82_FR_24457 82 FR 24356 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Program for Medical Devices (Medical Product Safety Network)

82 FR 24356 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Program for Medical Devices (Medical Product Safety Network)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 101 (May 26, 2017)

Page Range24356-24356
FR Document2017-10844

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Federal Register, Volume 82 Issue 101 (Friday, May 26, 2017) 
[Federal Register Volume 82, Number 101 (Friday, May 26, 2017)]
[Notices]
[Page 24356]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-10844]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) 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: Fax written comments on the collection of information by June 
26, 2017.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0471. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[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.

Adverse Event Program for Medical Devices (Medical Product Safety 
Network (MedSun)); OMB Control Number 0910-0471--Extension

    Under section 519 of the Federal Food, Drug, and Cosmetic Act (the 
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. 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 the Medical Product Safety Network (MedSun).
    FDA is seeking OMB clearance to continue to use electronic data 
collection to obtain the information on Form FDA 3500A (approved under 
OMB control number 0910-0291) 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 250 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 Web site 
as the report information.
    The burden estimate is based on the number of facilities 
participating in MedSun (250). FDA estimates an average of 15 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.
    In the Federal Register of January 19, 2017 (82 FR 6566), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Adverse event reporting.......             250              15           3,750  .75 (45 minutes)           2,813
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: May 22, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-10844 Filed 5-25-17; 8:45 am]
BILLING CODE 4164-01-P

24356 Federal Register / Vol. 82, No. 101 / Friday, May 26, 2017 / Notices Dated: May 22, 2017. FOR FURTHER INFORMATION CONTACT: on medical devices in clinical use. This Anna K. Abram, Amber Sanford, Office of Operations, system is called the Medical Product Deputy Commissioner for Policy, Planning, Food and Drug Administration, Three Safety Network (MedSun). Legislation, and Analysis. White Flint North, 10A63, 11601 FDA is seeking OMB clearance to [FR Doc. 2017–10818 Filed 5–25–17; 8:45 am] Landsdown St., North Bethesda, MD continue to use electronic data BILLING CODE 4164–01–P 20852, 301–796–8867, PRAStaff@ collection to obtain the information on fda.hhs.gov. Form FDA 3500A (approved under SUPPLEMENTARY INFORMATION: In OMB control number 0910–0291) DEPARTMENT OF HEALTH AND related to medical devices and tissue compliance with 44 U.S.C. 3507, FDA HUMAN SERVICES products from the user facilities has submitted the following proposed Food and Drug Administration collection of information to OMB for participating in MedSun, to obtain a review and clearance. demographic profile of the facilities, [Docket No. FDA–2017–N–0084] and for additional questions, which will Adverse Event Program for Medical permit FDA to better understand the Agency Information Collection Devices (Medical Product Safety cause of reported adverse events. Activities; Submission for Office of Network (MedSun)); OMB Control Participation in the program is Management and Budget Review; Number 0910–0471—Extension voluntary and includes approximately Comment Request; Adverse Event 250 facilities. Program for Medical Devices (Medical Under section 519 of the Federal Product Safety Network) Food, Drug, and Cosmetic Act (the In addition to collecting data on the FD&C Act) (21 U.S.C. 360i) authorizes electronic adverse event report form, AGENCY: Food and Drug Administration, FDA to require: (1) Manufacturers to MedSun collects additional information HHS. report medical device-related deaths, from participating sites about reported ACTION: Notice. serious injuries, and malfunctions and problems emerging from the MedSun (2) user facilities to report device-related hospitals. This data collection is also SUMMARY: The Food and Drug deaths directly to manufacturers and voluntary and is collected on the same Administration (FDA) is announcing FDA and serious injuries to the Web site as the report information. that a proposed collection of manufacturer. Section 213 of the Food information has been submitted to the The burden estimate is based on the and Drug Administration Modernization number of facilities participating in Office of Management and Budget Act of 1997 (Pub. L. 105–115) amended (OMB) for review and clearance under MedSun (250). FDA estimates an section 519(b) of the FD&C Act relating average of 15 reports per site annually. the Paperwork Reduction Act of 1995. to mandatory reporting by user facilities DATES: Fax written comments on the This estimate is based on MedSun of deaths, serious injuries, and serious working to promote reporting in general collection of information by June 26, illnesses associated with the use of 2017. from the sites, as well as promoting medical devices. This amendment reporting from specific parts of the ADDRESSES: To ensure that comments on legislated the replacement of universal hospitals, such as the pediatric the information collection are received, user facility reporting by a system that intensive care units, the OMB recommends that written is limited to a ‘‘. . . subset of user electrophysiology laboratories, and the comments be faxed to the Office of facilities that constitutes a hospital laboratories. Information and Regulatory Affairs, representative profile of user reports’’ OMB, Attn: FDA Desk Officer, Fax: 202– for device-related deaths and serious In the Federal Register of January 19, 395–7285, or emailed to oira_ injuries. This amendment is reflected in 2017 (82 FR 6566), FDA published a 60- submission@omb.eop.gov. All section 519(b)(5)(A) of the FD&C Act. day notice requesting public comment comments should be identified with the This legislation provides FDA with the on the proposed collection of OMB control number 0910–0471. Also opportunity to design and implement a information. No comments were include the FDA docket number found national surveillance network, received. in brackets in the heading of this composed of well-trained clinical FDA estimates the burden of this document. facilities, to provide high-quality data collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Average Number of Total annual Activity responses per burden per Total hours respondents responses respondent response Adverse event reporting ............................................................ 250 15 3,750 .75 (45 2,813 minutes). 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: May 22, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–10844 Filed 5–25–17; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 19:14 May 25, 2017 Jkt 241001 PO 00000 Frm 00082 Fmt 4703 Sfmt 9990 E:\FR\FM\26MYN1.SGM 26MYN1


Document Created: 2017-05-26 02:24:22
Document Modified: 2017-05-26 02:24:22
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesFax written comments on the collection of information by June 26, 2017.
ContactAmber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected]
FR Citation82 FR 24356 
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