[Federal Register: August 10, 2004 (Volume 69, Number 153)]
[Notices]
[Page 48508-48509]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10au04-94]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0332]
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 information
collection, 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 Modernization Act of 1997 (FDAMA).
DATES: Submit written and electronic comments on the collection of
information by October 12, 2004.
ADDRESSES: Submit electronic comments on the collection of information
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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: Peggy Robbins, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane
Rockville, MD 20857, 301-827-1223.
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.
[[Page 48509]]
Medical Devices; Third-Party Review Under FDAMA (OMB Control Number
0910-0375)--Extension
Section 210 of the Food and Drug Administration Modernization Act
of 1997 (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) 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
reviews 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
Respondents per Response Responses Response Total Hours
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Requests for 15 1 15 24 360
accreditation
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510(k) reviews 15 14 210 40 8,400
conducted by
accredited 3d
parties
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Totals 8,760
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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 Hours per
Recordkeepers per Recordkeeper Records Recordkeeper Total Hours
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510(k) reviews 15 14 210 10 2,100
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Totals 2,100
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The burdens are explained as follows:
I. Reporting
A. Requests for Accreditation
Under the agency's third-party review pilot program, the agency
received 37 applications for recognition as third-party reviewers, of
which the agency recognized 7. In the past 3 years, the agency has
averaged receipt of 15 applications for recognition of third-party
review accredited persons. The agency has accredited 15 of the
applicants to conduct third-party reviews.
B. 510(k) Reviews Conducted by Accredited Third Parties
In the 18 months under the Third-Party Review Pilot Program, FDA
received 22 submissions of 510(k)s that requested and were eligible for
review by third parties. The agency has experienced that the number of
510(k)s submitted annually for third-party review since the last OMB
approval in 2001 is approximately 210 annually, which is 14 annual
reviews per each of the estimated 15 accredited reviewers.
II. Recordkeeping
Third-party reviewers are required to keep records of their review
of each submission. The agency anticipates approximately 140 annual
submissions of 510(k)s for third-party review.
Dated: July 30, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-18167 Filed 8-9-04; 8:45 am]
BILLING CODE 4160-01-S