Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems; Guidance for Industry and Food and Drug Administration Staff; Availability, 50008-50009 [2015-20308]

Download as PDF 50008 Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Notices EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN Total burden hours Form name/activity Average hourly wage rate * Total cost burden Cognitive interviews (HSOPS 2.0 and supplemental items) ........................................... Pilot test and bridge study ............................................................................................... 90 2,297 a $35.38 b 34.98 $3,184.20 80,349.06 Total .......................................................................................................................... 2,387 na 83,533.26 a Based on the weighted average hourly wage in hospitals for one physician (29–1060; $101.53), one registered nurse (29–1141; $30.22), one general and operations manager (11–1021; $52.64), and six clinical lab techs (29–2010; $22.34) whose hourly wage is meant to represent wages for other hospital employees who may participate in cognitive interviews b Based on the weighted average hourly wage in hospitals for 1,981 registered nurses, 209 clinical lab techs, 176 physicians and surgeons, and 21 general and operations managers * National Industry-Specific Occupational Employment and Wage Estimates, May 2013, from the Bureau of Labor Statistics (available at https:// www.bls.gov/oes/current/naics4_621100.htm [for general medical and surgical hospitals, NAICS 622100]). Request for Comments In accordance with the Paperwork Reduction Act, comments on AHRQ’s information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ’s estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and included in the Agency’s subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record. Sharon B. Arnold, Deputy Director. [FR Doc. 2015–20359 Filed 8–17–15; 8:45 am] BILLING CODE 4160–90–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration asabaliauskas on DSK5VPTVN1PROD with NOTICES [Docket No. FDA–2013–D–0920] Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. VerDate Sep<11>2014 17:02 Aug 17, 2015 Jkt 235001 The Food and Drug Administration (FDA) is announcing the availability of the 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. 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: An electronic copy of the guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance document entitled ‘‘Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems’’ to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002. Send one selfaddressed adhesive label to assist that office in processing your request. Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the SUMMARY: PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 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: Katharine Chowdhury, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, Rm. 1222, Silver Spring, MD 20993–0002, 301– 796–6344, 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 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 • Nickel ion release This guidance provides crossreferences and updates to the related E:\FR\FM\18AUN1.SGM 18AUN1 Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Notices asabaliauskas on DSK5VPTVN1PROD with NOTICES sections of the existing ‘‘Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems’’ guidance. In the Federal Register on August 30, 2013 (78 FR 53773), FDA announced the availability of the draft guidance document. Interested persons were invited to comment by September 30, 2013. Four sets of comments were received and, in general, were supportive of the guidance. There were multiple comments regarding the need for clarification of acceptance criteria and the desire for a flow chart to visualize the overall testing paradigm described in the guidance update. In response to these comments, FDA revised the guidance document to include more specific information on acceptance criteria for pitting corrosion and surface oxide properties, as well as a flow chart. General concerns were noted that the guidance modifications might be interpreted to be more burdensome. However, the addition of the flowchart is intended to clarify when testing beyond pitting corrosion testing should be considered, and based on prior experience, it is anticipated that few stents will need further assessment. In addition, there were several comments regarding the lack of utility of post-fatigue pitting corrosion assessment. In response to these comments, as well as discussions at the March 2012 workshop, FDA has removed the suggestion to consider post-fatigue pitting corrosion testing when damage to samples is noted due to fatigue testing. There was also a comment that the 60-day suggested duration for nickel release may be unnecessarily long and burdensome, and in response, FDA has reduced the minimum duration to 30 days if the release rate falls below a predetermined level based on toxicological risk assessment. II. Significance of Guidance This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on certain non-clinical testing for coronary and peripheral stents. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it 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 downloading an electronic copy from the Internet. A search capability for all VerDate Sep<11>2014 17:02 Aug 17, 2015 Jkt 235001 Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov. Persons unable to download an electronic copy of ‘‘Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems ’’ may send an email request to CDRHGuidance@fda.hhs.gov to receive an electronic copy of the document. 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 12, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–20308 Filed 8–17–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–0640] Uncomplicated Gonorrhea: Developing Drugs for Treatment; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: PO 00000 Notice. Frm 00025 Fmt 4703 Sfmt 4703 50009 The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ‘‘Uncomplicated Gonorrhea: Developing Drugs for Treatment.’’ The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of uncomplicated gonorrhea. This guidance finalizes the draft guidance of the same name issued on June 19, 2014. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. 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. FOR FURTHER INFORMATION CONTACT: Maria Allende or Joseph Toerner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6244, Silver Spring, MD 20993–0002, 301– 796–1400. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Uncomplicated Gonorrhea: Developing Drugs for Treatment.’’ The purpose of this guidance is to assist sponsors in the development of drugs for the treatment of uncomplicated gonorrhea. This guidance describes approaches for trial designs for the evaluation of new drugs for the treatment of uncomplicated gonorrhea. The guidance focuses on the noninferiority trial design and describes an efficacy endpoint for which there is a welldefined treatment effect. The guidance also provides the justification for the noninferiority margin. After careful consideration of comments received in response to the draft guidance issued on June 19, 2014 (79 FR 35172), we added a brief discussion of the potential for pregnant women to be included in specific populations for drug development. In addition, this guidance E:\FR\FM\18AUN1.SGM 18AUN1

Agencies

[Federal Register Volume 80, Number 159 (Tuesday, August 18, 2015)]
[Notices]
[Pages 50008-50009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20308]

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

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;
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 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.

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: An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Select Updates for Non-Clinical Engineering Tests and Recommended
Labeling for Intravascular Stents and Associated Delivery Systems'' to
the Office of the Center Director, Guidance and Policy Development,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave. Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request.
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: Katharine Chowdhury, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave. Bldg. 66, Rm. 1222, Silver Spring, MD 20993-0002,
301-796-6344, 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 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
Nickel ion release

This guidance provides cross-references and updates to the related

[[Page 50009]]

sections of the existing ``Non-Clinical Engineering Tests and
Recommended Labeling for Intravascular Stents and Associated Delivery
Systems'' guidance.
In the Federal Register on August 30, 2013 (78 FR 53773), FDA
announced the availability of the draft guidance document. Interested
persons were invited to comment by September 30, 2013. Four sets of
comments were received and, in general, were supportive of the
guidance. There were multiple comments regarding the need for
clarification of acceptance criteria and the desire for a flow chart to
visualize the overall testing paradigm described in the guidance
update. In response to these comments, FDA revised the guidance
document to include more specific information on acceptance criteria
for pitting corrosion and surface oxide properties, as well as a flow
chart. General concerns were noted that the guidance modifications
might be interpreted to be more burdensome. However, the addition of
the flowchart is intended to clarify when testing beyond pitting
corrosion testing should be considered, and based on prior experience,
it is anticipated that few stents will need further assessment. In
addition, there were several comments regarding the lack of utility of
post-fatigue pitting corrosion assessment. In response to these
comments, as well as discussions at the March 2012 workshop, FDA has
removed the suggestion to consider post-fatigue pitting corrosion
testing when damage to samples is noted due to fatigue testing. There
was also a comment that the 60-day suggested duration for nickel
release may be unnecessarily long and burdensome, and in response, FDA
has reduced the minimum duration to 30 days if the release rate falls
below a predetermined level based on toxicological risk assessment.

II. Significance of Guidance

This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on certain non-clinical testing for coronary
and peripheral stents. It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it 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
downloading an electronic copy from the Internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://www.regulations.gov. Persons
unable to download an electronic copy of ``Select Updates for Non-
Clinical Engineering Tests and Recommended Labeling for Intravascular
Stents and Associated Delivery Systems '' may send an email request to
CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the
document. 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 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20308 Filed 8-17-15; 8:45 am]
BILLING CODE 4164-01-P

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