Document ID: FDA-2010-N-0447-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Devices Third-Party Review under Food and Drug Administration Modernization Act
Posted Date: 2010-09-22T04:00Z

[Federal Register: September 22, 2010 (Volume 75, Number 183)]
[Notices]               
[Page 57801-57802]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22se10-90]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
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 information collection 
requirements for the information collection in ``Medical Devices Third-
Party Review under the Food and Drug Administration Modernization Act 
of 1997.''

DATES: Submit either electronic or written comments on the collection 
of information by November 22, 2010.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. 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: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
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

[[Page 57802]]

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 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 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 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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                                                              No. of         Annual Frequency       Total Annual        Hours per
                Section 523 of the Act                     Respondents         per Response         Respondents          Response         Total Hours
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Requests for Accreditation                                              1                     1                  1                 24                 24
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510(k) reviews conducted by accredited third parties                   10                    26                260                 40             10,400
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Totals                                                                                                                                            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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                                                              No. of         Annual Frequency       Total Annual
                Section 523 of the Act                    Recordkeepers      per Recordkeeping        Records       Hours per  Record     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.

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.

    Dated: September 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-23633 Filed 9-21-10; 8:45 am]
BILLING CODE 4160-01-S