Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Notices 35279 

SUMMARY: The Office for Human 

Research Protections (OHRP), Office of 

the Assistant Secretary for Health is 

announcing the availability of three 

draft guidance documents titled, 

‘‘Scholarly and Journalistic Activities 

Deemed Not to be Research: 2018 

Requirements,’’ ‘‘When Continuing 

Review Is Not Required During the 6- 

Month Delay Period of July 19, 2018 

through January 20, 2019: 2018 

Requirements,’’ and ‘‘Elimination of 

Institutional Review Board (IRB) Review 

of Research Applications and Proposals: 

2018 Requirements,’’ respectively. 

DATES: Submit written comments by 

August 24, 2018. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

documents titled ‘‘Scholarly and 

Journalistic Activities Deemed Not to be 

Research: 2018 Requirements,’’ ‘‘When 

Continuing Review Is Not Required 

During the 6-Month Delay Period of July 

19, 2018 through January 20, 2019: 2018 

Requirements,’’ and ‘‘Elimination of 

Institutional Review Board (IRB) Review 

of Research Applications and Proposals: 

2018 Requirements,’’ respectively, to the 

Division of Policy and Assurances, 

Office for Human Research Protections, 

1101 Wootton Parkway, Suite 200, 

Rockville, MD 20852. Send one selfaddressed adhesive label to assist that 

office in processing your request, or fax 

your request to 240–453–6909. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

draft guidance documents. 

You may submit comments identified 

by docket ID number HHS–OS–OPHS– 

2018–0012 (Scholarly and Journalistic 

Activities Deemed Not to be Research: 

2018 Requirements), docket ID number 

HHS–OS–OPHS–2018–0013 (When 

Continuing Review Is Not Required 

During the 6-Month Delay Period of July 

19, 2018 through January 20, 2019: 2018 

Requirements), and docket ID number 

HHS–OS–OPHS–2018–0014 

(Elimination of Institutional Review 

Board (IRB) Review of Research 

Applications and Proposals: 2018 

Requirements), respectively, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Enter the docket 

ID number and click on ‘‘Search.’’ On 

the next page, click the ‘‘Comment 

Now’’ action and follow the 

instructions. 

• Mail/Hand Delivery/Courier [For 

Paper, Disk, or CD–ROM Submissions]: 

Irene Stith-Coleman, Ph.D., Office for 

Human Research Protections, 1101 

Wootton Parkway, Suite 200, Rockville, 

MD 20852. 

Comments received, including any 

personal information, will be posted 

without change to http://

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Irene Stith-Coleman, Ph.D., Office for 

Human Research Protections, 1101 

Wootton Parkway, Suite 200, Rockville, 

MD 20852, 240–453–6900; email 

Irene.Stith-Coleman@hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Overview 

OHRP, Office of the Assistant 

Secretary for Health, is announcing the 

availability of three draft guidance 

documents entitled ‘‘Scholarly and 

Journalistic Activities Deemed Not to be 

Research: 2018 Requirements,’’ ‘‘When 

Continuing Review Is Not Required 

During the 6-Month Delay Period of July 

19, 2018 through January 20, 2019: 2018 

Requirements,’’ and ‘‘Elimination of 

Institutional Review Board (IRB) Review 

of Research Applications and Proposals: 

2018 Requirements.’’ The draft guidance 

documents, when finalized, will 

represent OHRP’s current thinking on 

these topics. OHRP obtained input from 

HHS agencies and the Common Rule 

departments and agencies in developing 

the draft guidance documents. 

The ‘‘Scholarly and Journalistic 

Activities Deemed Not to be Research: 

2018 Requirements’’ draft guidance 

explains how certain scholarly and 

journalistic activities that focus directly 

on the specific individuals about whom 

the information is collected are deemed 

not to be research under the 2018 

Requirements of the regulations for the 

protection of human subjects (45 CFR 

part 46), and consequently do not have 

to satisfy the requirements of those 

regulations. It is intended for IRB 

administrators, IRB chairpersons, 

relevant institutional officials, and 

investigators who may be concerned 

about whether scholarly or journalistic 

activities need to satisfy the 2018 

Requirements of the regulations. 

The ‘‘When Continuing Review Is Not 

Required During the 6-Month Delay 

Period of July 19, 2018 through January 

20, 2019: 2018 Requirements’’ draft 

guidance provides information on the 

HHS regulations for the protection of 

human research subjects at 45 CFR part 

46 related to the circumstances in which 

continuing review of research is not 

required. In particular, this guidance 

applies to research that transitions to 

comply with the 2018 Requirements 

during the 6-month delay period from 

July 19, 2018 through January 20, 2019. 

This guidance only applies during the 6- 

month delay period. It is intended for 

Institutional Review Boards (IRBs), 

investigators, HHS funding agencies, 

and others that may be responsible for 

the review, conduct, or oversight of 

human subjects research conducted or 

supported by HHS. 

The ‘‘Elimination of Institutional 

Review Board (IRB) Review of Research 

Applications and Proposals: 2018 

Requirements’’ draft guidance provides 

guidance on the elimination of the 

requirement in the pre-2018 

Requirements (45 CFR 46.103(f)) that 

each application or proposal for 

research undergo IRB review and 

approval as part of the certification 

process. It is intended for Institutions, 

IRBs, investigators, HHS funding 

agencies, and others that may be 

responsible for the review, conduct, or 

oversight of nonexempt research 

involving human subjects conducted or 

supported by HHS. 

II. Electronic Access 

Persons with access may obtain the 

draft guidance documents on OHRP’s 

website at https://www.hhs.gov/ohrp/ 

regulations-and-policy/requests-forcomments/index.html. 

Dated: July 19, 2018. 

Jerry Menikoff, 

Director, Office for Human Research 

Protections. 

[FR Doc. 2018–15908 Filed 7–24–18; 8:45 am] 

BILLING CODE 4150–36–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 invention listed below is 

jointly owned by an agency of the U.S. 

Government with Vanderbilt University, 

University of Alabama and University of 

Pennsylvania and is available for 

licensing to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

FOR FURTHER INFORMATION CONTACT: 

Licensing information and copies of the 

U.S. patent application listed below 

may be obtained by communicating 

with Sury Vepa, Ph.D., J.D., Senior 

Licensing and Patenting Manager, 


daltland on DSKBBV9HB2PROD with NOTICES
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. 


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