6572 Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Notices 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Silver Spring, MD 

20993–0002, 240–506–4946, 

CBERVRBPAC@fda.hhs.gov; or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

FDA’s website at https://www.fda.gov/ 

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before coming to the meeting. 

SUPPLEMENTARY INFORMATION: Consistent 

with FDA’s regulations, this notice is 

being published with less than 15 days 

prior to the date of the meeting based on 

a determination that convening a 

meeting of the Vaccines and Related 

Biological Products Advisory 

Committee as soon as possible is 

warranted. This Federal Register notice 

could not be published 15 days prior to 

the date of the meeting due to a recent 

request to amend the Emergency Use 

Authorization (EUA) of the PfizerBioNTech COVID–19 mRNA vaccine for 

administration to children 6 months 

through 4 years of age, and the need for 

prompt discussion of this request given 

the COVID–19 pandemic. 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. On February 

15, 2022, the committee will meet in 

open session to discuss a request to 

amend the Emergency Use 

Authorization (EUA) of the PfizerBioNTech COVID–19 mRNA vaccine for 

administration to children 6 months 

through 4 years of age. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s website after 

the meeting. Background material is 

available at https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. The meeting will include slide 

presentations with audio components to 

allow the presentation of materials in a 

manner that most closely resembles an 

in-person advisory committee meeting. 

Procedure: On February 15, 2022, 

from 8:30 a.m. to 5 p.m. Eastern Time 

the meeting is open to the public. 

Interested persons may present data, 

information, or views, orally or in 

writing, on issues pending before the 

committee. All electronic and written 

submissions submitted to the Docket 

(see ADDRESSES) on or before February 

10, 2022, will be provided to the 

committee. Comments received after 

February 10, 2022, and by February 14, 

2022, will be taken into consideration 

by FDA. Oral presentations from the 

public will be scheduled between 

approximately 1 p.m. and 2 p.m. Eastern 

Time. Those individuals interested in 

making formal oral presentations should 

notify the contact person and submit a 

brief statement of the general nature of 

the evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before February 8, 2022. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled 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 

February 9, 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 Prabhakara 

Atreya or Christina Vert (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/ 

AdvisoryCommittees/AboutAdvisory

Committees/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 1, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–02390 Filed 2–3–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1411] 

Drug Product Tracing: The Effect of 

Section 585 of the Federal Food, Drug, 

and Cosmetic Act—Questions and 

Answers; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry entitled ‘‘Drug 

Product Tracing: The Effect of Section 

585 of the FD&C Act—Questions and 

Answers.’’ FDA is issuing this guidance 

to assist industry and State and local 

governments in understanding the 

effects of the uniform national policy set 

forth in the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) that was 

added by the Drug Supply Chain 

Security Act, which was enacted on 

November 27, 2013. This guidance is 

intended to help industry and States 

understand the law as it is currently in 

effect and clarify its effect on State 

product tracing. This guidance finalizes 

the draft guidance entitled ‘‘The Effect 

of Uniform National Policy on Drug 

Product Tracing and Wholesale Drug 

Distributor and Third-Party Logistics 

Provider Standards: Questions and 

Answers’’ issued on October 8, 2014. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on February 4, 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 


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Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Notices 6573 

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– 

2014–D–1411 for ‘‘Drug Product 

Tracing: The Effect of Section 585 of the 

FD&C Act—Questions and Answers.’’ 

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 this 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 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 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, 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 final guidance for industry entitled 

‘‘Drug Product Tracing: The Effect of 

585 of the FD&C Act—Questions and 

Answers.’’ Title II of the Drug Quality 

and Security Act (Pub. L. 113–54), 

which is also referred to as the Drug 

Supply Chain Security Act (DSCSA), 

enacted on November 27, 2013, 

established a Federal system for tracing 

prescription drug products through the 

pharmaceutical distribution supply 

chain and requires trading partners to 

provide, receive, and maintain certain 

product and distribution information. 

The DSCSA also requires FDA to 

establish Federal standards for licensing 

of wholesale drug distributors and thirdparty logistics providers (3PLs); the 

Agency is publishing a proposed rule 

with respect to those standards 

concurrently with this final guidance. 

Section 585 of the FD&C Act (21 U.S.C. 

360eee–4) sets forth a uniform national 

policy preempting States from 

establishing or continuing in effect 

certain standards and requirements. The 

guidance is intended to (1) help 

industry and States understand the law 

as it is currently in effect and (2) clarify 

the effect of section 585(a) on State 

product tracing. 

This guidance finalizes the draft 

guidance entitled ‘‘The Effect of 

Uniform National Policy on Drug 

Product Tracing and Wholesale Drug 

Distributor and Third-Party Logistics 

Provider Standards: Questions and 

Answers’’ issued on October 8, 2014 (79 

FR 60853). The draft guidance covered 

section 585(a) and (b) of the FD&C Act. 

This guidance does not cover the effect 

of section 585(b) of the FD&C Act, given 

that section 585(b) is addressed in the 

preamble to the proposed rule with 

respect to the standards for licensing 

wholesale distributors and 3PLs, 

published elsewhere in this issue of the 

Federal Register. FDA considered 

comments received on the draft 

guidance as the guidance was finalized. 

Changes from the draft to the final 

guidance include the removal of the 

discussion of the effect of 585(b) of the 

FD&C Act. The title of the guidance has 

been updated to reflect this change in 

content. In addition, editorial changes 

were made to improve clarity 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Drug Product 

Tracing: The Effect of 585 of the FD&C 

Act—Questions and Answers.’’ 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 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 guidance at https:// 


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6574 Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Notices 

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

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

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: January 25, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–01926 Filed 2–3–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–1041] 

Immunogenicity Information in Human 

Prescription Therapeutic Protein and 

Select Drug Product Labeling— 

Content and Format; Draft Guidance 

for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the availability of a draft 

guidance for industry entitled 

‘‘Immunogenicity Information in 

Human Prescription Therapeutic 

Protein and Select Drug Product 

Labeling—Content and Format.’’ This 

draft guidance provides 

recommendations for incorporating 

clinically relevant immunogenicity 

information into the labeling of 

products having immunogenicity 

assessments. Appropriate inclusion and 

consistent placement of 

immunogenicity information in the 

Prescribing Information helps to make 

clinically relevant information 

accessible to the health care practitioner 

and promotes the safe and effective use 

of prescription drug and biological 

products. When finalized, the 

recommendations in this guidance will 

supersede the immunogenicity labelingspecific recommendations in the 

guidances for industry entitled 

‘‘Labeling for Biosimilar Products’’ and 

‘‘Clinical Pharmacology Section of 

Labeling for Human Prescription Drug 

and Biological Products—Content and 

Format.’’ 

DATES: Submit either electronic or 

written comments on the draft guidance 

by April 5, 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’’). 

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– 

2021–D–1041 for ‘‘Immunogenicity 

Information in Human Prescription 

Therapeutic Protein and Select Drug 

Product Labeling—Content and 

Format.’’ 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 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: Eric 

Brodsky, Center for Drug Evaluation and 

Research, Food and Drug 


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