13738 Federal Register / Vol. 87, No. 47 / Thursday, March 10, 2022 / Notices 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by March 31, 2022. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact She-Chia Chen 

(see FOR FURTHER INFORMATION CONTACT) 

at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: February 28, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–05022 Filed 3–9–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–3462] 

Verification Systems Under the Drug 

Supply Chain Security Act for Certain 

Prescription Drugs; Draft Guidance for 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draft guidance entitled ‘‘Verification 

Systems Under the Drug Supply Chain 

Security Act for Certain Prescription 

Drugs.’’ This revised draft guidance 

addresses the verification systems that 

manufacturers, repackagers, wholesale 

distributors, and dispensers must have 

in place to comply with the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act), as amended by the Drug Supply 

Chain Security Act (DSCSA). 

Specifically, this revised draft guidance 

covers the statutory verification system 

requirements that include the 

quarantine and investigation of a 

product determined to be suspect and 

the quarantine and disposition of a 

product determined to be illegitimate. 

The revised draft guidance also 

addresses the statutory requirement for 

notification to the Agency of a product 

that has been cleared by a manufacturer, 

repackager, wholesale distributor, or 

dispenser (also referred to as ‘‘trading 

partners’’) after a suspect product 

investigation because it is determined 

that the product is not an illegitimate 

product. Finally, the revised draft 

guidance addresses the statutory 

requirement for responding to requests 

for verification and processing saleable 

returns. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on March 10, 2022. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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– 

2018–D–3462 for ‘‘Verification Systems 

Under the Drug Supply Chain Security 

Act for Certain Prescription Drugs; Draft 

Guidance for Industry; Availability.’’ 

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)). 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 47 / Thursday, March 10, 2022 / Notices 13739 

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 the office in processing 

your requests. The guidance may also be 

obtained by mail by calling CDER at at 

1–800–835–4709 or 240–402–8010. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Sarah Venti, 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, drugtrackandtrace@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a revised draft guidance for industry 

entitled ‘‘Verification Systems Under 

the Drug Supply Chain Security Act for 

Certain Prescription Drugs.’’ The 

DSCSA (Title II of Pub. L. 113–54) was 

signed into law on November 27, 2013. 

Section 202 of the DSCSA added section 

582 to the FD&C Act (21 U.S.C. 360eee– 

1), which established the requirement 

that trading partners have systems in 

place to enable them to comply with 

certain verification obligations. This 

revised draft guidance provides 

recommendations for robust verification 

systems for the determination, 

quarantine, and investigation of suspect 

products, as well as the quarantine, 

notification, and disposition of 

illegitimate products. This revised draft 

guidance also addresses: The manner in 

which FDA recommends that trading 

partners submit cleared product 

notifications (i.e., notifications that a 

suspect product is not an illegitimate 

product); the statutory requirements for 

responding to requests for verification; 

and the statutory requirements for 

processing saleable returns. 

In the Federal Register of October 25, 

2018 (83 FR 53880), FDA announced the 

availability of a draft guidance entitled 

‘‘Verification Systems Under the Drug 

Supply Chain Security Act for Certain 

Prescription Drugs’’ dated October 24, 

2018. FDA received several comments 

on the draft guidance, which have been 

taken into consideration. In response to 

comments received from stakeholders, 

this draft guidance revises the October 

2018 draft guidance to: (1) Provide 

FDA’s interpretation of what 

‘‘possession or control’’ means as used 

throughout the DSCSA; (2) explain that 

the guidance uses the term verification 

in referring to both the broad set of 

requirements set forth in paragraphs 

(b)(4), (c)(4), (d)(4), and (e)(4) of section 

582 of the FD&C Act in addition to 

using the term with the meaning 

defined in section 581(28) of the FD&C 

Act, where appropriate to the context; 

(3) recognize that, in cases where the 

DSCSA directs trading partners to 

coordinate with one another during 

investigations and dispositions of 

products, certain types of trading 

partners are typically better suited to 

handle specific aspects of those 

statutory requirements; (4) clarify that 

FDA will make requests for verification 

if a trading partner is in possession or 

control of a product that the Agency has 

determined to be suspect product; (5) 

clarify FDA’s understanding of what 

‘‘electronic quarantine’’ means; (6) 

clarify when samples of illegitimate 

product should be retained; (7) clarify 

FDA’s expectations related to the 

requirements for responding to requests 

for verification from authorized trading 

partners; (8) inform trading partners of 

the information that should be 

communicated among trading partners 

when determining whether a suspect 

product is illegitimate; and (9) inform 

trading partners of the information that 

should be included when responding to 

requests for verification from FDA and 

other trading partners (where 

applicable), and verifying saleable 

returned product. In addition, editorial 

changes were made to improve clarity. 

This revised draft guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft guidance, when 

finalized, will represent the current 

thinking of FDA on ‘‘Verification 

Systems Under the Drug Supply Chain 

Security Act for Certain Prescription 

Drugs.’’ 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 

This draft guidance includes 

information collection provisions that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act (PRA) of 

1995 (44 U.S.C. 3501–3520) (PRA). FDA 

intends to solicit public comment and 

obtain OMB approval for any 

information collections recommended 

in this guidance that are new or that 

would represent substantive or material 

modifications to those previously 

approved collections of information 

found in FDA regulations or guidance. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

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

guidances-drugs or https://

www.regulations.gov. 

Dated: March 1, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–05018 Filed 3–9–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Advancing 

Translational Science; Notice of 

Charter Renewal 

In accordance with Title 42 of the 

U.S. Code of Federal Regulations, 

Section 217a, notice is hereby given that 

the Charter for the National Center for 

Advancing Translational Sciences 

Advisory Council was renewed for an 

additional two-year period on February 

7, 2022. 

It is determined that the National 

Center for Advancing Translational 

Sciences Advisory Council is in the 

public interest in connection with the 

performance of duties imposed on the 

National Institutes of Health by law, and 

that these duties can best be performed 

through the advice and counsel of this 

group. 

Inquiries may be directed to Claire 

Harris, Director, Office of Federal 

Advisory Committee Policy, Office of 

the Director, National Institutes of 

Health, 6701 Democracy Boulevard, 

Suite 1000, Bethesda, Maryland 20892 

(Mail Stop Code 4875), Telephone (301) 

496–2123, or harriscl@mail.nih.gov. 

Dated: March 4, 2022. 

David W. Freeman, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–05029 Filed 3–9–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Alcohol Abuse 

and Alcoholism; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 


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