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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comment on draft guidance documents.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The draft guidance addresses issues [FR Doc. 02–28551 Filed 11–8–02; 8:45 am] and Drug Administration, 9200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 This [Docket No. 02D–0011] availability of this draft guidance
draft guidance is intended to assist document and invited interested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 However, this draft guidance Obstructive Sleep Apnea; Guidance for proposed to classify intraoral devices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The draft guidance provides specific ACTION: Notice. supersedes the draft guidance entitled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 electronic comments to http:// remaining voice prompts to complete
dockets.htm. your request.

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68676 Federal Register / Vol. 67, No. 218 / Tuesday, November 12, 2002 / Notices

Persons interested in obtaining a copy ADDRESSES) written or electronic ACTION: Notice of Funding Availability
of the guidance may also do so using the comments regarding this guidance at for Knowledge Dissemination
Internet. CDRH maintains an entry on any time. Two copies of any comments Conference Grants (Short Title:
the Internet for easy access to are to be submitted, except that SAMHSA Conference Grants—PA 03–
information including text, graphics, individuals may submit one copy. 002).
and files that may be downloaded to a Identify comments with the docket
personal computer with Internet access. number found in brackets in the SUMMARY: The Substance Abuse and
Updated on a regular basis, the CDRH heading of this document. The guidance Mental Health Services Administration
home page includes device safety alerts, document and received comments may (SAMHSA) Center for Mental Health
Federal Register reprints, information be seen in the Dockets Management
Services (CMHS), Center for Substance
on premarket submissions (including Branch between 9 a.m. and 4 p.m.,
Monday through Friday. Abuse Prevention (CSAP) and Center for
lists of approved applications and
Substance Abuse Treatment (CSAT)
manufacturers’ addresses), small Dated: October 28, 2002. announce the availability of Fiscal Year
manufacturers’ assistance, information Linda S. Kahan,
on video conferencing and electronic (FY) 2003 funds for grants for the
Deputy Director, Center for Devices and following activity. This notice is not a
submissions, Mammography Matters, Radiological Health.
and other device-oriented information. complete description of the activity;
[FR Doc. 02–28550 Filed 11–8–02; 8:45 am] potential applicants must obtain a copy
The CDRH home page may be accessed BILLING CODE 4160–01–S
at A search of the Program Announcement (PA),
capability for all CDRH guidance including Part I, Knowledge
documents is available at http:// DEPARTMENT OF HEALTH AND Dissemination Conference Grants (Short HUMAN SERVICES Title: SAMHSA Conference Grants—PA
Guidance documents are also available 03–002), and Part II, General Policies
on the Dockets Management Branch Substance Abuse and Mental Health and Procedures Applicable to All
Internet site at Services Administration SAMHSA Applications for
ohrms/dockets. Discretionary Grants and Cooperative
Fiscal Year 2003 Funding Agreements, before preparing and
IV. Comments Opportunities submitting an application.
Interested persons may submit to the AGENCY: Substance Abuse and Mental
Dockets Management Branch (see Health Services Administration, HHS.

Est. Funds Est. No. of

Activity Application deadline Project period
FY 2003 awards

Knowledge Dissemination Conference Grants ............... Jan. 10, 2003 and Sept. $825,000 20–30 3 years
10, 2003 and each Jan.
10 and Sept. 10 there-

The actual amount available for the procedures for peer review and activity for which detailed information
award may vary, depending on Advisory Council review of grant and is desired. All information necessary to
unanticipated program requirements cooperative agreement applications apply, including where to submit
and the number and quality of were published in the Federal Register applications and application deadline
applications received. This program is (Vol. 58, No. 126, page 35962) on July instructions, are included in the
being announced prior to the annual 2, 1993. application kit.
appropriation for FY 2003 for GENERAL INSTRUCTIONS: Applicants must Purpose: The Substance Abuse and
SAMHSA’s programs. Applications are use application form PHS 5161–1 (Rev. Mental Health Services Administration
invited based on the assumption that 7/00). The application kit contains the (SAMHSA), Center for Mental Health
sufficient funds will be appropriated for two-part application materials Services (CMHS), Center for Substance
FY 2003 to permit funding of a (complete programmatic guidance and Abuse Prevention (CSAP) and Center for
reasonable number of applications being instructions for preparing and Substance Abuse Treatment (CSAT)
hereby solicited. This program is being submitting applications), the PHS 5161– announce the availability of funds for
announced in order to allow applicants 1 which includes Standard Form 424 grants to disseminate knowledge about
sufficient time to plan and prepare (Face Page), and other documentation practices within the mental health
applications. Solicitation of applications and forms. Application kits may be services and substance abuse prevention
in advance of a final appropriation will obtained from: National Clearinghouse and treatment fields and to integrate
also enable the award of appropriated for Alcohol and Drug Information that knowledge into real-world practice
grant funds in an expeditious manner (NCADI), PO Box 2345, Rockville, MD as effectively and efficiently as possible.
and thus allow prompt implementation 20847–2345, Telephone: 1–800–729– Eligibility: Public and domestic
and evaluation of promising practices. 6686. private nonprofit organizations,
All applicants are reminded, however, The PHS 5161–1 application form and including State and local governments,
that we cannot guarantee sufficient the full text of the activity are also professional associations, voluntary
funds will be appropriated to permit available electronically via SAMHSA’s organizations, self-help groups,
SAMHSA to fund any applications. This World Wide Web Home Page: http:// consumer and provider services-
program is authorized under sections oriented constituency groups,
509, 520A and 516 of the Public Health When requesting an application kit, community based organizations, and
Service Act. SAMHSA’s policies and the applicant must specify the particular faith-based organizations, may apply

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