Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; MedWatch: The Food and Drug Administration Safety Information and Adverse Event Reporting Program, 14894-14897 [2022-05514]
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Federal Register / Vol. 87, No. 51 / Wednesday, March 16, 2022 / Notices
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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the guidance to the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Tami Belouin, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
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I. Background
FDA is announcing the availability of
a draft document entitled
‘‘Considerations for the Development of
Chimeric Antigen Receptor (CAR) T Cell
Products; Draft Guidance for Industry.’’
The draft guidance document is
intended to assist sponsors, including
industry and academic sponsors,
developing CAR T cell products. The
guidance includes CAR T cell-specific
recommendations regarding CMC,
pharmacology and toxicology, and
clinical study design. While the
guidance specifically focuses on CAR T
cell products, much of the information
and recommendations provided will
also be applicable to other genetically
modified lymphocyte products, such as
CAR Natural Killer cells or T cell
receptor-modified T cells.
Elsewhere in this issue of the Federal
Register, FDA is announcing the
availability of another human gene
therapy draft guidance document
entitled ‘‘Human Gene Therapy
Products Incorporating Human Genome
Editing: Draft Guidance for Industry.’’
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance, when finalized, will
represent the current thinking of FDA
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on ‘‘Considerations for the Development
of Chimeric Antigen Receptor (CAR) T
Cell Products.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 50 have been
approved under OMB control number
0910–0755; the collections of
information in 21 CFR part 211 have
been approved under OMB control
number 0910–0139; the collections of
information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014; the collections of
information in 21 CFR part 601 have
been approved under OMB control
number 0910–0338; and the collections
of information in 21 CFR part 1271 have
been approved under OMB control
number 0910–0543.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents/ or https://
www.regulations.gov.
Dated: March 10, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–05539 Filed 3–15–22; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1960]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; MedWatch: The
Food and Drug Administration Safety
Information and Adverse Event
Reporting Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by April 15,
2022.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
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–45, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
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.
SUMMARY:
MedWatch: The FDA Safety
Information and Adverse Event
Reporting Program
OMB Control Number 0910–0291—
Revision
I. Background
MedWatch is FDA’s program for
reporting serious reactions, product
quality problems, therapeutic
inequivalence/failure, and product use
errors associated with FDA-regulated
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Federal Register / Vol. 87, No. 51 / Wednesday, March 16, 2022 / Notices
products. Examples of these products
include prescription and over-thecounter medicines; biologics such as
blood components, blood/plasma
derivatives, and gene therapies; medical
devices such as hearing aids, breast
pumps, and pacemakers; combination
products such as pre-filled drug syringe,
metered-dose inhalers, and nasal spray;
special nutritional products such as
dietary supplements, medical foods, and
infant formulas; cosmetics such as
moisturizers, makeup, shampoos, hair
dyes, and tattoos; and food, such as
beverages and ingredients added to
foods.
MedWatch receives reports from the
public and, when appropriate, publishes
safety alerts intended to protect the
public health. More information
regarding the MedWatch program,
including user guides and consumer
assistance on reporting problems to
FDA, may be found on our website at
https://www.fda.gov/safety/medwatchfda-safety-information-and-adverseevent-reporting-program. Reports are
submitted to FDA by health
professionals, patients, and consumers,
and FDA issues an acknowledgement
upon receipt of the report. Forms may
be downloaded from our website at
https://www.fda.gov/safety/medicalproduct-safety-information/medwatchforms-fda-safety-reporting and
submitted by Fax or mail following the
instructions; by completing and
submitting forms online; or by calling
FDA at 800–FDA–1088 (800–322–1088)
and reporting by telephone.
Some adverse event reports (AERs)
are required to be submitted to FDA
(mandatory reporting), while other
reporting is done voluntarily (voluntary
reporting). Upon receipt of the report, it
is directed to the FDA center
responsible for ensuring the product’s
compliance with statutory requirements
under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) and/or any
related authorities. Certain requirements
regarding mandatory reporting of
adverse events or product problems
have been codified in Agency
regulations, including those found in 21
CFR parts 310, 314, 514, 600, 803, 1114,
and 1271.
We are revising the information
collection to include electronic
submission of AERs, currently approved
in OMB control number 0910–0645.
Most reports are submitted using the
Electronic Submissions Gateway (ESG),
our centralized system for securely
receiving electronic submissions.
Reports may also be submitted via the
Safety Reporting Portal (SRP), found at
https://www.safetyreporting.hhs.gov/
SRP2/en/Home.aspx?sid=c16bcd94-
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42a8-4a68-9272-df4a62d8462c, which is
intended to streamline the process of
reporting product safety issues to FDA
using ‘‘Rational Questionnaires.’’
II. MedWatch Reporting Forms
A. MedWatch Form FDA 3500
(Voluntary Reporting for Health
Professionals)
Form FDA 3500 is used by healthcare
professionals as well as consumers to
submit all reports not mandated by
Federal law or regulation. Individual
health professionals are not required to
submit reports with the exception of
certain adverse reactions following
immunization with vaccines as
mandated by the National Childhood
Vaccine Injury Act of 1986 (42 U.S.C.
300aa–1). Form FDA 3500 may be used
to report serious adverse events, product
problems, and product use errors and
therapeutic failures. Reporting is
supported for drugs, non-vaccine
biologicals, medical devices, special
nutritional products, cosmetics, and
nonprescription (over-the-counter)
human drug products marketed without
an approved application. Form FDA
3500 may also be used to submit reports
about tobacco products and dietary
supplements.
B. MedWatch Form FDA 3500A
(Mandatory Reporting)
Form FDA 3500A is used by
manufacturers, user facilities,
distributers, importers, and other
respondents subject to mandatory
reporting. Mandatory reporting of
adverse events or product experiences is
governed by statute and often codified
in Agency regulations. Mandatory
reporting of adverse reactions for human
cells, tissues, and cellular- and tissuebased products is codified at 21 CFR
1271.350.
Reporting Under Sections 760 and
761 of the FD&C Act. The Dietary
Supplement and Nonprescription Drug
Consumer Protection Act of 2006 (Pub.
L. 109–462) amended the FD&C Act by
adding sections 760 and 761 (21 U.S.C.
379aa and 379aa–1). Section 760 of the
FD&C Act defines ‘‘adverse event’’ and
‘‘serious adverse event’’ for
nonprescription drugs and prescribes
specific reporting requirements,
submission timing, and associated
recordkeeping. The final guidance
document entitled ‘‘Postmarketing
Adverse Event Reporting for
Nonprescription Human Drug Products
Marketed Without an Approved
Application,’’ available for download at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/postmarketing-adverse-
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14895
event-reporting-nonprescription-humandrug-products-marketed-withoutapproved, discusses the statutory
requirements and provides instructions
on the reporting elements and the use of
Form FDA 3500A. Similarly, section
761 of the FD&C Act defines ‘‘adverse
event’’ and ‘‘serious adverse event’’ for
dietary supplements and prescribes
specific reporting requirements,
submission timing, and associated
maintenance of reporting records. The
document entitled ‘‘Guidance for
Industry; Questions and Answers
Regarding Adverse Event Reporting and
Recordkeeping for Dietary Supplements
as Required by the Dietary Supplement
and Nonprescription Drug Consumer
Protection Act,’’ available at https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/
guidance-industry-questions-andanswers-regarding-adverse-eventreporting-and-recordkeeping-dietary,
discusses these statutory requirements
and provides instruction on the use and
submission of Form FDA 3500A and
discusses records required under
section 761.
C. MedWatch Form FDA 3500B
(Voluntary Reporting for Consumers)
Form FDA 3500B is a consumerfriendly version of Form FDA 3500 and
is used for voluntary reporting.
Respondents with access to the internet
may visit our website at https://
www.fda.gov and download Form FDA
3500B or contact us for assistance with
completing and submitting the
information. Form FDA 3500B is
available in both English and Spanish.
III. FDA Safety Reporting Portal
Rational Questionnaires
FDA currently receives several types
of adverse event reports electronically
via the SRP using rational
questionnaires. These include:
1. Reportable Food Registry
Section 417 of the FD&C Act (21
U.S.C. 350f) defines ‘‘reportable food’’
and establishes reporting requirements
for articles of foods (other than infant
formula or dietary supplements) for
which there is a reasonable probability
that the use of, or exposure to, will
cause serious adverse health
consequences or death to humans or
animals. We designed the reportable
food registry (RFR) rational
questionnaire to enable us to quickly
identify, track, and remove from
commerce an article of food (other than
infant formula or dietary supplements)
for which there is a reasonable
probability that the use of, or exposure
to, such article of food will cause
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Federal Register / Vol. 87, No. 51 / Wednesday, March 16, 2022 / Notices
serious adverse health consequences or
death to humans or animals. FDA’s
Center for Food Safety and Applied
Nutrition uses the information to help
ensure that these products are quickly
and efficiently removed from the market
to prevent foodborne illnesses. Both
mandatory and voluntary RFR reports
must be submitted via the SRP.
2. Food, Infant Formula, and Cosmetic
Adverse Event Reports
Rational questionnaires have also
been developed for submitting adverse
event reports for dietary supplements,
food, infant formula, and cosmetics.
3. Animal Food Adverse Event and
Product Problem Reports
Section 1002(b) of the FDA
Amendments Act of 2007 (Pub. L. 110–
85) directs 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
livestock food. Information collected in
these voluntary adverse event reports
contributes to our ability to identify
adulteration of the livestock food supply
and outbreaks of illness associated with
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.
4. Voluntary Tobacco Product Adverse
Event and Product Problem Reports
The Center for Tobacco Products
(CTP) has developed two voluntary
rational questionnaires on the SRP. The
first is utilized by consumers and
concerned citizens to report tobacco
product adverse event or product
problems. A second rational
questionnaire is used by tobacco
product investigators in clinical trials
with investigational tobacco products.
Both CTP voluntary rational
questionnaires capture tobacco-specific
adverse event and product problem
information from reporting entities such
as healthcare providers, researchers,
consumers, and other users of tobacco
products.
In the Federal Register of June 30,
2021 (86 FR 34754), we published a 60day notice requesting public comment
on the proposed collection of
information. One comment was received
requesting clarification with regard to
certain terms applicable to medical
device reporting and exemptions from
reporting. We note that information
collection pertaining to medical device
reporting is approved under OMB
control number 0910–0437. The
comment also discussed electronic
reporting currently approved in OMB
control number 0910–0645. Upon
consideration of the comment and to
help increase our organizational
efficiency, we are consolidating the
related reporting activities currently
approved in OMB control number 0910–
0645 into this single information
collection request. Upon OMB approval
of our request, we will discontinue
OMB control number 0910–0645. In
consideration of the comment, we have
also proposed the following updates to
the information collection instruments
to help clarify information to be
included in the corresponding data
fields:
1. Revising the ‘‘gender’’ field to
Forms FDA 3500, 3500A, and 3500B; to
align with Centers for Disease Control
and Prevention’s use of these terms
(https://www.cdc.gov/hiv/clinicians/
transforming-health/health-careproviders/collecting-sexualorientation.html), with the exception of
the term ‘‘Undifferentiated,’’ which is
included in the CDISC (Clinical Data
Interchange Standards Consortium)
language (premarket) standards (https://
www.cdisc.org/kb/articles/sex-andgender);
2. Revising Section B of Form FDA
3500 to the ‘‘product problem’’ field to
include information about the root
cause(s) of problem(s).
3. Revising instructions to clarify
reporting instructions for paper-based
reporting pertaining to adverse events
associated with tobacco products; and
4. Revising instructions to clarify the
term ‘‘smoking’’ refers to use of
combusted products (cigarettes, cigars,
pipes) to ‘‘tobacco product use,’’ which
encompasses combusted and noncombusted tobacco products.
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
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Number of
responses per
respondent
Number of
respondents
FDA form
Total annual
responses
Average burden
per response
Total hours
Reportable Foods Registry—Mandatory Reports .......
Reportable Foods Registry—Voluntary Reports .........
Food, Infant Formula, and Cosmetic Adverse Event
Reports.
Voluntary Dietary Supplement Adverse Event Reports.
Mandatory Dietary Supplement Adverse Event Reports.
Animal Food: Pet Food Reports ..................................
Animal Food: Livestock Food Reports ........................
Voluntary Tobacco Product Health Problem or Product Problem (i.e., adverse experience) Reports to
SRP (both questionnaires).
Mandatory Tobacco Product Health Problem or Product Problem (i.e., adverse experience) Reports.
875
5
1,165
1
1
1.2
875
5
1,398
0.6 (36 minutes) .....
0.6 (36 minutes) .....
0.6 (36 minutes) .....
525
3
839
360
1.2
432
0.6 (36 minutes) .....
259
80
12
960
1 .............................
960
2,024
25
204
1
1
1
2,024
25
204
0.6 (36 minutes) .....
0.6 (36 minutes) .....
0.6 (36 minutes) .....
1,214.40
15
122
1
1
1
0.6 (36 minutes) .....
1
Total ......................................................................
........................
........................
5,924
................................
3,938.4
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimate of the number of
respondents and the total annual
responses is based primarily on
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mandatory and voluntary adverse event
reports submitted to the Agency. The
estimated total annual responses are
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based on initial reports. Followup
reports, if any, are not counted as new
reports. Based on our experience with
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Federal Register / Vol. 87, No. 51 / Wednesday, March 16, 2022 / Notices
adverse event reporting, we assume it
takes respondents 0.6 hour to submit a
voluntary adverse event report via the
SRP, 1 hour to submit a mandatory
adverse event report via the SRP (except
CTP, which estimates 0.6 hour), and 0.6
hour to submit a mandatory AER via the
ESG (gateway-to-gateway transmission).
CTP used two data sources to estimate
the reporting burden for tobacco
product AEs. CTP researched the
number of voluntary AE reports
submitted to the center since the launch
of the first tobacco questionnaire in the
SRP in 2014. Our records indicated a
total of 1,426 initial reports over the last
7 full calendar years. We used the total
number of reports to average the number
of yearly reports to 204. As referenced
above, the premarket tobacco product
application rule requires firms to submit
adverse experience reports for tobacco
products with marketing orders. The
burden for these mandatory reports has
been approved under OMB control
number 0910–0879. For this collection,
we have included 1 hour to
acknowledge the inclusion under this
collection. Therefore, the estimate for
CTP voluntary and mandatory reports is
expected to be 123 hours.
The submission of mandatory reports
associated with drug products and
biological drug products is accounted
for and approved under OMB control
number 0910–0230; the submission of
mandatory reports associated with the
Vaccine Adverse Event Reporting
System is accounted for and approved
under OMB control number 0910–0308;
medical device report submissions are
accounted for and approved under OMB
control number 0910–0437; and the
submission of mandatory reports
associated with animal drug products is
accounted for and approved under OMB
control number 0910–0284.
Dated: March 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–05514 Filed 3–15–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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[Docket No. FDA–2021–D–0398]
Human Gene Therapy Products
Incorporating Human Genome Editing;
Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
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The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
document entitled ‘‘Human Gene
Therapy Products Incorporating Human
Genome Editing; Draft Guidance for
Industry.’’ The draft guidance document
provides recommendations to sponsors
developing human gene therapy
products incorporating genome editing
(GE) of human somatic cells.
Specifically, the guidance provides
recommendations regarding information
that should be provided in an
investigational new drug (IND)
application in order to assess the safety
and quality of the investigational GE
product, including information on
product design, product manufacturing,
product testing, preclinical safety
assessment, and clinical trial design.
DATES: Submit either electronic or
written comments on the draft guidance
by June 14, 2022 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
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
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14897
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–
2021–D–0398 for ‘‘Human Gene
Therapy Products Incorporating Human
Genome Editing; Draft Guidance for
Industry.’’ Received comments 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-201509-18/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.
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]]>Agencies
[Federal Register Volume 87, Number 51 (Wednesday, March 16, 2022)]
[Notices]
[Pages 14894-14897]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05514]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1960]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; MedWatch: The Food
and Drug Administration Safety Information and Adverse Event Reporting
Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by April 15, 2022.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
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-45, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
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.
MedWatch: The FDA Safety Information and Adverse Event Reporting
Program
OMB Control Number 0910-0291--Revision
I. Background
MedWatch is FDA's program for reporting serious reactions, product
quality problems, therapeutic inequivalence/failure, and product use
errors associated with FDA-regulated
[[Page 14895]]
products. Examples of these products include prescription and over-the-
counter medicines; biologics such as blood components, blood/plasma
derivatives, and gene therapies; medical devices such as hearing aids,
breast pumps, and pacemakers; combination products such as pre-filled
drug syringe, metered-dose inhalers, and nasal spray; special
nutritional products such as dietary supplements, medical foods, and
infant formulas; cosmetics such as moisturizers, makeup, shampoos, hair
dyes, and tattoos; and food, such as beverages and ingredients added to
foods.
MedWatch receives reports from the public and, when appropriate,
publishes safety alerts intended to protect the public health. More
information regarding the MedWatch program, including user guides and
consumer assistance on reporting problems to FDA, may be found on our
website at https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program. Reports are submitted to FDA by
health professionals, patients, and consumers, and FDA issues an
acknowledgement upon receipt of the report. Forms may be downloaded
from our website at https://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting and submitted by Fax or
mail following the instructions; by completing and submitting forms
online; or by calling FDA at 800-FDA-1088 (800-322-1088) and reporting
by telephone.
Some adverse event reports (AERs) are required to be submitted to
FDA (mandatory reporting), while other reporting is done voluntarily
(voluntary reporting). Upon receipt of the report, it is directed to
the FDA center responsible for ensuring the product's compliance with
statutory requirements under the Federal Food, Drug, and Cosmetic Act
(FD&C Act) and/or any related authorities. Certain requirements
regarding mandatory reporting of adverse events or product problems
have been codified in Agency regulations, including those found in 21
CFR parts 310, 314, 514, 600, 803, 1114, and 1271.
We are revising the information collection to include electronic
submission of AERs, currently approved in OMB control number 0910-0645.
Most reports are submitted using the Electronic Submissions Gateway
(ESG), our centralized system for securely receiving electronic
submissions. Reports may also be submitted via the Safety Reporting
Portal (SRP), found at https://www.safetyreporting.hhs.gov/SRP2/en/Home.aspx?sid=c16bcd94-42a8-4a68-9272-df4a62d8462c, which is intended
to streamline the process of reporting product safety issues to FDA
using ``Rational Questionnaires.''
II. MedWatch Reporting Forms
A. MedWatch Form FDA 3500 (Voluntary Reporting for Health
Professionals)
Form FDA 3500 is used by healthcare professionals as well as
consumers to submit all reports not mandated by Federal law or
regulation. Individual health professionals are not required to submit
reports with the exception of certain adverse reactions following
immunization with vaccines as mandated by the National Childhood
Vaccine Injury Act of 1986 (42 U.S.C. 300aa-1). Form FDA 3500 may be
used to report serious adverse events, product problems, and product
use errors and therapeutic failures. Reporting is supported for drugs,
non-vaccine biologicals, medical devices, special nutritional products,
cosmetics, and nonprescription (over-the-counter) human drug products
marketed without an approved application. Form FDA 3500 may also be
used to submit reports about tobacco products and dietary supplements.
B. MedWatch Form FDA 3500A (Mandatory Reporting)
Form FDA 3500A is used by manufacturers, user facilities,
distributers, importers, and other respondents subject to mandatory
reporting. Mandatory reporting of adverse events or product experiences
is governed by statute and often codified in Agency regulations.
Mandatory reporting of adverse reactions for human cells, tissues, and
cellular- and tissue-based products is codified at 21 CFR 1271.350.
Reporting Under Sections 760 and 761 of the FD&C Act. The Dietary
Supplement and Nonprescription Drug Consumer Protection Act of 2006
(Pub. L. 109-462) amended the FD&C Act by adding sections 760 and 761
(21 U.S.C. 379aa and 379aa-1). Section 760 of the FD&C Act defines
``adverse event'' and ``serious adverse event'' for nonprescription
drugs and prescribes specific reporting requirements, submission
timing, and associated recordkeeping. The final guidance document
entitled ``Postmarketing Adverse Event Reporting for Nonprescription
Human Drug Products Marketed Without an Approved Application,''
available for download at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarketing-adverse-event-reporting-nonprescription-human-drug-products-marketed-without-approved,
discusses the statutory requirements and provides instructions on the
reporting elements and the use of Form FDA 3500A. Similarly, section
761 of the FD&C Act defines ``adverse event'' and ``serious adverse
event'' for dietary supplements and prescribes specific reporting
requirements, submission timing, and associated maintenance of
reporting records. The document entitled ``Guidance for Industry;
Questions and Answers Regarding Adverse Event Reporting and
Recordkeeping for Dietary Supplements as Required by the Dietary
Supplement and Nonprescription Drug Consumer Protection Act,''
available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-adverse-event-reporting-and-recordkeeping-dietary, discusses these
statutory requirements and provides instruction on the use and
submission of Form FDA 3500A and discusses records required under
section 761.
C. MedWatch Form FDA 3500B (Voluntary Reporting for Consumers)
Form FDA 3500B is a consumer-friendly version of Form FDA 3500 and
is used for voluntary reporting. Respondents with access to the
internet may visit our website at https://www.fda.gov and download Form
FDA 3500B or contact us for assistance with completing and submitting
the information. Form FDA 3500B is available in both English and
Spanish.
III. FDA Safety Reporting Portal Rational Questionnaires
FDA currently receives several types of adverse event reports
electronically via the SRP using rational questionnaires. These
include:
1. Reportable Food Registry
Section 417 of the FD&C Act (21 U.S.C. 350f) defines ``reportable
food'' and establishes reporting requirements for articles of foods
(other than infant formula or dietary supplements) for which there is a
reasonable probability that the use of, or exposure to, will cause
serious adverse health consequences or death to humans or animals. We
designed the reportable food registry (RFR) rational questionnaire to
enable us to quickly identify, track, and remove from commerce an
article of food (other than infant formula or dietary supplements) for
which there is a reasonable probability that the use of, or exposure
to, such article of food will cause
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serious adverse health consequences or death to humans or animals.
FDA's Center for Food Safety and Applied Nutrition uses the information
to help ensure that these products are quickly and efficiently removed
from the market to prevent foodborne illnesses. Both mandatory and
voluntary RFR reports must be submitted via the SRP.
2. Food, Infant Formula, and Cosmetic Adverse Event Reports
Rational questionnaires have also been developed for submitting
adverse event reports for dietary supplements, food, infant formula,
and cosmetics.
3. Animal Food Adverse Event and Product Problem Reports
Section 1002(b) of the FDA Amendments Act of 2007 (Pub. L. 110-85)
directs 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 livestock food. Information
collected in these voluntary adverse event reports contributes to our
ability to identify adulteration of the livestock food supply and
outbreaks of illness associated with 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.
4. Voluntary Tobacco Product Adverse Event and Product Problem Reports
The Center for Tobacco Products (CTP) has developed two voluntary
rational questionnaires on the SRP. The first is utilized by consumers
and concerned citizens to report tobacco product adverse event or
product problems. A second rational questionnaire is used by tobacco
product investigators in clinical trials with investigational tobacco
products. Both CTP voluntary rational questionnaires capture tobacco-
specific adverse event and product problem information from reporting
entities such as healthcare providers, researchers, consumers, and
other users of tobacco products.
In the Federal Register of June 30, 2021 (86 FR 34754), we
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received requesting
clarification with regard to certain terms applicable to medical device
reporting and exemptions from reporting. We note that information
collection pertaining to medical device reporting is approved under OMB
control number 0910-0437. The comment also discussed electronic
reporting currently approved in OMB control number 0910-0645. Upon
consideration of the comment and to help increase our organizational
efficiency, we are consolidating the related reporting activities
currently approved in OMB control number 0910-0645 into this single
information collection request. Upon OMB approval of our request, we
will discontinue OMB control number 0910-0645. In consideration of the
comment, we have also proposed the following updates to the information
collection instruments to help clarify information to be included in
the corresponding data fields:
1. Revising the ``gender'' field to Forms FDA 3500, 3500A, and
3500B; to align with Centers for Disease Control and Prevention's use
of these terms (https://www.cdc.gov/hiv/clinicians/transforming-health/health-care-providers/collecting-sexual-orientation.html), with the
exception of the term ``Undifferentiated,'' which is included in the
CDISC (Clinical Data Interchange Standards Consortium) language
(premarket) standards (https://www.cdisc.org/kb/articles/sex-and-gender);
2. Revising Section B of Form FDA 3500 to the ``product problem''
field to include information about the root cause(s) of problem(s).
3. Revising instructions to clarify reporting instructions for
paper-based reporting pertaining to adverse events associated with
tobacco products; and
4. Revising instructions to clarify the term ``smoking'' refers to
use of combusted products (cigarettes, cigars, pipes) to ``tobacco
product use,'' which encompasses combusted and non-combusted tobacco
products.
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
FDA form Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reportable Foods Registry--Mandatory Reports. 875 1 875 0.6 (36 minutes)......................... 525
Reportable Foods Registry--Voluntary Reports. 5 1 5 0.6 (36 minutes)......................... 3
Food, Infant Formula, and Cosmetic Adverse 1,165 1.2 1,398 0.6 (36 minutes)......................... 839
Event Reports.
Voluntary Dietary Supplement Adverse Event 360 1.2 432 0.6 (36 minutes)......................... 259
Reports.
Mandatory Dietary Supplement Adverse Event 80 12 960 1........................................ 960
Reports.
Animal Food: Pet Food Reports................ 2,024 1 2,024 0.6 (36 minutes)......................... 1,214.40
Animal Food: Livestock Food Reports.......... 25 1 25 0.6 (36 minutes)......................... 15
Voluntary Tobacco Product Health Problem or 204 1 204 0.6 (36 minutes)......................... 122
Product Problem (i.e., adverse experience)
Reports to SRP (both questionnaires).
Mandatory Tobacco Product Health Problem or 1 1 1 0.6 (36 minutes)......................... 1
Product Problem (i.e., adverse experience)
Reports.
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Total.................................... .............. .............. 5,924 ......................................... 3,938.4
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimate of the number of respondents and the total annual
responses is based primarily on mandatory and voluntary adverse event
reports submitted to the Agency. The estimated total annual responses
are based on initial reports. Followup reports, if any, are not counted
as new reports. Based on our experience with
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adverse event reporting, we assume it takes respondents 0.6 hour to
submit a voluntary adverse event report via the SRP, 1 hour to submit a
mandatory adverse event report via the SRP (except CTP, which estimates
0.6 hour), and 0.6 hour to submit a mandatory AER via the ESG (gateway-
to-gateway transmission).
CTP used two data sources to estimate the reporting burden for
tobacco product AEs. CTP researched the number of voluntary AE reports
submitted to the center since the launch of the first tobacco
questionnaire in the SRP in 2014. Our records indicated a total of
1,426 initial reports over the last 7 full calendar years. We used the
total number of reports to average the number of yearly reports to 204.
As referenced above, the premarket tobacco product application rule
requires firms to submit adverse experience reports for tobacco
products with marketing orders. The burden for these mandatory reports
has been approved under OMB control number 0910-0879. For this
collection, we have included 1 hour to acknowledge the inclusion under
this collection. Therefore, the estimate for CTP voluntary and
mandatory reports is expected to be 123 hours.
The submission of mandatory reports associated with drug products
and biological drug products is accounted for and approved under OMB
control number 0910-0230; the submission of mandatory reports
associated with the Vaccine Adverse Event Reporting System is accounted
for and approved under OMB control number 0910-0308; medical device
report submissions are accounted for and approved under OMB control
number 0910-0437; and the submission of mandatory reports associated
with animal drug products is accounted for and approved under OMB
control number 0910-0284.
Dated: March 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-05514 Filed 3-15-22; 8:45 am]
BILLING CODE 4164-01-P
