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

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 Burden1 ---------------------------------------------------------------------------------------------------------------- Annual 21 CFR Section No. of Frequency per Total Annual Hours per Total Hours Respondents Response Responses Response ---------------------------------------------------------------------------------------------------------------- 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 ---------------------------------------------------------------------------------------------------------------- \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

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