65698 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Notices 

2016–0–CA–05]; Mexican Patent 

Application Number MX/A/2018/ 

010958 filed March 11, 2017 and 

entitled ‘‘Live Attenuated Zika Virus 

Vaccines,’’ [HHS Reference No. E–118– 

2016–0–MX–12]; Brazilian Patent 

Application Number 1120180683426 

filed September 11, 2018 and entitled 

‘‘Live Attenuated Zika Virus Vaccines,’’ 

[HHS Reference No. E–118–2016–0–BR– 

04]; Colombian Patent Application 

Number NC2018/0010874 filed March 

11, 2017 and entitled ‘‘Live Attenuated 

Zika Virus Vaccines,’’ [HHS Reference 

No. E–118–2016–0–CO–07]; and U.S. 

and foreign patent applications claiming 

priority to the aforementioned 

applications. 

The patent rights in this invention 

have been assigned to the Government 

of the United States of America. 

The prospective exclusive licensed 

territory may be limited to the United 

States of America, Canada, Mexico, 

Brazil and Colombia, and the field of 

use may be limited to: ‘‘Monovalent live 

attenuated Zika vaccines and 

multivalent live attenuated flavivirus 

vaccines.’’ 

Zika virus (ZIKV) is an emerging 

infectious disease that was first 

identified in 1947, and that has more 

recently become a major public health 

threat around the world. ZIKV has 

recently been shown to cause 

devastating neurological damage in 

infants and serious complications in 

adults in some cases, and may have 

other effects that have not yet been 

identified or definitively linked to the 

virus. There are no treatments or 

vaccines for this insidious virus. 

Recommendations that women who live 

in or travel to endemic areas avoid 

pregnancy for long periods of time are 

unrealistic, particularly in contexts 

where access to reproductive services is 

limited, and threaten to leave those 

most likely to suffer the devastating 

consequences of Zika without effective 

protection. There is therefore urgent 

need to develop biomedical 

interventions in parallel with ongoing 

public health efforts against ZIKV. 

No vaccine exists today to prevent 

ZIKV infections. The methods and 

compositions of this invention provide 

a means for prevention of ZIKV 

infection by immunization with live 

attenuated, immunogenic viral vaccines 

against ZIKV and/or Dengue virus. 

Many entities, governmental, 

academic, and commercial, are actively 

pursuing development of ZIKV vaccines 

each using a different approach to 

address this public health need. The 

U.S. Government is coordinating its 

vaccine development response to ZIKV 

and has published this plan at https:// 

www.phe.gov/Preparedness/planning/ 

Pages/zika-white-paper.aspx. 

Vaccine development approaches for 

ZIKV include but are not limited to 

inactivated virus (dead virus), live 

attenuated virus (weakened virus), 

recombinant viral vectors (weakened 

virus with target genes added), and 

subunit (portion of a virus) as well as 

mRNA- and DNA-based (gene-targeted). 

These various strategies provide 

multiple redundancies, expanded 

choice, and ensure short and long term 

maximal benefits to the public. 

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 

Institute of Allergy and Infectious 

Diseases receives written evidence and 

argument that establishes that the grant 

of the licenses would not be consistent 

with the requirements of 35 U.S.C. 209 

and 37 CFR part 404. 

Complete applications for a license in 

the prospective field of use that are 

timely filed in response to this notice 

will be treated as objections to the grant 

of the contemplated exclusive patent 

commercialization license. 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 in 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: December 11, 2018. 

Suzanne M. Frisbie, 

Deputy Director, Technology Transfer and 

Intellectual Property Office, National Institute 

of Allergy and Infectious Diseases. 

[FR Doc. 2018–27673 Filed 12–20–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) will publish a summary of 

information collection requests under 

OMB review, in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

documents, call the SAMHSA Reports 

Clearance Officer on (240) 276–1243. 

Project: 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, 

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 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Notices 65699 

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. 

Type of respondent Number of 

respondents 

Responses per 

respondent 

Total 

responses 

Hours per 

response 

Total annual 

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) 

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 

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 


amozie on DSK3GDR082PROD with NOTICES1
65700 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Notices 

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 

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

Instruments Number of 

respondents 

Responses per 

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 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent by January 22, 2019 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. 2018–27634 Filed 12–20–18; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Center for Substance Abuse 

Treatment; Notice of Meeting 

Pursuant to Public Law 92–463, 

notice is hereby given that the 

Substance Abuse and Mental Health 

Services Administration’s (SAMHSA) 

Center for Substance Abuse Treatment 

(CSAT) National Advisory Council 

(NAC) will meet on February 27, 2019, 

9:00 a.m.–5:00 p.m. (EDT). 

The meeting is open and will include 

consideration of minutes from the 

SAMHSA CSAT NAC meeting of August 

1, 2018; the Director’s Report; updates 

from the Division Directors; a budget 

update; discussions on recovery 

housing; discussions with SAMHSA 

leadership; and discussions expanding 

access to Medication-Assisted 

Treatment. 

The meeting will be held at SAMHSA, 

5600 Fishers Lane, Room 5N54, 

Rockville, MD 20857. Attendance by the 

public will be limited to space available 

and will be limited to the open sessions 

of the meeting. Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the Council. Written submissions 

should be forwarded to the contact 

person on or before February 1, 2019. 

Oral presentations from the public will 

be scheduled at the conclusion of the 

meeting. Individuals interested in 

making oral presentations must notify 

the contact person on or before February 

1, 2019. Five minutes will be allotted for 

each presentation. 

The open meeting session may be 

accessed via telephone. To attend on 

site, or to obtain the call-in number and 

access code, submit written or brief oral 

comments, or request special 

accommodations for persons with 

disabilities, please register on-line at 

http://nac.samhsa.gov/Registration/ 

meetingsRegistration.aspx, or 

communicate with the CSAT National 

Advisory Council Designated Federal 

Officer; Tracy Goss (see contact 

information below). 

Meeting information and a roster of 

Council members may be obtained by 

accessing the SAMHSA Committee 

website at http://www.samhsa.gov/ 

about-us/advisory-councils/csatVerDate Sep<11>2014 00:00 Dec 21, 2018 Jkt 247001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\21DEN1.SGM 21DEN1

amozie on DSK3GDR082PROD with NOTICES1