```

[Federal Register Volume 90, Number 11 (Friday, January 17, 2025)]
[Notices]
[Pages 5900-5909]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-01149]

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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.

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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

[[Page 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, 
[email protected].

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

[[Page 5902]]

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 
Sec.  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 post-approval 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 device-related 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, 
non-vaccine biologicals, medical devices, food products, special 
nutritional products, cosmetics, and non-prescription 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 Sec.  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,

[[Page 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/. 
Paper-based 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 
product-specific 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/PLAW-111publ274/pdf/PLAW-111publ274.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-and-adverse-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, sponsor-investigators 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

[[Page 5904]]

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)

[cir] Drug or Biologic
    [squf] Brand
    [squf] Generic or Biosimilar
    [squf] Over-the Counter (OTC)
    [squf] Compounded product (by a Pharmacy or an Outsourcing 
Facility)
[cir] Cosmetic
    [squf] Cosmetic for professional use only
    [squf] Cosmetic sold on a retail basis
[cir] Cannabinoid Hemp Products (such as products containing CBD)
[cir] 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

[[Page 5905]]

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):

[cir] Drug or Biologic
    [squf] Brand
    [squf] Generic or Biosimilar
    [squf] Over-the Counter (OTC)
    [squf] Compounded product (by a Pharmacy or an Outsourcing 
Facility)
[cir] Cosmetic
    [squf] Cosmetic for professional use only
    [squf] Cosmetic sold on a retail basis
[cir] 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 ``Non-expedited (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: [email protected]''; 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''.

[[Page 5906]]

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

[[Page 5907]]

the drug, biologic, including human cell, tissue, and cellular and 
tissue-based 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 FDA-assigned 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:
    [cir] Vaccines--report problems to the Vaccine Adverse Event 
Reporting System (VAERS) http://vaers.hhs.gov.
    [cir] Tobacco products, including e-cigarettes (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.
    [cir] 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:
    [squf] 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.
    [squf] 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-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
    Under ``How can I contact the FDA if I have questions?'' add a 
following toll-free 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)

[cir] Drug or Biologic
    [squf] Brand
    [squf] Generic or Biosimilar
    [squf] Over-the Counter (OTC)
    [squf] Compounded product (by a Pharmacy or an Outsourcing 
Facility)
[cir] Cosmetic
    [squf] Cosmetic for professional use only
    [squf] Cosmetic sold on a retail basis
[cir] Cannabinoid Hemp Products (such as products containing CBD
[cir] Other

    For field C12, revise instructions from ``How was it taken or used 
(for example,

[[Page 5908]]

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/about-gudid#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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
FDA center or 21 CFR section and/    Number of     responses per   Total annual   Average burden    Total hours
           or FDA form              respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
CBER/CDER, FDA 3500 (voluntary            58,711               1          58,711            0.66          38,749
 reporting).....................                                                    (40 minutes)
CBER, FDA 3500A; 600.80;                     599              98          58,702            1.21          71,029
 1271.350 (mandatory reporting).
CBER, FDA 3500B.................          13,750               1          13,750            0.46           6,325
                                                                                    (28 minutes)
CDER, FDA 3500B.................          18,961               1          18,961            0.46           8,722
                                                                                    (28 minutes)
CDRH, FDA 3500 and FDA 3500B....          15,304               1          15,304            0.46           7,040
                                                                                    (28 minutes)
CTP, FDA 3500...................              39               1              39            0.66              26
                                                                                    (40 minutes)
HFP, FDA 3500...................           7,442           1.061           7,895            0.66           5,211
                                                                                    (40 minutes)
HFP, FDA 3500A..................           1,659               1           1,659            1.21           2,007
Written requests for temporary                 1               1               1               1               1
 waiver under Sec.
 329.100(c)(2)..................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         139,110
----------------------------------------------------------------------------------------------------------------
\1\ There 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.

[[Page 5909]]

                 Table 2--Estimated Annual Reporting Burden E-Submissions Including via SRP \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
          FDA form 3800              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Reportable Foods Registry                    875               1             875         0.6 (36             525
 (mandatory reports)............                                                        minutes)
Reportable Foods Registry                      5               1               5         0.6 (36               3
 (voluntary reports)............                                                        minutes)
Food, Infant Formula, and                  1,165             1.2           1,398         0.6 (36             839
 Cosmetic Adverse Event Reports.                                                        minutes)
Voluntary Dietary Supplement                 360             1.2             432         0.6 (36             259
 Adverse Event Reports..........                                                        minutes)
Mandatory Dietary Supplement                  80              12             960               1             960
 Adverse Event Reports..........
Animal Food: Voluntary Pet Food            1,401               1           1,401         0.6 (36             841
 Reports........................                                                        minutes)
Animal Food: Voluntary Livestock              23               1              23         0.6 (36              14
 Food Reports...................                                                        minutes)
Voluntary Tobacco Product Health             176               1             176         0.6 (36             106
 Problem or Product Problem                                                             minutes)
 (i.e., adverse experience)
 Reports to SRP (both
 questionnaires)................
Mandatory Tobacco Product Health               3               6              18         0.6 (36              11
 Problem or Product Problem                                                             minutes)
 (i.e., adverse experience)
 Reports 1114.41(a)(2)..........
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............           5,924  ..............           3,961
----------------------------------------------------------------------------------------------------------------
\1\ There 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 e-submissions 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
```