49546 Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices 

TABLE 4—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN: HUMAN FOODS 1

21 CFR section; activity Number of 

respondents 

Number of 

disclosures per 

respondent 

Total annual 

disclosures 

Average burden 

per disclosure Total hours 

117.201(e); disclosure of food 

manufacturing facility address.

37,134 1 37,134 0.25 (15 minutes) .................... 9,284 

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

TABLE 5—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN: ANIMAL FOOD 1

21 CFR section; activity Number of 

respondents 

Number of 

disclosures per 

respondent 

Total annual 

disclosures 

Average burden 

per disclosure Total hours 

507.27(b); labeling for the animal food product contains 

the specific information and 

instructions needed so the 

food can be safely used for 

the intended animal species.

330 10 3,300 0.25 (15 minutes) .................... 825 

507.7(e)(1); change labels on 

products with labels.

1,120 4 4,480 1 .............................................. 4,480 

507.7(e)(2); change address 

on labeling (sales documents) for qualified facilities.

974 1 974 1 .............................................. 974 

507.25(a)(2); animal food, including raw materials, other 

ingredients, and rework, is 

accurately identified.

373 312 116,376 0.01 (36 seconds) ................... 1,163.76 

507.28(b); holding and distribution of human food byproducts for use as animal food.40,798 2 81,596 0.25 (15 minutes) .................... 20,399 

Total .................................. .............................. .............................. .............................. .................................................. 27,841.76 

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

Based on a review of the information 

collection since our last request for 

OMB approval, we have made slight 

adjustments to reflect a decrease in 

third-party disclosure burden associated 

with animal food. In this submission we 

provide a cumulative estimate for 

related disclosure activities that we had 

previously accounted for separately. 

Dated: August 31, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–19116 Filed 9–2–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0897] 

Oncologic Drugs 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 Oncologic Drugs 

Advisory Committee. The general 

function of the committee is to provide 

advice and recommendations to FDA on 

regulatory 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 

October 28, 2021, from 10:30 a.m. to 3 

p.m. Eastern Time. 

ADDRESSES: Please note that due to the 

impact of this 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. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2021–N–0897. 

The docket will close on October 27, 

2021. Submit either electronic or 

written comments on this public 

meeting by October 27, 2021. Please 

note that late, untimely filed comments 

will not be considered. Electronic 

comments must be submitted on or 

before October 27, 2021. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

October 27, 2021. 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 

October 14, 2021, 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: 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices 49547 

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–N–0897 for ‘‘Oncologic Drugs 

Advisory Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), 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.’’ FDA 

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 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 the 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. 

FOR FURTHER INFORMATION CONTACT: SheChia Chen, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, Rm. 2417, Silver Spring, 

MD 20993–0002, 240–402–5343, Fax: 

301–847–8533, ODAC@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 

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: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. The 

committee will discuss new drug 

application (NDA) 214383, PEPAXTO 

(melphalan flufenamide) for injection 

submitted by Oncopeptides AB, 

approved under 21 CFR 314.500 

(subpart H, accelerated approval 

regulations), in combination with 

dexamethasone for the treatment of 

adult patients with relapsed or 

refractory multiple myeloma who have 

received at least four prior lines of 

therapy and whose disease is refractory 

to at least one proteasome inhibitor, one 

immunomodulatory agent, and one 

CD38-directed monoclonal antibody. 

The committee will hear an update 

where the confirmatory trial 

demonstrated a worse overall survival 

in the melphalan flufenamide treatment 

arm compared to the control arm. 

Confirmatory studies are post-marketing 

studies to verify and describe the 

clinical benefit of a drug after it receives 

accelerated approval. Based on the 

update provided, the committee will 

have a general discussion focused on 

next steps for the product including 

whether the indication should remain 

on the market while additional trial(s) 

are conducted. 

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. All electronic and 

written submissions submitted to the 

Docket (see ADDRESSES) on or before 

October 14, 2021, will be provided to 

the committee. Oral presentations from 

the public will be scheduled between 

approximately 1 p.m. to 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 


lotter on DSK11XQN23PROD with NOTICES1
49548 Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices 

requested to make their presentation on 

or before October 5, 2021. 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 October 6, 2021. 

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/ 

AdvisoryCommittees/ 

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: August 30, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–19024 Filed 9–2–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–4844] 

‘‘Ruby Chocolate’’ Deviating From 

Identity Standard; Temporary Permit 

for Market Testing 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the extension of a 

temporary permit issued to Barry 

Callebaut U.S.A. LLC (the applicant) to 

market test products (designated as 

‘‘ruby chocolate’’) that deviate from the 

U.S. standards of identity for cacao 

products. The extension allows the 

applicant to continue to evaluate 

commercial viability of the product and 

to collect data on consumer acceptance 

of the product in support of a petition 

to establish a standard of identity for 

‘‘ruby chocolate.’’ We also invite other 

interested parties to participate in the 

market test. 

DATES: The new expiration date of the 

permit will be either the effective date 

of a final rule establishing a standard of 

identity for ‘‘ruby chocolate’’ that may 

result from the petition or 30 days after 

denial of the petition. 

FOR FURTHER INFORMATION CONTACT: 

Marjan Morravej, Center for Food Safety 

and Applied Nutrition (HFS–820), Food 

and Drug Administration, 5001 Campus 

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

2371; or Carrol Bascus, Center for Food 

Safety and Applied Nutrition, Office of 

Regulations and Policy (HFS–024), Food 

and Drug Administration, 5001 Campus 

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

2378. 

SUPPLEMENTARY INFORMATION: In 

accordance with § 130.17 (21 CFR 

130.17), we issued a temporary permit 

to Barry Callebaut U.S.A. LLC, 600 West 

Chicago Ave, Suite 860, Chicago, IL 

60654, to market test products identified 

as ‘‘ruby chocolate’’ that deviate from 

the requirements of the standards of 

identity for cacao products in part 163 

(21 CFR part 163) (84 FR 64541, 

November 22, 2019). We issued the 

permit to facilitate market testing of 

products that deviate from the 

requirements of the standard of identity 

for cacao products issued under section 

401 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 341). The 

permit covers limited interstate 

marketing tests of products identified as 

‘‘ruby chocolate.’’ These test products 

deviate from the U.S. standards of 

identity for cacao products (§§ 163.111, 

163.123, 163.124, 163.130, 163.135, 

163.140, and 163.145). 

For the purpose of this permit, ‘‘ruby 

chocolate’’ is the solid or semi-plastic 

food prepared by mixing and grinding 

cacao fat with one or more of the cacao 

ingredients (namely, chocolate liquor, 

breakfast cocoa, cocoa, and low-fat 

cocoa), citric acid, one or more of 

optional nutritive carbohydrate 

sweeteners. ‘‘Ruby chocolate’’ contains 

not less than 1.5 percent nonfat cacao 

solids, not less than 2.5 percent by 

weight of milk fat, not less than 12 

percent by weight of total milk solids, 

not more than 1.5 percent of 

emulsifying agents, and not more than 

5 percent of whey or whey products. It 

may also contain other ingredients such 

as antioxidants approved for food use, 

spices, natural and artificial flavorings, 

and other seasonings. However, these 

other ingredients cannot imitate the 

flavor of chocolate, milk, butter, berry, 

or another fruit. Additionally, ‘‘ruby 

chocolate’’ contains no added coloring. 

The test product ‘‘ruby chocolate’’ 

contains the principal ingredients used 

in most of the current standards for 

cacao products under part 163; 

however, it deviates from the current 

standard of identify for chocolate 

products in terms of its final 

composition, taste, and color. 

On February 19, 2021, the applicant 

asked us to extend the temporary permit 

so the applicant could have more time 

to market test the ‘‘ruby chocolate’’ and 

gain additional consumer acceptance in 

support of the petition to establish a 

standard for ‘‘ruby chocolate.’’ We find 

that it is in the interest of consumers to 

extend the permit for continued market 

testing of ‘‘ruby chocolate’’ to gain 

additional information on consumer 

expectations and acceptance. Therefore, 

under § 130.17(i), we are extending the 

temporary permit granted to Barry 

Callebaut U.S.A. LLC for temporary 

marketing of approximately 60 million 

pounds (27,215,540 kilograms) of ‘‘ruby 

chocolate’’ to provide continued market 

testing of the specified amount of 

product for the applicant on an annual 

basis. The test products will bear the 

name ‘‘ruby chocolate.’’ The new 

expiration date of the permit will be 

either the effective date of a final rule 

establishing a standard of identity for 

‘‘ruby chocolate’’ that may result from 

the petition or 30 days after denial of 

the petition. All other conditions and 

terms of this permit remain the same. 

In addition, we invite interested 

persons to participate in the market test 

under the conditions of the permit, 

except for the designated area of 

distribution. Any person who wishes to 

participate in the extended market test 

should notify, in writing, the Branch 

Chief, Product Evaluation Labeling 

Branch, Division of Food Labeling and 

Standards, Office of Nutrition and Food 

Labeling, Center for Food Safety and 

Applied Nutrition (HFS–820), Food and 

Drug Administration, 5001 Campus Dr., 

College Park, MD 20740. The 

notification must describe the amount to 

be distributed, the area of distribution, 

and include the labeling that will be 

used for the test product (see 

§ 130.17(i)). For information on what to 

include in the notification to FDA, see 

§ 130.17(c). Test products must be 

labeled in accordance with 21 CFR part 

101. 


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