Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Olfactory Test Device; Availability, 32988-32989 [E6-8792]

Download as PDF 32988 Federal Register / Vol. 71, No. 109 / Wednesday, June 7, 2006 / Notices danger to the health of individuals. The final regulation for Banned Devices (44 FR 29221), which issued on May 18, 1979 (part 895 (21 CFR part 895)), contained certain reporting requirements (§§ 895.21(d) and 895.22(a)). FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section 800.55(g) 895.21(d) and 895.22(a) Total 1There Annual Frequency per Response No. of Respondents 1 26 Total Annual Responses 1 1 Hours per Response 1 26 Total Hours 25 16 25 416 441 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 No. of Recordkeepers Annual Frequency per Recordkeeper Total Annual Records Hours per Record 1 21 CFR Section 1 1 20 800.55(k) 1There Dated: June 1, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–8838 Filed 6–6–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D–0190] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Olfactory Test Device; Availability AGENCY: Food and Drug Administration, HHS. rwilkins on PROD1PC63 with NOTICES 20 are no capital costs or operating and maintenance costs associated with this collection of information. FDA’s estimate of the burden under the administrative detention provision is based on FDA’s discussion with the last firm whose devices had been detained. Historically, FDA has had very few or no annual responses for this information collection. ACTION: Total Hours Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Class II Special Controls Guidance Document: Olfactory Test Device.’’ This guidance document describes a means by which the olfactory test device may comply with the requirement of special controls for class II devices. It includes recommendations for validation of device performance and labeling. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify these device types into class II (special controls). VerDate Aug<31>2005 17:54 Jun 06, 2006 Jkt 208001 Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document entitled ‘‘Class II Special Controls Guidance Document: Olfactory Test Device’’ 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 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: Eric A. Mann, Center for Devices and Radiological Health (HFZ–460), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301–594–2080. SUPPLEMENTARY INFORMATION: DATES: I. Background Elsewhere in this issue of the Federal Register, FDA is publishing a final rule classifying olfactory test device into class II (special controls) under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 360c(f)(2)). This guidance document will serve as the special control for olfactory test device. Section 513(f)(2) of the act provides that any person who submits a premarket notification under section 510(k) of the act (21 U.S.C. 360(k)) for a device that has not previously been classified may, within 30 days after receiving an order classifying the device in class III under section 513(f)(1) of the act, request FDA to classify the device under the criteria set forth in section 513(a)(1) of the act. FDA shall, within 60 days of receiving such a request, classify the device by written order. This classification shall be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the Federal Register announcing such classification. Because of the timeframes established by section 513(f)(2) of the act, FDA has determined, under § 10.115(g)(2) (21 CFR 10.115(g)(2)), that it is not feasible to allow for public participation before issuing this guidance as a final guidance document. Therefore, FDA is issuing this guidance document as a level 1 guidance document that is immediately in effect. FDA will consider any comments that are received in response to this notice to determine whether to amend the guidance document. II. Significance of Guidance This guidance is being issued consistent with FDA’s good guidance practices regulation (§ 10.115). The guidance represents the agency’s current thinking on olfactory test devices. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An E:\FR\FM\07JNN1.SGM 07JNN1 Federal Register / Vol. 71, No. 109 / Wednesday, June 7, 2006 / Notices alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by using the Internet. To receive ‘‘Class II Special Controls Guidance Document: Olfactory Test Device,’’ you may either send an email request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 240– 276–3151 to receive a hard copy. Please use the document number 1595 to identify the guidance you are requesting. 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 reprints, information on premarket submissions [including lists of approved applications and manufacturers’ addresses], small manufacturer’s 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. rwilkins on PROD1PC63 with NOTICES IV. Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501–3520). The collections of information addressed in the guidance document have been approved by OMB in accordance with the PRA under the regulations governing premarket notification submissions (21 CFR part 807, subpart E, OMB control number 0910–0120). The labeling provisions addressed in the guidance have been approved by OMB 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 VerDate Aug<31>2005 17:54 Jun 06, 2006 Jkt 208001 32989 individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments received may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their visit. Dated: May 24, 2006. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E6–8792 Filed 6–6–06; 8:45 am] (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) Dated: May 31, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06–5146 Filed 6–6–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the Board of Scientific Counselors for Basic Sciences National Cancer Institute. The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Cancer Institutes, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Board of Scientific Counselors for Basic Sciences National Cancer Institute. Date: July 10, 2006. Time: 11 a.m. to 4 p.m. Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators. Place: National Institutes of Health, National Cancer Institute, 9000 Rockville Pike, Building 31/Conference Room 6, Bethesda, MD 20892. Time: 7 p.m. to 11 p.m. Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators. Place: National Institutes of Health, National Cancer Institute, 9000 Rockville Pike, Building 31/Conference Room 6, Bethesda, MD 20892. Contact Person: Florence E. Farber, PhD., Executive Secretary, Office of the Director, National Cancer Institute, National Institutes of Health, 6116 Executive Boulevard, Room 2115, Bethesda, MD 20892. 301–496–7628. ff6p@nih.gov. In the interest of security, NIH has instituted stringent procedures for entrance PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the National Cancer Institute Board of Scientific Advisors. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. Name of Committee: National Cancer Institute Board of Scientific Advisors. Date: June 29–30, 2006. Time: June 29, 2006, 8 a.m. to 6 p.m. Agenda: Director’s Report; Ongoing and New Business; Reports Program Review Group(s); and Budget Presentation; Reports of Special Initiatives; RFA and RFP Concept Review; and Scientific Presentations. Place: National Institutes of Health, Building 31, C Wing, 6 Floor, Conference Rm. 10, 9000 Rockville Pike, Bethesda, MD 20892. Time: June 30, 2006, 8:30 a.m. to 1 p.m. Agenda: Ongoing and New Business; Reports of Program Review Group(s); and Budget Presentation; Reports of Special Initiatives; RFA and RFP Concept Review; and Scientific Presentations. Place: National Institutes of Health, Building 31, C Wing, 6 Floor, Conference Rm. 10, 9000 Rockville Pike, Bethesda, MD 20892. Contact Person: Paulette S. Gray, Ph.D., Executive Secretary, Director, Division of E:\FR\FM\07JNN1.SGM 07JNN1

Agencies

[Federal Register Volume 71, Number 109 (Wednesday, June 7, 2006)]
[Notices]
[Pages 32988-32989]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-8792]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0190]


Guidance for Industry and Food and Drug Administration Staff; 
Class II Special Controls Guidance Document: Olfactory Test Device; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Class II Special Controls 
Guidance Document: Olfactory Test Device.'' This guidance document 
describes a means by which the olfactory test device may comply with 
the requirement of special controls for class II devices. It includes 
recommendations for validation of device performance and labeling. 
Elsewhere in this issue of the Federal Register, FDA is publishing a 
final rule to classify these device types into class II (special 
controls).

DATES: Submit written or electronic comments on this guidance at any 
time. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Class II Special Controls Guidance Document: 
Olfactory Test Device'' 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 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: Eric A. Mann, Center for Devices and 
Radiological Health (HFZ-460), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2080.

SUPPLEMENTARY INFORMATION:

I. Background

    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule classifying olfactory test device into class II (special 
controls) under section 513(f)(2) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360c(f)(2)). This guidance document 
will serve as the special control for olfactory test device.
    Section 513(f)(2) of the act provides that any person who submits a 
premarket notification under section 510(k) of the act (21 U.S.C. 
360(k)) for a device that has not previously been classified may, 
within 30 days after receiving an order classifying the device in class 
III under section 513(f)(1) of the act, request FDA to classify the 
device under the criteria set forth in section 513(a)(1) of the act. 
FDA shall, within 60 days of receiving such a request, classify the 
device by written order. This classification shall be the initial 
classification of the device. Within 30 days after the issuance of an 
order classifying the device, FDA must publish a notice in the Federal 
Register announcing such classification. Because of the timeframes 
established by section 513(f)(2) of the act, FDA has determined, under 
Sec.  10.115(g)(2) (21 CFR 10.115(g)(2)), that it is not feasible to 
allow for public participation before issuing this guidance as a final 
guidance document. Therefore, FDA is issuing this guidance document as 
a level 1 guidance document that is immediately in effect. FDA will 
consider any comments that are received in response to this notice to 
determine whether to amend the guidance document.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (Sec.  10.115). The guidance represents the 
agency's current thinking on olfactory test devices. It does not create 
or confer any rights for or on any person and does not operate to bind 
FDA or the public. An

[[Page 32989]]

alternative approach may be used if such approach satisfies the 
requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
using the Internet. To receive ``Class II Special Controls Guidance 
Document: Olfactory Test Device,'' you may either send an e-mail 
request to dsmica@fda.hhs.gov to receive an electronic copy of the 
document or send a fax request to 240-276-3151 to receive a hard copy. 
Please use the document number 1595 to identify the guidance you are 
requesting.
    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 reprints, information on premarket submissions [including 
lists of approved applications and manufacturers' addresses], small 
manufacturer's 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 http:/
/www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). 
The collections of information addressed in the guidance document have 
been approved by OMB in accordance with the PRA under the regulations 
governing premarket notification submissions (21 CFR part 807, subpart 
E, OMB control number 0910-0120). The labeling provisions addressed in 
the guidance have been approved by OMB 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. Comments received may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: May 24, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-8792 Filed 6-6-06; 8:45 am]
BILLING CODE 4160-01-S

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