Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices 70667 

FDA published a 60-day notice for 

public comment in the Federal Register 

of June 12, 2023 (88 FR 38061) and 

received comments. While one 

comment appeared to question the 

purpose of the information collection, 

another comment supported FDA 

activities regarding the reporting of 

information covered by the collection. 

No comment suggested that we revise 

our burden estimate. 

We also received suggestions on how 

our submission form might be 

improved. In response to this comment, 

we are revising the submission form 

using asterisks to more clearly indicate 

which fields are required for submission 

versus non-required fields. The form 

also has been updated to allow 

submission of the company’s website. 

Similarly, one comment noted that 

current procedures do not allow for 

complete anonymity when submitting 

allegations of regulatory misconduct to 

FDA. The comment suggests changing 

the submission process to allow 

submission of attachments to the form, 

rather than via separate email. While we 

have not made changes regarding the 

submission process at this time, we 

appreciate these suggestions and 

continue to consider enhancements and 

updates to our systems as our limited 

resources permit. We recognize that 

confidentiality is an important concern. 

Under the Freedom of Information Act 

(FOIA) (5 U.S.C. 552), the public has 

broad access to government documents. 

However, FOIA provides certain 

exemptions from mandatory public 

disclosure of government records (5 

U.S.C. 552(b)(1–9)). FDA will make the 

fullest possible disclosure of records to 

the public, consistent with the rights of 

individuals to privacy, the property 

rights of persons in trade and 

confidential commercial or financial 

information. 

Finally, one comment expressed 

concern regarding verification by FDA 

of the accuracy and validity of the 

information (allegations) submitted. 

Allegations of regulatory misconduct 

related to medical devices are reviewed 

by CDRH. CDRH prioritizes the review 

of allegations based on the level of 

potential risks, within the context of an 

overall benefit-risk profile, to patients, 

and takes responsive action accordingly. 

We note, however, that subsequent 

questions or inquiry intended to clarify 

information submitted is not considered 

a collection of information under the 

PRA (see 5 CFR 1320.3(h)(9)) subject to 

OMB review and approval. To learn 

more about CDRH’s process for handling 

allegations, please visit: https://

www.fda.gov/medical-devices/medicaldevice-safety/reporting-allegationsregulatory-misconduct. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per 

response 

Total hours 

Electronic submission of voluntary allegations to 

CDRH.

2,500 1 2,500 0.25 (15 minutes) 625 

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

We recently consolidated the intake of 

allegations across CDRH Offices. This 

has improved our estimate and we have 

adjusted the number of responses 

accordingly. The number of responses is 

based on the voluntary allegations 

received by CDRH in 2022. The adjusted 

estimated burden for the information 

collection reflects an increase of 900 

responses and a corresponding increase 

of 225 hours. 

Dated: October 5, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–22463 Filed 10–11–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3848] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Regulations for In 

Vivo Radiopharmaceuticals Used for 

Diagnosis and Monitoring 

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 collections of 

information in the regulations for in 

vivo radiopharmaceuticals used for 

diagnosis and monitoring. 

DATES: Submit either electronic or 

written comments on the collection of 

information by December 11, 2023. 

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 December 11, 

2023. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of December 11, 2023. 

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 


ddrumheller on DSK120RN23PROD with NOTICES1
70668 Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices 

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– 

2023–N–3848 for ‘‘Regulations for In 

Vivo Radiopharmaceuticals Used for 

Diagnosis and Monitoring.’’ 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. 

‘‘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. 

Regulations for In Vivo 

Radiopharmaceuticals Used for 

Diagnosis and Monitoring—21 CFR Part 

315 

OMB Control Number 0910–0409— 

Extension 

This information collection supports 

our regulations in part 315 (21 CFR part 

315) that require manufacturers of 

diagnostic radiopharmaceuticals to 

submit information that demonstrates 

the safety and effectiveness of: (1) a new 

diagnostic radiopharmaceutical or (2) a 

new indication for use of an approved 

diagnostic radiopharmaceutical. 

Information about the safety or 

effectiveness of a diagnostic 

radiopharmaceutical enables us to 

properly evaluate the safety and 

effectiveness profiles of such 

radiopharmaceuticals. 

The information, which is usually 

submitted as part of a new drug 

application (NDA) or biologics license 

application or as a supplement to an 

approved application typically includes, 

but is not limited to: (1) nonclinical and 

clinical data on the pharmacology; (2) 

toxicology; (3) adverse events; (4) 

radiation safety assessments; and (5) 

chemistry, manufacturing, and controls. 

The content and format of an 

application for approval of a new drug 

are set forth in § 314.50 (21 CFR 314.50) 

and have been approved under OMB 

control number 0910–0001. 

In table 1, row 1, we estimate the 

annual reporting burden for preparing 

the safety and effectiveness sections of 

an application. This estimate does not 

include the time needed to conduct 

studies and clinical trials or other 

research from which the reported 

information is obtained. 

Based on past submissions of human 

drug applications, new indication 

supplements for diagnostic 

radiopharmaceuticals, or both, we 

estimate that three submissions will be 

received annually from three applicants 

and that 2,000 hours would be spent 

preparing the portions of the application 

that would be affected by this 

information collection. We further 

estimate the total time needed to 

prepare complete applications for 

diagnostic radiopharmaceuticals as 

approximately 6,000 hours. This 

information collection does not impose 

any additional reporting burden for 

safety and effectiveness information on 

diagnostic radiopharmaceuticals beyond 

the estimated burden of 2,000 hours, 

because safety and effectiveness 

information is already required in 

§ 314.50 and has been approved under 

OMB control number 0910–0001. In 

fact, clarification of our criteria for the 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices 70669 

evaluation of diagnostic 

radiopharmaceuticals in this 

information collection is intended to 

streamline overall information 

collection burdens, particularly for 

diagnostic radiopharmaceuticals that 

may have well-established, low-risk 

safety profiles by enabling 

manufacturers to tailor information 

submissions and avoid unnecessary 

clinical trials. 

In table 1, row 2, we estimate the 

annual reporting burden for preparing 

the safety and effectiveness sections of 

a supplement to an approved 

application. This estimate does not 

include the time needed to conduct 

studies and clinical trials or other 

research from which the reported 

information is obtained. 

Based on past submissions of human 

drug applications, new indication 

supplements for diagnostic 

radiopharmaceuticals, or both, we 

estimate that one submission will be 

received annually. We estimate the total 

time needed to prepare complete 

applications for supplements to new 

applications for diagnostic 

radiopharmaceuticals as approximately 

between 500 and 1,000 hours. We 

calculated the median of this estimate to 

arrive at approximately 750 hours. We 

further estimate that the total time 

needed to prepare the portions of the 

application that would be affected by 

this information collection as 750 hours. 

As previously stated, this information 

collection does not impose any 

additional reporting burden for safety 

and effectiveness information on 

diagnostic radiopharmaceuticals beyond 

the estimated burden of 750 hours, 

because safety and effectiveness 

information is already required in 

§ 314.50 and has been approved under 

OMB control number 0910–0001. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR NDAS AND SUPPLEMENTS TO APPROVED NDAS FOR

DIAGNOSTIC RADIOPHARMACEUTICALS 1

Manufacturers’ activity 

(21 CFR section) 

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

NDAs (§§ 315.4, 315.5, and 315.6) ..................................... 3 1 3 2,000 6,000 

Supplements to Approved NDAs (§§ 315.4, 315.5, and 

315.6) ............................................................................... 1 1 1 750 750 

Total .............................................................................. ........................ ........................ ........................ ........................ 6,750 

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

Since our last OMB approval, our 

estimated burden for the information 

collection reflects an overall decrease of 

11 responses with a corresponding 

decrease of 12,000 burden hours. We 

attribute this adjustment to a decrease in 

the number of submissions for NDAs for 

diagnostic radiopharmaceuticals and 

new indication supplements for 

diagnostic radiopharmaceuticals we 

received over the past few years. 

Dated: October 5, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–22460 Filed 10–11–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3768] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Adherence 

Potential and Patient Preference in 

Prescription Drug Promotion 

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 and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on a proposed study 

entitled ‘‘Adherence Potential and 

Patient Preference in Prescription Drug 

Promotion.’’ 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

December 11, 2023. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

December 11, 2023. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

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 


ddrumheller on DSK120RN23PROD with NOTICES1