Federal Register / Vol. 86, No. 140 / Monday, July 26, 2021 / Notices 40059 

encephalitis vaccine. No 

recommendation votes are scheduled. 

Agenda items are subject to change as 

priorities dictate. For more information 

on the meeting agenda visit https://

www.cdc.gov/vaccines/acip/meetings/ 

meetings-info.html. 

Meeting Information: The meeting 

will be webcast live via the World Wide 

Web; for more information on ACIP 

please visit the ACIP website: http://

www.cdc.gov/vaccines/acip/index.html. 

Public Participation 

Interested persons or organizations 

are invited to participate by submitting 

written views, recommendations, and 

data. Please note that comments 

received, including attachments and 

other supporting materials, are part of 

the public record and are subject to 

public disclosure. Comments will be 

posted on https://www.regulations.gov. 

Therefore, do not include any 

information in your comment or 

supporting materials that you consider 

confidential or inappropriate for public 

disclosure. If you include your name, 

contact information, or other 

information that identifies you in the 

body of your comments, that 

information will be on public display. 

CDC will review all submissions and 

may choose to redact, or withhold, 

submissions containing private or 

proprietary information such as Social 

Security numbers, medical information, 

inappropriate language, or duplicate/ 

near duplicate examples of a mass-mail 

campaign. CDC will carefully consider 

all comments submitted into the docket. 

Written Public Comment: The docket 

will be opened to receive written 

comments on September 1, 2021. 

Written comments must be received on 

or before September 30, 2021. 

Oral Public Comment: This meeting 

will include time for members of the 

public to make an oral comment. Oral 

public comment will occur before any 

scheduled votes including all votes 

relevant to the ACIP’s Affordable Care 

Act and Vaccines for Children Program 

roles. Priority will be given to 

individuals who submit a request to 

make an oral public comment before the 

meeting according to the procedures 

below. 

Procedure for Oral Public Comment: 

All persons interested in making an oral 

public comment at the September 29– 

30, 2021, ACIP meeting must submit a 

request at http://www.cdc.gov/vaccines/ 

acip/meetings/ no later than 11:59 p.m., 

EDT, September 24, 2021, according to 

the instructions provided. 

If the number of persons requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

time, CDC will conduct a lottery to 

determine the speakers for the 

scheduled public comment session. 

CDC staff will notify individuals 

regarding their request to speak by email 

September 28, 2021. To accommodate 

the significant interest in participation 

in the oral public comment session of 

ACIP meetings, each speaker will be 

limited to 3 minutes, and each speaker 

may only speak once per meeting. 

The Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Strategic Business Initiatives Unit, 

Office of the Chief Operating Officer, Centers 

for Disease Control and Prevention. 

[FR Doc. 2021–15799 Filed 7–23–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0651] 

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 public 

docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 

announces a forthcoming public 

advisory committee meeting of the 

Cellular, Tissue and Gene Therapies 

Advisory Committee (CTGTAC). The 

general function of the committee is to 

provide advice and recommendations to 

FDA on regulatory issues. Matters 

considered at the meeting will include 

discussion of the toxicity risks of adenoassociated virus (AAV) vector-based 

gene therapy products. The discussion 

topics include oncogenicity risks due to 

vector genome integration and safety 

issues identified during preclinical and/ 

or clinical evaluation. The meeting will 

be open to the public on both days. FDA 

is establishing a docket for public 

comment on this document. 

DATES: The meeting will be held on 

September 2 and 3, 2021, from 10 a.m. 

to 6 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/advisory-committees/ 

about-advisory-committees/commonquestions-and-answers-about-fdaadvisory-committee-meetings. The 

online web conference meeting will be 

available at the following links on the 

day of the meeting: Day 1 https://

youtu.be/58KjL9_p9Tw and Day 2 

https://youtu.be/yLggQF0XUUY. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2021–N–0651. 

The docket will close on September 1, 

2021. Submit either electronic or 

written comments on this public 

meeting on or before September 1, 2021. 

Please note that late, untimely filed 

comments will not be considered. The 

https://www.regulations.gov electronic 

filing system will accept comments 

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

of September 1, 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 

August 26, 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: 

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 


jbell on DSKJLSW7X2PROD with NOTICES
40060 Federal Register / Vol. 86, No. 140 / Monday, July 26, 2021 / Notices 

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–0651 for ‘‘Cellular, Tissue and 

Gene Therapies 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: 

Jarrod Collier or Joanne Lipkind, Center 

for Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

6268, Silver Spring, MD 20993–0002, 

ctgtac@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, before coming to the meeting, 

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. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. The CTGTAC 

committee will meet in open session on 

both days to discuss the toxicity risks of 

AAV vector-based gene therapy 

products. The discussion topics include 

oncogenicity risks due to vector genome 

integration and safety issues identified 

during preclinical and/or clinical 

evaluation. On September 2, 2021, in 

the morning, under session 1, the 

CTGTAC committee will meet to 

discuss and make recommendations on 

vector integration and oncogenicity 

risks. In the afternoon under session 2, 

the committee will discuss and make 

recommendations on hepatotoxicity 

issues. On September 3, 2021, in the 

morning under session 3, the committee 

will meet to discuss and make 

recommendations on thrombotic 

microangiopathy issues. In the 

afternoon under session 4, the 

committee will discuss and make 

recommendations on non-clinical 

findings of neurotoxicity, especially 

related to the dorsal root ganglion 

toxicity issues. Also, in the afternoon 

under session 5, the committee will 

discuss and make recommendations on 

clinical findings of neurotoxicity, based 

on brain magnetic resonance imaging 

studies. 

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 

August 26, 2021, will be provided to the 

committee. Oral presentations from the 

public will be scheduled twice each day 

between approximately 12:45 p.m. and 

1:15 p.m. and 4:05 p.m. and 4:35 p.m. 

on September 2, and between 11 a.m. 

and 11:30 a.m. and 1:50 p.m. and 2:20 

p.m. on September 3. 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 August 

18, 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 August 19, 2021. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 140 / Monday, July 26, 2021 / Notices 40061 

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 Jarrod Collier 

at ctgtac@fda.hhs.gov (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/about-advisory-committees/ 

public-conduct-during-fda-advisorycommittee-meetings 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: July 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–15783 Filed 7–23–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–Z–0025] 

Medical Devices; Class I Surgeon’s 

and Patient Examination Gloves 

AGENCY: Department of Health and 

Human Services (HHS), Food and Drug 

Administration (FDA). 

ACTION: Final order, determination. 

SUMMARY: The Department of Health and 

Human Services (HHS or ‘‘the 

Department’’) issued a Notice in the 

Federal Register of January 15, 2021, 

(‘‘the January 15 notice’’) which 

identified seven types of reserved class 

I devices that the Department had 

determined no longer require premarket 

notification. The Department and the 

Food and Drug Administration (FDA or 

‘‘the Agency’’) issued a Notice in the 

Federal Register of April 16, 2021 (‘‘the 

April 16 notice’’) explaining the basis 

for our current view that the seven types 

of reserved class I devices identified in 

the January 15 notice require a 

premarket notification, and explaining 

why the reasoning supporting the prior 

determination was unsound. HHS and 

FDA sought comment on the matters 

discussed in the April 16 notice, and 

have considered the comments that 

were submitted to the docket. HHS and 

FDA are issuing this final order and 

determination that the seven types of 

class I surgeon’s gloves and patient 

examination gloves listed in the January 

15 notice are reserved class I devices for 

which a premarket notification is 

required. 

DATES: Compliance date: All devices 

subject to this order shall comply with 

the order no later than August 25, 2021. 

ADDRESSES: 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: 

Angela Krueger, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1660, Silver Spring, 

MD 20993, 301–796–6380, or by email 

at RPG@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background Regarding Section 510(l) 

of the FD&C Act 

Under section 513 of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 360c), FDA must classify 

devices into one of three regulatory 

classes: Class I, class II, or class III. FDA 

classification of a device is determined 

by the amount of regulation necessary to 

provide a reasonable assurance of safety 

and effectiveness. The Medical Device 

Amendments of 1976 (‘‘1976 

amendments’’) (Pub. L. 94–295), and the 

Safe Medical Devices Act of 1990 (Pub. 

L. 101–629), require FDA to classify 

devices into class I (‘‘general controls’’) 

if there is information showing that the 

general controls of the FD&C Act are 

sufficient to assure safety and 

effectiveness; into class II (‘‘special 

controls’’), if general controls, by 

themselves, are insufficient to provide 

reasonable assurance of safety and 

effectiveness, but there is sufficient 

information to establish special controls 

to provide such assurance; and into 

class III (premarket approval), if there is 

insufficient information to support 

classifying a device into class I or class 

II and the device is a life sustaining or 

life supporting device, or is for a use 

which is of substantial importance in 

preventing impairment of human 

health, or presents a potential 

unreasonable risk of illness or injury. 

Unless a device is exempt from 

premarket notification, section 510(k) of 

the FD&C Act (21 U.S.C. 360(k)) and the 

implementing regulations, part 807 of 

Title 21 of the Code of Federal 

Regulations (CFR), require persons who 

intend to market a new device to submit 

a premarket notification (510(k)) 

demonstrating the new device is 

‘‘substantially equivalent’’ within the 

meaning of section 513(i) of the FD&C 

Act to a legally marketed device for 

which premarket approval is not 

required. Section 510(l)(1) of the FD&C 

Act, added to the statute by the Food 

and Drug Administration Modernization 

Act of 1997 (FDAMA), provides that a 

510(k) is not required for a class I 

device, except for any class I device 

intended for a use that is of substantial 

importance in preventing impairment of 

human health, or any class I device that 

presents a potential unreasonable risk of 

illness or injury. FDA refers to these as 

the ‘‘reserved criteria’’ and to class I 

devices subject to 510(k) as ‘‘class I 

reserved devices.’’ Thus, class I devices 

are exempt from the 510(k) 

requirements except for class I device 

types that meet the reserved criteria 

under section 510(l)(1). 

As discussed in the April 16 notice, 

since 2017, FDA has evaluated which 

devices meet the reserved criteria 

several times. See 86 FR 20167 at 20168. 

Each time, FDA has made its 

determinations available to the public 

through publication in the Federal 

Register. See 63 FR 5387, 63 FR 63222, 

65 FR 2296, 82 FR 17841, 84 FR 71794. 

In 1998, after FDAMA was enacted, 

FDA evaluated all class I devices in 

interstate commerce at that time, and 

published a notice in the Federal 

Register containing: (1) A list of device 

types that FDA believed met the 

reserved criteria and thus would remain 

subject to premarket notification and (2) 

a list of device types that FDA believed 

did not meet these criteria and thus 

would be exempt from such 

requirements. See 63 FR 5387. Although 

devices that did not meet the reserved 

criteria became exempt on February 19, 

1998, FDA also issued proposed and 

final rules amending the applicable 

classification regulations for these 

devices, as well as for five device types 

that FDA had exempted prior to 

FDAMA that, post-FDAMA, FDA 

determined meet the reserved criteria. 

See 63 FR 63222, 65 FR 2296. 

On December 13, 2016, the 21st 

Century Cures Act (Cures Act) amended 

section 510(l) of the FD&C Act, 

reorganizing section 510(l) into 

paragraphs 510(l)(1) and (2). Section 

510(l)(2) of the FD&C Act requires FDA 

to identify at least once every 5 years, 

through publication in the Federal 

Register, any type of class I device that 

the Agency determines no longer 

requires a report under section 510(k) of 

the FD&C Act to provide reasonable 

assurance of safety and effectiveness. 


jbell on DSKJLSW7X2PROD with NOTICES