83 FR 51970 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration Federal Register Volume 83, Issue 199 (October 15, 2018)
Substance Abuse and Mental Health Services Administration
Federal Register Volume 83, Issue 199 (October 15, 2018)
| Page Range | 51970-51972 | |
| FR Document | 2018-22409 |
[Federal Register Volume 83, Number 199 (Monday, October 15, 2018)] [Notices] [Pages 51970-51972] From the Federal Register Online [www.thefederalregister.org] [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 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
![51970 Federal Register / Vol. 83, No. 199 / Monday, October 15, 2018 / Notices
Place: National Institutes of Health, therapies for certain hereditary diseases Dated: October 4, 2018.
Rockledge 6700, Room 3185, MSC 6908, (e.g., sickle-cell disease). However, such Michael A. Shmilovich,
6700B Rockledge Drive, Bethesda, MD 20817 systems present some problems due to Senior Licensing and Patenting Manager,
(Telephone Conference Call).
constitutive expression of Cas9 National Heart, Lung, and Blood Institute,
Contact Person: Barbara J Thomas, Ph.D.,
endonuclease in lentiviral vector- Office of Technology Transfer and
Scientific Review Officer, Scientific Review Development.
Branch, National Human Genome Research transduced cells and the large size of the
Institute, National Institutes of Health, 5635 Cas9 gene. The variation of this [FR Doc. 2018–22360 Filed 10–12–18; 8:45 am]
Fishers Lane, Ste. 4076, MSC 9306, Bethesda, invention delivers the Cas9 BILLING CODE 4140–01–P
MD 20892–9306, 301–402–0838, endonuclease directly, instead of the
barbara.thomas@nih.gov.
gene encoding the protein. This system
(Catalogue of Federal Domestic Assistance DEPARTMENT OF HEALTH AND
comprises (a) a lentivirus vector particle HUMAN SERVICES
Program Nos. 93.172, Human Genome
Research, National Institutes of Health, HHS) comprising a lentiviral genome which
encodes at least one guide RNA Substance Abuse and Mental Health
Dated: October 5, 2018.
sequence that is complementary to a Services Administration
Sylvia L. Neal, first DNA sequence in a host cell
Program Analyst, Office of Federal Advisory genome, (b) a Cas9 protein, and Agency Information Collection
Committee Policy. Activities: Proposed Collection;
optionally (c) a donor nucleic acid
[FR Doc. 2018–22315 Filed 10–12–18; 8:45 am] Comment Request
molecule comprising a second DNA
BILLING CODE 4140–01–P
sequence. In addition, the invention In compliance with Section
provides a host cell comprising the 3506(c)(2)(A) of the Paperwork
DEPARTMENT OF HEALTH AND foregoing system, as well as a method of Reduction Act of 1995 concerning
HUMAN SERVICES altering a DNA sequence in a host cell opportunity for public comment on
comprising contacting a host cell with proposed collections of information, the
National Institutes of Health the foregoing system. Alternatively, the Substance Abuse and Mental Health
invention also provides a fusion protein Services Administration (SAMHSA)
Government-Owned Inventions; comprising a Cas9 protein and a will publish periodic summaries of
Availability for Licensing cyclophilin A (CypA) protein, wherein proposed projects. To request more
AGENCY: National Institutes of Health, the fusion protein binds to the lentivirus information on the proposed projects or
HHS. vector particle, as well as a lentiviral to obtain a copy of the information
ACTION: Notice. vector particle comprising such a fusion collection plans, call the SAMHSA
protein. Gene correction using the Reports Clearance Officer on (240) 276–
SUMMARY: The inventions listed below disclosed lentiviral vector systems are 1243.
are owned by an agency of the U.S. being tested with respect to the beta- Comments are invited on: (a) Whether
Government and are available for globin gene and the BCL11A gene (to the proposed collections of information
licensing in the U.S. to achieve treat sickle-cell disease) and will be are necessary for the proper
expeditious commercialization of used for induced pluripotent stem cell performance of the functions of the
results of federally-funded research and (iPS) generation. agency, including whether the
development. information shall have practical utility;
Potential Commercial Applications: (b) the accuracy of the agency’s estimate
FOR FURTHER INFORMATION CONTACT:
Licensing information may be obtained • Sickle cell disease of the burden of the proposed collection
by emailing the indicated licensing • gene therapy of information; (c) ways to enhance the
contact at the National Heart, Lung, and quality, utility, and clarity of the
Blood, Office of Technology Transfer Development Stage: information to be collected; and (d)
and Development Office of Technology • Early stage ways to minimize the burden of the
Transfer, 31 Center Drive Room 4A29, collection of information on
MSC2479, Bethesda, MD 20892–2479; Inventors: Naoya Uchida, Juan J. Haro respondents, including through the use
telephone: 301–402–5579. A signed Mora, John F. Tisdale (all of NHLBI) of automated collection techniques or
Confidential Disclosure Agreement may Relevant Publications: Demirci et al., other forms of information technology.
be required to receive any unpublished Cytotherapy. 2018 Jul;20(7):899–910. Proposed Project: Technology Transfer
information. doi: 10.1016/j.jcyt.2018.04.003. Epub Centers (TTC) Network Program
SUPPLEMENTARY INFORMATION: 2018 May 30. Monitoring—NEW
Technology description follows. Intellectual Property: HHS Reference The Substance Abuse and Mental
Lentiviral Protein Delivery System for No. E–165–2015; U.S Provisional Patent Health Administration’s (SAMHSA) will
RNA-Guided Genome Editing Application 62/236,223 filed October 2, monitor program performance of its
Available for licensing and 2015; International Patent Application Technology Transfer Centers (TTCs).
commercial development is an HIV–1- PCT/US2016/054759 filed September The TTCs disseminate current
based lentiviral vector system for gene 30, 2016, U.S. Continuation-in-Part behavioral health and HIV services
correction strategies involving a Application 15/942,673 filed April 2, research from the National Institute on
homologous recombination with a 2018 and European Patent Application Drug Abuse, National Institute on
khammond on DSK30JT082PROD with NOTICES
variation of the CRISPR/Cas9 system. 16782163.6 having an international Alcohol Abuse and Alcoholism,
Other such lentivirus-based vectors filing date of September 30, 2016. National Institute of Mental Health,
encode a guide RNA, which contains a Licensing Contact: Michael Agency for Healthcare Research and
specific sequence that recognizes a Shmilovich, Esq, CLP; 301–435–5019; Quality National Institute of Justice, and
target gene, and a Cas9 endonuclease, shmilovm@mail.nih.gov. other sources, as well as other SAMHSA
which cuts at the specific site. Such programs. To accomplish this, the TTCs
systems are being explored as potential develop and update state-of-the-art,
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![51972 Federal Register / Vol. 83, No. 199 / Monday, October 15, 2018 / Notices
Responses Total annual
Number of Total Hours per
Type of respondent per burden
respondents responses response
respondent hours
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
Responses Total annual
Number of Total Hours per
Type of respondent per burden
respondents responses response
respondent 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
Responses Total annual
Number of Total Hours per
Type of respondent per burden
respondents responses response
respondent 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
Responses
Number
Instruments per Burden hours
respondents respondents
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, DEPARTMENT OF HOMELAND ACTION: Notice.
SAMHSA Reports Clearance Officer, SECURITY
SUMMARY: Comments are requested on
Room 15E57–B, 5600 Fishers Lane,
Federal Emergency Management proposed flood hazard determinations,
Rockville, MD 20852 or email a copy at
Agency which may include additions or
summer.king@samhsa.hhs.gov. Written modifications of any Base Flood
comments should be received by Elevation (BFE), base flood depth,
khammond on DSK30JT082PROD with NOTICES
December 14, 2018. [Docket ID FEMA–2018–0002; Internal
Agency Docket No. FEMA–B–1853]
Special Flood Hazard Area (SFHA)
Summer King, boundary or zone designation, or
Statistician. Proposed Flood Hazard regulatory floodway on the Flood
Determinations Insurance Rate Maps (FIRMs), and
[FR Doc. 2018–22409 Filed 10–12–18; 8:45 am]
where applicable, in the supporting
BILLING CODE 4162–20–P
AGENCY:Federal Emergency Flood Insurance Study (FIS) reports for
Management Agency, DHS. the communities listed in the table
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Document Created: 2018-10-13 10:04:59
Document Modified: 2018-10-13 10:04:59
| 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 51970 |
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