Emerging Issues and Cross-Cutting Scientific Advances; Establishment of a Public Docket, 72058-72059 [2016-25223]
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72058
Federal Register / Vol. 81, No. 202 / Wednesday, October 19, 2016 / Notices
Dated: October 12, 2016.
Edwin L. Walker,
Acting Administrator and Assistant Secretary
for Aging.
detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
[FR Doc. 2016–25118 Filed 10–18–16; 8:45 am]
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–
2016–N–2406 for ‘‘Emerging Issues and
Cross-Cutting Scientific Advances.’’
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.
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–2406]
Emerging Issues and Cross-Cutting
Scientific Advances; Establishment of
a Public Docket
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of docket;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is establishing a
public docket to receive input on
emerging issues and cross-cutting
scientific advances that may impact
FDA preparedness and inter-Agency
activities. Interested parties are invited
to submit comments regarding emerging
technologies and cross-cutting scientific
advances of importance to FDA. The
focus is on areas that may impact FDA
in 5 or more years.
DATES: Submit either electronic or
written comments by October 21, 2019.
ADDRESSES: You may submit comments
as follows:
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
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
VerDate Sep<11>2014
17:39 Oct 18, 2016
Jkt 241001
Written/Paper Submissions
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
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:
Donna Mendrick, National Center for
Toxicological Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301–
796–8892, Donna.Mendrick@
fda.hhs.gov; or Michael Morgan, Office
of Regulatory Science and Innovation,
Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD
20993, 240–402–3832,
Michael.Morgan@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
responsible for protecting the public
health by assuring the safety, efficacy,
and security of human and veterinary
drugs, biological products, medical
devices, our Nation’s food supply,
cosmetics, and products that emit
radiation. FDA is tasked with advancing
the public health by helping to speed
innovations that protect the public
health. FDA also has responsibility for
regulating the manufacturing,
marketing, and distribution of tobacco
products, to protect the public health,
and to reduce tobacco use by minors.
Finally, FDA plays a significant role in
the Nation’s counterterrorism capability.
FDA fulfills this responsibility by
ensuring the security of the food supply,
and by fostering development of
medical products used to respond to
deliberate and naturally emerging
public health threats.
FDA’s ability to achieve its mission
relies on awareness of, and proactive
preparedness for, emerging issues and
scientific advances, which will impact
the development of regulated products
well in advance of formal FDA
regulatory submissions (e.g., 5–10
years). To realize this goal requires longrange horizon scanning by a cadre of
scientific leaders from FDA, other
government Agencies, interested
stakeholders, and the public. Emerging
sciences, such as synthetic biology, are
expected to impact FDA regulated
products in the relatively near term. The
goal of this initiative is to identify issues
and advances that will impact the
Agency in the longer term and thus may
be in their infancy.
FDA formed the Emerging Sciences
Working Group to provide an FDA-wide
science-based forum to identify and
E:\FR\FM\19OCN1.SGM
19OCN1
Federal Register / Vol. 81, No. 202 / Wednesday, October 19, 2016 / Notices
communicate scientific regulatory
approaches, in order to prepare for
anticipated high impact emerging
science and technology. Additionally,
the Emerging Sciences Working Group
informs and advises Agency and FDA
Center leadership on critical and crosscutting issues likely to impact
regulatory policy development.
The Emerging Sciences Working
Group is seeking input from the public
to identify emerging science and
technology. Results from long range
horizon scanning will assist FDA
regarding emerging issues and crosscutting scientific advances, which may
impact FDA preparedness in the future.
Dated: October 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–25223 Filed 10–18–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2016–E–0463; FDA–
2016–E–0532; FDA–2016–E–2468]
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
REPATHA and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of
applications to the Director of the U.S.
Patent and Trademark Office (USPTO),
Department of Commerce, for the
extension of a patent which claims that
human biological product.
DATES: Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by December 19, 2016.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
April 17, 2017. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows:
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:39 Oct 18, 2016
Jkt 241001
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
Determination of Regulatory Review
Period for Purposes of Patent
Extension; REPATHA
AGENCY:
Electronic 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 Nos. FDA–
2016–E–0463, FDA–2016–E–0532, and
FDA–2016–E–2468 for ‘‘Determination
of Regulatory Review Period for
Purposes of Patent Extension;
REPATHA.’’ 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
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
72059
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:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
E:\FR\FM\19OCN1.SGM
19OCN1
Agencies
[Federal Register Volume 81, Number 202 (Wednesday, October 19, 2016)]
[Notices]
[Pages 72058-72059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25223]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-2406]
Emerging Issues and Cross-Cutting Scientific Advances;
Establishment of a Public Docket
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of docket; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is establishing a
public docket to receive input on emerging issues and cross-cutting
scientific advances that may impact FDA preparedness and inter-Agency
activities. Interested parties are invited to submit comments regarding
emerging technologies and cross-cutting scientific advances of
importance to FDA. The focus is on areas that may impact FDA in 5 or
more years.
DATES: Submit either electronic or written comments by October 21,
2019.
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-2016-N-2406 for ``Emerging Issues and Cross-Cutting Scientific
Advances.'' 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: Donna Mendrick, National Center for
Toxicological Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993, 301-796-8892,
Donna.Mendrick@fda.hhs.gov; or Michael Morgan, Office of Regulatory
Science and Innovation, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993, 240-402-3832,
Michael.Morgan@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is responsible for protecting the public
health by assuring the safety, efficacy, and security of human and
veterinary drugs, biological products, medical devices, our Nation's
food supply, cosmetics, and products that emit radiation. FDA is tasked
with advancing the public health by helping to speed innovations that
protect the public health. FDA also has responsibility for regulating
the manufacturing, marketing, and distribution of tobacco products, to
protect the public health, and to reduce tobacco use by minors.
Finally, FDA plays a significant role in the Nation's counterterrorism
capability. FDA fulfills this responsibility by ensuring the security
of the food supply, and by fostering development of medical products
used to respond to deliberate and naturally emerging public health
threats.
FDA's ability to achieve its mission relies on awareness of, and
proactive preparedness for, emerging issues and scientific advances,
which will impact the development of regulated products well in advance
of formal FDA regulatory submissions (e.g., 5-10 years). To realize
this goal requires long-range horizon scanning by a cadre of scientific
leaders from FDA, other government Agencies, interested stakeholders,
and the public. Emerging sciences, such as synthetic biology, are
expected to impact FDA regulated products in the relatively near term.
The goal of this initiative is to identify issues and advances that
will impact the Agency in the longer term and thus may be in their
infancy.
FDA formed the Emerging Sciences Working Group to provide an FDA-
wide science-based forum to identify and
[[Page 72059]]
communicate scientific regulatory approaches, in order to prepare for
anticipated high impact emerging science and technology. Additionally,
the Emerging Sciences Working Group informs and advises Agency and FDA
Center leadership on critical and cross-cutting issues likely to impact
regulatory policy development.
The Emerging Sciences Working Group is seeking input from the
public to identify emerging science and technology. Results from long
range horizon scanning will assist FDA regarding emerging issues and
cross-cutting scientific advances, which may impact FDA preparedness in
the future.
Dated: October 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25223 Filed 10-18-16; 8:45 am]
BILLING CODE 4164-01-P