[Federal Register Volume 67, Number 96 (Friday, May 17, 2002)]
[Notices]
[Pages 35121-35122]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-12360]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1679]


Compliance Policy Guidance for FDA Staff and Industry on Blood 
Donor Classification Statement, Paid or Volunteer Donor; Availability

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 document entitled ``Blood Donor Classification 
Statements, Paid or Volunteer Donor,'' dated May 7, 2002. The guidance 
document provides guidance to FDA staff and industry for determining 
when blood or blood components should be labeled with a ``paid donor'' 
or ``volunteer donor'' classification statement. The document is 
intended to assist industry in determining when a donor incentive is 
considered a monetary payment, and to assist FDA employees in 
inspecting blood centers. This guidance finalizes the document entitled 
``Draft Compliance Policy Guidance for FDA Employees and Industry on 
Blood Donor Incentives,'' published in the Federal Register of January 
16, 2001 (66 FR 3605).

DATES:  Submit written or electronic comments on agency guidances at 
any time.

ADDRESSES:  Submit written requests for single copies of this 
compliance policy guidance to the Division of Compliance Policy (HFC-
230), Office of Regulatory Affairs, Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857. Send two self-addressed adhesive 
labels to assist the office in processing your requests. You may fax 
your request to 301-827-0852. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the guidance document.
     Submit written comments on the guidance document to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to 
http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Tom M. Chin, Division of Compliance 
Policy (HFC-230), Office of Regulatory Affairs, Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0410.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a compliance policy guidance 
document entitled ``Blood Donor Classification Statements, Paid or 
Volunteer Donor,'' dated May 7, 2002. The guidance document provides 
information to industry and FDA employees regarding when a blood donor 
incentive would require the blood or blood component to be labeled with 
a ``paid donor'' or ``volunteer donor'' classification statement.
    In the Federal Register of January 13, 1978 (43 FR 2142), FDA 
published a final rule requiring that blood and blood components 
intended for transfusion include a statement on the labels that 
indicated whether the products were collected from a paid or volunteer 
donor (Sec. 606.121(c)(5) (21 CFR 606.121(c)(5))). The regulation 
defines a ``paid donor'' as a person who receives monetary payment for 
blood donation (Sec. 606.121(c)(5)(i)). A volunteer donor is a person 
who does not receive monetary payment for blood donation 
(Sec. 606.121(c)(5)(ii)).
    The requirement for a donor classification statement applies only 
to blood and blood components intended for transfusion. It does not 
apply to blood and blood components intended for further manufacturing, 
such as Source Plasma.
    If the donor receives an incentive other than cash, the incentive 
must be evaluated to determine if it is readily convertible to cash. 
This guidance document provides FDA employees and industry with the 
factors that FDA uses to evaluate incentives, and provides some 
examples of incentives that the Center for Biologics Evaluation and 
Research has evaluated in the past.
    This guidance finalizes the draft guidance entitled ``Draft 
Compliance Policy Guidance for FDA Employees and Industry on Blood 
Donor Incentives'' (66 FR 3605). The title of the document was changed 
to more accurately reflect its contents.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). This guidance document represents 
the agency's current thinking on blood donor classification statements. 
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 and regulations.

III. Discussion of Comments

    The agency received a number of comments on the draft compliance 
policy guidance (66 FR 3605). All of the comments were considered when 
preparing the final document.
    Some of the comments requested further guidance on blood donor 
incentives that was outside of the scope of this document. FDA will 
consider issuing further guidance on the subject of blood donor 
incentives in the future.

IV. Comments

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

V. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/ora/compliance_ref/cpg/default.htm.


[[Page 35122]]


    Dated: May 7, 2002.
Dennis E. Baker,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 02-12360 Filed 5-16-02; 8:45 am]
BILLING CODE 4160-01-S