[Federal Register Volume 88, Number 12 (Thursday, January 19, 2023)]
[Notices]
[Pages 3417-3419]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00926]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0084]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Adverse Event Program for Medical Devices (Medical 
Product Safety Network)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 collections 
associated with the Adverse Event Program for Medical Devices (Medical 
Program Safety Network (MedSun)).

DATES: Either electronic or written comments on the collection of 
information must be submitted by March 20, 2023.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of March 20, 2023. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are received on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-N-0084 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Adverse Event Program for Medical 
Devices (Medical Product Safety Network).'' Received comments, those 
filed in a timely manner (see ADDRESSES), will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information

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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: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three 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. 3501-3521), 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.

Adverse Event Program for Medical Devices (Medical Product Safety 
Network (MedSun))

OMB Control Number 0910-0471--Extension

    Section 519 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
(21 U.S.C. 360i) authorizes FDA to require: (1) manufacturers to report 
medical device-related deaths, serious injuries, and malfunctions and 
(2) user facilities to report device-related deaths directly to 
manufacturers and FDA and serious injuries to the manufacturer. Section 
213 of the Food and Drug Administration Modernization Act of 1997 (Pub. 
L. 105-115) amended section 519(b) of the FD&C Act relating to 
mandatory reporting by user facilities of deaths, serious injuries, and 
serious illnesses associated with the use of medical devices. This 
amendment legislated the replacement of universal user facility 
reporting by a system that is limited to a ``. . . subset of user 
facilities that constitutes a representative profile of user reports'' 
for device-related deaths and serious injuries. This amendment is 
reflected in section 519(b)(5)(A) of the FD&C Act (21 U.S.C. 
360i(b)(5)(A)). This legislation provides FDA with the opportunity to 
design and implement a national surveillance network, composed of well-
trained clinical facilities, to provide high-quality data on medical 
devices in clinical use. This system is called MedSun. FDA is seeking 
OMB clearance to continue to use electronic data collection to obtain 
information related to medical devices and tissue products from the 
user facilities participating in MedSun, to obtain a demographic 
profile of the facilities, and for additional questions, which will 
permit FDA to better understand the cause of reported adverse events. 
Participation in the program is voluntary and includes approximately 
300 facilities. In addition to collecting data on the electronic 
adverse event report form, MedSun collects additional information from 
participating sites about reported problems emerging from the MedSun 
hospitals. This data collection is also voluntary and is collected on 
the same website as the report information. The burden estimate is 
based on the number of facilities participating in MedSun (300). FDA 
estimates an average of 18 reports per site annually. This estimate is 
based on MedSun working to promote reporting in general from the sites, 
as well as promoting reporting from specific parts of the hospitals, 
such as the pediatric intensive care units, the electrophysiology 
laboratories, and the hospital laboratories.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                   Number of
                   Activity                        Number of     responses per   Total annual          Average burden per response          Total hours
                                                  respondents     respondent       responses
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Adverse event reporting.......................             300              18           5,400  0.5 (30 minutes)........................           2,700
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 3419]]

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: January 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00926 Filed 1-18-23; 8:45 am]
BILLING CODE 4164-01-P


