[Federal Register Volume 62, Number 136 (Wednesday, July 16, 1997)]
[Notices]
[Pages 38098-38099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-18595]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0264]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
proposed collection of information listed below has been submitted to
the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995 (the PRA).
DATES: Submit written comments on the collection of information by
August 15, 1997.
ADDRESSES: Submit written comments on the collection of information to
the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn:
Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Judith V. Bigelow, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1479.
[[Page 38099]]
SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA
(44 U.S.C. 3507), FDA has submitted the following proposed collection
of information to OMB for review and clearance.
Information Required in a Premarket Notification Submission (21 CFR
807.87, 807.92, and 807.93) (OMB Control Number 0910-0281--
Reinstatement)
Under section 510(k) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360(k)), a premarket notification must be filed before the
introduction or delivery for introduction of a device intended for
human use. Under Sec. 807.87 (21 CFR 807.87), premarket notifications
are required to contain certain information, including the device name,
establishment registration number, class of the device, the device's
proposed labeling, action taken by the person required to register to
comply with performance standards, and a 510(k) summary as described in
Sec. 807.92 (21 CFR 807.92) or a 510(k) statement as described in
Sec. 807.93 (21 CFR 807.93). In addition, Sec. 807.87(i) requires that
those filing premarket notification who claim substantial equivalence
to certain devices as described in Sec. 807.87(i), that are classified
into class III, must submit to FDA a summary of safety and
effectiveness problems and a citation to the information upon which the
summary is based. The premarket notification submitter must also
furnish FDA with a certification that a reasonable search has been
conducted of all known information.
The information collected in the premarket notification is
necessary to enhance FDA's ability to ensure that only premarket
notification submissions for devices that are as safe and as effective
as legally marketed predicate devices are cleared for marketing. In
addition, FDA makes publicly available this information concerning
devices for which a marketing order has been issued, in order to
provide to the public the agency's basis for equivalence
determinations.
Respondents to this collection of information are medical device
manufacturers and distributors.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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807.87(h) and 807.92 (simple
510(k) summaries) 2,592 1 2,592 8 20,736
807.87(h) and 807.92 (complex
510(k) summaries) 247 1 247 12 2,964
807.87(h) and 807.93 (510(k)
statements) 2,896 1 2,896 1 2,896
807.87(i) and 807.94
(certifications) 208 1 208 40 8,320
Total 34,916
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There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA bases these estimates on conversations with industry and trade
association representatives, and from internal review of the documents
listed in the table above.
Under Sec. 807.93, anyone submitting a 510(k) statement must make
that information available to anyone who requests it.
Table 2.--Estimated Annual Recordkeeping Burden
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records Recordkeeper
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807.93 2,896 10 28,960 0.5 14,480
Total 14,480
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There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 7, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-18595 Filed 7-15-97; 8:45 am]
BILLING CODE 4160-01-F
