Federal Register / Vol. 87, No. 121 / Friday, June 24, 2022 / Notices 37863 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: June 17, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13520 Filed 6–23–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1262] 

Notice of Approval of Product Under 

Voucher: Rare Pediatric Disease 

Priority Review Voucher 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of approval of a product 

redeeming a priority review voucher. 

The Federal Food, Drug, and Cosmetic 

Act (FD&C Act), as amended by the 

Food and Drug Administration Safety 

and Innovation Act (FDASIA), 

authorizes FDA to award priority review 

vouchers to sponsors of approved rare 

pediatric disease product applications 

that meet certain criteria. FDA is 

required to publish notice of the 

issuance of priority review vouchers as 

well as the approval of products 

redeeming a priority review voucher. 

FDA has determined that the 

supplemental application for RINVOQ 

(upadacitinib), approved March 16, 

2022, meets the redemption criteria. 

FOR FURTHER INFORMATION CONTACT: 

Cathryn Lee, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–1394, email: Cathryn.Lee@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the approval of product 

redeeming a rare pediatric disease 

priority review voucher. Under section 

529 of the FD&C Act (21 U.S.C. 360ff), 

which was added by FDASIA, FDA will 

report the issuance of rare pediatric 

disease priority review vouchers and the 

approval of products for which a 

voucher was redeemed. FDA has 

determined that the supplemental 

application for RINVOQ (upadacitinib), 

approved March 16, 2022, meets the 

redemption criteria. 

For further information about the Rare 

Pediatric Disease Priority Review 

Voucher Program and for a link to the 

full text of section 529 of the FD&C Act, 

go to https://www.fda.gov/ForIndustry/ 

DevelopingProductsforRareDiseases

Conditions/RarePediatricDisease

PriorityVoucherProgram/default.htm. 

For further information about RINVOQ 

(upadacitinib), approved March 16, 

2022, go to the ‘‘Drugs@FDA’’ website at 

https://www.accessdata.fda.gov/scripts/ 

cder/daf/. 

Dated: June 21, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13607 Filed 6–23–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–2565] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; 510(k) Third-Party 

Review Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 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 the 510(k) ThirdParty Review Program. 

DATES: Submit either electronic or 

written comments on the collection of 

information by August 23, 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 August 23, 

2022. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of August 23, 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–D–2565 for ‘‘Agency Information 

Collection Activities; Submission for 

Office of Management and Budget 

Review; Comment Request; 510(k) 

Third-Party Review Program.’’ 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. 


jspears on DSK121TN23PROD with NOTICES1
37864 Federal Register / Vol. 87, No. 121 / Friday, June 24, 2022 / Notices 

• 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 

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: 

Rachel Showalter, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 240–994–7399, 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. 

510(k) Third-Party Review Program 

OMB Control Number 0910–0375— 

Extension 

Section 523 of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

360m), directs FDA to accredit persons 

in the private sector to review certain 

premarket notifications (510(k)s; see 21 

U.S.C. 360(k)). Participation in the 

510(k) third party (3P510k) review 

program by accredited persons is 

entirely voluntary. A third party 

wishing to participate will submit a 

request for accreditation to FDA. 

Accredited third-party reviewers have 

the ability to review a manufacturer’s 

510(k) submission for selected devices. 

After reviewing a submission, the 

reviewer will forward a copy of the 

510(k) submission, along with the 

reviewer’s documented review and 

recommendation, to FDA. Third-party 

reviewers should maintain records of 

their 510(k) reviews and a copy of the 

510(k) for a reasonable period of time, 

usually 3 years. 

Respondents to this information 

collection are businesses or government, 

and can be for-profit or not-for-profit 

organizations. 

The guidance ‘‘510(k) Third-Party 

Review Program, Guidance for Industry, 

Food and Drug Administration Staff and 

Third Party Review Organizations’’ 

(March 2020) (https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents/510k-third-partyreview-program) is intended to provide 

a comprehensive look into FDA’s 

current thinking regarding the 3P510k 

review program. This guidance 

document also reflects section 523 of 

the FD&C Act, which directs FDA to 

issue guidance on the factors that will 

be used in determining whether a class 

I or class II device type, or subset of 

such device types, is eligible for review 

by an accredited person. The 3P510k 

review program is intended to allow 

review of devices by third-party 510k 

review organizations (3PROs) to provide 

manufacturers of these devices an 

alternative review process that allows 

FDA to best utilize our resources on 

higher risk devices. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity; guidance document section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 2

Requests for accreditation (initial); Section VI ............ 1 1 1 24 ........................... 24 

Requests for accreditation (re-recognition); Section 

VI 

3 1 3 24 ........................... 72 

510(k) reviews conducted by accredited third parties; 

Section VI 

9 14 126 40 ........................... 5,040 

Complaints; Section VII ............................................... 1 1 1 0.25 (15 minutes) ... 1 

Total ...................................................................... ........................ ........................ ........................ ................................ 5,137 

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

2Totals have been rounded. 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 121 / Friday, June 24, 2022 / Notices 37865 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity; guidance document section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

510(k) reviews; Section VII .................................................. 9 14 126 10 1,260 

Records regarding qualifications to receive FDA recognition as a 3PRO; Section VII ............................................. 9 1 9 1 9 

Recordkeeping system regarding complaints; Section VII .. 9 1 9 2 18 

Total .............................................................................. ........................ ........................ ........................ ........................ 1,287 

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

Estimated Annual Recordkeeping 

Burden 

510(k) reviews: The 3PROs should 

retain copies of all 510(k) reviews and 

associated correspondence. Based on 

FDA’s recent experience with this 

program, we estimate the number of 

510(k)s submitted for 3P510k review to 

be 126 annually; approximately 14 

annual reviews for each of the 9 3PROs. 

We estimate the average burden per 

recordkeeping to be 10 hours. 

Records regarding qualifications to 

receive FDA recognition as a 3PRO: 

Under section 704(f) of the FD&C Act 

(21 U.S.C. 374(f)), a 3PRO must 

maintain records that support their 

initial and continuing qualifications to 

receive FDA recognition, including 

documentation of the training and 

qualifications of the 3PRO and its 

personnel; the procedures used by the 

3P510k review organization for 

handling confidential information; the 

compensation arrangements made by 

the 3PRO; and the procedures used by 

the 3PRO to identify and avoid conflicts 

of interest. Additionally, the guidance 

states that 3PROs should retain 

information on the identity and 

qualifications of all personnel who 

contributed to the technical review of 

each 510(k) submission and other 

relevant records. Because most of the 

burden of compiling the records is 

expressed in the reporting burden for 

requests for accreditation, we estimate 

the maintenance of such records to be 

1 hour per recordkeeping annually. 

Recordkeeping system regarding 

complaints: Section 523(b)(3)(F)(iv) of 

the FD&C Act requires 3PROs to agree 

in writing that they will promptly 

respond and attempt to resolve 

complaints regarding their activities. 

The guidance recommends that 3PROs 

establish a recordkeeping system for 

tracking the submission of those 

complaints and how those complaints 

were resolved, or attempted to be 

resolved. Based on our experience with 

the program and the recommendations 

in the guidance, we estimate the average 

burden per recordkeeping to be 2 hours 

annually. 

Based on our experience with the 

program since our last request for OMB 

approval, we have adjusted our burden 

estimate, which has resulted in a 

decrease to the currently approved 

burden. 

Dated: June 15, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13521 Filed 6–23–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–1152] 

Considerations for Rescinding 

Breakthrough Therapy Designation; 

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 a draft 

guidance for industry entitled 

‘‘Considerations for Rescinding 

Breakthrough Therapy Designation.’’ 

This guidance explains how, during its 

evaluation of a drug development 

program, FDA may consider whether to 

rescind a breakthrough therapy 

designation (BTD) that has been granted. 

The guidance is consistent with, and 

supplements, the information on BTD 

contained in the guidance for industry 

entitled ‘‘Expedited Programs for 

Serious Conditions—Drugs and 

Biologics’’ (May 2014) and in other BTD 

policies and procedures of the Center 

for Drug Evaluation and Research 

(CDER) and the Center for Biologics 

Evaluation and Research (CBER) to 

expedite the development and review of 

a breakthrough therapy. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by August 23, 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 


jspears on DSK121TN23PROD with NOTICES1