Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants; Public Workshop; Reopening of Comment Period, 76503-76504 [2015-30936]

Download as PDF Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Notices have been approved under OMB control number 0910–0625; 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 803 have been approved under OMB control number 0910–0437; the collections of information in 21 CFR part 820 have been approved under OMB control number 0910–0073; and the collections of information in 21 CFR part 801 have been approved under OMB control number 0910–0485. Dated: December 3, 2015. Peter Lurie, Associate Commissioner for Public Health Strategy and Analysis. [FR Doc. 2015–30972 Filed 12–8–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–3015] Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants; Public Workshop; Reopening of Comment Period AGENCY: Food and Drug Administration, HHS. Notice of public workshop; reopening of comment period. ACTION: 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 use of databases that contain information linking human genetic variations to disease, where such information has been curated by qualified professionals, to inform regulatory oversight of the clinical performance of genetic tests. The Agency is taking this action in response to requests to allow interested persons additional time to submit comments. SUMMARY: FDA is reopening the comment period for the notice of public workshop published September 9, 2015. Submit either electronic or written comments by December 24, 2015. ADDRESSES: You may submit comments as follows: mstockstill on DSK4VPTVN1PROD with NOTICES DATES: Electronic Submissions Submit electronic comments in the following way: VerDate Sep<11>2014 18:21 Dec 08, 2015 Jkt 238001 • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// 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 https://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–3015 for ‘‘Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://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 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 76503 the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://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: https://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 https:// 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: David Litwack, Center for Devices and Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 4548, Silver Spring, MD 20993, 301–796– 6697, ernest.litwack@fda.hhs.gov. In the Federal Register of September 9, 2015 (80 FR 54290), FDA published a notice of a public workshop with a deadline of November 25, 2015, to request comments on the workshop topics about the use of databases that contain information linking human genetic variations to disease, where such information has been curated by qualified professionals, to inform regulatory oversight of the clinical performance of genetic tests. Comments on the public workshop topics will inform FDA’s optimization of regulatory approaches for next-generation-based in vitro diagnostics. 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 decision making on these important issues. SUPPLEMENTARY INFORMATION: E:\FR\FM\09DEN1.SGM 09DEN1 76504 Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Notices Dated: December 3, 2015. Peter Lurie, Associate Commissioner for Public Health Strategy and Analysis. [FR Doc. 2015–30936 Filed 12–8–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–D–4380] Best Practices for Communication Between Investigational New Drug Sponsors and Food and Drug Administration During Drug Development; Draft Guidance for Industry and Review Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and review staff entitled ‘‘Best Practices for Communication Between IND Sponsors and FDA During Drug Development.’’ The purpose of this guidance is to describe best practices and procedures for timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development, which may facilitate earlier availability of safe and effective drugs to the American public. SUMMARY: 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 February 8, 2016. DATES: ADDRESSES: You may submit comments as follows: mstockstill on DSK4VPTVN1PROD with NOTICES Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// 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 VerDate Sep<11>2014 18:21 Dec 08, 2015 Jkt 238001 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 https://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–D–4380 for ‘‘Best Practices for Communication Between IND Sponsors and FDA During Drug Development; Draft Guidance for Industry and Review Staff; Availability.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://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 redacted/blacked out, will be available for public viewing and posted on https:// www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 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: https://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 https:// 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. Submit written requests for single copies of the draft 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, or Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, 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 draft guidance document. FOR FURTHER INFORMATION CONTACT: Rachel E. Hartford, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6312, Silver Spring, MD 20993–0002, 301– 796–0319; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry and review staff entitled ‘‘Best Practices for Communication Between IND Sponsors and FDA During Drug Development.’’ As part of the Prescription Drug User Fee Amendments of 2012, described in ‘‘Reauthorization Performance Goals E:\FR\FM\09DEN1.SGM 09DEN1

Agencies

[Federal Register Volume 80, Number 236 (Wednesday, December 9, 2015)]
[Notices]
[Pages 76503-76504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30936]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3015]


Use of Databases for Establishing the Clinical Relevance of Human 
Genetic Variants; Public Workshop; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

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

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

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 use 
of databases that contain information linking human genetic variations 
to disease, where such information has been curated by qualified 
professionals, to inform regulatory oversight of the clinical 
performance of genetic tests. 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 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: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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-3015 for ``Use of Databases for Establishing the Clinical 
Relevance of Human Genetic Variants.'' Received comments will be placed 
in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://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 redacted/blacked out, will be 
available for public viewing and posted on https://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: https://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 https://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: David Litwack, Center for Devices and 
Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 4548, 
Silver Spring, MD 20993, 301-796-6697, ernest.litwack@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 9, 2015 
(80 FR 54290), FDA published a notice of a public workshop with a 
deadline of November 25, 2015, to request comments on the workshop 
topics about the use of databases that contain information linking 
human genetic variations to disease, where such information has been 
curated by qualified professionals, to inform regulatory oversight of 
the clinical performance of genetic tests. Comments on the public 
workshop topics will inform FDA's optimization of regulatory approaches 
for next-generation-based in vitro diagnostics.
    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 decision making on these 
important issues.


[[Page 76504]]


    Dated: December 3, 2015.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2015-30936 Filed 12-8-15; 8:45 am]
BILLING CODE 4164-01-P

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