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Federal Register / Vol. 67, No.

216 / Thursday, November 7, 2002 / Notices 67859

drug applications (ANDAs) for sodium requesting that the agency determine DATES: Submit written or electronic
tetradecyl sulfate injection. whether sodium tetradecyl sulfate comments on this guidance by February
FOR FURTHER INFORMATION CONTACT: J. injection was withdrawn from sale for 5, 2003.
Kenneth Borgerding, Center for Drug reasons of safety or effectiveness. In ADDRESSES: Submit written requests for
Evaluation and Research (HFD–7), Food addition, on December 6, 2001, Omega single copies on a 3.5″ diskette of the
and Drug Administration, 5600 Fishers Laboratories, Ltd., submitted a citizen guidance document entitled ‘‘Class II
Lane, Rockville, MD 20857, 301–594– petition (Docket No. 01P–0350/CP2) Special Controls Guidance Document:
2041. under § 10.30 to FDA making the same Transcutaneous Air Conduction Hearing
request. FDA has reviewed its records Aid System; Guidance for Industry and
Congress enacted the Drug Price and has found no information to FDA’’ to the Division of Small
Competition and Patent Term indicate that sodium tetradecyl sulfate Manufacturers, International, and
Restoration Act of 1984 (Public Law 98– injection was withdrawn from the Consumer Assistance (HFZ–220), Center
417) (the 1984 amendments), which market for safety or efficacy reasons. for Devices and Radiological Health,
authorized the approval of duplicate Therefore, FDA concludes that the Food and Drug Administration, 1350
versions of drug products approved decision to not manufacture and market Piccard Dr., Rockville, MD 20850. Send
under an ANDA procedure. ANDA the product was not due to safety or two self-addressed adhesive labels to
sponsors must, with certain exceptions, efficacy concerns. Accordingly, the assist that office in processing your
show that the drug for which they are agency will maintain sodium tetradecyl request, or fax your request to 301–443–
seeking approval contains the same sulfate injection in the ‘‘Discontinued 8818. See the SUPPLEMENTARY
active ingredient in the same strength Drug Product List’’ section of the Orange INFORMATION section for information on
and dosage form as the ‘‘listed drug,’’ Book. The ‘‘Discontinued Drug Product electronic access to the guidance.
which is a version of the drug that was List’’ delineates, among other items, Submit written comments concerning
previously approved under a new drug drug products that have been this guidance to the Dockets
application (NDA). Sponsors of ANDAs discontinued from marketing for reasons Management Branch (HFA–305), Food
do not have to repeat the extensive other than safety or effectiveness. and Drug Administration, 5630 Fishers
clinical testing otherwise necessary to ANDAs that refer to sodium tetradecyl Lane, rm. 1061, Rockville, MD 20852.
gain approval of an NDA. The only sulfate injection may be approved by the Comments should be identified with the
clinical data required in an ANDA are agency. docket number found in brackets in the
data to show that the drug that is the Dated: October 28, 2002. heading of this document. Submit
subject of the ANDA is bioequivalent to Margaret M. Dotzel,
electronic comments to http://
the listed drug.
Associate Commissioner for Policy.
The 1984 amendments include what FOR FURTHER INFORMATION CONTACT: Eric
[FR Doc. 02–28400 Filed 11–6–02; 8:45 am]
is now section 505(j)(7) of the Federal M. Mann, Center for Devices and
Food, Drug, and Cosmetic Act (21 U.S.C. Radiological Health (HFZ–460), Food
355(j)(7)), which requires FDA to and Drug Administration, 9200
publish a list of all approved drugs. Corporate Blvd., Rockville, MD 20850,
FDA publishes this list as part of the 301–594–2080.
‘‘Approved Drug Products with SUPPLEMENTARY INFORMATION:
Therapeutic Equivalence Evaluations,’’ Food and Drug Administration I. Background
which is generally known as the
‘‘Orange Book.’’ Under FDA regulations, The TACHAS is intended to
[Docket No. 02D–0439]
drugs are withdrawn from the list if the compensate for impaired hearing
agency withdraws or suspends approval Medical Devices; Class II Special without occluding the ear canal. It
of the drug’s NDA or ANDA for reasons Controls Guidance Document: consists of an air conduction hearing aid
of safety or effectiveness or if FDA Transcutaneous Air Conduction attached to a surgically fitted tube
determines that the listed drug was Hearing Aid System; Guidance for system, which is placed through the soft
withdrawn from sale for reasons of Industry and FDA; Availability tissues between the post auricular
safety or effectiveness (21 CFR 314.162). region and the outer ear canal. This
Regulations also provide that the agency AGENCY: Food and Drug Administration, special control guidance document lists
must make a determination as to HHS. the risks to health identified by FDA
whether a listed drug was withdrawn and describes measures that, if followed
from sale for reasons of safety or ACTION: Notice. by manufacturers and combined with
effectiveness, before an ANDA that the general controls, will generally
refers to that listed drug may be SUMMARY: The Food and Drug address the risks associated with these
approved (21 CFR 314.161(a)(1)). FDA Administration (FDA) is announcing the devices.
may not approve an ANDA that does not availability of the guidance entitled Elsewhere in this issue of the Federal
refer to a listed drug. ‘‘Class II Special Controls Guidance Register, FDA is publishing a final rule
Sodium tetradecyl sulfate injection is Document: Transcutaneous Air classifying TACHAS into class II
the subject of NDA 5–970. On August Conduction Hearing Aid System; (special controls) under section 513(f)(2)
13, 1946, Elkins Sinn received approval Guidance for Industry and FDA.’’ This of the Federal Food, Drug, and Cosmetic
to market sodium tetradecyl sulfate document describes a means by which Act (the act) (21 U.S.C. 360c(f)(2)). This
injection. During 2000, Elkins Sinn transcutaneous air conduction hearing guidance document will serve as the
discontinued manufacture of this aid systems (TACHAS) may comply special control for the TACHAS device.
product. with the requirement of special controls Section 513(f)(2) of the act provides that
On August 13, 2001, Bennett and for class II devices. Elsewhere in this any person who submits a premarket
Company submitted a citizen petition issue of the Federal Register, FDA is notification under section 510(k) of the
(Docket No. 01P–0350/CP1) under publishing a final rule classifying act (21 U.S.C. 360(k)) for a device that
§ 10.30 (21 CFR 10.30) to FDA TACHAS into class II (special controls). has not previously been classified may,

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67860 Federal Register / Vol. 67, No. 216 / Thursday, November 7, 2002 / Notices

within 30 days after receiving an order manufacturers’ assistance, information Management and Budget, Room 10235,
classifying the device in class III under on video conferencing and electronic New Executive Office Building,
section 513(f)(1) of the act, request FDA submissions, Mammography Matters, Washington, DC 20503; Fax number
to classify the device under the criteria and other device-oriented information. (202) 395–2974; E-mail
set forth in section 513(a)(1) of the act. You may access the CDRH home page at
FDA shall, within 60 days of receiving You may
such a request, classify the device by search for all CDRH guidance
written order. This classification shall Wayne Eddins, Reports Management
documents at
be the initial classification of the device. Officer, QDAM, Department of Housing
guidance.html. Guidance documents are
Within 30 days after the issuance of an and Urban Development, 451 Seventh
also available on the Dockets
order classifying the device, FDA must Street, SW., Washington, DC 20410; e-
Management Branch Internet site at
publish a notice in the Federal Register mail;
announcing such classification. Because telephone (202) 708–2374. This is not a
of the timeframes established by section IV. Comments toll-free number. Copies of the proposed
513(f)(2) of the act, FDA has Interested persons may submit to forms and other available documents
determined, under § 10.115(g)(2) (21 Dockets Management Branch (see submitted to OMB may be obtained
CFR 10.115(g)(2)), that it is not feasible ADDRESSES) written comments regarding from Mr. Eddins.
to allow for public participation before this immediately in effect guidance by SUPPLEMENTARY INFORMATION: The
issuing this guidance as a final guidance (see DATES). Two copies of any Department has submitted the proposal
document. Therefore, FDA is issuing comments are to be submitted, except for the collection of information, as
this guidance document as a level 1 that individuals may submit one copy. described below, to OMB for review, as
guidance document that is immediately Identify comments with the docket required by the Paperwork Reduction
in effect. FDA will consider any number found in brackets in the Act (44 U.S.C. chapter 35). The Notice
comments that are received in response heading of this document. The guidance lists the following information: (1) The
to this notice to determine whether to document and comments received may title of the information collection
amend the guidance document. be seen in the Dockets Management proposal; (2) the office of the agency to
II. Significance of Guidance Branch between 9 a.m. and 4 p.m., collect the information; (3) the OMB
Monday through Friday. approval number, if applicable; (4) the
This guidance is being issued description of the need for the
Dated: October 28, 2002.
consistent with FDA’s good guidance information and its proposed use; (5)
practices (GGPs) regulation (§ 10.115). Linda S. Kahan,
Deputy Director, Center for Devices and
the agency form number, if applicable;
The guidance represents the agency’s (6) what members of the public will be
current thinking on TACHAS. It does Radiological Health.
[FR Doc. 02–28399 Filed 11–6–02; 8:45 am]
affected by the proposal; (7) how
not create or confer any rights for or on frequently information submissions will
any person and does not operate to bind BILLING CODE 4160–01–S
be required; (8) an estimate of the total
FDA or the public. An alternative number of hours needed to prepare the
approach may be used if such approach information submission including
satisfies the requirements of the DEPARTMENT OF HOUSING AND number of respondents, frequency of
applicable statute and regulations. This URBAN DEVELOPMENT response, and hours of response; (9)
guidance document is issued as a level [Docket No. FR–4734–N–66] whether the proposal is new, an
1 guidance consistent with GGPs. extension, reinstatement, or revision of
III. Electronic Access Notice of Submission of Proposed an information collection requirement;
Information Collection to OMB: and (10) the name and telephone
In order to receive the ‘‘Class II Requirements for Notification of Lead-
Special Controls Guidance Document: number of an agency official familiar
Based Paint Hazards in Federally- with the proposal and of the OMB Desk
Transcutaneous Air Conduction Hearing Owned Residential Properties and
Aid System; Guidance for Industry and Officer for the Department.
Housing Receiving Federal Assistance
FDA’’ via your fax machine, call the This Notice Also Lists the Following
CDRH Facts-On-Demand system at 800– AGENCY: Office of the Chief Information Information
899–0381 or 301–827–0111 from a Officer, HUD.
touch-tone telephone. Press 1 to enter Title of Proposal: Requirements for
ACTION: Notice.
the system. At the second voice prompt Notification of Lead-Based Paint
press 1 to order a document. Enter the SUMMARY: The proposed information Hazards in Federally-Owned Residential
document number (1414) followed by collection requirement described below Properties and Housing Receiving
the pound sign (#). Follow the has been submitted to the Office of Federal Assistance.
remaining voice prompts to complete Management and Budget (OMB) for OMB Approval Number: 2539–0009.
your request. review, as required by the Paperwork Form Numbers: None.
You may obtain a copy of the Reduction Act. The Department is Description of the Need for the
guidance from the Internet. CDRH soliciting public comments on the Information and its Proposed Use:
maintains an entry on the Internet for subject proposal. Requirements to provide a pamphlet on
easy access to information including DATES: Comments Due Date: December lead poisoning prevention to tenants
text, graphics, and files that you may 9, 2002. and purchasers, provision of a notice to
download to a personal computer. ADDRESSES: Interested persons are occupants on the results of hazard
Updated on a regular basis, the CDRH invited to submit comments regarding evaluation and hazard reduction
home page includes device safety alerts, this proposal. Comments should refer to actions, and special reporting
Federal Register reprints, information the proposal by name and/or OMB requirements if there is a child with an
on premarket submissions (including approval number (2539–0009) and environmental intervention blood lead
lists of approved applications and should be sent to: Lauren Wittenberg, level residing in the unit, and record
manufacturers’ addresses), small OMB Desk Officer, Office of keeping requirements.

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