[Federal Register Volume 62, Number 166 (Wednesday, August 27, 1997)]
[Notices]
[Pages 45425-45426]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22790]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97D-0345]


Guidance for Industry on Postmarketing Adverse Experience 
Reporting for Human Drug and Licensed Biological Products: 
Clarification of What to Report; 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 for industry entitled ``Postmarketing 
Adverse Experience Reporting for Human Drug and Licensed Biological 
Products: Clarification of What to Report.'' The purpose of this 
guidance document is to clarify requirements for postmarketing safety 
reporting. This guidance document is intended to improve the quality of 
safety reports submitted to FDA while streamlining the postmarketing 
surveillance of human drug and licensed biological products.

DATES: Written comments may be submitted at any time.

ADDRESSES: Submit written requests for single copies of the guidance 
for industry ``Postmarketing Adverse Experience Reporting for Human 
Drug and Licensed Biological Products: Clarification of What to 
Report'' to the

[[Page 45426]]

Drug Information Branch (HFD-210), Center for Drug Evaluation and 
Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857, or the Office of Communication, Training and Manufacturers 
Assistance (HFM-40), Center for Biologics Evaluation and Research, Food 
and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. 
Send one self-addressed adhesive label to assist the office in 
processing your requests. Submit written comments on the guidance 
document to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:
    For information concerning human drug products: Audrey A. Thomas, 
Center for Drug Evaluation and Research (HFD-7), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-5625.

    For information concerning human licensed biological products: 
Marcel E. Salive, Center for Biologics Evaluation and Research (HFM-
220), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 
20852-1448, 301-827-3974.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
guidance for industry entitled ``Postmarketing Adverse Experience 
Reporting for Human Drug and Licensed Biological Products: 
Clarification of What to Report.'' FDA has undertaken a major effort to 
clarify and revise its regulations regarding pre- and postmarketing 
safety reporting requirements for human drug and biological products. 
With regard to the postmarketing safety reporting regulations for human 
drug and licensed biological products, the agency published a proposed 
rule in the Federal Register of October 27, 1994 (59 FR 54046), to 
amend these requirements, as well as others, to implement international 
standards, and to facilitate the reporting of adverse experiences. FDA 
is still considering comments submitted in response to this proposed 
rule and will be finalizing the proposed amendments based on those 
comments as well as on recommendations developed by the International 
Conference on Harmonisation of Technical Requirements for Registration 
of Pharmaceuticals for Human Use (ICH) and by the World Health 
Organization's Council for International Organizations of Medical 
Sciences (CIOMS). In addition, in response to the President's 
regulatory reinvention initiative, which directed departments and 
agencies to eliminate or modify regulations that are outdated or 
otherwise in need of reform, FDA recently published a final rule in the 
Federal Register (62 FR 34166, June 25, 1997) that revokes the 
postmarketing safety reporting requirement to submit expedited 
increased frequency reports for human drug and licensed biological 
products.
    At this time, the agency is considering recommendations recently 
developed by ICH and plans to propose additional amendments to its 
postmarketing safety reporting regulations. Throughout this effort, the 
agency intends to develop guidances for industry to provide 
recommendations on how industry can best fulfill the postmarketing 
safety reporting requirements. FDA plans to prepare a single 
consolidated guidance document on this topic once the process is 
concluded.
    This guidance document: (1) Describes the information that should 
be obtained before an individual case of an adverse experience should 
be considered for submission to FDA in an expedited or periodic report; 
(2) clarifies how safety information from solicited contacts with 
patients should be handled; and (3) informs applicants and licensed 
manufacturers that FDA will entertain waiver requests for periodic 
submission of individual case reports for adverse experiences that are 
determined to be nonserious and labeled. The guidance for industry 
should be used in conjunction with CDER's ``Guideline for Postmarketing 
Reporting of Adverse Drug Experiences'' (March 1992) and CBER's 
``Guideline for Adverse Experience Reporting for Licensed Biological 
Products'' (October 1993).
    This guidance document represents the agency's current thinking on 
reporting of certain postmarketing adverse experiences for human drug 
and licensed biological products. 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 requirement of the applicable statute, regulations, or both.
    Interested persons may, at any time, submit written comments and 
requests on the guidance document to the Dockets Management Branch 
(address above). 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. The guidance document and received comments may be seen in 
the office above between 9 a.m. and 4 p.m., Monday through Friday.
    An electronic version of this guidance is also available on the 
Internet at http://www.fda.gov/cder/guidance.htm or <a href="http://www.fda.gov/
cber/guidelines.htm">http://www.fda.gov/
cber/guidelines.htm</a>.

    Dated: August 21, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-22790 Filed 8-26-97; 8:45 am]
BILLING CODE 4160-01-F