Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Notification of the Intent To Use An Accredited Person Under the Accredited Persons Inspection Program, 15846 [2018-07619]
Download as PDF
<![CDATA[
15846
Federal Register / Vol. 83, No. 71 / Thursday, April 12, 2018 / Notices
estimate since the previous OMB
approval.
in brackets in the heading of this
document.
Dated: April 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
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, PRAStaff@
fda.hhs.gov.
[FR Doc. 2018–07543 Filed 4–11–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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:
Food and Drug Administration
[Docket No. FDA–2017–N–6162]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Notification of the
Intent To Use An Accredited Person
Under the Accredited Persons
Inspection Program
AGENCY:
Food and Drug Administration,
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.
DATES: Fax written comments on the
collection of information by May 14,
2018.
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 0910–0569. Also
include the FDA docket number found
SUMMARY:
Notification of the Intent To Use An
Accredited Person Under the
Accredited Persons Inspection Program
OMB Control Number 0910–0569—
Extension
Section 201 of the Medical Device
User Fee and Modernization Act of 2002
(Pub. L. 107–250) amended section 704
of the Federal Food, Drug, and Cosmetic
Act by adding paragraph (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 superseded the
Agency’s previous guidance regarding
requests for third-party inspection and
may be found on the internet at https://
www.fda.gov/downloads/Medical
Devices/DeviceRegulationandGuidance/
GuidanceDocuments/UCM085252.pdf.
The guidance is intended to assist
device establishments in determining
whether they are eligible to participate
in the Accredited Persons (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 10 of these
manufacturers may use an AP in any
given year.
In the Federal Register of November
21, 2017 (82 FR 55379), 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 AP—374(g) .......................
10
1
10
15
150
sradovich on DSK3GMQ082PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Since the last approval of this
information collection, we have updated
the estimated number of respondents
from 20 to 10 respondents per year,
based on the reduced number of
VerDate Sep<11>2014
19:20 Apr 11, 2018
Jkt 244001
notifications received in recent years.
This adjustment has resulted in a 150hour reduction to the total hour burden
estimate.
PO 00000
Dated: April 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–07619 Filed 4–11–18; 8:45 am]
BILLING CODE 4164–01–P
Frm 00063
Fmt 4703
Sfmt 9990
E:\FR\FM\12APN1.SGM
12APN1
]]>Agencies
[Federal Register Volume 83, Number 71 (Thursday, April 12, 2018)]
[Notices]
[Page 15846]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07619]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-6162]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Notification of the
Intent To Use An Accredited Person Under the Accredited Persons
Inspection Program
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 May 14,
2018.
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 0910-0569.
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, 10A-12M, 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.
Notification of the Intent To Use An Accredited Person Under the
Accredited Persons Inspection Program
OMB Control Number 0910-0569--Extension
Section 201 of the Medical Device User Fee and Modernization Act of
2002 (Pub. L. 107-250) amended section 704 of the Federal Food, Drug,
and Cosmetic Act by adding paragraph (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 superseded the Agency's
previous guidance regarding requests for third-party inspection and may
be found on the internet at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM085252.pdf. The guidance is intended to assist device establishments
in determining whether they are eligible to participate in the
Accredited Persons (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 10
of these manufacturers may use an AP in any given year.
In the Federal Register of November 21, 2017 (82 FR 55379), 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 U.S.C. section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification regarding use of an AP--374(g)........................ 10 1 10 15 150
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Since the last approval of this information collection, we have
updated the estimated number of respondents from 20 to 10 respondents
per year, based on the reduced number of notifications received in
recent years. This adjustment has resulted in a 150-hour reduction to
the total hour burden estimate.
Dated: April 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07619 Filed 4-11-18; 8:45 am]
BILLING CODE 4164-01-P
