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December 29, 2003

Dockets Management Branch (HFA-305)

Food and Drug Administration

5630 Fishers Lane

Room 1061

Rockville, MD 20852

**Re: Docket No. 00D-1267, "Guidance for Industry: Recommendations for
Donor Questioning Regarding Possible Exposure to Malaria"**

Dear Docket Officer:

The American Association of Blood Banks (AABB) is the professional
society for over 8,000 individuals involved in blood banking and
transfusion medicine and represents approximately 2,000 institutional
members, including blood collection centers, hospital-based blood banks,
and transfusion services as they collect, process, distribute, and
transfuse blood and blood components and hematopoietic stem cells. Our
members are responsible for virtually all of the blood collected and
more than 80 percent of the blood transfused in this country. For over
50 years, the AABB\'s highest priority has been to maintain and enhance
the safety and availability of the nation\'s blood supply.

The AABB would like to file additional comment on one provision of the
draft guidance document titled "Recommendations for Donor Questioning
Regarding Possible Exposure to Malaria," issued in June 2000. These
comments primarily address the feasibility and logistics of implementing
Section III, 3, that states the following proposed deferral criteria:

"Persons that may possess a partial acquired immunity to malaria, such
as those that have previously resided in a malarious region for at least
five years (immigrants, refugees, citizens, persons who have been or who
are residents of endemic countries), should not be accepted as donors of
Whole Blood or blood components, including platelets, for a period of
three years since their last visit to a malarious region."

With regard to the benefit expected from adopting this new deferral
criterion, the AABB is aware that Dr. Monica Parise from the Centers for
Disease Control and Prevention is in the process of reanalyzing that
institution\'s transfusion-transmitted malaria database to provide the
most informative data on this issue. The AABB notes that preliminary
data from this database of more than 20 years of case reporting were
previously presented (1,2). These data are summarized as follows:

> Questions have been raised as to whether former residents of malarial
> endemic countries who return to visit their country of origin should
> be presumed to have retained some acquired immunity and so should be
> treated as immigrants and not travelers in terms of time for donor
> deferral. In 5 of 8 such cases in the previous analysis of the CDC
> database, the transfusion transmission arose from a donation made
> within one year after return from the country of origin. These donors
> should have been deferred under the current criterion. Two cases which
> occurred beyond one year but less than three years involved P.
> malariae. Given the natural history of P. malariae, it is likely that
> future donations given by these donors would have resulted in
> transfusion transmission, even if the donor had been deferred for
> three years under the proposed criterion. There was only one case (P.
> falciparum infection from a donation occurring 29 months after the
> visit) in which it could be inferred that the proposed new three-year
> deferral would probably have prevented the infection. This case was
> somewhat unusual, as the donor had made several long trips since his
> immigration that may have contributed to retaining some acquired
> immunity.

Recently, Dr. Susan Galel of Stanford University has reviewed published
information on all 16 U.S. transfusion-transmitted malaria cases that
have occurred since 1990 and has concluded that none of these cases
would have been prevented by application of the proposed deferral
criterion.

The logistic implications of implementing a recurring 3-year deferral of
such donors makes it questionable whether the limited expected benefits
would actually be achieved. Furthermore, the complexity of the donor
screening process will be significantly increased, contrary to one of
the major aims of the FDA-endorsed AABB Uniform Donor History
Questionnaire Task Force.

The reliability of donor histories related to locations and durations of
residence is poor. Galel et al (3) have previously demonstrated that
residence history was reported inconsistently by 35 percent of donors
with a history of residence in Chagas endemic areas. The proposed
malarial deferral criterion is even more complex than simple residence
history and would therefore be expected to produce even less reliable
results; it would also be expected to lead to increased post-donation
information and biological product deviation reports.

There are two potential ways to implement this proposed deferral
criterion. The first would be for donor screeners to solicit a lifetime
history of residence each time a donor reports travel outside the U.S.
within the past three years. The second method would be to add a
question that asks all presenting donors whether they ever lived outside
the U.S. for more than five years. In both methods, the donor\'s
lifetime history of residence would then need to be evaluated by the
donor screener. This process will be error prone and will adversely
increase donor processing time, one of the major disincentives to blood
donation.

Given the extraordinary success of the current malarial deferral
criteria, FDA should reconsider the inclusion of this approach to
malaria risk reduction in its pending guidance, and should assess the
attendant risk-benefit in consultation with CDC and the blood
organizations. When the AABB weighs the very limited benefit (if any) of
the proposed deferral criterion against the logistic complexities and
the potential effect on blood availability of the proposed criterion, we
recommend that the proposed deferral criterion not be adopted.

Sincerely,

Karen Shoos Lipton, JD

Chief Executive Officer

References:

1.  Mungai et al. (NEJM 2001: 344: 1973-1978)

2.  Parise, M., Blood Products Advisory Committee Meeting, June 18, 1999
    Transcript, p.74,75

3.  Galel et al. (Abstract S296, Transfusion 1997; 37(suppl):74S)