[Federal Register Volume 65, Number 113 (Monday, June 12, 2000)]
[Notices]
[Pages 36816-36817]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-14701]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1303]


Agency Information Collection Activities: Proposed Collection; 
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 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 a 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 reporting requirements 
relating to shipment of nonsterile devices that are to be sterilized 
elsewhere or are shipped to other establishments for further process 
labeling or repacking.

DATES: Submit written comments on the collection of information by 
August 11, 2000.

ADDRESSES: 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.

Agreement for Shipment of Devices for Sterilization--21 CFR 
801.150(e) (OMB Control No. 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: (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 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 contract sterilizers.
    FDA estimates the reporting burden of this collection of 
information as follows:

[[Page 36817]]



                                 Table 1.--Estimated Annual Reporting Burden\1\
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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(e)                             90              20           1,800               4           7,200
Total                                                                                              7,200
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 \1\There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    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.
    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.

    Dated: June 5, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-14701 Filed 6-9-00; 8:45 am]
BILLING CODE 4160-01-F