Federal Register / Vol. 87, No. 51 / Wednesday, March 16, 2022 / Notices 14891 

TABLE 1—FEE SCHEDULE FOR FY 

2022 

Fee category FY 2022 

fee rates 

OMOR: 

Tier 1 ....................................... $507,021 

Tier 2 ....................................... 101,404 

Facility Fees: 

MDF ........................................ 24,178 

CMO ........................................ 16,119 

VI. Fee Payment Options and 

Procedures 

The new fee rates are for the period 

from October 1, 2021, through 

September 30, 2022. To pay the OMOR, 

MDF, and CMO fees, complete an OTC 

Monograph User Fee Cover Sheet, 

available at: https://userfees.fda.gov/ 

OA_HTML/omufaCAcdLogin.jsp. A user 

fee identification (ID) number will be 

generated. Payment must be made in 

U.S. currency by electronic check or 

wire transfer, payable to the order of the 

Food and Drug Administration. The 

preferred payment method is online 

using electronic check (Automated 

Clearing House (ACH) also known as 

eCheck) or credit card for payments 

under $25,000 (Discover, VISA, 

MasterCard, American Express). 

FDA has partnered with the U.S. 

Department of the Treasury to use 

Pay.gov, a web-based payment 

application, for online electronic 

payment. The Pay.gov feature is 

available on the FDA website after 

completing the OTC Monograph User 

Fee Cover Sheet and generating the user 

fee ID number. Secure electronic 

payments can be submitted using the 

User Fees Payment Portal at https://

userfees.fda.gov/pay (Note: Only full 

payments are accepted. No partial 

payments can be made online). Once an 

invoice is located, ‘‘Pay Now’’ should be 

selected to be redirected to Pay.gov. 

Electronic payment options are based on 

the balance due. Payment by credit card 

is available for balances that are less 

than $25,000. If the balance exceeds this 

amount, only the ACH option is 

available. Payments must be made using 

U.S. bank accounts as well as U.S. credit 

cards. 

For payments made by wire transfer, 

include the unique user fee ID number 

to ensure that the payment is applied to 

the correct fee(s). Without the unique 

user fee ID number, the payment may 

not be applied, which could result in 

FDA not filing an OMOR request, for 

example, and other penalties. The 

originating financial institution may 

charge a wire transfer fee. Applicable 

wire transfer fees must be included with 

payment to ensure fees are fully paid. 

Questions about wire transfer fees 

should be addressed to the financial 

institution. The account information for 

wire transfers is as follows: U.S. 

Department of the Treasury, TREAS 

NYC, 33 Liberty St., New York, NY 

10045, Acct. No.: 75060099, Routing 

No.: 021030004, SWIFT: FRNYUS33. If 

needed, FDA’s tax identification 

number is 53–0196965. 

If you are assessed an FY 2022 

OMUFA facility fee and believe your 

facility is not an OTC monograph drug 

facility as described in this notice, 

please contact CDERCollections@

fda.hhs.gov. 

Dated: March 9, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–05542 Filed 3–14–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–N–1593] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Medical Device 

Accessories 

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 medical device 

accessory requests. 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 16, 2022. 

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 May 16, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of May 16, 2022. 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– 

2016–N–1593 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Medical 

Device Accessories.’’ 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 


jspears on DSK121TN23PROD with NOTICES1
14892 Federal Register / Vol. 87, No. 51 / Wednesday, March 16, 2022 / Notices 

1The guidance document is available on FDA’s 

website (https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/ 

medical-device-accessories-describing-accessoriesand-classification-pathways). 

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 

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. 

Medical Device Accessories 

OMB Control Number 0910–0823— 

Extension 

FDA’s guidance document entitled 

‘‘Medical Device Accessories— 

Describing Accessories and 

Classification Pathways’’ (the 

Accessories guidance) 1 is intended to 

provide guidance to industry and FDA 

staff about the regulation of accessories 

to medical devices, to describe FDA’s 

policy concerning the classification of 

accessories, and to discuss the 

application of this policy to devices that 

are commonly used as accessories to 

other medical devices. In addition, the 

guidance explains what devices FDA 

generally considers an ‘‘accessory’’ and 

describes the processes under section 

513(f)(6) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 360c(f)(6)) to 

allow requests for risk- and regulatory 

control-based classification of 

accessories. 

The FDA Reauthorization Act of 2017 

(FDARA) changed how FDA regulates 

medical device accessories. Specifically, 

section 707 of FDARA added section 

513(f)(6) to the statute and requires that 

FDA, upon request, classify existing and 

new accessories notwithstanding the 

classification of any other device with 

which such accessory is intended to be 

used. This means that the classification 

of an accessory may not be the same as 

its parent device, depending on the risks 

of the accessory when used as intended 

and the level of regulatory controls 

necessary for reasonable assurance of 

safety and effectiveness of the accessory. 

Until an accessory is distinctly 

classified, its existing classification will 

continue to apply. This provision does 

not preclude a manufacturer from 

submitting a De Novo request for an 

accessory. 

Depending on an accessory’s 

regulatory history, there are different 

submission types, tracking mechanisms, 

and deadlines: 

(1) Existing accessory types are those 

that have been identified in a 

classification regulation or granted 

marketing authorization as part of a 

510(k), pre-market application (PMA), 

or De Novo request (approved under 

OMB control numbers 0910–0120, 

0910–0231, and 0910–0844, 

respectively). Manufacturers with 

marketing authorization for an existing 

accessory may request appropriate 

classification through a new stand-alone 

premarket submission (Existing 

Accessory Request). Upon request, FDA 

is required to meet with a manufacturer 

or importer to discuss the appropriate 

classification of an existing accessory 

prior to submitting a written request. 

Existing Accessory Requests will be 

initially tracked as ‘‘Q-submissions’’ 

(approved under OMB control number 

0910–0756). FDA has a statutory 

deadline of 85 calendar days to respond 

to an Existing Accessory Request. 

(2) New accessory types are those that 

have not been granted marketing 

authorization as part of a 510(k), PMA, 

or De Novo request. Manufacturers may 

include new accessories into a 510(k) or 

PMA with the parent device (New 

Accessory Request). New Accessory 

Requests will have the same deadline as 

the 510(k) or PMA. Therefore, new 

accessory types should follow the 

applicable Medical Device User Fee 

Amendments of 2017 deadline for the 

parent submission. The decision for 

New Accessory Requests will be 

separate from the decision for the 

marketing application. 

For both Existing and New Accessory 

Requests, manufacturers must request 

proper classification of their accessory 

in the submission and include draft 

special controls, if requesting 

classification into class II. The processes 

that we use to classify an accessory will 

be like those used for De Novo requests. 

If FDA grants the Accessory Request, 

FDA must issue an order establishing a 

new classification regulation for the 

accessory type. If FDA denies the 

Accessory Request, FDA must issue a 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 51 / Wednesday, March 16, 2022 / Notices 14893 

letter with a detailed description and 

justification for our determination. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity; guidance for industry (GFI) section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Existing Accessory Request; GFI VI.A ................................ 10 1 10 40 400 

New Accessory Request ...................................................... 5 1 5 40 200 

Total .............................................................................. ........................ ........................ ........................ ........................ 600 

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

Based on an evaluation of the 

information collection, we have reduced 

the estimated number of existing 

requests from 15 to 10, and we have 

reduced the estimated number of new 

requests from 10 to 5. This adjustment 

results in an overall reduction to the 

information collection by 10 responses 

and 400 hours annually. We believe 

these adjustments more accurately 

reflect the current number of requests 

associated with medical device 

accessory classifications. 

Dated: March 2, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–05517 Filed 3–15–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–0404] 

Considerations for the Development of 

Chimeric Antigen Receptor T Cell 

Products; Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of the draft 

guidance entitled ‘‘Considerations for 

the Development of Chimeric Antigen 

Receptor T Cell Products; Draft 

Guidance for Industry.’’ The draft 

guidance document is intended to assist 

sponsors, including industry and 

academic sponsors, developing 

Chimeric Antigen Receptor (CAR) T cell 

products. The draft guidance includes 

CAR T cell-specific recommendations 

regarding chemistry, manufacturing, 

and control (CMC), pharmacology and 

toxicology, and clinical study design. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by June 14, 2022 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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– 

2021–D–0404 for ‘‘Considerations for 

the Development of Chimeric Antigen 

Receptor (CAR) T Cell Products; Draft 

Guidance for Industry.’’ 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 

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:// 


jspears on DSK121TN23PROD with NOTICES1