[Federal Register: August 12, 2003 (Volume 68, Number 155)]
[Notices]
[Page 47919-47920]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12au03-52]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0194]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request; Agreement for Shipment of Devices for
Sterilization
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
[[Page 47920]]
and Budget (OMB) for review and clearance under the Paperwork Reduction
Act of 1995.
DATES: Submit written comments on the collection of information by
September 11, 2003.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that written comments be faxed
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
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: In compliance with 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(e)
(OMB Control Number 0910-0131)--Extension
Under sections 501(c) and 502(a) of the Federal Food, Drug, and
Cosmetic Act (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(e) (21 CFR 801.150(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(e), manufacturers and sterilizers may
sign an agreement containing the following provisions: (1) Instructions
for maintaining accountability of the number of units in each shipment;
(2) acknowledgment that the devices that are nonsterile are being
shipped for further processing; and (3) specifications for
sterilization processing.
This agreement allows the manufacturer to ship misbranded 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.
The respondents to this collection of information are device
manufacturers and contact sterilizers.
In the Federal Register of May 21, 2003 (68 FR 27819), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the reporting burden of this collection of
information as follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Total
21 CFR Section No. of Annual Frequency Annual Hours per Total Hours
Respondents per Response Responses Response
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801.150(e) 90 20 1,800 4 7,200
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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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Total
21 CFR Section No. of Annual Frequency Annual Hours per Total Hours
Recordkeepers of Recordkeeping Records Recordkeeper
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801.150(a)(2) 90 20 1,800 .5 900
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA's estimate for the reporting burden is based on actual data
obtained from industry during the past 3 years where there are
approximately 90 firms subject to this requirement. It is estimated
that each of these firms on the average prepares 20 written agreements
each year. This estimate varies greatly, from 1 to 100, because some
firms provide sterilization services on a part time basis for only one
customer while others are large facilities with many customers. The
average time required to prepare each written agreement is estimated to
be 4 hours. This estimate varies depending on whether the agreement is
the initial agreement or is an annual renewal, on the format each firm
elects to use, and on the length of time required to reach agreement.
The estimate applies only to those portions of the written agreement
that pertain to the requirements imposed by this regulation. The
written agreement generally also includes contractual agreements that
are a customary and usual business practice. On the average, the total
annual recordkeeping burden is 7,200 hours (90 firms x 20 agreements x
4 hours).
The recordkeeping requirements for respondents consists of making
copies and maintaining the actual reporting requests which were
required under reporting section of this collection. To fulfill this
requirement, FDA estimates it will take about 30 minutes to copy each
package, for a total of 900 recordkeeping hours.
Dated: August 7, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-20523 Filed 8-11-03; 8:45 am]
BILLING CODE 4160-01-S