[Federal Register Volume 75, Number 183 (Wednesday, September 22, 2010)]
[Notices]
[Pages 57801-57802]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-23633]
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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, [email protected].
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]
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