[Federal Register Volume 64, Number 158 (Tuesday, August 17, 1999)]
[Notices]
[Pages 44739-44740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-21251]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (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.'' The 
guidance document is intended to provide recommendations 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'' issued on December 
11, 1996.


[[Page 44740]]


DATES: Written comments may be submitted at any time, however, comments 
should be submitted by October 18, 1999, to ensure adequate 
consideration in preparation of a revised document, if warranted. The 
agency is soliciting public comment, but is implementing this guidance 
document immediately because of the public health concerns related to 
the possible risk of transmission of CJD and nvCJD by blood and blood 
products.

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 301-827-3844. 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.'' 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'' sent by mail to blood and plasma 
establishments and plasma derivatives manufacturers on December 11, 
1996. See notice of availability (62 FR 49694, September 23, 1997).
    Recommendations addressed in the guidance document include: (1) 
Donor screening questions and deferral criteria, (2) disposition of 
implicated products, (3) consignee notification and recipient 
counseling, and (4) product labeling.
    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 guidance document 
is intended to provide information and does not set forth requirements.

II. Comments

    The agency is soliciting public comment, but is implementing this 
guidance document immediately because of the public health concerns 
related to the possible risk of transmission of CJD and nvCJD by blood 
and blood products. Additionally, the guidance presents a less 
burdersome policy for the management of blood components and plasma 
derivatives in cases where the donor has classic CJD or CJD risk 
factors. Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this guidance document. 
Written comments may be submitted at any time, however, comments should 
be submitted by October 18, 1999, to ensure adequate consideration in 
preparation of a revised document, if warranted. 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. 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

    Persons with access to the Internet may obtain the guidance 
document using the World Wide Web (WWW). For WWW access, connect to 
CBER at ``http://www.fda.gov/cber/guidelines.htm''.

    Dated: August 4, 1999.
 Margaret M. Dotzel,
 Acting Associate Commissioner for Policy.
[FR Doc. 99-21251 Filed 8-16-99; 8:45 am]
BILLING CODE 4160-01-F