Federal Register / Vol. 86, No. 38 / Monday, March 1, 2021 / Notices 12007 

RF Program Entrance Survey for 

Reentering Fathers. 

Æ Exit survey, with five versions: (1) 

HM Program Exit Survey for AdultFocused Programs; (2) HM Program Exit 

Survey for Youth-Focused Programs; (3) 

RF Program Exit Survey for CommunityBased Fathers; (4) RF Program Exit 

Survey for Community-Based Mothers; 

and (5) RF Program Exit Survey for 

Reentering Fathers. 

The measures used by the 2015 

grantee cohort were developed in 2014 

after extensive review of the research 

literature and grantees’ past measures. 

The performance measures, data 

collection instruments, and data 

collection system were revised in 2020 

based on a targeted analysis of existing 

measures, feedback from key 

stakeholders, and discussions with ACF 

staff and the 2015 cohort of grantees. 

ACF required the 2015 cohort of 

grantees to submit data on these 

standardized measures on a quarterly 

basis and proposes the same 

requirement for the 2020 cohort. In 

addition to the performance measures 

mentioned above, ACF proposes to 

repeat collection for these data 

submissions: 

• Semi-annual Performance Progress 

Report (PPR), with two versions: (1) 

Performance Progress Report for HM 

Programs, and (2) Performance Progress 

Report for RF Programs; and 

• Quarterly Performance Report 

(QPR), with two versions: (1) Quarterly 

Performance Progress Report for HM 

Programs, and (2) Quarterly 

Performance Progress Report for RF 

Programs. 

Grantees in the new cohort will also 

be required to engage in continuous 

quality improvement (CQI) planning 

and implementation using a proposed 

CQI plan template developed by ACF. 

The estimated burden for completing 

and updating this template is included 

in the table below. 

Respondents: Respondents include 

HM and RF grantee staff and program 

applicants and participants (participants 

are called ‘‘clients’’). 

ANNUAL BURDEN ESTIMATES

Instrument Respondent 

Number of 

respondents 

(total over 

request 

period) 

Number of 

responses per 

respondent 

(total over 

request 

period) 

Average 

burden per 

response 

(in hours) 

Total 

burden 

(in hours) 

Annual 

burden 

(in hours) 

1: Applicant Characteristics ................. Program applicants ............................. 273,840 1 0.25 68,460.0 22,820.0 

Program staff ...................................... 408 672 0.10 27,417.6 9,139.2 

2: Program Operations ........................ Program staff ...................................... 136 12 0.32 522.24 174.08 

3: Service Delivery Data ...................... Program staff ...................................... 2,040 126 0.50 128,520.0 42,840.0 

4: Entrance and Exit Surveys .............. Program clients (entrance) ................. 257,409 1 0.42 108,111.78 36,037.26 

Program clients (exit) .......................... 169,965 1 0.42 71,385.3 23,795.1 

Program staff (entrance and exit on 

paper).

32 3,506 0.10 11,219.2 3,739.73 

5: Semi-annual Performance Progress 

Report (PPR).

Program staff ...................................... 136 6 3 2,448.0 816.0 

6: Quarterly Performance Report 

(QPR).

Program staff ...................................... 136 6 1 816.0 272.0 

7: CQI Plan .......................................... Program staff ...................................... 136 3 4 1,632 544.0 

Estimated Total Annual Burden 

Hours: 140,177.37. 

Authority: Sec. 403. [42 U.S.C. 603]. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2021–04162 Filed 2–26–21; 8:45 am] 

BILLING CODE 4184–73–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. 

FOR FURTHER INFORMATION CONTACT: 

Licensing information and copies of 

patent applications may be obtained by 

emailing Brian W. Bailey, Ph.D., 

bbailey@mail.nih.gov, the indicated 

licensing contact at the National Heart, 

Lung, and Blood, Office of Technology 

Transfer and Development Office of 

Technology Transfer, 31 Center Drive, 

Room 4A29, MSC2479, Bethesda, MD 

20892–2479; telephone: 301–402–5579. 

A signed Confidential Disclosure 

Agreement may be required to receive 

any unpublished information. 

SUPPLEMENTARY INFORMATION: 

Technology description follows. 

Use of Statins To Treat or Prevent DrugInduced Hearing Loss 

Description of Technology 

Available for licensing and 

commercial development are patent 

rights covering methods of using 

atorvastatin and related statin 

compounds and derivatives to reduce or 

prevent drug-induced hearing loss that 

is caused as a side effect by ototoxic 

drugs such as cisplatin, which is 

commonly used in cancer therapies. At 

present, permanent hearing loss occurs 

in approximately half of all patients 

treated with cisplatin; consequently, 

every year many thousands of 

individuals experience partial loss of 

hearing and associated quality of life 

issues as a result of medically necessary 

chemoradiation therapies to treat their 

cancers. This technology addresses a 

large unmet need to eliminate or reduce 

hearing loss in patients that must 

undergo therapies involving ototoxic 

drugs. 

This technology is available for 

licensing for commercial development 

in accordance with 35 U.S.C. 209 and 37 

CFR part 404. 

Potential Commercial Applications 

• Repurposing existing statins, 

including atorvastatin, to treat or protect 

against permanent hearing loss arising 

from chemoradiation therapy involving 

ototoxic drugs. 

• Development of statin analogues or 

derivatives with enhanced abilities to 

treat or protect against hearing loss 

resulting from therapies involving 

cisplatin or other ototoxic drugs. 

12008 Federal Register / Vol. 86, No. 38 / Monday, March 1, 2021 / Notices 

Competitive Advantages 

• This invention addresses an urgent 

need to protect against permanent 

hearing loss resulting from therapies 

with commonly used but ototoxic drugs, 

including cisplatin. 

• Statins are already extensively used 

therapeutically to lower blood 

cholesterol and have well understood 

drug profiles, making them ideal 

candidates for repurposing. 

Development Stage: An observational 

clinical trial (NCT03225157) in patients 

with head and neck cancers has been 

completed. 

Inventors: Lisa Lynn Cunningham 

(NIDCD), Nicole C. Schmitt (NIDCD), 

and Katharine Ann Fernandez (NIDCD). 

Publications: J Clin Invest. 

2021;131(1):e142616. 

Intellectual Property: HHS Reference 

No. E–029–2020—PCT/US21/14918 

filed January 25, 2021; U.S. Patent 

Application No. 62/966,794 filed 

January 28, 2020. 

Licensing Contact: Brian W. Bailey, 

Ph.D.; 301–594–4094; bbailey@

mail.nih.gov. 

Bruce D. Goldstein, 

Director, National Heart, Lung, and Blood 

Institute, Office of Technology Transfer and 

Development, National Institutes of Health. 

[FR Doc. 2021–04069 Filed 2–26–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The National Heart, Lung, and 

Blood Institute (NHLBI), National 

Institutes of Health, Department of 

Health and Human Services, is 

contemplating the grant of sublicensable 

patent licenses to Simon Fraser 

University (‘‘Simon Fraser’’), a nonprofit university located in British 

Columbia, Canada, and Le Centre 

National de la Recherche Scientifique 

(‘‘CNRS’’), a public scientific and 

technological establishment located in 

France, its rights to the inventions and 

patents listed in the SUPPLEMENTARY

INFORMATION section of this notice. 

DATES: Only written comments and/or 

applications for a license which are 

received by the NHLBI Office of 

Technology Transfer and Development 

on or before March 16, 2021 will be 

considered. 

ADDRESSES: Requests for copies of the 

patent applications, inquiries, and 

comments relating to the contemplated 

exclusive patent license should be 

directed to: Brian W. Bailey, Ph.D., 

Senior Technology Transfer Manager, 

NHLBI Office of Technology Transfer 

and Development, 31 Center Drive, Rm. 

4A29, MSC 2479, Bethesda, MD 20892– 

2479 (for business mail), Telephone 

(301) 594–4094; Email: bbailey@

mail.nih.gov. 

SUPPLEMENTARY INFORMATION: The 

following and all continuing U.S. and 

foreign patents/patent applications 

thereof are the intellectual properties to 

be licensed under the prospective 

agreement to Stanford: United States 

Provisional Patent Application No. 62/ 

489,346 filed April 24, 2017 and 

entitled ‘‘FLUORIGEN–BINDING RNA 

APTAMERS’’ [HHS Reference No. E– 

152–2018/0–US–01]. 

The patent rights in these inventions 

have been assigned to the Government 

of the United States of America, Simon 

Fraser, and CNRS. The prospective 

patent license will be for the purpose of 

consolidating the patent rights to CNRS, 

one of the co-owners of said rights, for 

commercial development, and the 

purpose of consolidating the patent 

rights to CNRS and Simon Fraser for 

marketing. Consolidation of these coowned rights is intended to expedite 

development of the invention, 

consistent with the goals of the BayhDole Act codified as 35 U.S.C. 200–212. 

The prospective patent license will be 

worldwide, exclusive, and may be 

limited to those fields of use 

commensurate in scope with the patent 

rights. It will be sublicensable, and any 

sublicenses granted by CNRS or Simon 

Fraser will be subject to the provisions 

of 37 CFR part 401 and 404. 

This invention pertains to certain 

RNA aptamers with optimized 

fluorescent properties and fluorophore 

binding affinities as well as 

corresponding heterocyclic 

fluorophores. The technology consists of 

a suite of fluorescent RNA-fluorophore 

complexes within the ‘‘Mango’’ that 

have been optimized for live-cell 

imaging of RNA molecules without 

altering biological function, in a manner 

analogous to the way that fluorescently 

labeled proteins are used to study 

specific protein functions within cells. 

As such, this technology can be used as 

a powerful tool for live-cell study of 

RNA function and activity for research 

and diagnostic purposes. The 

prospective exclusive patent license 

will include terms for the sharing of 

royalty income with NHLBI from 

commercial sublicenses of the patent 

rights and may be granted unless within 

fifteen (15) days from the date of this 

published notice the NHLBI receives 

written 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. 

Complete applications for a license 

that are timely filed in response to this 

notice will be treated as objections to 

the grant of the contemplated exclusive 

patent license. 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. 

Licensing information and copies of 

patent applications may be obtained by 

emailing Brian W. Bailey, Ph.D., 

bbailey@mail.nih.gov, the indicated 

licensing contact at the National Heart, 

Lung, and Blood, Office of Technology 

Transfer and Development Office of 

Technology Transfer, 31 Center Drive, 

Room 4A29, MSC2479, Bethesda, MD 

20892–2479; telephone: 301–402–5579. 

A signed Confidential Disclosure 

Agreement may be required to receive 

any unpublished information. 

Licensing Contact: Brian W. Bailey, 

Ph.D.; 301–594–4094; bbailey@

mail.nih.gov. 

Bruce D. Goldstein, 

Director, Office of Technology Transfer and 

Development, National Heart, Lung, and 

Blood Institute, National Institutes of Health. 

[FR Doc. 2021–04070 Filed 2–26–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Mental Health; 

Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and