Agency Information Collection Activities: Proposed Collection; Comment Request, 51970-51972 [2018-22409]

Download as PDF 51970 Federal Register / Vol. 83, No. 199 / Monday, October 15, 2018 / Notices Place: National Institutes of Health, Rockledge 6700, Room 3185, MSC 6908, 6700B Rockledge Drive, Bethesda, MD 20817 (Telephone Conference Call). Contact Person: Barbara J Thomas, Ph.D., Scientific Review Officer, Scientific Review Branch, National Human Genome Research Institute, National Institutes of Health, 5635 Fishers Lane, Ste. 4076, MSC 9306, Bethesda, MD 20892–9306, 301–402–0838, barbara.thomas@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human Genome Research, National Institutes of Health, HHS) Dated: October 5, 2018. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–22315 Filed 10–12–18; 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. The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. to achieve expeditious commercialization of results of federally-funded research and development. FOR FURTHER INFORMATION CONTACT: Licensing information may be obtained by emailing 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 A signed Confidential Disclosure Agreement may be required to receive any unpublished information.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. khammond on DSK30JT082PROD with NOTICES SUMMARY: Lentiviral Protein Delivery System for RNA-Guided Genome Editing Available for licensing and commercial development is an HIV–1based lentiviral vector system for gene correction strategies involving a homologous recombination with a variation of the CRISPR/Cas9 system. Other such lentivirus-based vectors encode a guide RNA, which contains a specific sequence that recognizes a target gene, and a Cas9 endonuclease, which cuts at the specific site. Such systems are being explored as potential VerDate Sep<11>2014 21:34 Oct 12, 2018 Jkt 247001 therapies for certain hereditary diseases (e.g., sickle-cell disease). However, such systems present some problems due to constitutive expression of Cas9 endonuclease in lentiviral vectortransduced cells and the large size of the Cas9 gene. The variation of this invention delivers the Cas9 endonuclease directly, instead of the gene encoding the protein. This system comprises (a) a lentivirus vector particle comprising a lentiviral genome which encodes at least one guide RNA sequence that is complementary to a first DNA sequence in a host cell genome, (b) a Cas9 protein, and optionally (c) a donor nucleic acid molecule comprising a second DNA sequence. In addition, the invention provides a host cell comprising the foregoing system, as well as a method of altering a DNA sequence in a host cell comprising contacting a host cell with the foregoing system. Alternatively, the invention also provides a fusion protein comprising a Cas9 protein and a cyclophilin A (CypA) protein, wherein the fusion protein binds to the lentivirus vector particle, as well as a lentiviral vector particle comprising such a fusion protein. Gene correction using the disclosed lentiviral vector systems are being tested with respect to the betaglobin gene and the BCL11A gene (to treat sickle-cell disease) and will be used for induced pluripotent stem cell (iPS) generation. Potential Commercial Applications: • Sickle cell disease • gene therapy Development Stage: • Early stage Inventors: Naoya Uchida, Juan J. Haro Mora, John F. Tisdale (all of NHLBI) Relevant Publications: Demirci et al., Cytotherapy. 2018 Jul;20(7):899–910. doi: 10.1016/j.jcyt.2018.04.003. Epub 2018 May 30. Intellectual Property: HHS Reference No. E–165–2015; U.S Provisional Patent Application 62/236,223 filed October 2, 2015; International Patent Application PCT/US2016/054759 filed September 30, 2016, U.S. Continuation-in-Part Application 15/942,673 filed April 2, 2018 and European Patent Application 16782163.6 having an international filing date of September 30, 2016. Licensing Contact: Michael Shmilovich, Esq, CLP; 301–435–5019; shmilovm@mail.nih.gov. PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 Dated: October 4, 2018. Michael A. Shmilovich, Senior Licensing and Patenting Manager, National Heart, Lung, and Blood Institute, Office of Technology Transfer and Development. [FR Doc. 2018–22360 Filed 10–12–18; 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: Proposed Collection; Comment Request In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on (240) 276– 1243. Comments are invited on: (a) Whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Proposed Project: Technology Transfer Centers (TTC) Network Program Monitoring—NEW The Substance Abuse and Mental Health Administration’s (SAMHSA) will monitor program performance of its Technology Transfer Centers (TTCs). The TTCs disseminate current behavioral health and HIV services research from the National Institute on Drug Abuse, National Institute on Alcohol Abuse and Alcoholism, National Institute of Mental Health, Agency for Healthcare Research and Quality National Institute of Justice, and other sources, as well as other SAMHSA programs. To accomplish this, the TTCs develop and update state-of-the-art, E:\FR\FM\15OCN1.SGM 15OCN1 51971 Federal Register / Vol. 83, No. 199 / Monday, October 15, 2018 / Notices research-based curricula and professional development training. The TTCs hold a variety of events: Technical assistance events, meetings, trainings, and learning collaboratives. A TTC technical assistance event is defined as a jointly planned consultation generally involving a series of contacts between the TTC and an outside organization/institution during which the TTC provides expertise and gives direction toward resolving a problem or improving conditions. Technical assistance events can be categorized into universal, targeted and intensive. Other TTC events such as meetings, training, strategic planning and learning collaboratives are utilized to support technical assistance. These events are TTC-sponsored or cosponsored events in which a group of people representing one or more agencies other than the TTC work cooperatively on a project, problem, and/or policy. SAMHSA intends to use five (5) instruments for program monitoring of TTC events as well as ongoing quality improvement, which are described below. 1. Event Description Form (EDF): The EDF collects event information. This instrument asks approximately 10 questions of TTC faculty/staff relating to the event focus and format. It allows the TTCs and SAMHSA to track the number of events held (See Attachment 1). 2. TTC Post Event Form—Domestic: The Post Event Form—Domestic will be administered immediately following the event. It asks approximately 11 questions of each individual that participated in the event (Attachment 2). The instrument asks the participants to report on general demographic information (gender, race, level of education, primary profession), principal employment setting, employment zip code, satisfaction with the event, if they expect the event to benefit them professionally, if they expect the event to change their practice and if they would recommend the event to a colleague. 3. TTC Post Event Form— International: The Post Event Form— International will be administered immediately following the event. It asks 9 questions of each individual that participated in the event (Attachment 3). The instrument is very similar to the Post Event Form—Domestic and asks the participants to report gender, highest degree received, principal employment setting, employment postal code, satisfaction with the event, if they expect the event to benefit them professionally, if they expect the event to change their practice and if they would recommend the event to a colleague. The main difference between the international and domestic versions of the post event forms is the modification of the demographic questions to make the forms appropriate for distribution outside the U.S. context and relevant to existing PEPFAR indicators. For example, the race/ ethnicity questions from the domestic form are not included in the international form. Also, the personal code offers more spaces for characters to provide flexibility in how the personal code is constructed in different countries. Making these change assists SAMHSA in being culturally appropriate (e.g., participants of events of the South Africa HIV ATTC could be offended by being asked if they are ‘‘African American’’; the concept of ‘‘mother’s maiden name’’ does not exist in Vietnam). The change also makes the information better match the needs of PEPFAR, which provides the funding for these centers. 4. TTC Follow-up Form—Domestic: The Follow-up Form—Domestic will be administered 30-days after all events that last a minimum of three (3) hours. The form will be administered to a minimum of 25% of participants who consent to participate in the follow-up process. The form asks about 10 questions (Attachment 3). The instrument asks the participants to report if the information provided in at the event benefited their professional development, will change their practice, if they will use the information in their future work, if information will be shared with colleagues, how the event supported their work responsibilities, how the TTC can improve the events, Number of respondents khammond on DSK30JT082PROD with NOTICES Type of respondent ATTC Faculty/Staff: Event Description Form ................................................ Meeting and Technical Assistance Participants: Post-Event Form ........................................................... Follow-up Form .................................................................... VerDate Sep<11>2014 21:34 Oct 12, 2018 Jkt 247001 PO 00000 Responses per respondent what other topics would participants like to see TTCs address and in what format. 5. TTC Follow-up Form— International: The Follow-up Form— International will be administered 30days after all events that last a minimum of three (3) hours. The form will be administered to a minimum of 25% of participants who consent to participate in the follow-up process. The form asks about 10 questions (Attachment 5). The instrument asks the participants to report if the information provided at the event benefited their professional development, will change their practice, if they will use the information in their future work, if information will be shared with colleagues, how the event supported their work responsibilities, how the TTC can improve the events, what other topics would participants like to see TTCs address and in what format. The only difference between the domestic and international follow-up forms is that the international form offers more spaces for characters for the personal code to provide flexibility in how the personal code is constructed in different countries. While the instruments administered immediately at the end of each event are given to all participants, the instruments administered 30 days after each event are sent to a random sample of 25% of those participants who consented to follow-up. This sampling rule applies to all events that last a minimum of three (3) hours. The information collected on the TTC forms will assist SAMHSA in documenting the numbers and types of participants in TTC events, describing the extent to which participants report improvement in their professional development, and which method is most effective in disseminating knowledge to various audiences. This type of information is crucial to support SAMHSA in complying with GPRA reporting requirements and will inform future development of knowledge dissemination activities. The chart below summarizes the annualized burden for this project. Total responses Hours per response Total annual burden hours 250 1 250 .25 62.50 5,000 1 5,000 .12 600 Covered under CSAT Government Performance and Results Act (GPRA) Customer Satisfaction form (OMB #0930–0197). Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\15OCN1.SGM 15OCN1 51972 Federal Register / Vol. 83, No. 199 / Monday, October 15, 2018 / Notices Number of respondents Type of respondent Responses per respondent Total responses Total annual burden hours Hours per response Training Participants: Post-Event Form ........................................................... Follow-up Form ............................................................. 30,000 7,500 1 1 30,000 7,500 .16 .16 4,800 1,200 Total ....................................................................... 42,750 ........................ 42,750 ........................ 6,662.50 Number of respondents Type of respondent MHTTC Faculty/Staff: Event Description Form ................................................ Meeting and Technical Assistance Participants: Post-Event Form ........................................................... Follow-up Form .................................................................... Responses per respondent Total responses Total annual burden hours Hours per response 250 1 250 .25 62.50 5,000 1 5,000 .12 600 Covered under CSAT Government Performance and Results Act (GPRA) Customer Satisfaction form (OMB #0930–0197). Training Participants: Post-Event Form ........................................................... Follow-up Form ............................................................. 30,000 7,500 1 1 30,000 7,500 .16 .16 4,800 1,200 Total ....................................................................... 42,750 ........................ 42,750 ........................ 6,662.50 Number of respondents Type of respondent PTTC Faculty/Staff: Event Description Form ................................................ Meeting and Technical Assistance Participants: Post-Event Form ........................................................... Follow-up Form .................................................................... Responses per respondent Total responses Total annual burden hours Hours per response 250 1 250 .25 62.50 5,000 1 5,000 .12 600 Covered under CSAT Government Performance and Results Act (GPRA) Customer Satisfaction form (OMB #0930–0197) Training Participants: Post-Event Form ........................................................... Follow-up Form ............................................................. 30,000 7,500 1 1 30,000 7,500 .16 .16 4,800 1,200 Total ....................................................................... 42,750 ........................ 42,750 ........................ 6,662.50 SUMMARY TABLE Number respondents khammond on DSK30JT082PROD with NOTICES Instruments Responses per respondents Burden hours TTC Event Description Form ....................................................................................................... TTC Post Event Form—Domestic and International ................................................................... TTC Follow up Form—Domestic and International ..................................................................... 750 105,000 22,500 1 1 1 187.50 16,200 3,600 Total ............................................................................................................................... 128,250 1 19,987.50 Send comments to Summer King, SAMHSA Reports Clearance Officer, Room 15E57–B, 5600 Fishers Lane, Rockville, MD 20852 or email a copy at summer.king@samhsa.hhs.gov. Written comments should be received by December 14, 2018. Summer King, Statistician. [FR Doc. 2018–22409 Filed 10–12–18; 8:45 am] BILLING CODE 4162–20–P VerDate Sep<11>2014 21:34 Oct 12, 2018 DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID FEMA–2018–0002; Internal Agency Docket No. FEMA–B–1853] Proposed Flood Hazard Determinations Federal Emergency Management Agency, DHS. AGENCY: Jkt 247001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 ACTION: Notice. Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table SUMMARY: E:\FR\FM\15OCN1.SGM 15OCN1

Agencies

[Federal Register Volume 83, Number 199 (Monday, October 15, 2018)]
[Notices]
[Pages 51970-51972]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22409]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Agency Information Collection Activities: Proposed Collection; 
Comment Request

    In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction 
Act of 1995 concerning opportunity for public comment on proposed 
collections of information, the Substance Abuse and Mental Health 
Services Administration (SAMHSA) will publish periodic summaries of 
proposed projects. To request more information on the proposed projects 
or to obtain a copy of the information collection plans, call the 
SAMHSA Reports Clearance Officer on (240) 276-1243.
    Comments are invited on: (a) Whether the proposed collections of 
information are necessary for the proper performance of the functions 
of the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology.

Proposed Project: Technology Transfer Centers (TTC) Network Program 
Monitoring--NEW

    The Substance Abuse and Mental Health Administration's (SAMHSA) 
will monitor program performance of its Technology Transfer Centers 
(TTCs). The TTCs disseminate current behavioral health and HIV services 
research from the National Institute on Drug Abuse, National Institute 
on Alcohol Abuse and Alcoholism, National Institute of Mental Health, 
Agency for Healthcare Research and Quality National Institute of 
Justice, and other sources, as well as other SAMHSA programs. To 
accomplish this, the TTCs develop and update state-of-the-art,

[[Page 51971]]

research-based curricula and professional development training.
    The TTCs hold a variety of events: Technical assistance events, 
meetings, trainings, and learning collaboratives. A TTC technical 
assistance event is defined as a jointly planned consultation generally 
involving a series of contacts between the TTC and an outside 
organization/institution during which the TTC provides expertise and 
gives direction toward resolving a problem or improving conditions. 
Technical assistance events can be categorized into universal, targeted 
and intensive. Other TTC events such as meetings, training, strategic 
planning and learning collaboratives are utilized to support technical 
assistance. These events are TTC-sponsored or co-sponsored events in 
which a group of people representing one or more agencies other than 
the TTC work cooperatively on a project, problem, and/or policy.
    SAMHSA intends to use five (5) instruments for program monitoring 
of TTC events as well as ongoing quality improvement, which are 
described below.
    1. Event Description Form (EDF): The EDF collects event 
information. This instrument asks approximately 10 questions of TTC 
faculty/staff relating to the event focus and format. It allows the 
TTCs and SAMHSA to track the number of events held (See Attachment 1).
    2. TTC Post Event Form--Domestic: The Post Event Form--Domestic 
will be administered immediately following the event. It asks 
approximately 11 questions of each individual that participated in the 
event (Attachment 2). The instrument asks the participants to report on 
general demographic information (gender, race, level of education, 
primary profession), principal employment setting, employment zip code, 
satisfaction with the event, if they expect the event to benefit them 
professionally, if they expect the event to change their practice and 
if they would recommend the event to a colleague.
    3. TTC Post Event Form--International: The Post Event Form--
International will be administered immediately following the event. It 
asks 9 questions of each individual that participated in the event 
(Attachment 3). The instrument is very similar to the Post Event Form--
Domestic and asks the participants to report gender, highest degree 
received, principal employment setting, employment postal code, 
satisfaction with the event, if they expect the event to benefit them 
professionally, if they expect the event to change their practice and 
if they would recommend the event to a colleague. The main difference 
between the international and domestic versions of the post event forms 
is the modification of the demographic questions to make the forms 
appropriate for distribution outside the U.S. context and relevant to 
existing PEPFAR indicators. For example, the race/ethnicity questions 
from the domestic form are not included in the international form. 
Also, the personal code offers more spaces for characters to provide 
flexibility in how the personal code is constructed in different 
countries. Making these change assists SAMHSA in being culturally 
appropriate (e.g., participants of events of the South Africa HIV ATTC 
could be offended by being asked if they are ``African American''; the 
concept of ``mother's maiden name'' does not exist in Vietnam). The 
change also makes the information better match the needs of PEPFAR, 
which provides the funding for these centers.
    4. TTC Follow-up Form--Domestic: The Follow-up Form--Domestic will 
be administered 30-days after all events that last a minimum of three 
(3) hours. The form will be administered to a minimum of 25% of 
participants who consent to participate in the follow-up process. The 
form asks about 10 questions (Attachment 3). The instrument asks the 
participants to report if the information provided in at the event 
benefited their professional development, will change their practice, 
if they will use the information in their future work, if information 
will be shared with colleagues, how the event supported their work 
responsibilities, how the TTC can improve the events, what other topics 
would participants like to see TTCs address and in what format.
    5. TTC Follow-up Form--International: The Follow-up Form--
International will be administered 30-days after all events that last a 
minimum of three (3) hours. The form will be administered to a minimum 
of 25% of participants who consent to participate in the follow-up 
process. The form asks about 10 questions (Attachment 5). The 
instrument asks the participants to report if the information provided 
at the event benefited their professional development, will change 
their practice, if they will use the information in their future work, 
if information will be shared with colleagues, how the event supported 
their work responsibilities, how the TTC can improve the events, what 
other topics would participants like to see TTCs address and in what 
format. The only difference between the domestic and international 
follow-up forms is that the international form offers more spaces for 
characters for the personal code to provide flexibility in how the 
personal code is constructed in different countries. While the 
instruments administered immediately at the end of each event are given 
to all participants, the instruments administered 30 days after each 
event are sent to a random sample of 25% of those participants who 
consented to follow-up. This sampling rule applies to all events that 
last a minimum of three (3) hours.
    The information collected on the TTC forms will assist SAMHSA in 
documenting the numbers and types of participants in TTC events, 
describing the extent to which participants report improvement in their 
professional development, and which method is most effective in 
disseminating knowledge to various audiences. This type of information 
is crucial to support SAMHSA in complying with GPRA reporting 
requirements and will inform future development of knowledge 
dissemination activities.
    The chart below summarizes the annualized burden for this project.

----------------------------------------------------------------------------------------------------------------
                                     Number of     Responses per       Total         Hours per     Total annual
       Type of respondent           respondents     respondent       responses       response      burden hours
----------------------------------------------------------------------------------------------------------------
ATTC Faculty/Staff:
    Event Description Form......             250               1             250             .25           62.50
Meeting and Technical Assistance
 Participants:
    Post-Event Form.............           5,000               1           5,000             .12             600
                                 -------------------------------------------------------------------------------
Follow-up Form..................  Covered under CSAT Government Performance and Results Act (GPRA) Customer
                                  Satisfaction form (OMB #0930-0197).
                                 -------------------------------------------------------------------------------

[[Page 51972]]

 
Training Participants:
    Post-Event Form.............          30,000               1          30,000             .16           4,800
    Follow-up Form..............           7,500               1           7,500             .16           1,200
                                 -------------------------------------------------------------------------------
        Total...................          42,750  ..............          42,750  ..............        6,662.50
----------------------------------------------------------------------------------------------------------------


----------------------------------------------------------------------------------------------------------------
                                     Number of     Responses per       Total         Hours per     Total annual
       Type of respondent           respondents     respondent       responses       response      burden hours
----------------------------------------------------------------------------------------------------------------
MHTTC Faculty/Staff:
    Event Description Form......             250               1             250             .25           62.50
Meeting and Technical Assistance
 Participants:
    Post-Event Form.............           5,000               1           5,000             .12             600
                                 -------------------------------------------------------------------------------
Follow-up Form..................  Covered under CSAT Government Performance and Results Act (GPRA) Customer
                                  Satisfaction form (OMB #0930-0197).
                                 -------------------------------------------------------------------------------
Training Participants:
    Post-Event Form.............          30,000               1          30,000             .16           4,800
    Follow-up Form..............           7,500               1           7,500             .16           1,200
                                 -------------------------------------------------------------------------------
        Total...................          42,750  ..............          42,750  ..............        6,662.50
----------------------------------------------------------------------------------------------------------------


----------------------------------------------------------------------------------------------------------------
                                     Number of     Responses per       Total         Hours per     Total annual
       Type of respondent           respondents     respondent       responses       response      burden hours
----------------------------------------------------------------------------------------------------------------
PTTC Faculty/Staff:
    Event Description Form......             250               1             250             .25           62.50
Meeting and Technical Assistance
 Participants:
    Post-Event Form.............           5,000               1           5,000             .12             600
                                 -------------------------------------------------------------------------------
Follow-up Form..................  Covered under CSAT Government Performance and Results Act (GPRA) Customer
                                  Satisfaction form (OMB #0930-0197)
                                 -------------------------------------------------------------------------------
Training Participants:
    Post-Event Form.............          30,000               1          30,000             .16           4,800
    Follow-up Form..............           7,500               1           7,500             .16           1,200
                                 -------------------------------------------------------------------------------
        Total...................          42,750  ..............          42,750  ..............        6,662.50
----------------------------------------------------------------------------------------------------------------


                                                  Summary Table
----------------------------------------------------------------------------------------------------------------
                                                                      Number       Responses per
                           Instruments                              respondents     respondents    Burden hours
----------------------------------------------------------------------------------------------------------------
TTC Event Description Form......................................             750               1          187.50
TTC Post Event Form--Domestic and International.................         105,000               1          16,200
TTC Follow up Form--Domestic and International..................          22,500               1           3,600
                                                                 -----------------------------------------------
        Total...................................................         128,250               1       19,987.50
----------------------------------------------------------------------------------------------------------------

    Send comments to Summer King, SAMHSA Reports Clearance Officer, 
Room 15E57-B, 5600 Fishers Lane, Rockville, MD 20852 or email a copy at 
[email protected]. Written comments should be received by 
December 14, 2018.

Summer King,
Statistician.
[FR Doc. 2018-22409 Filed 10-12-18; 8:45 am]
 BILLING CODE 4162-20-P