[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]


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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.

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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 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\
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                                                                                         Number of
                     Activity/21 U.S.C. section                         Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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Notification regarding use of an AP--374(g)........................              10                1               10               15              150
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\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