[Federal Register Volume 59, Number 207 (Thursday, October 27, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-26484]


[[Page Unknown]]

[Federal Register: October 27, 1994]


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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