[Federal Register Volume 65, Number 238 (Monday, December 11, 2000)]
[Notices]
[Pages 77383-77384]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-31481]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1467]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Shipment of a Blood Product Prior to 
Completion of Testing for Hepatitis B Surface Antigen (HbsAg); and 
Shipment of Blood Products Known Reactive for HBsAg

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.

DATES: Submit written comments on the collection of information by 
January 10, 2001.

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: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.

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.

Shipment of a Blood Product Prior to Completion of Testing for 
Hepatitis B Surface Antigen (HBsAg)--(21 CFR 610.40(b)); and 
Shipment of Blood Products Known Reactive for HBsAg--(21 CFR 
610.40(d)) (OMB Control Number 0910-0168)--Extension

    Under sections 351 and 361 of the Public Health Service Act (42 
U.S.C. 262 and 264), FDA prescribes standards designed to ensure the 
safety, purity, potency, and effectiveness of biological products 
including blood and blood components and to prevent the transmission of 
communicable diseases. To accomplish this, FDA requires, among other 
things, that each unit of Whole Blood or Source Plasma be tested by a 
licensed serologic test for hepatitis

[[Page 77384]]

B surface antigen (HBsAg). Section 610.40(b)(4) (21 CFR 610.40(b)(4)) 
permits preapproved or emergency shipments of blood products for 
further manufacturing before the test for HBsAg is completed. To obtain 
approval for such shipments, the collection facility must submit a 
description of the control procedures to be used by the collection 
facility and manufacturer. Proper control procedures are essential to 
ensure the safe shipment, handling, and quarantine of untested or 
incompletely tested blood products, communication of test results, and 
appropriate use or disposal of the blood products based on the test 
results. Section 610.40(d)(1)(v) and (d)(2)(iv) requires that a 
collection facility notify FDA of shipments of HBsAg reactive source 
blood, plasma, or serum for manufacturing into hepatitis B vaccine and 
licensed or unlicensed in vitro diagnostic biological products, 
including clinical chemistry control reagents. The reporting 
requirements inform FDA of the shipment of potentially infectious 
biological products that may be capable of transmitting disease. FDA's 
monitoring of such activity is essential should any deviations occur 
that may require immediate corrective action to protect public safety.
    The respondents for this information collection are the blood 
collection facilities that ship hepatitis B reactive products. Only a 
few firms are actually engaged in shipping hepatitis B reactive 
products and making the reports required by Sec. 610.40. Also, there 
are very few to no emergency shipments per year related to further 
manufacturing and the only product currently shipped prior to 
completion of hepatitis B testing is a licensed product, Source 
Leukocytes. Shipments of Source Leukocytes are preapproved under the 
product license applications and do not require notification of 
shipment. Currently, there have been no respondents reporting emergency 
or preapproved shipments (Sec. 610.40(b)). However, FDA is listing one 
report per year for emergency or preapproved shipments to account for 
the possibility of future emergency shipments. The estimated number of 
respondents and total annual responses under Sec. 610.40(d) are based 
on the annual average of reports submitted to FDA in 1999. The hours 
per response are based on past FDA experience.
    In the Federal Register of September 7, 2000 (65 FR 54282), the 
agency requested comments on the proposed collection of information. No 
significant comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                  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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610.40(b) \2\                           1               1               0.5             0.5            11
610.40(d) \3\                          12               1.83           22               0.5            11.5
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ The notice involves a brief letter and an enclosure. The letter identifies who is making the shipment, to
  whom shipped, the nature of the emergency, the kind and quantity shipped, and date of shipment. The enclosure
  is a copy of the shippers written standard operating procedures for handling, labeling storage, and shipment
  of contaminated (contagious) product. The burden for development and maintenance of standard operating
  procedures is approved under OMB Control No. 0910-0116.
\3\ The notice of reactive product shipment is limited to information on: The identity of the kind and amount of
  source material shipped, the name and address of the consignee, the date of shipment, and the manner in which
  the source material is labeled.

    FDA has calculated no additional burden in this information 
collection package for the labeling requirements in Sec. 610.40(d) 
because the information and statements on the label necessary for 
public disclosure and safety are provided by FDA in these regulations. 
Under 5 CFR 1320.3(c)(2), the public disclosure of information 
originally supplied by the Federal Government to the recipient for the 
purpose of disclosure to the public is not a collection of information.

    Dated: December 5, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-31481 Filed 12-8-00; 8:45 am]
BILLING CODE 4160-01-F