[Federal Register Volume 73, Number 169 (Friday, August 29, 2008)]
[Notices]
[Pages 50976-50977]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-20113]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0313]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Request 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 
September 29, 2008.

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: 202-395-6974, 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: Denver Presley, Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

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.

[[Page 50977]]

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. On September 15, 
2005, FDA issued a guidance entitled, ``Requests for Inspection by an 
Accredited Person Under the Inspection by Accredited Persons Program 
Authorized by Section 201 of the Medical Device User Fee and 
Modernization Act 2002,'' http://www.fda.gov/cdrh/comp/guidance/1532.html. This guidance describes the eligibility criteria and the 
process for establishments to follow when requesting FDA's approval to 
have an accredited person (AP), conduct a quality system regulation 
inspection of their establishment under the new inspection by the 
Accredited Persons Program (AP program), instead of FDA. 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.
    In order to meet the eligibility criteria for requesting FDA 
approval to have an AP conduct a quality system regulations inspection 
of their establishment instead of FDA, applicants must submit a request 
with certain information. The following information must be submitted 
which shows that the applicant:
    (1) ``Manufactures, prepares, propagates, compounds, or processes'' 
class II or class III medical devices,
    (2) Markets at least one of the devices in the United States,
    (3) Markets or intends to market at least one of the devices in one 
or more foreign countries when one or both of the following two 
conditions are met:
    (a) One of the foreign countries certifies, accredits, or otherwise 
recognizes the selected AP applicant as a person authorized to conduct 
inspections of device establishments, or
    (b) A statement that the law of a country where the applicant 
markets or intends to market the device recognizes an inspection 
conducted by the FDA or an AP.
    (4) Provided the most recent inspection performed by FDA, or by an 
AP under the AP program and inspection was classified by FDA as either 
``No Action Indicated'' or ``Voluntary Action Indicated, ``and,
    (5) Provided notice advising FDA of their intent to use an AP, and 
identifying the AP applicant selected.
    In the Federal Register of June 3, 2008 (73 FR 31692), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden for this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                  Annual Frequency per       Total Annual           Hours per
            21 U.S.C. Section               No. of Respondents          Response              Responses             Response            Total 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 submit a request to use an AP in any given 
year.

    Dated: August 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-20113 Filed 8-28-08; 8:45 am]
BILLING CODE 4160-01-S