and report on trends in the 

effect of the COVID–19 pandemic on 

health care providers and uninsured or 

underinsured patients throughout the 

United States. 

HHS makes publicly available the 

names of payment recipients and the 

aggregate amounts received, for all 

providers who attest to receipt of a 

payment and acceptance of the Terms 

and Conditions or who retain payments 

for more than 90 days and are deemed 

to have accepted the Terms and 

Conditions. By accepting funds, the 

recipient consents to HHS publicly 

disclosing the payments that recipient 

has received. 

Likely Respondents: Health care 

providers that apply to receive, or have 

applied to receive, PRF, ARPA–R, CAF, 

or UIP payments, and attested to the 

associated Terms and Conditions. 

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 

Attestation Portal .................................................................. 130,000 1 130,000 0.25 32,500 

Application Portal ................................................................. 130,000 1 130,000 1.00 130,000 

CAF Application ................................................................... 15,000 1 15,000 1.00 15,000 

UIP Application .................................................................... 280,000 1 280,000 5.60 1,568,000 

Total .............................................................................. 555,000 ........................ 555,000 ........................ 1,745,500 

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. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2021–18018 Filed 8–20–21; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Information Technology 

Advisory Committee 2021 Schedule of 

Meetings 

AGENCY: Office of the National 

Coordinator for Health Information 

Technology (ONC), HHS. 

ACTION: Notice of meetings. 

SUMMARY: The Health Information 

Technology Advisory Committee 

(HITAC) was established in accordance 

with the 21st Century Cures Act and the 

Federal Advisory Committee Act. The 

HITAC, among other things, identifies 

priorities for standards adoption and 

makes recommendations to the National 

Coordinator for Health Information 

Technology (National Coordinator). The 

HITAC will hold public meetings 

throughout 2021. See list of public 

meetings below. 

FOR FURTHER INFORMATION CONTACT: 

Michael Berry, Designated Federal 

Officer, at Michael.Berry@hhs.gov, (202) 

701–0795. 

SUPPLEMENTARY INFORMATION: Section 

4003(e) of the 21st Century Cures Act 

(Pub. L. 114–255) establishes the Health 

Information Technology Advisory 

Committee (referred to as the ‘‘HITAC’’). 

The HITAC will be governed by the 

provisions of the Federal Advisory 

Committee Act (FACA) (Pub. L. 92– 

463), as amended, (5 U.S.C. App.), 

which sets forth standards for the 

formation and use of federal advisory 

committees. 

Composition 

The HITAC is comprised of at least 25 

members, of which: 


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