35280 Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Notices 

National Center for Advancing 

Translational Sciences, NIH, 9800 

Medical Center Drive, Rockville, MD 

20850, Phone: 301–827–7181, or email 

sury.vepa@nih.gov. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of 

unpublished patent applications. 

SUPPLEMENTARY INFORMATION: 

Technology description follows. 

Thiazole Based Inhibitors of Lactate 

Dehydrogenase (LDH) for the Treatment 

of Cancer 

Description of Technology: Agents 

that target enzymes involved in cancer 

cell metabolism offer an attractive 

therapeutic route in view of the 

potential to preferentially target cancer 

tissue over normal tissue. While normal 

tissue typically uses glycolysis as a 

major cellular metabolic path only when 

the oxygen supply is low, cancer tissue 

relies heavily on aerobic glycolysis 

regardless of the oxygen supply level. In 

addition, metabolic switching to a more 

glycolytic phenotype is a required step 

with inflammatory cells and other 

pathologies which require activated 

glycolysis in their metabolism. Lactate 

dehydrogenase (LDH) is involved in the 

final step of glycolysis, in which 

pyruvate is converted to lactate and the 

conversion of NADH to NAD+. There 

are two different genes of LDH, LDHA 

and LDHB, but both proteins (subunits) 

have the same active site and catalyze 

the conversion of pyruvate to lactate or 

lactate to pyruvate. In cancer patients, 

serum total lactate dehydrogenase 

(levels are often increased, and the gene 

for LDH, is up-regulated. LDH inhibition 

is expected to reduce the ability of the 

cell to effectively metabolize glucose 

and reduce tumor cell proliferation and 

tumor growth and other pathologies 

which involve a glycolytic metabolic 

switch. Thus, compounds that inhibit 

LDH activity have potential for the 

development of anti-cancer 

therapeutics. Previously developed LDH 

inhibitors have significant drawbacks, 

including poor potency and/or poor 

bioavailability, limiting their utility as 

therapeutics. The present technology 

provides novel 1 H-PYRAZOL-1 -YL– 

THIAZOLE based LDH inhibitors with 

improved potency, selectivity, and/or 

bioavailability for the treatment of 

cancer. 

This technology is available for 

licensing for commercial development 

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

CFR part 404, as well as for further 

development and evaluation under a 

research collaboration. 

Potential Commercial Applications: 

• Novel therapeutics for cancer AND 

indications which depend on a 

metabolic switch to glycolysis (e.g., 

inflammation, autoimmune disease, 

etc.) 

Competitive Advantages: 

• Novel LDH inhibitors with 

improved potency, selectivity, and/or 

bioavailability for the treatment of 

cancer. 

Development Stage: 

• Optimized lactate dehydrogenase 

inhibitors are in pre-clinical 

development. 

Inventors: 

• David J. Maloney, Alex Gregory 

Waterson, Ganesha Rai Bantukallu, Kyle 

Ryan Brimacombe, Plamen Christov, 

Chi V. Dang, Victor M. Darley-Usmar, 

Matthew Hall, Xin Hu, Ajit Jadhav, 

Somnath Jana, Kwangho Kim, William J. 

Moore, Brian T. Mott, Leonard M. 

Neckers, Anton Simeonov, Gary Allen 

Sulikowski, Daniel Jason URBAN, and 

Shyh Ming Yang. 

Publications: This manuscript reports 

early compounds in the series: https:// 

pubs.acs.org/doi/10.1021/ 

acs.jmedchem.7b00941. 

Intellectual Property: 1. SMALL 

MOLECULE INHIBITORS OF LACTATE 

DEHYDROGENASE AND METHODS 

OF USE THERE OF, PCT/US2015/ 

067895 filed on December 29, 2015 and 

published as WO 2016/109559 on July 

7, 2016 (HHS Ref. No. E–244–2014), and 

2. 1 H-PYRAZOL-1 -YL-THIAZOLES 

AS INHIBITORS OF LACTATE 

DEHYDROGENASE AND METHODS 

OF USE THERE OF, PCP/US2017/ 

040021 filed on June 29, 2017 and 

published as WO 2018/005807 on 

January 8, 2018 9HHS Ref. No. E–190– 

2016). 

Related Intellectual Property: HHS 

Reference Number E–293–2011. 

Licensing Contact: Sury Vepa, Ph.D., 

J.D., 301–827–7181; sury.vepa@nih.gov. 

Dated: July 5, 2018. 

Lili Portilla, 

Technology Development Coordinator, 

National Center for Advancing Translational 

Sciences. 

[FR Doc. 2018–15907 Filed 7–24–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) will publish a summary of 

information collection requests under 

OMB review, in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

chapter 35). To request a copy of these 

documents, call the SAMHSA Reports 

Clearance Officer on (240) 276–1243. 

Project: Projects for Assistance in 

Transition From Homelessness (PATH) 

Program Annual Report (OMB No. 

0930–0205)—Revision 

The Center for Mental Health Services 

awards grants each fiscal year to each of 

the states, the District of Columbia, the 

Commonwealth of Puerto Rico, the 

Virgin Islands, Guam, American Samoa, 

and the Commonwealth of the Northern 

Mariana Islands from allotments 

authorized under the PATH program 

established by Public Law 101–645, 42 

U.S.C. 290cc–21 et seq., the Stewart B. 

McKinney Homeless Assistance 

Amendments Act of 1990 (section 521 et 

seq. of the Public Health Service (PHS) 

Act) and the 21st Century Cures Act 

(Pub. L. 114–255). Section 522 of the 

PHS Act and the 21st Century Cures Act 

require that the grantee states and 

territories must expend their payments 

under the Act solely for making grants 

to political subdivisions of the state, and 

to nonprofit private entities (including 

community-based veterans’ 

organizations and other community 

organizations) for the purpose of 

providing services specified in the Act. 

Available funding is allotted in 

accordance with the formula provision 

of section 524 of the PHS Act. 

This submission is for a revision of 

the current approval of the annual 

grantee reporting requirements. Section 

528 of the PHS Act and the 21st Century 

Cures Act specify that not later than 

January 31 of each fiscal year, a funded 

entity will prepare and submit a report 

in such form and containing such 

information as is determined necessary 

for securing a record and description of 

the purposes for which amounts 

received under section 521 were 

expended during the preceding fiscal 

year and of the recipients of such 

amounts and determining whether such 

amounts were expended in accordance 

with statutory provisions. 

The proposed changes to the PATH 

Annual Report are as follows: 

1. Reporting on Contacts 

To ensure that all contacts made by 

PATH providers are reflected in the 

report, a new question has been added 

that reports out on all contacts provided 

during the reporting period. The 

previous PATH Annual Report only 

reported on contacts through the date of 

enrollment. 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Notices 35281 

2. Referrals Provided 

To align with the HMIS Data 

Standards, all PATH Referral response 

categories are now included in the 

PATH Annual Report. 

3. HMIS Data Standards Updates 

When needed, field response options 

and questions have been updated to 

align with the most recent version of the 

HMIS Data Standards. 

The estimated annual burden for 

these reporting requirements is 

summarized in the table below. 

Respondents Number of 

respondents 

Responses 

per 

respondent 

Burden per 

response 

(hrs.) 

Total burden 

States ............................................................................................................... 56 1 20 1,120 

Local provider agencies ................................................................................... 487 1 15 7,305 

Total .......................................................................................................... 543 ........................ ........................ 8,425 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent by August 24, 2018 to the 

SAMHSA Desk Officer at the Office of 

Information and Regulatory Affairs, 

Office of Management and Budget 

(OMB). To ensure timely receipt of 

comments, and to avoid potential delays 

in OMB’s receipt and processing of mail 

sent through the U.S. Postal Service, 

commenters are encouraged to submit 

their comments to OMB via email to: 

OIRA_Submission@omb.eop.gov. 

Although commenters are encouraged to 

send their comments via email, 

commenters may also fax their 

comments to: 202–395–7285. 

Commenters may also mail them to: 

Office of Management and Budget, 

Office of Information and Regulatory 

Affairs, New Executive Office Building, 

Room 10102, Washington, DC 20503. 

Summer King, 

Statistician. 

[FR Doc. 2018–15825 Filed 7–24–18; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Center for Substance Abuse 

Treatment: Notice of Meeting 

Pursuant to Public Law 92–463, 

notice is hereby given that the 

Substance Abuse and Mental Health 

Services Administration’s (SAMHSA’s) 

Center for Substance Abuse Treatment 

(CSAT) National Advisory Council will 

meet on September 11, 2018, 2:00 p.m.– 

3:00 p.m. (EDT) in a closed 

teleconference meeting. 

The meeting will include discussions 

and evaluations of grant applications 

reviewed by SAMHSA’s Initial Review 

Groups, and involve an examination of 

confidential financial and business 

information as well as personal 

information concerning the applicants. 

Therefore, the meeting will be closed to 

the public as determined by the 

SAMHSA Assistant Secretary for Mental 

Health and Substance Use in accordance 

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

Title 5 U.S.C. App. 2, 10(d). 

Meeting information and a roster of 

Council members may be obtained by 

accessing the SAMHSA Committee 

website at http://www.samhsa.gov/ 

about-us/advisory-councils/csatnational-advisory-council or by 

contacting the CSAT National Advisory 

Council Designated Federal Officer; 

Tracy Goss (see contact information 

below). 

Council Name: SAMHSA’s Center for 

Substance Abuse Treatment National 

Advisory Council. 

Date/Time/Type: September 11, 2018, 

2:00 p.m.–3:00 p.m. EDT, CLOSED. 

Place: SAMHSA, 5600 Fishers Lane, 

Rockville, Maryland 20857. 

Contact: Tracy Goss, Designated 

Federal Officer, CSAT National 

Advisory Council, 5600 Fishers Lane, 

Rockville, Maryland 20857 (mail), 

Telephone: (240) 276–0759, Fax: (240) 

276–2252, Email: tracy.goss@

samhsa.hhs.gov. 

Carlos Castillo, 

Committee Management Officer, SAMHSA. 

[FR Doc. 2018–15824 Filed 7–24–18; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Internal Agency Docket No. FEMA–4368– 

DR; Docket ID FEMA–2018–0001] 

New Jersey; Amendment No. 1 to 

Notice of a Major Disaster Declaration 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice. 

SUMMARY: This notice amends the notice 

of a major disaster declaration for the 

State of New Jersey (FEMA–4368–DR), 

dated June 8, 2018, and related 

determinations. 

DATES: This amendment was issued July 

13, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Dean Webster, Office of Response and 

Recovery, Federal Emergency 

Management Agency, 500 C Street SW, 

Washington, DC 20472, (202) 646–2833. 

SUPPLEMENTARY INFORMATION: The notice 

of a major disaster declaration for the 

State of New Jersey is hereby amended 

to include the following area among 

those areas determined to have been 

adversely affected by the event declared 

a major disaster by the President in his 

declaration of June 8, 2018. 

Burlington County for Public 

Assistance. 

The following Catalog of Federal Domestic 

Assistance Numbers (CFDA) are to be used 

for reporting and drawing funds: 97.030, 

Community Disaster Loans; 97.031, Cora 

Brown Fund; 97.032, Crisis Counseling; 

97.033, Disaster Legal Services; 97.034, 

Disaster Unemployment Assistance (DUA); 

97.046, Fire Management Assistance Grant; 

97.048, Disaster Housing Assistance to 

Individuals and Households In Presidentially 

Declared Disaster Areas; 97.049, 

Presidentially Declared Disaster Assistance— 

Disaster Housing Operations for Individuals 

and Households; 97.050 Presidentially 

Declared Disaster Assistance to Individuals 

and Households—Other Needs; 97.036, 

Disaster Grants—Public Assistance 

(Presidentially Declared Disasters); 97.039, 

Hazard Mitigation Grant. 

Brock Long, 

Administrator, Federal Emergency 

Management Agency. 

[FR Doc. 2018–15840 Filed 7–24–18; 8:45 am] 

BILLING CODE 9111–23–P 


daltland on DSKBBV9HB2PROD with NOTICES