[Federal Register Volume 62, Number 107 (Wednesday, June 4, 1997)]
[Notices]
[Pages 30591-30592]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14601]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0180]


Agency Information Collection Activities: Proposed Collection; 
Comment Request; Reinstatement

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 reinstatement of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on requirements relating to the 
preapproved or emergency shipment of a blood product for manufacturing 
prior to completion of hepatitis B surface antigen (HBsAg) testing and 
shipment of a blood product for manufacturing when the donor is known 
to be reactive for HBsAg.

DATES: Submit written comments on the collection of information by 
August 4, 1997.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

FOR FURTHER INFORMATION CONTACT: Margaret R. Wolff, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600

[[Page 30592]]

Fishers Lane, rm. 16B-19, 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 reinstatement 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 listed below.
    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)--Reinstatement

    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 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, 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) and (d)(2) requires that a 
collection facility notify FDA of each shipment 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. The 
respondents for this information collection are the blood collection 
facilities that are shipping hepatitis B reactive products. FDA's 
monitoring of such activity is essential in the event that any 
deviations occur that may require immediate corrective action to 
protect public safety. The labeling helps ensure that product is safely 
and appropriately handled and used by the collection facility, shipper, 
and manufacturer.
    Only a few firms are actually engaged in shipping hepatitis B 
reactive products and making the reports required by Sec. 610.40. 
Further, 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 for each 
shipment. Currently, there have been no respondents reporting emergency 
or preapproved shipments (Sec. 610.40(b)). However, FDA is currently 
listing one report per year for emergency or preapproved shipments to 
account for the possibility of future emergency shipments.
    FDA estimates the burden of this collection of information as 
follows:

                                        Estimated Annual Reporting Burden                                       
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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)\1\                            1               1               1               0.5             0.5     
610.40(d)\2\                            6               8.5            51               0.5            25.5     
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There are no capital costs or operating and maintenance costs associated with this information collection.      
\1\ This notice involves a brief letter and an enclosure. The letter identifies who is making the shipment, to  
  whom the product was shipped, the nature of the emergency, the kind and quantity shipped, and the 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. Preparation of the notice and duplication  
  of standard operating procedure documents is estimated at one half hour per notice.                           
\2\ 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: May 28, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-14601 Filed 6-3-97; 8:45 am]
BILLING CODE 4160-01-F