50132 Federal Register / Vol. 86, No. 170 / Tuesday, September 7, 2021 / Notices 

24 to 48 hours before the event, 

registrants will receive an email with 

the meeting link and a formal calendar 

invitation. 

Request to Provide Open Public 

Comment: During online registration, 

you may indicate if you wish to make 

open public comments during the 

public meeting and which topic(s) you 

would like to address. All requests to 

make public comments must be 

received by October 8, 2021 at 11:59 

p.m. Eastern Time. We will do our best 

to accommodate requests to make public 

comments. We are seeking to have a 

broad representation of ideas and issues 

presented at the meeting. Individuals 

and organizations with common 

interests are urged to consolidate or 

coordinate their comments. FDA will 

determine the amount of time allotted to 

each commenter, the meeting day, the 

approximate time open public 

comments are to be provided and notify 

all registrants who requested to make 

public comments. 

Streaming Webcast of the Public 

Meeting: This public meeting will be 

broadcast via YouTube. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

meeting is available, it will be accessible 

at https://www.regulations.gov. It may 

be viewed at the Dockets Management 

Staff (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20850. A link to 

the transcript will also be available on 

the internet at: https://www.fda.gov/ 

food/workshops-meetings-webinarsfood-and-dietary-supplements/new-erasmarter-food-safety-summit-ecommerce-ensuring-safety-foodsordered-online-and-delivered. 

Dated: August 31, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–19219 Filed 9–3–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–1529] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Reclassification 

Petitions for Medical Devices 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection associated with 

reclassification of medical devices. 

DATES: Submit either electronic or 

written comments on the collection of 

information by November 8, 2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before November 8, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of November 8, 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. 

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– 

2013–N–1529 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Reclassification Petitions for Medical 

Devices.’’ 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.’’ 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 


sradovich on DSKJLST7X2PROD with NOTICES
Federal Register / Vol. 86, No. 170 / Tuesday, September 7, 2021 / Notices 50133 

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: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Reclassification Petitions for Medical 

Devices 

OMB Control Number 0910–0138— 

Extension 

The Federal Food, Drug, and Cosmetic 

Act (FD&C Act) establishes the 

following three categories (classes) of 

devices, reflecting the regulatory 

controls needed to provide reasonable 

assurance of their safety and 

effectiveness: Class I (general controls), 

class II (special controls), and class III 

(premarket approval) (section 513(a)(1) 

of the FD&C Act (21 U.S.C. 360c(a)(1)). 

To change a device classification, FDA 

can initiate a reclassification, or an 

interested person can petition FDA to 

reclassify a device based on new 

information (section 513(e) of the FD&C 

Act). On July 9, 2012, the Food and 

Drug Administration Safety and 

Innovation Act (FDASIA) was enacted, 

changing the reclassification process 

under section 513(e) of the FD&C Act 

from rulemaking to an administrative 

order process. To reclassify a device 

under section 513(e) of the FD&C Act, 

FDA must do the following before 

making the reclassification final: (1) 

Publish a proposed order in the Federal 

Register which includes the proposed 

reclassification and a summary of the 

valid scientific evidence that supports 

the reclassification, (2) convene a device 

classification panel meeting, and (3) 

consider comments from the relevant 

public docket. 

FDASIA also amended the provisions 

of the FD&C Act authorizing FDA to 

require submission of a premarket 

approval application (PMA) for a 

preamendments class III device (referred 

to as a ‘‘call for PMAs’’). 

Preamendments devices are devices that 

were in commercial distribution before 

the enactment of the 1976 Amendments. 

Under the FD&C Act, preamendments 

devices classified into class III may be 

marketed upon clearance of a 510(k) 

submission, and submission of a PMA is 

not required until FDA has issued a 

final order requiring premarket approval 

(section 515(b) of the FD&C Act (21 

U.S.C. 360e(b)). As amended by 

FDASIA, the FD&C Act requires that 

FDA, in its call for PMAs, publish a 

proposed order in the Federal Register, 

hold a classification panel meeting, and 

consider comments on the proposed 

order (section 515(b) of the FD&C Act, 

as amended by FDASIA). 

Under the FD&C Act, FDA’s call for 

PMAs must, among other things, 

contain an opportunity for interested 

persons to request a change in the 

classification of the device based on 

new information (section 515(b)(2) of 

the FD&C Act). After consideration of 

comments on the proposed order and 

findings, FDA must either: (1) Finalize 

the call for PMAs by issuing an 

administrative order requiring approval 

of a PMA and publishing in the Federal 

Register findings with respect to: (i) The 

degree of risk of illness or injury 

designed to be eliminated or reduced by 

requiring the device to have an 

approved PMA or a declared completed 

product development protocol and (ii) 

the benefit to the public from the use of 

the device; or (2) publish a notice in the 

Federal Register terminating the 

proceeding and initiate a reclassification 

proceeding based on new information 

(section 515(b)(3) of the FD&C Act, as 

amended by FDASIA; see section 513(e) 

of the FD&C Act). 

The FD&C Act, as amended by 

FDASIA, now requires the use of 

administrative orders, rather than 

rulemaking, when FDA calls for PMAs 

for a preamendments device remaining 

in class III (section 515(b) of the FD&C 

Act, as amended by FDASIA). 

FDA refers to a device that was not in 

commercial distribution before the 1976 

Amendments as a postamendments 

device. Postamendments devices are 

classified automatically into class III by 

statute, without any rulemaking process 

(section 513(f)(1) of the FD&C Act). A 

postamendments device remains in 

class III and is subject to the PMA 

requirements unless and until: (1) FDA 

reclassifies the device into class I or II; 

(2) FDA issues an order classifying the 

device into class I or II via the De Novo 

classification process (see section 

513(f)(2) of the FD&C Act); or (3) FDA 

issues an order finding the device to be 

substantially equivalent to a predicate 

device that does not require the filing of 

a PMA (see section 513(i) of the FD&C 

Act). 

FDA may initiate, or the manufacturer 

or importer of a device may petition for, 

the reclassification of a 

postamendments device classified into 

class III by operation of law (section 

513(f)(3) of the FD&C Act). This FDAinitiated reclassification process 

consists of a proposed reclassification 

order, optional panel consultation, and 

a final reclassification order published 

in the Federal Register following 

consideration of comments and any 

panel recommendations or comments 

(§ 860.134(c) (21 CFR 860.134(c))). The 

reclassification order may, as 

appropriate, establish special controls to 

provide reasonable assurance of the 

safety and effectiveness of the device 

(§ 860.134(d)). 

Under the 1976 Amendments, 

Congress classified all those devices 

previously regulated as new drugs into 

class III (generally referred to as 

transitional devices). Under the FD&C 

Act, FDA may initiate, or the 

manufacturer or importer of a device 

may petition for, the reclassification of 

a transitional device remaining in class 

III (section 520(l)(2) of the FD&C Act (21 

U.S.C. 360j(l)(2)). The process for 

reclassification of transitional devices 

initiated by FDA is detailed in 21 

CFR 860.136(c). This process consists of 

a proposed reclassification order, 

optional panel consultation, and a final 


sradovich on DSKJLST7X2PROD with NOTICES
50134 Federal Register / Vol. 86, No. 170 / Tuesday, September 7, 2021 / Notices 

reclassification order published in the 

Federal Register following 

consideration of comments and any 

panel recommendations or comments. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; information collection activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

§ 860.123; supporting data for reclassification petitions ...... 6 1 6 497 2,982 

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 no 

adjustments to our burden estimate. 

Dated: August 31, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–19221 Filed 9–3–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0944] 

Pediatric Advisory Committee; Notice 

of Meeting; Establishment of a Public 

Docket; Request for Comments; 

Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice entitled ‘‘Pediatric Advisory 

Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments.’’ The document 

announced a meeting of the Pediatric 

Advisory Committee. The document 

was published with the incorrect docket 

number and end time of the meeting. 

This document corrects those errors. 

FOR FURTHER INFORMATION CONTACT: 

Marieann Brill, Office of the 

Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5154, Silver Spring, 

MD 20993, 240–402–3838, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area). Please call the 

Information Line for up-to-date 

information on this meeting. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of Tuesday, August 10, 

2021, in FR Doc. 2021–16984 (86 FR 

43666), the following corrections are 

made. 

1. On page 43666, in the first column, 

in the header of the document, and in 

the third column under ‘‘Instructions,’’ 

‘‘Docket No. FDA–2020–N–1648N’’ is 

changed to ‘‘Docket No. FDA–2021–N– 

0944’’. 

2. On page 43666, in the first column, 

the DATES portion of the document is 

changed to: ‘‘The meeting will be held 

on September 17, 2021, from 10 a.m. to 

3 p.m. Eastern Time.’’ 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to the advisory committees. 

Dated: August 31, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–19216 Filed 9–3–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0918] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Labeling 

Requirements for Prescription Drugs 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection associated with labeling 

requirements for prescription drugs. 

DATES: Submit either electronic or 

written comments on the collection of 

information by November 8, 2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before November 8, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of November 8, 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. 

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. 


sradovich on DSKJLST7X2PROD with NOTICES