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
37866 Federal Register / Vol. 87, No. 121 / Friday, June 24, 2022 / Notices 

1Available at: https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/ 

expedited-programs-serious-conditions-drugs-andbiologics. 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2021–D–1152 for ‘‘Considerations for 

Rescinding Breakthrough Therapy 

Designation.’’ 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://

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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002, or the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: Dat 

Doan, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 3334, Silver Spring, 

MD 20993, 240–402–8926, Dat.Doan@

fda.hhs.gov; or Stephen Ripley, Center 

for Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Considerations for Rescinding 

Breakthrough Therapy Designation.’’ 

This 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),1 in CDER’s 

Manual of Policies and Procedures 

6025.6 ‘‘Good Review Practice: 

Management of Breakthrough TherapyDesignated Drugs and Biologics,’’ and in 

CBER’s Standard Operating Policy and 

Procedure 8212 Version 2 ‘‘Management 

of Breakthrough Therapy-Designated 

Products: Sponsor Interactions and 

Status Assessment Including 

Rescinding.’’ 

Section 506(a) of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 356(a)) provides for the granting 

of BTD ‘‘if the drug is intended, alone 

or in combination with 1 or more other 

drugs, to treat a serious or lifethreatening disease or condition and 

preliminary clinical evidence indicates 

that the drug may demonstrate 

substantial improvement over existing 

therapies on 1 or more clinically 

significant endpoints, such as 

substantial treatment effects observed 

early in clinical development.’’ The 

BTD program is intended to facilitate 

and expedite the development of those 

drugs that receive designation and 

involves a resource commitment from 

FDA to provide early and frequent 

advice, conduct multidisciplinary 

meetings involving senior managers, 

and expedite the review of resultant 

marketing applications. Thus, over the 

course of product development, it is 

important that available evidence 

relevant to an application continues to 

meet the standards for BTD. 

The information and circumstances 

supporting the original grant of BTD for 

a particular application may change 

over time. For example, if a different 

drug is approved to treat the unmet 

need that informed the rationale for 

granting BTD, the designated drug’s 

preliminary clinical evidence may no 

longer meet the BTD criteria regarding 

substantial improvement over existing 

therapies (including the newly 

approved drug). In other cases, some 

drugs that appear promising in early 

development fail to meet their primary 

endpoints or the extent of benefit is 

more modest in later trials, and the 

magnitude of a treatment effect 

suggested by early development may not 

be replicable in later stages of 

development. Accordingly, in keeping 

with the Agency’s authority to grant 

BTD only to drugs that meet the legal 

criteria, FDA periodically assesses 

whether the criteria for BTD continue to 

be met for designated products. If the 

designation is no longer supported by 

subsequent data, FDA may rescind the 

designation. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Considerations for Rescinding 

Breakthrough Therapy Designation.’’ It 

does not establish any rights for any 

person and is not binding on FDA or the 

public. You can use an alternative 

approach if it satisfies the requirements 

of the applicable statutes and 

regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR part 312 have 

been approved under OMB control 

number 0910–0014; the collections of 

information in 21 CFR part 314 have 


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Federal Register / Vol. 87, No. 121 / Friday, June 24, 2022 / Notices 37867 

been approved under OMB control 

number 0910–0001; the collections of 

information in 21 CFR part 601 have 

been approved under OMB control 

number 0910–0338; and the collections 

of information in section 506 of the 

FD&C Act have been approved under 

OMB control number 0910–0765. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

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

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

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: June 17, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13528 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–2013–N–0403] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Protection of 

Human Subjects and Institutional 

Review Boards 

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 statutory and 

regulatory provisions governing human 

subject protection and institutional 

review boards. 

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– 

2013–N–0403 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Protection of Human Subjects and 

Institutional Review Boards.’’ 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 

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: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, 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. 


jspears on DSK121TN23PROD with NOTICES1