82 FR 41971 - Proposed Collection; 60-Day Comment Request; NCI Cancer Genetics Services Directory Web-Based Application and Update Mailer (National Cancer Institute)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 82, Issue 170 (September 5, 2017)
National Institutes of Health
Federal Register Volume 82, Issue 170 (September 5, 2017)
| Page Range | 41971-41972 | |
| FR Document | 2017-18667 |
[Federal Register Volume 82, Number 170 (Tuesday, September 5, 2017)] [Notices] [Pages 41971-41972] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-18667] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request; NCI Cancer Genetics Services Directory Web-Based Application and Update Mailer (National Cancer Institute) AGENCY: National Institutes of Health, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval. DATES: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Margaret Beckwith, Office of Cancer Content, Office of Communications and Public Liaison (OCPL), 9609 Medical Center Drive, Rockville, MD 20892 or call non-toll-free number 240-276-6600 or email your request, including your address to: [email protected]. Formal requests for additional plans and instruments must be requested in writing. SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: Written [[Page 41972]] comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Proposed Collection Title: NCI Cancer Genetics Services Directory Web-Based Application and Update Mailer, 0925-0639, Extension, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The Office of Communications and Public Liaison has created the NCI Cancer Genetics Services Directory on NCI's Web site Cancer.gov. This directory is a searchable collection of information about professionals who provide services related to cancer genetics. These services include cancer risk assessment, genetic counseling, and genetic susceptibility testing. The professionals have applied to be in the directory using an online application form and have met basic criteria outlined on the form. There are currently 552 genetics professionals listed in the directory. Approximately 30-60 new professionals are added to the directory each year. The applicants are nurses, physicians, genetic counselors, and other professionals who provide services related to cancer genetics. The information collected on the application form includes name, professional qualifications, practice locations, and the area of specialization. The information is updated annually using a Web-based update mailer that mirrors the application form. The NCI Cancer Genetics Services Directory is a unique resource for cancer patients and their families who are looking for information about their family risk of cancer and genetic counseling. Collecting applicant information and verifying it annually by using the NCI Cancer Genetics Services Directory Web-based Application Form and Update Mailer is important for providing this information to the public and for keeping it current. OMB approval is requested for 3 year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 180. Estimated Annualized Burden Hours -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average burden Form name Type of respondent Number of responses per per response Total annual respondents respondent (in hours) burden Hours -------------------------------------------------------------------------------------------------------------------------------------------------------- Web-based Application Form..................... Genetics Professional.................. 60 1 30/60 30 Web-based Update Mailer........................ Genetics Professional.................. 600 1 15/60 150 --------------------------------------------------------------- Totals..................................... ....................................... 660 660 .............. 180 -------------------------------------------------------------------------------------------------------------------------------------------------------- Dated: August 21, 2017. Karla Bailey, Project Clearance Liaison, National Cancer Institute, National Institutes of Health. [FR Doc. 2017-18667 Filed 9-1-17; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 82, No. 170 / Tuesday, September 5, 2017 / Notices 41971
Facsimile: (240)-276–5504 Email: nanotubes transistors and electronic Complete applications for a license in
greenejaime@mail.nih.gov. circuitry to quantitatively measure the prospective field of use that are filed
SUPPLEMENTARY INFORMATION: changes in gene expression levels. in response to this notice will be treated
Typically, microarrays are microscope as objections to the grant of the
Intellectual Property glass slides spotted with thousands of contemplated Exclusive
EP Patent 1999277 (Application No. different genes. The array does not have Commercialization Patent License
07753436.0) filed 19 March 2007, titled built-in reader, and the detection is Agreement. Comments and objections
‘‘Apparatus for biosensor microarrays based performed using a fluorescence scanner submitted to this notice will not be
on carbon nanotube transistors having after hybridization with fluorescent- made available for public inspection
biological probe materials, method for its
tagged target DNA. For simple nucleic and, to the extent permitted by law, will
production and method of electronically
detecting a biological target material’’, acid detection, current methods rely not be released under the Freedom of
validated in FR, DE, IE, and GB, HHS upon various combinations of Information Act, 5 U.S.C. 552.
Reference No.: E–056–2007/0–EP–04; enzymatic amplification of nucleic acids Dated: August 25, 2017.
Australia Patent 2007227415 (Application and fluorescent labeling of targets,
No. 2007227415) filed 10/16/08, titled Richard U. Rodriguez,
which entail enzymatic manipulation of
‘‘Apparatus for microarray binding sensors the nucleic acid being tested and Associate Director, Technology Transfer
having biological probe materials using Center, National Cancer Institute.
chemical labeling, respectively. These
carbon nanotube transistors’’, HHS Reference [FR Doc. 2017–18668 Filed 9–1–17; 8:45 am]
methods are both time consuming and
No.: E–056–2007/0–AU–05;
Canada Patent 2646465 (Application No. afford limited sensitivity. In cases where BILLING CODE 4140–01–P
2646465) filed 03/19/07, titled ‘‘Apparatus microarray technology is used as a tool
for microarray binding sensors having for monitoring gene expression patterns
biological probe materials using carbon and profiling of micro RNA (miRNA) in DEPARTMENT OF HEALTH AND
nanotube transistors’’, HHS Reference No.: E– normal and cancerous tissue, HUMAN SERVICES
056–2007/0–CA–06; quantification of changes has typically
Japan Patent 5048752 (Application No. National Institutes of Health
been optically-based. While this
2009–501490) filed 03/19/07, titled
technique is highly sensitive, use of Proposed Collection; 60-Day Comment
‘‘Apparatus for microarray binding sensors
having biological probe materials using optical methods impedes progress in Request; NCI Cancer Genetics
carbon nanotube transistors’’, HHS Reference both system miniaturization and in Services Directory Web-Based
No.: E–056–2007/0–JP–07; direct interfacing with data collection Application and Update Mailer
EP Patent 2570490 (Application No. electronics. (National Cancer Institute)
12160369.0) filed 03/19/07, titled ‘‘Apparatus To overcome the limitation of current
for microarray binding sensors having microarray technologies, the inventors AGENCY: National Institutes of Health,
biological probe materials using carbon have developed a highly sensitive HHS.
nanotube transistors’’, validated in FR, DE, microarray apparatus that uses carbon
and GB. HHS Reference No.: E–056–2007/0– ACTION: Notice.
EP–08;
nanotube transistors for the electronic
U.S. Patent 8,017,938 (Application No. 11/ detection of biological probe-target SUMMARY: In compliance with the
723,369), filed 19 March 2007, titled binding. The present invention provides requirement of the Paperwork
‘‘Apparatus for Microarray Binding Sensors an apparatus for biological target Reduction Act of 1995 to provide
Having Biological Probe Materials Using material detection which uses an array opportunity for public comment on
Carbon Nanotube Transistors’’, HHS Ref. No.: of carbon nanotube transistors, with proposed data collection projects, the
E–056–2007/0–US–03; and each being operated as a field effect National Cancer Institute (NCI) will
PCT Application No. PCT/US2007/06809, transistor. A single carbon nanotube publish periodic summaries of propose
filed 19 March 2007, now abandoned, titled transistor is associated with a distinct projects to be submitted to the Office of
‘‘Apparatus for Microarray Binding Sensors
Having Biological Probe Materials Using
biological probe material. The current Management and Budget (OMB) for
Carbon Nanotube Transistors’’, HHS Ref. No.: versus voltage characteristics or review and approval.
E–056–2007/0–PCT–02. transconductance between the source DATES: Comments regarding this
U.S. Provisional Patent Application No. and drain electrodes is measured before information collection are best assured
60/743,524, filed 17 March 2006, now and after a binding event between the of having their full effect if received
abandoned, titled ‘‘Apparatus for Microarray biological probe and target materials. By within 60 days of the date of this
DNA Binding Sensors Using Carbon using a mathematical relationship, the publication.
Nanotube Transistors’’, HHS Ref. No.: E–056– exact amount of target binding can be
2007/0–US–01. extracted. Importantly, the present FOR FURTHER INFORMATION CONTACT: To
The patent rights in these inventions apparatus offers a significant advantage obtain a copy of the data collection
have been assigned and/or exclusively in simplicity of protocol as the method plans and instruments, submit
licensed to the government of the used therewith does not require comments in writing, or request more
United States of America. chemical or enzymatic manipulation of information on the proposed project,
The prospective exclusive license the target being detected. contact: Margaret Beckwith, Office of
territory may be worldwide and the This notice is made in accordance Cancer Content, Office of
field of use may be limited to: ‘‘The with 35 U.S.C. 209 and 37 CFR part 404. Communications and Public Liaison
development of an FDA-approved or The prospective exclusive license will (OCPL), 9609 Medical Center Drive,
cleared in vitro diagnostic for the be royalty bearing, and the prospective Rockville, MD 20892 or call non-toll-
detection of hematological exclusive license may be granted unless free number 240–276–6600 or email
mstockstill on DSK30JT082PROD with NOTICES
malignancies, wherein nucleic acids within fifteen (15) days from the date of your request, including your address to:
encoding one or more of the following this published notice, the National nciocpl@mail.nih.gov. Formal requests
genes are detected: (1) BCR–ABL, (2) Cancer Institute receives written for additional plans and instruments
FLT3, (3) Btk, (4) Alk, (5) Bcl–2, (6) Akt, evidence and argument that establishes must be requested in writing.
and (7) PI3K.’’ that the grant of the license would not SUPPLEMENTARY INFORMATION: Section
This technology discloses a be consistent with the requirements of 3506(c)(2)(A) of the Paperwork
microarray apparatus that uses carbon 35 U.S.C. 209 and 37 CFR part 404. Reduction Act of 1995 requires: Written
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![41972 Federal Register / Vol. 82, No. 170 / Tuesday, September 5, 2017 / Notices
comments and/or suggestions from the 0639, Extension, National Cancer professionals who provide services
public and affected agencies are invited Institute (NCI), National Institutes of related to cancer genetics. The
to address one or more of the following Health (NIH). information collected on the application
points: (1) Whether the proposed Need and Use of Information form includes name, professional
collection of information is necessary Collection: The Office of qualifications, practice locations, and
for the proper performance of the Communications and Public Liaison has the area of specialization. The
function of the agency, including created the NCI Cancer Genetics information is updated annually using a
whether the information will have Services Directory on NCI’s Web site Web-based update mailer that mirrors
practical utility; (2) The accuracy of the Cancer.gov. This directory is a the application form.
agency’s estimate of the burden of the searchable collection of information The NCI Cancer Genetics Services
proposed collection of information, about professionals who provide Directory is a unique resource for cancer
including the validity of the services related to cancer genetics. patients and their families who are
methodology and assumptions used; (3) These services include cancer risk looking for information about their
Ways to enhance the quality, utility, and assessment, genetic counseling, and family risk of cancer and genetic
clarity of the information to be genetic susceptibility testing. The counseling. Collecting applicant
collected; and (4) Ways to minimize the professionals have applied to be in the information and verifying it annually by
burden of the collection of information directory using an online application using the NCI Cancer Genetics Services
on those who are to respond, including form and have met basic criteria Directory Web-based Application Form
the use of appropriate automated, outlined on the form. and Update Mailer is important for
electronic, mechanical, or other There are currently 552 genetics providing this information to the public
technological collection techniques or professionals listed in the directory. and for keeping it current.
other forms of information technology. Approximately 30–60 new professionals OMB approval is requested for 3 year.
Proposed Collection Title: NCI Cancer are added to the directory each year. There are no costs to respondents other
Genetics Services Directory Web-Based The applicants are nurses, physicians, than their time. The total estimated
Application and Update Mailer, 0925– genetic counselors, and other annualized burden hours are 180.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden Total annual
Form name Type of respondent responses per
respondents per response burden Hours
respondent (in hours)
Web-based Application Form ............ Genetics Professional ...................... 60 1 30/60 30
Web-based Update Mailer ................ Genetics Professional ...................... 600 1 15/60 150
Totals .......................................... .......................................................... 660 660 ........................ 180
Dated: August 21, 2017. Room 4A29, MSC2479, Bethesda, MD lung cysts and lung nodules (non-
Karla Bailey, 20892–2479; telephone: 301–402–5579. invasive ‘‘virtual biopsy’’) may provide
Project Clearance Liaison, National Cancer A signed Confidential Disclosure sufficient detail to distinguish the types
Institute, National Institutes of Health. Agreement may be required to receive of cystic lesions and lung nodules such
[FR Doc. 2017–18667 Filed 9–1–17; 8:45 am] copies of the patent applications. that the typical lung tissue pathologic
BILLING CODE 4140–01–P SUPPLEMENTARY INFORMATION: The biopsy would not be needed to make a
inventions listed below are owned by an diagnosis. The system includes placing
agency of the U.S. Government and are one or more x-ray detector panels near
DEPARTMENT OF HEALTH AND available for licensing in the U.S. in the patient’s body initially outside the
HUMAN SERVICES accordance with 35 U.S.C. 209 and 37 view of a CT scanner and then moved
CFR part 404 to achieve expeditious into place for a secondary scan. An
National Institutes of Health initial low dose scan, CT scan or X-ray,
commercialization of results of
federally-funded research and can be performed and if a high-
Government-Owned Inventions; resolution CT scan is then necessary a
Availability for Licensing development. Foreign patent
applications are filed on selected flat panel detector is positioned near the
AGENCY: National Institutes of Health, inventions to extend market coverage area of interest. It is preferable that the
HHS. for companies and may also be available flat panel detector be transparent to
for licensing. Technology description high-energy x-ray photons. The plurality
ACTION: Notice.
follows. of acquired images are then
SUMMARY: Availability for licensing U.S. reconstructed into a low and high-
Government owned intellectual Hybrid Computed Tomography resolution image.
property for commercial development. Scanning System Potential Commercial Applications:
FOR FURTHER INFORMATION CONTACT: Description of Technology: The • Non-invasive lung biopsies
mstockstill on DSK30JT082PROD with NOTICES
Licensing information and copies of the invention relates to a combination Development Stage:
patent applications listed below may be hybrid computed tomography (CT) • Early stage, no prototype.
obtained by emailing the indicated system that is particularly suited for Inventors: Han Wen (NHLBI)
licensing contact at the National Heart, elucidating stages in pulmonary Intellectual Property: HHS Reference
Lung, and Blood, Office of Technology diseases, notably cystic fibrosis and No. E–175–2017/0–US–01
Transfer and Development Office of lung cancer. Improved visualization of • U.S. Provisional Patent Application
Technology Transfer, 31 Center Drive lung parenchyma and the margins of 62/546,639 filed August 17, 2017.
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Document Created: 2017-09-02 03:25:04
Document Modified: 2017-09-02 03:25:04
| 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. | |
| Dates | Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. | |
| Contact | To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Margaret Beckwith, Office of Cancer Content, Office of Communications and Public Liaison (OCPL), 9609 Medical Center Drive, Rockville, MD 20892 or call non-toll-free number 240-276-6600 or email your request, including your | |
| FR Citation | 82 FR 41971 |
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