[Federal Register: March 29, 2005 (Volume 70, Number 59)]
[Notices]
[Page 15866-15867]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29mr05-76]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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]
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