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68674 Federal Register / Vol. 67, No.

218 / Tuesday, November 12, 2002 / Notices

treating the symptoms of sleep apnea. disclose any material connection Electronic Copies of Electronic
Dr. Currier is also charged with making between himself and any product, Records.’’ This draft guidance describes
false claims that clinical proof program or service he endorses. Parts VI the agency’s current thinking on issues
establishes the efficacy of SNORenz. and VII of the proposed order permit pertaining to furnishing FDA with
Further, the complaint alleges that the proposed respondent to make certain electronic copies of electronic records
proposed respondent failed to disclose claims for drugs or dietary supplements, that are subject to part 11. Part 11
that the product is not intended to treat respectively, that are permitted in requires persons to employ procedures
sleep apnea; that sleep apnea is a labeling under laws and/or regulations and controls for records subject to part
potentially life-threatening disorder administered by the U.S. Food and Drug 11 that include the ability to generate
characterized by loud snoring, frequent Administration. electronic copies of electronic records
interruptions of sleep, and daytime The remainder of the proposed order that are accurate, complete, and suitable
tiredness; and that persons experiencing contains standard requirements that for FDA inspection, review, and
those symptoms should seek medical respondent maintain advertising and copying. This requirement helps ensure
attention. In addition, the complaint any materials relied upon as that electronic records and electronic
alleges that, when Dr. Currier made substantiation for any representation signatures are trustworthy, reliable, and
claims about SNORenz’ efficacy, he covered by substantiation requirements compatible with FDA’s public health
failed to have a reasonable basis for under the order, notify the Commission responsibilities.
such claims consisting of an actual of any change in his employment, and DATES: Submit written or electronic
exercise of his represented expertise in file one or more reports detailing its comments on the draft guidance by
the causes and treatment for snoring. compliance with the order. Part XI of February 10, 2003. General comments
Finally, the complaint alleges that the the proposed order is a provision on agency guidance documents are
proposed respondent failed to disclose whereby the order, absent certain welcome at any time.
adequately that a material connection circumstances, terminates twenty years ADDRESSES: Submit written requests for
existed between himself and the from the date of issuance. single copies of the draft guidance to the
product’s manufacturer and marketer, The purpose of this analysis is to Division of Compliance Information and
Med Gen, Inc. facilitate public comment on the Quality Assurance (HFC–240), Office of
Part I of the consent order requires proposed order, and is not intended to Enforcement, 5600 Fishers Lane,
that Dr. Currier possess competent and constitute an official interpretation of Rockville, MD 20857. Send one self-
reliable scientific evidence to the agreement and proposed order or to addressed adhesive labels to assist that
substantiate representations that modify in any way their terms. office in processing your requests.
SNORenz or any other food, drug, or This proposed order, if issued in final Submit written comments on the draft
dietary supplement reduces or form, will resolve the claims alleged in guidance document to the Dockets
eliminates snoring or the sound of the complaint against the named Management Branch (HFA–305), Food
snoring; reduces or eliminates snoring respondent. It is not the Commission’s and Drug Administration, 5630 Fishers
or the sound of snoring for any specified intent that acceptance of this consent Lane, room 1061, Rockville, MD 20852.
period of time through a single agreement and issuance of a final Submit electronic comments to http://
application; or eliminates, reduces or decision and order will release any www.fda.gov/dockets/ecomments. See
mitigates the symptoms of sleep apnea. claims against any unnamed persons or the SUPPLEMENTARY INFORMATION section
It also requires that Dr. Currier, when entities associated with the conduct for electronic access to the draft
acting as an expert endorser, actually described in the complaint. guidance document.
exercise his represented expertise in the
By direction of the Commission. FOR FURTHER INFORMATION CONTACT: Paul
form of an examination or testing at
least as extensive as an expert in the Benjamin I. Berman, J. Motise, Office of Enforcement (HFC–
field would normally conduct. Acting Secretary. 240), Food and Drug Administration,
Part II of the order requires that, for [FR Doc. 02–28649 Filed 11–8–02; 8:45 am]
5600 Fishers Lane, Rockville, MD
any product Dr. Currier advertises that 20857, 301–827–0383, e-mail:
BILLING CODE 6750–01–P
has not been shown to be effective in pmotise@ora.fda.gov.
the treatment of sleep apnea, he must SUPPLEMENTARY INFORMATION:
affirmatively disclose, whenever the DEPARTMENT OF HEALTH AND I. Background
advertisement represents that the HUMAN SERVICES
product is effective in reducing or FDA is announcing the availability of
eliminating snoring or the sounds of Food and Drug Administration a draft guidance entitled ‘‘Guidance for
snoring, a warning statement about Industry, 21 CFR part 11; Electronic
sleep apnea and the need for physician [Docket No. 00D–1540] Records; Electronic Signatures,
consultation. Electronic Copies of Electronic
Draft Guidance for Industry on
Part III of the order requires proposed Records.’’ In the Federal Register of
Electronic Records; Electronic
respondent to substantiate any March 20, 1997 (62 FR 13430), FDA
Signatures, Electronic Copies of
representation about the benefits, published a regulation providing criteria
Electronic Records; Availability
performance, efficacy, or safety of under which the agency considers
SNORenz or any other product, service AGENCY: Food and Drug Administration, electronic records and electronic
or program. If Dr. Currier makes such HHS. signatures to be trustworthy, reliable,
representations as an expert endorser, ACTION: Notice. and generally equivalent to paper
he must possess substantiation in the records and handwritten signatures
form of an examination or testing at SUMMARY: The Food and Drug executed on paper (‘‘part 11’’). The
least as extensive as an expert in the Administration (FDA) is announcing the preamble to part 11 (21 CFR part 11)
field would normally conduct. Part IV availability of a draft guidance for stated that the agency anticipated
prohibits false claims about scientific industry entitled ‘‘Guidance for issuing supplemental guidance
support for any product, service, or Industry, 21 CFR Part 11; Electronic documents and would afford all
program. Part V requires that Dr. Currier Records; Electronic Signatures, interested parties the opportunity to

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Federal Register / Vol. 67, No. 218 / Tuesday, November 12, 2002 / Notices 68675

comment on draft guidance documents. Dated: October 28, 2002. FOR FURTHER INFORMATION CONTACT:
Therefore, FDA is making this draft Margaret M. Dotzel, Susan Runner, Center for Devices and
guidance available for public comment. Associate Commissioner for Policy. Radiological Health (HFZ–480), Food
The draft guidance addresses issues [FR Doc. 02–28551 Filed 11–8–02; 8:45 am] and Drug Administration, 9200
pertaining to providing FDA with BILLING CODE 4160–01–S
Corporate Blvd., Rockville, MD 20850,
electronic copies of electronic records 301–827–5283.
subject to part 11 that are accurate, SUPPLEMENTARY INFORMATION:
complete, and suitable for FDA DEPARTMENT OF HEALTH AND
inspection, review, and copying. Part 11 HUMAN SERVICES I. Background
requires persons to be able to furnish In the Federal Register of April 5,
FDA with electronic copies of electronic Food and Drug Administration 2002 (67 FR 16406), FDA announced the
records that are subject to part 11. This [Docket No. 02D–0011] availability of this draft guidance
draft guidance is intended to assist document and invited interested
people who must meet this requirement; Medical Devices; Class II Special persons to comment on it by July 5,
it may also assist FDA staff who apply Controls Guidance Document: 2002. Also in the Federal Register of
part 11 to persons subject to the Intraoral Devices for Snoring and/or April 5, 2002 (67 FR 16338), FDA
regulation. However, this draft guidance Obstructive Sleep Apnea; Guidance for proposed to classify intraoral devices
is not intended to address issues related Industry and FDA; Availability used to control or treat simple snoring
to electronic records that are submitted and/or obstructive sleep apnea into
to FDA but that are not required to be AGENCY: Food and Drug Administration, class II with this guidance document as
maintained. HHS. the special control. This guidance
The draft guidance provides specific ACTION: Notice. supersedes the draft guidance entitled
information on key principles and ‘‘Class II Special Controls Guidance
practices on electronic copies of SUMMARY: The Food and Drug
Document: Intraoral Devices for Snoring
electronic records, and it addresses Administration (FDA) is announcing the and Obstructive Sleep Apnea; Guidance
some frequently asked questions. availability of the guidance entitled for Industry and FDA.’’
However, it is not intended to cover ‘‘Class II Special Controls Guidance
FDA received one comment on the
every aspect of generating electronic Document: Intraoral Devices for Snoring
draft guidance from the National
copies of electronic records that are and/or Obstructive Sleep Apnea;
Association of Dental Laboratories. We
accurate, complete, and suitable for Guidance for Industry and FDA.’’ This
considered this comment and agree that
FDA inspection, review and copying. document provides recommendations
the guidance does not change the
This level 1 draft guidance is being for complying with the premarket
regulatory requirements for dental
issued consistent with FDA’s good notification requirements for these
laboratories. We also revised the
guidance practices regulation (21 CFR devices. Elsewhere in this issue of the
guidance to clarify how a manufacturer
10.115). This draft guidance, when Federal Register, FDA is publishing a
may submit an abbreviated 510(k) when
finalized, will represent the agency’s final rule to classify these devices.
relying on a class II special controls
current thinking on providing FDA with DATES: Submit written or electronic guidance document.
electronic copies of electronic records. It comments on the guidance at any time.
General comments on agency guidance II. Significance of Guidance
does not create or confer any rights for
or on any person and does not operate documents are welcome at any time. This guidance is being issued
to bind FDA or the public. An ADDRESSES: Submit written requests for consistent with FDA’s good guidance
alternative approach may be used if single copies on a 3.5″ diskette of the practices regulation (21 CFR 10.115).
such approach satisfies the guidance entitled ‘‘Class II Special This guidance represents the agency’s
requirements of the applicable statutes Controls Guidance Document: Intraoral current thinking on 510(k) submissions
and regulations. Devices for Snoring and/or Obstructive for intraoral devices for snoring and/or
Sleep Apnea; Guidance for Industry and obstructive sleep apnea. It does not
II. Comments
FDA’’ to the Division of Small create or confer any rights for or on any
Interested persons may submit to the Manufacturers, International, and person and does not operate to bind
Dockets Management Branch (see Consumer Assistance (HFZ–220), Center FDA or the public. An alternative
ADDRESSES) written or electronic for Devices and Radiological Health, approach may be used if such approach
comments on the draft guidance. Two Food and Drug Administration, 1350 satisfies the requirements of the
copies of any nonelectronic comments Piccard Dr., Rockville, MD 20850. Send applicable statute and regulations.
are to be submitted, except that two self-addressed adhesive labels to
III. Electronic Access
individuals may submit one copy. assist that office in processing your
Comments are to be identified with the request, or fax you request to 301–443– In order to receive ‘‘Class II Special
docket number found in brackets in the 8818. See the SUPPLEMENTARY Controls Guidance Document: Intraoral
heading of this document. A copy of the INFORMATION section for information on Devices for Snoring and/or Obstructive
draft guidance and received comments electric access to the guidance. Sleep Apnea; Guidance for Industry and
are available for public examination in Submit written comments concerning FDA’’ via your fax machine, call the
the Dockets Management Branch this guidance to the Dockets CDRH Facts-On-Demand system at 800–
between 9 a.m. and 4 p.m., Monday Management Branch (HFA–305), Food 899–0381 or 301–827–0111 from a
through Friday. and Drug Administration, 5630 Fishers touch-tone telephone. Press 1 to enter
Lane, rm. 1061, Rockville, MD 20852. the system. At the second voice prompt
III. Electronic Access
Comments should be identified with the press 1 to order a document. Enter the
Persons with access to the Internet docket number found in the brackets in document number (1378) followed by
may obtain the document at http:// the heading of this document. Submit the pound sign (#). Follow the
www.fda.gov/ohrms/dockets/dockets/ electronic comments to http:// remaining voice prompts to complete
dockets.htm. www.fda.gov/dockets/ecomments. your request.

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