[Federal Register Volume 65, Number 174 (Thursday, September 7, 2000)]
[Notices]
[Pages 54282-54283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22951]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1467]


Agency Information Collection Activities; Proposed Collection; 
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 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 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 the information collection 
requirements relating to FDA regulations for the 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.

DATES: Submit written or electronic comments on the collection of 
information by November 6, 2000.

ADDRESSES: Submit electronic comments on the collection of information 
via the Internet at: http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm. 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: 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: 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 request 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.

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 42 U.S.C. 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 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.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 54283]]



                                 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
610.40(d) \3\                          12               1.83           22               0.5            11
Total                                                                                                  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 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: August, 30 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-22951 Filed 9-6-00; 8:45 am]
BILLING CODE 4160-01-F