Federal Register / Vol. 87, No. 72 / Thursday, April 14, 2022 / Notices 22221 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact AnnMarie 

Williams at Annmarie.Williams@

fda.hhs.gov, or 301–796–5966 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/about-advisory-committees/ 

public-conduct-during-fda-advisorycommittee-meetings for procedures on 

public conduct during advisory 

committee meetings. Please be advised 

that, during the virtual scenario 

breakout discussions, FDA will prepare 

a summary of the discussion in lieu of 

detailed transcripts. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: April 11, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08013 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–2019–D–3324] 

Reconditioning of Fish and Fishery 

Products by Segregation; Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the availability of a 

final guidance for industry entitled 

‘‘Reconditioning of Fish and Fishery 

Products by Segregation.’’ This guidance 

is intended to provide industry with an 

explanation of two potential approaches 

to recondition fish and fishery products 

by effectively segregating adulterated 

portions of an article from portions not 

containing the adulterant to ensure that 

only safe and wholesome product 

reaches consumers. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on April 14, 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– 

2019–D–3324 for ‘‘Reconditioning of 

Fish and Fishery Products by 

Segregation.’’ 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.’’ We 

will review this copy, including the 

claimed confidential information, in our 

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 Office of Food 

Safety, Center for Food Safety and 

Applied Nutrition, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740. Send two selfaddressed adhesive labels to assist that 

office in processing your request. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance. 

FOR FURTHER INFORMATION CONTACT: 

Steven Bloodgood, Division of Seafood 

Safety, Office of Food Safety, Center for 

Food Safety and Applied Nutrition 

(HFS–325), Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–5316; 

or Lauren Kleinman, Office of 

Regulations and Policy (HFS–024), 

Center for Food Safety and Applied 

Nutrition, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2378. 

SUPPLEMENTARY INFORMATION: 

I. Background 

We are announcing the availability of 

a guidance for industry entitled 

‘‘Reconditioning of Fish and Fishery 

Products by Segregation.’’ We are 

issuing the guidance consistent with our 


lotter on DSK11XQN23PROD with NOTICES1
22222 Federal Register / Vol. 87, No. 72 / Thursday, April 14, 2022 / Notices 

good guidance practices regulation (21 

CFR 10.115). The guidance represents 

the current thinking of FDA on this 

topic. 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 intended to help 

owners of fish and fishery products, or 

their representatives, interested in 

bringing adulterated products into 

compliance with the Federal Food, 

Drug, and Cosmetic Act by means of 

segregating non-violative product from 

adulterated product. Specifically, this 

document provides guidance on: 

• Segregation based on a productionrelated rationale supported by 

production records or information 

identifying the cause of the adulteration 

along with sampling and testing to 

confirm that the segregation was 

successful; or 

• Segregation based on the results of 

statistically significant sampling and 

testing. 

In the Federal Register of September 

17, 2019 (84 FR 48935), we announced 

a draft guidance for industry entitled 

‘‘Reconditioning of Fish and Fishery 

Products by Segregation’’ and gave 

interested parties an opportunity to 

submit comments by November 18, 

2019, for us to consider before 

beginning work on the final version of 

the guidance. We received comments on 

the draft guidance and have modified 

the final guidance where appropriate. 

Changes to the guidance include the 

addition of a detailed explanation for 

our more robust sampling 

recommendations. The guidance 

announced in this notice finalizes the 

draft guidance dated September 2019. 

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 1.94(b) and 21 

CFR 1.95(a) and (b) using Form FDA 766 

have been approved under the OMB 

control number 0910–0025. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/FoodGuidances, 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https://

www.regulations.gov. Use the FDA 

website listed in the previous sentence 

to find the most current version of the 

guidance. 

Dated: April 8, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–07979 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–N–4626] 

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; Request for Nominations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for nominations. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing updated information 

for interested parties to nominate bulk 

drug substances or renominate bulk 

drug substances that were previously 

nominated without adequate supporting 

information, 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 nonfood-producing 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 the 

guidance for industry #256 entitled 

‘‘Compounding Animal Drugs from Bulk 

Drug Substances.’’ Individuals may also 

comment on bulk drug substances that 

have been reviewed by FDA and added 

to these lists, or nominations that are 

currently under FDA review. 

DATES: You may submit either electronic 

or written nominations and comments 

at any time. 

ADDRESSES: You may submit 

nominations and comments by any of 

the following methods. 

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 in 

the following ways: 

• Mail/Hand Delivery/Courier (for 

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–N–4626 for ‘‘Lists of Bulk Drug 

Substances for Compounding: Office 

Stock Drugs for Use in NonfoodProducing Animals or Drugs for Use in 

Food-Producing Animals or FreeRanging Wildlife Species.’’ 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 


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