[Federal Register Volume 62, Number 244 (Friday, December 19, 1997)]
[Notices]
[Pages 66633-66634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33091]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0485]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

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 (the PRA).

DATES: Submit written comments on the collection of information by 
January 20, 1998.
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: 
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 section 3507 of the PRA 
(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--Reinstatement)

    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, 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 
respondent's for this information collection are the blood collection 
facilities that are shipping hepatitis B reactive products. FDA's 
monitoring of such activity is essential should 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. 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 for each 
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.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden<SUP>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               1               0.5             0.5     
610.40(d)\3\                            6               8.5            51               0.5            25.5     
TOTAL                                                                                                  26       
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of            
  information.                                                                                                  
\2\ This 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. Preparation of the notice and duplication of standard         
  operating procedure documents is estimated at one half hour per notice.                                       
\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

[[Page 66634]]

supplied by the Federal Government to the recipient for the purpose of 
disclosure to the public is not a collection of information.

    Dated: December 10, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-33091 Filed 12-18-97; 8:45 am]
BILLING CODE 4160-01-F