[Federal Register Volume 71, Number 213 (Friday, November 3, 2006)]
[Notices]
[Page 64718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-18603]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0326]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Inspection by 
Accredited Persons Program Under the Medical Device User Fee and 
Modernization Act of 2002

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 
December 4, 2006.

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.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

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.

Medical Devices: Inspection by Accredited Persons Program Under the 
Medical Device User Fee and Modernization Act of 2002 (OMB Control 
Number 0910-0510)--Extension

    The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) 
(Public Law 107-250) was signed into law on October 26, 2002. Section 
201 of MDUFMA adds a new paragraph ``g'' to section 704 of the Federal, 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 374), directing FDA 
to accredit third parties (accredited persons or APs) to conduct 
inspections of eligible manufacturers of class II or class III devices. 
This is a voluntary program.
    FDA has a guidance document that provides information for those 
interested in participating in this program. The guidance is entitled 
``Implementation of the Inspection by Accredited Persons Program Under 
the Medical Device User Fee and Modernization Act of 2002; 
Accreditation Criteria.''
    In the Federal Register of August 24, 2006 (71 FR 50067), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    Respondents are expected to be businesses or other for profit 
organizations.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
                Information Collection                     Respondents         per Response          Responses           Response         Total Hours
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Request for Accreditation                                               3                     1                  3                 80                240
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Total Hours                                                                                                                                          240
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA based these estimates on conversations with industry, trade 
association representatives, and internal FDA estimates. Once an 
organization is accredited, it will not be required to reapply.

    Dated: October 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-18603 Filed 11-2-06; 8:45 am]
BILLING CODE 4160-01-S