[Federal Register Volume 83, Number 52 (Friday, March 16, 2018)]
[Notices]
[Pages 11756-11759]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05337]


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

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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed 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 revisions to Forms FDA 3500, 3500A, and 
3500B used in the FDA Medical Products Reporting Program.

DATES: Submit either electronic or written comments on the collection 
of information by May 15, 2018.

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 May 15, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of May 15, 2018. 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 ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; 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 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.
     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.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three

[[Page 11757]]

White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 
20852, 301-796-8867, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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

    Members of the public use FDA's MedWatch system to report adverse 
events, product problems, errors with the use of a human medical 
product, or when evidence of therapeutic failure is suspected or 
identified in clinical use. To ensure the marketing of safe and 
effective products, it is critical that postmarketing adverse outcomes 
and product problems are reported for all FDA-regulated human 
healthcare products, including drugs (prescription and 
nonprescription), biologics, medical devices, dietary supplements, and 
other special nutritional products (e.g. infant formula and medical 
foods), and cosmetics. To facilitate reporting on human medical 
products (except vaccines) during their postapproval and marketed 
lifetimes, three forms (collectively known as the MedWatch forms) are 
available from the Agency. Form FDA 3500 is intended to be used for 
voluntary (i.e., not mandated by law or regulation) reporting by 
healthcare professionals. Form FDA 3500B is written in plain language 
and is intended to be used for voluntary reporting (i.e., not mandated 
by law or regulation) by consumers (i.e., patients and their 
caregivers). Form FDA 3500A is used for mandatory reporting (i.e., 
required by law or regulation). 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 then take whatever action is necessary to reduce, 
mitigate, or eliminate the public's exposure to the risk through 
regulatory and public health interventions.

Authorizing Statutes and Codified Regulations

    The Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 
353b, 355, 360i, 360l, and 393); and the Public Health Service Act (42 
U.S.C. 262) represent the statutory authority for the FDA to collect 
mandatory adverse event reports from regulated industry on medical 
products once approved for marketing--to monitor the safety of drugs, 
biologics, medical devices, and dietary supplements. There are no laws 
or regulations mandating the post-market reporting for medical foods, 
infant formula, cosmetics, or tobacco products, and the reporting for 
these products is done voluntarily.
    Requirements regarding mandatory reporting of adverse events or 
product problems have been codified in parts 310, 314, 600, and 803 (21 
CFR 310, 314, 600, and 803), specifically Sec. Sec.  310.305, 314.80, 
314.98, 600.80, 803.30, 803.50, 803.53, 803.56, 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 reactions for human cells, 
tissues, and cellular- and tissue-based products (HCT/Ps) has been 
codified in 21 CFR 1271.350.

Use of Form 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 health professionals are not required by law or 
regulation to submit reports to the Agency or the manufacturer with the 
exception of Childhood Vaccine Injury Act of 1986 (42 U.S.C. 300aa-1). 
Reports for vaccines are not submitted via MedWatch or MedWatch forms, 
but are submitted to the Vaccines Adverse Event Reporting System (see 
https://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 (21 U.S.C. 342) after that product is marketed. 
Therefore, the Agency depends on the voluntary reporting by health 
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 previously 
received by the Agency on paper versions of Form FDA 3500 (or Form FDA 
3500B) (by mail or fax). Currently, electronic reports may be sent to 
the Agency via an online submission route called the Safety Reporting 
Portal (https://www.safetyreporting.hhs.gov/). In that case, Form FDA 
3500 (or Form FDA 3500B) is not used.
    Form FDA 3500 may be used to report to the Agency serious adverse 
events, product problems, and 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.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM163919.pdf) or reporters may 
electronically submit a report via the MedWatch Online Voluntary 
Reporting Form (https://www.accessdata.fda.gov/scripts/medwatch/). 
Reporting is supported for drugs, non-vaccine biologicals, medical 
devices, special nutritional products, cosmetics, and non-prescription 
(over the counter (OTC)) human drug products marketed without an 
approved

[[Page 11758]]

application. The paper form may also be used to submit reports about 
tobacco products and dietary supplements. Electronic reports for 
tobacco products and dietary supplements may be submitted to the Agency 
via an online submission route called the Safety Reporting Portal 
(https://www.safetyreporting.hhs.gov/).

Use of Form 3500B (Consumer Voluntary Reporting)

    This voluntary version of the form may be used by consumers (i.e. 
patients and their caregivers) to submit reports not mandated by 
Federal law or regulation. Individual patients or their 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 serious adverse outcomes and other product 
problems associated with human medical products, (https://www.fda.gov/Safety/ReportaProblem/default.htm). Since the inception of the MedWatch 
program, launched in July 1993 by then FDA Commissioner David Kessler, 
the program has been promoting and facilitating voluntary reporting by 
both the general 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).
    On March 25, 2008, section 906 of the Food and Drug Administration 
Amendments Act of 2007 (Pub. L. 110-85) amended section 502(n) of the 
FD&C Act (21 U.S.C. 352) and mandated 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/safety/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 reporting via the MedWatch 
process.
    Since 2013, FDA has made available Form FDA 3500B. It was proposed 
during the previous authorization in 2012 and is a version of Form FDA 
3500 that is tailored for consumers and written in plain language (in 
conformance with the Plain Writing Act of 2010 (Pub. L. 111-274), 
https://www.gpo.gov/fdsys/pkg/PLAW-111publ274/pdf/PLAW-111publ274.pdf).
    Form FDA 3500B 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 general 
public. Form FDA 3500B may be used to report to the Agency adverse 
events, product problems, and product use errors. 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.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM349464.pdf) or electronically submit a report via the MedWatch 
Online Voluntary Reporting Form (https://www.accessdata.fda.gov/scripts/medwatch/). Reporting is supported for drugs, non-vaccine 
biologicals, medical devices, special nutritional products, cosmetics, 
and non-prescription OTC human drug products marketed without an 
approved application. The paper form may also be used to submit reports 
about tobacco products and dietary supplements. Electronic reports for 
tobacco products and dietary supplements may be submitted to the Agency 
via an online submission route called the Safety Reporting Portal 
(https://www.safetyreporting.hhs.gov/).

I. Use of Form FDA 3500A (Mandatory Version)

A. Drug and Biological Products

    In sections 505(b) and (j), 503B, and 704 (21 U.S.C. 355(b) and 
(j), 353B, and 374) of the FD&C Act, Congress has required that 
important safety information relating to all human drug products be 
made available to the FDA so that it can take appropriate action to 
protect the public health when necessary. Section 702 of the FD&C Act 
(21 U.S.C. 372) authorizes investigational powers to the FDA for 
enforcement of the FD&C Act. These statutory requirements regarding 
mandatory reporting have been codified by FDA under parts 310 and 314 
(drugs) and 600 (biological products). Mandatory reporting of adverse 
reactions for HCT/Ps has been codified in Sec.  1271.350.

B. OTC Monograph Drug Products and Dietary Supplements

    Section 760 of the FD&C Act provides for mandatory safety reporting 
for non-prescription human drug products marketed without an approved 
application as described in the Dietary Supplement and Nonprescription 
Drug Consumer Protection Act (Pub. L. 109-462, December 22, 2006), 
which became law on December 22, 2006. The law requires manufacturers, 
packers, and distributors of nonprescription, over-the-counter (OTC) 
human drug products marketed without an approved application (OTC 
monograph drug products) to submit reports of adverse experiences from 
domestic sources. The law also requires reports of serious adverse 
events to be submitted to FDA by manufacturers of dietary supplements.

C. Postmarketing Safety Reports--Changes in Format Starting in June 
2018

Current requirements specify that postmarketing adverse experience 
reports must be submitted on paper on Form FDA Form 3500A (or the CIOMS 
(Council for International Organizations of Medical Sciences) I form 
for serious, unexpected adverse experiences from a foreign source). For 
the last several years the Agency has accepted electronic submissions 
in lieu of the paper Form FDA 3500A on the condition they are submitted 
in a manner that the Agency can process, review, and archive. On June 
10, 2014, the Agency issued a final rule entitled ``Postmarketing 
Safety Reports for Human Drug and Biological Products; Electronic 
Submission Requirements'' (79 FR 33072) that requires electronic 
submission of all mandatory postmarketing safety reports, including 
individual case safety reports. Entities with mandatory reporting 
obligations under parts 310 and 314 (drugs) and 600 (biological 
products) and specified under section 760 of the FD&C Act must 
implement this rule within 1 year of the issuance date (by June 10, 
2015). For more information see: https://www.gpo.gov/fdsys/pkg/FR-2014-06-10/pdf/2014-13480.pdf.

D. 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 
be required to provide assurance that such devices are not adulterated 
or misbranded and to otherwise assure its safety and effectiveness. The 
Safe Medical Devices Act of 1990 (Pub. L. 101-629), signed into law on 
November 28, 1990, amends section 519 of the FD&C Act. The

[[Page 11759]]

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 Form FDA 3500A for reporting to FDA on medical 
devices. The Medical Device User Fee and Modernization Act of 2002 
(MDUFMA) (Pub. L. 107-250), signed into law October 26, 2002, amended 
section 519 of the FD&C Act. The MDUFMA amendment (section 303) 
required FDA to revise the MedWatch forms to facilitate the reporting 
of information relating to reprocessed single-use devices, including 
the name of the reprocessor and whether the device has been reused.

II. Proposed Modification to Existing Forms FDA 3500, 3500A, and 3500B

    General changes--The proposed modifications to Forms FDA 3500 and 
3500A reflect changes that will bring the form into conformance, since 
the previous authorization in 2015, with current regulations, rules, 
and guidances.
    The proposed extension to Forms FDA 3500, 3500A, and 3500B will 
only have changes in the form instructions to provide clarity of 
reporting. The proposed changes are regulatory driven, improving the 
Centers' work, and improving report processing. The Agency welcomes 
comments about translation of Form FDA 3500B (consumer) into Spanish 
and other languages.
    Formatting modifications are being proposed to several fields to 
enhance the quality, utility, and clarity of the information.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of
       FDA Center/FDA Form/21 CFR section           Number of     responses per   Total annual         Average burden per response          Total hours
                                                   respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Center for Biologics Evaluation and Research/
 Center for Drug Evaluation and Research:
    Form 3500..................................          14,727               1          14,727  0.66 (40 min)..........................           9,720
    Form 3500A (Sec.  Sec.   310.305, 314.80,               599              98          58,702  1.21...................................          71,029
     314.98, 600.80, 1271.350).
    Form 3500A (Sec.  Sec.   310.305                         50               2             100  1.21...................................             121
     outsourcing facilities).
Center for Devices and Radiological Health:
    Form 3500..................................           5,233               1           5,233  0.66 (40 min)..........................           3,454
    Form 3500A (803)...........................           2,277             296         673,992  1.21...................................         815,530
Center for Food Safety and Applied Nutrition:
    Form 3500..................................           1,793               1           1,793  0.66 (40 min)..........................           1,183
    Form 3500A.................................           1,659               1           1,659  1.21...................................           2,007
Center for Tobacco Products:
    Form 3500..................................              39               1              39  0.66 (40 min)..........................              26
All Centers:
    Form 3500B.................................          13,750               1          13,750  0.46 (28 min)..........................           6,325
                                                --------------------------------------------------------------------------------------------------------
        Total..................................  ..............  ..............  ..............  .......................................         909,395
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The burden estimates have not changed from the current approval.

    Dated: March 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-05337 Filed 3-15-18; 8:45 am]
 BILLING CODE 4164-01-P


