[Federal Register Volume 65, Number 111 (Thursday, June 8, 2000)]
[Notices]
[Pages 36452-36453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-14371]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1267]


Draft ``Guidance for Industry: Recommendations for Donor 
Questioning Regarding Possible Exposure to Malaria;'' 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availability of a draft guidance document entitled ``Guidance for 
Industry: Recommendations for Donor Questioning Regarding Possible 
Exposure to Malaria'' dated May 2000. The draft guidance document 
provides recommended questions for deferral of donors at increased risk 
for malaria. The guidance document also provides the recommendations 
for donor questioning regarding travel to vacation resorts located in 
malarious regions. The draft guidance document currently being 
announced, when finalized, will replace the recommendations in the 
guidance entitled ``Recommendations for Deferral of Donors for Malaria 
Risk'' dated July 26, 1994.

DATES: Submit written comments on the draft guidance to ensure their 
adequate consideration in preparation of the final document by 
September 6, 2000.

ADDRESSES: Submit written requests for single copies of ``Guidance for 
Industry: Recommendations for Donor

[[Page 36453]]

Questioning Regarding Possible Exposure to Malaria'' dated May 2000 to 
the Office of Communication, Training, and Manufacturers Assistance 
(HFM-40), Center for Biologics Evaluation and Research (CBER), Food and 
Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. 
Send one self-addressed adhesive label to assist the office in 
processing your requests. The document may also be obtained by mail by 
calling the CBER Voice Information System at 1-800-835-4709 or 301-827-
1800, or by fax by calling the FAX Information System at 1-888-CBER-FAX 
or 301-827-3844. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.
    Submit written comments on the document to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance document 
entitled ``Guidance for Industry: Recommendations for Donor Questioning 
Regarding Possible Exposure to Malaria'' dated May 2000. The draft 
guidance document recommends questions to be asked of donors to 
determine possible exposure to malaria. The draft guidance document 
also provides recommendations for deferral of donors for malarial risk. 
The recommendations apply only to donations containing intact Red Blood 
Cells or platelets. Donations used for preparing plasma or plasma 
derivatives devoid of intact Red Blood Cells or platelets are excluded. 
The draft guidance document currently being announced, when finalized, 
will replace the recommendations in the guidance entitled 
``Recommendations for Deferral of Donors for Malaria Risk'' dated July 
26, 1994.
    The draft guidance document represents the agency's current 
thinking on malarial risks for prospective donors. 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 statute, regulations, or 
both. As with other guidance documents, FDA does not intend this 
document to be all-inclusive and cautions that not all information may 
be applicable to all situations. The document is intended to provide 
information and does not set forth requirements.

II. Comments

    The draft guidance document is being distributed for comment 
purposes only and is not intended for implementation at this time. 
Interested persons may submit to the Dockets Management Branch (address 
above) written comments regarding this draft guidance document. Submit 
written comments to ensure adequate consideration in preparation of the 
final document by September 6, 2000. Two copies of any comments are to 
be submitted, except individuals may submit one copy. Comments are to 
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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/cber/guidelines.htm.

    Dated: May 18, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-14371 Filed 6-7-00; 8:45 am]
BILLING CODE 4160-01-F