Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Notices 5909 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN E-SUBMISSIONS INCLUDING VIA SRP 1

FDA form 3800 Number of respondents 

Number of responses per 

respondent 

Total annual 

responses 

Average burden per response 

Total hours 

Reportable Foods Registry (mandatory reports) ................. 875 1 875 0.6 (36 

minutes) 

525 

Reportable Foods Registry (voluntary reports) ................... 5 1 5 0.6 (36 

minutes) 

3 

Food, Infant Formula, and Cosmetic Adverse Event Reports .................................................................................. 1,165 1.2 1,398 0.6 (36 

minutes) 

839 

Voluntary Dietary Supplement Adverse Event Reports ...... 360 1.2 432 0.6 (36 

minutes) 

259 

Mandatory Dietary Supplement Adverse Event Reports ..... 80 12 960 1 960 

Animal Food: Voluntary Pet Food Reports .......................... 1,401 1 1,401 0.6 (36 

minutes) 

841 

Animal Food: Voluntary Livestock Food Reports ................ 23 1 23 0.6 (36 

minutes) 

14 

Voluntary Tobacco Product Health Problem or Product 

Problem (i.e., adverse experience) Reports to SRP 

(both questionnaires) ........................................................ 176 1 176 0.6 (36 

minutes) 

106 

Mandatory Tobacco Product Health Problem or Product 

Problem (i.e., adverse experience) Reports 

1114.41(a)(2) .................................................................... 3 6 18 0.6 (36 

minutes) 

11 

Total .............................................................................. ........................ ........................ 5,924 ........................ 3,961 

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

The number of respondents for the 

Voluntary Tobacco Product Health 

Problem or Product Problem Reports esubmissions has decreased from 204 to 

176, according to an updated analysis. 

Based on burden estimates associated 

with the Premarket Tobacco Product 

applications and Recordkeeping 

Requirements regulation, we have 

decreased the average burden per 

response from 1 hour to 36 minutes for 

‘‘1114.41(a)(2); Mandatory Tobacco 

Product Health Problem or Product 

Problem Reports.’’ 

CVM reports a decrease in the number 

of submissions received over the last 

few years. 

FDA’s Center for Drug Evaluation and 

Research (CDER) and Center for 

Biologics Evaluation and Research 

(CBER) has increased the number of 

direct safety reports from healthcare 

providers and consumers. Additionally, 

CDER mandatory reports Form FDA 

3500A previously included in this 

information collection, are now reported 

in the approved information collection, 

OMB control number 0910–0230. 

However, increases in receipts of CBER 

mandatory reports have obscured any 

decrease in burden. Adverse event 

reports related to 21 CFR 310.305 from 

outsourcing facilities are also included 

in OMB control number 0910–0230 and 

decreases the total burden of this 

collection. 

Based on updated data, the Center for 

Devices and Radiological Health (CDRH) 

has revised our estimate for forms FDA 

3500 and FDA 3500B. Additionally, we 

have determined that the estimate 

previously reported in this information 

collection for mandatory reporting 

under part 803, associated with medical 

device products, using Form FDA 

3500A, is redundant with our approved 

burden estimates in OMB control 

number 0910–0437 ‘‘Medical Device 

Reporting (under part 803).’’ We have 

therefore removed CDRH reporting via 

Form FDA 3500A from this information 

collection request and continue to 

account for its burden in OMB control 

number 0910–0437. 

Based on Agency experience the 

Human Food Program’s estimated 

burden for the information collection 

reflects an overall increase. We attribute 

this adjustment to an increase in the 

number of submissions we received 

over the last few years, due primarily to 

changes in the infant formula industry. 

Therefore, the cumulative changes, 

both program changes which include 

form revisions, and adjustments 

reflecting fluctuations in submissions, 

as well as removing double-counted 

burden reflects and overall increase of 

116,014 hours to the total burden for 

this information collection. 

Dated: January 7, 2025. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2025–01149 Filed 1–16–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–5943] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Tobacco Product 

Establishment Registration and Listing 

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 revision of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on ‘‘Tobacco Product 

Establishment Registration and Listing.’’ 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

March 18, 2025. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 


KHAMMOND on DSK9W7S144PROD with NOTICES
5910 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Notices 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

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

March 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–5943 for ‘‘Tobacco Product 

Establishment Registration and Listing.’’ 

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 revision 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. 

Tobacco Product Establishment 

Registration and Listing 

OMB Control Number 0910–0650— 

Revision 

This information collection supports 

the Food and Drug Administration 

regulations and guidance. Tobacco 

products are generally governed by 

chapter IX of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (sections 

900 through 921) (21 U.S.C. 387 through 

21 U.S.C. 387u). 

Section 905 of the FD&C Act requires 

the annual registration of any 

‘‘establishment in any State engaged in 

the manufacture, preparation, 

compounding, or processing of a 

tobacco product or tobacco products.’’ 

Section 905 of the FD&C Act requires 

this registration be completed by 

December 31 of each year. The Secretary 

of Health and Human Services 

(Secretary) has delegated to the 

Commissioner of Food and Drugs the 

responsibility for administering the 

FD&C Act, including section 905. 

Section 905 of the FD&C Act requires 

owners or operators of each 

establishment to register: (1) their name; 

(2) places of business; (3) a list of all 

tobacco products which are 

manufactured by that person; (4) a copy 

of all labeling and a reference to the 

authority for the marketing of any 

tobacco product subject to a tobacco 


KHAMMOND on DSK9W7S144PROD with NOTICES
Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Notices 5911 

1Tobacco Product: as stated in section 201(rr) of 

the FD&C Act in relevant part, a tobacco product: 

(1) means any product made or derived from 

tobacco, or containing nicotine from any source, 

that is intended for human consumption, including 

any component, part, or accessory of a tobacco 

product (except for raw materials other than 

tobacco used in manufacturing a component, part, 

or accessory of a tobacco product); and (2) does not 

mean an article that is a drug defined under section 

201(g)(1) of the FD&C Act, a device defined under 

section 201(h) of the FD&C Act, or a combination 

product described in section 503(g) of the FD&C 

Act, or a food under section 201(f) of the FD&C Act 

if it contains no nicotine, or no more than trace 

amounts of naturally occurring nicotine. 

2Premium Cigars: on August 9, 2023, the U.S. 

District Court for the District of Columbia issued an 

Continued 

product standard under section 907 of 

the FD&C Act (21 U.S.C. 387g) or to 

premarket review under section 910 of 

the FD&C Act (21 U.S.C. 387j); (5) a 

copy of all consumer information and 

other labeling; (6) a representative 

sampling of advertisements; (7) upon 

request made by the Secretary for good 

cause, a copy of all advertisements for 

a particular tobacco product; and (8) 

upon request made by the Secretary, if 

the registrant has determined that a 

tobacco product contained in the 

product list is not subject to a tobacco 

product standard established under 

section 907 of the FD&C Act, a brief 

statement of the basis upon which the 

registrant made such determination. 

FDA collects the information 

submitted pursuant to section 905 of the 

FD&C Act through the Tobacco 

Registration and Product Listing Module 

Next Generation (TRLM NG) electronic 

portal, and through paper forms; Form 

FDA 3741, ‘‘Registration and Listing for 

Owners and Operators of Domestic 

Tobacco Product Establishments,’’ 

available at https://www.fda.gov/media/ 

77915/download, and Form FDA 3741a, 

‘‘Registration and Listing for Owners 

and Operators of Domestic Deemed 

Tobacco Product Establishments,’’ 

available at https://www.fda.gov/media/ 

99863/download) for those individuals 

who are unable to submit online 

through TRLM NG. TRLM NG is 

designed to streamline the data entry 

process for registration and product 

listing. FDA strongly encourages 

electronic submission through TRLM 

NG, available at https://www.fda.gov/ 

tobacco-products/manufacturing/ 

tobacco-registration-and-listing-modulenext-generation-trlm-ng-instructions, to 

facilitate efficiency and timeliness of 

data submission and management. 

FDA has also published a guidance 

for industry entitled ‘‘Registration and 

Product Listing for Owners and 

Operators of Domestic Tobacco Product 

Establishments’’ (March 2023; https://

www.fda.gov/downloads/ 

TobaccoProducts/Labeling/

RulesRegulationsGuidance/ 

UCM191940.pdf). This guidance is 

intended to assist persons making 

tobacco product establishment 

registration and product listing 

submissions to FDA. 

At this time, FDA is proposing several 

updates to the information submitted 

pursuant to section 905 of the FD&C Act 

through Form FDA 3741, Form FDA 

3741a, and the corresponding 

information submitted electronically 

through TRLM NG. The updates 

include: (1) merging the contents of 

Form FDA 3741a into Form FDA 3741 

to create an updated and comprehensive 

Form FDA 3741, ‘‘Registration and 

Product Listing of Tobacco Product 

Manufacturing Establishments’’; (2) 

restructuring and developing sections of 

the updated Form FDA 3741 for ease of 

navigation and data input; (3) updating 

terminology of the updated Form FDA 

3741 for clarity; (4) updating 

instructions of the updated Form FDA 

3741 for clarity; and (5) aligning tobacco 

product categories and subcategories of 

the updated Form FDA 3741 to be 

consistent with other FDA tobacco 

forms. Finally, FDA is proposing to add 

a new product listing spreadsheet (Form 

FDA 3741b) to this information 

collection. FDA anticipates the new 

Form FDA 3741b will streamline 

product listing submissions and 

subsequent FDA review. 

Although these proposed updates will 

increase the overall length of the 

updated and comprehensive Form FDA 

3741 and the corresponding information 

submitted electronically through TRLM 

NG, FDA anticipates these updates will 

streamline the navigation and 

completion of Form FDA 3741, cut 

down on redundancies, increase overall 

user efficiency and ultimately enable 

industry to more accurately and 

efficiently convey the required 

registration and listing information to 

FDA as required by section 905 of the 

FD&C Act. Both ‘‘Registration and 

Listing for Owners and Operators of 

Domestic Tobacco Product 

Establishments’’; Form FDA 3741 and 

‘‘Registration and Listing for Owners 

and Operators of Domestic Deemed 

Tobacco Product Establishments’’; Form 

FDA 3741a will be discontinued upon 

implementation of the updated and 

comprehensive Form FDA 3741; 

‘‘Registration and Product Listing of 

Tobacco Product Manufacturing 

Establishments’’. 

Section 904(a)(1) of the FD&C Act 

requires that each tobacco product 

manufacturer or importer submit ‘‘a 

listing of all ingredients, including 

tobacco, substances, compounds, and 

additives that are, as of such date, added 

by the manufacturer to the tobacco, 

paper, filter, or other part of each 

tobacco product by brand and by 

quantity in each brand and subbrand’’ 

by December 22, 2009. This section 

applies only to those tobacco products 

manufactured and distributed before 

June 22, 2009, and which are still 

manufactured as of the date of the 

ingredient listing submission. 

Section 904(c) of the FD&C Act 

requires that a tobacco product 

manufacturer: (1) provide all 

information required under section 

904(a) of the FD&C Act to FDA ‘‘at least 

90 days prior to the delivery for 

introduction into interstate commerce of 

a tobacco product not on the market on 

the date of enactment’’; (2) advise FDA 

in writing at least 90 days prior to 

adding any new tobacco additive or 

increasing in quantity an existing 

tobacco additive, except for those 

additives that have been designated by 

FDA through regulation as not a human 

or animal carcinogen, or otherwise 

harmful to health under intended 

conditions of use; and (3) advise FDA in 

writing at least 60 days of such action 

of eliminating or decreasing an existing 

additive, or adding or increasing an 

additive that has been designated by 

FDA through regulation as not a human 

or animal carcinogen, or otherwise 

harmful to health under intended 

conditions of use. 

FDA collects the information 

submitted pursuant to section 904(a)(1) 

and 904(c) of the FD&C Act through an 

electronic portal, and through a paper 

form (Form FDA 3742, ‘‘Listing of 

Ingredients in Tobacco Products’’ 

available at https://www.fda.gov/media/ 

77661/download) for those individuals 

who choose not to use the electronic 

portal. 

In addition to the development of the 

electronic portal and paper form, FDA 

published a guidance entitled ‘‘Listing 

of Ingredients in Tobacco Products’’ 

(March 2023; https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents/listing-ingredientstobacco-products). This guidance is 

intended to assist persons making 

tobacco product ingredient listing 

submissions. FDA also provides a 

technical guide, embedded hints, and a 

web tutorial to the electronic portal, 

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

industry/fda-esubmitter/usingesubmitter-prepare-tobacco-productsubmissions. 

The Tobacco Control Act also gave 

FDA the authority to issue a regulation 

deeming all other products that meet the 

statutory definition of a tobacco 

product 1 2 to be subject to Chapter 9 of 


KHAMMOND on DSK9W7S144PROD with NOTICES
5912 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Notices 

order vacating FDA’s rule deeming tobacco 

products to be subject to FDA’s tobacco product 

authorities ‘‘insofar as it applies to premium 

cigars.’’ Cigar Ass’n of Am. v. FDA, No. 16-cv01460, Dkt. No. 277 (D.D.C. Aug. 9, 2023), appeal 

filed No. 23–5220 (D.C. Cir. Sep. 29, 2023). 

For purposes of its ruling, the court specified that 

premium cigars are those cigars that: (1) are 

wrapped in whole tobacco leaf; (2) contain a 100 

percent leaf tobacco binder; (3) contain at least 50 

percent (of the filler by weight) long filler tobacco; 

(4) are handmade or hand rolled; (5) have no filter, 

nontobacco tip, or nontobacco mouthpiece; (6) do 

not have a characterizing flavor other than tobacco; 

(7) contain only tobacco, water, and vegetable gum 

with no other ingredients or additives; and (8) 

weigh more than 6 pounds per 1,000 units. FDA 

recognizes that, absent further relief, it is bound by 

the District Court’s order. The Agency is continuing 

to evaluate the evolving legal and practical 

circumstances surrounding premium cigars and 

will provide further information as it is available. 

the FD&C Act (section 901(b) of the 

FD&C Act (21 U.S.C. 387a(b))). On May 

10, 2016, FDA issued that rule, 

extending FDA’s tobacco product 

authority to all products that meet the 

definition of tobacco product in the law 

(except for accessories of newly 

regulated tobacco products), including 

electronic nicotine delivery systems, 

cigars, hookah tobacco, pipe tobacco, 

nicotine gels, and dissolvables that were 

not already subject to the FD&C Act, and 

other tobacco products that may be 

developed in the future (81 FR 28974 at 

28976) (‘‘the final deeming rule’’). 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1

FDA form/activity/FD&C section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses Hours per response Total hours 

Establishment Registration (Initial), the initial registration of a tobacco product establishment 

(Current) Form FDA 3741, Registration and 

Product Listing for Owners and Operators of 

Domestic Establishments; Form FDA 3741a– 

Registration and Listing for Owners and Operators of Domestic Deemed Tobacco Product 

Establishments (Electronic and Paper submissions) Sections 905(b), 905(c), 905(d), 905(h), 

or 905(i).

75 1 75 1.6 (96 minutes) ........... 120 

Establishment Registration (Initial), the initial registration of a tobacco product establishment 

(Updated) Form FDA 3741, Registration and 

Product Listing of Tobacco Product Manufacturing Establishments Sections 905(b), 905(c), 

905(d), 905(h), or 905(i).

75 1 75 1.5 (90 mins) ................ 113 

Establishment Registration (Renewal), the registration renewal of a tobacco product establishment (Current) Form FDA 3741, Registration and Product Listing for Owners and Operators of Domestic Establishments; Form 

3741a–Registration and Listing for Owners 

and Operators of Domestic Deemed Tobacco 

Product Establishments (Electronic and Paper 

submissions) Sections 905(b), 905(c), 905(d), 

905(h), or 905(i).

1,003 1 1,003 .17 (10 minutes) ........... 171 

Establishment Registration (Renewal), the registration renewal of a tobacco product establishment (Updated) Form FDA 3741, Registration and Product Listing of Tobacco Product 

Manufacturing Establishments Sections 905(b), 

905(c), 905(d), 905(h), or 905(i).

1,003 1 1,003 .33 (20 min) .................. 331 

Product Listing (Initial), the initial listing of tobacco products (New) Form FDA 3741b, 

(New) Product List and Material File Information Spreadsheet.

75 1 75 2 (120 mins) ................. 150 

Product Listing (Renewal) updates to the tobacco product listings (New) Form FDA 3741b, 

(New) Product List and Material File Information Spreadsheet.

1,003 1 1,003 .5 (30 mins) .................. 502 

Tobacco Product Listing Form FDA 3742, Listing 

of Ingredients Section 904(a)(1).

16 1 16 2 (120 mins) ................. 32 

Tobacco Product Listing Form FDA 3742, Listing 

of Ingredients Section 904(c).

37 10 370 .40 (24 minutes) ........... 148 

Obtaining a Dun and Bradstreet D–U–N–S Number.100 1 100 0.5 (30 minutes) ........... 50 

Total ............................................................... ........................ ........................ 2,642 ....................................... 1,617 

We have revised our burden estimates 

to this information collection. FDA has 

based these estimates on experience 

with this information collection, 

information we have available from 

interactions with industry, registration 

and listing reports, and TRLM NG. 


KHAMMOND on DSK9W7S144PROD with NOTICES
Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Notices 5913 

Based on updated data, we have 

revised our estimate for sections 905(b), 

905(c), 905(d), 905(h), or 905(i) of the 

FD&C Act. ‘‘Tobacco Product 

Establishment Initial Registration and 

Listing’’; Form FDA 3741: ‘‘Registration 

and Product Listing for Owners and 

Operators of Domestic Establishments’’; 

Form FDA 3741a: ‘‘Registration and 

Listing for Owners and Operators of 

Domestic Deemed Tobacco Product 

Establishments’’ (Electronic and Paper 

submissions) reflects a reduction from 

200 to 75 respondents and ‘‘Tobacco 

Product Establishment Renewal 

Registration and Listing’’; Form FDA 

3741: ‘‘Registration and Product Listing 

for Owners and Operators of Domestic 

Establishments’’; Form FDA 3741a: 

‘‘Registration and Listing for Owners 

and Operators of Domestic Deemed 

Tobacco Product Establishments’’ 

(Electronic and Paper submissions) 

reflects a reduction from 2,572 to 1,003 

respondents. 

Under sections 905(b), 905(c), 905(d), 

905(h), or 905(i) of the FD&C Act, FDA 

estimates up to 75 new establishments 

will submit one initial establishment 

registration and product listing report 

each year. These estimates reflect the 

burden that will be associated with this 

information collection upon OMB 

approval of the revision and 

implementation of the proposed 

updates. The Agency estimates that up 

to 75 tobacco establishments will each 

submit 1 initial establishment 

registration and product listing report 

each year using the new Form FDA 

3741, ‘‘Registration and Product Listing 

of Tobacco Product Manufacturing 

Establishments’’, which is expected to 

take 1.5 hours, for a total 113 burden 

hours. 

FDA estimates up to 75 

establishments will submit one initial 

listing of tobacco products report each 

year. These estimates reflect the burden 

that will be associated with this 

information collection upon OMB 

approval of the revision and 

implementation of the proposed 

updates. The Agency estimates that up 

to 75 tobacco establishments will each 

submit 1 initial product list and 

material file information spreadsheet 

each year using the new Form FDA 

3741b, which is expected to take 2 

hours, for a total 150 burden hours. 

FDA estimates that the confirmation 

or updating of establishment registration 

and product listing information as 

required by section 905 of the FD&C Act 

will take 20 minutes annually per 

confirmation or update per 

establishment. These estimates reflect 

the burden that will be associated with 

this information collection upon OMB 

approval of the revision and 

implementation of the proposed 

updates. Based on FDA’s experience 

with current establishment registration 

and product listings submitted to the 

Agency, the Agency estimates that on 

average 1,003 establishments will each 

submit one confirmation or updated 

report each year, using the new Form 

FDA 3741, which is expected to take 

0.33 hour (20 minutes) for a total 331 

burden hours. 

FDA estimates that the confirmation 

or updating of listing of tobacco 

products will take 30 minutes annually 

per confirmation or update per 

establishment. These estimates reflect 

the burden that will be associated with 

this information collection upon OMB 

approval of the revision and 

implementation of the proposed 

updates. Based on FDA’s experience 

with current establishment registration 

and product listings submitted to the 

Agency, the Agency estimates that on 

average 1,003 establishments will each 

submit one confirmation or updated 

report each year, using the new Form 

FDA 3741b, which is expected to take 

0.5 hour (30 minutes) for a total 502 

burden hours. 

FDA estimates that the submission of 

ingredient listings required by section 

904(a)(1) of the FD&C Act for each 

establishment will take 2 hours initially. 

Ingredients may be submitted 

electronically through the CTP portal or 

if unable to submit ingredients 

electronically then by mail using Form 

FDA 3742. FDA estimates that 16 

establishments will initially submit one 

report annually at 2 hours per report, for 

a total of 32 hours. 

Based on FDA’s experience and the 

number of new products authorized to 

be introduced or delivered for 

introduction into interstate commerce 

submitted over the past 3 years, FDA 

estimates that 37 establishments will 

each submit 10 reports (one every 6 

months). FDA also estimates that the 

confirmation or updating of product 

(ingredient) listing information required 

by section 904(c) of the FD&C Act is 

expected to take 0.40 hour (24 minutes) 

for a total 148 burden hours. FDA 

estimates that obtaining a DUNS (data 

universal numbering system) number 

will take 30 minutes. FDA assumes that 

all new establishment facilities that will 

be required to initially register under 

section 905 of the FD&C Act would 

obtain a DUNS number. FDA estimates 

that up to 100 establishments that 

would need to obtain this number each 

year. The total industry burden to obtain 

a DUNS number is 50 hours. 

Our estimated burden for the 

information collection reflects an 

overall increase of 655 hours and a 

decrease of 616 responses. We attribute 

this adjustment to the proposed 

revisions to this information collection 

to add the updated and comprehensive 

Form FDA 3741, ‘‘Registration and 

Product Listing of Tobacco Product 

Manufacturing Establishments’’ and add 

Form FDA 3741b, ‘‘Product List and 

Material File Information Spreadsheet’’. 

Dated: January 14, 2025. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2025–01217 Filed 1–16–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; Maternal and Child Health 

Jurisdictional Survey Instrument for 

the Title V MCH Block Grant Program 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, 

HRSA submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. OMB may act on 

HRSA’s ICR only after the 30-day 

comment period for this notice has 

closed. 

DATES: Comments on this ICR should be 

received no later than February 18, 

2025. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under Review—Open for 

Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email 

Joella Roland, the HRSA Information 

Collection Clearance Officer, at 


KHAMMOND on DSK9W7S144PROD with NOTICES