81 FR 72058 - Emerging Issues and Cross-Cutting Scientific Advances; Establishment of a Public Docket
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 202 (October 19, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 202 (October 19, 2016)
| Page Range | 72058-72059 | |
| FR Document | 2016-25223 |
[Federal Register Volume 81, Number 202 (Wednesday, October 19, 2016)] [Notices] [Pages 72058-72059] From the Federal Register Online [www.thefederalregister.org] [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: 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-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 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: Donna Mendrick, National Center for Toxicological Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-8892, [email protected]; or Michael Morgan, Office of Regulatory Science and Innovation, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240-402-3832, [email protected]. 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
![72058 Federal Register / Vol. 81, No. 202 / Wednesday, October 19, 2016 / Notices
Dated: October 12, 2016. detailed (see ‘‘Written/Paper Docket: For access to the docket to
Edwin L. Walker, Submissions’’ and ‘‘Instructions’’). read background documents or the
Acting Administrator and Assistant Secretary electronic and written/paper comments
Written/Paper Submissions
for Aging. received, go to http://
[FR Doc. 2016–25118 Filed 10–18–16; 8:45 am] Submit written/paper submissions as www.regulations.gov and insert the
BILLING CODE 4154–01–P follows: docket number, found in brackets in the
• Mail/Hand delivery/Courier (for heading of this document, into the
written/paper submissions): Division of ‘‘Search’’ box and follow the prompts
DEPARTMENT OF HEALTH AND Dockets Management (HFA–305), Food and/or go to the Division of Dockets
HUMAN SERVICES and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm.
Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852.
Food and Drug Administration • For written/paper comments FOR FURTHER INFORMATION CONTACT:
[Docket No. FDA–2016–N–2406] submitted to the Division of Dockets Donna Mendrick, National Center for
Management, FDA will post your Toxicological Research, Food and Drug
Emerging Issues and Cross-Cutting comment, as well as any attachments, Administration, 10903 New Hampshire
Scientific Advances; Establishment of except for information submitted, Ave., Silver Spring, MD 20993, 301–
a Public Docket marked and identified, as confidential, 796–8892, Donna.Mendrick@
if submitted as detailed in fda.hhs.gov; or Michael Morgan, Office
AGENCY: Food and Drug Administration,
‘‘Instructions.’’ of Regulatory Science and Innovation,
HHS.
Instructions: All submissions received Food and Drug Administration, 10903
ACTION: Notice; establishment of docket; New Hampshire Ave., Silver Spring, MD
must include the Docket No. FDA–
request for comments. 20993, 240–402–3832,
2016–N–2406 for ‘‘Emerging Issues and
SUMMARY: The Food and Drug Cross-Cutting Scientific Advances.’’ Michael.Morgan@fda.hhs.gov.
Administration (FDA) is establishing a Received comments will be placed in SUPPLEMENTARY INFORMATION: FDA is
public docket to receive input on the docket and, except for those responsible for protecting the public
emerging issues and cross-cutting submitted as ‘‘Confidential health by assuring the safety, efficacy,
scientific advances that may impact Submissions,’’ publicly viewable at and security of human and veterinary
FDA preparedness and inter-Agency http://www.regulations.gov or at the drugs, biological products, medical
activities. Interested parties are invited Division of Dockets Management devices, our Nation’s food supply,
to submit comments regarding emerging between 9 a.m. and 4 p.m., Monday cosmetics, and products that emit
technologies and cross-cutting scientific through Friday. radiation. FDA is tasked with advancing
advances of importance to FDA. The • Confidential Submissions—To the public health by helping to speed
focus is on areas that may impact FDA submit a comment with confidential innovations that protect the public
in 5 or more years. information that you do not wish to be health. FDA also has responsibility for
DATES: Submit either electronic or made publicly available submit your regulating the manufacturing,
written comments by October 21, 2019. comments only as a written/paper marketing, and distribution of tobacco
ADDRESSES: You may submit comments submission. You should submit two products, to protect the public health,
as follows: copies total. One copy will include the and to reduce tobacco use by minors.
information you claim to be confidential Finally, FDA plays a significant role in
Electronic Submissions with a heading or cover note that states the Nation’s counterterrorism capability.
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS FDA fulfills this responsibility by
following way: CONFIDENTIAL INFORMATION.’’ The ensuring the security of the food supply,
• Federal eRulemaking Portal: http:// Agency will review this copy, including and by fostering development of
www.regulations.gov. Follow the the claimed confidential information, in medical products used to respond to
instructions for submitting comments. its consideration of comments. The deliberate and naturally emerging
Comments submitted electronically, second copy, which will have the public health threats.
including attachments, to http:// claimed confidential information FDA’s ability to achieve its mission
www.regulations.gov will be posted to redacted/blacked out, will be available relies on awareness of, and proactive
the docket unchanged. Because your for public viewing and posted on http:// preparedness for, emerging issues and
comment will be made public, you are www.regulations.gov. Submit both scientific advances, which will impact
solely responsible for ensuring that your copies to the Division of Dockets the development of regulated products
comment does not include any Management. If you do not wish your well in advance of formal FDA
confidential information that you or a name and contact information to be regulatory submissions (e.g., 5–10
third party may not wish to be posted, made publicly available, you can years). To realize this goal requires long-
such as medical information, your or provide this information on the cover range horizon scanning by a cadre of
anyone else’s Social Security number, or sheet and not in the body of your scientific leaders from FDA, other
confidential business information, such comments and you must identify this government Agencies, interested
as a manufacturing process. Please note information as ‘‘confidential.’’ Any stakeholders, and the public. Emerging
that if you include your name, contact information marked as ‘‘confidential’’ sciences, such as synthetic biology, are
information, or other information that will not be disclosed except in expected to impact FDA regulated
accordance with 21 CFR 10.20 and other
sradovich on DSK3GMQ082PROD with NOTICES
identifies you in the body of your products in the relatively near term. The
comments, that information will be applicable disclosure law. For more goal of this initiative is to identify issues
posted on http://www.regulations.gov. information about FDA’s posting of and advances that will impact the
• If you want to submit a comment comments to public dockets, see 80 FR Agency in the longer term and thus may
with confidential information that you 56469, September 18, 2015, or access be in their infancy.
do not wish to be made available to the the information at: http://www.fda.gov/ FDA formed the Emerging Sciences
public submit the comment as a written/ regulatoryinformation/dockets/ Working Group to provide an FDA-wide
paper submission and in the manner default.htm. science-based forum to identify and
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![Federal Register / Vol. 81, No. 202 / Wednesday, October 19, 2016 / Notices 72059
communicate scientific regulatory Electronic Submissions copies total. One copy will include the
approaches, in order to prepare for Submit electronic comments in the information you claim to be confidential
anticipated high impact emerging following way: with a heading or cover note that states
science and technology. Additionally, • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS
the Emerging Sciences Working Group www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
informs and advises Agency and FDA instructions for submitting comments. Agency will review this copy, including
Center leadership on critical and cross- Comments submitted electronically, the claimed confidential information, in
cutting issues likely to impact including attachments, to http:// its consideration of comments. The
regulatory policy development. www.regulations.gov will be posted to second copy, which will have the
The Emerging Sciences Working the docket unchanged. Because your claimed confidential information
Group is seeking input from the public comment will be made public, you are redacted/blacked out, will be available
to identify emerging science and solely responsible for ensuring that your for public viewing and posted on http://
technology. Results from long range comment does not include any www.regulations.gov. Submit both
horizon scanning will assist FDA confidential information that you or a copies to the Division of Dockets
regarding emerging issues and cross- third party may not wish to be posted, Management. If you do not wish your
cutting scientific advances, which may such as medical information, your or name and contact information to be
impact FDA preparedness in the future. anyone else’s Social Security number, or made publicly available, you can
Dated: October 13, 2016. confidential business information, such provide this information on the cover
Leslie Kux, as a manufacturing process. Please note sheet and not in the body of your
that if you include your name, contact comments and you must identify this
Associate Commissioner for Policy.
information, or other information that information as ‘‘confidential.’’ Any
[FR Doc. 2016–25223 Filed 10–18–16; 8:45 am]
identifies you in the body of your information marked as ‘‘confidential’’
BILLING CODE 4164–01–P will not be disclosed except in
comments, that information will be
posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other
• If you want to submit a comment applicable disclosure law. For more
DEPARTMENT OF HEALTH AND
with confidential information that you information about FDA’s posting of
HUMAN SERVICES
do not wish to be made available to the comments to public dockets, see 80 FR
Food and Drug Administration public, submit the comment as a 56469, September 18, 2015, or access
written/paper submission and in the the information at: http://www.fda.gov/
manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/
[Docket Nos. FDA–2016–E–0463; FDA–
Submissions’’ and ‘‘Instructions’’). default.htm.
2016–E–0532; FDA–2016–E–2468]
Docket: For access to the docket to
Determination of Regulatory Review Written/Paper Submissions read background documents or the
Period for Purposes of Patent Submit written/paper submissions as electronic and written/paper comments
Extension; REPATHA follows: received, go to http://
• Mail/Hand delivery/Courier (for www.regulations.gov and insert the
AGENCY: Food and Drug Administration, written/paper submissions): Division of docket number, found in brackets in the
HHS. Dockets Management (HFA–305), Food heading of this document, into the
ACTION: Notice. and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets
SUMMARY: The Food and Drug • For written/paper comments Management, 5630 Fishers Lane, Rm.
Administration (FDA) has determined submitted to the Division of Dockets 1061, Rockville, MD 20852.
the regulatory review period for Management, FDA will post your
REPATHA and is publishing this notice FOR FURTHER INFORMATION CONTACT:
comment, as well as any attachments, Beverly Friedman, Office of Regulatory
of that determination as required by except for information submitted,
law. FDA has made the determination Policy, Food and Drug Administration,
marked and identified, as confidential, 10903 New Hampshire Ave., Bldg. 51,
because of the submission of if submitted as detailed in
applications to the Director of the U.S. Rm. 6250, Silver Spring, MD 20993,
‘‘Instructions.’’ 301–796–3600.
Patent and Trademark Office (USPTO), Instructions: All submissions received
Department of Commerce, for the must include the Docket Nos. FDA– SUPPLEMENTARY INFORMATION:
extension of a patent which claims that 2016–E–0463, FDA–2016–E–0532, and
human biological product. I. Background
FDA–2016–E–2468 for ‘‘Determination
DATES: Anyone with knowledge that any of Regulatory Review Period for The Drug Price Competition and
of the dates as published (see the Purposes of Patent Extension; Patent Term Restoration Act of 1984
SUPPLEMENTARY INFORMATION section) are REPATHA.’’ Received comments will be (Pub. L. 98–417) and the Generic
incorrect may submit either electronic placed in the docket and, except for Animal Drug and Patent Term
or written comments and ask for a those submitted as ‘‘Confidential Restoration Act (Pub. L. 100–670)
redetermination by December 19, 2016. Submissions,’’ publicly viewable at generally provide that a patent may be
Furthermore, any interested person may http://www.regulations.gov or at the extended for a period of up to 5 years
petition FDA for a determination Division of Dockets Management so long as the patented item (human
regarding whether the applicant for between 9 a.m. and 4 p.m., Monday drug product, animal drug product,
sradovich on DSK3GMQ082PROD with NOTICES
extension acted with due diligence through Friday. medical device, food additive, or color
during the regulatory review period by • Confidential Submissions—To additive) was subject to regulatory
April 17, 2017. See ‘‘Petitions’’ in the submit a comment with confidential review by FDA before the item was
SUPPLEMENTARY INFORMATION section for information that you do not wish to be marketed. Under these acts, a product’s
more information. made publicly available, submit your regulatory review period forms the basis
ADDRESSES: You may submit comments comments only as a written/paper for determining the amount of extension
as follows: submission. You should submit two an applicant may receive.
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Document Created: 2016-10-19 02:11:39
Document Modified: 2016-10-19 02:11:39
| 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; establishment of docket; request for comments. | |
| Dates | Submit either electronic or written comments by October 21, 2019. | |
| Contact | Donna Mendrick, National Center for Toxicological Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-8892, [email protected]; or Michael Morgan, Office of Regulatory Science and Innovation, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240-402-3832, [email protected] | |
| FR Citation | 81 FR 72058 |
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