[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Medical Devices; Draft Guidance for FDA Staff on Civil Money 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availability of the draft guidance entitled ``Guidance for FDA Staff on 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DATES: Written comments concerning this draft guidance must be received 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electronic access to the draft guidance.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single copies on a 3.5'' diskette of the draft guidance entitled 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]
BILLING CODE 4160-01-F