Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Notices 20429 

Our estimated burden for the 

information collection reflects an 

overall increase of 25,425 hours and a 

corresponding increase of 84,703 

records. We attribute this increase to the 

inclusion of external control testing 

laboratories that perform only 

specialized chemical, microbiological, 

or sterility testing functions to support 

manufacturing and release of final PET 

drug products. 

Dated: March 30, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–07392 Filed 4–6–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–4951] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Medical Devices; 

Humanitarian Use Devices 

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 information 

collection requirements for 

humanitarian use devices (HUDs). 

DATES: Submit either electronic or 

written comments on the collection of 

information by June 6, 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 June 6, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of June 6, 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– 

2017–N–4951 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Medical 

Devices; Humanitarian Use 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 

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 


khammond on DSKJM1Z7X2PROD with NOTICES
20430 Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Notices 

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 Devices; Humanitarian Use 

Devices—21 CFR Part 814 

OMB Control Number 0910–0332— 

Revision 

This collection of information 

implements the humanitarian use 

devices (HUDs) provision of section 

520(m) of the Federal Food, Drug, and 

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

360j(m)) and part 814, subpart H (21 

CFR part 814, subpart H). Under section 

520(m) of the FD&C Act, FDA is 

authorized to exempt an HUD from the 

effectiveness requirements of sections 

514 and 515 of the FD&C Act (21 U.S.C. 

360d and 360e) provided that the 

device: (1) Is designed to treat or 

diagnose a disease or condition that 

affects no more than 8,000 individuals 

in the United States; (2) would not be 

available to a person with a disease or 

condition unless an exemption is 

granted and there is no comparable 

device other than another HUD 

approved under this exemption that is 

available to treat or diagnose such 

disease or condition; and (3) will not 

expose patients to an unreasonable or 

significant risk of illness or injury and 

the probable benefit to health from the 

use of the device outweighs the risk of 

injury or illness from its use, taking into 

account the probable risks and benefits 

of currently available devices or 

alternative forms of treatment. 

Respondents may submit a 

humanitarian device exemption (HDE) 

application seeking exemption from the 

effectiveness requirements of sections 

514 and 515 of the FD&C Act as 

authorized by section 520(m)(2) of the 

FD&C Act. The information collected 

will assist FDA in making 

determinations on the following: (1) 

Whether to grant HUD designation of a 

medical device; (2) whether to exempt 

an HUD from the effectiveness 

requirements under sections 514 and 

515 of the FD&C Act, provided that the 

device meets requirements set forth 

under section 520(m) of the FD&C Act; 

and (3) whether to grant marketing 

approval(s) for the HUD. Failure to 

collect this information would prevent 

FDA from making a determination on 

the factors listed previously in this 

document. Further, the collected 

information would also enable FDA to 

determine whether the holder of an 

HUD is in compliance with the HUD 

provisions under section 520(m) of the 

FD&C Act. 

HUDs approved under an HDE cannot 

be sold for an amount that exceeds the 

costs of research and development, 

fabrication, and distribution of the 

device (i.e., for profit), except in narrow 

circumstances. Under section 

520(m)(6)(A)(i) of the FD&C Act, a HUD 

approved under an HDE is eligible to be 

sold for profit if the device meets the 

following criteria: The device is 

intended for the treatment or diagnosis 

of a disease or condition that occurs in 

pediatric patients or in a pediatric 

subpopulation, and such device is 

labeled for use in pediatric patients or 

in a pediatric subpopulation in which 

the disease or condition occurs; or the 

device is intended for the treatment or 

diagnosis of a disease or condition that 

does not occur in pediatric patients, or 

that occurs in pediatric patients in such 

numbers that the development of the 

device for such patients is impossible, 

highly impracticable, or unsafe. 

Section 520(m)(6)(A)(ii) of the FD&C 

Act, provides that the Secretary of 

Health and Human Services will 

determine the annual distribution 

number (ADN) for devices that meet the 

eligibility criteria to be permitted to be 

sold for profit. The Cures Act amended 

the FD&C Act definition of the ADN as 

the number of devices reasonably 

needed to treat, diagnose, or cure a 

population of 8,000 individuals in the 

United States. 

Section 520(m)(6)(A)(iii) of the FD&C 

Act provides that an HDE holder 

immediately notify the Agency if the 

number of such devices distributed 

during any calendar year exceeds the 

ADN. Section 520(m)(6)(C) of the FD&C 

Act provides that an HDE holder may 

petition to modify the ADN if additional 

information arises. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity/21 CFR section or FD&C act section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Request for HUD designation—814.102 ............................................................ 20 1 20 40 800 

HDE Application—814.104 ................................................................................. 4 1 4 328 1,312 

HDE Amendments and resubmitted HDEs—814.106 ........................................ 20 5 100 50 5,000 

HDE Supplements—814.108 .............................................................................. 116 1 116 80 9,280 

Notification of withdrawal of an HDE—814.116(e)(3) ......................................... 2 1 2 1 2 

Notification of withdrawal of institutional review board approval—814.124(b) ... 1 1 1 2 2 

Periodic reports—814.126(b)(1) .......................................................................... 50 1 50 120 6,000 

Pediatric Subpopulation and Patient Information—515A(a)(2) of the FD&C Act 

(21 U.S.C. 360e–1(a)(2)) ................................................................................. 1 1 1 100 100 

Exemption from Profit Prohibition Information—520(m)(6)(A)(i) and (ii) of the 

FD&C Act ......................................................................................................... 1 1 1 50 50 

Request for Determination of Eligibility Criteria—613(b) of the Food and Drug 

Administration Safety and Innovation Act ....................................................... 1 1 1 10 10 

ADN Notification—520(m)(6)(A)(iii) of the FD&C Act ......................................... 1 1 1 100 100 

ADN Modification—520(m)(6)(C) of the FD&C Act ............................................ 1 1 1 100 100 

Total ............................................................................................................. ........................ .......................... ........................ ........................ 22,756 

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


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Notices 20431 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity/21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

HDE Records—814.126(b)(2) ........................................................................... 62 1 62 2 124 

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

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Activity/21 CFR section Number of 

respondents 

Number of 

disclosures per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Notification of emergency use—814.124(a) ....................................................... 22 1 22 1 22 

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

Our estimated burden for the 

information collection reflects an 

increase of 360 total burden hours and 

a corresponding increase of five total 

annual responses. For efficiency of 

Agency operations, we are consolidating 

the related information activity and 

account for burden associated with HDE 

regulations currently approved in OMB 

control number 0910–0661. As a result, 

there is an increase in the total number 

of burden hours for this information 

collection. 

Dated: March 30, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–07376 Filed 4–6–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–3903] 

Chronic Hepatitis B Virus Infection: 

Developing Drugs for Treatment; 

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 final 

guidance for industry entitled ‘‘Chronic 

Hepatitis B Virus Infection: Developing 

Drugs for Treatment.’’ The purpose of 

this guidance is to assist sponsors in the 

clinical development of drugs and 

biologics for the treatment of chronic 

hepatitis B virus (HBV) infection from 

the initial investigational new drug 

application (IND) through the new drug 

application (NDA)/biologics license 

application (BLA) and postmarketing 

phases. This guidance finalizes the draft 

guidance of the same title issued on 

November 2, 2018. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on April 7, 2022. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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– 

2018–D–3903 for ‘‘Chronic Hepatitis B 

Virus Infection: Developing Drugs for 

Treatment.’’ 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. 


khammond on DSKJM1Z7X2PROD with NOTICES