[Federal Register Volume 70, Number 59 (Tuesday, March 29, 2005)]
[Notices]
[Pages 15866-15867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-6200]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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 guidances for industry entitled ``Premarketing 
Risk Assessment,'' ``Development and Use of Risk Minimization Action 
Plans,'' and ``Good Pharmacovigilance Practices and 
Pharmacoepidemiologic Assessment.'' These 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 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.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of the 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, 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. These guidances may also be obtained by mail by calling 
CBER at 1-800-4709 or 301-827-1800. Send three self-addressed

[[Page 15867]]

adhesive labels to assist the office in processing your requests. 
Submit written comments on the guidance 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 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 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 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 the availability of three concept papers on March 
7, 2003 (68 FR 11120). Each concept paper focused on one aspect of risk 
management. FDA held a public workshop on April 9 to 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 
the draft guidances. The draft guidances were published on May 5, 2004 
(69 FR 25130), and the public was provided with an opportunity to 
comment on them until July 6, 2004. FDA considered all of the comments 
received in producing the final guidances.
    The guidances address risk management issues pertinent to the 
successive stages of a product's lifecycle, specifically the following 
topics: (1) During medical product development, (2) during product 
application review and approval, and (3) during the postmarketing 
period. The approaches recommended in the guidances are part of a 
broad, ongoing, and comprehensive effort by the agency to provide 
additional guidance to industry on measures that can be employed to 
minimize the risks while preserving the benefits of medical products.
    These 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 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.
    FDA recommends that as new products are developed, 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 guidances are being issued consistent with FDA's good 
guidances practices regulation (21 CFR 10.115). The guidances represent 
the agency's current thinking on this topic. 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 an 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 comments on the guidances at any time. Submit a 
single copy of electronic comments or two paper copies of any mailed 
comments, except that individuals may submit one paper copy. Comments 
are to be identified with the docket numbers found in brackets in the 
heading of this document. The guidances and received comments may be 
seen 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 March 31, 2005) and 0910-0338 (until 
August 31, 2005).

IV. Electronic Access

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

    Dated: March 24, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-6200 Filed 3-24-05; 4:30 pm]
BILLING CODE 4160-01-S