Federal Register / Vol. 86, No. 160 / Monday, August 23, 2021 / Notices 47113 

on May 20, 2021 (86 FR 27447). This 

notice announces draft product-specific 

guidances, either new or revised, that 

are posted on FDA’s website. 

II. Drug Products for Which New Draft 

Product-Specific Guidances Are 

Available 

FDA is announcing the availability of 

new draft product-specific guidances for 

industry for drug products containing 

the following active ingredients: 

TABLE 1—NEW DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS

Active ingredient(s) 

Acyclovir 

Albuterol sulfate; Ipratropium bromide 

Amisulpride 

Avapritinib 

Carbinoxamine maleate 

Cefiderocol sulfate tosylate 

Copper dotatate Cu-64 

Esomeprazole magnesium 

Estradiol 

Ethinyl estradiol; Levonorgestrel 

Fostemsavir tromethamine 

Indomethacin 

Ipratropium bromide 

Lasmiditan succinate 

Leuprolide acetate 

Loteprednol etabonate 

Olodaterol hydrochloride 

Osilodrostat phosphate 

Ozanimod hydrochloride 

Paliperidone palmitate 

Semaglutide 

Sufentanil citrate 

Tazemetostat hydrobromide 

III. Drug Products for Which Revised 

Draft Product-Specific Guidances Are 

Available 

FDA is announcing the availability of 

revised draft product-specific guidances 

for industry for drug products 

containing the following active 

ingredients: 

TABLE 2—REVISED DRAFT PRODUCTSPECIFIC GUIDANCES FOR DRUG

PRODUCTS

Active ingredient(s) 

Bexarotene 

Budesonide 

Eltrombopaq olamine (multiple referenced 

listed drugs) 

Ferric citrate 

Letrozole 

Leuprolide acetate (multiple referenced listed 

drugs) 

Liothyronine sodium 

Loteprednol etabonate 

Nystatin 

Orlistat 

Paclitaxel 

Podofilox 

TABLE 2—REVISED DRAFT PRODUCTSPECIFIC GUIDANCES FOR DRUG

PRODUCTS—Continued 

Active ingredient(s) 

Sodium zirconium cyclosilicate 

Tazarotene 

For a complete history of previously 

published Federal Register notices 

related to product-specific guidances, go 

to https://www.regulations.gov and 

enter Docket No. FDA–2007–D–0369. 

These draft guidances are being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). These draft guidances, when 

finalized, will represent the current 

thinking of FDA on, among other things, 

the product-specific design of BE 

studies to support ANDAs. They do not 

establish any rights for any person and 

are not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

IV. Paperwork Reduction Act of 1995 

FDA tentatively concludes that these 

draft guidances contain no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required. 

V. Electronic Access 

Persons with access to the internet 

may obtain the draft guidances at either 

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. 2021–18072 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–N–0359] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Human Drug 

Compounding, Repackaging, and 

Related Activities Regarding Sections 

503A and 503B of the Federal Food, 

Drug, and Cosmetic Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by September 

22, 2021. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

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. The OMB 

control number for this information 

collection is 0910–0858. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Human Drug Compounding, 

Repackaging, and Related Activities 

Regarding Sections 503A and 503B of 

the Federal Food, Drug, and Cosmetic 

Act 

OMB Control Number 0910–0858— 

Revision 

This information collection supports 

implementation of sections 503A and 

503B of the Federal Food, Drug, and 


jbell on DSKJLSW7X2PROD with NOTICES
47114 Federal Register / Vol. 86, No. 160 / Monday, August 23, 2021 / Notices 

1 Guidance documents applicable to animal drug 

compounding regulated by our Center for 

Veterinary Medicine would also be returned if no 

FDA Organization is selected; this information 

collection covers only those Compounding 

documents issued by the Center for Drug Evaluation 

and Research. 

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

353a and 21 U.S.C. 353b), which govern 

compounding by pharmacies, 

outsourcing facilities, and other entities. 

Compounding is generally a practice in 

which a licensed pharmacist, a licensed 

physician, or, in the case of an 

outsourcing facility, a person under the 

supervision of a licensed pharmacist, 

combines, mixes, or alters ingredients of 

a drug to create a medication tailored to 

the needs of an individual patient. 

Although compounded drugs can serve 

an important medical need for certain 

patients, they also present risks to 

patients. Our compounding program 

aims to protect patients from unsafe, 

ineffective, and poor quality 

compounded drugs, while preserving 

access to lawfully-marketed 

compounded drugs for patients who 

have a medical need for them. 

Respondents to the information 

collection are pharmacies, outsourcing 

facilities, and other entities. 

To assist respondents in complying 

with statutory requirements, we have 

issued the following topic-specific 

guidance documents: 

TABLE 1—PUBLISHED GUIDANCE DOCUMENTS REGARDING SECTIONS 503A AND 503B OF THE FD&C ACT

Title Notice of availability 

publication date 

Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities (‘‘Radiopharmaceutical Compounding and Repackaging Guidance’’).September 26, 2018 (83 FR 

48633). 

Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities (‘‘Radiopharmaceutical Outsourcing Repackaging Guidance’’).September 26, 2018 (83 FR 

48630). 

Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities (‘‘Repackaging Guidance’’).January 13, 2017 (82 FR 

4343). 

Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (‘‘Biologics Guidance’’).January 19, 2018 (83 FR 

2787). 

These guidance documents were 

issued consistent with our Good 

Guidance Practice regulations in 21 CFR 

part 10.115 which provide for public 

comment at any time. The guidance 

documents communicate our current 

thinking on the respective topics and 

include information collection that may 

result in expenditures of time and effort 

by respondents. In our notices of 

availability we also solicited public 

comment under the PRA on the 

information collection provisions. FDA 

has developed and maintains a 

searchable guidance database available 

at: https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments. Guidance documents 

covered by this information collection 

may be found by choosing ‘‘Center for 

Drug Evaluation and Research’’ from 

among the FDA Organizations, and by 

selecting the term ‘‘Compounding’’ from 

among the possible ‘‘Topic’’ filters.1 For 

efficiency of operations we are 

consolidating the related information 

collections. 

Compounding and Repackaging of 

Radiopharmaceuticals by StateLicensed Nuclear Pharmacies, Federal 

Facilities, and Certain Other Entities 

Because Congress explicitly excluded 

radiopharmaceuticals from section 503A 

of the FD&C Act (see section 

503A(d)(2)), compounded 

radiopharmaceuticals are not eligible for 

the exemptions under section 503A 

from section 505 of the FD&C Act (21 

U.S.C. 355) (concerning new drug 

approval requirements), section 

502(f)(1) of the FD&C Act (21 U.S.C. 

352(f)(1)) (concerning labeling with 

adequate directions for use), and section 

501(a)(2)(B) of the FD&C Act (21 U.S.C. 

351(a)(2)B)) (concerning current good 

manufacturing practice (CGMP) 

requirements). In addition, the FD&C 

Act does not provide an exemption for 

repackaged radiopharmaceuticals. This 

guidance document describes the 

conditions under which FDA does not 

intend to take action for violations of 

sections 505, 502(f)(1), and 501(a)(2)(B) 

of the FD&C Act when a state-licensed 

nuclear pharmacy, Federal facility, or 

other facility that is not an outsourcing 

facility and that holds a radioactive 

materials license for medical use issued 

by the Nuclear Regulatory Commission 

or by an Agreement State compounds or 

repackages radiopharmaceuticals for 

human use. The guidance explains that 

one condition is that the compounded 

radiopharmaceutical is not essentially a 

copy of an approved 

radiopharmaceutical. As described in 

the guidance, FDA does not intend to 

consider a compounded 

radiopharmaceutical to be essentially a 

copy if, among other reasons, there is a 

change between the compounded 

radiopharmaceutical and the approved 

radiopharmaceutical that produces a 

clinical difference for an identified 

individual patient, as determined by the 

prescribing practitioner and 

documented in writing on the 

prescription or order. In addition, FDA 

does not intend to consider a 

compounded radiopharmaceutical to be 

essentially a copy if the FDA-approved 

radiopharmaceutical is on FDA’s drug 

shortage list (see section 506E of the 

FD&C Act (21 U.S.C. 356e)) at the time 

of compounding and distribution. If the 

facility compounded a drug that is 

identical or nearly identical to an 

approved drug product that appeared on 

FDA’s drug shortage list, the facility 

should maintain documentation (e.g., a 

notation on the order for the 

compounded drug) regarding the status 

of the drug on FDA’s drug shortage list 

at the time of compounding, 

distribution, and dispensing. 

Radiopharmaceutical Outsourcing 

Repackaging Guidance 

In contrast to section 503A, section 

503B of the FD&C Act does not exclude 

radiopharmaceuticals. Therefore, FDA’s 

overall policies regarding section 503B 

apply to the compounding of 

radiopharmaceutical drug products. 

However, we have developed specific 

policies that apply only to the 

compounding of radiopharmaceuticals 

by outsourcing facilities using bulk drug 

substances and to the compounding of 

radiopharmaceuticals by outsourcing 

facilities that are essentially copies of 

approved drugs when such 

compounding is limited to minor 

deviations, as that term is defined in the 

guidance. FDA issued this guidance in 

part to describe the conditions under 

which the Agency does not generally 

intend to take action for violations of 

sections 505 and 502(f)(1) of the FD&C 

Act when an outsourcing facility 

repackages radiopharmaceuticals for 

human use. 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 160 / Monday, August 23, 2021 / Notices 47115 

As discussed in the guidance, one 

condition is that if a 

radiopharmaceutical is repackaged by 

an outsourcing facility, the label on the 

immediate container (primary 

packaging, e.g., the syringe) of the 

repackaged product includes certain 

information. The guidance also provides 

that the label on the container from 

which the individual units are removed 

for administration (secondary 

packaging, e.g., the bag, box, or other 

package in which the repackaged 

products are distributed) includes: (1) 

The active and inactive ingredients, if 

the immediate product label is too small 

to include this information, and 

directions for use, including (as 

appropriate) dosage and administration 

and (2) the following information to 

facilitate adverse event reporting: and 

1–800–FDA–1088. 

Repackaging Guidance 

This guidance describes the 

conditions under which FDA does not 

intend to take action for violations of 

sections 505 (concerning new drug 

applications), 502(f)(1) (concerning 

labeling with adequate directions for 

use), 582 ((21 U.S.C. 360eee–1) 

concerning drug supply chain security 

requirements), and (where specified in 

the guidance) section 501(a)(2)(B) of the 

FD&C Act (concerning CGMPs), when a 

state-licensed pharmacy, Federal 

facility, or outsourcing facility 

repackages certain prescription drug 

products. One condition discussed in 

the guidance is that if a drug is 

repackaged by an outsourcing facility, 

the label on the immediate container 

(primary packaging, e.g., the syringe) of 

the repackaged product includes certain 

information described in the guidance. 

Another condition discussed in the 

guidance is that the label on the 

container from which the individual 

units are removed for administration 

(secondary packaging, e.g., the bag, box, 

or other package in which the 

repackaged products are distributed) 

includes: (1) The active and inactive 

ingredients, if the immediate product 

label is too small to include this 

information, and directions for use, 

including (as appropriate) dosage and 

administration, (2) directions for use, 

including, as appropriate, dosage and 

administration, and (3) the following 

information to facilitate adverse event 

reporting: https://www.fda.gov/ 

medwatch and 1–800–FDA–1088. 

Biologics Guidance 

Certain licensed biological products 

may sometimes be mixed, diluted, or 

repackaged in a way not described in 

the approved labeling for the product to 

meet the needs of a specific patient. As 

described in the guidance, biological 

products subject to licensure under 

section 351 of the Public Health Service 

(PHS) Act (42 U.S.C. 262) are not 

eligible for the statutory exemptions 

available to certain compounded drugs 

under sections 503A and 503B of the 

FD&C Act. In addition, a biological 

product that is mixed, diluted, or 

repackaged outside the scope of an 

approved Biologics License Application 

(BLA) is considered an unlicensed 

biological product under section 351 of 

the PHS Act. 

This guidance document describes 

several conditions under which FDA 

does not intend to take action for 

violations of section 351 of the PHS Act 

and sections 502(f)(1), 582, and (where 

specified) 501(a)(2)(B) of the FD&C Act, 

when a State-licensed pharmacy, a 

Federal facility, or an outsourcing 

facility dilutes, mixes, or repackages 

certain biological products outside the 

scope of an approved BLA. 

One condition discussed in the 

guidance is that if the labeling for the 

licensed biological product includes 

storage instructions, handling 

instructions, or both (for example, 

protect from light, do not freeze, keep at 

specified storage temperature), the 

labeling for the biological product that 

is mixed, diluted, or repackaged 

specifies the same storage conditions. 

Another condition described in the 

guidance is that, if the biological 

product is mixed, diluted, or repackaged 

by an outsourcing facility, the label on 

the immediate container (primary 

packaging, for example, the syringe) of 

the mixed, diluted, or repackaged 

product includes certain information 

described in the guidance. In addition, 

the guidance communicates that as a 

condition for biological products mixed, 

diluted, or repackaged by an 

outsourcing facility that, if the 

immediate product label is too small to 

bear the active and inactive ingredients, 

such information is included on the 

label of the container from which the 

individual units are removed for 

administration (secondary packaging, 

for example, the bag, box, or other 

package in which the mixed, diluted, or 

repackaged biological products are 

distributed). 

The guidance also communicates our 

thinking about the condition for 

biological products mixed, diluted, or 

repackaged by an outsourcing facility 

that the label on the container from 

which the individual units are removed 

for administration include directions for 

use. These directions include, as 

appropriate, the dosage and 

administration and the following 

information to facilitate adverse event 

reporting: https://www.fda.gov/ 

medwatch and 1–800–FDA–1088. 

Finally, another condition described 

in the guidance is that outsourcing 

facilities maintain records of the testing 

performed in accordance with 

‘‘Appendix A—Assigning a BUD for 

Repackaged Biological Products Based 

On Stability Testing’’ of the guidance for 

biological products repackaged by 

outsourcing facilities for which the 

beyond use date (BUD) is established 

based on a stability program conducted 

in accordance with Appendix A. 

Section III.C of the guidance, 

‘‘Licensed Allergenic Extracts for 

Subcutaneous Immunotherapy,’’ 

discusses the preparation of 

prescription sets (that is, licensed 

allergenic extracts that are mixed and 

diluted to provide subcutaneous 

immunotherapy to an individual 

patient) by a physician, a State-licensed 

pharmacy, a Federal facility, or an 

outsourcing facility. Another condition 

described in the guidance is that if the 

prescription set is prepared by an 

outsourcing facility, the label of the 

container from which the individual 

units of the prescription set are removed 

for administration (secondary 

packaging) includes the following 

information to facilitate adverse event 

reporting: https://www.fda.gov/ 

medwatch and 1–800–FDA–1088. Each 

prescription set prepared by an 

outsourcing facility is also accompanied 

by instructions for use. 

In the Federal Register of April 29, 

2021 (86 FR 22674), we published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. No comments were 

received. 

We estimate the burden of the 

information collection as follows: 


jbell on DSKJLSW7X2PROD with NOTICES
47116 Federal Register / Vol. 86, No. 160 / Monday, August 23, 2021 / Notices 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Radiopharmaceutical Guidance 

Consultation between the compounder and prescriber and 

the notation on the prescription or order documenting 

the prescriber’s determination of clinical difference.

10 25 250 .05 (3 minutes).12.5 

Radiopharmaceutical Outsourcing And Repackaging Guidance 

Designing, testing, and producing each label on immediate 

containers, packages and/or outer containers.

2 5 10 0.5 (30 minutes).5 

Repackaging Guidance 

Designing, testing, and producing each label on immediate 

containers, packages, and/or outer containers.

6 21 126 1 .................... 126 

Biannual product reports identifying drug products repackaged by the outsourcing facility during the previous 6- 

month period (Guidance Section III.A.).

3 4 12 3 .................... 24 

Biologics Guidance 

Designing, testing, and producing the label, container, 

packages, and/or outer containers for each mixed, diluted, or repackaged biological product.

15 5 75 0.5 (30 minutes).37.5 

Designing, testing, and producing each label on immediate 

containers, packages and/or outer containers for each licensed allergenic extract.

5 300 1,500 0.5 (30 minutes).750 

Maintaining records of testing performed in accordance 

with Biologics Guidance Appendix A.

5 30 150 0.083 (5 minutes).12.5 

Total ............................................................................... ........................ ........................ 2,123 ....................... 967.5 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

As defined in 44 U.S.C. 3502(13), the 

term ‘‘recordkeeping requirement’’ 

means a requirement imposed on 

respondents to maintain specified 

records, as well as a requirement to 

‘‘retain such records; notify third 

parties, the Federal Government, or the 

public of the existence of such records; 

disclose such records to third parties, 

the Federal Government, or the public; 

or report to third parties, the Federal 

Government, or the public regarding 

such records.’’ For purposes of our 

analysis, therefore, we have 

characterized the burden associated 

with the time and effort expended on 

the information collection 

recommendations discussed in the 

respective guidance documents as 

recordkeeping activities. At the same 

time, our findings show that compliance 

with recordkeeping requirements 

applicable to compounded and 

repackaged drug products is standard 

practice in the compounding and selling 

of these drug products under States’ 

pharmacy laws and other State laws 

governing recordkeeping by healthcare 

professionals and healthcare facilities. 

We have therefore excluded from our 

estimate recordkeeping practices 

discussed in the respective guidance 

documents we consider usual and 

customary. We invite comment on this 

assumption. 

Radiopharmaceutical Compounding 

and Repackaging Guidance 

We estimate 10 compounders 

annually will consult a prescriber to 

determine whether a compounded 

radiopharmaceutical has a change that 

produces a clinical difference for an 

identified individual patient as 

compared to the comparable approved 

radiopharmaceutical. We estimate that 

those compounders will document this 

determination on 250 prescriptions or 

orders for compounded 

radiopharmaceuticals. We assume 

consultation between the compounder 

and the prescriber and noting this 

determination on each prescription or 

order that does not already document 

this determination will take 3 minutes 

(0.05 hours) per prescription or order, 

for a total of approximately 12.5 hours. 

Radiopharmaceutical Outsourcing and 

Repackaging Guidance 

We estimate a total of 2 outsourcing 

facilities annually will each design, test, 

and produce an average of 5 different 

labels for a total of 10 labels, as 

described in the guidance (including 

directions for use). We assume that 

designing, testing, and producing each 

label will take 30 minutes (0.5 hours) for 

each repackaged radiopharmaceutical, 

for a total of 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. 

Repackaging Guidance 

Based on current data for outsourcing 

facilities, we estimate 6 outsourcing 

facilities annually will submit an initial 

report identifying all drugs repackaged 

in the facility in the previous year. For 

the purposes of this estimate, each 

product’s structured product labeling 

(SPL) submission is considered a 

separate response and therefore each 

facility’s product report will include 

multiple responses. Taking into account 

that a particular product that is 

repackaged may come in different 

strengths and can be reported in a single 


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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– 


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