Federal Register / Vol. 87, No. 96 / Wednesday, May 18, 2022 / Notices 30227 

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 

Agency’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: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. The Science 

Board to the Food and Drug 

Administration will consider challenges 

in evaluating the safety of dietary 

supplement and food ingredients with 

predicted pharmacological activity, 

utilizing cannabinoids as a case study. 

The Science Board to the Food and Drug 

Administration will also hear about the 

Agency’s enhanced efforts to spur the 

development, qualification, and 

adoption of new alternative methods for 

regulatory use that can replace, reduce, 

and refine animal testing and have the 

potential to provide both more timely 

and more predictive information to 

accelerate product development and 

enhance emergency preparedness. The 

Science Board to the Food and Drug 

Administration will also hear about the 

Agency’s enhanced efforts to ensure 

optimal organization, infrastructure, and 

expertise for data science efforts in 

alignment with its regulatory scope and 

evidence-based decision making, in 

support of FDA’s public health 

priorities. 

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 on FDA’s 

website at the time of the advisory 

committee meeting. Background 

material and the link to the online 

teleconference meeting room will be 

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: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before June 7, 2022. Oral 

presentations from the public will be 

scheduled between approximately 11 

a.m. and 12 p.m. 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 June 1, 

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 June 7, 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 Rakesh 

Raghuwanshi (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: May 13, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–10697 Filed 5–17–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–D–0401] 

Safety Considerations for Container 

Labels and Carton Labeling Design To 

Minimize Medication Errors; 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 final 

guidance for industry entitled ‘‘Safety 

Considerations for Container Labels and 

Carton Labeling Design to Minimize 

Medication Errors.’’ The guidance 

focuses on safety aspects of the 

container label and carton labeling 

design for human prescription drug and 

biological products. The guidance 

provides sponsors of new drug 

applications (NDAs), biologics license 

applications (BLAs), abbreviated new 

drug applications (ANDAs), and 

prescription drugs marketed without an 

approved NDA or ANDA with a set of 

principles and recommendations for 

ensuring that critical elements of 

product container labels and carton 

labeling are designed to promote safe 

dispensing, administration, and use of 

the product. This guidance finalizes the 

draft guidance of the same title issued 

on April 24, 2013. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on May 18, 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’’). 


lotter on DSK11XQN23PROD with NOTICES1
30228 Federal Register / Vol. 87, No. 96 / Wednesday, May 18, 2022 / Notices 

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– 

2013–D–0401 for ‘‘Safety Considerations 

for Container Labels and Carton 

Labeling Design to Minimize 

Medication Errors.’’ 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 to the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), 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: 

Irene Z. Chan, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 4420, 

Silver Spring, MD 20993–0002, 301– 

796–3962; 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 guidance for industry entitled ‘‘Safety 

Considerations for Container Labels and 

Carton Labeling Design To Minimize 

Medication Errors.’’ In Title I of the 

Food and Drug Administration 

Amendments Act of 2007 (FDAAA) 

(Pub. L. 110–85), Congress reauthorized 

and expanded the Prescription Drug 

User Fee Act (PDUFA) program for 

fiscal years 2008 through 2012. As part 

of the performance goals and procedures 

set forth in an enclosure to the letter 

from the Secretary of Health and Human 

Services referred to in section 101(c) of 

FDAAA, FDA committed to certain 

performance goals and procedures. (See 

https://wayback.archive-it.org/7993/ 

20171115015358/https://www.fda.gov/ 

ForIndustry/UserFees/Prescription

DrugUserFee/ucm119243.htm). In that 

letter, FDA stated that it would use fees 

collected under PDUFA to implement 

various measures to reduce medication 

errors related to look-alike and soundalike proprietary names, unclear label 

abbreviations, acronyms, dose 

designations, and error-prone label and 

packaging designs. Among these 

measures, FDA agreed that, after public 

consultation with academia, industry, 

other stakeholders, and the general 

public, the Agency would publish a 

draft guidance describing practices for 

naming, labeling, and packaging drugs 

and biologics to reduce medication 

errors. On June 24 and 25, 2010, FDA 

held a public workshop and opened a 

public docket (Docket No. FDA–2010– 

N–0168) to receive comments on these 

measures. After reviewing public input, 

a draft guidance was subsequently 

published by FDA in April 2013 (Docket 

No. FDA–2013–D–0401). Additional 

public comment was provided through 

a docket. This guidance presents FDA’s 

final recommendations and conclusions 

after having reviewed this public input 

and considered information learned 

through evaluating postmarketing 

medication errors. 

This guidance is intended to help 

entities holding NDAs, BLAs, and 

ANDAs and entities manufacturing or 

distributing prescription drugs marketed 

without an approved application. This 

guidance focuses on safety aspects of 

the application holder’s container label 

and carton labeling design, and it 

provides a set of principles and 

recommendations for ensuring that 

critical elements of a product’s 

container label and carton labeling are 

designed to promote safe dispensing, 

administration, and use of the product. 

The recommendations in this 

guidance are intended to provide best 

practices on how to improve the 

container label and carton labeling of 

prescription drug and biological 

products to minimize medication errors. 

The guidance also provides examples of 

container label and carton labeling 

designs that resulted in postmarketing 

medication errors. 

This guidance finalizes the draft 

guidance entitled ‘‘Safety 

Considerations for Container Labels and 

Carton Labeling Design to Minimize 

Medication Errors’’ published in the 

Federal Register of April 24, 2013 (78 

FR 24211). FDA considered comments 

received on the draft guidance as the 

guidance was finalized. Changes from 

the draft to the final guidance include 

revisions to clarify language that some 

commenters considered unnecessarily 

restrictive and emphasize that labeling 

statements should be considered within 

a risk framework. In addition, the 

guidance has been updated to reflect 

regulations and policy that have been 

established since the draft guidance was 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 96 / Wednesday, May 18, 2022 / Notices 30229 

published. Furthermore, 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 ‘‘Safety 

Considerations for Container Labels and 

Carton Labeling Design to Minimize 

Medication Errors.’’ 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 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001. The collections of 

information in 21 CFR part 601 have 

been approved under OMB control 

number 0910–0338. The collections of 

information in 21 CFR part 203 

described in the final rule entitled 

‘‘Prescription Drug Marketing Act of 

1987; Prescription Drug Amendments of 

1992; Policies, Requirements, and 

Administrative Policies’’ have been 

approved under OMB control number 

0910–0435. The collections of 

information in part 201 (21 CFR part 

201) described in the final rule entitled 

‘‘Bar Code Label Requirement for 

Human Drug Products and Biological 

Products’’ have been approved under 

OMB control number 0910–0537. The 

collections of information for 

prescription drug product labeling in 

§ 201.56 and 201.57 (21 CFR 201.56 and 

201.57) have been approved under OMB 

control number 0910–0572. The 

collections of information described in 

the FDA guidance for industry entitled 

‘‘Drug Supply Chain Security Act 

Implementation: Identification of 

Suspect Product and Notification’’ have 

been approved under OMB control 

number 0910–0806. 

In addition, the inclusion of warning 

statements on labels for certain drug 

products would be exempt from review 

by OMB under the PRA because the 

public disclosure of information 

originally supplied by the Federal 

government to the recipient for the 

purpose of disclosure to the public is 

not included within the definition of 

‘‘collection of information’’ (see 5 CFR 

1320.3(c)(2)). 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

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: May 12, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–10699 Filed 5–17–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0880] 

Assessing User Fees Under the 

Generic Drug User Fee Amendments of 

2017; 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 final 

guidance for industry entitled 

‘‘Assessing User Fees Under the Generic 

Drug User Fee Amendments of 2017.’’ 

This guidance provides stakeholders 

information regarding the 

implementation of the Generic Drug 

User Fee Amendments of 2017 (GDUFA 

II) and policies and procedures 

surrounding its application. This 

guidance is finalizing FDA’s draft 

guidance for industry ‘‘Assessing User 

Fees Under the Generic Drug User Fee 

Amendments of 2017,’’ published in 

November 2019. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on May 18, 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– 

2012–D–0880 for ‘‘Assessing User Fees 

Under the Generic Drug User Fee 

Amendments of 2017.’’ 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 


lotter on DSK11XQN23PROD with NOTICES1