[Federal Register: August 12, 2003 (Volume 68, Number 155)]
[Page 47919-47920]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003N-0194]

Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Agreement for Shipment of Devices for 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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\
         21 CFR Section                 No. of        Annual Frequency     Annual       Hours per    Total Hours
                                     Respondents        per Response     Responses      Response
801.150(e)                                       90                 20        1,800        4               7,200
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

                               Table 2.--Estimated Annual Recordkeeping Burden\1\
       21 CFR Section               No. of        Annual Frequency     Annual         Hours per      Total Hours
                                Recordkeepers     of Recordkeeping    Records       Recordkeeper
801.150(a)(2)                                90                 20        1,800           .5                 900
\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]