Document ID: FDA-2009-N-0474-0002
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2010-01-19T05:00Z

[Federal Register Volume 75, Number 11 (Tuesday, January 19, 2010)]
[Notices]
[Page 2871]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-796]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0474]

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 
February 18, 2010.

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 oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0510. 
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 (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-5156, 
Daniel.Gittleson@fda.hhs.gov.

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.

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) 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.''
    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.
    In the Federal Register of October 22, 2009 (74 FR 54570), 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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Section of                   No. of       Annual Frequency  per    Total Annual      Hours per
  the Act       Item       Respondents           Response            Responses       Response       Total Hours
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704(g)      Request for               3                        1               3              80             240
             Accreditat
             ion
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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.

    Dated: January 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-796 Filed 1-15-10; 8:45 am]
BILLING CODE 4160-01-S