Federal Register / Vol. 74, No. 36 / Wednesday, February 25, 2009 / Notices 8559 

applications and foreign counterparts, to 

NeuroMark, Inc., which has offices in 

Boulder, CO. The patent rights in these 

inventions have been assigned to and/or 

exclusively licensed to the Government 

of the United States of America. 

The prospective exclusive license 

territory may be worldwide, licensees 

will need to address the medical 

usefulness of multi-gene test formats 

should data be developed to support 

such approaches and the term of the 

agreement may be commensurate with 

commercial incentives and public 

health needs. The field of use may be 

limited to: 

FDA approved diagnostic test kits for 

predicting the emergence of suicidal ideation 

subsequent to anti-depressant treatment and 

for screening patients to identify those 

patients more likely to exhibit an increased 

risk of treatment-emergent suicidal ideation 

by assaying for the presence of a genotype in 

the patients which is associated with an 

increased risk of treatment-emergent suicidal 

ideation. 

DATES: Only written comments and/or 

applications for a license which are 

received by the NIH Office of 

Technology Transfer on or before April 

27, 2009 will be considered. 

ADDRESSES: Requests for copies of the 

patent application, inquiries, comments, 

and other materials relating to the 

contemplated exclusive license should 

be directed to: Norbert Pontzer, Senior 

Licensing and Patenting Manager, Office 

of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, MD 

20852–3804; Telephone: (301) 435– 

5502; Facsimile: (301) 402–0220; E-mail: 

pontzern@mail.nih.gov. 

SUPPLEMENTARY INFORMATION: Suicidal 

ideation is an uncommon symptom than 

can emerge during antidepressant 

treatment. The Food and Drug 

Administration (FDA) requires a black 

box warning of worsening depression 

and/or emergence of suicidality (i.e., 

development of suicidal thoughts or 

behavior) for both adult and pediatric 

patients taking antidepressant 

medications. While use of 

antidepressants fell after to the black 

box warning, studies suggest that 

pediatric suicides may actually be 

rising. This has led to concerns that the 

black box warning led to a decrease in 

treatment and resulted in an overall 

increase in suicides. The Sequenced 

Treatment Alternatives for Depression 

(STAR*D) trial at NIH found that 

versions of genes coding for components 

of the brain’s chemical messenger 

system may be linked to suicidal 

thinking associated with antidepressant 

use. If links between genes and suicidal 

thinking are validated under a license, 

depressed individuals at higher risk for 

suicide could benefit from closer 

monitoring, alternative treatments, or 

specialty care while allowing more 

aggressive treatment in individuals 

without the increased risk. 

The prospective exclusive license will 

be royalty bearing and will comply with 

the terms and conditions of 35 U.S.C. 

209 and 37 CFR 404.7. The prospective 

exclusive license may be granted unless 

within sixty (60) days from the date of 

this published notice, the NIH 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 404.7. 

Applications for a license in the field 

of use filed in response to this notice 

will be treated as objections to the grant 

of the contemplated exclusive license. 

Comments and objections submitted to 

this notice will not be made available 

for public inspection and, to the extent 

permitted by law, will not be released 

under the Freedom of Information Act, 

5 U.S.C. 552. 

February 18, 2009. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E9–4053 Filed 2–24–09; 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: Strategic Prevention 

Framework State Incentive Grant (SPF 

SIG) Program (OMB No. 0930–0279) 

Revision 

SAMHSA’s Center for Substance 

Abuse Prevention (CSAP) is responsible 

for the evaluation instruments of the 

Strategic Prevention Framework State 

Incentive Grant (SPF SIG) Program. The 

program is a major national initiative 

designed to: (1) Prevent the onset and 

reduce the progression of substance 

abuse, including childhood and 

underage drinking; (2) reduce substance 

abuse related problems in communities; 

and (3) build prevention capacity and 

infrastructure at the State/territory/tribe 

and community levels. 

Five steps comprise the SPF: 

Step 1: Profile population needs, 

resources, and readiness to address 

needs and gaps. 

Step 2: Mobilize and/or build capacity 

to address needs. 

Step 3: Develop a comprehensive 

strategic plan. 

Step 4: Implement evidence-based 

prevention programs, policies, and 

practices. 

Step 5: Monitor, evaluate, sustain, and 

improve or replace those that fail. 

An evaluation team is currently 

implementing a multi-method, quasiexperimental evaluation of the first two 

SPF SIG cohorts receiving grants in FY 

2004 and FY 2005. This notice invites 

comment on grantee-level, communitylevel, and participant-level data 

collection instruments designed for the 

cross-site evaluation of 16 Cohort 3 

grantees receiving grants in FY 2006 and 

20 Cohort 4 grantees. Since the ultimate 

goal is to fund all eligible jurisdictions, 

there are no control groups at the 

grantee level. The primary evaluation 

objective is to determine the impact of 

SPF SIG on the SAMHSA National 

Outcomes Measures (NOMs). Data 

collected at the grantee, community, 

and participant levels using the three 

instruments will be combined in an 

analysis that investigates the 

relationship, if any, between the SPF 

process and substance use outcomes at 

individual and community levels. The 

instruments will be included in an OMB 

review package submitted immediately 

after the expiration of the comment 

period and are the main focus of this 

announcement. 

Grantee-Level Data Collection 

Two instruments were developed for 

assessing grantee-level effects. Both 

instruments are guides for interviews 

that will be conducted by the grantees’ 

evaluators twice over the life of the SPF 

SIG award. These instruments are 

modified versions of those used in the 

SPF SIG Cohort 1 and 2 Cross-Site 

Evaluation Study (OMB No. 09300279). 

The total burden of the original 

instruments has been reduced by 

deleting several questions and replacing 

the majority of open-ended questions 

with multiple-choice-response 

questions. The Strategic Prevention 

Framework Implementation Interview 

Protocol will be used to assess the 

relationship between SPF 


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8560 Federal Register / Vol. 74, No. 36 / Wednesday, February 25, 2009 / Notices 

implementation and change in the 

NOMs. The Infrastructure Instrument 

will capture data to assess infrastructure 

change and to test the relationship of 

this change to outcomes. 

Prevention infrastructure refers to the 

organizational features of the system 

that delivers prevention services, 

including all procedures related to 

planning, data management systems, 

workforce development, intervention 

implementation, evaluation and 

monitoring, financial management, and 

sustainability. The estimated annual 

burden for grantee-level data collection 

is outlined below: 

GRANTEE LEVEL INSTRUMENT BURDEN ESTIMATE

Survey type Content description Respondent 

Burden per 

respondent 

(hrs.) 

Number of 

respondents 

Number of 

responses per 

respondent 

Total burden 

(hrs.) 

Grantee-Level Instrument (GLI) 

Grantee SPF implementation.SEW activities; SPF activities, including cultural 

competence through all 

5 steps.

Grantee ........ 3 .5 36 2 252 

Grantee Infrastructure ........ Grantee progress over 

time toward implementation of these best practices.

Grantee ........ 1 .25 36 2 90 

Total burden ............... ............................................ ...................... .......................... ........................ ........................ 342 

Average annual 

burden over 4 

Years.

............................................ ...................... .......................... ........................ ........................ 85 .5 

Community-Level Data Collection 

(Revision) 

The Community-Level Instrument is a 

two part, web-based survey for 

capturing information about SPF SIG 

implementation at the subrecipient 

community level. The instrument is a 

modified version of the one in use in the 

SPF SIG Cohorts 1 and 2 Cross-Site 

Evaluation Study (OMB No. 09300279). 

The total burden of the original 

instrument was reduced by deleting 

several questions. 

Part 1 of the instrument focuses on 

the five SPF SIG steps and efforts to 

ensure cultural competency throughout 

the SPF SIG process. Part 2 will capture 

data on the specific intervention(s) 

implemented at the community level, 

including both individual-focused and 

environmental prevention strategies. 

Part 2 is a modular instrument that 

includes separate subforms for each of 

the eight different intervention types. 

This part will be completed for each 

intervention implemented during the 

reporting period, selecting only those 

subforms that apply to the interventions 

being reported. Community partners 

receiving SPF SIG awards will be 

required to complete the entire online 

survey once and enter updates every six 

months, using a secure password 

system. The estimated annual burden 

for community-level data collection is 

displayed in the next table. Note that 

the total burden assumes an average of 

15 community-level subrecipients per 

grantee (a total of 540 respondents), an 

average of three distinct interventions 

implemented by each community, and 

two survey updates per year. 

Additionally, some questions will be 

addressed only once and the responses 

will be used to pre-fill subsequent 

updates. As community partners work 

through the SPF steps, they will report 

only on step-related activities. For 

example, needs assessment activities 

will likely precede monitoring and 

evaluation activities. Thus, respondents 

will answer questions related to needs 

assessment in the first few reports but 

will not need to address monitoring and 

evaluation items until later in the 

implementation process. 

COMMUNITY LEVEL INSTRUMENT BURDEN ESTIMATE

Survey type Content description Respondent 

Burden per 

respondent 

(hrs.) 

Number of 

respondents 

Number of 

responses per 

respondent 

Total burden 

(hrs.) 

Community-Level Instrument (CLI) 

Reporting Period 1 

Part I, 1–20 ........................ Community Contact Information.Grantee ........ 1 .5 36 1 54 

Part I, 21–172 .................... Community SPF Activities Community .. 3 .0 540 1 1,620 

Part II, 1–33 ....................... Prevention Intervention Information.Community .. .67 540 3 1,085 .4 

Part II, 34–138 ................... Intervention Type-Specific 

Information.

Community .. .33 540 3 534 .6 


pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 74, No. 36 / Wednesday, February 25, 2009 / Notices 8561 

COMMUNITY LEVEL INSTRUMENT BURDEN ESTIMATE—Continued 

Survey type Content description Respondent 

Burden per 

respondent 

(hrs.) 

Number of 

respondents 

Number of 

responses per 

respondent 

Total burden 

(hrs.) 

............................................ Community .. .......................... ........................ ........................ 3,240 

CLI Part I Reporting Period 2–4 (Annual Updates) 

Part I, 1–20 ........................ Community Contact Information.Grantee ........ .25 36 3 27 

Part I, 21–172 .................... Community SPF Activities Community .. .75 540 3 1,215 

Community-Level Instrument (CLI) Burden 

CLI Part II Reporting Periods 2–8 (Bi-Annual Updates) 

Part II, 1–33 ....................... Prevention Intervention Information.Community .. .33 540 21 3,742 .2 

Part II, 34–138 ................... Intervention Type-Specific 

Information.

Community .. .17 540 21 1,927 .8 

Total burden and cost: 

Period 2–8.

............................................ Grantee ........ .......................... ........................ ........................ 27 

............................................ Community .. .......................... ........................ ........................ 6,885 

Total burden and cost 

over 8 reporting periods.

............................................ Grantee ........ .......................... ........................ ........................ 81 

............................................ Community .. .......................... ........................ ........................ 10,125 

Average annual burden and cost over 4 

years.

............................................ Grantee ........ .......................... ........................ ........................ 20 .3 

............................................ Community .. .......................... ........................ ........................ 2,531 .3 

Participant-Level Data Collection (New 

Section) 

Participant-level data will be 

collected from all participants in direct 

service programs which last 30 days or 

more. Two instruments will be used for 

this purpose, one for participants aged 

12–17 (youth instrument) and the other 

for participants aged 18 or older (adult 

instrument). The core sections of the 

two instruments will be the CSAP 

NOMs Adult and Youth Programs 

Survey Forms (OMB No. 09300230). 

Local evaluators will have the option of 

selecting one or more additional survey 

items from a standard menu of validated 

questions not included in the NOMs 

Instruments, based on site-specific 

targeted program outcomes. These 

optional questions will be added to the 

NOMs Instruments to create site-specific 

instruments. No site-specific instrument 

created in this fashion will exceed an 

average completion time of 50 minutes. 

The participant-level instruments will 

be administered to each participant at 

program entry, program exit, and six 

months after program exit. The 

following burden estimation is based on 

the assumption that each of the 540 

community subrecipients will serve 50 

participants per year in direct-service 

interventions lasting 30 days or more, 

amounting to 27,000 participants per 

year. 

PARTICIPANT LEVEL INSTRUMENT BURDEN ESTIMATE

Survey type Content description Respondent 

Burden per 

respondent 

(hrs.) 

Number of 

respondents 

Number of 

responses per 

respondent 

Total burden 

(hrs.) 

Participant-Level Instrument (PLI) 

Baseline .............................. ............................................. Participant .... .83 27,000 4 89,640 

Intervention completion ...... ............................................. Participant .... .83 22,500 4 74,700 

Follow-up ............................ ............................................. Participant .... .83 18,900 4 62,748 

Total ............................. ............................................. ...................... 2 .5 68,400 ........................ ........................

Total burden over 

4 Years.

............................................. ...................... .......................... ........................ ........................ 227,088 

Average annual 

burden over 4 

Years.

............................................. ...................... .......................... ........................ ........................ 56,772 


pwalker on PROD1PC71 with NOTICES
8562 Federal Register / Vol. 74, No. 36 / Wednesday, February 25, 2009 / Notices 

Overall SPF-SIG Data Collection 

Across the three instruments, it is 

estimated that the average number of 

annual respondents will be 36 granteelevel directors, 540 community-level 

directors, and 68,400 intervention-level 

participants. The average annual hour 

burden will be 685.2 hours for the 36 

grantee-level directors (19 hours per 

grantee director); 2,531.3 hours for the 

540 community-level directors (4.69 

hours per community director); and 

56,772 hours for 68,400 interventionlevel participants (0.83 hours per 

intervention participant). 

ALL THREE INSTRUMENT BURDEN ESTIMATE

Survey type Respondent 

Burden per 

respondent 

(hrs.) 

Number of 

respondents 

Total burden 

(hrs.) 

GLI ......................................................................................... Grantee .................................. 19.00 36 685 .2 

CLI ......................................................................................... Community ............................ 4.69 540 2531 .3 

PLI .......................................................................................... Participant .............................. .83 68,400 56,772 

Average Annual burden ......................................................... ................................................ ........................ 68,976 59,988 .5 

Total burden over 4 Years ............................................. ................................................ ........................ 275,904 239,954 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent by March 27, 2009 to: SAMHSA 

Desk Officer, Human Resources and 

Housing Branch, Office of Management 

and Budget, New Executive Office 

Building, Room 10235, Washington, DC 

20503; due to potential delays in OMB’s 

receipt and processing of mail sent 

through the U.S. Postal Service, 

respondents are encouraged to submit 

comments by fax to: 202–395–6974. 

Dated: February 19, 2009. 

Elaine Parry, 

Acting Director, Office of Program Services. 

[FR Doc. E9–4012 Filed 2–24–09; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

Agency Information Collection 

Activities: Form I–829, Extension of a 

Currently Approved Information 

Collection; Comment Request 

ACTION: 30-Day Notice of Information 

Collection Under Review: Form I–829, 

Petition by Entrepreneur to Remove 

Conditions; OMB Control No. 1615– 

0045. 

The Department of Homeland 

Security, U.S. Citizenship and 

Immigration Services (USCIS) has 

submitted the following information 

collection request to the Office of 

Management and Budget (OMB) for 

review and clearance in accordance 

with the Paperwork Reduction Act of 

1995. The information collection was 

previously published in the Federal 

Register on December 15, 2008, at 73 FR 

76038, allowing for a 60-day public 

comment period. USCIS did not receive 

any comments for this information 

collection. 

The purpose of this notice is to allow 

an additional 30 days for public 

comments. Comments are encouraged 

and will be accepted until March 27, 

2009. This process is conducted in 

accordance with 5 CFR 1320.10. 

Written comments and/or suggestions 

regarding the item(s) contained in this 

notice, especially regarding the 

estimated public burden and associated 

response time, should be directed to the 

Department of Homeland Security 

(DHS), and to the Office of Information 

and Regulatory Affairs, Office of 

Management and Budget (OMB), USCIS 

Desk Officer. Comments may be 

submitted to: USCIS, Chief, Regulatory 

Management Division, Clearance Office, 

111 Massachusetts Avenue, Suite 3008, 

Washington, DC 20529–2210. 

Comments may also be submitted to 

DHS via facsimile to 202–272–8352 or 

via e-mail at rfs.regs@dhs.gov, and to the 

OMB USCIS Desk Officer via facsimile 

at 202–395–6974 or via e-mail at 

oira_submission@omb.eop.gov. 

When submitting comments by e-mail 

please make sure to add OMB Control 

Number 1615–0045 in the subject box. 

Written comments and suggestions from 

the public and affected agencies should 

address one or more of the following 

four points: 

(1) Evaluate whether the collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information will have practical utility; 

(2) Evaluate the accuracy of the 

agency’s estimate of the burden of the 

collection of information, including the 

validity of the methodology and 

assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

(4) Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques, or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses. 

Overview of This Information 

Collection 

(1) Type of Information Collection: 

Extension of an existing information 

collection. 

(2) Title of the Form/Collection: 

Petition by Entrepreneur to Remove 

Conditions. 

(3) Agency form number, if any, and 

the applicable component of the 

Department of Homeland Security 

sponsoring the collection: Form I–829. 

U.S. Citizenship and Immigration 

Services. 

(4) Affected public who will be asked 

or required to respond, as well as a brief 

abstract: Primary: Individuals and 

households. This form is used by a 

conditional resident alien entrepreneur 

who obtained such status through a 

qualifying investment, to apply to 

remove conditions on his or her 

conditional residence, and on the 

conditional residence for his or her 

spouse and children(s). 

(5) An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to 

respond: 200 responses at 2 hours and 

5 minutes (2.083) per response. 

(6) An estimate of the total public 

burden (in hours) associated with the 

collection: 416 annual burden hours. 

If you have additional comments, 

suggestions, or need a copy of the 

proposed information collection 

instrument with instructions, or 

additional information, please visit the 

USCIS Web site at: http:// 

www.regulations.gov/search/index.jsp. 


pwalker on PROD1PC71 with NOTICES