82_FR_19819 82 FR 19738 - Government-Owned Inventions; Availability for Licensing

82 FR 19738 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 81 (April 28, 2017)

Page Range19738-19739
FR Document2017-08596

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.

Federal Register, Volume 82 Issue 81 (Friday, April 28, 2017) 
[Federal Register Volume 82, Number 81 (Friday, April 28, 2017)]
[Notices]
[Pages 19738-19739]
From the Federal Register Online  [www.thefederalregister.org]
[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 [email protected] or 
[email protected].

    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

19738 Federal Register / Vol. 82, No. 81 / Friday, April 28, 2017 / Notices • If you want to submit a comment applicable disclosure law. For more Interested persons are requested to with confidential information that you information about FDA’s posting of provide any other relevant information do not wish to be made available to the comments to public dockets, see 80 FR that may inform FDA’s development of public, submit the comment as a 56469, September 18, 2015, or access a pilot project under the DSCSA. written/paper submission and in the the information at: https://www.gpo.gov/ FDA is reopening the comment period manner detailed (see ‘‘Written/Paper fdsys/pkg/FR-2015-09-18/pdf/2015- for the Request for Information for 1 Submissions’’ and ‘‘Instructions’’). 23389.pdf. year, until April 30, 2018. The Agency Docket: For access to the docket to believes that an additional comment Written/Paper Submissions read background documents or the period of 1 year will allow time for Submit written/paper submissions as electronic and written/paper comments interested persons to submit new, follows: received, go to https:// additional, or updated comments on • Mail/Hand delivery/Courier (for www.regulations.gov/ and insert the these important issues. written/paper submissions): Division of docket number, found in brackets in the Dated: April 19, 2017. Dockets Management (HFA–305), Food heading of this document, into the Anna K. Abram, and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts Deputy Commissioner for Policy, Planning, Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments and/or go to the Division of Dockets Legislation, and Analysis. submitted to the Division of Dockets Management, 5630 Fishers Lane, Rm. [FR Doc. 2017–08583 Filed 4–27–17; 8:45 am] Management, FDA will post your 1061, Rockville, MD 20852. BILLING CODE 4164–01–P comment, as well as any attachments, FOR FURTHER INFORMATION CONTACT: except for information submitted, Daniel Bellingham, Office of marked and identified, as confidential, Compliance, Center for Drug Evaluation DEPARTMENT OF HEALTH AND if submitted as detailed in and Research, Food and Drug HUMAN SERVICES ‘‘Instructions.’’ Administration, 10903 New Hampshire Instructions: All submissions received Ave., Silver Spring, MD 20993–0002, Food and Drug Administration must include the Docket No. FDA– 301–796–3130, DSCSAPilotProjects@ [Docket No. FDA–2017–N–1393] 2016–N–1114 for ’’ Pharmaceutical fda.hhs.gov. Distribution Supply Chain Pilot Government-Owned Inventions; Projects; Reopening of Comment Period; SUPPLEMENTARY INFORMATION: In the Availability for Licensing Request for Information.’’ Received Federal Register of April 15, 2016, FDA comments, those filed in a timely published a Request for Information AGENCY: Food and Drug Administration, manner (see DATES), will be placed in with a 30-day comment period to HHS. the docket and, except for those request comments relating to FDA ACTION: Notice. submitted as ‘‘Confidential implementation of the DSCSA. To permit additional and update SUMMARY: The invention listed in this Submissions,’’ publicly viewable at submissions, we are reopening this document is owned by an agency of the https://www.regulations.gov/ or at the comment period and extending it for U.S. Government and is available for Division of Dockets Management April 30, 2018. We are particularly licensing to achieve expeditious between 9 a.m. and 4 p.m., Monday interested in comments regarding past commercialization of results of federally through Friday. • Confidential Submissions—To or present pilot projects related to funded research and development. submit a comment with confidential enhancing the safety and security of the FOR FURTHER INFORMATION CONTACT: information that you do not wish to be pharmaceutical distribution supply Licensing information and copies of the made publicly available, submit your chain. Stakeholders that may be patent applications listed in this comments only as a written/paper interested in responding to this request document may be obtained by writing to submission. You should submit two for information include manufacturers, the indicated licensing contact at the copies total. One copy will include the repackagers, wholesale distributors, Food and Drug Administration (FDA) information you claim to be confidential dispensers, State and Federal Technology Transfer Program, 10903 with a heading or cover note that states authorities, solution providers, and New Hampshire Ave., Bldg. 1, Rm. ‘‘THIS DOCUMENT CONTAINS standards organizations, and other 4213, Silver Spring, MD 20993, CONFIDENTIAL INFORMATION.’’ The interested persons. FDA is particularly telephone: 240–402–2561, FAX: 301– Agency will review this copy, including interested in learning about the 847–3539. A signed Confidential the claimed confidential information, in practices, processes, and systems that Disclosure Agreement will be required its consideration of comments. The supply chain stakeholders have used or to receive copies of the patent second copy, which will have the considered using in such pilot projects. applications. claimed confidential information This includes, but is not limited to, SUPPLEMENTARY INFORMATION: redacted/blacked out, will be available information about the following: Technology descriptions follow. for public viewing and posted on • Utilizing the product identifier for Title of Abstract: Solid-Phase https://www.regulations.gov/. Submit tracing of a product, which may include Purification of Synthetic DNA both copies to the Division of Dockets verification of the product identifier of Sequences. Management. If you do not wish your a product, including the use of Description of Technology: Scientists name and contact information to be aggregation and inference; at FDA have developed a high- asabaliauskas on DSK3SPTVN1PROD with NOTICES made publicly available, you can • Technical capabilities each sector of throughput method for purifying full- provide this information on the cover the supply chain to comply with length phosphorothioate and native sheet and not in the body of your systems and processes needed to utilize DNA sequences. This method comprises comments and you must identify this the product identifier to enhance the a modified silica gel that enables information as ‘‘confidential.’’ Any tracing of a product; or capture of DNA sequences information marked as ‘‘confidential’’ • System attributes that are necessary functionalized with a novel linker will not be disclosed except in to implement the requirements specifically designed for exclusive accordance with 21 CFR 10.20 and other established under the DSCSA. capture of full-length sequences. This VerDate Sep<11>2014 17:38 Apr 27, 2017 Jkt 241001 PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 E:\FR\FM\28APN1.SGM 28APN1

Federal Register / Vol. 82, No. 81 / Friday, April 28, 2017 / Notices 19739 technology has been shown to generate SUMMARY: In compliance with the the Health Workforce Connector’s DNA sequences of high purity without Paperwork Reduction Act of 1995, search capability with Google Maps. the need of expensive equipment and HRSA has submitted an Information Need and Proposed Use of the associated accessories. This discovery Collection Request (ICR) to the Office of Information: Information will be may improve the availability of pure Management and Budget (OMB) for collected from users in the following DNA sequences for clinical and/or review and approval. Comments two ways: synthetic biology applications. submitted during the first public review (1) Account Creation: Creating an Potential Commercial Applications: of this ICR will be provided to OMB. account is optional, but to create an • A high-throughput purification OMB will accept further comments from account, the user will be required to technique for producing small and large the public during the review and enter their first name, last name, and quantities of highly pure DNA approval period. email address. Those are the only sequences. DATES: Comments on this ICR should be mandatory fields in the profile account Competitive Advantages: received no later than May 30, 2017. creation process and will be used to • Cost effective. ADDRESSES: Submit your comments, send an automated email allowing the • High-throughput capabilities. including the Information Collection user to validate their login credentials. • Time saving. • High purity. Request Title, to the desk officer for This information will also be used to Development Stage: HRSA, either by email to OIRA_ validate any users who already exist • In vitro data available. submission@omb.eop.gov or by fax to within the Bureau of Health Workforce Inventors: 202–395–5806. Management Information Systems Serge L. Beaucage. FOR FURTHER INFORMATION CONTACT: To Solution (BMISS) database and allow an Andrzej Grajkowski. request a copy of the clearance requests initial import of existing data at the Publication: Grajkowski, A., J. Cieslak, submitted to OMB for review, email the request of the user. and S.L. Beaucage, ‘‘Solid-Phase HRSA Information Collection Clearance (2) Profile Completion: Users may fill Purification of Synthetic DNA Officer at paperwork@hrsa.gov or call out a profile, but this function will be Sequences,’’ The Journal of Organic (301) 443–1984. completely optional and will include Chemistry, 81 (15): pp. 6165–6175, SUPPLEMENTARY INFORMATION: When fields such as location, discipline, 2016; DOI: 10.1021/acs.joc.6b01020. submitting comments or requesting specialty, and languages spoken. The Intellectual Property: U.S. Provisional information, please include the information collected, if ‘published’ by Patent Application No. 62/356,214, filed information request collection title for the user, will allow internal BMISS Site June 29, 2016, FDA Reference No. E– reference, in compliance with Section Points of Contact the ability to search on 2016–005. 3506(c)(2)(A) of the Paperwork anyone who may be a potential Licensing and Collaborative Research Reduction Act of 1995. candidate for job opportunities at the Opportunity: Information Collection Request Title: site. All information collected will be Parties interested in licensing this Health Workforce Connector OMB No. stored within existing secure BMISS technology should contact Charlene 0906–xxxx—NEW databases and will be used internally for Maddox at Charlene.Maddox@ Abstract: The Health Workforce report generation on an as-needed basis. fda.hhs.gov or FDAInventionlicensing@ Connector is being developed to expand Likely Respondents: Potential users fda.hhs.gov. on the current National Health Service will include individuals searching for a Dated: April 19, 2017. Corps (NHSC) Jobs Center, which health care job opportunity or an NHSC Anna K. Abram, includes positions approved for NHSC or NURSE Corps health care facility, Deputy Commissioner for Policy, Planning, scholarship and loan repayment and health care facilities searching for Legislation, and Analysis. obligors. The new Health Workforce potential candidates to fill open health [FR Doc. 2017–08596 Filed 4–27–17; 8:45 am] Connector will provide a central care job opportunities at their sites. BILLING CODE 4164–01–P platform to connect participants in both Burden Statement: Burden in this the NHSC and NURSE Corps programs context means the time expended by with facilities that are approved for persons to generate, maintain, retain, DEPARTMENT OF HEALTH AND performance of their NHSC or NURSE disclose or provide the information HUMAN SERVICES Corps service obligation. The Health requested. This includes the time Workforce Connector will become a needed to review instructions; to Health Resources and Services resource that engages any health care develop, acquire, install and utilize Administration professional or student interested in technology and systems for the purpose providing primary care services in of collecting, validating and verifying Agency Information Collection underserved communities (whether or information, processing and Activities: Submission to OMB for not those individuals are obligated to maintaining information, and disclosing Review and Approval; Public Comment the NHSC or NURSE Corps) with and providing information; to train Request; Information Collection facilities in need of health care personnel and to be able to respond to Request Title: Health Workforce providers. The Health Workforce a collection of information; to search Connector, OMB No. 0906–xxxx—NEW Connector will also allow users to create data sources; to complete and review AGENCY: Health Resources and Services a profile, search for NHSC and NURSE the collection of information; and to asabaliauskas on DSK3SPTVN1PROD with NOTICES Administration (HRSA), Department of Corps sites, find job opportunities, and transmit or otherwise disclose the Health and Human Services. will be searchable by Site Points of information. The total annual burden Contact. Like the current NHSC Jobs hours estimated for this ICR are ACTION: Notice. Center, individuals will be able to use summarized in the table below. VerDate Sep<11>2014 17:38 Apr 27, 2017 Jkt 241001 PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 E:\FR\FM\28APN1.SGM 28APN1


Document Created: 2017-04-28 03:02:52
Document Modified: 2017-04-28 03:02:52
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactLicensing 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.
FR Citation82 FR 19738 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR