[Federal Register: March 12, 2001 (Volume 66, Number 48)]
[Notices]
[Page 14391-14392]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12mr01-81]
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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Draft Guidance for Industry on Postmarketing Safety Reporting for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availability of a draft guidance for industry entitled ``Postmarketing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 This draft guidance is intended to assist applicants and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DATES: Submit written comments on the draft guidance by May 11, 2001.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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Drug Information Branch (HFD-210), Center for Drug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 Submit written comments on the draft
guidance to the Dockets Management Branch (HFA-305), Food and Drug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FDA is announcing the availability of a draft guidance for industry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 This draft guidance discusses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]
BILLING CODE 4160-01-S