22212 Federal Register / Vol. 87, No. 72 / Thursday, April 14, 2022 / Notices 

populations in the United States, such 

as Black or African American, Hispanic/ 

Latino, Indigenous and Native 

American, Asian, Native Hawaiian and 

Other Pacific Islanders, and other 

persons of color. Adequate 

representation in clinical trial(s) and 

studies supporting regulatory 

submissions helps ensure that the data 

generated in the development program 

reflects the racial and ethnic diversity of 

intended use population for the medical 

product, if approved, and may 

potentially identify safety or efficacy 

outcomes that may be associated with, 

or occurring more frequently, within 

these populations. This is one of many 

efforts by FDA to help address the 

participation of underrepresented 

populations in clinical trials relating to 

FDA regulated products. 

This draft guidance is being issued 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The draft guidance, when finalized, will 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 ‘‘Diversity Plans to Improve 

Enrollment of Participants from 

Unrepresented Racial and Ethnic 

Populations in Clinical Trials.’’ 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 parts 50 and 56 

have been approved under OMB control 

number 0910–0130; 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 312 have 

been approved under OMB control 

number 0910–0014; 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 800 have 

been approved under OMB control 

number 0910–0625; and the collections 

of information pertaining to submission 

of a biologics license application under 

section 351(k) of the Public Health 

Service Act have been approved under 

OMB control number 0910–0719. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance 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: April 8, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–07978 Filed 4–13–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–4533] 

Compounding Animal Drugs From 

Bulk Drug Substances; Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing the availability of a final 

guidance for industry (GFI) #256 

entitled ‘‘Compounding Animal Drugs 

from Bulk Drug Substances.’’ This 

guidance describes FDA’s current 

thinking about compounding animal 

drugs from bulk drug substances, 

identifies our enforcement priorities 

with respect to drugs compounded from 

bulk drug substances, and describes 

circumstances under which FDA 

generally does not intend to take action 

against veterinarians or pharmacists in 

either State-licensed pharmacies or 

Federal facilities, who compound 

animal drugs from bulk drug substances. 

We are also 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 (PRA). 

DATES: The announcement of the 

guidance is published in the Federal 

Register on April 14, 2022. Submit 

written comments (including 

recommendations) on the collection of 

information by May 16, 2022. 

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–NEW. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

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–4533 for ‘‘Compounding 

Animal Drugs from Bulk Drug 

Substances.’’ 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. 


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Federal Register / Vol. 87, No. 72 / Thursday, April 14, 2022 / Notices 22213 

1Elsewhere in this issue of the Federal Register, 

FDA is requesting nominations or renominations for 

bulk drug substances to be included on the ‘‘Lists 

of Bulk Drug Substances for Compounding Office 

Stock Drugs for Use in Nonfood-Producing Animals 

or Drugs for Use in Food-Producing Animals or 

Free-Ranging Wildlife Species’’ for inclusion on a 

list of bulk drug substances for compounding 

certain animal drugs without a patient specific 

prescription (i.e., office stock) for use in nonfoodproducing animals or for inclusion on a list of 

compounded drugs for use as antidotes for foodproducing animals or for use as sedatives or 

anesthetics for free-ranging wildlife species as 

described in GFI #256. That Federal Register notice 

describes information requested by FDA to evaluate 

nominations and explains when FDA will include 

bulk drug substances on a list. Such nominations 

will be collected in a separate docket. 

• 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 guidance to the Policy and 

Regulations Staff (HFV–6), Center for 

Veterinary Medicine, Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed 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: 

Cindy Burnsteel, Office of Surveillance 

and Compliance (HFV–200), Food and 

Drug Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–402–7011. 

Regarding the proposed collection of 

information: 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: 

I. Background 

In the Federal Register of November 

20, 2019 (84 FR 64085), FDA published 

the notice of availability for draft GFI 

#256 entitled ‘‘Compounding Animal 

Drugs from Bulk Drug Substances’’ with 

a 90-day comment period. In response 

to requests from interested parties, we 

extended the comment period to July 

17, 2020, and then to October 15, 2020. 

We requested comments on the draft 

guidance with respect to animal drug 

compounding from bulk drug 

substances under certain circumstances 

when no other medically appropriate 

treatment option exists. This final GFI 

#256 describes FDA’s current thinking 

about compounding animal drugs from 

bulk drug substances, identifies our 

enforcement priorities with respect to 

drugs compounded from bulk drug 

substances, and describes circumstances 

under which FDA generally does not 

intend to take action against 

veterinarians or pharmacists in either 

State-licensed pharmacies or Federal 

facilities, who compound animal drugs 

from bulk drug substances. FDA does 

not intend to take action under sections 

501(a)(2)(B) and (a)(5), 502(f), and 512(a) 

of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 351(a)(2)(B) and (a)(5), 

352(f), and 360(b)) under the 

circumstances described in GFI #256. 

FDA received numerous comments on 

the draft guidance, which were 

considered as the guidance was 

finalized. Changes made in response to 

comments include identifying 

compliance with relevant State and 

local laws as the standard for 

compounding methods and eliminating 

references to United States 

Pharmacopeia and National Formulary 

Chapters <795> ‘‘Pharmaceutical 

Compounding—Nonsterile 

Preparations’’ and <797> 

‘‘Pharmaceutical Compounding—Sterile 

Preparations.’’ We also revised the 

recommended label statement regarding 

reporting of adverse events to include 

reporting to the pharmacy as well as 

FDA. 

We also made a number of changes 

related to recommendations for copies 

of approved products. We simplified the 

definition of ‘‘copy’’ used in the 

guidance and clarified that ‘‘clinical 

difference’’ includes issues affecting 

patient compliance and the safety of 

these who administer the drug, but 

excludes cost differences between 

approved and compounded products. 

The final guidance includes examples of 

how to briefly describe the medical 

rationale for making a copy, such as the 

compounding pharmacist contacting the 

prescribing veterinarian to obtain the 

rationale and noting it in the 

compounding records as an alternative 

to the veterinarian noting the rationale 

on the prescription. It also provides 

examples of rationales to explain why 

an approved drug cannot be used in a 

legal extralabel manner to compound a 

drug with the same active moiety. 

We also made changes to lists of bulk 

drug substances for compounding office 

stock for nonfood-producing animals or 

antidotes for food-producing animals. 

As outlined in the Appendix to the final 

guidance,1 we streamlined the 

nomination process for these bulk drug 

substances, reducing the information 

requested by FDA to support a 

nomination. The list of bulk substances 

to compound drugs for use in foodproducing animals has been expanded 

to encompass nominations of sedatives 

or anesthetics for free-ranging wildlife 

species. 

In addition, editorial changes were 

made to improve clarity in the final 

guidance. The guidance announced in 

this notice finalizes the draft guidance 

dated November 2019. However, as 

explained in section II of this notice, the 

information collection 

recommendations footnoted with an 

asterisk are subject to OMB review and 

approval and are not for current 

implementation. 

This level 1 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 compounding 

animal drugs from bulk drug substances. 

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. 


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22214 Federal Register / Vol. 87, No. 72 / Thursday, April 14, 2022 / Notices 

2American Pharmacists Association, ‘‘Frequently 

Asked Questions About Pharmaceutical 

Compounding,’’ n.d., https://www.pharmacist.com/ 

Practice/Patient-Care-Services/Compounding/ 

Compounding-FAQs (accessed September 15, 2021). 

We currently have no data on the number of 

veterinarians who compound drugs for individual 

patients, specifically, compound drugs from bulk 

drug substances for individual patients; therefore, 

we are including this class of respondents in our 

burden estimate. 

II. Paperwork Reduction Act of 1995 

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

FDA has submitted the following 

proposed collection of information to 

OMB for review and clearance. FDA is 

issuing this guidance as final, footnoting 

with an asterisk recommendation that 

include information collection subject 

to review and approval by OMB under 

the PRA. FDA will implement the 

information collection 

recommendations if OMB approves 

them. At that time, FDA will announce 

OMB approval in the Federal Register 

and update the guidance to reflect this 

approval. 

Title: Compounding Animal Drugs 

from Bulk Drug Substances (OMB 

Control Number 0910–NEW). 

Description of Respondents: The 

respondents to the information 

collection are pharmacists in either 

State-licensed pharmacies or Federal 

facilities, or veterinarians who 

compound animal drugs from bulk drug 

substances. 

Description: The Center for Veterinary 

Medicine has developed GFI #256 to 

address a need for Agency guidance in 

its work with the animal health 

industry. The guidance describes FDA’s 

current thinking, based on our current 

understanding of the risks of animal 

drugs compounded from bulk drug 

substances, and describes the 

circumstances under which FDA 

generally does not intend to take 

enforcement action against pharmacists 

and veterinarians who compound 

animal drugs from bulk drug substances. 

In the Federal Register of November 

20, 2019 (84 FR 64085), we published a 

notice of availability announcing draft 

guidance GFI #256, including an 

analysis under the PRA, and solicited 

public comment on the proposed 

collection of information. Comments 

regarding the information collection 

included concerns that the guidance 

document will impose requirements not 

placed on other prescribers. In any other 

setting, the comments suggested, the 

prescription itself serves as 

documentation of the veterinarian’s 

determination of clinical need. We 

disagree with these comments 

suggesting that a prescription serves the 

same purpose as the medical rationale 

documentation recommended in GFI 

#256. The documentation of the medical 

rationale by the compounding 

pharmacist is recommended for copies 

of approved products because a 

prescription demonstrates an animal’s 

need for a prescription drug but does 

not explain why an approved product 

could not be used legally to treat the 

animal. The medical rationale addresses 

the clinical need for an animal drug 

compounded from a bulk drug 

substance when there is an approved 

product available. 

Our exercise of discretion is 

dependent upon our ability to assess 

whether the circumstances under which 

FDA intends to exercise such discretion, 

as described in the guidance, exist. FDA 

staff may use pharmacy and veterinary 

records, among other things, to 

determine the circumstances 

surrounding the compounding activity. 

Except with regard to the 

recommendations that compounders 

document rationales for prescribing a 

compounded product from a bulk drug 

substance, routine business records kept 

by pharmacists who compound animal 

drugs from bulk drug substances and 

veterinarians who compound animal 

drugs from bulk drug substances, as 

well as veterinarians prescribing 

compounded animal drugs within a 

valid veterinarian-client-patient 

relationship, should be adequate to 

demonstrate that the circumstances 

described in the guidance exist. While 

we believe it is usual and customary 

business practice for veterinarians to 

document medical rationales for 

prescribing a compounded product as 

recommended in the guidance, we 

acknowledge that documenting this 

information by the pharmacist 

compounder, as well as documenting 

the rationale for using a bulk drug 

substance as the source of the active 

ingredient by the veterinarian/ 

pharmacist compounder, may not be 

usual and customary practice. We have 

therefore included an estimate for 

recordkeeping to account for burden 

beyond that which may be usual and 

customary for respondents who follow 

the recommended documentation of 

rationales for compounding the drug 

product from bulk drug substance as 

discussed in the guidance. 

We estimate the burden of the 

information collection as follows: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 2

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Documenting rationales by licensed veterinarian/pharmacist compounder.7,500 1,134 8,505,000 0.017 (1 minute) .. 144,585 

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

2 Rounded to the nearest whole number. 

We have revised figures from our 60- 

day notice to reflect a more recent 

review of our experience with the 

information collection. 

Sections III.A.5 and III.A.6 of the 

guidance describe circumstances under 

which FDA recommends veterinarian 

and pharmacist compounders document 

the prescribing veterinarian’s medical 

rationale and the reason that a bulk drug 

substance is being used as the source of 

the active ingredient. Based on our 

evaluation, we believe it is usual and 

customary business practice for 

veterinarians to document the medical 

rationale, as recommended in the 

guidance. However, we believe 

pharmacist compounders may not 

document the information 

recommended in the guidance as a 

usual and customary business practice. 

According to the American Pharmacists 

Association, of the approximately 

56,000 community-based pharmacies in 

the United States, about 7,500 

pharmacies specialize in compounding 

services.2 We assume 11,339,400 

prescriptions will be written for 

compounded animal drugs annually. 

Based on our experience with the 

regulation of compounded animal 

drugs, we assume 50 to 75 percent of 

these prescriptions will result in 

documenting rationales as discussed in 

the guidance. Using the upper-bound 

estimate of 75 percent, approximately 

8,504,550 prescriptions (0.75 × 


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Federal Register / Vol. 87, No. 72 / Thursday, April 14, 2022 / Notices 22215 

11,339,400 prescriptions) will 

necessitate documenting rationales. 

Averaging this figure equally among 

7,500 compounding pharmacies, 1,134 

(rounded to the nearest whole number) 

rationales will be documented annually, 

for a total of 8,505,000 records. We 

estimate it will take 1 minute (0.017 

hours) to document the rationales 

described in the guidance, for a total of 

144,585 hours, as reported in table 1. 

Under 5 CFR 1320.3(b)(2), the time, 

effort, and financial resources necessary 

to comply with a collection of 

information are excluded from the 

burden estimate if the reporting, 

recordkeeping, or disclosure activities 

needed to comply are usual and 

customary because they would occur in 

the normal course of activities. If the 

compounded drug is compounded for 

use as an antidote for food-producing 

animals or for use as a sedative or 

anesthetic for free-ranging wildlife 

species, section III.C.3 of the guidance 

recommends that the veterinarian 

establishes and documents a 

scientifically based withdrawal time 

that ensures residues of the: (1) Antidote 

and the underlying toxin or (2) sedative 

or anesthetic are not present in the 

animal at the time of slaughter or 

harvest or the veterinarian ensures the 

animal does not enter the food supply. 

We believe that it is usual and 

customary for veterinarians to establish 

and document a scientifically based 

withdrawal time as a matter of 

maintaining an adequate medical record 

in routine practice and, therefore, 

estimate no burden for the time it would 

take for a veterinarian to make this 

record. See 5 CFR 1320.3(b)(2). 

In addition, the guidance makes a 

number of recommendations regarding 

the labeling of animal drugs 

compounded from bulk drug 

substances. In sections III.A.8, III.B.6, 

and III.C.6, the guidance recommends 

basic information that pharmacists and 

veterinarians should include on the 

label of the compounded drug, such as 

the name and strength of the drug and 

the name, address, and contact 

information for the compounding 

pharmacy or compounding veterinarian. 

We believe that it is usual and 

customary for pharmacists and 

veterinarians to include such 

information on the labels of 

compounded animal drugs in the 

normal course of their activities, and 

therefore, estimate no burden for the 

time it would take to prepare such 

labeling. See 5 CFR 1320.3(b)(2). 

Sections III.A.8, III.B.6, and III.C.6 of the 

guidance also recommend compounders 

(pharmacists and veterinarians) include 

several specific statements on the label 

of animal drugs compounded from bulk 

drug substances (e.g., ‘‘This is a 

compounded drug. Not an FDA 

approved or indexed drug.’’). Because 

these recommended labeling statements 

are public disclosure of information 

originally supplied by the Federal 

Government to the recipient for the 

purpose of disclosure to the public (5 

CFR 1320.3(c)(2)), they are exempt from 

OMB review and approval under the 

PRA. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/animal-veterinary/ 

guidance-regulations/guidanceindustry, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: April 11, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08092 Filed 4–13–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0470] 

Cellular, Tissue and Gene Therapies 

Advisory Committee; Notice of 

Meeting; Establishment of a Public 

Docket; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Cellular, Tissue and Gene 

Therapies Advisory Committee. The 

general function of the committee is to 

provide advice and recommendations to 

FDA on scientific issues. The meeting 

will be open to the public. FDA is 

establishing a docket for public 

comment on this document. 

DATES: The meeting will be held on June 

9, 2022, from 10 a.m. to 6 p.m. and June 

10, 2022, from 10 a.m. to 4 p.m. Eastern 

Time. 

ADDRESSES: Please note that due to the 

impact of the COVID–19 pandemic, all 

meeting participants will be joining this 

advisory committee meeting via an 

online teleconferencing platform. 

Answers to commonly asked questions 

about FDA advisory committee meetings 

may be accessed at: https://

www.fda.gov/AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. 

The online web conference meeting 

will be available at the following link on 

the day of the meeting: Day 1 June 9 

link: https://youtu.be/RvtTK3KNl5g and 

Day 2 June 10 link: https://youtu.be/ 

Eo2BXnGienc. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2022–N–0470. 

The docket will close on June 8, 2022. 

Submit either electronic or written 

comments on this public meeting on or 

before June 8, 2022. Please note that 

late, untimely filed comments will not 

be considered. Electronic comments 

must be submitted on or before June 8, 

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

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of June 8, 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. 

Comments received on or before June 

2, 2022, will be provided to the 

committee. Comments received after 

that date will be taken into 

consideration by FDA. In the event that 

the meeting is cancelled, FDA will 

continue to evaluate any relevant 

applications or information, and 

consider any comments submitted to the 

docket, as appropriate. 

You may submit comments 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 


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