Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities; Availability, 17476-17477 [E6-4961]

Download as PDF 17476 Federal Register / Vol. 71, No. 66 / Thursday, April 6, 2006 / Notices security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations may apply but are not limited to: the Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the EGovernment Act of 2002, the ClingerCohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A–130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: all pertinent National Institute of Standards and Technology publications; the HHS Information Systems Program Handbook and the CMS Information Security Handbook. RETENTION AND DISPOSAL: CMS will retain identifiable MEDPAR data for a total period not to exceed 25 years. All claims-related records are encompassed by the document preservation order and will be retained until notification is received from DOJ. Director, Division of Acute Care, Hospital and Ambulatory Provider Group, Center for Medicare Management, CMS, Room C4–08–06, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. sroberts on PROD1PC70 with NOTICES NOTIFICATION PROCEDURE: For purpose of access, the subject individual should write to the system manager who will require the system name, HICN, address, age, gender, and for verification purposes, the subject individual’s name (woman’s maiden name, if applicable) and social security number (SSN). Furnishing the SSN is voluntary, but it may make searching for a record easier and prevent delay. RECORD ACCESS PROCEDURE: For purpose of access, use the same procedures outlined in Notification 19:52 Apr 05, 2006 CONTESTING RECORD PROCEDURES: The subject individual should contact the system manager named above, and reasonably identify the record and specify the information to be contested. State the corrective action sought and the reasons for the correction with supporting justification. (These procedures are in accordance with Department regulation 45 CFR 5b.7). RECORD SOURCE CATEGORIES: CMS’s National Claims History system of records, enrollment data on Medicare beneficiaries, and SSI eligibility information from the Social Security Administration. SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT: None. [FR Doc. E6–4953 Filed 4–5–06; 8:45 am] Jkt 208001 Submit written requests for single copies of the draft guidance document entitled ‘‘Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ–220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one selfaddressed adhesive label to assist that office in processing your request, or fax your request to 301–443–8818. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this draft guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. Identify comments with the docket number found in brackets in the heading of this document. ADDRESSES: DEPARTMENT OF HEALTH AND HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: Charles N. Durfor, Center for Devices and Radiological Health (HFZ–410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301– 594–3090. Food and Drug Administration SUPPLEMENTARY INFORMATION: [Docket No. 2006D–0112] I. Background BILLING CODE 4120–01–P Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities; Availability AGENCY: Food and Drug Administration, HHS. ACTION: SYSTEM MANAGER AND ADDRESS: VerDate Aug<31>2005 Procedures above. Requestors should also reasonably specify the record contents being sought. (These procedures are in accordance with Department regulation 45 CFR 5b.5(a)(2)). Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance for industry and FDA entitled ‘‘Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities.’’ It was developed as a special control to support the reclassification of the topical oxygen chamber for extremities (TOCE) from class III (premarket approval) into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to reclassify the TOCE device from class III into class II (special controls). This draft guidance is neither final nor is it in effect at this time. DATES: Submit written or electronic comments on this draft guidance by July 5, 2006. PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 FDA is announcing the availability of a draft guidance for industry and FDA staff entitled ‘‘Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities.’’ Following the effective date of any final reclassification rule based on this proposal, any firm submitting a premarket notification (510(k)) for the TOCE will need to address the issues covered in the special controls guidance document. However, the firm need only show that its device meets the recommendations of the guidance document or in some other way provides equivalent assurances of safety and effectiveness. II. Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency’s current thinking on the TOCE. 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 requirements of the applicable statute and regulations. E:\FR\FM\06APN1.SGM 06APN1 Federal Register / Vol. 71, No. 66 / Thursday, April 6, 2006 / Notices III. Electronic Access To receive ‘‘Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities’’ by fax, call the CDRH Facts-On-Demand system at 800–899–0381 or 301–827–0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number (1582) followed by the pound sign (#). Follow the remaining voice prompts to complete your request. Persons interested in obtaining a copy of the draft guidance may also do so by using the Internet. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, Federal Register notices, 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 web site may be accessed at https://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available at https:// www.fda.gov/cdrh/guidance.html. Guidance documents are also available on the Division of Dockets Management Internet site at https://www.fda.gov/ ohrms/dockets. IV. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520) (the PRA). The collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910–0120. The collections of information in 21 CFR part 801 have been approved under OMB control number 0910–0485. sroberts on PROD1PC70 with NOTICES V. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES), written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received VerDate Aug<31>2005 19:52 Apr 05, 2006 Jkt 208001 comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: March 27, 2006. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E6–4961 Filed 4–5–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HOMELAND SECURITY Transportation Security Administration Aviation Security Advisory Committee Meeting Transportation Security Administration (TSA), DHS. ACTION: Notice of meeting. AGENCY: This notice announces a public meeting of the Aviation Security Advisory Committee (ASAC). DATES: The meeting will take place on May 3, 2006, from 9 a.m. to 12:30 p.m., or until the conclusion of the committee’s business. ADDRESSES: The meeting will be held at the Residence Inn by Marriott Pentagon City, 550 Army Navy Drive, Arlington VA 22202. FOR FURTHER INFORMATION CONTACT: Joseph Corrao, Office of Transportation Sector Network Integration, Transportation Security Administration, 601 South 12th Street, Arlington, VA 22202–4220; telephone 571–227–2980, e-mail joseph.corrao@dhs.gov. SUPPLEMENTARY INFORMATION: This meeting is announced pursuant to section 10(a)(2) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.). The agenda for the meeting will include— • Final report on the actions of the Airport Security Design Guidelines Working Group; • Status reports on the actions of the Air Cargo Security Working Group, the Aviation Security Impact Assessment Working Group, and the Baggage Security Investment Study Working Group; and • Other aviation security topics. This meeting is open to the public but attendance is limited to space available. Doors open at 8:30 a.m. Members of the public must make advance arrangements to present oral statements at the meeting. Written statements may be presented to the committee by providing copies of them to the person listed under the heading FOR FURTHER INFORMATION CONTACT prior to or at the meeting. Anyone in need of SUMMARY: PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 17477 assistance or a reasonable accommodation for the meeting should contact the person listed under the heading FOR FURTHER INFORMATION CONTACT. In addition, sign and oral interpretation, as well as a listening device, can be made available at the meeting if requested 10 calendar days before the meeting. Arrangements may be made by contacting the person listed under the heading FOR FURTHER INFORMATION CONTACT. Issued in Arlington, Virginia, on March 31, 2006. Charlotte Bryan, Acting Assistant Administrator, Transportation Sector Network Management. [FR Doc. E6–5032 Filed 4–5–06; 8:45 am] BILLING CODE 4910–62–P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR–5042–N–02] Notice of Proposed Information Collection: Healthy Homes and Lead Hazard Control Programs Data Collection—Progress Reporting Office of Healthy Homes and Lead Hazard Control, HUD. ACTION: Notice. AGENCY: SUMMARY: The revised information collection requirement described below will be submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. DATES: Comments Due Date: June 5, 2006. Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Katina Flythe, Reports Liaison Officer, Department of Housing and Urban Development, 451 7th Street, SW., Room P–3206, Washington, DC 20410. FOR FURTHER INFORMATION CONTACT: Lillian Deitzer, Reports Management Officer, Q, Department of Housing and Urban Development, 451 Seventh Street, SW., Washington, DC 20410; (202) 708– 2374. (This is not a toll-free number. Hearing- or speech-impaired persons may access the number above via TTY by calling the toll-free Federal Information Relay Service at 1–800– 877–8339). SUPPLEMENTARY INFORMATION: The Department will submit the proposed information collection to OMB for ADDRESSES: E:\FR\FM\06APN1.SGM 06APN1

Agencies

[Federal Register Volume 71, Number 66 (Thursday, April 6, 2006)]
[Notices]
[Pages 17476-17477]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-4961]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0112]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Class II Special Controls Guidance Document: Topical Oxygen 
Chamber for Extremities; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance for industry and FDA entitled 
``Class II Special Controls Guidance Document: Topical Oxygen Chamber 
for Extremities.'' It was developed as a special control to support the 
reclassification of the topical oxygen chamber for extremities (TOCE) 
from class III (premarket approval) into class II (special controls). 
Elsewhere in this issue of the Federal Register, FDA is publishing a 
proposed rule to reclassify the TOCE device from class III into class 
II (special controls). This draft guidance is neither final nor is it 
in effect at this time.

DATES:  Submit written or electronic comments on this draft guidance by 
July 5, 2006.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Class II Special Controls Guidance 
Document: Topical Oxygen Chamber for Extremities to the Division of 
Small Manufacturers, International, and Consumer Assistance (HFZ-220), 
Center for Devices and Radiological Health, Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-
addressed adhesive label to assist that office in processing your 
request, or fax your request to 301-443-8818. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidance.
    Submit written comments concerning this draft guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments to https://www.fda.gov/dockets/ecomments. Identify comments 
with the docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Charles N. Durfor, Center for Devices 
and Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301- 594-3090.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
and FDA staff entitled ``Class II Special Controls Guidance Document: 
Topical Oxygen Chamber for Extremities.''
    Following the effective date of any final reclassification rule 
based on this proposal, any firm submitting a premarket notification 
(510(k)) for the TOCE will need to address the issues covered in the 
special controls guidance document. However, the firm need only show 
that its device meets the recommendations of the guidance document or 
in some other way provides equivalent assurances of safety and 
effectiveness.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on the TOCE. 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 requirements of the applicable statute 
and regulations.

[[Page 17477]]

III. Electronic Access

    To receive ``Class II Special Controls Guidance Document: Topical 
Oxygen Chamber for Extremities'' by fax, call the CDRH Facts-On-Demand 
system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. 
Press 1 to enter the system. At the second voice prompt, press 1 to 
order a document. Enter the document number (1582) followed by the 
pound sign (). Follow the remaining voice prompts to complete 
your request.
    Persons interested in obtaining a copy of the draft guidance may 
also do so by using the Internet. CDRH maintains an entry on the 
Internet for easy access to information including text, graphics, and 
files that may be downloaded to a personal computer with Internet 
access. Updated on a regular basis, the CDRH home page includes device 
safety alerts, Federal Register notices, 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 web site may be 
accessed at https://www.fda.gov/cdrh. A search capability for all CDRH 
guidance documents is available at https://www.fda.gov/cdrh/
guidance.html. Guidance documents are also available on the Division of 
Dockets Management Internet site at https://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) (the 
PRA). The collections of information in 21 CFR part 807, subpart E, 
have been approved under OMB control number 0910-0120. The collections 
of information in 21 CFR part 801 have been approved under OMB control 
number 0910-0485.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), written or electronic comments regarding this 
document. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with the docket number found 
in brackets in the heading of this document. Received comments may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: March 27, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-4961 Filed 4-5-06; 8:45 am]
BILLING CODE 4160-01-S

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