Document ID: FDA-2010-N-0447-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Third Party Review Program Under the Food and Drug Administration Modernization Act
Posted Date: 2010-12-28T05:00Z

[Federal Register Volume 75, Number 248 (Tuesday, December 28, 2010)]
[Notices]
[Pages 81616-81617]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-32603]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0447]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Medical Devices; 
Third Party Review Program Under the Food and Drug Administration 
Modernization Act

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 (the PRA).

DATES: Fax written comments on the collection of information by January 
27, 2011.

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 0910-0375. 
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, e-mail: 
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.

Medical Devices; Third Party Review Program Under the Food and Drug 
Administration Modernization Act--(OMB Control Number 0910-0375)--
Extension

    Section 210 of the Food and Drug Administration Modernization Act 
(FDAMA) established section 523 of the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act) (21 U.S.C. 360m), directing FDA to accredit persons 
in the private sector to review certain premarket notifications 
(510(k)s). Participation in this third-party review program by 
accredited persons is entirely voluntary. A third party wishing to 
participate will submit a request for accreditation to FDA. Accredited 
third-party reviewers have the ability to review a manufacturer's 
510(k) of the FD&C Act (21 U.S.C. 360) submission for selected devices. 
After reviewing a submission, the reviewer will forward a copy of the 
510(k) submission, along with the reviewer's documented review and 
recommendation to FDA. Third-party reviewers should maintain records of 
their 510(k) reviews and a copy of the 510(k) for a reasonable period 
of time, usually a period of 3 years.
    This information collection will allow FDA to continue to implement 
the accredited person review program established by FDAMA and improve 
the efficiency of 510(k) review for low- to moderate-risk devices.
    Respondents to this information collection are businesses or other 
for-profit organizations.

I. Reporting

510(k) Reviews Conducted by Accredited Third Parties

    According to FDA's data in 2009, the Agency has experienced that 
the number of 510(k)s submitted for third-party review is approximately 
260 annually, which is 26 annual reviews per each of the 10 accredited 
reviewers.

II. Recordkeeping

    Third party reviewers are required to keep records of their review 
of each submission. According to FDA's in 2009, the Agency anticipates 
approximately 260 submissions of 510(k)s for third-party review per 
year.
    In the Federal Register of September 22, 2010 (75 FR 57801), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment; however, it was 
not PRA related.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 81617]]

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                      Annual
   Section 523 of the FD&C Act        No. of       frequency per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
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Requests for accreditation......               1               1               1              24              24
510(k) reviews conducted by                   10              26             260              40          10,400
 accredited third parties.......
    Total.......................  ..............  ..............  ..............  ..............          10,424
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                                           Annual
                    Section 523 of the FD&C Act                           No. of       frequency per     Total annual      Hours  per      Total hours
                                                                      recordkeepers    recordkeeping       records           record
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510(k) reviews.....................................................              10               26              260               10            2,600
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: December 21, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-32603 Filed 12-27-10; 8:45 am]
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