[Federal Register Volume 76, Number 186 (Monday, September 26, 2011)]
[Notices]
[Pages 59400-59401]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-24582]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0322]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Requests for 
Inspection Under the Inspection by Accredited Persons 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 October 
26, 2011.

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 e-mailed 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: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
[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.

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 (Pub. L. 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 http://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 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

[[Page 59401]]

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 100 
of these manufacturers may use an AP in any given year.
    In the Federal Register of May 23, 2011 (76 FR 29764), 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
        21 U.S.C. section            Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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374(g)..........................             100               1             100              15          1,500
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: September 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-24582 Filed 9-23-11; 8:45 am]
BILLING CODE 4160-01-P