70676 Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices 

Advisory Committee Membership 

Nomination Portal: https://

www.accessdata.fda.gov/scripts/ 

FACTRSPortal/FACTRS/index.cfm or by 

mail to Advisory Committee Oversight 

and Management Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5103, Silver Spring, 

MD 20993–0002. 

Information about becoming a 

member on an FDA advisory committee 

can also be obtained by visiting FDA’s 

website at https://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

FOR FURTHER INFORMATION CONTACT: 

Margaret Ames, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5213, Silver Spring, 

MD 20993–0002, 301–796–5960, email: 

margaret.ames@fda.hhs.gov. 

For questions relating to the Digital 

Health Advisory Committee, contact 

James Swink, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Room 5211, Silver 

Spring, MD 20993–0002, 301–796–6313, 

James.swink@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

requesting nominations for a pool of 

nonvoting industry representatives for 

the Digital Health Advisory Committee 

(this position may be filled by 

representatives of different medical 

device areas based on areas of expertise 

relevant to the topics being considered 

by the Advisory Committee). 

Elsewhere in this Federal Register, 

FDA is publishing separate documents 

regarding: 

1. Digital Health Advisory Committee; 

Notice of Establishment 

2. Request for Nominations for Voting 

Members for the Digital Health 

Advisory Committee 

3. Request for Nominations of 

Individuals and Consumer 

Organizations for the Digital Health 

Advisory Committee 

I. General Description of the 

Committee’s Duties 

The Committee provides advice on 

complex scientific and technical issues 

related to Digital Health Technologies 

(DHTs). This also may include advice 

on the regulation of DHTs, and/or their 

use, including use of DHTs in clinical 

trials or postmarket studies subject to 

FDA regulation. Topics relating to 

DHTs, such as artificial intelligence/ 

machine learning, augmented reality, 

virtual reality, digital therapeutics, 

wearables, remote patient monitoring, 

and software, may be considered by the 

Committee. The Committee advises the 

Commissioner on issues related to 

DHTs, including, for example, realworld data, real-world evidence, 

patient-generated health data, 

interoperability, personalized medicine/ 

genetics, decentralized clinical trials, 

use of DHTs in clinical trials for medical 

products, cybersecurity, DHT user 

experience, and Agency policies and 

regulations regarding these 

technologies. The Committee provides 

relevant expertise and perspective to 

improve Agency understanding of the 

benefits, risks, and clinical outcomes 

associated with use of DHTs. The 

Committee performs its duties by 

providing advice and recommendations 

on new approaches to develop and 

evaluate DHTs and to promote 

innovation of DHTs, as well as 

identifying risks, barriers, or unintended 

consequences that could result from 

proposed or established Agency policy 

or regulation for topics related to DHTs. 

II. Qualifications 

Persons nominated for the Digital 

Health Advisory Committee should be 

full-time employees of firms that 

manufacture medical device products, 

or consulting firms that represent 

manufacturers or have similar 

appropriate ties to industry. 

III. Selection Procedure 

Any industry organization interested 

in participating in the selection of an 

appropriate nonvoting member to 

represent industry interest must send a 

letter stating that interest to the FDA 

contact (see FOR FURTHER INFORMATION

CONTACT) within 30 days of publication 

of this document (see DATES). Within the 

subsequent 45 days, FDA will send a 

letter to each organization that has 

expressed an interest, attaching a 

complete list of all such organizations; 

and a list of all nominees along with 

their current resumes or curriculum 

vitae. The letter will also state that it is 

the responsibility of the interested 

organizations to confer with one another 

and to select a candidate or candidates 

(to serve in a pool of individuals, with 

varying areas of expertise), to represent 

industry interest for the committee, 

within 60 days after the receipt of the 

FDA letter. The interested organizations 

are not bound by the list of nominees in 

selecting a candidate or candidates. 

However, if no individual is selected 

within 60 days, the Commissioner will 

select temporary nonvoting members (or 

pool of individuals) to represent 

industry interests. 

IV. Nomination Procedure 

Individuals may self-nominate and/or 

an organization may nominate one or 

more individuals to serve as a 

temporary nonvoting industry 

representative. Nominations must 

include a cover letter and a current, 

complete re ́sume ́ or curriculum vitae for 

each nominee, including current 

business and/or home address, 

telephone number, and email address if 

available; and a signed copy of the 

Acknowledgement and Consent form 

available at the FDA Advisory 

Committee Membership Nomination 

Portal (see ADDRESSES). Nominations 

should specify the advisory committee 

for which the nominee is recommended 

within 30 days of publication of this 

document (see DATES). Nominations 

should also acknowledge that the 

nominee is aware of the nomination, 

unless self-nominated. FDA will 

forward all nominations to the 

organizations expressing interest in 

participating in the selection process for 

the committee. Only interested industry 

organizations participate in the 

selection process. Persons who 

nominate themselves as nonvoting 

industry representatives will not 

participate in the selection process. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: October 6, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–22568 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–4181] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Cattle Materials 

Prohibited From Use in Animal Food or 

Feed 

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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices 70677 

response to the notice. This notice 

solicits comments on the reporting and 

recordkeeping requirements for cattle 

materials prohibited from use in animal 

food or feed. 

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 

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–4181 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Cattle 

Materials Prohibited From Use in 

Animal Food or Feed.’’ 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: 

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. 

Cattle Materials Prohibited From Use in 

Animal Food or Feed—21 CFR 

589.2001 

OMB Control Number 0910–0627— 

Extension 

This information collection supports 

implementation of Agency statutory and 

regulatory requirements regarding 

substances prohibited from use in 

animal food or feed. Bovine spongiform 

encephalopathy (BSE) is a progressive 

and fatal neurological disorder of cattle 

that results from an unconventional 

transmissible agent. Our regulation at 

§ 589.2001 (21 CFR 589.2001) is 

designed to safeguard against the 

establishment and amplification of BSE 

in the United States through animal 

feed. The regulation prohibits the use of 

certain cattle origin materials in the 

food or feed of all animals. These 


ddrumheller on DSK120RN23PROD with NOTICES1
70678 Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices 

materials are referred to as ‘‘cattle 

materials prohibited in animal feed’’ or 

CMPAF. Under § 589.2001, no animal 

feed or feed ingredient can contain 

CMPAF. As a result, we impose 

requirements on renderers that process 

cattle materials, including reporting and 

recordkeeping requirements. The 

reporting and recordkeeping 

requirements are necessary because 

once materials are separated from an 

animal it may not be possible, without 

records, to know whether the cattle 

material meets the requirements of our 

regulation. 

Under our regulations, we may 

designate a country from which cattle 

materials are not considered CMPAF. A 

country seeking to be so designated 

must send a written request to the 

Director of the Center for Veterinary 

Medicine, including certain required 

information. We use the information 

provided to determine whether to grant 

a request for designation and to impose 

conditions if a request is granted. 

Additionally, designated countries will 

be subject to our future review to 

determine whether their designations 

remain appropriate. As part of this 

process, we may ask designated 

countries at any time to confirm that 

their BSE situation and the information 

submitted by them in support of their 

original application remains unchanged. 

We may revoke a country’s designation 

if we determine that it is no longer 

appropriate. Therefore, designated 

countries may respond to our periodic 

requests by submitting information to 

confirm their designations remain 

appropriate. We use the information to 

ensure their designations remain 

appropriate. 

Renderers that receive, manufacture, 

process, blend, or distribute CMPAF, or 

products that contain or may contain 

CMPAF, must take measures to ensure 

that the materials are not introduced 

into animal feed, including maintaining 

adequate written procedures specifying 

how such processes are to be carried 

out. 

Description of Respondents: 

Respondents to this information 

collection are foreign governments 

seeking designation under § 589.2001(f) 

and rendering facilities that process 

cattle materials. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR part; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

589.2001(f); Process for designating countries to request 

exemption from the requirements of this regulation ........ 1 1 1 40 40 

589.2001(f); response to request for review by FDA .......... 1 1 1 26 26 

Total .............................................................................. ........................ ........................ ........................ ........................ 66 

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

The information the country is 

required to submit includes information 

about that country’s BSE case history, 

risk factors, measures to prevent the 

introduction and transmission of BSE, 

and any other information relevant to 

determining whether the cattle materials 

from the requesting country do or do not 

meet the definitions set forth in 

§ 589.2001(b)(1). 

Since the last renewal, we have 

reduced the request for designation 

burden from 80 hours to 40 hours. This 

reduction is because respondents are 

required to provide this information to 

other entities in order to comply with 

international standards and therefore 

will have already compiled the 

necessary information. 

Our estimate of the reporting burden 

for designation under § 589.2001(f) is 

based on estimates found in our final 

rule. Since the rule’s effective date in 

2009, only two requests for designation 

have been received; however, we retain 

our current estimate of one to permit 

such requests for designation by 

respondents and to permit related 

responses to FDA. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR part; activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

589.2001(c)(2)(ii), 589.2001(c)(2)(vi) and (c)(3)(i), and 

589.2001(c)(3)(i)(A) and (B); Rendering facilities maintain written procedures and records, and certification or 

documentation from the supplier ...................................... 145 1 145 45 6,525 

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

The burden we attribute to 

recordkeeping activities is assumed to 

be distributed among the individual 

elements and averaged among 

respondents. The total number of 

recordkeepers contains a subset of 50 

recordkeepers who maintain written 

procedures and records specifically 

required by 21 CFR 589.2001(c). 

We have adjusted our recordkeeping 

burden estimate in Table 2, which 

results in a decrease of 2,525 hours. 

This is based primarily on consolidation 

within the industry and a decrease in 

the estimated number of respondents 

subject to recordkeeping requirements. 

Based on our review since the last 

OMB approval, there is an overall 

adjustment decrease of 2,565 burden 

hours. The adjustment is attributable to 

decreases in the average reporting 

burden time and in respondent subject 

to recordkeeping requirements. 

Dated: October 5, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–22495 Filed 10–11–23; 8:45 am] 

BILLING CODE 4164–01–P 


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