[Federal Register Volume 64, Number 225 (Tuesday, November 23, 1999)]
[Notices]
[Pages 65715-65716]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30526]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97D-0318]


Guidance for Industry: Revised Precautionary Measures to Reduce 
the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) 
and New Variant Creutzfeldt-Jakob Disease (nvCJD) by Blood and Blood 
Products; 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 guidance document (dated November 1999) entitled 
``Guidance for Industry: Revised Precautionary Measures to Reduce the 
Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and 
New Variant Creutzfeldt-Jakob Disease (nvCJD) by Blood and Blood 
Products.'' The guidance document provides comprehensive current 
recommendations, including new recommendations concerning nvCJD, to all 
registered blood and plasma establishments and all establishments 
engaged in manufacturing plasma derivatives. The guidance document is 
intended to replace the FDA guidance entitled ``Revised Precautionary 
Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-
Jakob Disease (CJD) by Blood and Blood Products,'' dated August 1999.

DATES: Written comments may be submitted at any time. The guidance is 
released for immediate implementation. For the purposes of this 
guidance document, FDA interprets immediate implementation to mean as 
soon as feasible, but not later than April 17, 2000.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Guidance for Industry: Revised Precautionary 
Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-
Jakob Disease (CJD) and New Variant Creutzfeldt-Jakob Disease (nvCJD) 
by Blood and Blood Products'' 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 that office in processing your requests. The guidance 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 3019827-3844. 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.

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 guidance document entitled 
``Guidance for Industry: Revised Precautionary Measures to Reduce the 
Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and 
New Variant Creutzfeldt-Jakob Disease (nvCJD) by Blood and Blood 
Products.'' This guidance document is intended to replace the FDA 
guidance entitled ``Revised Precautionary Measures to Reduce the 
Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) by 
Blood and Blood Products'' dated August 1999 (64 FR 44739, August 17, 
1999). The guidance document provides comprehensive current 
recommendations, including new recommendations concerning nvCJD, to all 
registered blood and plasma establishments and all establishments 
engaged in manufacturing plasma derivatives.
    FDA issued the August 1999 guidance for immediate implementation, 
and the agency requested that comments on the guidance document be 
submitted within 60 days of the notice of availability that published 
in the Federal Register announcing the guidance document. After 
reviewing the comments received, FDA has revised the August 1999 
guidance document by issuing this guidance document. Significant 
changes made to the August 1999 draft guidance document since the 60-
day comment period closed are as follows:
    (1) A new recommended deferral for donors who have injected bovine 
insulin since 1980 unless it has been established that the product was 
not manufactured since 1980 from cattle in the United Kingdom;
    (2) Removal of the deferral for recipients of human-pituitary 
derived gonadotropins;
    (3) A change in the suggested question to exclude donors with dura 
mater transplants;
    (4) In the case of travel to the United Kingdom, a change in the 
recommended frequency for donor questioning, now specified to take 
place only once for the donor;
    (5) An exception to consignee notification for the purpose of 
retrieval, quarantine, and destruction of blood components if there is 
definite knowledge that the plasma given to a consignee will no longer 
exist in the form of unpooled units; and
    (6) Additional clarification with regard to recipient tracing and 
notification in cases where the donor has CJD, nvCJD or risk factors 
for CJD.
    This guidance document is released for immediate implementation. 
For the purpose of this guidance document, FDA interprets immediate 
implementation to mean as soon as feasible, but not later than April 
17, 2000. FDA recognizes that the scientific technology for determining 
individuals at risk for CJD and nvCJD, and detecting the infectious 
agents in tissues and in products, is continuing to advance, and that 
there may be a need for future updating of the relevant guidance.
    The guidance document represents the agency's current thinking on 
precautionary measures to reduce the possible risk and to assure that 
blood and blood products are not adulterated or misbranded, within the 
meaning of the Federal Food, Drug, and Cosmetic Act, and are safe, pure 
and potent within the meaning of the Public Health Service Act. 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

    Interested persons, may at any time, submit to the Dockets 
Management Branch (address above) written comments regarding this 
guidance document. Two copies of any comments are to be submitted, 
except that

[[Page 65716]]

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

III. Electronic Access

    A copy of the guidance document may be obtained through FDA's 
Internet site at http://www.fda.gov/cber/guidelines.htm.

    Dated: November 16, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-30526 Filed 11-22-99; 8:45 am]
BILLING CODE 4160-01-F