[Federal Register Volume 69, Number 87 (Wednesday, May 5, 2004)]
[Notices]
[Pages 25130-25132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-10028]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 2004D-0187, 2004D-0188, and 2004D-0189]


Draft Guidances for Industry on Premarketing Risk Assessment; 
Development and Use of Risk Minimization Action Plans; and Good 
Pharmacovigilance Practices and Pharmacoepidemiologic Assessment; 
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 three draft guidances for industry entitled 
``Premarketing Risk Assessment,'' ``Development and Use of Risk 
Minimization Action Plans,'' and ``Good Pharmacovigilance Practices and 
Pharmacoepidemiologic Assessment.'' All are dated May 2004. These draft 
guidances provide guidance to industry on risk management activities 
for drug products, including biological drug products, in the Center 
for Drug Evaluation and Research (CDER) and the Center for Biologics 
Evaluation and Research (CBER). The draft guidances address, 
respectively, premarket risk assessment; the development, 
implementation, and evaluation of risk minimization action plans for 
drug products; and good pharmacovigilance practices and 
pharmacoepidemiologic assessment of observational data.

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DATES: Submit written or electronic comments on the draft guidances by 
July 6, 2004. General comments on agency guidance documents are welcome 
at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidances to the Division of Drug Information (HFD-240), Center for 
Drug Evaluation and Research, Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive 
label to assist that office in processing your requests. Submit written 
comments on the draft guidances to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. Identify each set of comments with the corresponding 
docket number of the draft guidance as follows: Docket No. [2004D-0187] 
``Premarketing Risk Assessment,'' Docket No. [2004D-0188] ``Development 
and Use of Risk Minimization Action Plans,'' and Docket No. [2004D-
0189] ``Good Pharmacovigilance Practices and Pharmacoepidemiologic 
Assessment.'' See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance documents.

FOR FURTHER INFORMATION CONTACT: For ``Premarketing Risk Assessment'': 
Barbara Gould, Center for Drug Evaluation and Research (HFD-550), Food 
and Drug Administration, 9201 Corporate Blvd., Rockville, MD 20850, 
301-827-2504, or
    Patricia Rohan, Center for Biologics Evaluation and Research (HFM-
485), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 
20852-1448, 301-827-3070.
    For ``Development and Use of Risk Minimization Action Plans'': 
Christine Bechtel, Center for Drug Evaluation and Research (HFD-006), 
Food and Drug Administration, 1451 Rockville Pike, Rockville, MD 20852, 
301-443-5572, or
    Mark Weinstein, Center for Biologics Evaluation and Research (HFM-
300), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 
20852, 301-827-3518.
    For ``Good Pharmacovigilance Practices and Pharmacoepidemiologic 
Assessment'': Patrick Guinn, Center for Drug Evaluation and Research 
(HFD-6), Food and Drug Administration, 5515 Security Lane, Rockville, 
MD 20852, 301-443-5590, or
    Miles Braun, Center for Biologics Evaluation and Research (HFM-
220), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 
20852, 301-827-6090.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of three draft guidances for 
industry entitled ``Premarketing Risk Assessment,'' ``Development and 
Use of Risk Minimization Action Plans,'' and ``Good Pharmacovigilance 
Practices and Pharmacoepidemiologic Assessment.'' These three guidances 
were produced in part to fulfill FDA's commitment to certain risk 
management performance goals agreed to in relation to the Prescription 
Drug User Fee Act upon its reauthorization in June 2002. As an initial 
step, FDA announced on March 7, 2003 (68 FR 11120), the availability of 
three concept papers. Each concept paper focused on one aspect of risk 
management. FDA held a public workshop on April 9-11, 2003, to obtain 
comment on the concept papers. The comments submitted on the concept 
papers and at the public meeting were considered in developing these 
draft guidances.
    These three draft guidances address risk management issues 
pertinent to the successive stages of a product's lifecycle, 
specifically: (1) During medical product development, (2) during 
product application review and approval, and (3) during the 
postmarketing period. The approaches recommended in the draft guidances 
should not be viewed as a new collection of generalized and discrete 
tools for risk minimization but rather as part of much broader, 
ongoing, and comprehensive efforts to provide additional guidance to 
industry on measures that can be employed to minimize the risks while 
preserving benefits of medical products.
    The draft guidances recommend that sponsors consider specific risk 
minimization efforts beyond routine risk minimization measures for the 
few products presenting unusual types or levels of risk. In these 
circumstances, using strategies that go beyond routine risk assessment 
and minimization may further improve the product's benefit-risk 
balance. FDA is specifically soliciting public comment on how to best 
characterize the types and levels of risk that might suggest the need 
for a risk management plan.
    FDA understands that risk management programs generate costs and 
place new burdens on product developers, health care practitioners, and 
patients. FDA recommends that, whenever possible, sponsors give every 
consideration to using the least burdensome method to achieve the 
desired public health outcome. For example, making increasing use of 
automatic reporting and future notification systems for adverse events 
will help the agency learn quickly of potential problems. Use of 
networks for electronic prescribing can enable the real-time, efficient 
collection of data on adverse events and even alert physicians to 
adverse events at the time of prescribing.
    As new products are developed, FDA recommends that sponsors seek to 
identify risk signals as early as possible in a product's development 
cycle, to evaluate the risks, to communicate predictable risk and 
benefit information effectively and thoroughly, and to employ efforts 
to manage these risks as efficiently as possible.
    These draft guidances are being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidances, 
when finalized, will represent the agency's current thinking on these 
topics. They do not create or confer any rights for or on any person 
and do not operate to bind FDA or the public. An alternative approach 
may be used if such approach satisfies the requirements of the 
applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the draft guidances. 
Two copies of mailed comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket numbers found in brackets in the heading of this document. 
Identify each set of comments with the corresponding docket number of 
the draft guidance as follows: Docket No. [2004D-0187] ``Premarketing 
Risk Assessment,'' Docket No. [2004D-0188] ``Development and Use of 
Risk Minimization Action Plans,'' and Docket No. [2004D-0189] ``Good 
Pharmacovigilance Practices and Pharmacoepidemiologic Assessment.'' The 
draft guidances and received comments are available for public 
examination in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.

III. Paperwork Reduction Act of 1995

    These guidances contain information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collection(s) of information in the guidances were approved under OMB 
control numbers 0910-0001 (until

[[Page 25132]]

March 31, 2005) and 0910-0338 (until August 31, 2005).

IV. Electronic Access

    Persons with access to the Internet may obtain the documents at 
http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/guidelines.htm, or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: April 26, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-10028 Filed 5-4-04; 8:45 am]
BILLING CODE 4160-01-S