[Federal Register: May 17, 2002 (Volume 67, Number 96)]
[Notices]
[Page 35121-35122]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17my02-75]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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