[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]
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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 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