[Federal Register Volume 64, Number 109 (Tuesday, June 8, 1999)]
[Notices]
[Pages 30527-30528]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14405]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-1273]
Medical Devices; Draft Guidance for FDA Staff on Civil Money
Penalty Policy; 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availability of the draft guidance entitled ``Guidance for FDA Staff on
Civil Money Penalty Policy.'' The civil money penalty (CMP) policy is
intended for use by all FDA Regional and District Directors for the
purpose of advising their field personnel when considering potential
CMP recommendations under the Safe Medical Devices Act of 1990 (SMDA).
DATES: Written comments concerning this draft guidance must be received
by September 7, 1999.
ADDRESSES: See the SUPPLEMENTARY INFORMATION section for information on
electronic access to the draft guidance. Submit written requests for
single copies on a 3.5'' diskette of the draft guidance entitled
``Guidance for FDA Staff on Civil Money Penalty Policy'' to the
Division of Small Manufacturers Assistance (HFZ-220), Center for
Devices and Radiological Health, Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive
labels to assist that office in processing your request, or fax your
request to 301-443-8818. Written comments concerning this guidance must
be submitted to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Comments should be
[[Page 30528]]
identified with the docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Andrea P. Latish, Center for Devices
and Radiological Health (HFZ-330), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 301-594-4611.
SUPPLEMENTARY INFORMATION:
I. Background
The SMDA amended section 303(f) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 333(f)) to authorize FDA to impose
CMP actions for all violations of the act involving medical devices
except for current good manufacturing practice (CGMP) and medical
device report violations that do not constitute a significant or
knowing departure from such requirements or a risk to public health,
filth violations in devices that are not otherwise defective, and minor
violations for tracking and reports of corrections and removals. Thus,
FDA has considerable latitude when applying CMP to violations involving
devices.
FDA has developed a package of three documents that set forth the
agency's policy concerning the application of civil money penalties for
violations of the act involving medical devices. The three draft
guidance documents are: ``Application of the Safe Medical Devices Act
Civil Money Penalty Policy,'' ``Safe Medical Devices Act Civil Money
Penalty Fee Matrix,'' and ``Safe Medical Devices Act Civil Money
Penalty Decision Tree.''
The ``Application of the Safe Medical Devices Act Civil Money
Penalty Policy'' outlines the use of the CMP for CGMP and premarket
notification (510(k)) violations for chronic and repeat violators, and
for less significant violations. It also discusses the relationship
between CMP and seizure or injunction. The ``Safe Medical Devices Act
Civil Money Penalty Decision Tree'' outlines whether the evidence and
information collected justifies pursuing a CMP case. It is not an all-
inclusive list of every issue that should be considered, but rather a
series of questions to guide FDA's decision. The ``Safe Medical Devices
Act Civil Money Penalty Fee Matrix'' is a procedure for calculating the
penalty amount that will be assessed. The schedule set forth in the
matrix covers the statutory factors that FDA is required to evaluate
under the SMDA in determining the appropriateness of the case. The
matrix will help to ensure consistency in the assessment of a CMP.
FDA is making these three draft guidance documents available to all
FDA Regional and District Directors for the purposes of advising field
personnel. FDA is announcing the availability of these documents to the
public in order to advise persons who may be affected by FDA's policy
and to obtain comment on whether the policy should be revised.
This guidance package of three documents takes into consideration
the Presidential Memorandum, dated April 21, 1995, and the Small
Business Regulatory Enforcement Fairness Act of 1996, both of which
allow monies spent on corrective actions to be deducted from the fine
imposed. CMP action, therefore, can provide noncompliant firms with a
financial incentive to come into compliance.
The final CMP rule governing the procedures to be used in CMP
matters was published in the Federal Register of July 27, 1995 (60 FR
38612), and is codified at 21 CFR part 17.
This draft guidance represents the agency's current thinking on the
use of CMP recommendations made under the SMDA. 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 applicable statute, regulations, or both. This draft
guidance is issued as a Level 1 draft guidance consistent with good
guidance practices.
II. Electronic Access
In order to receive ``Guidance for FDA Staff on Civil Money Penalty
Policy'' via your fax machine, call the CDRH Facts-On-Demand (FOD)
system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. At
the first voice prompt press 1 to access DSMA Facts, at second voice
prompt press 2, and then enter the document number (1124) followed by
the pound sign (#). Then follow the remaining voice prompts to complete
your request.
Persons interested in obtaining a copy of the draft guidance may
also do so using the World Wide Web (WWW). The Center for Devices and
Radiological Health (CDRH) maintains an entry on the WWW for easy
access to information including text, graphics, and files that may be
downloaded to a personal computer with access to the WWW. Updated on a
regular basis, the CDRH home page includes the civil money penalty
guidance documents package, device safety alerts, Federal Register
reprints, information on premarket submissions (including lists of
approved applications and manufacturers' addresses), small
manufacturers' assistance, information on video conferencing and
electronic submissions, mammography matters, and other device-oriented
information. The CDRH home page may be accessed at ``http://
www.fda.gov/cdrh''. ``Guidance for FDA Staff on Civil Money Penalty
Policy'' will be available at ``http://www.fda.gov/cdrh/oc''.
III. Comments
Interested persons may, on or before September 7, 1999, submit to
the Dockets Management Branch (address above) written comments
regarding this 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 may be seen
in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: May 25, 1999.
Linda S. Kahan.
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 99-14405 Filed 6-7-99; 8:45 am]
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