Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus Species Detection, 28688-28689 [2011-12081]

Download as PDF 28688 Federal Register / Vol. 76, No. 96 / Wednesday, May 18, 2011 / Proposed Rules are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: ‘‘Comments to Docket No. FAA–2011–0047/Airspace Docket No. 11–AGL–1.’’ The postcard will be date/time stamped and returned to the commenter. wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1 Availability of NPRMs An electronic copy of this document may be downloaded through the Internet at https://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA’s Web page at https:// www.faa.gov/airports_airtraffic/ air_traffic/publications/ airspace_amendments/. You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see ADDRESSES section for address and phone number) between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. An informal docket may also be examined during normal business hours at the office of the Central Service Center, 2601 Meacham Blvd., Fort Worth, TX 76137. Persons interested in being placed on a mailing list for future NPRMs should contact the FAA’s Office of Rulemaking, (202) 267–9677, to request a copy of Advisory Circular No. 11–2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure. The Proposal This action proposes to amend Title 14, Code of Federal Regulations (14 CFR), Part 71 by amending Class E airspace extending upward from 700 feet above the surface for standard instrument approach procedures at Grand Marais/Cook County Airport, Grand Marais, MN. Controlled airspace is needed for the safety and management of IFR operations at the airport. Class E airspace areas are published in Paragraph 6005 of FAA Order 7400.9U, dated August 18, 2010 and effective September 15, 2010, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document would be published subsequently in the Order. VerDate Mar<15>2010 14:57 May 17, 2011 Jkt 223001 The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore, (1) Is not a ‘‘significant regulatory action’’ under Executive Order 12866; (2) is not a ‘‘significant rule’’ under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. The FAA’s authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency’s authority. This rulemaking is promulgated under the authority described in subtitle VII, part A, subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend controlled airspace at Grand Marais/Cook County Airport, Grand Marais, MN. Paragraph 6005 Class E Airspace areas extending upward from 700 feet or more above the surface of the earth. List of Subjects in 14 CFR Part 71 Airspace, Incorporation by reference, Navigation (air). AGENCY: The Proposed Amendment In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows: SUMMARY: PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 1. The authority citation for part 71 continues to read as follows: Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– 1963 Comp., p. 389. § 71.1 [Amended] 2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9U, Airspace Designations and Reporting Points, dated August 18, 2010, and effective September 15, 2010, is amended as follows: PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 * * * * * AGL MN E5 Grand Marais, MN [Amended] Grand Marais/Cook County Airport, MN (Lat. 47°50′18″ N., long. 90°22′59″ W.) Cook County NDB (Lat. 47°50′24″ N., long. 90°23′08″ W.) That airspace extending upward from 700 feet above the surface within a 6.4-mile radius of Grand Marais/Cook County Airport, and within 2 miles each side of the 275° bearing from the airport extending from the 6.4-mile radius to 8.3 miles west of the airport, and within 2.2 miles each side of the 104° bearing from the Cook County NDB extending from the 6.4-mile radius to 7 miles east of the airport, excluding that airspace which overlies P–204. Issued in Fort Worth, TX, on May 11, 2011. Walter L. Tweedy, Acting Manager, Operations Support Group, ATO Central Service Center. [FR Doc. 2011–12103 Filed 5–17–11; 8:45 am] BILLING CODE 4901–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA–2011–D–0102] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus Species Detection Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection.’’ This draft guidance document describes means by which in vitro diagnostic devices for Bacillus species (spp.) detection may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to classify in vitro diagnostic devices for Bacillus spp. detection into class II, subject to special controls. This draft guidance is not final nor is it in effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the E:\FR\FM\18MYP1.SGM 18MYP1 Federal Register / Vol. 76, No. 96 / Wednesday, May 18, 2011 / Proposed Rules final version of the guidance, submit either electronic or written comments on the draft guidance by August 16, 2011. Submit written requests for single copies of the draft guidance document entitled ‘‘Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection’’ to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301–847– 8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Beena Puri, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5553, Silver Spring, MD 20993–0002, 301–796–6202. SUPPLEMENTARY INFORMATION: wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1 ADDRESSES: I. Background This draft special controls guidance document was developed to support the proposed classification of in vitro diagnostic devices for Bacillus spp. detection, a previously unclassified preamendments device, into class II (special controls). On March 7, 2002, the Microbiology Devices Panel (the Panel) recommended that in vitro diagnostic devices for Bacillus spp. detection be classified into class II. The Panel believed that class II with the special controls (guidance document and limitations on the distribution) would provide reasonable assurance of the safety and effectiveness of the device. After the panel meeting, FDA found three additional in vitro diagnostic devices for Bacillus spp. detection to be substantially equivalent to another device within that type. This device has the same intended use as its predicate device but makes use of newer nucleic acid amplification technology (NAAT). While NAAT detection devices exhibit technological differences from the preamendments Bacillus spp. detection VerDate Mar<15>2010 14:57 May 17, 2011 Jkt 223001 devices, FDA has determined that they are as safe and effective as, and do not raise different questions of safety and effectiveness than, their predicates. (See section 513(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(i)).) This draft guidance document identifies the proposed classification regulation and product code and issues of safety and effectiveness that require special controls. Elsewhere in this Federal Register, in its publication of the proposed classification regulation, FDA is including proposed distribution limitations as another special control. FDA believes that the special controls described in the draft guidance and the proposed regulation when combined with general controls will be sufficient to provide reasonable assurance of the safety and effectiveness of these devices. II. Significance of Special Controls Guidance Document FDA believes that adherence to the recommendations described in this guidance document, if finalized, in addition to general controls, and the special control in the proposed rule, if finalized, will provide reasonable assurance of the safety and effectiveness of in vitro diagnostic devices for Bacillus spp. detection classified under § 866.3045 (21 CFR 866.3045). If classified as a class II device under § 866.3045, an in vitro diagnostic device for Bacillus spp. detection will need to comply with the requirement for special controls; manufacturers will need to address the issues requiring special controls as identified in the guidance document or by some other means that provides equivalent assurances of safety and effectiveness as well as comply with any additional controls specified in the classification regulation itself. 28689 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 (the PRA) (44 U.S.C. 3501–3520). The collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910–0120, and the collections of information in 21 CFR part 801, and 21 CFR 809.10 have been approved under OMB control number 0910–0485. The labeling requirement listed in Section 8A, ‘‘Intended Use,’’ is not subject to review under the PRA because it is a public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public (5 CFR 1320.3(c)(2) and 21 CFR 1040.10(g)). V. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES), either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments 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: May 12, 2011. Nancy K. Stade, Deputy Director for Policy, Center for Devices and Radiological Health. [FR Doc. 2011–12081 Filed 5–17–11; 8:45 am] BILLING CODE 4160–01–P III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. A search capability for all CDRH guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov. To receive ‘‘Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection,’’ 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 301–847–8149 to receive a hard copy. Please use the document number 1667 to identify the guidance you are requesting. PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA–2011–N–0103] Microbiology Devices; Classification of In Vitro Diagnostic Device for Bacillus Species Detection AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. The Food and Drug Administration (FDA) is proposing to classify in vitro diagnostic devices for Bacillus species (spp). detection into SUMMARY: E:\FR\FM\18MYP1.SGM 18MYP1

Agencies

[Federal Register Volume 76, Number 96 (Wednesday, May 18, 2011)]
[Proposed Rules]
[Pages 28688-28689]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-12081]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2011-D-0102]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Class II Special Controls Guidance Document: In Vitro Diagnostic 
Devices for Bacillus Species Detection

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Class II Special Controls 
Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. 
Detection.'' This draft guidance document describes means by which in 
vitro diagnostic devices for Bacillus species (spp.) detection may 
comply with the requirement of special controls for class II devices. 
Elsewhere in this issue of the Federal Register, FDA is publishing a 
proposed rule to classify in vitro diagnostic devices for Bacillus spp. 
detection into class II, subject to special controls. This draft 
guidance is not final nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comments on 
this draft guidance before it begins work on the

[[Page 28689]]

final version of the guidance, submit either electronic or written 
comments on the draft guidance by August 16, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Class II Special Controls Guidance 
Document: In Vitro Diagnostic Devices for Bacillus spp. Detection'' to 
the Division of Small Manufacturers, International, and Consumer 
Assistance, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request, or fax your request to 301-847-
8149. See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the guidance.
    Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Beena Puri, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5553, Silver Spring, MD 20993-0002, 301-796-6202.

SUPPLEMENTARY INFORMATION: 

I. Background

    This draft special controls guidance document was developed to 
support the proposed classification of in vitro diagnostic devices for 
Bacillus spp. detection, a previously unclassified preamendments 
device, into class II (special controls). On March 7, 2002, the 
Microbiology Devices Panel (the Panel) recommended that in vitro 
diagnostic devices for Bacillus spp. detection be classified into class 
II. The Panel believed that class II with the special controls 
(guidance document and limitations on the distribution) would provide 
reasonable assurance of the safety and effectiveness of the device.
    After the panel meeting, FDA found three additional in vitro 
diagnostic devices for Bacillus spp. detection to be substantially 
equivalent to another device within that type. This device has the same 
intended use as its predicate device but makes use of newer nucleic 
acid amplification technology (NAAT). While NAAT detection devices 
exhibit technological differences from the preamendments Bacillus spp. 
detection devices, FDA has determined that they are as safe and 
effective as, and do not raise different questions of safety and 
effectiveness than, their predicates. (See section 513(i) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(i)).)
    This draft guidance document identifies the proposed classification 
regulation and product code and issues of safety and effectiveness that 
require special controls. Elsewhere in this Federal Register, in its 
publication of the proposed classification regulation, FDA is including 
proposed distribution limitations as another special control. FDA 
believes that the special controls described in the draft guidance and 
the proposed regulation when combined with general controls will be 
sufficient to provide reasonable assurance of the safety and 
effectiveness of these devices.

II. Significance of Special Controls Guidance Document

    FDA believes that adherence to the recommendations described in 
this guidance document, if finalized, in addition to general controls, 
and the special control in the proposed rule, if finalized, will 
provide reasonable assurance of the safety and effectiveness of in 
vitro diagnostic devices for Bacillus spp. detection classified under 
Sec.  866.3045 (21 CFR 866.3045). If classified as a class II device 
under Sec.  866.3045, an in vitro diagnostic device for Bacillus spp. 
detection will need to comply with the requirement for special 
controls; manufacturers will need to address the issues requiring 
special controls as identified in the guidance document or by some 
other means that provides equivalent assurances of safety and 
effectiveness as well as comply with any additional controls specified 
in the classification regulation itself.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. A search capability for all CDRH guidance 
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at https://www.regulations.gov. To receive 
``Class II Special Controls Guidance Document: In Vitro Diagnostic 
Devices for Bacillus spp. Detection,'' 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 301-847-8149 to receive a hard copy. 
Please use the document number 1667 to identify the guidance you are 
requesting.

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 (the PRA) (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 807, subpart E, 
have been approved under OMB control number 0910-0120, and the 
collections of information in 21 CFR part 801, and 21 CFR 809.10 have 
been approved under OMB control number 0910-0485.
    The labeling requirement listed in Section 8A, ``Intended Use,'' is 
not subject to review under the PRA because it is a public disclosure 
of information originally supplied by the Federal Government to the 
recipient for the purpose of disclosure to the public (5 CFR 
1320.3(c)(2) and 21 CFR 1040.10(g)).

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments 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: May 12, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-12081 Filed 5-17-11; 8:45 am]
BILLING CODE 4160-01-P

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