Federal Register / Vol. 86, No. 152 / Wednesday, August 11, 2021 / Notices 44029 

fda.hhs.gov, 301–796–8398, 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 

Agency’s website at https://

www.fda.gov/advisory-committees and 

scroll down to the appropriate advisory 

committee meeting link or call the 

advisory committee information line to 

learn about possible modifications. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. On October 

6, 2021, the committee will discuss and 

make recommendations on the topic 

‘‘Medical Device Recalls.’’ Once a 

medical device is available in the U.S. 

marketplace and in widespread use, 

unforeseen problems can sometimes 

lead to a recall. When a device is 

defective or potentially harmful, 

recalling that product—removing it from 

the market or correcting the problem— 

is the most effective means for 

protecting the public. A company may 

recall a device after discovering a 

problem on its own, or after FDA raises 

concerns. In rare cases, FDA may 

require a company to recall a device. 

When a device is recalled, FDA reviews 

the company’s strategy for resolving the 

problem by assessing the relative degree 

of risk associated with the product and 

making sure the strategy effectively 

resolves the problem with the device. 

FDA provides transparency and 

communicates information when the 

public needs to be alerted to a serious 

hazard, as well as once the recall has 

been appropriately resolved. The 

recommendations provided by the 

committee will address factors FDA and 

industry should consider to effectively 

communicate medical device recall 

information to patients and the public, 

including but not limited to content, 

format, methods used to disseminate the 

message, and timing of communication. 

The committee will also consider 

concerns patients have about changes to 

their device in response to a recall and 

will discuss ways patient perspectives 

could be incorporated in FDA and 

industry benefit-risk decision making, 

as well as the healthcare provider and 

patient decision-making process related 

to a recalled medical device, including 

implanted devices. 

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, and the background 

material will be posted on FDA’s 

website after the meeting. Background 

materials will be available at https://

www.fda.gov/advisory-committees/ 

committees-and-meeting-materials/ 

patient-engagement-advisorycommittee. Select the link for the 2021 

Meeting Materials. 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. Oral presentations 

from the public will be scheduled on 

October 6, 2021, between approximately 

2 p.m. to 3 p.m. Eastern Time. Those 

individuals interested in making formal 

oral presentations should notify the 

contact person (see FOR FURTHER

INFORMATION CONTACT). The notification 

should include 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 

September 8, 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 September 10, 2021. 

Individuals who do not wish to speak at 

the open public hearing session but 

would like their comments to be heard 

by the committee may send written 

submissions to the contact person on or 

before September 16, 2021. 

Virtual Breakout Session: Individuals 

interested in participating in the virtual 

breakout scenario discussions will need 

to sign up to participate on or before 

September 22, 2021. The signup sheet, 

as well as, additional information 

pertaining to the virtual scenario 

discussions will be available at https:// 

www.fdalive.com/peac. Everyone who 

signs up in advance and provides a 

valid email address will receive an 

email at least 2 days prior to the meeting 

with information on how to access the 

virtual platform that will host the 

virtual breakout scenario discussions. 

Please note due to limited technology 

capacity, participation in the virtual 

breakout scenario discussions will be 

limited to 150 participants. Once 

capacity reaches 150 participants, the 

breakout session will be closed to 

additional participants. Additional 

information regarding the virtual 

breakout scenario discussions will be 

provided at https://www.fdalive.com/ 

peac. 

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 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: August 6, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–17118 Filed 8–10–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 


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44030 Federal Register / Vol. 86, No. 152 / Wednesday, August 11, 2021 / Notices 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Special 

Emphasis Panel Clinical Trials & Biomarker 

Studies in Stroke. 

Date: August 18, 2021. 

Time: 11:00 a.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852, (Virtual 

Meeting). 

Contact Person: Shanta Rajaram, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, Division of Extramural Activities, 

NINDS/NIH, NSC, 6001 Executive Blvd., 

Suite 3208, MSC 9529, Rockville, MD 20852, 

(301) 435–6033, rajarams@mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.853, Clinical Research 

Related to Neurological Disorders; 93.854, 

Biological Basis Research in the 

Neurosciences, National Institutes of Health, 

HHS) 

Dated: August 5, 2021. 

Tyeshia M. Roberson-Curtis, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–17102 Filed 8–10–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

[Docket No. USCBP–2021–0028] 

Receipt of Domestic Interested Party 

Petition Concerning the Tariff 

Classification of Dried Onion Products 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: Notice of receipt of domestic 

interested party petition; solicitation of 

comments. 

SUMMARY: U.S. Customs and Border 

Protection (CBP) has received a petition 

submitted on behalf of a domestic 

interested party requesting the 

reclassification, under the Harmonized 

Tariff Schedule of the United States 

(HTSUS), of certain dried onion 

products. CBP currently classifies the 

subject dried onion products under 

subheading 2005.99.20, HTSUS, as 

onions prepared or preserved otherwise 

than by vinegar or acetic acid. Petitioner 

contends that the proper classification 

for the subject dried onion products is 

under subheading 0712.20.20, HTSUS, 

as dried onion powder not further 

prepared. This document invites 

comments with regard to the correctness 

of the current classification. 

DATES: Comments must be received on 

or before October 12, 2021. 

ADDRESSES: You may submit comments, 

identified by docket number, by the first 

method listed below: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments 

via docket number USCBP–2021–0028. 

• Mail: Due to COVID–19-related 

restrictions, CBP has temporarily 

suspended its ability to receive public 

comments by mail. 

Instructions: All submissions received 

must include the agency name and 

docket number for this notice of 

domestic interested party petition 

concerning the tariff classification of 

dried onion products. All comments 

received will be posted without change 

to http://www.regulations.gov, including 

any personal information provided. 

Docket: For access to the docket to 

read background documents, exhibits, 

or comments received, go to http://

www.regulations.gov. Due to the 

relevant COVID–19-related restrictions, 

CBP has temporarily suspended on-site 

public inspection of public comments. 

FOR FURTHER INFORMATION CONTACT: 

Tanya Secor, Food, Textiles and 

Marking Branch, Regulations and 

Rulings, Office of Trade, U.S. Customs 

and Border Protection, at (202) 325– 

0062 or by email at tanya.j.secor@

cbp.dhs.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

A petition has been filed under 

section 516 of the Tariff Act of 1930, as 

amended (19 U.S.C. 1516), on behalf of 

Olam West Coast Inc. (Petitioner or 

Olam), which is an agri-business and 

supplier of food, ingredients, and raw 

materials, based in Fresno, California. 

Olam manages a wide range of 

production, processing, and supply of 

agricultural products in twelve states, 

with a majority of its operations in 

California. Olam’s largest onion and 

garlic plant is in Gilroy, California. 

Olam meets all of the requirements of a 

domestic interested party set forth in 19 

U.S.C. 1516(a)(2) and section 175.3(a) in 

title 19 of the Code of Federal 

Regulations (19 CFR 175.3(a)). 

In New York Ruling Letter (NY) 

N265994 (July 9, 2015), NY N261449 

(February 20, 2015), NY N257752 

(October 24, 2014), and NY M86441 

(October 13, 2006), CBP classified 

various mixtures of onion powder and 

salt or other ingredients as prepared or 

preserved onions in subheading 

2005.99.20 of the Harmonized Tariff 

Schedule of the United States (HTSUS), 

which provides for ‘‘Other vegetables 

prepared or preserved otherwise than by 

vinegar or acetic acid, not frozen, other 

than products of heading 2006: Other 

vegetables and mixtures of vegetables: 

Other: Onions.’’ Petitioner contends that 

the proper classification for the onion 

powder mixtures is dried onion powder 

in subheading 0712.20.20, HTSUS, 

which provides for ‘‘Dried vegetables, 

whole, cut, sliced, broken or in powder, 

but not further prepared: Onions: 

Powder or flour.’’ 

Applicable Legal Principles 

Classification under the HTSUS is 

determined in accordance with the 

General Rules of Interpretation (GRIs) 

and, in the absence of special language 

or context which otherwise requires, by 

the Additional U.S. Rules of 

Interpretation (ARIs). GRI 1 provides 

that the classification of goods shall be 

determined according to the terms of the 

headings and any relative section or 

chapter notes. In the event that the 

goods cannot be classified solely on the 

basis of GRI 1, and if the headings and 

legal notes do not otherwise require, 

GRIs 2 through 6 may be applied in 

order. GRI 3(b) applies to mixtures, 

which are prima facie, classifiable 

under two or more headings and which 

cannot be classified by reference to GRI 

3(a). Pursuant to GRI 3(b), mixtures 

shall be classified as if they consisted of 

the material or component which gives 

them their essential character. 

Note 3 to Chapter 7, HTSUS, provides 

that heading 0712 covers all dried 

vegetables of the kinds falling in 

headings 0701 to 0711, excluding 

certain vegetables but including onions. 

Note 1(a) to Chapter 20, HTSUS, 

provides that this chapter does not 

cover vegetables, fruit or nuts, prepared 

or preserved by the processes specified 

in Chapter 7, 8, or 11. Conversely, Note 

3 to Chapter 20, HTSUS, provides in 

pertinent part that heading 2005 covers, 

as the case may be, only those products 

of Chapter 7, which have been prepared 

or preserved by processes other than 

those referred to in Note 1(a). 

The Explanatory Notes (ENs) to the 

Harmonized Commodity Description 

and Coding System represent the official 

interpretation of the tariff at the 

international level. While neither legally 

binding nor dispositive, the ENs provide 

a commentary on the scope of each 

heading of the HTSUS and are generally 

indicative of the proper interpretation of 


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