Federal Register / Vol. 89, No. 244 / Thursday, December 19, 2024 / Notices 103835 

Based on a review of the information 

collection since our last request for 

OMB approval, we have increased our 

burden estimate by 35 hours and 70 

responses due to the program change of 

collecting samples and analytical 

results. We attribute the burden change 

to an increase in responses. This 

estimate is based on our experience 

with this information collection and the 

number of certificates received in the 

past 3 years. 

Dated: December 12, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–30228 Filed 12–18–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–5234] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Food Labeling: 

Notification Procedures for Statements 

on Dietary Supplements 

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 the information 

collection provisions of the regulation 

requiring the manufacturer, packer, or 

distributor of a dietary supplement to 

notify us that it is marketing a dietary 

supplement product that bears on its 

label or in its labeling a statement 

provided for in the Federal Food, Drug, 

and Cosmetic Act (FD&C Act). 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

February 18, 2025. 

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 

February 18, 2025. 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– 

2024–N–5234 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Food 

Labeling: Notification Procedures for 

Statements on Dietary Supplements.’’ 

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: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, 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. 


lotter on DSK11XQN23PROD with NOTICES1
103836 Federal Register / Vol. 89, No. 244 / Thursday, December 19, 2024 / Notices 

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. 

Food Labeling: Notification Procedures 

for Statements on Dietary 

Supplements—21 CFR 101.93 

OMB Control Number 0910–0331— 

Extension 

Section 403(r)(6) of the FD&C Act (21 

U.S.C. 343(r)(6)) and § 101.93 (21 CFR 

101.93) require that, no later than 30 

days after the first marketing, we be 

notified by the manufacturer, packer, or 

distributor of a dietary supplement that 

it is marketing a dietary supplement 

product that bears on its label or in its 

labeling a statement provided for in 

section 403(r)(6) of the FD&C Act. In 

accordance with these requirements, 

submissions must include: (1) the name 

and address of the manufacturer, 

packer, or distributor of the dietary 

supplement product; (2) the text of the 

statement that is being made; (3) the 

name of the dietary ingredient or 

supplement that is the subject of the 

statement; (4) the name of the dietary 

supplement (including the brand name); 

and (5) the signature of a responsible 

individual or the person who can certify 

the accuracy of the information 

presented, and who must certify that the 

information contained in the notice is 

complete and accurate, and that the 

notifying firm has substantiation that 

the statement is truthful and not 

misleading. 

Our electronic form (Form FDA 3955) 

allows respondents to the information 

collection to electronically submit 

notifications to FDA via the Food 

Applications Regulatory Management 

(FARM) system. Firms that prefer to 

submit a paper notification in a format 

of their own choosing still have the 

option to do so; however, Form FDA 

3955 prompts respondents to include 

certain elements in their structure/ 

function claim notification (SFCN) 

described in § 101.93 in a standard 

electronic format and helps respondents 

organize their SFCN to include only the 

information needed for our review of 

the claim. Note that the SFCN, whether 

electronic or paper, is used for all 

claims made pursuant to section 

403(r)(6) of the FD&C Act, including 

nutrient deficiency claims and general 

well-being claims in addition to 

structure/function claims. The 

electronic form, and any optional 

elements prepared as attachments to the 

form (e.g., label), can be submitted in 

electronic format via FARM. 

Submissions of SFCNs will continue to 

be allowed in paper format. We use this 

information to evaluate whether 

statements made for dietary ingredients 

or dietary supplements are permissible 

under section 403(r)(6) of the FD&C Act. 

We also provide information on our 

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

information-industry-dietarysupplements/notificationsstructurefunction-and-related-claimsdietary-supplement-labeling, which may 

serve as a helpful resource to 

respondents. 

Description of Respondents: 

Respondents to this collection of 

information include manufacturers, 

packers, or distributors of dietary 

supplements that bear section 403(r)(6) 

of the FD&C Act statements on their 

labels or labeling. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; activity; form No. Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response 

Total 

hours 

101.93; Statements for Dietary Supplements; Form FDA 

3955.

3,690 1 3,690 0.75 (45 minutes) .. 2,768 

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

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

This estimate is based on our experience 

with this information collection and the 

number of notifications received in the 

past 3 years, which has remained 

constant. 

Dated: December 12, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–30231 Filed 12–18–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–3379] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Laboratory 

Accreditation for Analyses of Foods 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by January 21, 

2025. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 


lotter on DSK11XQN23PROD with NOTICES1