80 FR 26278 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Reporting: Manufacturer, Importer, User Facility, and Distributor Reporting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 88 (May 7, 2015)

Page Range		26278-26280
FR Document		2015-10995

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the 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 medical device reporting (MDR); manufacturer, importer, user facility, and distributor reporting.

Federal Register, Volume 80 Issue 88 (Thursday, May 7, 2015)

[Federal Register Volume 80, Number 88 (Thursday, May 7, 2015)]
[Notices]
[Pages 26278-26280]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-10995]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0110]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Medical Device Reporting: Manufacturer, Importer, User 
Facility, and Distributor Reporting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 medical device reporting 
(MDR); manufacturer, importer, user facility, and distributor 
reporting.

DATES: Submit either electronic or written comments on the collection 
of information by July 6, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [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

[[Page 26279]]

of automated collection techniques, when appropriate, and other forms 
of information technology.

Medical Device Reporting: Manufacturer, Importer, User Facility, and 
Distributor Reporting (21 CFR part 803) OMB Control Number 0910-0437--
Extension

    Section 519(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) (21 U.S.C. 360i(a)(1)) requires every manufacturer or importer to 
report whenever the manufacturer or importer receives or otherwise 
becomes aware of information that reasonably suggests that one of its 
marketed devices may have caused or contributed to a death or serious 
injury or has malfunctioned and that such device or a similar device 
marketed by the manufacturer or importer would be likely to cause or 
contribute to a death or serious injury if the malfunction were to 
recur.
    Section 519(b)(1)(A) of the FD&C Act requires whenever a device 
user facility receives or otherwise becomes aware of information that 
reasonably suggests that a device has or may have caused or contributed 
to the death or serious illness, of a patient of the facility, the 
facility shall, as soon as practicable but not later than 10 working 
days after becoming aware of the information, report the information to 
the Secretary of HHS and, if the identity of the manufacturer is known, 
to the manufacturer of the device.
    Section 519(b)(1)(B) of the FD&C Act requires whenever a device 
user facility receives or otherwise becomes aware of information that 
reasonably suggests that a device has or may have caused or contributed 
to the serious illness of, or serious injury to, a patient of the 
facility, shall, as soon as practicable but not later than 10 working 
days after becoming aware of the information, report the information to 
the manufacturer of the device or to the Secretary of HHS if the 
identity of the manufacturer is not known.
    Complete, accurate, and timely adverse event information is 
necessary for the identification of emerging device problems. 
Information from these reports will be used to evaluate risks 
associated with medical devices which will enable FDA to take 
appropriate regulatory measures in protection of the public health 
under section 519 of the FD&C Act. Thus FDA is requesting approval for 
these information collection requirements which are being implemented 
under part 803.
    Respondents to this collection of information are businesses or 
other for-profit and nonprofit organizations including user facilities, 
manufacturers, and importers of medical devices.
    Part 803 requires user facilities to report to the device 
manufacturer and to FDA in case of a death, incidents where a medical 
device caused or contributed to a death or serious injury. 
Additionally, user facilities are required to annually submit the 
number and summary of advents reported during the calendar year using 
Form FDA 3419. Manufacturers of medical devices are required to report 
to FDA when they become aware of information indicating that one of 
their devices may have caused or contributed to death or serious injury 
or has malfunctioned in such a way, that should the malfunction recur, 
it would be likely to cause or contribute to a death or serious injury. 
Device importers report deaths and serious injuries to the 
manufacturers and FDA. Importers report malfunctions only to the 
manufacturers, unless they are unknown, then the reports are sent to 
FDA.
    The number of respondents for each CFR section in table 1 is based 
upon the number of respondents entered into FDA's internal databases. 
FDA estimates, based on its experience and interaction with the medical 
device community, that all reporting CFR sections are expected to take 
1 hour to complete, with the exception of Sec.  803.19. Section 803.19 
is expected to take approximately 3 hours to complete, but is only 
required for reporting the summarized data quarterly to FDA. By 
summarizing events, the total time used to report for this section is 
reduced because the respondents do not submit a full report for each 
event they report in a quarterly summary report.
    The Agency believes that the majority of manufacturers, user 
facilities, and importers have already established written procedures 
to document complaints and information to meet the MDR requirements as 
part of their internal quality control system. There are an estimated 
30,000 medical device distributors. Although they do not submit MDR 
reports, they must maintain records of complaints under Sec.  
803.18(d).
    The Agency has estimated that on average 220 user facilities, 
importers, and manufacturers would annually be required to establish 
new procedures, or revise existing procedures, in order to comply with 
this provision.
    Therefore, FDA estimates the one-time burden to respondents for 
establishing or revising procedures under Sec.  803.17 to be 2,200 
hours (220 respondents x 10 hours). For those entities, a one-time 
burden of 10 hours is estimated for establishing written MDR 
procedures. The remaining manufacturers, user facilities, and 
importers, not required to revise their written procedures to comply 
with this provision, are excluded from the burden because the 
recordkeeping activities needed to comply with this provision are 
considered ``usual and customary'' under 5 CFR 1320.3(b)(2).
    Under Sec.  803.18, 30,000 respondents represent distributors, 
importers, and other respondents to this information collection. FDA 
estimates that it should take them approximately 1.5 hours to complete 
the recordkeeping requirement for this section. Total hours for this 
section equal 45,000 hours.

Reporting Requirements

    Part 803 requires user facilities to report incidents where a 
medical device caused or contributed a death or serious injury to the 
device manufacturer and to FDA in the case of a death. Manufacturers of 
medical devices are required to report to FDA when they become aware of 
information indicating that one of their devices may have caused or 
contributed to death or serious injury or has malfunctioned in such a 
way that, should the malfunction recur, it would be likely to cause or 
contribute to a death or serious injury. Device importers report deaths 
and serious injuries to the manufacturers and FDA. Importers report 
malfunctions only to the manufacturers (see third-party disclosure 
burden table), unless the manufacturers are unknown, then the reports 
are sent to FDA.
    FDA estimates, based on its experience and interaction with the 
medical device community, that all reporting CFR sections are expected 
to take 1 hour to complete with the exception of Sec.  803.19. Section 
803.19 is expected to take approximately 3 hours to complete, but is 
only required to report the summarized data quarterly to FDA. By 
summarizing events, the total time used to report for this section is 
reduced because the respondents do not submit a full report for each 
event they report in a quarterly summary report.

Recordkeeping Requirements

    The Agency believes that the majority of manufacturers, user 
facilities, and importers have already established written procedures 
to document complaints and information to meet the MDR requirements as 
part of their internal quality control system. There are an estimated 
30,000 medical device distributors. Although they do not submit MDR 
reports, they must maintain records of complaints under Sec.  
803.18(d). We estimate that it will take

[[Page 26280]]

each respondent 1.5 hours annually to maintain the records.
    The Agency has estimated that on average, 220 user facilities, 
importers, and manufacturers would annually be required, under Sec.  
803.17, to establish new procedures, or revise existing procedures, in 
order to comply with this provision. We estimate that it will take each 
respondent 10 hours annually to establish new procedures, or revise 
existing procedures.

Third-Party Disclosure Burden

    Under Sec. Sec.  803.40 and 803.42, device importers report deaths 
and serious injuries to the manufacturers and FDA. Importers report 
malfunctions only to the manufacturers, unless they are unknown, then 
the reports are sent to FDA. We estimate that it will take respondents 
1 hour annually to report the information.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Number of                        Average
                       CFR section                         FDA form No.      Number of     responses per   Total annual     burden per      Total hours
                                                                            respondents     respondent       responses       response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exemptions--803.19......................................  ..............              57               4             228               3             684
User Facility Reporting--803.30 and 803.32..............  ..............             544               9           4,896               1           4,896
User Facility Annual Reporting--803.33..................            3419             195               1             195               1             195
Importer Reporting, Death and Serious Injury--803.40 and  ..............               1               1               1               1               1
 803.42.................................................
Manufacturer Reporting--803.50, through 803.53..........  ..............           1,239             243         301,077               1         301,077
Supplemental Reports--803.56............................  ..............             124             302          37,448               1          37,448
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............  ..............         344,301
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of
         21 CFR section             Number of      records per    Total annual   Average  burden    Total hours
                                  recordkeepers   recordkeeper       records       per  record
----------------------------------------------------------------------------------------------------------------
MDR Procedures--803.17.........             220               1             220             10             2,200
MDR Files--803.18..............          30,000               1          30,000              1.5          45,000
                                --------------------------------------------------------------------------------
    Total......................  ..............  ..............  ..............  ...............          47,200
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                           21 CFR section                               Number of     disclosures per    Total annual   Average  burden    Total hours
                                                                       respondents       respondent      disclosures    per  disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Importer Reporting, Malfunctions--803.40 and 803.42................               1               25               25                1               25
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: May 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-10995 Filed 5-6-15; 8:45 am]
 BILLING CODE 4164-01-P

26278 Federal Register / Vol. 80, No. 88 / Thursday, May 7, 2015 / Notices

of the testing phase and approval phase Management (see ADDRESSES) either information, and to allow 60 days for
as specified in 35 U.S.C. 156(g)(1)(B). electronic or written comments and ask public comment in response to the
FDA has approved for marketing the for a redetermination by July 6, 2015. notice. This notice solicits comments on
human drug product OSENI (alogliptin Furthermore, any interested person may medical device reporting (MDR);
benzoate and pioglitazone petition FDA for a determination manufacturer, importer, user facility,
hydrochloride). OSENI is indicated as regarding whether the applicant for and distributor reporting.
an adjunct to diet and exercise to extension acted with due diligence DATES: Submit either electronic or
improve glycemic control in adults with during the regulatory review period by written comments on the collection of
type 2 diabetes mellitus. Subsequent to November 3, 2015. To meet its burden, information by July 6, 2015.
this approval, the USPTO received a the petition must contain sufficient facts ADDRESSES: Submit electronic
patent term restoration application for to merit an FDA investigation. (See H. comments on the collection of
OSENI (U.S. Patent No. 6,329,404) from Rept. 857, part 1, 98th Cong., 2d sess., information to http://
Takeda Pharmaceutical Company pp. 41–42, 1984.) Petitions should be in www.regulations.gov. Submit written
Limited, and the USPTO requested the format specified in 21 CFR 10.30. comments on the collection of
FDA’s assistance in determining this Interested persons may submit to the information to the Division of Dockets
patent’s eligibility for patent term Division of Dockets Management (see Management (HFA–305), Food and Drug
restoration. In a letter dated May 2, ADDRESSES) electronic or written Administration, 5630 Fishers Lane, Rm.
2014, FDA advised the USPTO that this comments and written or electronic 1061, Rockville, MD 20852. All
human drug product had undergone a petitions. It is only necessary to send comments should be identified with the
regulatory review period and that the one set of comments. Identify comments docket number found in brackets in the
approval of OSENI represented the first with the docket number found in heading of this document.
permitted commercial marketing or use brackets in the heading of this FOR FURTHER INFORMATION CONTACT: FDA
of the product. Thereafter, the USPTO document. If you submit a written PRA Staff, Office of Operations, Food
requested that FDA determine the petition, two copies are required. A and Drug Administration, 8455
product’s regulatory review period. petition submitted electronically must Colesville Rd., COLE–14526, Silver
FDA has determined that the be submitted to http:// Spring, MD 20993–0002, PRAStaff@
applicable regulatory review period for www.regulations.gov, Docket No. FDA– fda.hhs.gov.
OSENI is 2,482 days. Of this time, 895 2013–S–0610.
days occurred during the testing phase SUPPLEMENTARY INFORMATION: Under the
Comments and petitions that have not PRA (44 U.S.C. 3501–3520), Federal
of the regulatory review period, while been made publicly available on
1,587 days occurred during the approval Agencies must obtain approval from the
http://www.regulations.gov may be Office of Management and Budget
phase. These periods of time were viewed in the Division of Dockets
derived from the following dates: (OMB) for each collection of
Management between 9 a.m. and 4 p.m., information they conduct or sponsor.
1. The date an exemption under
Monday through Friday. ‘‘Collection of information’’ is defined
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21 Dated: May 1, 2015. in 44 U.S.C. 3502(3) and 5 CFR
U.S.C. 355(i)) became effective: April Leslie Kux, 1320.3(c) and includes Agency requests
12, 2006. The applicant claims April 13, Associate Commissioner for Policy. or requirements that members of the
2006, as the date the investigational new [FR Doc. 2015–11002 Filed 5–6–15; 8:45 am] public submit reports, keep records, or
drug application (IND) became effective. BILLING CODE 4164–01–P
provide information to a third party.
However, FDA records indicate that the Section 3506(c)(2)(A) of the PRA (44
IND effective date was April 12, 2006, U.S.C. 3506(c)(2)(A)) requires Federal
which was 30 days after FDA receipt of DEPARTMENT OF HEALTH AND Agencies to provide a 60-day notice in
the IND. HUMAN SERVICES the Federal Register concerning each
2. The date the application was proposed collection of information,
initially submitted with respect to the Food and Drug Administration including each proposed extension of an
human drug product under section existing collection of information,
[Docket No. FDA–2012–N–0110]
505(b) of the FD&C Act: September 22, before submitting the collection to OMB
2008. FDA has verified the applicant’s Agency Information Collection for approval. To comply with this
claim that the new drug application Activities; Proposed Collection; requirement, FDA is publishing notice
(NDA) for OSENI (NDA 22–426) was Comment Request; Medical Device of the proposed collection of
submitted on September 22, 2008. Reporting: Manufacturer, Importer, information set forth in this document.
3. The date the application was With respect to the following
User Facility, and Distributor Reporting
approved: January 25, 2013. FDA has collection of information, FDA invites
verified the applicant’s claim that NDA AGENCY: Food and Drug Administration, comments on these topics: (1) Whether
22–426 was approved on January 25, HHS. the proposed collection of information
2013. ACTION: Notice. is necessary for the proper performance
This determination of the regulatory of FDA’s functions, including whether
review period establishes the maximum SUMMARY: The Food and Drug the information will have practical
potential length of a patent extension. Administration (FDA) is announcing an utility; (2) the accuracy of FDA’s
However, the USPTO applies several opportunity for public comment on the estimate of the burden of the proposed
mstockstill on DSK4VPTVN1PROD with NOTICES

statutory limitations in its calculations proposed collection of certain collection of information, including the
of the actual period for patent extension. information by the Agency. Under the validity of the methodology and
In its application for patent extension, Paperwork Reduction Act of 1995 (the assumptions used; (3) ways to enhance
this applicant seeks 1,826 days of patent PRA), Federal Agencies are required to the quality, utility, and clarity of the
term extension. publish notice in the Federal Register information to be collected; and (4)
Anyone with knowledge that any of concerning each proposed collection of ways to minimize the burden of the
the dates as published are incorrect may information, including each proposed collection of information on
submit to the Division of Dockets extension of an existing collection of respondents, including through the use

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26280 Federal Register / Vol. 80, No. 88 / Thursday, May 7, 2015 / Notices

each respondent 1.5 hours annually to provision. We estimate that it will take Importers report malfunctions only to
maintain the records. each respondent 10 hours annually to the manufacturers, unless they are
The Agency has estimated that on establish new procedures, or revise unknown, then the reports are sent to
average, 220 user facilities, importers, existing procedures. FDA. We estimate that it will take
and manufacturers would annually be Third-Party Disclosure Burden respondents 1 hour annually to report
required, under § 803.17, to establish the information.
Under §§ 803.40 and 803.42, device
new procedures, or revise existing importers report deaths and serious FDA estimates the burden of this
procedures, in order to comply with this injuries to the manufacturers and FDA. collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
CFR section FDA form No. responses per burden per Total hours
respondents responses
respondent response

Exemptions—803.19 ................................ ........................ 57 4 228 3 684
User Facility Reporting—803.30 and
803.32 ................................................... ........................ 544 9 4,896 1 4,896
User Facility Annual Reporting—803.33 3419 195 1 195 1 195
Importer Reporting, Death and Serious
Injury—803.40 and 803.42 ................... ........................ 1 1 1 1 1
Manufacturer Reporting—803.50,
through 803.53 ..................................... ........................ 1,239 243 301,077 1 301,077
Supplemental Reports—803.56 ............... ........................ 124 302 37,448 1 37,448

Total .................................................. ........................ ........................ ........................ ........................ ........................ 344,301
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
21 CFR section records per burden per Total hours
recordkeepers records
recordkeeper record

MDR Procedures—803.17 ................................................. 220 1 220 10 2,200
MDR Files—803.18 ............................................................ 30,000 1 30,000 1.5 45,000

Total ............................................................................ ........................ ........................ ........................ .......................... 47,200
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual
21 CFR section burden per Total hours
respondents per disclosures disclosure
respondent

Importer Reporting, Malfunctions—803.40 and 803.42 ....... 1 25 25 1 25
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: May 4, 2015. DEPARTMENT OF HEALTH AND Administration (FDA). The meeting will
Leslie Kux, HUMAN SERVICES be open to the public.
Associate Commissioner for Policy. Name of Committees: Bone,
Food and Drug Administration Reproductive, and Urologic Drugs
[FR Doc. 2015–10995 Filed 5–6–15; 8:45 am]
Advisory Committee, and the Drug
BILLING CODE 4164–01–P
[Docket No. FDA–2015–N–0001] Safety and Risk Management Advisory
Committee.
Joint Meeting of the Bone, General Function of the Committees:
Reproductive, and Urologic Drugs To provide advice and
Advisory Committee, and the Drug recommendations to the Agency on
Safety and Risk Management Advisory FDA’s regulatory issues.
Committee; Notice of Meeting Date and Time: The meeting will be
mstockstill on DSK4VPTVN1PROD with NOTICES

AGENCY: Food and Drug Administration, held on June 4, 2015, from 8 a.m. to 5
HHS. p.m.
ACTION: Notice. Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
This notice announces a forthcoming Conference Center, the Great Room (Rm.
meeting of two public advisory 1503), Silver Spring, MD 20993–0002.
committees of the Food and Drug Answers to commonly asked questions

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Document Created: 2015-12-16 07:50:06
Document Modified: 2015-12-16 07:50:06

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by July 6, 2015.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		80 FR 26278

80 FR 26278 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Reporting: Manufacturer, Importer, User Facility, and Distributor Reporting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 88 (May 7, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration