[Federal Register Volume 66, Number 103 (Tuesday, May 29, 2001)]
[Notices]
[Pages 29142-29143]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-13301]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 01N-0222]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Devices; Third-Party Review Under FDAMA
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 medical devices; third-party review under the Food and
Drug Administration Modernization Act of 1997 (FDAMA).
DATES: Submit written or electronic comments on the collection of
information by July 30, 2001.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm.
Submit written comments on the collection of information to the Dockets
Management Branch (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 Schlosburg, Office of
Information Resources Management (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: (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 (OMB Control No.
0910-0375)--Extension
Section 210 of FDAMA established a new section 523 of the Federal
Food, Drug, and Cosmetic Act (the act), directing FDA to accredit
persons in the private sector to review certain premarket applications
and notifications. As with the third-party pilot program conducted
previously by FDA, 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. Accredited third-
party reviewers have the ability to review a manufacturer's 510(k)
[[Page 29143]]
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. 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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Annual
Item No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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Requests for accreditation..... 40 1 40 24 960
510(k) reviews conducted by 35 4 140 40 5,600
accredited third parties.......
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Total ........................ 6,560
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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
Item Recordkeepers per Recordkeeper Records Recordkeeper Total Hours
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510(k) reviews..................................... 35 4 140 10 1,400
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Total ............................................ 1,400
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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:
1. 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.
Under this expanded program, the agency anticipates that it will not
see a significant increase in the number of applicants. Therefore, the
agency is estimating that it will receive 40 applications. The agency
anticipates that it will accredit 35 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 only 22
510(k)s that requested and were eligible for review by third parties.
Because the third-party review program is not as limited in time, and
is expanded in scope, the agency anticipates that the number of 510(k)s
submitted for third-party review will remain the same as they were
during the last OMB approval in 1998. The agency anticipates that it
will receive approximately 140 third-party review submissions annually,
i.e., approximately 4 annual reviews per each of the estimated 35
accredited reviewers.
2. 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.
The estimate of the times required for record preparation and
maintenance is based on agency communication with industry. Other
information needed to calculate the total burden hours (i.e., adverse
drug reaction, lack of effectiveness, and product defect reports) are
derived from agency records and experience.
Dated: May 18, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-13301 Filed 5-25-01; 8:45 am]
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