[Federal Register Volume 62, Number 171 (Thursday, September 4, 1997)]
[Notices]
[Page 46744]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23507]
[[Page 46744]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0022]
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
October 6, 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,
Attention: 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.
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.
Agreement for Shipment of Devices for Sterilization--21 CFR
801.150(a)(2) and (e) (OMB Control No. 0910-0131--Reinstatement)
Under sections 501(c) and 502(a) of the act (21 U.S.C. 351(c) and
352(a)), nonsterile devices that are labeled as sterile but are in
interstate transit to a facility to be sterilized are adulterated and
misbranded. FDA regulations in Sec. 801.150(a)(2) and (e) (21 CFR
801.150(a)(2) and (e)) establish a control mechanism by which firms may
manufacture and label medical devices as sterile at one establishment
and ship the devices in interstate commerce for sterilization at
another establishment, a practice that facilitates the processing of
devices and is economically necessary for some firms. Under
Sec. 801.150(a)(2) and (e), manufacturers and sterilizers may sign an
agreement containing the following: (1) Instructions for maintaining
accountability of the number of units in each shipment; (2)
acknowledgment that the devices are nonsterile, being shipped for
further processing; and (3) specifications for sterilization
processing.
This agreement allows the manufacturer to ship nonsterile products
to be sterilized without initiating regulatory action and provides FDA
with a means to protect consumers from use of nonsterile products.
During routine plant inspections, FDA normally reviews agreements that
must be kept for 2 years after final shipment or delivery of devices.
To discontinue this reporting and recordkeeping procedure would place
an economic hardship on the industry and an additional burden on FDA to
monitor products in interstate commerce for failure to comply with
adulteration and misbranding provisions of the act.
The respondents to this collection of information are device
manufacturers and contract sterilizers.
FDA estimates the reporting 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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801.150 90 20 1,800 4 7,200
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There are no capital costs or operating and maintenance costs associated with this collection of information.
No burden has been estimated for the recordkeeping requirement in
Sec. 801.150(a)(2) because these records are maintained as a usual and
customary part of normal business activities. Under 5 CFR 1320.3(b)(2),
the time, effort, and financial resources necessary to comply with a
collection of information are excluded from the burden estimate if the
reporting, recordkeeping, or disclosure activities needed to comply are
usual and customary because they would occur in the normal course of
activities.
FDA's estimate of the burden is based on actual data obtained from
industry during the past 3 years where there are approximately 90 firms
subject to this requirement.
Dated: August 27, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-23507 Filed 9-3-97; 8:45 am]
BILLING CODE 4160-01-F
