[Federal Register Volume 66, Number 10 (Tuesday, January 16, 2001)]
[Notices]
[Page 3605]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-1127]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1679 ]


Draft Compliance Policy Guidance for FDA Employees and Industry 
on Blood Donor Incentives; 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 the draft compliance policy guidance entitled ``Sec. 
230.150 Blood Donor Incentives.'' The draft guidance is intended to 
provide guidance to FDA employees and industry for evaluating blood 
donor incentives that may consist of cash or other incentives.

DATES: Submit written comments on the draft guidance by March 19, 2001. 
General comments on agency guidance documents may be submitted at any 
time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Compliance Policy (HFC-230), Office of 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 
that office in processing your request. You may fax your request to 
301-827-0852. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance. Submit written comments on this draft guidance 
to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: JoAnne C. Marrone, Division of 
Compliance Policy (HFC-230), Office of Regulatory Affairs, Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
1242.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 13, 1978 (43 FR 2142), FDA 
published a final rule requiring that blood and blood products intended 
for transfusion include a statement on the labels that indicated 
whether the products were collected from paid or volunteer donors. This 
labeling requirement appears at 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 a blood donation (Sec. 606.121(c)(5)(i)). 
A volunteer donor is a person who does not receive monetary payment for 
a blood donation (Sec. 606.121(c)(5)(ii)). The regulation also defines 
certain benefits that do not constitute monetary payment. Those 
benefits, described in Sec. 606.121(c)(5)(iii), include time off from 
work, membership in blood assurance programs, and cancellation of non-
replacement fees, as long as the benefits are not readily convertible 
to cash. Products collected from blood donors who have received such 
incentives may be labeled with the ``volunteer donor'' classification 
statement.
    The requirement that the label of a blood product indicate whether 
the product came from a volunteer or a paid donor applies only to blood 
and blood components intended for transfusion. It does not apply to 
products that will be used 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. 
The draft guidance document provides FDA employees and industry with 
some examples of incentives and identifies some factors to consider 
when determining whether an incentive is readily convertible to cash. 
The draft guidance advises FDA employees that they may cite deviations 
from blood and blood product labeling requirements on Form FDA 483 
(inspectional observations).

II. Significance of Guidance

    This draft guidance document represents the agency's current 
thinking on blood donor incentives. The draft guidance is not intended 
for implementation at this time. 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 applicable statute, regulations, or both.
    The agency has adopted good guidance practices (GGP's) which set 
forth the agency's policies and procedures for the development, 
issuance, and use of guidance documents (65 FR 56468, September 19, 
2000 ). This draft guidance document is being issued as Level 1 
guidance consistent with GGP's.

III. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this draft guidance by March 
19, 2001. Submit to the contact person (address above) written comments 
regarding this draft guidance after March 19, 2001. Such comments will 
be considered when the draft guidance is finalized. Two copies of any 
comments are to be submitted, except that individuals may submit one 
copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. The guidance document and 
received comments may be seen in the Dockets Management Branch between 
9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons interested in obtaining a copy of the draft guidance on the 
Internet may access the draft at http://www.fda.gov/ora/
compliance__ref/cpg/default.htm.

    Dated: January 5, 2001.
Dennis E. Baker,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 01-1127 Filed 1-12-01; 8:45 am]
BILLING CODE: 4160-01-S