[Federal Register Volume 78, Number 131 (Tuesday, July 9, 2013)]
[Notices]
[Pages 41065-41066]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-16402]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0795]


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.

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 the information collection 
associated with medical devices third-party review under the Food and 
Drug Administration Modernization Act of 1997 (FDAMA).

DATES: Submit either electronic or written comments on the collection 
of information by September 9, 2013.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written

[[Page 41066]]

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: 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: 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 FDAMA--21 U.S.C. 360m (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) 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
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                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per 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.......
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    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
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                                                                                         Number of                       Average burden
                              Activity                                  Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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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.

I. Reporting

510(k) Reviews Conducted by Accredited Third Parties

    According to FDA's data, 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 data, the Agency anticipates 
approximately 260 submissions of 510(k)s for third-party review per 
year.

    Dated: July 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-16402 Filed 7-8-13; 8:45 am]
BILLING CODE 4160-01-P