Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 10122-10123 [2015-03843]

Download as PDF 10122 Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices The third comment asserted that we underestimated the reporting burden of the NDIN procedures under § 190.6 by failing to take into account the recommendations in the draft guidance entitled ‘‘Dietary Supplements: New Dietary Ingredient Notifications and Related Issues’’ (the 2011 draft guidance) (available at https:// www.fda.gov/Food/Guidance Regulation/GuidanceDocuments RegulatoryInformation/ DietarySupplements/ucm257563.htm). FDA announced the availability of the 2011 draft guidance for comment in a notice published in the Federal Register of July 5, 2011 (76 FR 39111). Although we agree with the commenter that information collection recommendations in guidance are subject to the PRA, we intend to meet our PRA obligations in that regard separately at a later time. The 2011 draft guidance was published solely for the purpose of seeking comment, and it has not been made final. Moreover, FDA intends to publish a revised draft guidance for comment later this year, and the revised draft guidance will supersede the 2011 draft guidance. Although we expect the revised draft guidance to be followed by a final guidance, there will be an interim period where no guidance on NDINs is in effect. The purpose of the current PRA proceeding is to seek comment on and obtain OMB approval for the NDIN collections of information in effect during this interim period, which are those found in the FDA’s NDIN regulations at § 190.6 and in the electronic NDIN submission forms that we have made available for comment. After publishing a revised draft guidance on NDINs and related issues, we intend to publish a 60-day notice inviting comment on the proposed collections of information associated with that document. At that time, we will carefully evaluate all comments we receive. We estimate the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 21 CFR section Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours 190.6 .................................................................................... 55 1 55 20 1,100 asabaliauskas on DSK5VPTVN1PROD with NOTICES 1 There are no operating and maintenance costs associated with this collection of information. We believe that the burden of the premarket notification requirement on industry is limited and reasonable because we are requesting only safety and identity information that the manufacturer or distributor should already have developed to satisfy itself that a dietary supplement containing a new dietary ingredient is in compliance with the FD&C Act. In the past, commenters have argued that our burden estimate is too low. We carefully considered the issue and believe that burden estimates of greater than 20 hours per notification likely include the burden associated with researching and generating safety data for a new dietary ingredient. Under section 413(a)(2) of the FD&C Act, a dietary supplement that contains a new dietary ingredient is deemed to be adulterated unless there is a history of use or other evidence of safety establishing that the new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling of the dietary supplement. This requirement is separate from and additional to the requirement to submit a premarket notification for the new dietary ingredient. FDA’s regulation on NDINs, § 190.6(a), requires the manufacturer or distributor of the dietary supplement, or of the new dietary ingredient, to submit to FDA the information that forms the basis for its conclusion that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe. Thus, § 190.6 only requires the VerDate Sep<11>2014 18:05 Feb 24, 2015 Jkt 235001 manufacturer or distributor to extract and summarize information that should have already been developed to meet the safety requirement in section 413(a)(2) of the FD&C Act. We estimate that extracting and summarizing the relevant information from what exists in the company’s files and presenting it in a format that meets the requirements of § 190.6 will take approximately 20 hours of work per notification. However, we seek comments on this estimate. We encourage comments offering alternative burden estimates to include documentation to support the alternative estimate. We further estimate that 55 respondents will submit 1 premarket notification each. We base our estimate of the number of respondents on notifications received over the past 3 years, which averaged about 55 notifications per year. Dated: February 19, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–03833 Filed 2–24–15; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–D–0230] Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices; 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 a draft guidance entitled ‘‘Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices.’’ This draft guidance provides industry and Agency staff with recommendations regarding the technical performance assessment data that should be provided for regulatory evaluation of a digital whole slide imaging (WSI) system. 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 of 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 May 26, 2015. ADDRESSES: An electronic copy of the guidance document is available for SUMMARY: E:\FR\FM\25FEN1.SGM 25FEN1 Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices 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 draft guidance document entitled ‘‘Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices’’ 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 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: Nicholas Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5570, Silver Spring, MD 20993–0002, 301–796–4310; or Aldo Badano, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 62, Rm. 3116, Silver Spring, MD 20993–0002, 301–796–2534. SUPPLEMENTARY INFORMATION: asabaliauskas on DSK5VPTVN1PROD with NOTICES I. Background Recent technological advances in digital microscopy, in particular the development of whole slide scanning systems, have accelerated the adoption of digital imaging in pathology, similar to the digital transformation that radiology departments have experienced over the last decade. FDA regulates WSI systems manufacturers to ensure that the images produced for clinical intended uses are safe and effective for such purposes. Essential to the regulation of these systems is the understanding of the technical performance of the components in the imaging chain, from image acquisition to image display and their effect on pathologist’s diagnostic performance and workflow. This draft guidance provides industry and Agency staff with recommendations regarding the technical performance assessment data that should be included for regulatory evaluation of a WSI. This document does not cover the clinical submission data that may be necessary to support approval or clearance. The VerDate Sep<11>2014 18:05 Feb 24, 2015 Jkt 235001 guidance provides our suggestions on how to best characterize the technical aspects that are relevant to WSI performance for their intended use and determine any possible limitations that might affect their safety and effectiveness. 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 technical performance assessment of digital pathology WSI 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 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 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 ‘‘Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1400053 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, the collections of information in 21 CFR part 814 have been approved under OMB control number 0910–0231, and the collections of information in 21 CFR part 801 and 21 CFR 809.10 have been approved under OMB control number 0910–0485. V. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 10123 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: February 19, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–03843 Filed 2–24–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–0001] Pediatric Ethics Subcommittee of the Pediatric Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. 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: Pediatric Ethics Subcommittee of the Pediatric Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency regarding ethical protections for children in FDA-regulated clinical trials. Date and Time: The meeting will be held on Monday, March 23, 2015 from 8:30 a.m. to 4:30 p.m. Location: Doubletree by Hilton Hotel, 8727 Colesville Rd., Silver Spring, MD 20910. Answers to commonly asked questions, including information regarding special accommodations due to a disability, visitor parking, and transportation, may be accessed at: https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm408555.htm. Contact Person: Walter Ellenberg, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5154, Silver Spring, MD 20993, 301–796– 0885, email walter.ellenberg@ fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– E:\FR\FM\25FEN1.SGM 25FEN1

Agencies

[Federal Register Volume 80, Number 37 (Wednesday, February 25, 2015)]
[Notices]
[Pages 10122-10123]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-03843]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-0230]


Technical Performance Assessment of Digital Pathology Whole Slide 
Imaging Devices; 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 a draft guidance entitled ``Technical Performance 
Assessment of Digital Pathology Whole Slide Imaging Devices.'' This 
draft guidance provides industry and Agency staff with recommendations 
regarding the technical performance assessment data that should be 
provided for regulatory evaluation of a digital whole slide imaging 
(WSI) system. 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 of 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 May 26, 2015.

ADDRESSES: An electronic copy of the guidance document is available for

[[Page 10123]]

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 draft guidance document entitled 
``Technical Performance Assessment of Digital Pathology Whole Slide 
Imaging Devices'' 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 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: Nicholas Anderson, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5570, Silver Spring, MD 20993-0002, 301-
796-4310; or Aldo Badano, Center for Devices and Radiological Health, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 62, Rm. 
3116, Silver Spring, MD 20993-0002, 301-796-2534.

SUPPLEMENTARY INFORMATION: 

I. Background

    Recent technological advances in digital microscopy, in particular 
the development of whole slide scanning systems, have accelerated the 
adoption of digital imaging in pathology, similar to the digital 
transformation that radiology departments have experienced over the 
last decade. FDA regulates WSI systems manufacturers to ensure that the 
images produced for clinical intended uses are safe and effective for 
such purposes. Essential to the regulation of these systems is the 
understanding of the technical performance of the components in the 
imaging chain, from image acquisition to image display and their effect 
on pathologist's diagnostic performance and workflow.
    This draft guidance provides industry and Agency staff with 
recommendations regarding the technical performance assessment data 
that should be included for regulatory evaluation of a WSI. This 
document does not cover the clinical submission data that may be 
necessary to support approval or clearance. The guidance provides our 
suggestions on how to best characterize the technical aspects that are 
relevant to WSI performance for their intended use and determine any 
possible limitations that might affect their safety and effectiveness.

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 technical 
performance assessment of digital pathology WSI 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 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 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 ``Technical Performance 
Assessment of Digital Pathology Whole Slide Imaging Devices'' may send 
an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic 
copy of the document. Please use the document number 1400053 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, the collections 
of information in 21 CFR part 814 have been approved under OMB control 
number 0910-0231, and the collections of information in 21 CFR part 801 
and 21 CFR 809.10 have been approved under OMB control number 0910-
0485.

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: February 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03843 Filed 2-24-15; 8:45 am]
BILLING CODE 4164-01-P
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