[Federal Register Volume 86, Number 123 (Wednesday, June 30, 2021)]
[Notices]
[Pages 34754-34757]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13943]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1960]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; MedWatch: The Food and Drug Administration Medical 
Products Reporting Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
associated with FDA's MedWatch adverse experience reporting (AER) 
program.

DATES: Submit either electronic or written comments on the collection 
of information by August 30, 2021.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before August 30, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of August 30, 2021. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked, and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-N-1960 for ``MedWatch: The FDA Medical Products Reporting 
Program.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential

[[Page 34755]]

Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: 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, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

MedWatch: The FDA Medical Products Reporting Program

OMB Control Number 0910-0291--Extension

    This information collection supports FDA laws and regulations 
governing adverse event reports and product experience reports for FDA-
regulated products. The Federal Food, Drug, and Cosmetic Act (FD&C Act) 
(21 U.S.C. 353b, 355, 360i, 360l, 379aa, and 393) and the Public Health 
Service Act (42 U.S.C. 262) authorize FDA to collect adverse event 
reports and product experience reports from regulated industry and to 
monitor the safety of drugs, biologics, medical devices, and dietary 
supplements. These reporting and recordkeeping requirements are found 
in FDA regulations, discussed in Agency guidance, and included in 
Agency forms. Although there are no laws or regulations mandating 
postmarket reporting for medical foods, infant formula, cosmetics, or 
tobacco products, we encourage voluntary reporting of adverse 
experiences associated with these products.
    To facilitate both consumer and industry reporting of adverse 
events and experiences with FDA-regulated products, we developed the 
MedWatch program. The MedWatch program allows anyone to submit reports 
to FDA on adverse events, including injuries and/or deaths, as well as 
other product experiences associated with the products we regulate. 
While the MedWatch program provides for both paper-based and electronic 
reporting, this information collection covers paper-based reporting. 
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 approved under OMB 
control number 0910-0230.
    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

[[Page 34756]]

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 (Voluntary Reporting)

    This voluntary version of the form may be used by healthcare 
professionals to submit all reports not mandated by Federal law or 
regulation. Individual healthcare professionals are not required by law 
or regulation to submit reports to the Agency or the manufacturer, 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 http://vaers.hhs.gov), which is jointly administered by FDA 
and the Centers for Disease Control and Prevention.
    Hospitals are not required by Federal law or regulation to submit 
reports associated with drug products, biological products, or special 
nutritional products. However, hospitals and other user facilities are 
required by Federal law to report medical device-related deaths and 
serious injuries.
    Under Federal law and regulation (section 761(b)(1) of the FD&C 
Act), a dietary supplement manufacturer, packer, or distributor whose 
name appears on the label of a dietary supplement marketed in the 
United States is required to submit to FDA any serious adverse event 
report it receives regarding use of the dietary supplement in the 
United States. However, FDA bears the burden to gather and review 
evidence that a dietary supplement may be adulterated under section 402 
of the FD&C Act after that product is marketed. Therefore, the Agency 
depends on the voluntary reporting by healthcare professionals and 
especially by consumers of suspected serious adverse events and product 
quality problems associated with the use of dietary supplements. All 
dietary supplement reports were originally received by the Agency on 
paper versions of Form FDA 3500 (by mail or fax). Today, electronic 
reports may be sent to the Agency via an online submission route called 
the Safety Reporting Portal at http://www.safetyreporting.hhs.gov/. In 
that case, the Form FDA 3500 is not used.
    Form FDA 3500 may be used to report to the Agency adverse events, 
product problems, product use errors, and therapeutic failures. The 
form is provided in both paper and electronic formats. Reporters may 
mail or fax paper forms to the Agency. A fillable .pdf version of the 
form is available at https://www.accessdata.fda.gov/scripts/medwatch/ 
or electronically submit a report via the MedWatch Online Voluntary 
Reporting Form at https://www.accessdata.fda.gov/scripts/medwatch/. 
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 http://www.safetyreporting.hhs.gov/. 
Electronic reports for tobacco products may be submitted to the Agency 
via the tobacco questionnaire within the online Safety Reporting Portal 
at http://www.safetyreporting.hhs.gov/.

Use of Form FDA 3500A--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 0910-0645, 
established to support electronic reporting to our MedWatch program. At 
the same time, regulations 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. While most reporting 
associated with medical device products is covered under OMB control 
number 0910-0437, we retain coverage for paper-based adverse experience 
report submissions in this collection.

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 http://www.safetyreporting.hhs.gov/. Paper-
based dietary supplement reports may be submitted using the MedWatch 
Form FDA 3500A.

Use of Form FDA 3500B--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

[[Page 34757]]

website at https://www.fda.gov/safety/report-problem-fda for more 
information. Since the inception of the MedWatch program in July 1993, 
the program has been promoting and facilitating voluntary reporting by 
both the public and healthcare professionals. FDA has further 
encouraged voluntary reporting by requiring inclusion of the MedWatch 
toll-free phone number or the MedWatch 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 
https://www.fda.gov/medwatch, 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.
    Since 2013, FDA has made available the 3500B form. Proposed during 
the previous authorization in 2012, the 3500B form is a version of the 
3500 form that is tailored for consumers and written in plain language 
in conformance with the Plain Writing Act of 2010 (https://www.govinfo.gov/content/pkg/PLAW-111publ274/pdf/PLAW-111publ274.pdf). 
The 3500B form evolved from several iterations of draft versions, with 
input from human factors experts, from other regulatory agencies and 
with extensive input from consumer advocacy groups and the public. 
Since 2019, the 3500B form has been available in Spanish at https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda and available to 
upload electronically since 2021 at https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.spanish.
    Form FDA 3500B, may be 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 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 https://www.accessdata.fda.gov/scripts/medwatch/. A fillable .pdf version of 
the form, available at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM349464.pdf may be downloaded, completed, 
and mailed or faxed to the Agency. Reporting is supported for drugs, 
non-vaccine biologicals, medical devices, food products, special 
nutritional products, cosmetics, and non-prescription human drug 
products marketed without an approved application. The paper form may 
also be used to submit reports about dietary supplements. Electronic 
reports for dietary supplements may be submitted to the Agency via an 
online submission route called the Safety Reporting Portal at http://www.safetyreporting.hhs.gov/. Electronic reports for tobacco products 
may be submitted to the Agency via the tobacco questionnaire within the 
online Safety Reporting Portal at http://www.safetyreporting.hhs.gov/.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
FDA center or 21 CFR section and/    Number of     responses per   Total annual   Average burden    Total hours
           or FDA form              respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Center for Biologics Evaluation           14,727               1          14,727        0.66 (40           9,720
 and Research/Center for Drug                                                           minutes)
 Evaluation and Research: Form
 3500...........................
Form 3500A(Sec.  Sec.   310.305,             599              98          58,702            1.21          71,029
 314.80, 314.98, 600.80, and
 1271.350)......................
Form 3500A (Sec.   310.305                    50               2             100            1.21             121
 outsourcing facilities)........
Center for Devices and                     5,233               1           5,233        0.66 (40           3,454
 Radiological Health: Form 3500.                                                        minutes)
Form 3500A (part 803)...........           2,277             296         673,992            1.21         815,530
Center for Food Safety and                 1,793               1           1,793        0.66 (40           1,183
 Applied Nutrition: Form 3500...                                                        minutes)
Form 3500A......................           1,659               1           1,659            1.21           2,007
Center for Tobacco Products:                  39               1              39        0.66 (40              26
 Form 3500......................                                                        minutes)
All Centers: Form 3500B.........          13,750               1         13, 750        0.46 (28           6,325
                                                                                        minutes)
Written requests for temporary                 1               1               1               1               1
 waiver under Sec.
 329.100(c)(2)..................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         909,396
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We are retaining the currently approved burden estimates for the 
information collection.

    Dated: June 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13943 Filed 6-29-21; 8:45 am]
BILLING CODE 4164-01-P


