Document ID: FDA-2013-N-0795-0002
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2013-12-04T05:00Z

[Federal Register Volume 78, Number 233 (Wednesday, December 4, 2013)]
[Notices]
[Pages 72894-72895]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-29010]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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 January 
3, 2014.

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

[[Page 72895]]

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@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 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 (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.
    In the Federal Register of July 9, 2013 (78 FR 41065), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information to which one comment was received but was 
unrelated to the information collection.
    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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Requests for Accreditation...............................                  1                  1                  1                 24                 24
510(k) Reviews Conducted by Accredited Third Parties.....                 10                 26                260                 40             10,400
                                                          ----------------------------------------------------------------------------------------------
    Total................................................  .................  .................  .................  .................             10,424
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

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.

                                                     Table 2--Estimated Annual Recordkeeping Burden
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                                                           Number of       Number of records     Total annual     Average burden per
                      Activity                           recordkeepers     per recordkeeper         records          recordkeeping        Total hours
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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.

    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: November 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-29010 Filed 12-3-13; 8:45 am]
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