[Federal Register Volume 64, Number 158 (Tuesday, August 17, 1999)]
[Notices]
[Pages 44740-44741]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-21255]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-2407]


Evaluation and Processing of Post Donation Information Reports; 
Compliance Policy Guide; Guidance for FDA Personnel; Availability; 
Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a new compliance policy guide (CPG) entitled 
``Evaluation and Processing of Post Donation Information Reports'' 
(section 230.140). This document provides guidance to FDA field and 
headquarters staff regarding FDA's policy related to the evaluation and 
processing of post donation information reports for blood and blood 
components.

DATES: Written comments may be provided at any time.

ADDRESSES: Submit written requests for single copies of the CPG 
entitled ``Evaluation and Processing of Post Donation Information 
Reports'' (section 230.140) to the Director, Division of Compliance 
Policy (HFC-230), Office of Enforcement, Office of Regulatory Affairs 
(ORA), 5600 Fishers Lane, Rockville, MD 20857. Send two self-addressed 
adhesive labels to assist that office in processing your requests, or 
you may fax your request to 301-827-0482. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document. 
Written comments should be identified with the docket number found in 
brackets in the heading of this document and should be sent to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.


[[Page 44741]]


FOR FURTHER INFORMATION CONTACT: Sharon O'Callaghan, Center For 
Biologics Evaluation and Research (CBER) (HFM-650), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-
1191.
SUPPLEMENTARY INFORMATION:

 I. Background

     CBER issued a memorandum to blood establishments on December 10, 
1993, that provided guidance concerning process control procedures that 
should be established and maintained for the receipt, evaluation, 
investigation, and followup of post donation information reports. Post 
donation information includes information provided by the donor or 
other source and received or obtained following a donation, or at a 
subsequent donation during the health history screening process that 
relates to the suitability of the donor or of the blood or blood 
component. This CPG provides regulatory guidance relative to the 
evaluation and processing of this information.
     This Level 2 guidance document is being issued consistent with 
FDA's good guidance practices (62 FR 8961, February 27, 1997). It 
represents the agency's current thinking on the evaluation and 
processing of post donation reports. It does not create or confer any 
rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the requirements of the applicable statutes, regulations, or both.

 II. Request for Comments

     Written comments concerning the guidance may be submitted to the 
Dockets Management Branch (address above) at any time. Two copies of 
any comments are to be submitted, except that individuals may submit 
one copy. Written comments and requests for copies are to be identified 
with the docket number found in brackets in the heading of this 
document. A copy of the CPG and received comments are available for 
public examination in the office above between 9 a.m. and 4 p.m., 
Monday through Friday.

 III. Electronic Access

     An electronic version of the CPG (section 230.140) is also 
available on the Internet by connecting to the ORA home page at 
``http://www.fda.gov/ora/compliance__ref/default.htm''.

    Dated: August 9, 1999.
Dennis E. Baker,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 99-21255 Filed 8-16-99; 8:45 am]
BILLING CODE 4160-01-F