Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation Systems; Availability, 44594-44595 [2011-18805]

Download as PDF 44594 Federal Register / Vol. 76, No. 143 / Tuesday, July 26, 2011 / Notices Dated: July 21, 2011. David Dorsey, Acting Deputy Commissioner for Policy, Planning and Budget. DEPARTMENT OF HEALTH AND HUMAN SERVICES MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Ann H. Costello, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2460, Silver Spring, MD 20993–0002, 301–796–6493. SUPPLEMENTARY INFORMATION: Food and Drug Administration I. Background [Docket No. FDA–2011–D–0465] This guidance document will serve as the special control for rTMS systems. Section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(2)) provides that any person who submits a premarket notification under section 510(k) of the FD&C 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 FD&C Act, request FDA to classify the device under the criteria set forth in section 513(a)(1) of the FD&C Act. FDA will, within 60 days of receiving such a request, classify the device by written order. This classification will 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 this classification. Because of the timeframes established by section 513(f)(2) of the FD&C Act, FDA has determined, under 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. Thus, FDA is issuing this guidance document as a level 1 guidance document that is for immediate implementation. FDA will consider any comments that are received in response to this notice to determine whether to revise the guidance document. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule classifying rTMS systems into class II (special controls), under section 513(f)(2) of the FD&C Act. [FR Doc. 2011–18880 Filed 7–25–11; 8:45 am] BILLING CODE 4160–01–P Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation Systems; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation Systems.’’ This guidance document describes a means by which a repetitive transcranial magnetic stimulation (rTMS) system may comply with the requirement of special controls for class II devices. This guidance document is being immediately implemented as the special control for rTMS systems, but it remains subject to comment in accordance with the Agency’s good guidance practices. DATES: Submit either electronic or written 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: Repetitive Transcranial Magnetic Stimulation Systems’’ 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 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, sroberts on DSK5SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 16:12 Jul 25, 2011 Jkt 223001 II. Significance of Special Controls Guidance FDA believes that adherence to the recommendations described in this guidance, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of rTMS systems classified under 882.5805 (21 CFR 882.5805). In order to be classified as a class II device under 882.5805, a rTMS system must comply with the requirements of special controls; manufacturers must address the issues requiring special controls as PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 identified in the guidance document, either by following the recommendations in the guidance document or by some other means that provides equivalent assurances of safety and effectiveness. III. Electronic Access Persons interested in obtaining a copy of the 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: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems’’ 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 paper copy. Please use the document number 1728 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This 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 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 56.115 have been approved under OMB control number 0910–0130; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910–0078; and 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) 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. E:\FR\FM\26JYN1.SGM 26JYN1 Federal Register / Vol. 76, No. 143 / Tuesday, July 26, 2011 / Notices Dated: July 20, 2011. Nancy K. Stade, Deputy Director for Policy, Center for Devices and Radiological Health. [FR Doc. 2011–18805 Filed 7–25–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0002] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. sroberts on DSK5SPTVN1PROD with NOTICES ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Oncologic Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on September 14, 2011, from 8 a.m. to 5 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993– 0002. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/default.htm; under the heading ‘‘Resources for You,’’ click on ‘‘Public Meetings at the FDA White Oak Campus.’’ Please note that visitors to the White Oak Campus must enter through Building 1. Contact Person: Caleb Briggs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301– 796–9001, FAX: 301–847–8533, e-mail: ODAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), and follow the prompts to the desired center or product area. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site and VerDate Mar<15>2010 16:12 Jul 25, 2011 Jkt 223001 call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: On September 14, 2011, during the morning session, the committee will discuss new drug application 021825, with the proposed trade name Ferriprox (deferiprone) filmcoated tablets, application submitted by ApoPharma, Inc., represented by Cato Research Ltd. (authorized U.S. agent). The proposed indication (use) for this product is for the treatment of patients with transfusional iron overload (excess iron in the body related to blood transfusions), when current chelation therapy is inadequate. (Chelation therapy in these patients binds iron in a form that allows it to be eliminated from the body). During the afternoon session, the committee will consider the development of products for the treatment of patients with nonmetastatic castration resistant prostate cancer (CRPC) who have a rising serum level of prostate-specific antigen (PSA) despite being on androgen deprivation therapy (ADT). There are no products currently approved for this indication. No specific products will be presented or discussed; rather, the committee will be asked to consider possible trial designs and suitable clinical endpoints to establish efficacy that would support a labeled indication for treatment of nonmetastatic CRPC after PSA progression on ADT. Because ADT is an unproven therapy for this condition with serious long-term toxicity, the committee will be asked whether approval of a new therapy in conjunction with continued ADT would be appropriate for patients with non-metastatic CRPC. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before August 30, 2011. Oral presentations from the public will be scheduled between approximately 10:30 to 11 a.m., and 3 to 3:30 p.m. PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 44595 Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before August 22, 2011. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by August 23, 2011. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Caleb Briggs at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: July 20, 2011. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2011–18877 Filed 7–25–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0002] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee E:\FR\FM\26JYN1.SGM 26JYN1

Agencies

[Federal Register Volume 76, Number 143 (Tuesday, July 26, 2011)]
[Notices]
[Pages 44594-44595]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18805]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0465]

Guidance for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Document: Repetitive Transcranial
Magnetic Stimulation Systems; 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: Repetitive Transcranial Magnetic Stimulation
Systems.'' This guidance document describes a means by which a
repetitive transcranial magnetic stimulation (rTMS) system may comply
with the requirement of special controls for class II devices. This
guidance document is being immediately implemented as the special
control for rTMS systems, but it remains subject to comment in
accordance with the Agency's good guidance practices.

DATES: Submit either electronic or written 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:
Repetitive Transcranial Magnetic Stimulation Systems'' 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 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: Ann H. Costello, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2460, Silver Spring, MD 20993-0002, 301-
796-6493.

SUPPLEMENTARY INFORMATION:

I. Background

This guidance document will serve as the special control for rTMS
systems. Section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 360c(f)(2)) provides that any person who
submits a premarket notification under section 510(k) of the FD&C 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 FD&C Act, request FDA to
classify the device under the criteria set forth in section 513(a)(1)
of the FD&C Act. FDA will, within 60 days of receiving such a request,
classify the device by written order. This classification will 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 this classification. Because of the
timeframes established by section 513(f)(2) of the FD&C Act, FDA has
determined, under 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. Thus, FDA is issuing this guidance document as a
level 1 guidance document that is for immediate implementation. FDA
will consider any comments that are received in response to this notice
to determine whether to revise the guidance document. Elsewhere in this
issue of the Federal Register, FDA is publishing a final rule
classifying rTMS systems into class II (special controls), under
section 513(f)(2) of the FD&C Act.

II. Significance of Special Controls Guidance

FDA believes that adherence to the recommendations described in
this guidance, in addition to the general controls, will provide
reasonable assurance of the safety and effectiveness of rTMS systems
classified under 882.5805 (21 CFR 882.5805). In order to be classified
as a class II device under 882.5805, a rTMS system must comply with the
requirements of special controls; manufacturers must address the issues
requiring special controls as identified in the guidance document,
either by following the recommendations in the guidance document or by
some other means that provides equivalent assurances of safety and
effectiveness.

III. Electronic Access

Persons interested in obtaining a copy of the 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:
Repetitive Transcranial Magnetic Stimulation (rTMS) Systems'' 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 paper copy. Please use the document number 1728 to
identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

This 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
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 56.115 have been approved under OMB control
number 0910-0130; the collections of information in 21 CFR part 812
have been approved under OMB control number 0910-0078; and 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) 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.

[[Page 44595]]

Dated: July 20, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-18805 Filed 7-25-11; 8:45 am]
BILLING CODE 4160-01-P

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