[Federal Register Volume 66, Number 48 (Monday, March 12, 2001)]
[Notices]
[Pages 14391-14392]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-6053]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0056]


Draft Guidance for Industry on Postmarketing Safety Reporting for 
Human Drug and Biological Products Including Vaccines; 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availability of a draft guidance for industry entitled ``Postmarketing 
Safety Reporting for Human Drug and Biological Products Including 
Vaccines.'' This draft guidance is intended to assist applicants and 
other responsible parties in fulfilling FDA's postmarketing safety 
reporting requirements for marketed human drugs and biological 
products.

DATES: Submit written comments on the draft guidance by May 11, 2001. 
General comments on agency guidance documents are welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Drug Information Branch (HFD-210), Center for Drug 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 that 
office in processing your request. Submit written comments on the draft 
guidance to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:
    For information concerning human drug products: Min C. Chen, Center 
for Drug Evaluation and Research (HFD-430), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3169.
    For information concerning human biological products: Miles M. 
Braun, Center for Biologics Evaluation and Research (HFM-220), Food and 
Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 
301-827-3974.

SUPPLEMENTARY INFORMATION:

I. Description of the Guidance

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Postmarketing Safety Reporting for Human Drug and Biological 
Products Including Vaccines.'' This draft guidance discusses 
postmarketing safety reporting requirements for prescription drugs 
marketed for human use without an approved application Sec. 310.305 (21 
CFR 310.305), human drugs with approved new drug applications (NDA) 
Sec. 314.80 (21 CFR 314.80), human drugs with approved abbreviated new 
drug applications (21 CFR 314.98), and human biological products with 
approved biologics license applications (BLA) Secs. 600.80 and 600.81 
(21 CFR 600.80 and 600.81).
    This draft guidance does not apply to in vitro diagnostic products, 
whole blood or its components, or product manufacturing defects (unless 
the defect is associated with an adverse experience in humans). 
Moreover, it does not discuss the following: Investigational new drug 
application safety reports (21 CFR 312.32), safety update reports for 
drugs (21 CFR 314.50(d)(5)(vi)), approved NDA annual reports (21 CFR 
314.81(b)(2)), or approved BLA annual reports (21 CFR 601.28).
    Currently, FDA has three guidances for industry on postmarketing 
safety reporting: ``Guideline for Postmarketing Reporting of Adverse 
Drug Experiences'' (March 1992), ``Guideline for Adverse Experience 
Reporting for Licensed Biological Products'' (October 1993), and 
``Postmarketing Adverse Experience Reporting for Human Drug and 
Licensed Biological Products: Clarification of What to Report'' (August 
27, 1997). This draft guidance for industry consolidates the three 
existing guidances into a single document and revises the information 
contained within them to be consistent with the final rulemaking 
described below.
    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 expedited safety reporting regulations for human drug

[[Page 14392]]

and biological products, the agency published a final rule in the 
Federal Register of October 7, 1997 (62 FR 52237), amending these 
requirements, as well as others, to implement certain definitions, 
reporting periods, and formats recommended by the International 
Conference on Harmonization of Technical Requirements for Registration 
of Pharmaceuticals for Human Use (ICH). In addition, FDA published a 
final rule in the Federal Register of June 25, 1997 (62 FR 34166), that 
revokes the postmarketing safety reporting requirement to submit 
increased frequency reports for human drug and biological products in 
an expedited manner. This draft guidance for industry revises the 
agency's existing guidances on postmarketing safety reporting to be 
consistent with the final rules of June 25, 1997, and October 7, 1997.
    At this time, the agency is considering additional recommendations 
developed by ICH and plans to propose other amendments to its 
postmarketing safety reporting regulations. As additional amendments 
are made to these regulations, the agency intends to develop guidances 
for industry to provide recommendations on how industry can fulfill 
these requirements.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115; 65 FR 56468, September 
19, 2000). The draft guidance represents the agency's current thinking 
on postmarketing safety reporting for human drug and biological 
products including vaccines. 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 statutes and regulations.

II. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the draft guidance. 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 draft guidance and 
received comments are available for public examination in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

III. Paperwork Reduction Act of 1995

    This notice contains no new collections of information. The 
information requested for marketed human drug and biological products 
is already covered by the collection of information on postmarketing 
safety reporting regulations (Secs. 310.305, 314.80, 600.80, and 
600.81) submitted to the Office of Management and Budget (OMB) for 
review and clearance. In accordance with the Paperwork Reduction Act of 
1995 (44 U.S.C. 3501-3520), OMB approved the information collection for 
MedWatch--The FDA Medical Products Reporting Program (Forms FDA 3500 
and FDA 3500A) and assigned it OMB control number 0910-0291. The 
approval for 0910-0291 expires on March 31, 2001; an extension has been 
requested and is pending at OMB. OMB also approved the information 
collection for adverse experience reporting for marketed drugs and 
licensed biological products and assigned them OMB control numbers 
0910-0230 and 0910-0308, respectively. The approval for 0910-0230 
expires on May 31, 2002, and the approval for 0910-0308 expires on May 
31, 2001.

IV. Electronic Access

    Copies of this draft guidance for industry are available on the 
Internet at http://www.fda.gov/cder/guidance/index.htm and at http://www.fda.gov/cber/guidelines.htm.

    Dated: March 2, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-6053 Filed 3-9-01; 8:45 am]
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