[Federal Register Volume 62, Number 184 (Tuesday, September 23, 1997)]
[Notices]
[Pages 49694-49695]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25181]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


Revised Precautionary Measures to Reduce the Possible 
Transmission of Creutzfeldt-Jakob Disease (CJD) by Blood and Blood 
Products; Guidance Document; 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 entitled ``Revised Precautionary 
Measures to Reduce the Possible Transmission of Creutzfeldt-Jakob 
Disease (CJD) by Blood and Blood Products,'' dated December 11, 1996. 
The guidance document is intended to provide recommendations to the 
blood industry and may include information useful to other interested 
persons.

DATES: Written comments may be submitted at any time.

ADDRESSES: Submit written requests for single copies of ``Revised 
Precautionary Measures to Reduce the Possible Transmission of 
Creutzfeldt-Jakob Disease (CJD) 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 301-
827-3844. Submit written comments on the guidance document to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Joseph Wilczek, Center for Biologics 
Evaluation and Research (HFM-350), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-827-3514.
SUPPLEMENTARY INFORMATION:  FDA is announcing the availability of a 
guidance document entitled ``Revised Precautionary Measures to Reduce 
the Possible Transmission of Creutzfeldt-Jakob Disease (CJD) by Blood 
and Blood Products,'' dated December 11, 1996, and sent to all 
registered blood and plasma establishments and all establishments 
engaged in manufacturing plasma derivatives.
    The guidance document updates and supersedes the FDA guidance 
documents of August 8, 1995, entitled ``Disposition of Products Derived 
from Donors Diagnosed with, or at Known High Risk for, Creutzfeldt-
Jakob Disease'' and ``Precautionary Measures to Further Reduce the 
Possible Risk of Transmission of Creutzfeldt-Jakob Disease by Blood and 
Blood Products,'' and the November 25, 1987, guidance document entitled 
``Deferral of Donors Who Have Received Human Pituitary-Derived Growth 
Hormone.''
    The guidance document presents recommendations for donor deferral, 
product disposition, recipient notification, and labeling. The 
recommendations were developed after considering donor and product risk 
factors and the impact such recommendations could have on the 
availability of blood and blood products. Topics addressed in the 
guidance document include: (1) Recommended questions that will help 
identify donors at an increased risk for CJD; (2) recommended actions 
to take when a donor is identified to be at an increased risk for 
developing CJD; (3) recommended actions to take when a donor is 
subsequently diagnosed with CJD; (4) recommendations for recipient 
notification and counseling; (5) recommendations for disposition of 
implicated products; and (6) recommendations for the labeling of 
implicated products intended for research or further manufacture into 
non-injectable products. The guidance document also includes FDA's 
recommendations regarding ``lookback'' notification of persons possibly 
exposed to CJD contaminated blood or blood products.
    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. It is intended to provide recommendations 
and does not set forth requirements. In response to public comment, 
development of suitable alternatives or other new information, FDA may 
revise the guidance document at anytime to improve its usefulness. Any 
revisions to this guidance document will be announced in the Federal 
Register. The recommendations in the guidance document represent the 
agency's current thinking on precautionary measures to use to reduce 
the possible transmission of CJD by blood and blood products. 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.
    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the guidance document. 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. Any comments previously 
submitted to the Division of Blood Applications (HFM-370), CBER, FDA, 
do not have to be resubmitted. Comments previously submitted will be 
filed with the Dockets Management Branch (address above) under the 
docket number in the heading of this document. The guidance document 
and received comments may be seen in the office above between 9 a.m. 
and 4 p.m., Monday through Friday. Received comments will be considered 
in determining whether further revision is warranted.
    Persons with access to the Internet may obtain the guidance 
document

[[Page 49695]]

using the World Wide Web (WWW). For WWW access, connect to CBER's site 
at ``http://www.fda.gov/cber/memo.htm''.

    Dated: September 16, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-25181 Filed 9-22-97; 8:45 am]
BILLING CODE 4160-01-F