Proposed Collection; 60-Day Comment Request; Division of Extramural Research and Training (DERT) Extramural Grantee Data Collection National Institute of Environmental Health Science (NIEHS), 50897-50898 [2021-19693]

Download as PDF 50897 Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404. In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a license application, will not be treated confidentially, and may be made publicly available. License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information from these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552. Dated: September 7, 2021. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. 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. To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dr. Kristianna Pettibone, Evaluator, Program Analysis Branch, NIEHS, NIH, 530 Davis Dr., Room 3055, Morrisville, NC 20560, or call non-tollfree number (984) 287–3303 or Email your request, including your address to: pettibonekg@niehs.nih.gov. Formal requests for additional plans and instruments must be requested in writing. FOR FURTHER INFORMATION CONTACT: Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: Written 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: Division of Extramural Research and Training SUPPLEMENTARY INFORMATION: [FR Doc. 2021–19618 Filed 9–10–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request; Division of Extramural Research and Training (DERT) Extramural Grantee Data Collection National Institute of Environmental Health Science (NIEHS) National Institutes of Health, Health and Human Services (HHS). ACTION: Notice. AGENCY: 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 Institute of Environmental Health Sciences (NIEHS), will publish periodic summaries of proposed SUMMARY: (DERT) Extramural Grantee Data Collection, 0925–0757, Expiration Date 11/30/2021—REVISION, National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). Need and Use of Information Collection: In order to make informed management decisions about its research programs and to demonstrate the outputs, outcomes and impacts of its research programs NIEHS will collect, analyze and report on data from extramural grantees who are currently receiving funding or who have received funding in the past on topics such as: (1) Key scientific outcomes achieved through the research and the impact on the field of environmental health science; (2) Contribution of research findings to program goals and objectives; (3) Satisfaction with the program support received; (4) Challenges and benefits of the funding mechanism used to support the science; and (5) Emerging research areas and gaps in the research. Information gained from this primary data collection will be used in conjunction with data from grantee progress reports and presentations at grantee meetings to inform internal programs and new funding initiatives. Outcome information to be collected includes measures of agency-funded research resulting in dissemination of findings, investigator career development, grant-funded knowledge and products, commercial products and drugs, laws, regulations and standards, guidelines and recommendations, information on patents and new drug applications and community outreach and public awareness relevant to extramural research funding and emerging areas of research. OMB approval is requested for 3 years. There are no costs to respondents, other than their time. The total estimated annualized burden hours are 700. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents lotter on DSK11XQN23PROD with NOTICES1 Type of respondent Number of responses per respondent Average time per response (in hours) Total annual burden hour NICHD Grantee ............................................................................................... NIDCD Grantee ............................................................................................... NIMH Grantee .................................................................................................. NINDS Grantee ................................................................................................ NCI Grantee ..................................................................................................... NIEHS Grantee ................................................................................................ 200 200 200 200 400 200 1 1 1 1 1 1 30/60 30/60 30/60 30/60 30/60 30/60 100 100 100 100 200 100 Total .......................................................................................................... 1,400 1,400 ........................ 700 VerDate Sep<11>2014 17:39 Sep 10, 2021 Jkt 253001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\13SEN1.SGM 13SEN1 50898 Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices Jane M. Lambert, Project Clearance Liaison, National Institute of Environmental Health Sciences, National Institutes of Health. [FR Doc. 2021–19693 Filed 9–10–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive Patent License: Development and Commercialization of Cell Therapies for Cancer AGENCY: National Institutes of Health, HHS. ACTION: Notice. The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to Athenex, Inc. (‘‘Athenex’’) headquartered in Buffalo, NY. SUMMARY: Only written comments and/or applications for a license which are received by the National Cancer Institute’s Technology Transfer Center on or before September 28, 2021 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, and comments relating to the contemplated an Exclusive Patent License should be directed to: Suna Gulay French, Ph.D., Technology Transfer Manager, NCI Technology Transfer Center, Telephone: (240)–276–5530; Email: suna.gulay@ nih.gov. DATES: SUPPLEMENTARY INFORMATION: Intellectual Property GROUP A: lotter on DSK11XQN23PROD with NOTICES1 E–237–2017–0/2: T Cell Receptors Recognizing Mutated P53 1. US Provisional Patent Application 62/565,383, filed September 29, 2017 (E–237–2017–0–US–01); 2. International Patent Application PCT/US2018/051285, filed September 17, 2018 (E–237–2017–2–PCT–01); 3. Australian Patent Application 2018342246, filed September 17, 2018 (E–237–2017–2–AU–02); 4. Brazilian Patent Application BR112020006012–7, filed September 17, 2018 (E–237–2017–2–BR–03); VerDate Sep<11>2014 17:39 Sep 10, 2021 Jkt 253001 5. Canadian Patent Application 3977024, filed September 17, 2018 (E– 237–2017–2–CA–04); 6. Chinese Patent Application 201880074539.8, filed September 17, 2018 (E–237–2017–2–CN–05); 7. Costa Rica Patent Application 2020–0170, filed September 17, 2018 (E–237–2017–2–CR–06); 8. Eurasian Patent Application 202090757, filed September 17, 2018 (E–237–2017–2–EA–07); 9. European Patent Application 18780006.5, filed September 17, 2018 (E–237–2017–2–EP–08); 10. Israeli Patent Application 273515, filed September 17, 2018 (E–237–2017– 2–IL–09); 11. India Patent Application 202047013911, filed September 17, 2018 (E–237–2017–2–IN–10); 12. Japanese Patent Application 2020– 517556, filed September 17, 2018 (E– 237–2017–2–JP–11); 13. Korean Patent Application 2020– 7012344, filed September 17, 2018 (E– 237–2017–2–KR–12); 14. Mexico Patent Application MX/a/ 2020/003504, filed September 17, 2018 (E–237–2017–2–MX–13); 15. New Zealand Patent Application 763023, filed September 17, 2018 (E– 237–2017–2–NZ–14); 16. Singapore Patent Application 11202002636P, filed September 17, 2018 (E–237–2017–2–SG–15); 17. United States Utility Patent Application 16/651,242, filed September 17, 2018 (E–237–2017–2– US–16); and 18. Hong Kong Patent Application 62020021272.3, filed November 30, 2020 (E–237–2017–2–HK–17). E–135–2019: T Cell Receptors Recognizing R175H or Y220C Mutation in P53 1. US Provisional Patent Application 62/867,619, filed June 27, 2019 (E–135– 2019–0–US–01); 2. International Patent Application PCT/US2020/039785, filed June 26, 2020 (E–135–2019–0–PCT–02); and 3. Taiwanese Patent Application 109121744, filed June 26, 2020 (E–135– 2019–0–TW–03). E–173–2020: T Cell Receptors Recognizing R273C or Y220C Mutation in P53 1. US Provisional Patent Application 63/074,747, filed September 4, 2020 (E– 173–2020–0–US–01). E–098–2018: T Cell Receptors Which Recognize Mutated EGFR 1. US Provisional Patent Application 62/665,234, filed May 1, 2018 (E–098– 2018–0–US–01); PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 2. International Patent Application PCT/US2019/030108, filed May 1, 2019 (E–098–2018–0–PCT–02); 3. Australian Patent Application 2019263233, filed May 1, 2019 (E–098– 2018–0–AU–03); 4. Canadian Patent Application 3,099,106, filed May 1, 2019 (E–098– 2018–0–CA–04); 5. European Patent Application 19723615.1, filed May 1, 2019 (E–098– 2018–0–EP–05); and 6. United States Utility Patent Application 17/051,860, filed May 1, 2019 (E–098–2018–0–US–06). E–165–2020: HLA Class II-Restricted DRB T Cell Receptors Against RAS With G12D Mutation 1. US Provisional Application 63/ 050,9131, filed July 13, 2020 (E–165– 2020–0–US–01); and 2. International Patent Application PCT/US2021/041375, filed July 13, 2021 (E–165–2020–0–PCT–02). E–172–2020: HLA Class II-Restricted DRB T Cell Receptors Against RAS With G12V Mutation 1. US Provisional Application 63/ 052,502, filed July 16, 2020 (E–172– 2020–0–US–01); and 2. International Patent Application PCT/US2021/041737, filed July 15, 2021 (E–172–2020–0–PCT–02). E–189–2020: HLA Class II-Restricted DQ T Cell Receptors Against RAS With G13D Mutation 1. US Provisional Application 63/ 086,674, filed October 2, 2020 (E–189– 2020–0–US–01). E–190–2020: HLA Class I-Restricted T Cell Receptors Against RAS With G12V Mutation 1. US Provisional Application 63/ 060,340, filed August 3, 2020 (E–190– 2020–0–US–01) and U.S., PCT and foreign patent applications claiming priority to the aforementioned application. GROUP B: E–237–2017–1: Methods of Isolating T Cells Having Antigenic Specificity for a P53 Cancer-Specific Mutation 1. US Provisional Patent Application 62/565,464, filed September 29, 2017 (E–237–2017–1–US–01); 2. International Patent Application PCT/US2018/051280, filed September 17, 2018 (E–237–2017–1–PCT–02); 3. Australian Patent Application 2018342245, filed September 17, 2018 (E–237–2017–1–AU–03); 4. Canadian Patent Application 3080274, filed September 17, 2018 (E– 237–2017–1–CA–04); E:\FR\FM\13SEN1.SGM 13SEN1

Agencies

[Federal Register Volume 86, Number 174 (Monday, September 13, 2021)]
[Notices]
[Pages 50897-50898]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19693]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment Request; Division of 
Extramural Research and Training (DERT) Extramural Grantee Data 
Collection National Institute of Environmental Health Science (NIEHS)

AGENCY: National Institutes of Health, Health and Human Services (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 Institute of Environmental Health 
Sciences (NIEHS), will publish periodic summaries of proposed 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: Dr. 
Kristianna Pettibone, Evaluator, Program Analysis Branch, NIEHS, NIH, 
530 Davis Dr., Room 3055, Morrisville, NC 20560, or call non-toll-free 
number (984) 287-3303 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 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: Division of Extramural Research and 
Training (DERT) Extramural Grantee Data Collection, 0925-0757, 
Expiration Date 11/30/2021--REVISION, National Institute of 
Environmental Health Sciences (NIEHS), National Institutes of Health 
(NIH).
    Need and Use of Information Collection: In order to make informed 
management decisions about its research programs and to demonstrate the 
outputs, outcomes and impacts of its research programs NIEHS will 
collect, analyze and report on data from extramural grantees who are 
currently receiving funding or who have received funding in the past on 
topics such as: (1) Key scientific outcomes achieved through the 
research and the impact on the field of environmental health science; 
(2) Contribution of research findings to program goals and objectives; 
(3) Satisfaction with the program support received; (4) Challenges and 
benefits of the funding mechanism used to support the science; and (5) 
Emerging research areas and gaps in the research.
    Information gained from this primary data collection will be used 
in conjunction with data from grantee progress reports and 
presentations at grantee meetings to inform internal programs and new 
funding initiatives. Outcome information to be collected includes 
measures of agency-funded research resulting in dissemination of 
findings, investigator career development, grant-funded knowledge and 
products, commercial products and drugs, laws, regulations and 
standards, guidelines and recommendations, information on patents and 
new drug applications and community outreach and public awareness 
relevant to extramural research funding and emerging areas of research.
    OMB approval is requested for 3 years. There are no costs to 
respondents, other than their time. The total estimated annualized 
burden hours are 700.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of     Average time
               Type of respondent                    Number of     responses per   per response    Total annual
                                                    respondents     respondent      (in hours)      burden hour
----------------------------------------------------------------------------------------------------------------
NICHD Grantee...................................             200               1           30/60             100
NIDCD Grantee...................................             200               1           30/60             100
NIMH Grantee....................................             200               1           30/60             100
NINDS Grantee...................................             200               1           30/60             100
NCI Grantee.....................................             400               1           30/60             200
NIEHS Grantee...................................             200               1           30/60             100
                                                 ---------------------------------------------------------------
    Total.......................................           1,400           1,400  ..............             700
----------------------------------------------------------------------------------------------------------------



[[Page 50898]]

Jane M. Lambert,
Project Clearance Liaison, National Institute of Environmental Health 
Sciences, National Institutes of Health.
[FR Doc. 2021-19693 Filed 9-10-21; 8:45 am]
BILLING CODE 4140-01-P