[Federal Register Volume 76, Number 99 (Monday, May 23, 2011)]
[Notices]
[Pages 29764-29765]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-12552]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; 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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the eligibility criteria and 
the process to be followed by establishments when notifying FDA of a 
manufacturer's intent

[[Page 29765]]

to have an accredited third party conduct a quality systems regulation 
inspection of their establishment instead of FDA, under the inspections 
by the Accredited Persons (AP) Program.

DATES: Submit either electronic or written comments on the collection 
of information by July 22, 2011.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Requests for Inspection Under the Inspection by Accredited Persons 
Program--21 U.S.C. 374(g) (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 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 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of                      Average  burden
                         21 U.S.C. Section                              Number of      responses per     Total annual    per  response     Total hours
                                                                       respondents       respondent      respondents       (in hours)
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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.

    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.

    Dated: May 12, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-12552 Filed 5-20-11; 8:45 am]
BILLING CODE 4160-01-P