47118 Federal Register / Vol. 86, No. 160 / Monday, August 23, 2021 / Notices 

2013–D–1464 for ‘‘Bioequivalence 

Studies With Pharmacokinetic 

Endpoints for Drugs Submitted Under 

an ANDA.’’ Received comments 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 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

David Coppersmith, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1673, 

Silver Spring, MD 20993–0002, 301– 

796–9193. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a revised draft guidance for industry 

entitled ‘‘Bioequivalence Studies With 

Pharmacokinetic Endpoints for Drugs 

Submitted Under an ANDA.’’ The 

revised draft guidance supersedes the 

draft guidance ‘‘Bioequivalence Studies 

With Pharmacokinetic Endpoints for 

Drugs Submitted Under an ANDA,’’ 

which was announced in the Federal 

Register on December 5, 2013 (78 FR 

73199). FDA received nine comments 

on the draft guidance, which were 

considered before publication of this 

revised draft guidance. 

This revised draft guidance provides 

recommendations to applicants 

planning to include BE information in 

ANDAs and ANDA supplements. In 

addition, this guidance describes how to 

meet the BE requirements set forth in 

the FD&C Act and FDA regulations. This 

guidance is generally applicable to 

dosage forms intended for oral 

administration and to non-orally 

administered drug products in which 

reliance on systemic exposure measures 

is suitable for documenting BE (e.g., 

transdermal delivery systems and 

certain rectal and nasal drug products). 

This guidance will also be useful to 

applicants planning BE studies intended 

to be conducted during the postapproval period for changes to a drug 

product approved in an ANDA. FDA 

recommends that applicants consult this 

revised draft guidance, in conjunction 

with any relevant product-specific 

guidances for industry, when 

considering the appropriate BE study 

and/or other studies for a proposed drug 

product. 

This revised draft guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The revised draft guidance, 

when finalized, will represent the 

current thinking of FDA on 

‘‘Bioequivalence Studies With 

Pharmacokinetic Endpoints for Drugs 

Submitted Under an ANDA.’’ It does not 

establish any rights for any person and 

is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

II. Paperwork Reduction Act of 1995 

FDA tentatively concludes that this 

draft guidance contains no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: August 18, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–18073 Filed 8–20–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–P–0292] 

Determination That ORTHO-CEPT 

(Desogestrel-Ethinyl Estradiol) 21- and 

28-Day Oral Tablets, 0.15 Milligram/ 

0.03 Milligram, Were Not Withdrawn 

From Sale for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 

has determined that ORTHO-CEPT 

(desogestrel-ethinyl estradiol) 21- and 

28-day oral tablets, 0.15 milligram (mg)/ 

0.03 mg, were not withdrawn from sale 

for reasons of safety or effectiveness. 

This determination means that FDA will 

not begin procedures to withdraw 

approval of abbreviated new drug 

applications (ANDAs) that refer to this 

drug product, and it will allow FDA to 

continue to approve ANDAs that refer to 

the product as long as they meet 

relevant legal and regulatory 

requirements. 

FOR FURTHER INFORMATION CONTACT: 

Stacy Kane, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6236, Silver Spring, 

MD 20993–0002, 301–796–8363, 

Stacy.Kane@fda.hhs.gov. 


jbell on DSKJLSW7X2PROD with NOTICES
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 


jbell on DSKJLSW7X2PROD with NOTICES