80 FR 76503 - Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants; 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)
Food and Drug Administration
Federal Register Volume 80, Issue 236 (December 9, 2015)
| Page Range | 76503-76504 | |
| FR Document | 2015-30936 |
[Federal Register Volume 80, Number 236 (Wednesday, December 9, 2015)] [Notices] [Pages 76503-76504] From the Federal Register Online [www.thefederalregister.org] [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: 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-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 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 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: David Litwack, Center for Devices and Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 4548, Silver Spring, MD 20993, 301-796-6697, [email protected]. 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
![Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Notices 76503
have been approved under OMB control • Federal eRulemaking Portal: http:// the claimed confidential information, in
number 0910–0625; the collections of www.regulations.gov. Follow the its consideration of comments. The
information in 21 CFR part 807, subpart instructions for submitting comments. second copy, which will have the
E have been approved under OMB Comments submitted electronically, claimed confidential information
control number 0910–0120; the including attachments, to http:// redacted/blacked out, will be available
collections of information in 21 CFR www.regulations.gov will be posted to for public viewing and posted on
part 803 have been approved under the docket unchanged. Because your http://www.regulations.gov. Submit
OMB control number 0910–0437; the comment will be made public, you are both copies to the Division of Dockets
collections of information in 21 CFR solely responsible for ensuring that your Management. If you do not wish your
part 820 have been approved under comment does not include any name and contact information to be
OMB control number 0910–0073; and confidential information that you or a made publicly available, you can
the collections of information in 21 CFR third party may not wish to be posted, provide this information on the cover
part 801 have been approved under such as medical information, your or sheet and not in the body of your
OMB control number 0910–0485. anyone else’s Social Security number, or comments and you must identify this
Dated: December 3, 2015.
confidential business information, such information as ‘‘confidential.’’ Any
as a manufacturing process. Please note information marked as ‘‘confidential’’
Peter Lurie,
that if you include your name, contact will not be disclosed except in
Associate Commissioner for Public Health information, or other information that
Strategy and Analysis.
accordance with 21 CFR 10.20 and other
identifies you in the body of your applicable disclosure law. For more
[FR Doc. 2015–30972 Filed 12–8–15; 8:45 am] comments, that information will be information about FDA’s posting of
BILLING CODE 4164–01–P posted on http://www.regulations.gov. comments to public dockets, see 80 FR
• If you want to submit a comment 56469, September 18, 2015, or access
with confidential information that you the information at: http://www.fda.gov/
DEPARTMENT OF HEALTH AND do not wish to be made available to the
HUMAN SERVICES regulatoryinformation/dockets/
public, submit the comment as a default.htm.
written/paper submission and in the
Food and Drug Administration Docket: For access to the docket to
manner detailed (see ‘‘Written/Paper
read background documents or the
Submissions’’ and ‘‘Instructions’’).
[Docket No. FDA–2015–N–3015] electronic and written/paper comments
Written/Paper Submissions received, go to http://
Use of Databases for Establishing the Submit written/paper submissions as www.regulations.gov and insert the
Clinical Relevance of Human Genetic follows: docket number, found in brackets in the
Variants; Public Workshop; Reopening • Mail/Hand delivery/Courier (for heading of this document, into the
of Comment Period written/paper submissions): Division of ‘‘Search’’ box and follow the prompts
Dockets Management (HFA–305), Food and/or go to the Division of Dockets
AGENCY: Food and Drug Administration, Management, 5630 Fishers Lane, Rm.
HHS. and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852.
ACTION:Notice of public workshop; • For written/paper comments
reopening of comment period. FOR FURTHER INFORMATION CONTACT:
submitted to the Division of Dockets David Litwack, Center for Devices and
SUMMARY: The Food and Drug Management, FDA will post your Radiological Health, Food and Drug
Administration (FDA) is reopening the comment, as well as any attachments, Administration, Bldg. 66, Rm. 4548,
comment period for the notice of a except for information submitted, Silver Spring, MD 20993, 301–796–
public workshop that appeared in the marked and identified, as confidential, 6697, ernest.litwack@fda.hhs.gov.
Federal Register of September 9, 2015. if submitted as detailed in
‘‘Instructions.’’ SUPPLEMENTARY INFORMATION: In the
In the notice of the public workshop, Federal Register of September 9, 2015
FDA requested comments on the Instructions: All submissions received
must include the Docket No. FDA– (80 FR 54290), FDA published a notice
workshop topics about the use of of a public workshop with a deadline of
databases that contain information 2015–N–3015 for ‘‘Use of Databases for
Establishing the Clinical Relevance of November 25, 2015, to request
linking human genetic variations to comments on the workshop topics about
disease, where such information has Human Genetic Variants.’’ Received
comments will be placed in the docket the use of databases that contain
been curated by qualified professionals, information linking human genetic
to inform regulatory oversight of the and, except for those submitted as
‘‘Confidential Submissions,’’ publicly variations to disease, where such
clinical performance of genetic tests. information has been curated by
The Agency is taking this action in viewable at http://www.regulations.gov
or at the Division of Dockets qualified professionals, to inform
response to requests to allow interested regulatory oversight of the clinical
persons additional time to submit Management between 9 a.m. and 4 p.m.,
Monday through Friday. performance of genetic tests. Comments
comments.
• Confidential Submissions—To on the public workshop topics will
DATES: FDA is reopening the comment submit a comment with confidential inform FDA’s optimization of regulatory
period for the notice of public workshop information that you do not wish to be approaches for next-generation-based in
published September 9, 2015. Submit made publicly available, submit your vitro diagnostics.
either electronic or written comments
mstockstill on DSK4VPTVN1PROD with NOTICES
comments only as a written/paper FDA is reopening the comment period
by December 24, 2015. submission. You should submit two for the notice of the public workshop
ADDRESSES: You may submit comments copies total. One copy will include the until December 24, 2015. The Agency
as follows: information you claim to be confidential believes that the extension allows
with a heading or cover note that states adequate time for interested persons to
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS submit comments without significantly
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The delaying decision making on these
following way: Agency will review this copy, including important issues.
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![76504 Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Notices
Dated: December 3, 2015. third party may not wish to be posted, name and contact information to be
Peter Lurie, such as medical information, your or made publicly available, you can
Associate Commissioner for Public Health anyone else’s Social Security number, or provide this information on the cover
Strategy and Analysis. confidential business information, such sheet and not in the body of your
[FR Doc. 2015–30936 Filed 12–8–15; 8:45 am] as a manufacturing process. Please note comments and you must identify this
BILLING CODE 4164–01–P that if you include your name, contact information as ‘‘confidential.’’ Any
information, or other information that information marked as ‘‘confidential’’
identifies you in the body of your will not be disclosed except in
DEPARTMENT OF HEALTH AND comments, that information will be accordance with 21 CFR 10.20 and other
HUMAN SERVICES posted on http://www.regulations.gov. applicable disclosure law. For more
• If you want to submit a comment information about FDA’s posting of
Food and Drug Administration with confidential information that you comments to public dockets, see 80 FR
do not wish to be made available to the 56469, September 18, 2015, or access
[Docket No. FDA–2015–D–4380]
public, submit the comment as a the information at: http://www.fda.gov/
Best Practices for Communication written/paper submission and in the regulatoryinformation/dockets/
Between Investigational New Drug manner detailed (see ‘‘Written/Paper default.htm.
Sponsors and Food and Drug Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
Administration During Drug Written/Paper Submissions read background documents or the
Development; Draft Guidance for electronic and written/paper comments
Submit written/paper submissions as received, go to http://
Industry and Review Staff; Availability
follows: www.regulations.gov and insert the
AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for
docket number, found in brackets in the
HHS. written/paper submissions): Division of
heading of this document, into the
ACTION: Notice of availability. Dockets Management (HFA–305), Food
‘‘Search’’ box and follow the prompts
and Drug Administration, 5630 Fishers
and/or go to the Division of Dockets
SUMMARY: The Food and Drug Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments Management, 5630 Fishers Lane, Rm.
Administration (FDA or Agency) is 1061, Rockville, MD 20852.
announcing the availability of a draft submitted to the Division of Dockets
Management, FDA will post your Submit written requests for single
guidance for industry and review staff copies of the draft guidance to the
entitled ‘‘Best Practices for comment, as well as any attachments,
except for information submitted, Division of Drug Information, Center for
Communication Between IND Sponsors Drug Evaluation and Research, Food
and FDA During Drug Development.’’ marked and identified, as confidential,
if submitted as detailed in and Drug Administration, 10001 New
The purpose of this guidance is to Hampshire Ave., Hillandale Building,
describe best practices and procedures ‘‘Instructions.’’
Instructions: All submissions received 4th Floor, Silver Spring, MD 20993–
for timely, transparent, and effective 0002, or Office of Communication,
communications between must include the Docket No. FDA–
2015–D–4380 for ‘‘Best Practices for Outreach, and Development, Center for
investigational new drug application Biologics Evaluation and Research,
(IND) sponsors and FDA at critical Communication Between IND Sponsors
and FDA During Drug Development; Food and Drug Administration, 10903
junctures in drug development, which New Hampshire Ave., Bldg. 71, Rm.
may facilitate earlier availability of safe Draft Guidance for Industry and Review
Staff; Availability.’’ Received comments 3128, Silver Spring, MD 20993–0002.
and effective drugs to the American Send one self-addressed adhesive label
public. will be placed in the docket and, except
for those submitted as ‘‘Confidential to assist that office in processing your
DATES: Although you can comment on Submissions,’’ publicly viewable at requests. See the SUPPLEMENTARY
any guidance at any time (see 21 CFR http://www.regulations.gov or at the INFORMATION section for electronic
10.115(g)(5)), to ensure that the Agency Division of Dockets Management access to the draft guidance document.
considers your comment on this draft between 9 a.m. and 4 p.m., Monday FOR FURTHER INFORMATION CONTACT:
guidance before it begins work on the through Friday. Rachel E. Hartford, Center for Drug
final version of the guidance, submit • Confidential Submissions—To Evaluation and Research, Food and
either electronic or written comments submit a comment with confidential Drug Administration, 10903 New
on the draft guidance by February 8, information that you do not wish to be Hampshire Ave., Bldg. 22, Rm. 6312,
2016. made publicly available, submit your Silver Spring, MD 20993–0002, 301–
ADDRESSES: You may submit comments comments only as a written/paper 796–0319; or Stephen Ripley, Center for
as follows: submission. You should submit two Biologics Evaluation and Research,
copies total. One copy will include the Food and Drug Administration, 10903
Electronic Submissions information you claim to be confidential New Hampshire Ave. Bldg. 71, Rm.
Submit electronic comments in the with a heading or cover note that states 7301, Silver Spring, MD 20993–0002,
following way: ‘‘THIS DOCUMENT CONTAINS 240–402–7911.
• Federal eRulemaking Portal: http:// CONFIDENTIAL INFORMATION.’’ The SUPPLEMENTARY INFORMATION:
www.regulations.gov. Follow the Agency will review this copy, including
instructions for submitting comments. the claimed confidential information, in I. Background
mstockstill on DSK4VPTVN1PROD with NOTICES
Comments submitted electronically, its consideration of comments. The FDA is announcing the availability of
including attachments, to http:// second copy, which will have the a draft guidance for industry and review
www.regulations.gov will be posted to claimed confidential information staff entitled ‘‘Best Practices for
the docket unchanged. Because your redacted/blacked out, will be available Communication Between IND Sponsors
comment will be made public, you are for public viewing and posted on http:// and FDA During Drug Development.’’
solely responsible for ensuring that your www.regulations.gov. Submit both As part of the Prescription Drug User
comment does not include any copies to the Division of Dockets Fee Amendments of 2012, described in
confidential information that you or a Management. If you do not wish your ‘‘Reauthorization Performance Goals
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Document Created: 2015-12-14 13:32:05
Document Modified: 2015-12-14 13:32:05
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of public workshop; reopening of comment period. | |
| 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. | |
| Contact | David Litwack, Center for Devices and Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 4548, Silver Spring, MD 20993, 301-796-6697, [email protected] | |
| FR Citation | 80 FR 76503 |
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