[Federal Register Volume 72, Number 119 (Thursday, June 21, 2007)]
[Notices]
[Pages 34257-34259]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-11981]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0227]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Medical Devices Third-Party Review Under the Food and 
Drug Administration Modernization Act

AGENCY: Food and Drug Administration, HHS.

[[Page 34258]]


ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
requirements for ``Medical Devices Third-Party Review under the Food 
and Drug Administration Modernization Act of 1997 (FDAMA).''

DATES: Submit written or electronic comments on the collection of 
information by August 20, 2007.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. Submit written comments on 
the collection of information to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Medical Devices Third-Party Review Under the Food and Drug 
Administration Modernization Act--Section 523, Federal Food, Drug, and 
Cosmetic Act (OMB Control Number 0910-0375)--Extension

    Section 210 of 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) of the 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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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  Section 523 of         No. of        Annual Frequency     Total Annual        Hours per
     the Act          Respondents        per Response        Responses           Response         Total Hours
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Requests for                       1                  1                  1                 24                 24
 accreditation
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510(k) reviews                    14                 24                336                 40             13,440
 conducted by
 accredited third
 parties
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Totals             .................  .................  .................  .................            13,464
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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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  Section 523 of         No. of        Annual Frequency     Total Annual
     the Act         Recordkeepers    per Recordkeeping       Records       Hours per  Record     Total Hours
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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.


[[Page 34259]]

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)s 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 annual submissions of 510(k)s for third-party review.

    Dated: June 14, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-11981 Filed 6-20-07; 8:45 am]
BILLING CODE 4160-01-S