80_FR_76736 80 FR 76500 - Standards-Based Approach to Analytical Performance Evaluation of Next Generation Sequencing in Vitro Diagnostic Tests; Public Workshop; Reopening of Comment Period

80 FR 76500 - Standards-Based Approach to Analytical Performance Evaluation of Next Generation Sequencing in Vitro Diagnostic Tests; Public Workshop; Reopening of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 236 (December 9, 2015)

Page Range76500-76501
FR Document2015-30937

The Food and Drug Administration (FDA) is reopening the comment period for the notice of a public workshop that appeared in the Federal Register of September 9, 2015. In the notice of the public workshop, FDA requested comments on the workshop topics about the proposed standards-based regulatory strategy for next-generation sequencing (NGS) tests that produce results on variation in the human genome. The Agency is taking this action in response to requests to allow interested persons additional time to submit comments.

Federal Register, Volume 80 Issue 236 (Wednesday, December 9, 2015) 
[Federal Register Volume 80, Number 236 (Wednesday, December 9, 2015)]
[Notices]
[Pages 76500-76501]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-30937]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2881]


Standards-Based Approach to Analytical Performance Evaluation of 
Next Generation Sequencing in Vitro Diagnostic Tests; Public Workshop; 
Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening the 
comment period for the notice of a public workshop that appeared in the 
Federal Register of September 9, 2015. In the notice of the public 
workshop, FDA requested comments on the workshop topics about the 
proposed standards-based regulatory strategy for next-generation 
sequencing (NGS) tests that produce results on variation in the human 
genome. The Agency is taking this action in response to requests to 
allow interested persons additional time to submit comments.

DATES: FDA is reopening the comment period for the notice of the public 
workshop published September 9, 2015. Submit either electronic or 
written comments by December 24, 2015.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-N-2881 for ``Standards-Based Approach to Analytical 
Performance Evaluation of Next-Generation Sequencing In Vitro 
Diagnostic Tests.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information

[[Page 76501]]

redacted/blacked out, will be available for public viewing and posted 
on http://www.regulations.gov. Submit both copies to the Division of 
Dockets Management. If you do not wish your name and contact 
information to be made publicly available, you can provide this 
information on the cover sheet and not in the body of your comments and 
you must identify this information as ``confidential.'' Any information 
marked as ``confidential'' will not be disclosed except in accordance 
with 21 CFR 10.20 and other applicable disclosure law. For more 
information about FDA's posting of comments to public dockets, see 80 
FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Zivana Tezak, Center for Devices and 
Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 4544, 
Silver Spring, MD 20993, 301-796-6206, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of September 9, 2015 
(80 FR 54292), FDA published a notice of a public workshop with a 
deadline of November 25, 2015, to request comments on the workshop 
topics about the proposed standards-based regulatory strategy for NGS 
tests that produce results on variation in the human genome. Comments 
on the public meeting topics will inform FDA's development of such 
strategies.
    FDA is reopening the comment period for the notice of the public 
workshop until December 24, 2015. The Agency believes that the 
extension allows adequate time for interested persons to submit 
comments without significantly delaying decisionmaking on these 
important issues.

    Dated: December 3, 2015.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2015-30937 Filed 12-8-15; 8:45 am]
BILLING CODE 4164-01-P

76500 Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Notices ANNUAL BURDEN ESTIMATES—Continued Annual Number of Average Total number Annual burden Instrument number of responses per burden hours of respondents hours respondents respondent per response 13. Study MIS nFORM for grantees to report session ad- herence to curriculum ....................................................... 48 24 312 .08 599 Estimated Total Annual Burden DEPARTMENT OF HEALTH AND that if you include your name, contact Hours: 5,314 HUMAN SERVICES information, or other information that In compliance with the requirements identifies you in the body of your Food and Drug Administration comments, that information will be of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the [Docket No. FDA–2015–N–2881] posted on http://www.regulations.gov. • If you want to submit a comment Administration for Children and Standards-Based Approach to with confidential information that you Families is soliciting public comment do not wish to be made available to the on the specific aspects of the Analytical Performance Evaluation of Next Generation Sequencing in Vitro public, submit the comment as a information collection described above. written/paper submission and in the Diagnostic Tests; Public Workshop; Copies of the proposed collection of manner detailed (see ‘‘Written/Paper Reopening of Comment Period information can be obtained and Submissions’’ and ‘‘Instructions’’). comments may be forwarded by writing AGENCY: Food and Drug Administration, to the Administration for Children and HHS. Written/Paper Submissions Families, Office of Planning, Research ACTION:Notice of public workshop; Submit written/paper submissions as and Evaluation, 370 L’Enfant reopening of comment period. follows: Promenade SW., Washington, DC 20447, • Mail/Hand delivery/Courier (for Attn: OPRE Reports Clearance Officer. SUMMARY: The Food and Drug written/paper submissions): Division of Email address: OPREinfocollection@ Administration (FDA) is reopening the Dockets Management (HFA–305), Food comment period for the notice of a and Drug Administration, 5630 Fishers acf.hhs.gov. All requests should be public workshop that appeared in the Lane, Rm. 1061, Rockville, MD 20852. identified by the title of the information collection. Federal Register of September 9, 2015. • For written/paper comments In the notice of the public workshop, submitted to the Division of Dockets The Department specifically requests FDA requested comments on the Management, FDA will post your comments on (a) whether the proposed workshop topics about the proposed comment, as well as any attachments, collection of information is necessary standards-based regulatory strategy for except for information submitted, for the proper performance of the next-generation sequencing (NGS) tests marked and identified, as confidential, functions of the agency, including that produce results on variation in the if submitted as detailed in whether the information shall have human genome. The Agency is taking ‘‘Instructions.’’ practical utility; (b) the accuracy of the this action in response to requests to Instructions: All submissions received agency’s estimate of the burden of the allow interested persons additional time must include the Docket No. FDA– proposed collection of information; (c) to submit comments. 2015–N–2881 for ‘‘Standards-Based the quality, utility, and clarity of the DATES: FDA is reopening the comment Approach to Analytical Performance information to be collected; and (d) period for the notice of the public Evaluation of Next-Generation ways to minimize the burden of the workshop published September 9, 2015. Sequencing In Vitro Diagnostic Tests.’’ collection of information on Submit either electronic or written Received comments will be placed in respondents, including through the use comments by December 24, 2015. the docket and, except for those of automated collection techniques or ADDRESSES: You may submit comments submitted as ‘‘Confidential other forms of information technology. as follows: Submissions,’’ publicly viewable at Consideration will be given to http://www.regulations.gov or at the Electronic Submissions Division of Dockets Management comments and suggestions submitted within 60 days of this publication. Submit electronic comments in the between 9 a.m. and 4 p.m., Monday following way: through Friday. Robert Sargis, • Federal eRulemaking Portal: http:// • Confidential Submissions—To ACF Certifying Officer. www.regulations.gov. Follow the submit a comment with confidential [FR Doc. 2015–30994 Filed 12–8–15; 8:45 am] instructions for submitting comments. information that you do not wish to be Comments submitted electronically, made publicly available, submit your BILLING CODE 4184–73–P including attachments, to http:// comments only as a written/paper www.regulations.gov will be posted to submission. You should submit two the docket unchanged. Because your copies total. One copy will include the comment will be made public, you are information you claim to be confidential mstockstill on DSK4VPTVN1PROD with NOTICES solely responsible for ensuring that your with a heading or cover note that states comment does not include any ‘‘THIS DOCUMENT CONTAINS confidential information that you or a CONFIDENTIAL INFORMATION.’’ The third party may not wish to be posted, Agency will review this copy, including such as medical information, your or the claimed confidential information, in anyone else’s Social Security number, or its consideration of comments. The confidential business information, such second copy, which will have the as a manufacturing process. Please note claimed confidential information VerDate Sep<11>2014 18:21 Dec 08, 2015 Jkt 238001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\09DEN1.SGM 09DEN1

Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Notices 76501 redacted/blacked out, will be available DEPARTMENT OF HEALTH AND • If you want to submit a comment for public viewing and posted on HUMAN SERVICES with confidential information that you http://www.regulations.gov. Submit do not wish to be made available to the both copies to the Division of Dockets Food and Drug Administration public, submit the comment as a Management. If you do not wish your written/paper submission and in the [Docket No. FDA–2015–D–2261] manner detailed (see ‘‘Written/Paper name and contact information to be made publicly available, you can Premarket Notification Requirements Submissions’’ and ‘‘Instructions’’). provide this information on the cover Concerning Gowns Intended for Use in Written/Paper Submissions sheet and not in the body of your Health Care Settings; Guidance for Submit written/paper submissions as comments and you must identify this Industry and Food and Drug follows: information as ‘‘confidential.’’ Any Administration Staff; Availability • Mail/Hand delivery/Courier (for information marked as ‘‘confidential’’ written/paper submissions): Division of will not be disclosed except in AGENCY: Food and Drug Administration, HHS. Dockets Management (HFA–305), Food accordance with 21 CFR 10.20 and other and Drug Administration, 5630 Fishers applicable disclosure law. For more ACTION: Notice of availability. Lane, Rm. 1061, Rockville, MD 20852. information about FDA’s posting of SUMMARY: The Food and Drug • For written/paper comments comments to public dockets, see 80 FR Administration (FDA or Agency) is submitted to the Division of Dockets 56469, September 18, 2015, or access announcing the availability of the Management, FDA will post your the information at: http://www.fda.gov/ guidance entitled ‘‘Premarket comment, as well as any attachments, regulatoryinformation/dockets/ Notification Requirements Concerning except for information submitted, default.htm. Gowns Intended for Use in Health Care marked and identified, as confidential, Docket: For access to the docket to Settings.’’ FDA is issuing this guidance if submitted as detailed in to describe the Agency’s premarket ‘‘Instructions.’’ read background documents or the Instructions: All submissions received electronic and written/paper comments regulatory requirements and the must include the Docket No. FDA– received, go to http:// performance testing needed to support 2015–D–2261 for ‘‘Premarket www.regulations.gov and insert the liquid barrier claims for gowns intended Notification Requirements Concerning docket number, found in brackets in the for use in health care settings. This Gowns Intended for Use in Health Care heading of this document, into the guidance is being issued in light of the Settings.’’ Received comments will be ‘‘Search’’ box and follow the prompts public health importance of personal placed in the docket and, except for and/or go to the Division of Dockets protective equipment in health care those submitted as ‘‘Confidential Management, 5630 Fishers Lane, Rm. settings and the recognition that Submissions,’’ publicly viewable at 1061, Rockville, MD 20852. terminology used to describe gowns has http://www.regulations.gov or at the evolved, including by FDA, industry, Division of Dockets Management FOR FURTHER INFORMATION CONTACT: the standards community, and health between 9 a.m. and 4 p.m., Monday Zivana Tezak, Center for Devices and care professionals. through Friday. Radiological Health, Food and Drug DATES: Submit either electronic or • Confidential Submissions—To Administration, Bldg. 66, Rm. 4544, written comments on this guidance at submit a comment with confidential Silver Spring, MD 20993, 301–796– any time. General comments on Agency information that you do not wish to be 6206, zivana.tezak@fda.hhs.gov. guidance documents are welcome at any made publicly available, submit your SUPPLEMENTARY INFORMATION: In the time. comments only as a written/paper Federal Register of September 9, 2015 ADDRESSES: You may submit comments submission. You should submit two (80 FR 54292), FDA published a notice as follows: copies total. One copy will include the of a public workshop with a deadline of information you claim to be confidential Electronic Submissions with a heading or cover note that states November 25, 2015, to request comments on the workshop topics about Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS the proposed standards-based regulatory following way: CONFIDENTIAL INFORMATION’’. The strategy for NGS tests that produce • Federal eRulemaking Portal: http:// Agency will review this copy, including www.regulations.gov. Follow the the claimed confidential information, in results on variation in the human instructions for submitting comments. its consideration of comments. The genome. Comments on the public Comments submitted electronically, second copy, which will have the meeting topics will inform FDA’s including attachments, to http:// claimed confidential information development of such strategies. www.regulations.gov will be posted to redacted/blacked out, will be available FDA is reopening the comment period the docket unchanged. Because your for public viewing and posted on http:// for the notice of the public workshop comment will be made public, you are www.regulations.gov. Submit both until December 24, 2015. The Agency solely responsible for ensuring that your copies to the Division of Dockets believes that the extension allows comment does not include any Management. If you do not wish your adequate time for interested persons to confidential information that you or a name and contact information to be submit comments without significantly third party may not wish to be posted, made publicly available, you can delaying decisionmaking on these such as medical information, your or provide this information on the cover mstockstill on DSK4VPTVN1PROD with NOTICES important issues. anyone else’s Social Security number, or sheet and not in the body of your Dated: December 3, 2015. confidential business information, such comments and you must identify this as a manufacturing process. Please note information as ‘‘confidential.’’ Any Peter Lurie, that if you include your name, contact information marked as ‘‘confidential’’ Associate Commissioner for Public Health information, or other information that will not be disclosed except in Strategy and Analysis. identifies you in the body of your accordance with 21 CFR 10.20 and other [FR Doc. 2015–30937 Filed 12–8–15; 8:45 am] comments, that information will be applicable disclosure law. For more BILLING CODE 4164–01–P posted on http://www.regulations.gov. VerDate Sep<11>2014 18:21 Dec 08, 2015 Jkt 238001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\09DEN1.SGM 09DEN1


Document Created: 2015-12-14 13:33:02
Document Modified: 2015-12-14 13:33:02
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of public workshop; reopening of comment period.
DatesFDA is reopening the comment period for the notice of the public workshop published September 9, 2015. Submit either electronic or written comments by December 24, 2015.
ContactZivana Tezak, Center for Devices and Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 4544, Silver Spring, MD 20993, 301-796-6206, [email protected]
FR Citation80 FR 76500 
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