Guideline for Adverse Experience Reporting for Licensed Biological Products; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Docket No. 85D-0505]

Guideline for Adverse Experience Reporting for Licensed

Biological 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 guideline entitled ``Guideline for Adverse Experience

Reporting for Licensed Biological Products.'' The purpose of this

guideline is to assist manufacturers of biological products in

developing and implementing procedures to report to FDA adverse

experiences associated with biological products. Elsewhere in this

issue of the Federal Register, FDA is issuing a final rule amending the

biologics regulations to which this guideline applies.

ADDRESSES: Submit written requests for single copies of ``Guideline for

Adverse Experience Reporting for Licensed Biological Products'' to the

Congressional and Consumer Affairs Branch (HFM-12), Food and Drug

Administration, 1401 Rockville Pike, suite 200 North, Rockville, MD

20852-1448, 301-594-2000. Send two self-addressed adhesive labels to

assist that office in processing your requests. Persons with access to

the INTERNET may request this document from ``CBER--

[email protected].'' The document may also be obtained by calling

the CBER FAX Information System at 301-594-1939 from a FAX machine with

a touch tone phone attached or built in. Submit written comments on the

guideline to the Dockets Management Branch (HFA-305), Food and Drug

Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.

Requests and comments should be identified with the docket number found

in brackets in the heading of this document. A copy of ``Guideline for

Adverse Experience Reporting for Licensed Biological Products'' and

received comments are available for public examination in the Docket

Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Paula McKeever, Center for Biologics

Evaluation and Research (HFM-635), Food and Drug Administration, suite

200 North, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-3074.

SUPPLEMENTARY INFORMATION: In the Federal Register of March 29, 1990

(55 FR 11611), FDA issued a proposed rule that would require

manufacturers of licensed biological products to report to FDA certain

adverse experiences associated with their products. In the same issue

of the Federal Register (55 FR 11655), FDA published a notice

announcing the availability of a draft guideline for reporting adverse

experiences associated with licensed biological products, FDA offered

the public 60 days for comment on the proposed rule and draft

guideline.

Elsewhere in this issue of the Federal Register, FDA is issuing a

final rule which, upon the effective date, with require manufacturers

of licensed biological products to report to FDA: (1) Within 15 working

days all adverse experiences associated with the use of a biological

product that are both serious and unexpected; (2) within 15 working

days any significant increase in the frequency of a serious, but

expected, adverse experience and any significant increase in frequency

of therapeutic failures; and (3) periodically all other adverse

experiences and product distribution and disposition data. This notice

is to announce the availability of a guideline based on the draft

guideline made available in 1990. The guideline offers guidance for

meeting the reporting requirements of 21 CFR 600.80 and 600.81 and for

meeting the vaccines adverse experience reporting requirements in

accordance with section 2125 of the Public Health Service Act as

amended by the National Childhood Vaccine Injury Act of 1986.

The guidelines was prepared by the Division of Biostatistics and

Epidemiology, Office of Establishment Licensing and Product

Surveillance, Center for Biologics Evaluation and Research, FDA. In

developing the guideline, consideration was given to the comments

received on the proposed rule and on the draft guideline.

Changes from the draft guideline are generally editorial in nature

or made to conform to amendments made in the final rule discussed

elsewhere in this issue of the Federal Register. The guideline has also

been formatted to be more consistent with the similar guideline,

``Guideline for Postmarketing Reporting of Adverse Drug Experiences,''

applicable to reporting adverse experiences associated with human

drugs.

Elsewhere in this issue of the Federal Register, FDA is also

issuing a proposed rule that would revise and update the reporting

requirements for adverse experiences related to both biological

products and human drugs. When FDA issues the final rule based on that

proposed rule, FDA will also issue a notice of availability of revised

guidelines relating to biological products and human drugs to be

consistent with the final rule. Comments received in response to the

proposed rule will be considered for the next revision of the

guidelines applicable to biological products and human drugs.

Guidelines provide general information to persons dealing with FDA

and do not include decisions or advice on particular situations. A

person may follow a guideline or may follow different procedures or

practices. When different procedures or practices are chosen, a person

may, but is not required to, discuss the matter in advance with FDA to

prevent the expenditure of money and effort on an activity that may

later be determined to be unacceptable.

A guideline represents the position of FDA on a procedure or

practice at the time of its issuance. However, a guideline does not

bind the agency, and it does not create or confer any rights,

privileges, or benefits for or on any person. FDA may, at its

discretion, recommend or initiate legal or administrative action

against a person or product with respect to an action taken in

conformity with a guideline provided that the legal or administrative

action is consistent with applicable statutes and regulations.

Interested persons may submit written comments on the guideline to

the Dockets Management Branch (address above). These comments will be

considered in determining whether additional revision of the guideline

is appropriate. Two copies of any comments are to be submitted, except

individuals may submit one copy. Comments are to be identified with the

docket number found in brackets in the heading of this document. The

guideline and received comments may be seen in the Dockets Management

Branch, between 9 a.m. and 4 p.m., Monday through Friday.

Dated: October 13, 1994.

William K. Hubbard,

Interim Deputy Commissioner for Policy.

[FR Doc. 94-26484 Filed 10-26-94; 8:45 am]

BILLING CODE 4160-01-F-M