Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Humanitarian Use Devices, 71110-71111 [2014-28183]
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Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Notices
Notification of the Intent To Use an
Accredited Person Under the
Accredited Persons Inspection Program
(Formerly Requests for Inspection
Under the Inspection by Accredited
Persons Program)—(OMB Control
Number 0910–0569)—Extension
Section 201 of the Medical Device
User Fee and Modernization Act of 2002
(Public Law 107–250) amended section
704 of the Federal Food, Drug, and
Cosmetic Act by adding subsection (g)
(21 U.S.C. 374(g)). This amendment
authorized FDA to establish a voluntary
third-party inspection program
applicable to manufacturers of class II or
class III medical devices who meet
certain eligibility criteria. In 2007, the
program was modified by the Food and
Drug Administration Amendments Act
of 2007 by revising eligibility criteria
and by no longer requiring prior
approval by FDA. To reflect the
revisions, FDA modified the title of the
collection of information and on March
2, 2009, issued a guidance entitled
‘‘Manufacturer’s Notification of the
Intent to Use an Accredited Person
Under the Accredited Persons
Inspection Program Authorized by
Section 228 of the Food and Drug
Administration Amendments Act of
2007.’’ This guidance supersedes the
Agency’s previous guidance regarding
requests for third-party inspection and
may be found on the Internet at
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/ucm085187.htm.
This guidance is intended to assist
device establishments in determining
whether they are eligible to participate
in the Accredited Person (AP) Program
and, if so, how to submit notification of
their intent to use the program. The AP
Program applies to manufacturers who
currently market their medical devices
in the United States and who also
market or plan to market their devices
in foreign countries. Such
manufacturers may need current
inspections of their establishments to
operate in global commerce.
There are approximately 8,000 foreign
and 10,000 domestic manufacturers of
medical devices. Approximately 5,000
of these firms only manufacture class I
devices and are, therefore, not eligible
for the AP Program. In addition, 40
percent of the domestic firms do not
export devices and therefore are not
eligible to participate in the AP
Program. Further, 10 to 15 percent of the
firms are not eligible due to the results
of their previous inspection. FDA
estimates there are 4,000 domestic
manufacturers and 4,000 foreign
manufacturers that are eligible for
inclusion under the AP Program. Based
on communications with industry, FDA
estimates that on an annual basis
approximately 20 of these
manufacturers may use an AP in any
given year.
In the Federal Register of May 28,
2014 (79 FR 30619), 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
Activity/21 U.S.C. section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Notification regarding use of an accredited person—374(g)
20
1
20
15
300
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 24, 2014.
Leslie Kux,
Associate Commissioner for Policy.
DATES:
[FR Doc. 2014–28184 Filed 11–28–14; 8:45 am]
ADDRESSES:
Fax written comments on the
collection of information by December
31, 2014.
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 oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0332. Also
include the FDA docket number found
in brackets in the heading of this
document.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0619]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices;
Humanitarian Use Devices
AGENCY:
asabaliauskas on DSK5VPTVN1PROD with NOTICES
HHS.
ACTION:
Notice.
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.
SUMMARY:
VerDate Sep<11>2014
14:08 Nov 28, 2014
Jkt 235001
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration,
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
Medical Devices; Humanitarian Use
Devices—21 CFR 814 (OMB Control
Number 0910–0332)—Extension
This collection of information
implements the Humanitarian Use
Devices (HUD) provision of section
520(m) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
360j(m)) and subpart H, part 814 (21
CFR part 814). Under section 520(m) of
the FD&C Act, FDA is authorized to
exempt an HUD from the effectiveness
requirements of sections 514 and 515 of
the FD&C Act (21 U.S.C. 360d and 360e)
provided that the device: (1) Is used to
treat or diagnose a disease or condition
that affects fewer than 4,000 individuals
in the United States; (2) would not be
available to a person with such a disease
or condition unless an exemption is
granted because there is no comparable
device other than another HUD
approved under this exemption that is
available to treat or diagnose the disease
or condition; and (3) will not expose
patients to an unreasonable or
significant risk of illness or injury with
the probable benefit to health from
using the device outweighing the risk of
injury or illness from its use. This takes
E:\FR\FM\01DEN1.SGM
01DEN1
71111
Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Notices
into account the probable risks and
benefits of currently available devices or
alternative forms of treatment.
The information collected will assist
FDA in making determinations on the
following: (1) Whether to grant HUD
designation of a medical device; (2)
exempt an HUD from the effectiveness
requirements under sections 514 and
515 of the FD&C Act, provided that the
device meets requirements set forth
under section 520(m) of the FD&C Act;
and (3) whether to grant marketing
approval(s) for the HUD. Failure to
collect this information would prevent
FDA from making a determination on
the factors listed previously in this
document. Further, the collected
information would also enable FDA to
determine whether the holder of an
HUD is in compliance with the HUD
provisions under section 520(m) of the
FD&C Act.
The number of respondents in tables
1, 2, and 3 of this document are an
average based on data for the previous
3 years, i.e., fiscal years 2011 through
2013. The number of annual reports
submitted under § 814.126(b)(1) in table
1 reflects 32 respondents with approved
HUD applications. Likewise, under
§ 814.126(b)(2) in table 2, the number of
recordkeepers is 247.
In the Federal Register of June 10,
2014 (79 FR 33197), 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
respondents
Activity/21 CFR section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Request for HUD designation—814.102 .............................
Humanitarian device exemption (HDE) application—
814.104 .............................................................................
HDE amendments and resubmitted HDEs—814.106 .........
HDE supplements—814.108 ...............................................
Notification of withdrawal of an HDE—814.116(e)(3) .........
Notification of withdrawal of institutional review board approval—814.124(b) ...........................................................
Periodic reports—814.126(b)(1) ..........................................
16
1
16
40
640
7
14
112
8
1
5
1
1
7
70
112
8
320
50
80
1
2,240
3,500
8,960
8
3
32
1
1
3
32
2
120
6
3,840
Total ..............................................................................
........................
........................
........................
........................
19,194
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity/21 CFR section
Number of
recordkeepers
Number of
records per
recordkeeping
Total annual
records
Average
burden per
recordkeeping
Total hours
HDE Records—814.126(b)(2) ..............................................
247
1
247
2
494
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 24, 2014.
Leslie Kux,
Associate Commissioner for Policy.
February 5, 2015. The workshop was
announced in the Federal Register of
October 22, 2014. This amendment
reflects the addition of a Comments
section and updates an incorrect Web
site in the Meeting Materials section.
FOR FURTHER INFORMATION CONTACT:
Carlos Bell, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6358, Silver Spring,
MD 20993, 301–796–3714, FAX: 301–
847–3529, email: SentinelInitiative@
fda.hhs.gov.
[FR Doc. 2014–28183 Filed 11–28–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1952]
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Seventh Annual Sentinel Initiative;
Public Workshop; Amendment of
Notice
AGENCY:
SUPPLEMENTARY INFORMATION:
Food and Drug Administration,
HHS.
Notice of public workshop;
amendment of notice.
ACTION:
The Food and Drug
Administration (FDA) is announcing an
amendment to the notice of a public
workshop entitled ‘‘Seventh Annual
Sentinel Initiative’’ to be held on
SUMMARY:
VerDate Sep<11>2014
14:08 Nov 28, 2014
Jkt 235001
In the Federal Register of October 22,
2014 (79 FR 63130), FDA announced
that a public workshop entitled
‘‘Seventh Annual Sentinel Initiative’’
will be held on February 5, 2015.
1. On page 63131, in the second
column, in the sixth line of the Meeting
Materials section, the Web site ‘‘https://
www.brookings.edu//health/events’’ is
changed to read ‘‘https://
www.brookings.edu/events’’.
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
2. On page 63131, in the second
column, a Comments section is added
between the Meeting Materials section
and the Transcripts section to read:
‘‘Comments: FDA is holding this
public workshop to obtain information
about a variety of topics on active
medical product surveillance. The
deadline for submitting comments
regarding this public workshop is March
10, 2015.
Regardless of attendance in person or
through the Web cast, interested persons
may submit either electronic comments
to https://www.regulations.gov or written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
E:\FR\FM\01DEN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 230 (Monday, December 1, 2014)]
[Notices]
[Pages 71110-71111]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28183]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0619]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Devices;
Humanitarian Use Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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
December 31, 2014.
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 oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0332.
Also include the FDA 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, PRAStaff@fda.hhs.gov.
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.
Medical Devices; Humanitarian Use Devices--21 CFR 814 (OMB Control
Number 0910-0332)--Extension
This collection of information implements the Humanitarian Use
Devices (HUD) provision of section 520(m) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(m)) and subpart H, part
814 (21 CFR part 814). Under section 520(m) of the FD&C Act, FDA is
authorized to exempt an HUD from the effectiveness requirements of
sections 514 and 515 of the FD&C Act (21 U.S.C. 360d and 360e) provided
that the device: (1) Is used to treat or diagnose a disease or
condition that affects fewer than 4,000 individuals in the United
States; (2) would not be available to a person with such a disease or
condition unless an exemption is granted because there is no comparable
device other than another HUD approved under this exemption that is
available to treat or diagnose the disease or condition; and (3) will
not expose patients to an unreasonable or significant risk of illness
or injury with the probable benefit to health from using the device
outweighing the risk of injury or illness from its use. This takes
[[Page 71111]]
into account the probable risks and benefits of currently available
devices or alternative forms of treatment.
The information collected will assist FDA in making determinations
on the following: (1) Whether to grant HUD designation of a medical
device; (2) exempt an HUD from the effectiveness requirements under
sections 514 and 515 of the FD&C Act, provided that the device meets
requirements set forth under section 520(m) of the FD&C Act; and (3)
whether to grant marketing approval(s) for the HUD. Failure to collect
this information would prevent FDA from making a determination on the
factors listed previously in this document. Further, the collected
information would also enable FDA to determine whether the holder of an
HUD is in compliance with the HUD provisions under section 520(m) of
the FD&C Act.
The number of respondents in tables 1, 2, and 3 of this document
are an average based on data for the previous 3 years, i.e., fiscal
years 2011 through 2013. The number of annual reports submitted under
Sec. 814.126(b)(1) in table 1 reflects 32 respondents with approved
HUD applications. Likewise, under Sec. 814.126(b)(2) in table 2, the
number of recordkeepers is 247.
In the Federal Register of June 10, 2014 (79 FR 33197), 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/21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Request for HUD designation-- 16 1 16 40 640
814.102........................
Humanitarian device exemption 7 1 7 320 2,240
(HDE) application--814.104.....
HDE amendments and resubmitted 14 5 70 50 3,500
HDEs--814.106..................
HDE supplements--814.108........ 112 1 112 80 8,960
Notification of withdrawal of an 8 1 8 1 8
HDE--814.116(e)(3).............
Notification of withdrawal of 3 1 3 2 6
institutional review board
approval--814.124(b)...........
Periodic reports--814.126(b)(1). 32 1 32 120 3,840
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 19,194
----------------------------------------------------------------------------------------------------------------
\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 burden
Activity/21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeping records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
HDE Records--814.126(b)(2)......................................... 247 1 247 2 494
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 24, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28183 Filed 11-28-14; 8:45 am]
BILLING CODE 4164-01-P
