83 FR 35280 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration

Federal Register Volume 83, Issue 143 (July 25, 2018)

Page Range		35280-35281
FR Document		2018-15825

Federal Register, Volume 83 Issue 143 (Wednesday, July 25, 2018)

[Federal Register Volume 83, Number 143 (Wednesday, July 25, 2018)]
[Notices]
[Pages 35280-35281]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-15825]

-----------------------------------------------------------------------

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.

[[Page 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.

----------------------------------------------------------------------------------------------------------------
Burden per
Respondents Number of Responses per response Total burden
respondents respondent (hrs.)
----------------------------------------------------------------------------------------------------------------
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

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

National Center for Advancing metabolic switch to glycolysis (e.g., OMB review, in compliance with the
Translational Sciences, NIH, 9800 inflammation, autoimmune disease, Paperwork Reduction Act (44 U.S.C.
Medical Center Drive, Rockville, MD etc.) chapter 35). To request a copy of these
20850, Phone: 301–827–7181, or email Competitive Advantages: documents, call the SAMHSA Reports
sury.vepa@nih.gov. A signed • Novel LDH inhibitors with Clearance Officer on (240) 276–1243.
Confidential Disclosure Agreement will improved potency, selectivity, and/or
be required to receive copies of bioavailability for the treatment of Project: Projects for Assistance in
unpublished patent applications. cancer. Transition From Homelessness (PATH)
Development Stage: Program Annual Report (OMB No.
SUPPLEMENTARY INFORMATION:
• Optimized lactate dehydrogenase 0930–0205)—Revision
Technology description follows.
inhibitors are in pre-clinical The Center for Mental Health Services
Thiazole Based Inhibitors of Lactate development.
Dehydrogenase (LDH) for the Treatment awards grants each fiscal year to each of
Inventors: the states, the District of Columbia, the
of Cancer • David J. Maloney, Alex Gregory
Commonwealth of Puerto Rico, the
Description of Technology: Agents Waterson, Ganesha Rai Bantukallu, Kyle
Virgin Islands, Guam, American Samoa,
that target enzymes involved in cancer Ryan Brimacombe, Plamen Christov,
and the Commonwealth of the Northern
cell metabolism offer an attractive Chi V. Dang, Victor M. Darley-Usmar,
Mariana Islands from allotments
therapeutic route in view of the Matthew Hall, Xin Hu, Ajit Jadhav,
authorized under the PATH program
potential to preferentially target cancer Somnath Jana, Kwangho Kim, William J.
established by Public Law 101–645, 42
tissue over normal tissue. While normal Moore, Brian T. Mott, Leonard M.
U.S.C. 290cc–21 et seq., the Stewart B.
tissue typically uses glycolysis as a Neckers, Anton Simeonov, Gary Allen
McKinney Homeless Assistance
major cellular metabolic path only when Sulikowski, Daniel Jason URBAN, and
Amendments Act of 1990 (section 521 et
the oxygen supply is low, cancer tissue Shyh Ming Yang.
seq. of the Public Health Service (PHS)
relies heavily on aerobic glycolysis Publications: This manuscript reports
regardless of the oxygen supply level. In Act) and the 21st Century Cures Act
early compounds in the series: https://
addition, metabolic switching to a more (Pub. L. 114–255). Section 522 of the
pubs.acs.org/doi/10.1021/
glycolytic phenotype is a required step PHS Act and the 21st Century Cures Act
acs.jmedchem.7b00941.
with inflammatory cells and other require that the grantee states and
Intellectual Property: 1. SMALL
pathologies which require activated territories must expend their payments
MOLECULE INHIBITORS OF LACTATE
glycolysis in their metabolism. Lactate under the Act solely for making grants
DEHYDROGENASE AND METHODS
dehydrogenase (LDH) is involved in the to political subdivisions of the state, and
OF USE THERE OF, PCT/US2015/
final step of glycolysis, in which to nonprofit private entities (including
067895 filed on December 29, 2015 and
pyruvate is converted to lactate and the community-based veterans’
published as WO 2016/109559 on July
conversion of NADH to NAD+. There organizations and other community
7, 2016 (HHS Ref. No. E–244–2014), and
are two different genes of LDH, LDHA organizations) for the purpose of
2. 1 H-PYRAZOL-1 -YL-THIAZOLES
and LDHB, but both proteins (subunits) providing services specified in the Act.
AS INHIBITORS OF LACTATE
have the same active site and catalyze Available funding is allotted in
DEHYDROGENASE AND METHODS
the conversion of pyruvate to lactate or accordance with the formula provision
OF USE THERE OF, PCP/US2017/
lactate to pyruvate. In cancer patients, of section 524 of the PHS Act.
040021 filed on June 29, 2017 and
serum total lactate dehydrogenase published as WO 2018/005807 on This submission is for a revision of
(levels are often increased, and the gene January 8, 2018 9HHS Ref. No. E–190– the current approval of the annual
for LDH, is up-regulated. LDH inhibition 2016). grantee reporting requirements. Section
is expected to reduce the ability of the Related Intellectual Property: HHS 528 of the PHS Act and the 21st Century
cell to effectively metabolize glucose Reference Number E–293–2011. Cures Act specify that not later than
and reduce tumor cell proliferation and Licensing Contact: Sury Vepa, Ph.D., January 31 of each fiscal year, a funded
tumor growth and other pathologies J.D., 301–827–7181; sury.vepa@nih.gov. entity will prepare and submit a report
which involve a glycolytic metabolic in such form and containing such
Dated: July 5, 2018.
switch. Thus, compounds that inhibit information as is determined necessary
LDH activity have potential for the Lili Portilla,
for securing a record and description of
development of anti-cancer Technology Development Coordinator,
the purposes for which amounts
therapeutics. Previously developed LDH National Center for Advancing Translational
Sciences. received under section 521 were
inhibitors have significant drawbacks, expended during the preceding fiscal
including poor potency and/or poor [FR Doc. 2018–15907 Filed 7–24–18; 8:45 am]
year and of the recipients of such
bioavailability, limiting their utility as BILLING CODE 4140–01–P
amounts and determining whether such
therapeutics. The present technology amounts were expended in accordance
provides novel 1 H-PYRAZOL-1 -YL– with statutory provisions.
THIAZOLE based LDH inhibitors with DEPARTMENT OF HEALTH AND
HUMAN SERVICES The proposed changes to the PATH
improved potency, selectivity, and/or
Annual Report are as follows:
bioavailability for the treatment of Substance Abuse and Mental Health
cancer. Services Administration 1. Reporting on Contacts
This technology is available for
licensing for commercial development Agency Information Collection To ensure that all contacts made by
daltland on DSKBBV9HB2PROD with NOTICES

in accordance with 35 U.S.C. 209 and 37 Activities: Submission for OMB PATH providers are reflected in the
CFR part 404, as well as for further Review; Comment Request report, a new question has been added
development and evaluation under a that reports out on all contacts provided
research collaboration. Periodically, the Substance Abuse and during the reporting period. The
Potential Commercial Applications: Mental Health Services Administration previous PATH Annual Report only
• Novel therapeutics for cancer AND (SAMHSA) will publish a summary of reported on contacts through the date of
indications which depend on a information collection requests under enrollment.

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Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Notices 35281

2. Referrals Provided 3. HMIS Data Standards Updates The estimated annual burden for
To align with the HMIS Data When needed, field response options these reporting requirements is
Standards, all PATH Referral response and questions have been updated to summarized in the table below.
categories are now included in the align with the most recent version of the
PATH Annual Report. HMIS Data Standards.

Responses Burden per
Number of
Respondents per response Total burden
respondents respondent (hrs.)

States ............................................................................................................... 56 1 20 1,120
Local provider agencies ................................................................................... 487 1 15 7,305

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

Written comments and information as well as personal ACTION: Notice.
recommendations concerning the information concerning the applicants.
proposed information collection should Therefore, the meeting will be closed to SUMMARY: This notice amends the notice
be sent by August 24, 2018 to the the public as determined by the of a major disaster declaration for the
SAMHSA Desk Officer at the Office of SAMHSA Assistant Secretary for Mental State of New Jersey (FEMA–4368–DR),
Information and Regulatory Affairs, Health and Substance Use in accordance dated June 8, 2018, and related
Office of Management and Budget with Title 5 U.S.C 552b(c)(4) and (6) and determinations.
(OMB). To ensure timely receipt of Title 5 U.S.C. App. 2, 10(d).
comments, and to avoid potential delays Meeting information and a roster of DATES: This amendment was issued July
in OMB’s receipt and processing of mail Council members may be obtained by 13, 2018.
sent through the U.S. Postal Service, accessing the SAMHSA Committee
commenters are encouraged to submit FOR FURTHER INFORMATION CONTACT:
website at http://www.samhsa.gov/
their comments to OMB via email to: about-us/advisory-councils/csat- Dean Webster, Office of Response and
OIRA_Submission@omb.eop.gov. national-advisory-council or by Recovery, Federal Emergency
Although commenters are encouraged to contacting the CSAT National Advisory Management Agency, 500 C Street SW,
send their comments via email, Council Designated Federal Officer; Washington, DC 20472, (202) 646–2833.
commenters may also fax their Tracy Goss (see contact information SUPPLEMENTARY INFORMATION: The notice
comments to: 202–395–7285. below). of a major disaster declaration for the
Commenters may also mail them to: Council Name: SAMHSA’s Center for State of New Jersey is hereby amended
Office of Management and Budget, Substance Abuse Treatment National to include the following area among
Office of Information and Regulatory Advisory Council. those areas determined to have been
Affairs, New Executive Office Building, Date/Time/Type: September 11, 2018, adversely affected by the event declared
Room 10102, Washington, DC 20503. 2:00 p.m.–3:00 p.m. EDT, CLOSED. a major disaster by the President in his
Summer King, Place: SAMHSA, 5600 Fishers Lane, declaration of June 8, 2018.
Statistician.
Rockville, Maryland 20857.
Contact: Tracy Goss, Designated Burlington County for Public
[FR Doc. 2018–15825 Filed 7–24–18; 8:45 am] Assistance.
Federal Officer, CSAT National
BILLING CODE 4162–20–P
Advisory Council, 5600 Fishers Lane, The following Catalog of Federal Domestic
Rockville, Maryland 20857 (mail), Assistance Numbers (CFDA) are to be used
DEPARTMENT OF HEALTH AND Telephone: (240) 276–0759, Fax: (240) for reporting and drawing funds: 97.030,
HUMAN SERVICES 276–2252, Email: tracy.goss@ Community Disaster Loans; 97.031, Cora
samhsa.hhs.gov. Brown Fund; 97.032, Crisis Counseling;
Substance Abuse and Mental Health 97.033, Disaster Legal Services; 97.034,
Carlos Castillo,
Services Administration Disaster Unemployment Assistance (DUA);
Committee Management Officer, SAMHSA. 97.046, Fire Management Assistance Grant;
Center for Substance Abuse [FR Doc. 2018–15824 Filed 7–24–18; 8:45 am] 97.048, Disaster Housing Assistance to
Treatment: Notice of Meeting BILLING CODE 4162–20–P Individuals and Households In Presidentially
Declared Disaster Areas; 97.049,
Pursuant to Public Law 92–463, Presidentially Declared Disaster Assistance—
notice is hereby given that the DEPARTMENT OF HOMELAND Disaster Housing Operations for Individuals
Substance Abuse and Mental Health SECURITY and Households; 97.050 Presidentially
Services Administration’s (SAMHSA’s) Declared Disaster Assistance to Individuals
Center for Substance Abuse Treatment Federal Emergency Management and Households—Other Needs; 97.036,
(CSAT) National Advisory Council will Agency Disaster Grants—Public Assistance
meet on September 11, 2018, 2:00 p.m.– (Presidentially Declared Disasters); 97.039,
daltland on DSKBBV9HB2PROD with NOTICES

3:00 p.m. (EDT) in a closed [Internal Agency Docket No. FEMA–4368–
Hazard Mitigation Grant.
teleconference meeting. DR; Docket ID FEMA–2018–0001]
The meeting will include discussions Brock Long,
New Jersey; Amendment No. 1 to
and evaluations of grant applications Administrator, Federal Emergency
Notice of a Major Disaster Declaration Management Agency.
reviewed by SAMHSA’s Initial Review
Groups, and involve an examination of AGENCY:Federal Emergency [FR Doc. 2018–15840 Filed 7–24–18; 8:45 am]
confidential financial and business Management Agency, DHS. BILLING CODE 9111–23–P

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Document Created: 2018-07-25 00:44:31
Document Modified: 2018-07-25 00:44:31

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
FR Citation		83 FR 35280

83 FR 35280 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESSubstance Abuse and Mental Health Services Administration

Federal Register Volume 83, Issue 143 (July 25, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration