Government-Owned Inventions; Availability for Licensing, 19738-19739 [2017-08596]
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Federal Register / Vol. 82, No. 81 / Friday, April 28, 2017 / Notices
asabaliauskas on DSK3SPTVN1PROD with NOTICES
• 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–1114 for ’’ Pharmaceutical
Distribution Supply Chain Pilot
Projects; Reopening of Comment Period;
Request for Information.’’ Received
comments, those filed in a timely
manner (see DATES), 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
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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
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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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
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:
Daniel Bellingham, Office of
Compliance, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–3130, DSCSAPilotProjects@
fda.hhs.gov.
In the
Federal Register of April 15, 2016, FDA
published a Request for Information
with a 30-day comment period to
request comments relating to FDA
implementation of the DSCSA. To
permit additional and update
submissions, we are reopening this
comment period and extending it for
April 30, 2018. We are particularly
interested in comments regarding past
or present pilot projects related to
enhancing the safety and security of the
pharmaceutical distribution supply
chain. Stakeholders that may be
interested in responding to this request
for information include manufacturers,
repackagers, wholesale distributors,
dispensers, State and Federal
authorities, solution providers, and
standards organizations, and other
interested persons. FDA is particularly
interested in learning about the
practices, processes, and systems that
supply chain stakeholders have used or
considered using in such pilot projects.
This includes, but is not limited to,
information about the following:
• Utilizing the product identifier for
tracing of a product, which may include
verification of the product identifier of
a product, including the use of
aggregation and inference;
• Technical capabilities each sector of
the supply chain to comply with
systems and processes needed to utilize
the product identifier to enhance the
tracing of a product; or
• System attributes that are necessary
to implement the requirements
established under the DSCSA.
SUPPLEMENTARY INFORMATION:
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Interested persons are requested to
provide any other relevant information
that may inform FDA’s development of
a pilot project under the DSCSA.
FDA is reopening the comment period
for the Request for Information for 1
year, until April 30, 2018. The Agency
believes that an additional comment
period of 1 year will allow time for
interested persons to submit new,
additional, or updated comments on
these important issues.
Dated: April 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–08583 Filed 4–27–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–1393]
Government-Owned Inventions;
Availability for Licensing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The invention listed in this
document is owned by an agency of the
U.S. Government and is available for
licensing to achieve expeditious
commercialization of results of federally
funded research and development.
FOR FURTHER INFORMATION CONTACT:
Licensing information and copies of the
patent applications listed in this
document may be obtained by writing to
the indicated licensing contact at the
Food and Drug Administration (FDA)
Technology Transfer Program, 10903
New Hampshire Ave., Bldg. 1, Rm.
4213, Silver Spring, MD 20993,
telephone: 240–402–2561, FAX: 301–
847–3539. A signed Confidential
Disclosure Agreement will be required
to receive copies of the patent
applications.
SUMMARY:
SUPPLEMENTARY INFORMATION:
Technology descriptions follow.
Title of Abstract: Solid-Phase
Purification of Synthetic DNA
Sequences.
Description of Technology: Scientists
at FDA have developed a highthroughput method for purifying fulllength phosphorothioate and native
DNA sequences. This method comprises
a modified silica gel that enables
capture of DNA sequences
functionalized with a novel linker
specifically designed for exclusive
capture of full-length sequences. This
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Federal Register / Vol. 82, No. 81 / Friday, April 28, 2017 / Notices
technology has been shown to generate
DNA sequences of high purity without
the need of expensive equipment and
associated accessories. This discovery
may improve the availability of pure
DNA sequences for clinical and/or
synthetic biology applications.
Potential Commercial Applications:
• A high-throughput purification
technique for producing small and large
quantities of highly pure DNA
sequences.
Competitive Advantages:
• Cost effective.
• High-throughput capabilities.
• Time saving.
• High purity.
Development Stage:
• In vitro data available.
Inventors:
Serge L. Beaucage.
Andrzej Grajkowski.
Publication: Grajkowski, A., J. Cieslak,
and S.L. Beaucage, ‘‘Solid-Phase
Purification of Synthetic DNA
Sequences,’’ The Journal of Organic
Chemistry, 81 (15): pp. 6165–6175,
2016; DOI: 10.1021/acs.joc.6b01020.
Intellectual Property: U.S. Provisional
Patent Application No. 62/356,214, filed
June 29, 2016, FDA Reference No. E–
2016–005.
Licensing and Collaborative Research
Opportunity:
Parties interested in licensing this
technology should contact Charlene
Maddox at Charlene.Maddox@
fda.hhs.gov or FDAInventionlicensing@
fda.hhs.gov.
Dated: April 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–08596 Filed 4–27–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Information Collection
Request Title: Health Workforce
Connector, OMB No. 0906–xxxx—NEW
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
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In compliance with the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than May 30, 2017.
ADDRESSES: Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to OIRA_
submission@omb.eop.gov or by fax to
202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference, in compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995.
Information Collection Request Title:
Health Workforce Connector OMB No.
0906–xxxx—NEW
Abstract: The Health Workforce
Connector is being developed to expand
on the current National Health Service
Corps (NHSC) Jobs Center, which
includes positions approved for NHSC
scholarship and loan repayment
obligors. The new Health Workforce
Connector will provide a central
platform to connect participants in both
the NHSC and NURSE Corps programs
with facilities that are approved for
performance of their NHSC or NURSE
Corps service obligation. The Health
Workforce Connector will become a
resource that engages any health care
professional or student interested in
providing primary care services in
underserved communities (whether or
not those individuals are obligated to
the NHSC or NURSE Corps) with
facilities in need of health care
providers. The Health Workforce
Connector will also allow users to create
a profile, search for NHSC and NURSE
Corps sites, find job opportunities, and
will be searchable by Site Points of
Contact. Like the current NHSC Jobs
Center, individuals will be able to use
SUMMARY:
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19739
the Health Workforce Connector’s
search capability with Google Maps.
Need and Proposed Use of the
Information: Information will be
collected from users in the following
two ways:
(1) Account Creation: Creating an
account is optional, but to create an
account, the user will be required to
enter their first name, last name, and
email address. Those are the only
mandatory fields in the profile account
creation process and will be used to
send an automated email allowing the
user to validate their login credentials.
This information will also be used to
validate any users who already exist
within the Bureau of Health Workforce
Management Information Systems
Solution (BMISS) database and allow an
initial import of existing data at the
request of the user.
(2) Profile Completion: Users may fill
out a profile, but this function will be
completely optional and will include
fields such as location, discipline,
specialty, and languages spoken. The
information collected, if ‘published’ by
the user, will allow internal BMISS Site
Points of Contact the ability to search on
anyone who may be a potential
candidate for job opportunities at the
site. All information collected will be
stored within existing secure BMISS
databases and will be used internally for
report generation on an as-needed basis.
Likely Respondents: Potential users
will include individuals searching for a
health care job opportunity or an NHSC
or NURSE Corps health care facility,
and health care facilities searching for
potential candidates to fill open health
care job opportunities at their sites.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
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]]>Agencies
[Federal Register Volume 82, Number 81 (Friday, April 28, 2017)]
[Notices]
[Pages 19738-19739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08596]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-1393]
Government-Owned Inventions; Availability for Licensing
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The invention listed in this document is owned by an agency of
the U.S. Government and is available for licensing to achieve
expeditious commercialization of results of federally funded research
and development.
FOR FURTHER INFORMATION CONTACT: Licensing information and copies of
the patent applications listed in this document may be obtained by
writing to the indicated licensing contact at the Food and Drug
Administration (FDA) Technology Transfer Program, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4213, Silver Spring, MD 20993, telephone: 240-402-
2561, FAX: 301-847-3539. A signed Confidential Disclosure Agreement
will be required to receive copies of the patent applications.
SUPPLEMENTARY INFORMATION: Technology descriptions follow.
Title of Abstract: Solid-Phase Purification of Synthetic DNA
Sequences.
Description of Technology: Scientists at FDA have developed a high-
throughput method for purifying full-length phosphorothioate and native
DNA sequences. This method comprises a modified silica gel that enables
capture of DNA sequences functionalized with a novel linker
specifically designed for exclusive capture of full-length sequences.
This
[[Page 19739]]
technology has been shown to generate DNA sequences of high purity
without the need of expensive equipment and associated accessories.
This discovery may improve the availability of pure DNA sequences for
clinical and/or synthetic biology applications.
Potential Commercial Applications:
A high-throughput purification technique for producing
small and large quantities of highly pure DNA sequences.
Competitive Advantages:
Cost effective.
High-throughput capabilities.
Time saving.
High purity.
Development Stage:
In vitro data available.
Inventors:
Serge L. Beaucage.
Andrzej Grajkowski.
Publication: Grajkowski, A., J. Cieslak, and S.L. Beaucage,
``Solid-Phase Purification of Synthetic DNA Sequences,'' The Journal of
Organic Chemistry, 81 (15): pp. 6165-6175, 2016; DOI: 10.1021/
acs.joc.6b01020.
Intellectual Property: U.S. Provisional Patent Application No. 62/
356,214, filed June 29, 2016, FDA Reference No. E-2016-005.
Licensing and Collaborative Research Opportunity:
Parties interested in licensing this technology should contact
Charlene Maddox at Charlene.Maddox@fda.hhs.gov or
FDAInventionlicensing@fda.hhs.gov.
Dated: April 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08596 Filed 4-27-17; 8:45 am]
BILLING CODE 4164-01-P
