[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
