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

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

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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]

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