Document ID: FDA-2012-N-0427-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Devices; Inspection by Accredited Persons Program
Posted Date: 2013-01-31T05:00Z

[Federal Register Volume 78, Number 21 (Thursday, January 31, 2013)]
[Notices]
[Pages 6821-6822]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02092]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0427]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Medical Devices; 
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 March 
4, 2013.

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 emailed 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, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 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) 
(Pub. L. 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 FD&C 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 May 09, 2012 (77 FR 27234), 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                        Average
          Section of the FD&C Act                     Activity               Number of     responses per   Total annual     burden per      Total hours
                                                                            respondents     respondent       responses       response
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704(g)....................................  Request for accreditation...               1               1               1              80              80
                                                                                                                                         ---------------
    Total.................................  ............................  ..............  ..............  ..............  ..............              80
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

[[Page 6822]]

    Dated: January 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-02092 Filed 1-30-13; 8:45 am]
BILLING CODE 4160-01-P