83 FR 15846 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 71 (April 12, 2018)

Page Range		15846-15846
FR Document		2018-07619

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 83 Issue 71 (Thursday, April 12, 2018)

[Federal Register Volume 83, Number 71 (Thursday, April 12, 2018)]
[Notices]
[Page 15846]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-07619]


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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

15846 Federal Register / Vol. 83, No. 71 / Thursday, April 12, 2018 / Notices

estimate since the previous OMB in brackets in the heading of this requests for third-party inspection and
approval. document. may be found on the internet at https://
Dated: April 6, 2018. FOR FURTHER INFORMATION CONTACT:
www.fda.gov/downloads/Medical
Leslie Kux, Amber Sanford, Office of Operations, Devices/DeviceRegulationandGuidance/
Associate Commissioner for Policy. Food and Drug Administration, Three GuidanceDocuments/UCM085252.pdf.
White Flint North, 10A–12M, 11601 The guidance is intended to assist
[FR Doc. 2018–07543 Filed 4–11–18; 8:45 am]
Landsdown St., North Bethesda, MD device establishments in determining
BILLING CODE 4164–01–P
20852, 301–796–8867, PRAStaff@ whether they are eligible to participate
fda.hhs.gov. in the Accredited Persons (AP) Program
DEPARTMENT OF HEALTH AND and, if so, how to submit notification of
SUPPLEMENTARY INFORMATION: In their intent to use the program. The AP
HUMAN SERVICES compliance with 44 U.S.C. 3507, FDA Program applies to manufacturers who
has submitted the following proposed currently market their medical devices
Food and Drug Administration
collection of information to OMB for in the United States and who also
[Docket No. FDA–2017–N–6162] review and clearance. market or plan to market their devices
Notification of the Intent To Use An in foreign countries. Such
Agency Information Collection
Accredited Person Under the manufacturers may need current
Activities; Submission for Office of
Accredited Persons Inspection Program inspections of their establishments to
Management and Budget Review;
operate in global commerce.
Comment Request; Notification of the OMB Control Number 0910–0569—
Intent To Use An Accredited Person There are approximately 8,000 foreign
Extension and 10,000 domestic manufacturers of
Under the Accredited Persons
Inspection Program Section 201 of the Medical Device medical devices. Approximately 5,000
User Fee and Modernization Act of 2002 of these firms only manufacture class I
AGENCY: Food and Drug Administration, (Pub. L. 107–250) amended section 704 devices and are, therefore, not eligible
HHS. of the Federal Food, Drug, and Cosmetic for the AP Program. In addition, 40
ACTION: Notice. Act by adding paragraph (g) (21 U.S.C. percent of the domestic firms do not
374(g)). This amendment authorized export devices and therefore are not
SUMMARY: The Food and Drug FDA to establish a voluntary third-party eligible to participate in the AP
Administration (FDA) is announcing inspection program applicable to Program. Further, 10 to 15 percent of the
that a proposed collection of manufacturers of class II or class III firms are not eligible due to the results
information has been submitted to the medical devices who meet certain of their previous inspection. FDA
Office of Management and Budget eligibility criteria. In 2007, the program estimates there are 4,000 domestic
(OMB) for review and clearance under was modified by the Food and Drug manufacturers and 4,000 foreign
the Paperwork Reduction Act of 1995. Administration Amendments Act of manufacturers that are eligible for
DATES: Fax written comments on the 2007 by revising eligibility criteria and inclusion under the AP Program. Based
collection of information by May 14, by no longer requiring prior approval by on communications with industry, FDA
2018. FDA. To reflect the revisions, FDA estimates that on an annual basis
ADDRESSES: To ensure that comments on modified the title of the collection of approximately 10 of these
the information collection are received, information and on March 2, 2009, manufacturers may use an AP in any
OMB recommends that written issued a guidance entitled given year.
comments be faxed to the Office of ‘‘Manufacturer’s Notification of the In the Federal Register of November
Information and Regulatory Affairs, Intent to Use an Accredited Person 21, 2017 (82 FR 55379), FDA published
OMB, Attn: FDA Desk Officer, Fax: 202– Under the Accredited Persons a 60-day notice requesting public
395–7285, or emailed to oira_ Inspection Program Authorized by comment on the proposed collection of
submission@omb.eop.gov. All Section 228 of the Food and Drug information. No comments were
comments should be identified with the Administration Amendments Act of received.
OMB control number 0910–0569. Also 2007.’’ This guidance superseded the FDA estimates the burden of this
include the FDA docket number found Agency’s previous guidance regarding collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity/21 U.S.C. section responses per burden per Total hours
respondents responses
respondent 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 notifications received in recent years. Dated: April 6, 2018.
information collection, we have updated This adjustment has resulted in a 150- Leslie Kux,
sradovich on DSK3GMQ082PROD with NOTICES

the estimated number of respondents hour reduction to the total hour burden Associate Commissioner for Policy.
from 20 to 10 respondents per year, estimate. [FR Doc. 2018–07619 Filed 4–11–18; 8:45 am]
based on the reduced number of BILLING CODE 4164–01–P

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Document Created: 2018-11-02 08:15:31
Document Modified: 2018-11-02 08:15:31

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		Fax written comments on the collection of information by May 14, 2018.
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]
FR Citation		83 FR 15846

83 FR 15846 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 71 (April 12, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration