Agency Information Collection Activities: Submission for OMB Review; Comment Request, 28967-28968 [2020-10308]

Download as PDF Federal Register / Vol. 85, No. 94 / Thursday, May 14, 2020 / Notices Medical Center Drive, RM 1E530, MSC 9702, Bethesda, MD 20892–9702 (for business mail), Rockville, MD 20850– 9702; Telephone: (240)-276–7856; Facsimile: (240)-276–5504; Email: jim.knabb@nih.gov. SUPPLEMENTARY INFORMATION: jbell on DSKJLSW7X2PROD with NOTICES Intellectual Property E–097–2018–0: Anti-CD33 Chimeric Antigen Receptors for Treatment of Human Acute Myeloid Leukemia 1. U.S. Provisional Patent Application 62/643,015, filed March 14, 2018 (E– 097–2018–0–US–01); 2. International Patent Application PCT/US2019/022,309, filed March 14, 2019 (E–097–2018–0–PCT–02) The patent rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America. The prospective exclusive license territory may be worldwide, and the fields of use may be limited to the following: An exclusive license to: 1. The development of a CD33specific logic-gated CAR-based immunotherapy using autologous human T cells transduced with lentiviral vectors, wherein the viral transduction leads to the expression of a CAR that targets CD33 (comprised of the CD33-binding domain referenced as Hu195 or hP67.6 in the invention as well as an intracellular signaling domain), for the prophylaxis or treatment of CD33-expressing cancers. For clarity, ‘‘CD33-specific logic-gated CAR-based immunotherapy’’ means therapies where the CAR-expressing T cells recognize CD33 and are engineered to respond to one or more additional antigens (but not necessarily all of the signals). 2. The development of a CD33specific logic-gated CAR-based immunotherapy using allogeneic human NK cells transduced with lentiviral vectors, wherein the viral transduction leads to the expression of a CAR that targets CD33 (comprised of the CD33binding domain referenced as Hu195 or hP67.6 in the invention as well as an intracellular signaling domain), for the prophylaxis or treatment of CD33expressing cancers. For clarity, ‘‘CD33specific logic-gated CAR-based immunotherapy’’ means therapies where the CAR-expressing NK cells recognize CD33 and are engineered to respond to one or more additional antigens (but not necessarily all of the signals). This technology discloses a CAR therapy that targets CD33 by utilizing the anti-CD33 binder known as Hu195 VerDate Sep<11>2014 18:29 May 13, 2020 Jkt 250001 or hP67.6 for the treatment of hematological malignancies. CD33 is a validated immunotherapeutic target that is expressed on the surface of the vast majority of acute myelogenous leukemia (AML) blasts and cells in chronic myeloid leukemia-blast crisis (CML– BC). This Notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within thirty (30) days from the date of this published Notice, the National Cancer Institute 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. 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: May 7, 2020. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2020–10303 Filed 5–13–20; 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. To request a copy of these documents, call or email the SAMHSA Reports Clearance Officer on (240) 276–0361 or carlos.graham@ samhsa.hhs.gov. PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 28967 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 (114–255 Pub. L). Section 522 of the PHS Act and the 21st Century Cures Act requires 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 2020 Annual Report are as follows: 1. 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. Effective October 1, 2019, the HMIS Data Standards have been further updated. The changes in the HMIS Data Standards are reflected in this version of the PATH Annual Report Manual, and include: —Updates to response categories for Living Situation —Addition of an ‘‘Unable to Locate Client’’ response option to PATH Status E:\FR\FM\14MYN1.SGM 14MYN1 28968 Federal Register / Vol. 85, No. 94 / Thursday, May 14, 2020 / Notices —Addition of a demographic question on history with domestic violence The estimated annual burden for these reporting requirements is summarized in the table below. Number of respondents Respondents Burden per response (hrs.) Total burden States ............................................................................................................... Local provider agencies ................................................................................... 56 476 1 1 15 15 840 7,140 Total .......................................................................................................... 532 ........................ ........................ 7,980 Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function. Carlos Graham, Social Science Analyst. [FR Doc. 2020–10308 Filed 5–13–20; 8:45 am] BILLING CODE 4162–20–P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID: FEMA–2020–0023; OMB No. 1660–0005] Agency Information Collection Activities: Proposed Collection; Comment Request; FEMA Inspection and Claims Forms Federal Emergency Management Agency, DHS. ACTION: Notice and request for comments. AGENCY: The Federal Emergency Management Agency, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on a revision of a currently approved information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning the collection of information related to the flood insurance claims process and the housing inspection damage assessment process. SUMMARY: jbell on DSKJLSW7X2PROD with NOTICES Responses per respondent Comments must be submitted on or before July 13, 2020. ADDRESSES: To avoid duplicate submissions to the docket, please use only one of the following means to submit comments: DATES: VerDate Sep<11>2014 18:29 May 13, 2020 Jkt 250001 (1) Online. Submit comments at www.regulations.gov under Docket ID FEMA–2020–0023. Follow the instructions for submitting comments. (2) Mail. Submit written comments to Docket Manager, Office of Chief Counsel, DHS/FEMA, 500 C Street SW, 8NE, Washington, DC 20472–3100. All submissions received must include the agency name and Docket ID. Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at http://www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to read the Privacy and Security Notice that is available via a link on the homepage of www.regulations.gov. FOR FURTHER INFORMATION CONTACT: For information related to Claims Forms, contact: Daniel Claire, Program Analyst, Federal Insurance & Mitigation Administration, 202–552–9891, Daniel.Claire@fema.dhs.gov. For information related to Housing Inspection Instruments, contact: Brian Thompson, Supervisory Program Specialist, FEMA Recovery Directorate, Brian.Thompson6@fema.dhs.gov. You may contact the Information Management Division for copies of the proposed collection of information at email address: FEMA-InformationCollections-Management@fema.dhs.gov. SUPPLEMENTARY INFORMATION: Congress created the National Flood Insurance Program (NFIP) through enactment of the National Flood Insurance Act of 1968 (NFIA) (Title XIII of Pub. L. 90– 448, 82 Stat. 476), codified at 42 U.S.C. 4001 et seq. The NFIP is a Federal program enabling property owners in participating communities to purchase insurance as a protection against flood losses in exchange for state and community floodplain management requirements that reduce the risk of future flood damages. Communities participate in the NFIP based on an agreement between the community and FEMA. If a community adopts and PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 enforces a floodplain management ordinance to reduce future flood risk to new construction in floodplains, FEMA will make flood insurance available within the community as a financial protection against flood losses. Accordingly, the NFIP is comprised of three key activities: flood insurance, floodplain management and flood hazard mapping. A prospective policyholder may purchase an NFIP flood insurance policy either: (1) Directly from the Federal Government through a direct servicing agent (referred to as ‘‘NFIP Direct’’), or (2) from a participating private insurance company through the Write Your Own (WYO) Program. The Standard Flood Insurance Policy (SFIP) sets out the terms and conditions of insurance. See 44 CFR part 61, Appendix A. FEMA establishes terms, rate structures, and premium costs of SFIPs. The terms, coverage limits, and flood insurance premiums are the same whether purchased from the NFIP Direct or the WYO Program. See 44 CFR 62.23(a). All flood loss claims presented under the NFIP are paid directly with U.S. Treasury funds, regardless of whether the policy is issued by the government (FEMA) directly or by a WYO company. The information in this collection includes all the data necessary to adjudicate claims for damages and benefits resulting from flood losses. In addition to the requirements of the NFIA, section 205 of the BunningBereuter-Blumenauer Flood Insurance Reform Act of 2004 (42 U.S.C. 4011 note) required FEMA to establish a claims appeals process. FEMA implemented the claim appeal process at 44 CFR 62.20. Pertaining to housing inspections, the Robert T. Stafford Disaster Relief and Emergency Assistance Act (Stafford Act), Pub. L. 93–288, as amended, is the legal basis for FEMA to provide financial assistance and services to individuals applying for disaster assistance benefits in the event of a Federally-declared disaster. Regulations in 44 CFR 206.110—Federal Assistance E:\FR\FM\14MYN1.SGM 14MYN1

Agencies

[Federal Register Volume 85, Number 94 (Thursday, May 14, 2020)]
[Notices]
[Pages 28967-28968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10308]


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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. To request a copy of these documents, call or email the 
SAMHSA Reports Clearance Officer on (240) 276-0361 or 
[email protected].

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 (114-255 Pub. L). 
Section 522 of the PHS Act and the 21st Century Cures Act requires 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 2020 Annual Report are as follows:

1. 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.
    Effective October 1, 2019, the HMIS Data Standards have been 
further updated. The changes in the HMIS Data Standards are reflected 
in this version of the PATH Annual Report Manual, and include:

--Updates to response categories for Living Situation
--Addition of an ``Unable to Locate Client'' response option to PATH 
Status

[[Page 28968]]

--Addition of a demographic question on history with domestic violence

    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              15             840
Local provider agencies.........................             476               1              15           7,140
                                                 ---------------------------------------------------------------
    Total.......................................             532  ..............  ..............           7,980
----------------------------------------------------------------------------------------------------------------

    Written comments and recommendations for the proposed information 
collection should be sent within 30 days of publication of this notice 
to www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under 30-day Review--Open for 
Public Comments'' or by using the search function.

Carlos Graham,
Social Science Analyst.
[FR Doc. 2020-10308 Filed 5-13-20; 8:45 am]
BILLING CODE 4162-20-P