5900 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Notices 

• 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: Dat 

Doan, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 3334, Silver Spring, 

MD 20993–0002, 240–402–8926 or 301– 

796–2500, dat.doan@fda.hhs.gov; James 

Myers, Center for Biologics Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 7301, Silver Spring, 

MD 20993–0002, 240–402–7911; or Paul 

Kluetz, Oncology Center of Excellence, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 22, Rm. 

2223, Silver Spring, MD 20993, 301– 

796–9567, Paul.Kluetz@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of December 6, 2024, 

FDA published a notice of availability 

with a 60-day comment period to 

request comments on the draft guidance 

for industry entitled ‘‘Expedited 

Program for Serious Conditions— 

Accelerated Approval of Drugs and 

Biologics.’’ The Agency has received 

requests for a 30-day extension of the 

comment period. The requests conveyed 

concern that the current 60-day 

comment period does not allow 

sufficient time to develop a meaningful 

or thoughtful response to the draft 

guidance. 

FDA has considered the requests and 

is extending the comment period for 30 

days, until March 6, 2025. The Agency 

believes that a 30-day extension allows 

adequate time for interested persons to 

submit comments on this draft 

guidance. 

Dated: January 14, 2025. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2025–01179 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–2023–N–3595] 

Agency Information Collection 

Activities; Proposed Collection; 

Improving the Quality and 

Representativeness of the Treatment 

Center Program Data—Data 

Modifications to the Current Survey 

Instrument Format to Minimize 

Misclassification; Withdrawal of Notice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; withdrawal. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

withdrawal of a notice that was 

published in the Federal Register of 

October 18, 2023. 

DATES: The notice is withdrawn on 

January 17, 2025. 

FOR FURTHER INFORMATION CONTACT: 

Darren Eicken, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave. Bldg. 51, Rm. 6206, 

Silver Spring, MD 20993–0002, 240– 

402–0978. 

SUPPLEMENTARY INFORMATION: In a notice 

published in the Federal Register of 

October 18, 2023 (88 FR 71875), 

‘‘Agency Information Collection 

Activities; Proposed Collection; 

Comment Request: Improving the 

Quality and Representativeness of the 

Treatment Center Program Data—Data 

Modifications to the Current Survey 

Instrument Format to Minimize 

Misclassification.’’ FDA requested 

comment on the information collection 

associated with the proposed study 

entitled ‘‘Improving the Quality and 

Representativeness of the Treatment 

Center Program Data—Data 

Modifications to the Current Survey 

Instrument Format to Minimize 

Misclassification.’’ 

Under the Paperwork Reduction Act 

of 1995, 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. 

In the October 18, 2023, Federal 

Register notice, FDA proposed a new 

collection of information. However, 

FDA no longer intends to proceed with 

the proposed study due to 

circumstances and timing surrounding 

the execution of the study. Therefore, 

we are withdrawing the October 18, 

2023 notice. 

Dated: January 13, 2025. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2025–01152 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–5468] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Food and Drug 

Administration’s Adverse Event and 

Product Experience Reporting 

Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, the 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 information 

collection associated with FDA’s 


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Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Notices 5901 

adverse event reports and product 

experience reports for FDA-regulated 

products. 

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 

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–5468 for ‘‘FDA’s Adverse Event 

and Product Experience Reporting 

Program.’’ 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. 

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. 

FDA’s Adverse Event and Product 

Experience Reporting Program 

OMB Control Number 0910–0291— 

Extension 

This information collection supports 

FDA laws and regulations governing 

adverse event reports and product 

experience reports for FDA-regulated 

products. The Federal Food, Drug, and 

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

353b, 355, 360i, 360l, 379aa, and 393) 

and the Public Health Service Act (42 

U.S.C. 262) authorize FDA to collect 

adverse event reports and product 

experience reports from regulated 

industry and to monitor the safety of 

drugs, biologics, medical devices, and 

dietary supplements. These reporting 

and recordkeeping requirements are 

found in FDA regulations, discussed in 

Agency guidance, and included in 

Agency forms. Although there are no 

laws or regulations mandating 

postmarket reporting for medical foods, 

infant formula, cosmetics, or tobacco 

products, we encourage voluntary 


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5902 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Notices 

reporting of adverse experiences 

associated with these products. 

To facilitate both consumer and 

industry reporting of adverse events and 

experiences with FDA-regulated 

products, we developed the MedWatch 

program. The MedWatch program 

allows anyone to submit reports to FDA 

on adverse events, including injuries 

and/or deaths, as well as other product 

experiences associated with the 

products we regulate. Requirements 

regarding mandatory reporting of 

adverse events or product problems 

have been codified in parts 310, 314, 

329, 600, and 803 (21 CFR parts 310, 

314, 329, 600, and 803), and specified 

in sections 503B, 760, and 761 of the 

FD&C Act (21 U.S.C. 353b, 379aa, and 

379aa–1). Mandatory reporting of 

adverse events for human cells, tissues, 

and cellular- and tissue-based products 

(HCT/Ps) have been codified in 

§ 1271.350 (21 CFR 1271.350). Other 

postmarketing reporting associated with 

requirements found in sections 201, 

502, 505, and 701 (21 U.S.C. 321, 352, 

355, and 371) of the FD&C Act and 

applicable to certain drug products with 

and without approved applications are 

approved under OMB control number 

0910–0230. Mandatory reporting under 

part 803, associated with medical device 

products, using Form FDA 3500A, is 

approved under OMB control number 

0910–0437. 

Since 1993, mandatory adverse event 

reporting has been supplemented by 

voluntary reporting by healthcare 

professionals, patients, and consumers 

via the MedWatch reporting process. To 

carry out its responsibilities, the Agency 

needs to be informed when an adverse 

event, product problem, error with use 

of a human medical product, or 

evidence of therapeutic failure is 

suspected or identified in clinical use. 

When FDA receives this information 

from healthcare professionals, patients, 

or consumers, the report becomes data 

that will be used to assess and evaluate 

the risk associated with the product. 

FDA will take any necessary action to 

reduce, mitigate, or eliminate the 

public’s exposure to the risk through 

regulatory and public health 

interventions. 

To implement these reporting 

provisions for FDA-regulated products 

(except vaccines) during their postapproval and marketed lifetimes, we 

developed the following three forms, 

available for download from our website 

or upon request to the Agency: (1) Form 

FDA 3500 may be used for voluntary 

(i.e., not mandated by law or regulation) 

reporting by healthcare professionals; 

(2) Form FDA 3500A is used for 

mandatory reporting (i.e., required by 

law or regulation); and (3) Form FDA 

3500B, available in English and 

Spanish, is written in plain language 

and may be used for voluntary reporting 

(i.e., not mandated by law or regulation) 

by consumers (i.e., patients and their 

caregivers). Respondents to the 

information collection are healthcare 

professionals, medical care 

organizations and other user facilities 

(e.g., extended care facilities, 

ambulatory surgical centers), 

consumers, manufacturers of 

biologicals, food products including 

dietary supplements and special 

nutritional products (e.g., infant formula 

and medical foods), cosmetics, drug 

products or medical devices, and 

importers. 

I. Use of Form FDA 3500, MedWatch— 

the Safety Information and Adverse 

Event Reporting Program (Voluntary 

Reporting) 

This voluntary version of the form 

may be used by healthcare professionals 

to submit all reports not mandated by 

Federal law or regulation. Individual 

healthcare professionals are not 

required by law or regulation to submit 

reports to the Agency or the 

manufacturer, except for certain adverse 

events following immunization with 

vaccines as mandated by the National 

Childhood Vaccine Injury Act of 1986. 

Reports for vaccines are not submitted 

via MedWatch or MedWatch forms but 

are submitted to the Vaccines Adverse 

Event Reporting System (VAERS; see 

http://vaers.hhs.gov), which is jointly 

administered by FDA and the Centers 

for Disease Control and Prevention. 

Hospitals are not required by Federal 

law or regulation to submit reports 

associated with drug products, 

biological products, or special 

nutritional products. However, hospitals 

and other user facilities are required by 

Federal law to report medical devicerelated deaths and serious injuries 

(approved under OMB control number 

0910–0437). 

Under Federal law and regulation 

(section 761(b)(1) of the FD&C Act), a 

dietary supplement manufacturer, 

packer, or distributor whose name 

appears on the label of a dietary 

supplement marketed in the United 

States is required to submit to FDA any 

serious adverse event report it receives 

regarding use of the dietary supplement 

in the United States. However, FDA 

bears the burden to gather and review 

evidence that a dietary supplement may 

be adulterated under section 402 of the 

FD&C Act (21 U.S.C 342) after that 

product is marketed. Therefore, the 

Agency depends on the voluntary 

reporting by healthcare professionals 

and especially by consumers of 

suspected serious adverse events and 

product quality problems associated 

with the use of dietary supplements. All 

dietary supplement reports were 

originally received by the Agency on 

paper versions of Form FDA 3500 (by 

mail or fax). Today, electronic reports 

may be sent to the Agency via an online 

submission route called the Safety 

Reporting Portal at http://

www.safetyreporting.fda.gov/. In that 

case, the Form FDA 3500 is not used. 

Form FDA 3500 may be used to report 

to the Agency adverse events, product 

problems, product use errors, and 

therapeutic failures. The form is 

provided in both paper and electronic 

formats. Reporters may mail or fax 

forms to the Agency. A fillable PDF 

version of the form is available at 

https://www.accessdata.fda.gov/scripts/ 

medwatch/ or respondents can 

electronically submit a report via the 

MedWatch Online Voluntary Reporting 

Form at https://

www.accessdata.fda.gov/scripts/ 

medwatch/. 

Reporting using Form FDA 3500 in 

paper form is supported for drugs, nonvaccine biologicals, medical devices, 

food products, special nutritional 

products, cosmetics, and nonprescription human drug products 

marketed without an approved 

application, and dietary supplements. 

Electronic reports for FDA products may 

be submitted to the Agency via an 

online submission route called the 

Safety Reporting Portal at http://

www.safetyreporting.fda.gov/. 

Electronic reports for tobacco products 

may be submitted to the Agency via the 

tobacco questionnaire within the online 

Safety Reporting Portal at http://

www.safetyreporting.fda.gov/. 

II. Use of Form FDA 3500A, MedWatch 

for Use by User-Facilities, Importers, 

Distributors, and Manufacturers 

(Mandatory Reporting) 

A. Drug and Biological Products 

Sections 503B, 505(j), and 704 of the 

FD&C Act (21 U.S.C. 374) require that 

important safety information relating to 

all human prescription drug products be 

made available to FDA in the event it 

becomes necessary to take appropriate 

action to ensure protection of the public 

health. Mandatory reporting of adverse 

events for HCT/Ps is codified in 

§ 1271.350. Consistent with statutory 

requirements, information is required to 

be submitted electronically and 

therefore we account for most all reports 

under OMB control number 0910–0230 

to support electronic reporting to our 

MedWatch program. At the same time, 


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Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Notices 5903 

regulations are provided for waivers 

from the electronic submission 

requirements and we therefore account 

for paper-based reporting in this 

information collection. 

B. Medical Device Products 

Section 519 of the FD&C Act (21 

U.S.C. 360i) requires manufacturers and 

importers of devices intended for 

human use to establish and maintain 

records, make reports, and provide 

information as the Secretary of Health 

and Human Services (the Secretary) may 

by regulation reasonably require 

assuring that such devices are not 

adulterated or misbranded and to 

otherwise assure its safety and 

effectiveness. The Safe Medical Device 

Act of 1990 (Pub. L. 101–629), signed 

into law on November 28, 1990, amends 

section 519 of the FD&C Act. The 

amendment requires that user facilities 

such as hospitals, nursing homes, 

ambulatory surgical facilities, and 

outpatient treatment facilities report 

deaths related to medical devices to 

FDA and to the manufacturer, if known. 

Serious illnesses and injuries are to be 

reported to the manufacturer or to FDA 

if the manufacturer is not known. These 

statutory requirements regarding 

mandatory reporting have been codified 

by FDA under part 803. Part 803 

mandates the use of Form FDA 3500A 

for reporting to FDA on medical 

devices. Mandatory reporting associated 

with medical device products using 

Form FDA 3500A is approved under 

OMB control number 0910–0437. 

C. Dietary Supplements 

Section 502(x) of the FD&C Act 

implements the requirements of The 

Dietary Supplement and 

Nonprescription Drug Consumer 

Protection Act, which became law (Pub. 

L. 109–462) on December 22, 2006. 

These requirements apply to 

manufacturers, packers, and distributors 

of nonprescription human drug 

products marketed without an approved 

application. The law requires reports of 

serious adverse events to be submitted 

to the Agency by manufacturers of 

dietary supplements. 

Electronic reports for dietary 

supplements may be submitted using 

the Safety Reporting Portal at http://

www.safetyreporting.fda.gov/. Paperbased dietary supplement reports may 

be submitted using the MedWatch Form 

FDA 3500A. 

III. Use of Form FDA 3500B, MedWatch 

Consumer Voluntary Reporting 

This voluntary version of the form 

may be used by consumers, patients, or 

caregivers to submit reports not 

mandated by Federal law or regulation. 

Individual consumers, patients, or 

caregivers are not required by law or 

regulation to submit reports to the 

Agency or the manufacturer. FDA 

supports and encourages direct 

reporting to the Agency by consumers of 

suspected adverse events and other 

product problems associated with 

human medical products, food, dietary 

supplements, and cosmetic products, 

and invite these respondents to visit our 

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

report-problem-fda for more 

information. Since the inception of the 

MedWatch program in July 1993, the 

program has been promoting and 

facilitating voluntary reporting by both 

the public and healthcare professionals. 

FDA has further encouraged voluntary 

reporting by requiring inclusion of the 

MedWatch toll-free phone number or 

the MedWatch website on all outpatient 

drug prescriptions dispensed, as 

mandated by section 17 of the Best 

Pharmaceuticals for Children Act (Pub. 

L. 107–109). 

Section 906 of the FDA Amendments 

Act (FDAAA) amended section 502(n) of 

the FD&C Act, mandating that published 

direct-to-consumer advertisements for 

prescription drugs include the following 

statement printed in conspicuous text 

(this includes vaccine products): ‘‘You 

are encouraged to report negative side 

effects of prescription drugs to the FDA. 

Visit https://www.fda.gov/medwatch, or 

call 1–800–FDA–1088.’’ Most private 

vendors of consumer medication 

information, which is the drug productspecific instructions dispensed to 

consumers at outpatient pharmacies, 

remind patients to report ‘‘side effects’’ 

to FDA and provide contact information 

to permit MedWatch reporting. 

Form FDA 3500B, first made available 

in 2013, was tailored for consumers and 

has been written in plain language to 

conform with the Plain Writing Act of 

2010 (Pub. L. 111–274) (https://

www.govinfo.gov/content/pkg/PLAW111publ274/pdf/PLAW111publ274.pdf), and has evolved with 

input from human factors experts, from 

other regulatory agencies, and with 

extensive input from consumer 

advocacy groups and the public. It is 

used to report adverse events, product 

problems, product use errors, and 

problems after switching from one 

product maker to another maker to the 

Agency. The form is available in 

Spanish at https://www.fda.gov/safety/ 

medwatch-fda-safety-information-andadverse-event-reporting-program/ 

reporting-serious-problems-fda, and 

since 2021, has been available to upload 

electronically at https://

www.accessdata.fda.gov/scripts/ 

medwatch/ 

index.cfm?action=reporting.spanish. 

The form is provided in both paper and 

electronic formats. Respondents may 

submit reports by mail or fax to the 

Agency, or electronically submit a 

report via the MedWatch Online 

Voluntary Reporting Form at https://

www.accessdata.fda.gov/scripts/ 

medwatch/. A fillable PDF version of 

the form, available at http://

www.fda.gov/downloads/AboutFDA/ 

ReportsManualsForms/Forms/ 

UCM349464.pdf, may be downloaded, 

completed, and mailed or faxed to the 

Agency. Reporting is supported for 

drugs, non-vaccine biologicals, medical 

devices, food products, special 

nutritional products, cosmetics, and 

non-prescription human drug products 

marketed without an approved 

application. The paper form may also be 

used to submit reports about dietary 

supplements. Electronic reports for 

dietary supplements may be submitted 

to the Agency via an online submission 

route called the Safety Reporting Portal 

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

IV. Use of Form FDA 3800, Safety 

Reporting Portal 

The Safety Reporting Portal (SRP) 

streamlines the process of reporting 

product safety issues to FDA. 

Organizations and people in certain 

professional roles, such as the 

following, may be required by law to 

submit safety reports under some 

circumstances: food manufacturers, 

processors, packers, and holders; 

researchers; an applicant of an approved 

drug product or a manufacturer; 

distributor or packer listed on the label 

of any marketed drug product; drug 

manufacturers, sponsors, sponsorinvestigators of investigational drugs 

and biologics; dietary supplement 

manufacturers, packers, and 

distributors; and tobacco product 

manufacturers. 

Others, including healthcare 

providers, public health officials, and 

other professionals, as well as 

consumers and concerned citizens, may 

voluntarily submit reports if they 

encounter safety issues with a product 

and/or harmful effects that they believe 

are related to a product. The 

information collection includes the 

following Agency forms, available 

electronically, via the Safety Reporting 

Portal: 

• Center for Veterinary Medicine 

(CVM)—Voluntary reporting of adverse 

events and product problems involving 

pet food or livestock food. Section 

1002(b) of the FDAAA directed the 

Secretary to establish an early warning 

and surveillance system to identify 


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adulteration of the pet food supply and 

outbreaks of illness associated with pet 

food. We developed the Pet Food Early 

Warning System rational questionnaire 

as a user-friendly data collection tool, as 

well as a questionnaire for collecting 

voluntary adverse event reports 

associated with pet and livestock food. 

Information collected in these voluntary 

adverse event reports contribute to 

CVM’s ability to identify adulteration of 

the pet and livestock food supply and 

outbreaks of illness associated with pet 

and livestock food. We use the 

information collected to help ensure 

that such products are quickly and 

efficiently removed from the market to 

prevent foodborne illnesses. 

• Center for Tobacco Products 

(CTP)—Voluntary Tobacco Product 

Health Problem or Product Problem 

Reports (i.e., Adverse experience 

reports). Voluntary adverse experience 

reports have been collected from 

consumers/concerned citizens and 

healthcare professionals via the SRP’s 

Tobacco Problem Report (TPR) 

questionnaire since January 10, 2014, 

from tobacco product manufacturers via 

the SRP TPR since June 10, 2016, and 

from researchers engaged in clinical 

trials using investigational or legally 

marketed tobacco products via the SRP 

Tobacco Investigator Report (TIR) 

questionnaire since June 10, 2016. 

• CTP—Mandatory Tobacco Product 

Health Problem or Product Problem 

Reports (i.e., Adverse experience 

reports). On October 5, 2021 (86 FR 

55300), FDA published a final rule 

entitled ‘‘Premarket Tobacco Product 

Applications and Recordkeeping 

Requirements.’’ The rule establishes 

regulatory definitions (21 CFR 1114.3) 

for adverse experience, serious adverse 

experience, and unexpected adverse 

experience associated with tobacco 

product use. The final rule, in effect 

since November 4, 2021, requires 

premarket applicants (manufacturers of 

new tobacco products) who receive 

marketing granted orders to report all 

serious and unexpected adverse 

experiences associated with the tobacco 

product (21 CFR 1114.41(a)(2)) that have 

been reported to the applicant or of 

which the applicant is aware, to the SRP 

or in another manner designated by 

FDA, within 15 calendar days of their 

awareness. 

V. Proposed Modifications to Existing 

Forms 3500, 3500A, and 3500B 

A. General Changes 

The proposed modifications to Form 

FDA 3500, Form FDA 3500A, and Form 

FDA 3500B (English and Spanish) 

reflect changes that will bring the forms 

into conformity, since the previous 

authorization in 2022, with current 

regulations, rules, and guidances. The 

proposed extension to Form FDA 3500, 

Form FDA 3500A, and Form FDA 3500B 

will only have changes in the form 

instructions to provide clarity of 

reporting. The proposed changes fall 

into one of three categories: (1) 

regulatory driven revisions, (2) work 

improvements for the Center, and (3) 

report processing improvements. 

Formatting modifications are being 

proposed to several fields to enhance 

the quality, utility, and clarity of the 

information. We also propose to update 

the mailing address to Attn: MedWatch 

Program, White Oak Campus, Building 

22, G0207, 10903 New Hampshire Ave., 

Silver Spring, MD 20993. 

B. Changes Proposed for Form FDA 

3500 

Throughout the form, we propose to 

add calendar functionality to all date 

fields for uniformity and 

standardization of date format. 

In the header, we propose to specify 

the intended reporters at the top of the 

form (i.e., Health Professional Voluntary 

Reporting). In section A, we propose to 

revise ‘‘Undifferentiated’’ to ‘‘Intersex’’ 

in field 3a; combine the ‘‘Ethnicity’’ 

(field A5) and ‘‘Race’’ (field A6) fields 

as outlined in the Statistical Policy 

Directive No. 15: Standards for 

Maintaining, Collecting, and Presenting 

Federal Data on Race and Ethnicity 

(SPD 15) issued on March 29, 2024; and 

add new text ‘‘What is your race and/ 

or ethnicity? Select all that apply.’’ 

The selections will also include 

descriptions of each category. The data 

fields include the following: 

• American Indian or Alaska Native— 

For example, Navajo Nation, Blackfeet 

Tribe of the Blackfeet Indian 

Reservation of Montana, Native Village 

of Barrow Inupiat Traditional 

Government, Nome Eskimo Community, 

Aztec, Maya, etc. 

• Asian—For example, Chinese, 

Asian Indian, Filipino, Vietnamese, 

Korean, Japanese, etc. 

• Black or African American—For 

example, African American, Jamaican, 

Haitian, Nigerian, Ethiopian, Somali, 

etc. 

• Hispanic or Latino—For example, 

Mexican, Puerto Rican, Salvadoran, 

Cuban, Dominican, Guatemalan, etc. 

• Middle Eastern or North African— 

For example, Lebanese, Iranian, 

Egyptian, Syrian, Iraqi, Israeli, etc. 

• Native Hawaiian or Pacific 

Islander—For example, Native 

Hawaiian, Samoan, Chamorro, Tongan, 

Fijian, Marshallese, etc. 

• White—For example, English, 

German, Irish, Italian, Polish, Scottish, 

etc. 

In section B, we propose to reorder 

the outcomes attributed to the adverse 

events list so that ‘‘Other Serious or 

Important Medical Events’’ appears as 

the last choice of the outcomes listed in 

field B2, and add a field for reference 

ranges in the ‘‘Relevant Test/Laboratory 

Data’’ section (field B6). 

In section C, we propose to add a field 

for ‘‘Where (e.g., website, pharmacy/ 

store/state of purchase) was the suspect 

product obtained?’’ and ‘‘When (date) 

was the suspect product obtained?’’ 

In section D, we propose to remove 

‘‘This report involves cosmetic, dietary 

supplement, food/medical food, and 

other.’’ Cosmetic will now be captured 

under the ‘‘Product Type’’ section field 

D5. 

We propose to add ‘‘Usage Dates’’ 

after ‘‘Treatment Dates/Therapy Dates’’ 

and add ‘‘Usage’’ after ‘‘Treatment’’ and 

‘‘Therapy’’ in field D3. We propose to 

revise the ‘‘Product Type’’ section (field 

D5) as follows: (Dietary supplement and 

Food/medical food selections will be 

removed. Adverse events involving 

these products should be submitted 

through the Safety Reporting Portal) 

Æ Drug or Biologic 

■ Brand 

■ Generic or Biosimilar 

■ Over-the Counter (OTC) 

■ Compounded product (by a 

Pharmacy or an Outsourcing 

Facility) 

Æ Cosmetic 

■ Cosmetic for professional use only 

■ Cosmetic sold on a retail basis 

Æ Cannabinoid Hemp Products (such as 

products containing CBD) 

Æ Other 

In section E, we propose to 

interchange the fields 2a and 2b so that 

‘‘Procode’’ will now appear in field 2a 

and ‘‘Common Device Name’’ will 

appear in field 2b. 

In section G, we propose to add a field 

entitled ‘‘Packer’’ to the list under ‘‘Also 

Reported To’’ in field G4. 

In the ‘‘Advice about Voluntary 

Reporting’’ section, we propose to 

remove ‘‘Special nutritional products 

(dietary supplements, medical foods, 

infant formulas)’’ and ‘‘Food (including 

beverages and ingredients added to 

foods’’ and add ‘‘If your report involves 

a health problem or product problem 

with foods or special nutritional 

products such as infant formulas, 

dietary supplements, or medical foods’’, 

go to https://

www.safetyreporting.fda.gov or call 1– 

888–723–3366 to report. 

We propose to revise ‘‘If your report 

involves a health problem or a product 


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problem with a tobacco product, go to 

https://www.safetyreporting.fda.gov or 

call 1–877–287–1363 to report.’’ to ‘‘If 

your report involves a health problem or 

a product problem with a tobacco 

product, including e-cigarettes 

(nicotine-containing vapes) or nicotine 

pouches, go to https://

www.safetyreporting.fda.gov or call 1– 

877–287–1363 to report.’’ 

C. Changes Proposed for Form FDA 

3500A 

Throughout the form, we propose to 

add calendar functionality to all date 

fields for uniformity and 

standardization of date format. 

In the header, we propose to revise 

‘‘For use by user-facilities, importers, 

distributors and manufacturers’’ to ‘‘For 

use by user-facilities, importers, 

distributors, manufacturers and 

packers.’’ We propose to remove the 

header ‘‘FDA USE ONLY’’ and revise 

the ‘‘Exemption/Variance #’’ field to 

‘‘Exemption/Variance/Alternative #.’’ 

In section A, we propose to revise 

‘‘Undifferentiated’’ to ‘‘Intersex’’ in field 

3, combine the ‘‘Ethnicity’’ (field A5) 

and ‘‘Race’’ (field A6) fields as outlined 

in the Statistical Policy Directive No. 15: 

Standards for Maintaining, Collecting, 

and Presenting Federal Data on Race 

and Ethnicity (SPD 15) issued on March 

29, 2024, and propose to add the new 

text ‘‘What is your race and/or 

ethnicity? Select all that apply.’’ The 

selections will also include descriptions 

of each category. 

The data fields include the following: 

combine the ‘‘Ethnicity’’ (field A5) and 

‘‘Race’’ (field A6) fields as outlined in 

the Statistical Policy Directive No. 15: 

Standards for Maintaining, Collecting, 

and Presenting Federal Data on Race 

and Ethnicity (SPD 15) issued on March 

29, 2024 and add ‘‘What is your race 

and/or ethnicity? Select all that apply.’’ 

The selections will also include 

descriptions of each category. 

The data fields include: 

• American Indian or Alaska 

Native—For example, Navajo Nation, 

Blackfeet Tribe of the Blackfeet Indian 

Reservation of Montana, Native Village 

of Barrow Inupiat Traditional 

Government, Nome Eskimo Community, 

Aztec, Maya, etc. 

• Asian—For example, Chinese, 

Asian Indian, Filipino, Vietnamese, 

Korean, Japanese, etc. 

• Black or African American—For 

example, African American, Jamaican, 

Haitian, Nigerian, Ethiopian, Somali, 

etc. 

• Hispanic or Latino—For example, 

Mexican, Puerto Rican, Salvadoran, 

Cuban, Dominican, Guatemalan, etc. 

• Middle Eastern or North African— 

For example, Lebanese, Iranian, 

Egyptian, Syrian, Iraqi, Israeli, etc. 

• Native Hawaiian or Pacific 

Islander—For example, Native 

Hawaiian, Samoan, Chamorro, Tongan, 

Fijian, Marshallese, etc. 

• White—For example, English, 

German, Irish, Italian, Polish, Scottish, 

etc. 

In section B, we propose to reorder 

the outcomes attributed to adverse 

events list so that ‘‘Other Serious or 

Important Medical Events’’ appears as 

the last choice of the outcomes listed in 

field B2, add ‘‘Describe Event or 

Problem’’ on page 1 and add ‘‘Describe 

Event or Problem (continued)’’ on page 

2 (field B5), and add a field for reference 

ranges in the ‘‘Relevant Test/Laboratory 

Data’’ section (field B6) 

In section C, we propose to revise the 

‘‘Name, Strength, Manufacturer/ 

Compounder’’ field under 

‘‘Manufacturer/Compounder Name’’ to 

include a new field for ‘‘FEI # for 

cosmetics’’. This revision applies to 

‘‘Suspect Product #1’’ and ‘‘Suspect 

Product #2.’’ (field C1). We propose to 

revise ‘‘Usage Dates’’ after ‘‘Treatment 

Dates/Therapy Dates’’ and add ‘‘Usage’’ 

after ‘‘Treatment’’ and ‘‘Therapy.’’ (field 

C4). 

We propose to revise the ‘‘Product 

Type’’ section (field C6) as follows 

(applies to Suspect Product #1 and 

Suspect Product #2): 

Æ Drug or Biologic 

■ Brand 

■ Generic or Biosimilar 

■ Over-the Counter (OTC) 

■ Compounded product (by a 

Pharmacy or an Outsourcing 

Facility) 

Æ Cosmetic 

■ Cosmetic for professional use only 

■ Cosmetic sold on a retail basis 

Æ Other 

In section D, we propose to 

interchange fields 2a and 2b. ‘‘Procode’’ 

will now appear in field 2a and 

‘‘Common Device Name’’ will appear in 

field 2b. 

In section F, we propose to revise the 

‘‘User Facility or Importer Name/ 

Address’’ field to ‘‘User Facility or 

Importer Name/Address/Email’’ (field 

F3), add the two selections ‘‘Initial’’ and 

‘‘Follow-up #____.’’ with checkboxes in 

the ‘‘Type of Report’’ field (field F7), 

and delete the ‘‘Date of This Report (01– 

JAN–1900)’’ field (field F8). This 

information is requested in ‘‘Report Sent 

to FDA?’’ (field F11) or ‘‘Report Sent to 

Manufacturer?’’ (field F13). 

In section G, we propose to revise 

‘‘Contact Office (and Manufacturing Site 

for Devices)’’ or ‘‘Compounding 

Outsourcing Facility’’ to ‘‘Contact Office 

(and Manufacturing Site for Devices)’’ or 

‘‘Compounding Outsourcing Facility or 

Responsible Person’’ (field G1), revise 

‘‘Use Facility’’ to ‘‘User Facility’’ in the 

‘‘Report Source’’ field (field G2), revise 

‘‘Date Received by Manufacturer (01– 

JAN–1900)’’ to ‘‘Date Received by 

Manufacturer (01–JAN–1900)’’ or 

‘‘Responsible Person’’ (field G3), revise 

‘‘ANDA #’’ to ‘‘ANDA/Pre-ANDA #.’’ 

(field G4), revise ‘‘Periodic’’ to ‘‘Nonexpedited (periodic)’’ under ‘‘Type of 

Report’’ field (field G6), and revise ‘‘If 

action reported to FDA under 21 U.S.C. 

360i(g), list correction/removal 

reporting number:’’ to ‘‘If action 

reported to FDA under 21 U.S.C. 

360i(g), list FDA-assigned recall number 

or include a statement.’’ (field H9) 

VI. Changes Proposed for Form FDA 

3500A Instructional Supplement 

The FDA Form 3500A instructional 

supplement will be revised to correct 

grammatical errors and to clarify 

reporting instructions. In addition to 

these changes, the FDA Form 3500A 

instructional supplement will include 

revisions based on the Modernization of 

Cosmetics Registration Act of 2022. 

A. General Instructions 

The instructional supplement will 

include the following revisions 

specifically pertaining to cosmetics: 

• Add ‘‘or cosmetic product’’ to ‘‘If no 

suspect medical device is involved in a 

reported adverse event (i.e., when 

reporting ONLY a suspect drug or, 

biologic) ONLY sections A, B, C, E, and 

G are to be filled out’’; 

• Remove ‘‘or’’ between drug and 

biologic; 

• Add ‘‘When reporting ONLY a 

cosmetic product, the sections and/or 

subsections/blocks that are not relevant 

to cosmetics should be left blank.’’; 

• Add ‘‘Cosmetic Products: 

Responsible persons submitting serious 

adverse event reports for cosmetic 

products using Form FDA 3500A should 

include a copy of the label on or within 

the retail packaging of the cosmetic 

product, along with any information 

that can be provided to support the 

report, such as scans of labels and 

images of the serious adverse event. 

This may be submitted to FDA:’’; 

• Add ‘‘via email at: CosmeticAERS@

fda.hhs.gov’’; and 

• Add ‘‘Or by mail to: FDA CDER 

Mail Center, Attn: Cosmetics MedWatch 

Reports. White Oak Campus, Building 

22, G0207, 10903 New Hampshire Ave., 

Silver Spring, MD 20993’’. 


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B. Front Page 

For the front page, there are the 

following revisions: 

• Add ‘‘For cosmetic products, the 

User Facility/Importer Report # and 

Exemption/Variance # should be left 

blank in this section.’’; 

• Add ‘‘(mfr report #): after 

‘‘Manufacturer report #’’; 

• Revise ‘‘The manufacturer report 

number is also entered in block G9 on 

the back of the form’’ to ‘‘The 

manufacturer report number is also 

entered in block G8 on the back of the 

form.’’; 

• Add ‘‘and for responsible persons 

for cosmetic products:’’ to ‘‘For drug 

and biologics manufacturers’’; and 

• Add ‘‘that’’ and ‘‘or the responsible 

person to ‘‘The ‘‘mfr report #’’ is the 

number the manufacturer chooses to 

uniquely identify the report, and should 

conform to any applicable regulations or 

guidances.’’ 

C. Section B: Adverse Event or Product 

Problem 

In section ‘‘B1: Type of Report’’ 

adverse event, include ‘‘or cosmetic 

product’’ to ‘‘Any incident where the 

use of a product (drug or biologic, 

including human cell, tissue, or cellular 

or tissue-based product (HCT/P), at any 

dose, or a medical device (including in 

vitro diagnostic products), is suspected 

to have resulted in an adverse outcome 

in a patient.’’ 

In section ‘‘B2: Outcomes attributed to 

adverse event’’, add ‘‘and Cosmetic 

Products’’ to’’ Drugs and Biologics’’, and 

include the regulatory reference ‘‘21 

CFR and section 605 of the FD&C Act, 

respectively.’’ 

Under ‘‘Disability or Permanent 

Damage,’’ add ‘‘or cosmetic products: 

Check if the adverse event resulted in a 

persistent or significant disability or 

incapacity.’’ 

Under ‘‘Congenital Anomaly/Birth 

Defect,’’ remove ‘‘medical.’’ 

Under ‘‘Other Serious (Important 

Medical Events),’’ add ‘‘Cosmetic 

Products: Check if the other categories 

are not applicable, such as when the 

adverse event results in an infection or 

significant disfigurement (including 

serious and persistent rashes, second- or 

third-degree burns, significant hair loss, 

or persistent or significant alteration of 

appearance) other than as intended, 

under conditions of use that are 

customary or usual. Describe the 

outcomes in the actual narrative of the 

event in block B5.’’ 

In section ‘‘B4: Date of this Report,’’ 

add ‘‘, and cosmetic products’’ to ‘‘For 

all mandatory reports filed for Medical 

Devices, Drugs, and Biologics, including 

human cells, tissues, and cellular and 

tissue-based products, enter the date the 

report is submitted to the FDA.’’ 

In section ‘‘B5: Describe Event or 

Problem,’’ add ‘‘For cosmetics, please 

indicate whether the product was for 

professional use only; describe the 

amount and frequency used; for which 

body parts the cosmetic product was 

used; and outcomes.’’ 

D. Section C: Suspect Product(s) 

In section ‘‘C: Suspect Product (s),’’ 

add ‘‘For cosmetic products, fill out 

ONLY the blocks that are relevant to 

cosmetic products.’’ 

In subsection C1, add the following 

after the ‘‘Name, Strength, 

Manufacturer/Compounder’’ 

instruction: ‘‘For cosmetics: In the 

product name field, enter the statement 

of identity as such name appears on the 

label. If the product names in the listing 

are not unique, then also include 

distinguishing information for 

identification purposes. For example, 

please include a brand name or a code 

that the responsible person uses to 

distinguish the product. Such 

information may also be included, in 

addition to the product name, even 

when product names in the listing are 

unique. If you believe certain 

distinguishing information is 

confidential, please include that 

distinguishing information in 

parentheses.’’ 

In subsection C1, add after the ‘‘NDC# 

or Unique ID’’ instruction: ‘‘For 

cosmetic product(s), if available, the 

FDA Establishment Identifier (FEI) 

number obtained by the owner or 

operator of a facility(ies), of the facility 

that manufactured or processed the 

affected cosmetic product(s). FEI is also 

known as the Firm or Facility 

Establishment Identifier.’’ 

In section ‘‘C2: List Medical Products 

and Treatment Given at the Same time 

of the Event and Date,’’ add ‘‘For 

cosmetic reports include all related 

cosmetic products used at the same 

time.’’ 

In section ‘‘C3: Dose, Frequency & 

Route Used,’’ add ‘‘or the consumer’’ 

after ‘‘Describe how the product was 

used by the patient’’ and add ‘‘or 

number of applications, area of 

application’’ in the parentheses after 

‘‘(e.g., 500 mg QID orally or 10 mg every 

other day IV).’’ 

In section ‘‘C4: Treatment/Therapy 

Start and Stop Dates,’’ add ‘‘Usage’’ to 

the ‘‘C4: Treatment/Therapy Start and 

Stop Dates’’ heading, and add 

‘‘treatment/therapy’’ and ‘‘or usage’’ to 

the following sentence: ‘‘Provide the 

date of administration was started (or 

best estimate) and the date stopped (or 

best estimate).’’ 

In section C6, add ‘‘Cosmetics for 

Professional Use Only, Cosmetics Sold 

on a Retail Basis,’’ after ‘‘Biosimilar,’’ 

and before ‘‘please check the best option 

that best fits this medical product.’’ 

In section C7, add ‘‘For cosmetic 

products, if available, include best by/ 

use by date’’ to the ‘‘Expiration date’’ 

after the current instruction. 

E. Section G: All Manufacturers 

In section G, add ‘‘AND 

RESPONSIBLE PERSONS’’ to the 

‘‘SECTION G: ALL 

MANUFACTURERS’’ heading, ‘‘or 

responsible persons (in case of cosmetic 

products)’’ to the sentence, ‘‘This 

section is to be filled out by all 

manufacturers,’’ ‘‘or cosmetic product’’ 

to ‘‘NOTE: If a drug, biologic, including 

human cell, tissue, and cellular and 

tissue-based product (HCT/P),’’ and ‘‘(or 

responsible person in case of cosmetic 

product)’’ to the ‘‘manufacturer is 

reporting an adverse event in which no 

suspect medical device is involved, 

section G may be identically reproduced 

in place of section D on the front of the 

form so that a one-page form may be 

submitted.’’ Also add ‘‘For cosmetic 

products, fill out ONLY the blocks that 

are relevant to cosmetic products.’’ 

In section, ‘‘G1: Contact Office (and 

manufacturing site for devices) or 

Compounding Outsourcing Facility,’’ 

add ‘‘or Responsible Person (in case of 

cosmetic products)’’ to ‘‘Contact Office 

(and manufacturing site for devices) or 

Compounding Outsourcing Facility’’ 

heading and add ‘‘For cosmetic 

products, enter the information of the 

responsible person, which means the 

manufacturer, packer, or distributor of a 

cosmetic product whose name appears 

on the label of the cosmetic product’’ to 

the last sentence 

In section ‘‘G2: Report Source,’’ add 

‘‘and Cosmetic Products’’ to the 

sentence ‘‘Drugs and Biologics, 

including HCT/Ps: a separate 3500A 

form must be completed for each 

identifiable patient described in the 

article or manuscript.’’ Remove the text 

‘‘, and’’ between ‘‘Drugs and Biologics.’’ 

In section ‘‘G3: Date received by 

manufacturer,’’ add ‘‘or responsible 

person (in case of cosmetic product)’’ to 

the heading and add ‘‘responsible 

person,’’ to the following sentence: 

‘‘This means the date when the 

applicant, manufacturer, corporate 

affiliate, etc. receives information that 

an adverse event or medical device 

malfunction has occurred.’’ 

In section G6: Type of Report under 

‘‘15-day,’’ add the following: ‘‘, and 

cosmetic products’’ to ‘‘As specified in 


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the drug, biologic, including human 

cell, tissue, and cellular and tissuebased product (HCT/P),’’ ‘‘or 

requirements’’ to ‘‘regulations for 

reports of serious and unexpected 

adverse events,’’ change the ‘‘Periodic’’ 

label to ‘‘Non-expedited (Periodic);’’ and 

add ‘‘For Cosmetic products, use this 

option for non-serious adverse event.’’ 

Under Follow-up, add ‘‘and cosmetic 

products’’ to ‘‘Follow-up reports on 

drugs, biologics, including HCT/Ps, 

should contain information that was 

submitted in the original report if the 

information is still correct.’’ 

In section ‘‘G7: Adverse Event 

Term(s),’’ add ‘‘, and cosmetic 

products’’ to ‘‘[for use by drug, biologic, 

including human cell, tissue, and 

cellular and tissue-based product (HCT/ 

P),’’ add ‘‘(or responsible persons, in 

case of cosmetic products)’’ to 

‘‘manufacturers only]’’and remove ‘‘or 

WHOART’’ from the list of accepted 

standards. 

In ‘‘G8: Manufacturer Report 

Number,’’ remove ‘‘If submitting a 

follow-up to a report originally obtained 

from FDA through a MedWatch to 

Manufacturer program transmission of a 

serious direct report, check the ‘Other’ 

box in block G2 and enter the FDAassigned report number there’’ and add 

‘‘For cosmetics: The manufacturer 

report number is the number the 

responsible person chooses to uniquely 

identify the report, and should conform 

to any applicable regulations or 

guidances. The submission will not be 

considered complete without this 

information. While FDA currently does 

not have a mandatory format for the 

Manufacturer Report Number for 

reporting cosmetic adverse events, we 

strongly encourage you to use a 

numbering system that provides unique 

information of the adverse event 

reported, such as the year, company 

name, and the case report number.’’ 

VII. Changes Proposed for Form FDA 

3500B 

In the instructions section, we 

propose to make the following revisions: 

• Under ‘‘When do I use this form?’’, 

revise the first bullet to ‘‘You were hurt 

or had a bad side effect (including new 

or worsening symptoms) after taking a 

drug or using a medical device or 

product’’ to ‘‘You were hurt or had a 

bad side effect (including new or 

worsening symptoms) after using a 

product, drug, cosmetic or a medical 

device.’’; and 

• Add the word ‘‘cosmetic’’ after the 

word ‘‘drug’’ in the following bullets: 

‘‘You used a product, drug, cosmetic, or 

medical device incorrectly which could 

have or led to unsafe use’’ and ‘‘You 

noticed a problem with the quality of 

the product, drug, cosmetic, or medical 

device.’’ 

Under ‘‘Don’t use this form to 

report:’’, add the hyperlink for the 

Vaccine Adverse Event Reporting 

System, add descriptive language under 

tobacco products about e-cigarettes and 

nicotine pouches, remove the word 

cosmetic from the safety reporting portal 

language, and revise the hyperlink to 

the SRP. Also, add the following: 

Æ Vaccines—report problems to the 

Vaccine Adverse Event Reporting 

System (VAERS) http://vaers.hhs.gov. 

Æ Tobacco products, including ecigarettes (nicotine-containing vapes) 

and nicotine pouches, report health or 

product problems to the Safety 

Reporting Portal (SRP) https://

www.safetyreporting.fda.gov/ or call 1– 

877–287–1363. 

Æ Remove the word ‘‘cosmetic’’ from 

the last bullet—Food or dietary 

supplement products—report problems 

to the SRP https://

www.safetyreporting.fda.gov/. 

Under ‘‘What types of products 

should I use this form for?’’, add a 

comma between ‘‘bone), allergenics’’ in 

the first bullet, remove ‘‘makeup’’ in the 

third bullet, add a bullet for 

‘‘Cannabinoid Hemp Products (such as 

products containing CBD’’, and remove 

the last bullet ‘‘Foods (including 

beverages and ingredients added to 

foods). 

Under ‘‘Are there specific instructions 

for filling out the form?’’, the first two 

bullets in this section will remain 

unchanged and new text will be added 

for the third and fourth bullets to read 

as follows: 

■ Including or attaching images of all 

sides of the product will help FDA 

review your report but is not required. 

Please do not send the products to FDA. 

■ The Global Unique Device 

Identification Database (GUDID) 

contains key device identification 

information submitted to FDA about 

medical devices that have Unique 

Device Identifiers (UDI). In 

collaboration with the National Library 

of Medicine, FDA has created a portal, 

called Access GUDID, to make device 

identification information in the GUDID 

available for everyone. For more 

information regarding the UDI#, refer to 

the UDI web page, https://www.fda.gov/ 

medical-devices/device-advicecomprehensive-regulatory-assistance/ 

unique-device-identification-systemudi-system. 

Under ‘‘How can I contact the FDA if 

I have questions?’’ add a following tollfree phone number for cosmetics: 1– 

888–723–3366, and add the following 

language to match that of the MedWatch 

Online application: ‘‘If this is a medical 

emergency, please call 911’’ and ‘‘If you 

have a mental health crisis, please call 

988.’’ 

In section ‘‘A—About the Problem,’’ 

we propose to add a field for reference 

ranges in the ‘‘Relevant Test/Laboratory 

Data’’ section (field A5). 

In section ‘‘B—Product Availability,’’ 

we propose to revise the question in 

field B2 from ‘‘Do you have a picture of 

the product? (check yes if you are 

including a picture)’’ to ‘‘Do you have 

a picture of the product including 

product labels if reporting cosmetics? 

While not required, pictures of all sides 

of the product will help FDA review 

your report. (check yes if you are 

including pictures).’’ 

Under the section, ‘‘For a problem 

with a product, including,’’ remove ‘‘or 

make-up products’’ from the fourth 

bullet and remove the following bullets 

3 and 5: ‘‘nutrition products, such as 

vitamins and minerals, herbal remedies, 

infant formulas, and medical food’’ and 

‘‘foods (including beverages and 

ingredients added to foods). 

Under the section ‘‘For a health or 

product problem with a food, cosmetic, 

dietary supplement or tobacco product,’’ 

remove the word ‘‘cosmetic’’ and revise 

the hyperlink to the SRP to https://

www.safetyreporting.fda.gov/. 

In section ‘‘C: About the Products,’’ 

we propose to remove ‘‘This report is 

about,’’ or field ‘‘C1. Product’’ field will 

be updated, and add a section for a 

second suspect product and design the 

two sections for suspect product on the 

same page to facilitate the addition of 

another page if the reporter needs to 

report more than two products. 

For field C3, we propose to add 

‘‘usage’’ after ‘‘therapy.’’ The revised 

language will be ‘‘Check if therapy/ 

usage is on-going.’’ 

We propose to revise the field 

‘‘Product Type’’ (field C5) as follows: 

‘‘(Note: Dietary supplement and Food/ 

Medical Food selections will be 

removed. Adverse events involving 

these products should be submitted 

through the Safety Reporting Portal) 

Æ Drug or Biologic 

■ Brand 

■ Generic or Biosimilar 

■ Over-the Counter (OTC) 

■ Compounded product (by a 

Pharmacy or an Outsourcing 

Facility) 

Æ Cosmetic 

■ Cosmetic for professional use only 

■ Cosmetic sold on a retail basis 

Æ Cannabinoid Hemp Products (such as 

products containing CBD 

Æ Other 

For field C12, revise instructions from 

‘‘How was it taken or used (for example, 


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5908 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Notices 

by mouth, injection, or on the skin)?’’ to 

‘‘How was it taken or used (for example, 

by mouth, injection, inhaled, or on the 

skin)?’’, add a field for ‘‘Purchase Date’’, 

and add a field for ‘‘Where (e.g., 

website, pharmacy/store/state of 

purchase) was the suspect product 

obtained?’’ and ‘‘When (date) was the 

suspect product obtained?’’ We propose 

addition of fields to capture ‘‘Place of 

Purchase Name,’’ ‘‘web page/URL (if 

purchased online),’’ and ‘‘Place of 

Purchase City and State/Province.’’ 

Under section ‘‘D—About the Medical 

Device,’’ we propose to add text to read 

as ‘‘Unique Device Identifier (UDI) 

number—Please record all symbols, 

letters and numbers located under the 

barcode. An example of a UDI number 

can be found at https://

accessgudid.nlm.nih.gov/aboutgudid#what-is-udi’’ for field D7. 

Under section ‘‘E—About the Person 

Who Had the Problem,’’ we propose to 

revise ‘‘Undifferentiated’’ to ‘‘Intersex’’ 

in field 2a, add calendar functionality to 

field E4 (Date of Birth) for uniformity in 

reporting and to ensure correct reporting 

of date format, and combine the 

‘‘Ethnicity’’ (field E6) and ‘‘Race’’ (field 

E7) fields as outlined in the Statistical 

Policy Directive No. 15: Standards for 

Maintaining, Collecting, and Presenting 

Federal Data on Race and Ethnicity 

(SPD 15) issued on March 29, 2024. We 

propose to add new text ‘‘What is your 

race and/or ethnicity? Select all that 

apply.’’ The selections will also include 

descriptions of each category.’’ 

The data fields include: 

• American Indian or Alaska 

Native—For example, Navajo Nation, 

Blackfeet Tribe of the Blackfeet Indian 

Reservation of Montana, Native Village 

of Barrow Inupiat Traditional 

Government, Nome Eskimo Community, 

Aztec, Maya, etc. 

• Asian—For example, Chinese, 

Asian Indian, Filipino, Vietnamese, 

Korean, Japanese, etc. 

• Black or African American—For 

example, African American, Jamaican, 

Haitian, Nigerian, Ethiopian, Somali, 

etc. 

• Hispanic or Latino—For example, 

Mexican, Puerto Rican, Salvadoran, 

Cuban, Dominican, Guatemalan, etc. 

• Middle Eastern or North African— 

For example, Lebanese, Iranian, 

Egyptian, Syrian, Iraqi, Israeli, etc. 

• Native Hawaiian or Pacific 

Islander—For example, Native 

Hawaiian, Samoan, Chamorro, Tongan, 

Fijian, Marshallese, etc. 

• White—For example, English, 

German, Irish, Italian, Polish, Scottish, 

etc. 

Under section F, ‘‘About the Person 

Filling Out This Form,’’ we propose to 

change the title of the field from ‘‘City 

and State/Province’’ to ‘‘City and State/ 

Province (including your State/Province 

will help FDA review your report) for 

field F4, and under ‘‘Send This Report 

by mail or fax,’’ revise the mailing 

address to the following: Attn: 

MedWatch Program, White Oak 

Campus, Building 22, G0207, 10903 

New Hampshire Ave., Silver Spring, MD 

20993. 

FDA welcomes comments from the 

public and interested parties on a 

proposed report concept. 

VIII. Consumer Complaint Form 

The consumer complaint form will be 

used by all Centers to facilitate reporting 

complaints and product problems from 

the public to FDA. The four required 

data elements (patient identifier, 

description of event or problem, product 

name, and reporter), demographic 

information, and contact information 

(phone number and/or email address) 

may be requested. This form will be 

available externally with the long-term 

goal to allow submission of streamlined 

reports online. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

FDA center or 21 CFR section and/or FDA form Number of respondents 

Number of responses per 

respondent 

Total annual 

responses 

Average burden per response 

Total hours 

CBER/CDER, FDA 3500 (voluntary reporting) .................... 58,711 1 58,711 0.66 

(40 minutes) 

38,749 

CBER, FDA 3500A; 600.80; 1271.350 (mandatory reporting) .................................................................................... 599 98 58,702 1.21 71,029 

CBER, FDA 3500B .............................................................. 13,750 1 13,750 0.46 

(28 minutes) 

6,325 

CDER, FDA 3500B .............................................................. 18,961 1 18,961 0.46 

(28 minutes) 

8,722 

CDRH, FDA 3500 and FDA 3500B ..................................... 15,304 1 15,304 0.46 

(28 minutes) 

7,040 

CTP, FDA 3500 ................................................................... 39 1 39 0.66 

(40 minutes) 

26 

HFP, FDA 3500 ................................................................... 7,442 1.061 7,895 0.66 

(40 minutes) 

5,211 

HFP, FDA 3500A ................................................................. 1,659 1 1,659 1.21 2,007 

Written requests for temporary waiver under 

§ 329.100(c)(2) ................................................................. 1 1 1 1 1 

Total .............................................................................. ........................ ........................ ........................ ........................ 139,110 

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

CBER = Center for Biologics Evaluation and Research 

CDER = Center for Drug Evaluation and Research 

CDRH = Center for Devices and Radiological Health 

HFP = Human Foods Program 

CTP = Center for Tobacco Products 

The estimates in table 1 are based on 

current Agency data and our experience 

with the information collection. 


KHAMMOND on DSK9W7S144PROD with NOTICES
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