[Federal Register Volume 72, Number 222 (Monday, November 19, 2007)]
[Notices]
[Pages 65038-65039]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-22586]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No 2007N-0227]


Agency Information Collection Activities: Submission for Office 
of Management and Budget Review; Comment Request; Medical Devices 
Third-Party Review 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.

DATES: Fax written comments on the collection of information by 
December 19, 2007.

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 0910-0375. Also 
include the FDA docket number found in brackets in the heading of this 
document.

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 Third-Party Review Under the Food and Drug 
Administration Modernization Act; Section 523 of the Federal Food, 
Drug, and Cosmetic 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 act) (21 U.S.C. 360m), directing FDA to accredit persons in 
the private sector to review certain premarket applications and 
notifications. 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) 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

[[Page 65039]]

person review program established by FDAMA and improve the efficiency 
of 510(k) review for low to moderate risk devices.
    In the Federal Register of June 21, 2007 (72 FR 34257), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    Respondents to this information collection are businesses or other 
for-profit organizations.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
  Section 523 of         No. of        Annual Frequency     Total Annual        Hours per
     the act          Respondents        per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
Requests for                       1                  1                  1                 24                 24
 accreditation
----------------------------------------------------------------------------------------------------------------
510(k) reviews                    14                 24                336                 40             13,440
 conducted by
 accredited third
 parties
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Total                                                                                                     13,464
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 1.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
  Section 523 of         No. of        Annual Frequency     Total Annual        Hours per
     the act         Recordkeepers        per Record          Records          Recordkeeper       Total Hours
----------------------------------------------------------------------------------------------------------------
510(k) reviews by                 14                 24                336                 10              3,600
 third-party
 reviewers
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

I. Reporting

A. Requests for Accreditation

    FDA now has approximately 8 years of experience with third-party 
reviews under section 523 of the act. Currently there are 11 active 
accredited third parties. FDA does not expect to receive more than 1 
application for accreditation per year for a total of 14 accredited 
third parties who will be conducting third-party reviews.

B. 510(k) Reviews Conducted by Accredited Third Parties

    FDA has received 784 510(k) submissions with a third-party review 
since 2004. FDA estimates that over the next 3 years, they will 
accredit 1 third-party reviewer per year for a total of 14 third 
parties. Each third-party reviewer expects to review a total of 24 
510(k) submissions per year for an annual total of 336 applications.

II. Recordkeeping

    Third-party reviewers are required to keep records of their review 
of each submission. At the end of 3 years, the agency expects to have 
14 accredited persons for review with each third party reviewing on 
average 24 510(k) applications per year. The agency anticipates 
approximately 336 510(k) annual submissions for third-party review.

    Dated: November 14, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-22586 Filed 11-16-07; 8:45 am]
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