Federal Register / Vol. 86, No. 160 / Monday, August 23, 2021 / Notices 47117 

SPL response, we estimate that each 

facility will average approximately 6 

products. 

Similarly, we estimate that 6 

outsourcing facilities will submit an 

initial report identifying all drugs 

repackaged in the facility in the past 

year. Taking into account that a 

particular product that is repackaged 

may come in different strengths and can 

be reported in a single SPL response, we 

assume that each facility will average 6 

products. Our estimate is based on 

current product reporting data. We 

expect that each product report will 

consist of multiple SPL responses per 

facility and assume preparing and 

electronically submitting this 

information will take up to 2 hours for 

each initial SPL response. 

We also estimate 3 registered 

outsourcing facilities will submit a 

report twice each year (June and 

December) that identifies all drugs 

repackaged at the facility in the 

previous 6 months. We also estimate 

that an average of 3 facilities will 

prepare and submit 3 SPL responses and 

assume that preparing and submitting 

this information electronically could 

also take up to 2 hours per response. If 

a product was not repackaged during a 

particular reporting period, outsourcing 

facilities do not need to send an SPL 

response for that product during that 

reporting period. Our figures reflect 

what we believe to be the average 

burden among respondents. We expect 

to receive no waiver requests from the 

electronic submission process for initial 

product reports and semiannual reports. 

Biologics Guidance 

We estimate 15 outsourcing facilities 

annually who mix, dilute, or repackage 

biological products will each design, 

test, and produce 5 different labels, for 

a total of 75 labels that include the 

information set forth in section III.B— 

‘‘Mixing, Diluting, or Repackaging 

Licensed Biological Products’’ of the 

guidance (including directions for use) 

as well as inclusion of storage 

instructions, handling instructions, or 

both. We assume that designing, testing, 

and producing each label will take 30 

minutes (0.5 hours). We consider that 

the provision to include ‘‘https://

www.fda.gov/medwatch’’ and ‘‘1–800– 

FDA–1088’’ is not a collection of 

information as defined in 5 CFR 

1320.3(c)(2) and is therefore exempt 

from OMB review and approval under 

the PRA. 

We estimate that annually a total of 5 

outsourcing facilities that prepare 

prescription sets will each include on 

the labels, packages, and/or containers 

of approximately 300 prescription sets 

the information set forth in section III.C 

‘‘Licensed Allergenic Extracts for 

Subcutaneous Immunotherapy’’ of the 

draft guidance (including directions for 

use), for a total of 1,500 disclosures. We 

assume the initial process of designing, 

testing, and producing labeling and 

attaching to each prescription set each 

label, package, and/or container will 

take approximately 30 minutes (0.5 

hours), for a total of approximately 750 

hours. 

Finally, we estimate that annually five 

outsourcing facilities who repackage 

biological products and establish a BUD 

in accordance with Appendix A— 

‘‘Assigning a BUD for Repackaged 

Biological Products Based On Stability 

Testing’’ will maintain 150 records of 

the testing, as described in Appendix A 

of the guidance. We assume maintaining 

the records will take 5 minutes per 

record, for a total of 12.5 hours. 

Our estimated burden for the 

information collection reflects program 

changes and adjustments. We are 

changing the scope of the information 

collection to include burden attendant 

to provisions found in the Agency 

guidance documents discussed in this 

notice and have adjusted our estimate to 

reflect a resulting increase of 955 hours 

and 1,873 responses annually. 

Dated: August 5, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–17996 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–2013–D–1464] 

Bioequivalence Studies With 

Pharmacokinetic Endpoints for Drugs 

Submitted Under an Abbreviated New 

Drug Application; Draft Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a revised 

draft guidance for industry entitled 

‘‘Bioequivalence Studies With 

Pharmacokinetic Endpoints for Drugs 

Submitted Under an ANDA.’’ This 

revised draft supersedes the draft 

guidance entitled ‘‘Bioequivalence 

Studies With Pharmacokinetic 

Endpoints for Drug Products Submitted 

Under an ANDA,’’ which was 

announced in the Federal Register on 

December 5, 2013. This revised draft 

guidance provides recommendations to 

applicants planning to include 

bioequivalence (BE) information in 

abbreviated new drug applications 

(ANDAs) and ANDA supplements. In 

addition, this guidance describes how to 

meet the BE requirements set forth in 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) and FDA regulations. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by October 22, 2021 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 


jbell on DSKJLSW7X2PROD with NOTICES
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