40254 Federal Register / Vol. 87, No. 128 / Wednesday, July 6, 2022 / Notices 

expiry dating extensions under section 

564A of the FDC&C Act. We attribute 

greater burden to those requests for FDA 

to review pre-EUA packages submitted 

by product sponsors than burden we 

attribute to those submitted by Federal 

agencies (e.g., Centers for Disease 

Control and Prevention, the Department 

of Defense), and have considered other 

factors that contribute to variability in 

burden for reporting, including the type 

of product and whether there is a 

previously reviewed pre-EUA package 

or investigational application. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Records associated with conditions of authorization Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

EUA Holders ........................................................................ 648 2 1,296 25 32,400 

State and local Public Health Authorities ............................ 1 1 1 3 3 

Total .............................................................................. ........................ ........................ 1,297 ........................ 32,403 

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

We provide a conservative estimate 

for respondent recordkeeping, 

recognizing that the Federal 

Government performs much of this 

activity in conjunction with 

submissions. We do not include burden 

for public health authorities who may 

need to submit emergency dispensing 

orders or expiration date extension 

requests, assuming covered entities 

already maintain these records for the 

products they stockpile. 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Information collection activity Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Dissemination of required information by EUA Holder or 

Authorized Stakeholder .................................................... 635 2 1270 5 6350 

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

Our third-party disclosure estimate is 

based on the number of EUA holders 

and authorized stakeholders 

disseminating information, including 

fact sheets, advertising, and promotional 

materials. 

We have increased our burden 

estimate for the information collection 

to reflect the increase in submissions we 

have received over the last 3 years. 

Dated: June 23, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–14347 Filed 7–5–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–1956] 

Identifying Trading Partners Under the 

Drug Supply Chain Security Act; 

Revised 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 

‘‘Identifying Trading Partners Under the 

Drug Supply Chain Security Act.’’ FDA 

is issuing this guidance to assist 

industry and State and local 

governments in understanding how to 

categorize the entities in the drug 

supply chain in accordance with the 

Drug Supply Chain Security Act 

(DSCSA). The revised draft guidance 

explains how to determine when certain 

statutory requirements will apply to 

entities that are considered trading 

partners in the drug supply chain. It 

also discusses the activities of privatelabel distributors, salvagers, and returns 

processors and reverse logistics 

providers. Additionally, the revised 

draft guidance discusses the distribution 

of drugs for emergency medical reasons, 

office use, non-human research 

purposes, and research purposes in 

humans under an investigational new 

drug application. This guidance revises 

the August 2017 draft guidance entitled 

‘‘Identifying Trading Partners Under the 

Drug Supply Chain Security Act.’’ 

DATES: Submit either electronic or 

written comments on the draft guidance 

by September 6, 2022 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’’). 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 128 / Wednesday, July 6, 2022 / Notices 40255 

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– 

2017–D–1956 for ‘‘Identifying Trading 

Partners Under the Drug Supply Chain 

Security Act.’’ 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; or to the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

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: 

Aaron Weisbuch, Office of Compliance, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–3130, Aaron.Weisbuch@

fda.hhs.gov or drugtrackandtrace@

fda.hhs.gov; or Stephen Ripley, Center 

for Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a revised draft guidance for industry 

entitled ‘‘Identifying Trading Partners 

Under the Drug Supply Chain Security 

Act.’’ The DSCSA (Title II of Pub. L. 

113–54) establishes new requirements to 

develop and enhance drug distribution 

security by 2023. It does this, in part, by 

defining different types of entities in the 

drug supply chain as trading partners 

(manufacturers, repackagers, wholesale 

distributors, third-party logistics 

providers, and dispensers). Among 

other things, the DSCSA requires that 

trading partners of manufacturers, 

wholesale distributors, dispensers, and 

repackagers meet the applicable 

requirements for being ‘‘authorized 

trading partners.’’ 

In addition, the DSCSA outlines 

requirements for specific trading 

partners, including drug product 

tracing, verification, and licensure 

requirements (where applicable). This 

revised draft guidance describes the 

activities and requirements for entities 

that are considered to be a 

manufacturer, repackager, wholesale 

drug distributor, third-party logistics 

provider, and/or dispenser and therefore 

considered a trading partner under the 

DSCSA. This guidance revises the draft 

guidance entitled ‘‘Identifying Trading 

Partners Under the Drug Supply Chain 

Security Act’’ that was published on 

August 24, 2017 (82 FR 40159). 

In response to public comments 

received and policy considerations, 

FDA has added or revised its current 

thinking on the status of some entities 

as trading partners, including privatelabel distributors, salvagers, and returns 

processors and reverse logistics 

providers. The Agency has also 

provided clarification on certain drug 

distribution scenarios, including 

distribution for emergency medical use, 

office use, non-human research 

purposes, and research in humans 

under an investigational new drug 

application. FDA also addresses the 

interpretation of section 582(a)(7) of the 

Federal Food, Drug, and Cosmetic Act, 

which discusses third-party logistics 

providers licensure status prior to the 

effective date of the forthcoming 

regulations establishing licensure 

standards. 

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 ‘‘Identifying 

Trading Partners Under the Drug Supply 

Chain Security Act.’’ 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. This 

guidance is not subject to Executive 

Order 12866. 

II. Paperwork Reduction Act of 1995 

FDA tentatively concludes that this 

revised 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, https://

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryVerDate Sep<11>2014 18:29 Jul 05, 2022 Jkt 256001 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 E:\FR\FM\06JYN1.SGM 06JYN1

jspears on DSK121TN23PROD with NOTICES1
40256 Federal Register / Vol. 87, No. 128 / Wednesday, July 6, 2022 / Notices 

information-biologics/biologicsguidances, or https://

www.regulations.gov. 

Dated: June 27, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–14345 Filed 7–5–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2012–N–0559; FDA– 

2018–N–4206; FDA–2017–D–5225; FDA– 

2018–N–3758; FDA–2018–D–4533] 

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: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, 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 

PHS Guideline on Infectious Disease Issues in Xenotransplantation .................................................................... 0910–0456 6/30/2025 

MDUFMA Small Business Qualification Certification .............................................................................................. 0910–0508 6/30/2025 

Foreign Supplier Verification Programs for Importers of Food for Humans and Animals ...................................... 0910–0752 6/30/2025 

Expanded Access to Investigational Drugs for Treatment Use .............................................................................. 0910–0814 6/30/2025 

Compounding Animal Drugs from Bulk Drug Substances ...................................................................................... 0910–0904 6/30/2025 

Dated: June 29, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–14348 Filed 7–5–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–E–0450] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; MARGENZA 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for MARGENZA and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human 

biological product. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by September 6, 2022. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

January 3, 2023. See ‘‘Petitions’’ in the 

SUPPLEMENTARY INFORMATION section for 

more information. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before September 6, 

2022. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of September 6, 2022. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

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’’). 


jspears on DSK121TN23PROD with NOTICES1