Notice2025-11605
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration's Adverse Event and Product Experience Reporting Program
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Published
June 25, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 90 Issue 120 (Wednesday, June 25, 2025)</title>
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[Federal Register Volume 90, Number 120 (Wednesday, June 25, 2025)]
[Notices]
[Pages 27029-27037]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-11605]
[[Page 27029]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-5468]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by July 25, 2025.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0291. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#fcacaebdaf889d9a9abc9a989dd294948fd29b938a"><span class="__cf_email__" data-cfemail="18484a594b6c797e7e587e7c793670706b367f776e">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
FDA's Adverse Event and Product Experience Reporting Program
OMB Control Number 0910-0291--Revision
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 not all respondents to the information
collection are required to submit reports, we encourage voluntary
reporting of adverse experiences associated with any FDA-regulated
product.
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 310, 314, 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 accounted for in
OMB control number 0910-0230. Mandatory reporting under 21 CFR part
803, associated with medical device products, using form FDA 3500a, is
accounted for in 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 biological, food products including dietary supplements and special
nutritional products (e.g., infant formula and medical foods),
cosmetics, drug products or medical devices, and importers.
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 health care
professionals to submit all reports not mandated by Federal law or
regulation. Individual health care professionals are not required by
law or regulation to submit reports to the Agency or the manufacturer,
with the exception of 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 <a href="http://vaers.hhs.gov">http://vaers.hhs.gov</a>), 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 to report medical device-related deaths and serious injuries
(accounted for in OMB control number 0910-0437).
Under Federal law and regulation (section 761(b)(1) of the FD&C
Act), a
[[Page 27030]]
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
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 <a href="http://www.safetyreporting.fda.gov/">http://www.safetyreporting.fda.gov/</a>. 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 paper forms to the Agency. A fillable .pdf version of the
form is available at <a href="https://www.accessdata.fda.gov/scripts/medwatch/">https://www.accessdata.fda.gov/scripts/medwatch/</a>
or electronically submit a report via the MedWatch Online Voluntary
Reporting Form at <a href="https://www.accessdata.fda.gov/scripts/medwatch/">https://www.accessdata.fda.gov/scripts/medwatch/</a>.
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 <a href="http://www.safetyreporting.fda.gov/">http://www.safetyreporting.fda.gov/</a>.
Electronic reports for tobacco products may be submitted to the
Agency via the tobacco questionnaire within the online Safety Reporting
Portal at <a href="http://www.safetyreporting.fda.gov/">http://www.safetyreporting.fda.gov/</a>.
Use of Form FDA 3500A, MedWatch for use by User-Facilities, Importers,
Distributors, and Manufacturers (Mandatory Reporting)
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,
regulations are provided for waivers from the electronic submission
requirements and we therefore account for paper-based reporting in this
information collection.
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 may by regulation reasonably
require to assure that such devices are not adulterated or misbranded
and to otherwise assure its safety and effectiveness. The Safe Medical
Device Act of 1990, 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 21 CFR
part 803 (part 803). Part 803 mandates the use of the Form FDA 3500A
for reporting to FDA on medical devices. Mandatory reporting associated
with medical device products using form FDA 3500A is accounted for in
OMB control number 0910-0437.
Dietary Supplements
Section 502(x) in 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 <a href="http://www.safetyreporting.fda.gov/">http://www.safetyreporting.fda.gov/</a>.
Paper-based dietary supplement reports may be submitted using the
MedWatch Form FDA 3500A.
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 <a href="https://www.fda.gov/safety/report-problem-fda">https://www.fda.gov/safety/report-problem-fda</a> 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 internet address 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 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
<a href="https://www.fda.gov/medwatch">https://www.fda.gov/medwatch</a>, or call 1-800-FDA-1088.'' Most private
vendors of consumer medication information, 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, since it was first made available in 2013 was
tailored for
[[Page 27031]]
consumers and written in plain language in conformance with the Plain
Writing Act of 2010 (<a href="https://www.govinfo.gov/content/pkg/PLAW-111publ274/pdf/PLAW-111publ274.pdf">https://www.govinfo.gov/content/pkg/PLAW-111publ274/pdf/PLAW-111publ274.pdf</a>) 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 <a href="https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda">https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda</a> and available to upload electronically
since 2021 at <a href="https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.spanish">https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.spanish</a> and provided in both paper and
electronic formats. Respondents may submit reports by mail or fax paper
forms to the Agency or electronically submit a report via the MedWatch
Online Voluntary Reporting Form at <a href="https://www.accessdata.fda.gov/scripts/medwatch/">https://www.accessdata.fda.gov/scripts/medwatch/</a>. A fillable.pdf version of the form, available at
<a href="http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM349464.pdf">http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM349464.pdf</a> 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 <a href="http://www.safetyreporting.fda.gov/">http://www.safetyreporting.fda.gov/</a>.
Use of Form FDA 3800, Safety Reporting Portal
The Safety Reporting Portal (SRP) streamlines the process of
reporting product safety issues to the 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, 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--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 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--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
Safety Reporting Portal's (SRP) 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. For efficiency of Agency operations,
we have consolidated activities associated with adverse event reporting
previously approved under OMB control number 0910-0879 into this
collection.
Mandatory Tobacco Product Health Problem or Product Problem Reports
(i.e., Adverse experience reports). On October 5, 2021 (86 FR 55300),
FDA published a rule titled ``Premarket Tobacco Product Applications
and Recordkeeping Requirements (PMTA)''. The rule establishes
regulatory definitions (Sec. 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
(Sec. 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.
Proposed Modifications to Existing Forms 3500, 3500A and 3500B
General Changes
The proposed modifications to Form FDA 3500, 3500A and Form FDA
3500B (English and Spanish) reflect changes that will bring the forms
into conformation, 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 add mailing
address to Attn: MedWatch Program, White Oak Campus, Building 22,
G0207, 10903 New Hampshire Ave., Silver Spring, MD 20993.
Changes Proposed for Form FDA 3500
Throughout the form, we propose to:
<bullet> 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 form (i.e., Health Professional Voluntary Reporting).
In Section A, we propose to:
<bullet> based on the executive order, Defending Women from Gender
Ideology Extremism and Restoring Biological Truth to the Federal
Government, signed by President Donald J. Trump on January 20, 2025,
revise the Sex field to include two options, Male and Female. and
remove the Gender field. combine the Ethnicity (Field A5) and Race
(Field A6) fields as
[[Page 27032]]
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. Add new text--``What is
your race and/or ethnicity? Select all that apply.'' The data fields
include:
[ssquf] American Indian or Alaska Native
[ssquf] Asian
[ssquf] Black or African American
[ssquf] Hispanic or Latino
[ssquf] Middle Eastern or North African
[ssquf] Native Hawaiian or Pacific Islander
[ssquf] White
In Section B, we propose to:
<bullet> re-order 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.
<bullet> Add field for reference ranges in the Relevant Test/
Laboratory Data section (Field B6)
In Section C, we propose to:
<bullet> Add 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:
<bullet> Remove `This report involves cosmetic, dietary supplement,
food/medical food and other.'' Cosmetic will now be captured under the
``Product Type'' section Field D5.)
<bullet> add ``Usage Dates'' after ``Treatment Dates/Therapy
Dates'' and add ``Usage'' after ``treatment'' and ``Therapy'' in Field
D3.
<bullet> revise the ``Product Type'' section (Field D5) 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
[ssquf] Brand
[ssquf] Generic or Biosimilar
[ssquf] Over-the Counter (OTC)
[ssquf] Compounded product (by a Pharmacy or an Outsourcing
Facility)
[cir] Cosmetic
[ssquf] Cosmetic for professional use only
[ssquf] 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.
``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 ``Packer'' to the list
under ``Also Reported to'' in Field G4.
In the Advice about Voluntary Reporting section, we propose to:
<bullet> remove:
[cir] Special nutritional products (dietary supplements, medical
foods, infant formulas)
[cir] Food (including beverages and ingredients added to foods)
<bullet> add:
[cir] 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 <a href="https://www.safetyreporting.fda.gov">https://www.safetyreporting.fda.gov</a> or call 1-888-723-3366 to report.
<bullet> revise:
[cir] ``If your report involves a health problem or a product
problem with a tobacco product, go to <a href="https://www.safetyreporting.fda.gov">https://www.safetyreporting.fda.gov</a> 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 <a href="https://www.safetyreporting.fda.gov">https://www.safetyreporting.fda.gov</a> or call 1-
877-287-1363 to report.''
Changes Proposed for Form FDA 3500A
Throughout the form, we propose to:
<bullet> add calendar functionality to all date fields for
uniformity and standardization of date format.
In the header, we propose to:
<bullet> revise ``For use by user-facilities, importers,
distributors and manufacturers'' to ``For use by user-facilities,
importers, distributors, manufacturers and packers.''
<bullet> remove the header ``FDA USE ONLY''
<bullet> revise ``Exemption/Variance #'' field to ``Exemption/
Variance/Alternative #.''
In Section A, we propose to:
<bullet> based on the executive order, Defending Women from Gender
Ideology Extremism and Restoring Biological Truth to the Federal
Government, signed by President Donald J. Trump on January 20, 2025,
revise the Sex field to include two options, Male and Female. and
remove the Gender field.
<bullet> 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. Add new text--
``What is your race and/or ethnicity?'' Select all that apply.
[cir] The data fields include:
<bullet> 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. Add new text--
``What is your race and/or ethnicity? Select all that apply.''
[cir] The data fields include:
[ssquf] American Indian or Alaska Native
[ssquf] Asian
[ssquf] Black or African American
[ssquf] Hispanic or Latino
[ssquf] Middle Eastern or North African
[ssquf] Native Hawaiian or Pacific Islander
[ssquf] White
In Section B, we propose to:
<bullet> re-order 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.
<bullet> add language on page 1 ``Describe Event or Problem'' and
on page 2 ``Describe Event or Problem (continued)'' (Field B5)
<bullet> add field for reference ranges in the Relevant Test/
Laboratory Data section (Field B6)
In Section C, we propose to:
<bullet> 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)
<bullet> add ``Usage Dates'' after ``Treatment Dates/Therapy
Dates'' and add ``Usage'' after ``treatment'' and ``Therapy.'' (Field
C4)
<bullet> revise the ``Product Type'' section (Field C6) as follows
(applies to Suspect Product #1 and Suspect Product #2):
[cir] Drug or Biologic
[ssquf] Brand
[ssquf] Generic or Biosimilar
[ssquf] Over-the Counter (OTC)
[ssquf] Compounded product (by a Pharmacy or an Outsourcing
Facility)
[cir] Cosmetic
[ssquf] Cosmetic for professional use only
[ssquf] Cosmetic sold on a retail basis
[cir] Other
In section D, we propose to interchange the 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:
[cir] revise to ``User Facility or Importer Name/Address'' field to
``User Facility or Importer Name/Address/Email'' (Field F3)
<bullet> add the following two selections with checkboxes,
``Initial'' and ``Follow-up #_.'' in the Type of Report field (Field
F7)
<bullet> delete ``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).
[[Page 27033]]
In Section G, we propose to:
<bullet> 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)
<bullet> revise ``Use Facility'' to ``User Facility'' in the Report
Source field (Field G2)
<bullet> revise ``Date Received by Manufacturer (01-JAN-1900)'' to
``Date Received by Manufacturer (01-JAN-1900) or Responsible Person''
(Field G3)
<bullet> revise ``ANDA #'' to ``ANDA/Pre-ANDA #.'' (Field G4)
<bullet> revise ``Periodic'' to ``Non-expedited (periodic)'' under
``Type of Report'' field (Field G6)
<bullet> 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)
Changes Proposed for Form FDA 3500A Instructional Supplement
<bullet> The FDA Form 3500A instructional supplement will be
revised to correct grammatical errors and to clarify reporting
instructions.
<bullet> In addition to these changes, the FDA Form 3500A
instructional supplement will include revisions based on the
Modernization of Cosmetics Registration Act of 2022 (MoCRA). The
instructional supplement will include the following revisions
specifically pertaining to cosmetics:
General Instructions
<bullet> Add the text ``, 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:
<bullet> Remove the text ``or,'' between drug and biologic
<bullet> Add the text ``When reporting ONLY a cosmetic product, the
sections and/or subsections/blocks that are not relevant to cosmetics
should be left blank.''
<bullet> Add the text ``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:''
<bullet> Add the text ``via email at: <a href="/cdn-cgi/l/email-protection#d695b9a5bbb3a2bfb59793848596b0b2b7f8bebea5f8b1b9a0"><span class="__cf_email__" data-cfemail="3b785448565e4f52587a7e69687b5d5f5a15535348155c544d">[email protected]</span></a>''
<bullet> Add the text ``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''
Front Page
<bullet> Add the text ``For cosmetic products, the User Facility/
Importer Report # and Exemption/Variance # should be left blank in this
section.''
<bullet> Add the text ``(mfr report #): after ``Manufacturer report
#''
<bullet> Revise the text ``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.''
<bullet> Add the text ``and for responsible persons for cosmetic
products:'' to ``For drug and biologics manufacturers''
<bullet> Add the text ``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.''
Section B: Adverse Event or Product Problem
<bullet> B1: Type of Report
[cir] Adverse event: Include the text ``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.
<bullet> B2: Outcomes attributed to adverse event
<bullet> Add ``and Cosmetic Products'' to'' Drugs and Biologics''
<bullet> Include the regulatory reference ``21 CFR and Section 605
of the FD&C Act, respectively.''
<bullet> Under Disability or Permanent Damage, add the following
text:
[cir] For cosmetic products, check if the adverse event resulted in
a persistent or significant disability or incapacity.
<bullet> Under Congenital Anomaly/Birth Defect, remove the text
``medical.''
<bullet> Under Other Serious (Important Medical Events), add the
following text:
[cir] 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.
<bullet> B4: Date of this Report
[cir] Add the text ``, 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.''
<bullet> B5: Describe Event or Problem
Add the text ``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.''
Section C: Suspect Product(s)
<bullet> Add the text ``For cosmetic products, fill out ONLY the
blocks that are relevant to cosmetic products.''
<bullet> C1: Add the following text 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''.
<bullet> C1: Add the following text 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.''
<bullet> C2: List Medical Products and Treatment Given at the Same
time of the Event and Date
<bullet> Add the text ``For cosmetic reports include all related
cosmetic products used at the same time.''
<bullet> C3: Dose, Frequency & Route Used
<bullet> Add the text ``or the consumer'' after ``Describe how the
product was used by the patient''
<bullet> Add the words ``or number of applications, area of
application)'' after ``(e.g., 500 mg QID orally or 10 mg every other
day IV.''
<bullet> C4: Treatment/Therapy Start and Stop Dates
<bullet> Add the text ``Usage'' to the C4: Treatment/Therapy Start
and Stop Dates heading
[[Page 27034]]
<bullet> Add the text ``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).''
<bullet> C6: Add the text ``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.''
<bullet> C7: Add the text ``For cosmetic products, if available,
include best by/use by date'' to the ``Expiration date'' after the
current instruction.
Section G: All Manufacturers
<bullet> Add the text ``AND RESPONSIBLE PERSONS'' to the Section G:
ALL MANUFACTURERS heading
<bullet> Add the text ``or responsible persons (in case of cosmetic
products)'' to the sentence, ``This section is to be filled out by all
manufacturers.''
<bullet> Add the text ``or cosmetic product'' to ``NOTE: If a drug,
biologic, including human cell, tissue, and cellular and tissue-based
product (HCT/P),''
<bullet> Add the text ``(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.''
<bullet> Add the following text, ``For cosmetic products, fill out
ONLY the blocks that are relevant to cosmetic products.''
<bullet> G1: Contact Office (and manufacturing site for devices) or
Compounding Outsourcing Facility
[cir] Add ``or Responsible Person (in case of cosmetic products)''
to ``Contact Office (and manufacturing site for devices) or Compounding
Outsourcing Facility'' heading
[cir] Add this text as the last sentence ``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.''
<bullet> G2: Report Source:
[cir] Add the text ``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.''
<bullet> G3: Date received by manufacturer:
[cir] Add the text ``or responsible person (in case of cosmetic
product)'' to the heading
[cir] Add the text ``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.''
<bullet> G6: Type of Report:
[cir] Under 15-day, add the following text ``, and cosmetic
products'' to ``As specified in the drug, biologic, including human
cell, tissue, and cellular and tissue- based product (HCT/P),''
[cir] Under 15-day, add the following text ``or requirements,'' to
``regulations
for reports of serious and unexpected adverse events.''
[cir] Change the ``Periodic'' label to ``Non-expedited (Periodic)''
and add ``For Cosmetic products, use this option for non-serious
adverse event.''
[cir] Under Follow-up, add the text ``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.''
<bullet> G7: Adverse Event Term(s):
[cir] Add the text ``, and cosmetic products'' to ``[for use by
drug, biologic, including human cell, tissue, and cellular and tissue-
based product (HCT/P),''
[cir] Add the text ``(or responsible persons, in case of cosmetic
products)'' to ``manufacturers only]''
[cir] Remove the text ``or WHOART'' from the list of accepted
standards.
<bullet> G8: Manufacturer Report Number
[cir] Remove the following text that refers to the MedWatch to
Manufacturer program. ``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.''
[cir] 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.
Changes Proposed for Form FDA 3500B
In the instructions section, we propose to make the following
revisions:
<bullet> Under ``When do I use this form?''
[cir] 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.''
[cir] Add the word ``cosmetic'' after the word ``drug'' in the
following bullets:
[ssquf] You used a product, drug, cosmetic, or medical device
incorrectly which could have or led to unsafe use.
[ssquf] You noticed a problem with the quality of the product,
drug, cosmetic, or medical device.
<bullet> Under ``Don't use this form to report:''
[cir] Add the hyperlink for the Vaccine Adverse Event Reporting
System (VAERS), 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 Safety
Reporting Portal.
[cir] Vaccines--report problems to the Vaccine Adverse Event
Reporting System (VAERS) <a href="http://vaers.hhs.gov">http://vaers.hhs.gov</a>.
[cir] Tobacco products, including e-cigarettes (nicotine-containing
vapes) and nicotine pouches--report health or product problems to the
Safety Reporting Portal (SRP) <a href="https://www.safetyreporting.fda.gov/">https://www.safetyreporting.fda.gov/</a> 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 <a href="https://www.safetyreporting.fda.gov/">https://www.safetyreporting.fda.gov/</a>.
<bullet> Under ``What types of products should I use this form
for?''
[cir] In the first bullet, add a comma between ``bone),
allergenics''
[cir] In the third bullet, remove the word ``makeup.''
[cir] Add bullet for ``Cannabinoid Hemp Products (such as products
containing CBD''
[cir] Remove last bullet: Foods (including beverages and
ingredients added to foods)
<bullet> Under ``Are there specific instructions for filling out
the form?''
[cir] The first two bullets in this section will remain unchanged.
[cir] New text will be added for the third and fourth bullet.
[ssquf] 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 the FDA.
[ssquf] The Global Unique Device Identification Database (GUDID)
contains key device identification information submitted to the FDA
about medical devices that have Unique Device Identifiers (UDI). In
[[Page 27035]]
collaboration with the National Library of Medicine, the 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, <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system</a>.
<bullet> Under ``How can I contact the FDA if I have questions?''
add a phone number for cosmetics.
[cir] For Cosmetics: Toll-free line: 1-888-723-3366
<bullet> Add language to match that of the MedWatch Online
application
[cir] If this is a medical emergency, please call 911.
[cir] If you have a mental health crisis, please call 988.
In Section A--About the Problem, we propose to:
<bullet> Add field for reference ranges in the Relevant Test/
Laboratory Data section (Field A5)
In Section B--Product Availability, we propose to:
<bullet> Revise the question in Field B2 from ``Do you have a
picture of the product? (check yes if you are including a picture)'' to
``2. 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)
<bullet> Under the section, ``For a problem with a product,
including''
[cir] Remove the language ``or make-up products'' from the fourth
bullet.
[cir] Remove bullets 3 and 5:
<bullet> nutrition products, such as vitamins and minerals, herbal
remedies, infant formulas, and medical foods
<bullet> foods (including beverages and ingredients added to foods)
<bullet> Under the section ``For a health or product problem with a
food, cosmetic, dietary supplement or tobacco product''
[cir] Remove the word ``cosmetic.''
[cir] Revise the hyperlink to the Safety Reporting Portal to
<a href="https://www.safetyreporting.fda.gov/">https://www.safetyreporting.fda.gov/</a>
In Section C: About the Products, we propose to:
<bullet> Remove ``This report is about'' or field C1. Product type
field will be updated.
<bullet> 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.
<bullet> For field C3, add the word ``usage'' after ``therapy.''
Revised language will be ``Check if therapy/usage is on-going.''
<bullet> 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
[ssquf] Brand
[ssquf] Generic or Biosimilar
[ssquf] Over-the Counter (OTC)
[ssquf] Compounded product (by a Pharmacy or an Outsourcing
Facility)
[cir] Cosmetic
[ssquf] Cosmetic for professional use only
[ssquf] Cosmetic sold on a retail basis
[cir] Cannabinoid Hemp Products (such as products containing CBD
[cir] Other
<bullet> For Field C12, revise instructions from ``How was it taken
or used (for example, by mouth, injection, or on the skin)?'' to ``How
was it taken or used (for example, by mouth, injection, inhaled, or on
the skin)?'' to add the word ``inhaled.''
<bullet> Add a field for ``Purchase Date.''
<bullet> 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. 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:
<bullet> For field D7, 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
<a href="https://accessgudid.nlm.nih.gov/about-gudid#what-is-udi">https://accessgudid.nlm.nih.gov/about-gudid#what-is-udi</a>.''
Under Section E--About the Person Who Had the Problem, we propose
to:
<bullet> based on the executive order, Defending Women from Gender
Ideology Extremism and Restoring Biological Truth to the Federal
Government, signed by President Donald J. Trump on January 20, 2025,
revise the Sex field to include two options, Male and Female. and
remove the Gender field.
<bullet> Add calendar functionality to Field E4 (Date of Birth) for
uniformity in reporting and to ensure correct reporting of date format.
[cir] 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. Add new text--``What is
your race and/or ethnicity? Select all that apply.'' The data fields
include:
<bullet> American Indian or Alaska Native
<bullet> Asian
<bullet> Black or African American
<bullet> Hispanic or Latino
<bullet> Middle Eastern or North African
<bullet> Native Hawaiian or Pacific Islander
<bullet> White
Under Section F--About the Person Filling Out This Form, we propose
to:
<bullet> For Field F4, 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).''
Under ``Send This Report by Mail or Fax,'' revise the mailing
address to Attn: MedWatch Program, White Oak Campus, Building 22,
G0207, 10903 New Hampshire Ave., Silver Spring, MD 20993.
Changes Proposed for Form FDA 3800, Safety Reporting Portal
The Center for Tobacco Products (CTP) proposes to make non-
substantive changes to the Tobacco Product Report (TPR) and Tobacco
Investigator Report (TIR) questionnaires in the Safety Reporting
Portal. The proposed changes clarify the instructions, clarify existing
questions, and simplify certain response fields.
CTP also proposes to modify the instructions in response to
findings in a user experience study that was completed in 2024. For
example, participants wanted the instructions to indicate how long the
report typically takes to complete. CTP proposes to replace some
structured answer lists with free text boxes to shorten the
questionnaire and better align with the MedWatch forms. CTP proposes to
remove structured answer choices that have been rarely or never used,
while maintaining the current functionality that allows uncommon
responses to be provided in free-text boxes. CTP proposes to replace
certain free-text or structured answer choices with searchable drop-
down menus to assist in answer selection.
The proposed changes do not change the breadth or depth of data
collected in the questionnaires or the number of required questions.
The proposed changes aim to reduce the burden on the reporter by
shortening the questionnaire and streamlining the questions and
instructions. The proposed changes are supported by the results of a
user experience study that was completed in 2024.
In the Federal Register of January 17, 2025 (90 FR 5900), we
published a 60-day notice soliciting public comment on the proposed
collection of information.
[[Page 27036]]
Two comments were received supporting FDA's addition of a ``cannabinoid
hemp product'' category for reporting adverse events, but encouraged
FDA to include additional categories as well that would allow for
specific data as it pertained to a wider variety of individual
products. A third comment was received encouraging the enhancement of
FDA's MAUDE system using automated technologies that would allow for
easier input by respondents. FDA appreciates each comment and although
we continue to modify applicable forms to increase the utility of the
information collection as our limited resources allow, we are proposing
no other modifications at this time and have made no changes in the
estimated burden based on these public comments.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
FDA Center or 21 CFR Section and/ Number of responses per Total annual burden per Total hours
or FDA Form respondents respondent responses 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.
Table 2--Estimated Annual Reporting Burden E-Submissions Including via SRP \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
FDA Form 3800 Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Reportable Foods Registry 875 1 875 0.6 525
(mandatory reports)............ (36 minutes)
Reportable Foods Registry 5 1 5 0.6 3
(voluntary reports)............ (36 minutes)
Food, Infant Formula, and 1,165 1.2 1,398 0.6 839
Cosmetic Adverse Event Reports. (36 minutes)
Voluntary Dietary Supplement 360 1.2 432 0.6 259
Adverse Event Reports.......... (36 minutes)
Mandatory Dietary Supplement 80 12 960 1 960
Adverse Event Reports..........
Animal Food: Voluntary Pet Food 1,401 1 1,401 0.6 841
Reports........................ (36 minutes)
Animal Food: Voluntary Livestock 23 1 23 0.6 14
Food Reports................... (36 minutes)
Voluntary Tobacco Product Health 176 1 176 0.6 106
Problem or Product Problem (36 minutes)
(i.e., adverse experience)
Reports to SRP (both
questionnaires)................
Mandatory Tobacco Product Health 3 6 18 0.6 11
Problem or Product Problem (36 minutes)
(i.e., adverse experience)
Reports 1114.41(a)(2)..........
-------------------------------------------------------------------------------
[[Page 27037]]
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.
CDER/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 21 CFR 310.305 from outsourcing facilities are also
included in 0910-0230 and decreases the total burden of this
collection.
Based on updated data, 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 21 CFR 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 21 CFR part 803). We have therefore removed CDRH reporting via
FDA 3500A from this information collection request and continue to
account for its burden in OMB control number 0910-0437.
Based on agency experience HFP'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: June 18, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-11605 Filed 6-24-25; 8:45 am]
BILLING CODE P
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.