Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 53773-53774 [2013-21191]

Download as PDF Federal Register / Vol. 78, No. 169 / Friday, August 30, 2013 / Notices Dated: August 27, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–21236 Filed 8–29–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–0920] Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Select Updates for NonClinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems.’’ FDA has developed this guidance to inform the coronary and peripheral stent industry about selected updates to FDA’s thinking regarding certain non-clinical testing for these devices. While FDA is considering more substantial updates to the ‘‘NonClinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems’’ guidance (https:// www.fda.gov/medicaldevices/ deviceregulationandguidance/ guidancedocuments/ucm071863.htm), we are issuing this update on select sections in order to notify the industry in a timely manner of our revised recommendations. This draft guidance is not final nor is it in effect at this time.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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 30, 2013. ADDRESSES: Submit written requests for single copies of the draft guidance document entitled ‘‘Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems’’ to the Division of Small Manufacturers, International, and Consumer Assistance, Center for tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 18:00 Aug 29, 2013 Jkt 229001 Devices and Radiological Health (CDRH), 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: Lindsay Pack, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.66, Rm. 1270, Silver Spring, MD 20993–0002, 301–796–5214; or Erica Takai, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.62, Rm. 3226, Silver Spring, MD 20993–0002, 301–796–6353. SUPPLEMENTARY INFORMATION: I. Background FDA held a public workshop entitled ‘‘Cardiovascular Metallic Implants: Corrosion, Surface Characterization, and Nickel Leaching’’ on March 8 and 9, 2012, that provided information on current practices for performing these tests (see https://www.fda.gov/ MedicalDevices/NewsEvents/ WorkshopsConferences/ ucm287535.htm). A group of participants from industry, test facilities, and academia provided comments on practices for corrosion testing and nickel ion release testing. Based on the discussion at the workshop, this draft guidance updates a key aspect of sample conditioning for pitting corrosion testing that is less burdensome, and includes additional information on when galvanic corrosion testing may be omitted with justification, based on information gained from the workshop. This guidance provides updates only for the following topics: • Pitting corrosion potential; • Galvanic corrosion; • Surface characterization; and • Nickel ion release. This draft guidance provides crossreferences and updates to the related sections of the existing ‘‘Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 53773 Associated Delivery Systems’’ guidance. Following the close of the comment period on this guidance, FDA intends to consider the comments received, revise this draft guidance as appropriate, and publish it in final. Simultaneously, FDA will issue an update to the existing guidance to add cross-references where this selected updates guidance supersedes the existing recommendations. Subsequently, FDA will incorporate the elements of the final select updates guidance into an anticipated revision of the entire ‘‘NonClinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems’’ guidance. This draft guidance also lists the relevant product codes for stents addressed in the guidance. Of note is that the product code NXP (Stent, Tibial), which is not currently listed in the existing ‘‘Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems’’ guidance, has been added. This product code was not created until after the current guidance was published, however, the recommendations in this draft guidance are applicable to tibial stents. Further, FDA will include this product code in the anticipated revision of the entire ‘‘Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems’’ guidance. 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 certain non-clinical testing for coronary and peripheral stents. 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. 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 ‘‘Select Updates for NonClinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems,’’ you may either send E:\FR\FM\30AUN1.SGM 30AUN1 53774 Federal Register / Vol. 78, No. 169 / Friday, August 30, 2013 / Notices an email 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 1826 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 (44 U.S.C. 3501–3520). The collections of information in 21 CFR part 814 have been approved under OMB control number 0910–0231. V. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of 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, and will be posted to the docket at https:// www.regulations.gov. Dated: August 23, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–21191 Filed 8–29–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID FEMA–2013–0019; OMB No. 1660–0026] Agency Information Collection Activities: Submission for OMB Review; Comment Request Federal Emergency Management Agency, DHS. ACTION: Notice. AGENCY: The Federal Emergency Management Agency (FEMA) will submit the information collection abstracted below to the Office of Management and Budget for review and clearance in accordance with the requirements of the Paperwork Reduction Act of 1995. The submission will describe the nature of the tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 18:00 Aug 29, 2013 Jkt 229001 information collection, the categories of respondents, the estimated burden (i.e., the time, effort and resources used by respondents to respond) and cost, and the actual data collection instruments FEMA will use. DATES: Comments must be submitted on or before September 30, 2013. ADDRESSES: Submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the Desk Officer for the Department of Homeland Security, Federal Emergency Management Agency, and sent via electronic mail to oira.submission@omb.eop.gov or faxed to (202) 395–5806. FOR FURTHER INFORMATION CONTACT: Requests for additional information or copies of the information collection should be made to Director, Records Management Division, 1800 South Bell Street, Arlington, VA 20598–3005, facsimile number (202) 646–3347, or email address FEMA-InformationCollections-Management@dhs.gov. SUPPLEMENTARY INFORMATION: Collection of Information Title: State Administrative Plan for the Hazard Mitigation Grant Program. Type of information collection: Extension, without change, of a currently approved information collection. Form Titles and Numbers: None. Abstract: The State Administrative Plan is a procedural guide that details how the State will administer the HMGP. The State must have a current administrative plan approved by the appropriate FEMA Regional Administrator before receiving HMGP funds. The administrative plan may take any form including a chapter within a comprehensive State mitigation program strategy. Affected Public: State, local or Tribal government. Estimated Number of Respondents: 32. Estimated Total Annual Burden Hours: 512. Estimated Cost: There are no recordkeeping, capital, start-up or maintenance costs associated with this information collection. Dated: August 22, 2013. Charlene D. Myrthil, Director, Records Management Division, Mission Support Bureau, Federal Emergency Management Agency, Department of Homeland Security. [FR Doc. 2013–21244 Filed 8–29–13; 8:45 am] BILLING CODE 9110–13–P PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID FEMA–2013–0040] Guide for the Evaluation of Alert and Notification Systems for Nuclear Power Plants, FEMA–REP–10, Rev. 1 Federal Emergency Management Agency; DHS. ACTION: Notice of availability of proposed policy; request for comments. AGENCY: The Federal Emergency Management Agency (FEMA) requests public comments on the Guide for the Evaluation of Alert and Notification Systems for Nuclear Power Plants, FEMA–REP–10, Rev. 1. DATES: Comments must be received by October 29, 2013. ADDRESSES: You may submit comments, identified by Docket ID FEMA–2013– 0040, by one of the following methods: Federal eRulemaking Portal: https:// www.regulations.gov Follow the instructions for submitting comments. Please note that this proposed policy is not a rulemaking and the Federal Rulemaking Portal is being utilized only as a mechanism for receiving comments. Mail/Hand Delivery/Courier: Regulatory Affairs Division, Office of Chief Counsel, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472. FOR FURTHER INFORMATION CONTACT: John Schafer, Engineer, Professional Services Branch, Technological Hazards Division, Protection and National Preparedness Directorate, John.Schafer@ fema.dhs.gov. (202) 341–4896. SUPPLEMENTARY INFORMATION: SUMMARY: I. Public Participation Instructions: All submissions received must include the agency name and docket ID. Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at https:// www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to read the Privacy Act notice, which can be viewed by clicking on the ‘‘Privacy Notice’’ link on the homepage of www.regulations.gov. You may submit your comments and material by methods specified in the ADDRESSES section. Please submit your comments and any supporting material by only one means to avoid the receipt and review of duplicate submissions. E:\FR\FM\30AUN1.SGM 30AUN1

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[Federal Register Volume 78, Number 169 (Friday, August 30, 2013)]
[Notices]
[Pages 53773-53774]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-21191]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0920]


Select Updates for Non-Clinical Engineering Tests and Recommended 
Labeling for Intravascular Stents and Associated Delivery Systems; 
Draft Guidance for Industry and Food and Drug Administration Staff; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Select Updates for Non-
Clinical Engineering Tests and Recommended Labeling for Intravascular 
Stents and Associated Delivery Systems.'' FDA has developed this 
guidance to inform the coronary and peripheral stent industry about 
selected updates to FDA's thinking regarding certain non-clinical 
testing for these devices. While FDA is considering more substantial 
updates to the ``Non-Clinical Engineering Tests and Recommended 
Labeling for Intravascular Stents and Associated Delivery Systems'' 
guidance (https://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm071863.htm), we are 
issuing this update on select sections in order to notify the industry 
in a timely manner of our revised recommendations. 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 comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 30, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Select Updates for Non-Clinical 
Engineering Tests and Recommended Labeling for Intravascular Stents and 
Associated Delivery Systems'' to the Division of Small Manufacturers, 
International, and Consumer Assistance, Center for Devices and 
Radiological Health (CDRH), 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: Lindsay Pack, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg.66, Rm. 1270, Silver Spring, MD 20993-0002, 301-796-5214; or 
Erica Takai, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg.62, Rm. 3226, Silver 
Spring, MD 20993-0002, 301-796-6353.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA held a public workshop entitled ``Cardiovascular Metallic 
Implants: Corrosion, Surface Characterization, and Nickel Leaching'' on 
March 8 and 9, 2012, that provided information on current practices for 
performing these tests (see https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm287535.htm). A group of participants 
from industry, test facilities, and academia provided comments on 
practices for corrosion testing and nickel ion release testing. Based 
on the discussion at the workshop, this draft guidance updates a key 
aspect of sample conditioning for pitting corrosion testing that is 
less burdensome, and includes additional information on when galvanic 
corrosion testing may be omitted with justification, based on 
information gained from the workshop. This guidance provides updates 
only for the following topics:
     Pitting corrosion potential;
     Galvanic corrosion;
     Surface characterization; and
     Nickel ion release.
    This draft guidance provides cross-references and updates to the 
related sections of the existing ``Non-Clinical Engineering Tests and 
Recommended Labeling for Intravascular Stents and Associated Delivery 
Systems'' guidance. Following the close of the comment period on this 
guidance, FDA intends to consider the comments received, revise this 
draft guidance as appropriate, and publish it in final. Simultaneously, 
FDA will issue an update to the existing guidance to add cross-
references where this selected updates guidance supersedes the existing 
recommendations. Subsequently, FDA will incorporate the elements of the 
final select updates guidance into an anticipated revision of the 
entire ``Non-Clinical Engineering Tests and Recommended Labeling for 
Intravascular Stents and Associated Delivery Systems'' guidance.
    This draft guidance also lists the relevant product codes for 
stents addressed in the guidance. Of note is that the product code NXP 
(Stent, Tibial), which is not currently listed in the existing ``Non-
Clinical Engineering Tests and Recommended Labeling for Intravascular 
Stents and Associated Delivery Systems'' guidance, has been added. This 
product code was not created until after the current guidance was 
published, however, the recommendations in this draft guidance are 
applicable to tibial stents. Further, FDA will include this product 
code in the anticipated revision of the entire ``Non-Clinical 
Engineering Tests and Recommended Labeling for Intravascular Stents and 
Associated Delivery Systems'' guidance.

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 certain non-
clinical testing for coronary and peripheral stents. 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.

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 ``Select Updates for Non-Clinical Engineering Tests and 
Recommended Labeling for Intravascular Stents and Associated Delivery 
Systems,'' you may either send

[[Page 53774]]

an email 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 1826 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 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 814 have been approved under 
OMB control number 0910-0231.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to https://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of 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, and will be posted to the docket at https://www.regulations.gov.

    Dated: August 23, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-21191 Filed 8-29-13; 8:45 am]
BILLING CODE 4160-01-P
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