17964 Federal Register / Vol. 74, No. 74 / Monday, April 20, 2009 / Notices 

Experience Reporting is approved under 

OMB Control No. 0910–0230 through 

April 30, 2009; and IND regulations are 

approved under OMB Control No. 0910– 

0014 through May 31, 2009) and any 

additional burden imposed by this 

proposed collection would be minimal. 

Thus, FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Request for Consideration; Pending 

Application on File 1 1 1 15 15 

Request for Consideration; No Application Pending 1 1 1 50 50 

Pre-Emergency Submissions; Pending Application on File 10 1 10 20 200 

Pre-Emergency Submissions; No Application Pending 3 1 3 75 225 

Manufacturers of an Unapproved 

EUA Product 3 4 12 2 24 

State and Local Public Health Officials; Unapproved EUA Product 30 4 120 2 240 

Total 754 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2.—ESTIMATED RECORDKEEPING ANNUAL BURDEN1

No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

Manufacturers of an Unapproved 

EUA Product 3 4 12 25 300 

State and Local Public Health Officials; Unapproved EUA Product 30 4 120 3 360 

Total 660 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The annual burden estimate for this 

information collection is 1,414 hours. 

The estimated reporting burden for this 

collection is 754 hours and the 

estimated recordkeeping burden is 660 

hours. 

Dated: April 10, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–8922 Filed 4–17–09; 8:45 am] 

BILLING CODE 4160–01–S 

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: Evaluation of Networking 

Suicide Prevention Hotlines (OMB No. 

0930–0274)—Revision 

This project revision includes the 

continuation of two previously 

approved data collection activities 

[Evaluation of Networking Suicide 

Prevention Hotlines Follow-Up 

Assessment (OMB No. 0930–0274) and 

Call Monitoring of National Suicide 

Prevention Lifeline Form (OMB No. 

0930–0275)], and a revision to expand 

the scope of the ongoing evaluation in 

an effort to advance the understanding 

of crisis hotline utilization and its 

impact. The Substance Abuse and 

Mental Health Services 

Administration’s (SAMHSA), Center for 

Mental Health Services (CMHS) funds a 

National Suicide Prevention Lifeline 

Network (NSPL), consisting of two tollfree telephone numbers, that route calls 

from anywhere in the United States to 

a network of local crisis centers. In turn, 

the local centers link callers to local 

emergency, mental health, and social 

service resources. 

The overarching purpose of the 

proposed Evaluation of the Networking 

Suicide Prevention Hotlines—Revision 

is to (1) continue to monitor and ensure 

quality of calls and gather follow-up 

information from the callers themselves, 

(2) expand the number of centers 

participating in order to assess whether 

the two national suicide prevention 

hotline numbers (i.e., 1–800–273–TALK 

and 1–800–SUICIDE) reach similar or 

complimentary populations of at risk 

callers, and, (3) to evaluate additional 

but related activities (e.g., motivational 

interviewing and safety planning) 

recently funded through a new 

cooperative agreement between 


rmajette on PRODPC74 with NOTICES
Federal Register / Vol. 74, No. 74 / Monday, April 20, 2009 / Notices 17965 

SAMHSA and crisis hotline centers in 

the NSPL. In total this effort’s proposed 

evaluation includes six data collection 

activities. 

Clearance is being requested to 

continue the following two previously 

approved data collection activities to 

continue call quality monitoring and 

caller follow-up assessment activities. 

The number of centers proposed to 

participate in these continuing activities 

is sufficient to address the additional 

question related to use of the two 

existing hotline numbers. 

(1) To ensure quality, the vast 

majority of crisis centers conduct on-site 

monitoring of selected calls by 

supervisors or trainers using 

unobtrusive listening devices. To 

monitor the quality of calls and to 

inform the development of training for 

networked crisis centers, the national 

Suicide Prevention Lifeline proposes to 

remotely monitor calls routed to sixteen 

crisis centers during the shifts of 

consenting staff. The procedures are 

anonymous in that neither staff nor 

callers will be identified on the Call 

Monitoring Form. The monitor, a trained 

crisis worker, will code the type of 

problem presented by the caller, the 

elements of a suicide risk assessment 

that are completed by the crisis worker 

as well as what action plan is developed 

with and/or what referral(s) are 

provided to the caller. No centers will 

be identified in the reports. 

During the shifts of consenting crisis 

staff, a recording will inform callers that 

some calls may be monitored for quality 

assurance purposes. Previous 

comparisons of matched centers that did 

and did not play the recordings found 

no difference in hang-up rates before the 

calls were answered or within the first 

15 seconds of the calls. 

The 18 centers to be monitored are 

selected based on the geographic 

region(s) they serve and center call 

volume. A total of 1,320 calls will be 

monitored during year 1 of the proposed 

three year clearance period. 

(2) With input from multiple experts 

in the field of suicide prevention, a 

telephone interview survey was created 

to collect data on follow-up assessments 

from consenting individuals calling the 

Lifeline network. 

During year 1 of the proposed three 

year clearance period, a total of 1,095 

callers will be recruited from 18 of the 

approximately 100 crisis hotline centers 

that participate in the Lifeline network. 

Trained crisis workers will conduct the 

follow-up assessment (‘‘Crisis Hotline 

Telephone Follow-Up Assessment’’) 

within one month of the initial call. 

Assessments will be conducted only one 

time for each client. Strict measures to 

ensure privacy will be followed. 

Telephone scripts provide potential 

participants with standardized 

information to inform their consent 

decision. Using the Crisis Hotline 

Telephone Initial Script, trained crisis 

counselors will ask for permission to 

have the evaluation staff re-contact the 

caller. The Crisis Hotline Telephone 

Consent Script, used at the time of recontact, incorporates the required 

elements of a written consent form, 

The resulting data will measure (a) 

suicide risk status at the time and since 

the call, (b) depressive symptoms at 

follow-up, (c) service utilization since 

the call, (d) barriers to service access, 

and (e) the client’s perception of the 

efficacy of the hotline intervention. 

Clearance is also being requested for 

four new activities are being proposed to 

evaluate the process and impact of 

motivational training and safety 

planning (MI/SP) with callers who have 

expressed suicidal desire. Five centers 

will train counselors to implement an 

intervention with callers during the 

initial call to a center, which 

incorporates aspects of motivational 

interviewing and safety planning (MI/ 

SP) and utilizes an evidence-based 

practice model to provide follow-up to 

callers who have expressed a suicidal 

desire. An assessment of MI/SP fidelity 

and process measures will be 

incorporated into the design through the 

observation of calls via silent 

monitoring and the administration of 

two self-administered questionnaires to 

crisis center counselors. The impact 

assessment of MI/SP counselor training 

will include silent monitoring of calls 

and follow-up telephone interviews 

with callers to assess their emotions and 

behaviors following their interaction 

with the MI/SP trained counselor. 

(1) Research monitors, trained crisis 

counselors not affiliated with the 

centers in the project, will access a 

remote ‘‘real-time’’ monitoring system 

through the Internet to conduct silent 

monitoring. Monitors will complete the 

‘‘MI/SP Silent Monitoring Form,’’ to 

gather: (a) Call specifics for each call 

such as date, time, and length; (b) 

suicide risk status of the caller; (c) 

information on elements of safety 

planning, such as making the 

environment safe and identifying 

triggers that led to the caller’s 

suicidality; (d) types of referrals the 

counselor gave and to what services; (e) 

ratings of counselor behaviors and caller 

behavioral changes that occurred; and 

(f) re-contact permission status. At the 

end of the call and once the counselor 

deems the intervention to be complete, 

counselors will ask all appropriate 

callers, using the MI/SP Caller Initial 

Script, for permission to be re-contacted 

by research staff for a follow-up 

interview. Only a caller whose call has 

been silently monitored is eligible to be 

followed by the research team; thus, 

counselors will state that the caller may 

be contacted by the research team if 

randomly selected for a follow-up call. 

A total of 1110 calls will be monitored 

across the 3-year data collection period. 

Prior to monitoring and collecting of the 

data, crisis counselors must have read 

and signed a MI/SP Counselor Consent. 

This form explains the purpose of the 

research, privacy, risks and benefits, 

what the study entails, and participant 

rights. 

(2) The ‘‘MI/SP Counselor Attitude 

Questionnaire’’ attitude questionnaire 

will be administered to counselors at 

the conclusion of their MI/SP training 

and be used as a possible predictor of 

fidelity of the MI//SP intervention. 

Information to be gathered includes (a) 

counselors’ views of the applicability of 

the MI/SP for preparing them to conduct 

safety planning and follow up with 

callers; (b) possible anticipated 

challenges (i.e., impeding factors) to 

applying the MI/SP training in their 

centers; (c) the relationship of the MI/ 

SP model to their centers; (d) the extent 

to which trainees are provided with or 

obtain adequate resources to enable 

them to use MI/SP on the job; (h) 

impeding and facilitating factors; and 

(9) attitudes about counselors’ selfefficacy to use MI/SP and views on its 

utility. It is expected that a total of 225 

counselors will be trained over the 

course of 3 years in an effort to maintain 

175 counselors at any given time. Thus, 

a total of 225 counselors are expected to 

complete this questionnaire during the 

3-year data collection period. 

(3) Counselors will be asked to 

complete the ‘‘MI/SP Counselor Followup Questionnaire’’ for each call that is 

monitored. The questionnaire will 

incorporate an assessment of the 

outreach, telephonic follow up and/or 

other strategies that the center has 

proposed to implement, and whether 

the counselor was able to implement the 

center’s site plan as originally 

conceived. The questionnaire will also 

include items on the demographic 

characteristics of the caller, whether 

contact was successfully made with the 

caller, whether the caller followed 

through with the safety plan and/or 

referral given by the counselor, whether 

MI/SP was re-implemented during the 

follow-up contact, whether another 

follow-up is scheduled, the educational 

and crisis experience of the person 

attempting re-contact with the caller, 

and that person’s prior experience with 


rmajette on PRODPC74 with NOTICES
17966 Federal Register / Vol. 74, No. 74 / Monday, April 20, 2009 / Notices 

follow-up. Barriers to implementing the 

follow-up, as well as types of deviation 

from the site’s follow-up plan will also 

be assessed. Open-ended questions 

about what led to deviations from the 

site’s follow-up plan will also be 

included. In total, it is expected that 

counselors will complete the 

questionnaire for each of the calls that 

were monitored. 

(4) Researchers will begin conducting 

follow-up interviews with callers 

approximately 6 weeks after the initial 

call to the center. This follow-up 

telephone interview (‘‘MI/SP Caller 

Follow-up Interview’’) will be conducted 

to collect information on demographic 

characteristics, gather caller feedback on 

the initial call made to the center, 

suicide risk status at the time of and 

since the call, current depressive 

symptomatology, follow through with 

the safety plan and referrals made by the 

crisis counselor, and barriers to service. 

Taking into account attrition and the 

number of callers who do not give 

consent, it is expected that the total 

number of follow-up interviews 

conducted by the research team will not 

exceed 885. The MI/SP Caller Initial 

Script protects the privacy of callers by 

asking the caller how and when they 

want to be contacted, and what type of 

message (if any) can be left on an 

answering machine or with the person 

picking up the telephone. The caller 

also has the option of not providing 

contact information to the crisis center 

if he/she prefers to call the evaluation 

team back directly. The telephone script 

used when the evaluation team contacts 

the participant for their follow-up 

interview (MI/SP Caller Follow-up 

Consent Script, see Attachment H) 

includes (1) the fact that the information 

collection is sponsored by an agency of 

the Federal Government, (2) the purpose 

of the information collection and the 

uses which will be made of the results, 

(3) the voluntary nature of participation, 

and (4) the extent to which responses 

will be held confidential. 

The estimated response burden to 

collect this information is as follows 

annualized over the requested three year 

clearance period is presented below: 

TOTAL AND ANNUALIZED AVERAGES: RESPONDENTS, RESPONSES AND HOURS

Instrument Number of 

respondents 

Number of 

responses per 

respondent* 

Hours/ 

response 

Response 

burden* 

National Suicide Prevention Lifeline—Call Monitoring Form ........................... 10 44 .58 249 

Crisis Hotline Telephone Initial Script .............................................................. 365 1 .08 29 

Crisis Hotline Telephone Consent Script ......................................................... 365 1 .17 62 

Crisis Hotline Telephone Follow-up Assessment ............................................ 365 1 .67 245 

MI/SP Silent Monitoring Form .......................................................................... 10 37 .58 214 

MI/SP Caller Initial Script ................................................................................. 368 1 .08 29 

MI/SP Caller Follow-up Consent Script ........................................................... 368 1 .17 63 

MI/SP Caller Follow-up Interview .................................................................... 295 1 .67 198 

MI/SP Counselor Consent ............................................................................... 75 1 .08 6 

MI/SP Counselor Attitudes Questionnaire ....................................................... 75 1 .25 19 

MI/SP Counselor Follow-up Questionnaire ..................................................... 175 2 .17 89 

Total .......................................................................................................... 2,471 ........................ ........................ 1,181 

* Rounded to the nearest whole number. 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent by May 20, 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: April 13, 2009. 

Elaine Parry, 

Director, Office of Program Services. 

[FR Doc. E9–8974 Filed 4–17–09; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Criteria for Vaccination Requirements 

for U.S. Immigration Purposes 

[Correction] 

A notice ‘‘Criteria for Vaccination 

Requirements for U.S. Immigration 

Purposes’’ was published in the Federal 

Register on April 8, 2009 (74 FR 15986). 

This notice is corrected as follows: On 

page 15986 second column, under 

DATES, second sentence should read: 

Comments received after May 8, 2009, 

will be considered to the extent 

possible. 

Dated: April 13, 2009. 

James D. Seligman, 

Chief Information Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. E9–8981 Filed 4–17–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Mental Health; 

Notice of Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the 

Interagency Autism Coordinating 

Committee. 

The meeting will be open to the 

public, with attendance limited to space 

availability, and will be accessible by 

videocast. Individuals who plan to 

attend and need special assistance, such 

as sign language interpretation or other 

reasonable accommodations, should 

inform the Contact Person listed below 

at least 5 business days in advance of 

the meeting. 

Name of Committee: Interagency Autism 

Coordinating Committee (IACC). 

Date: May 4, 2009. 

Time: 9 a.m. to 4 p.m. 


rmajette on PRODPC74 with NOTICES