Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Notices 51283 

The regulations contain information 

collection requirements. The Act 

authorizes funds to support activities on 

behalf of individuals with significant 

(severe) mental illness (adults) or 

emotional impairment (children/youth) 

[42 U.S.C. 10802(4)]. Only entities that 

are designated by the governor of each 

State, the five (5) territories (American 

Samoa, Guam, the Northern Mariana 

Islands, Puerto Rico, and the U.S. Virgin 

Islands), the American Indian 

Consortium (the Hopi and Navajo 

Nations in the Southwest), and the 

Mayor of the District of Columbia to 

protect and advocate the rights of 

persons with developmental disabilities 

under Title I, Subtitle C—Protection and 

Advocacy of Individual Rights, the 

Developmental Disabilities Assistance 

and Bill of Rights Act of 2000 (42 U.S.C. 

150041 et seq.) are eligible to receive 

PAIMI Program grants [42 U.S.C. at 

10802(2)]. These grants are based on a 

formula prescribed by the Secretary at 

42 U.S.C. at 10822(a)(1)(A). 

On January 1, each eligible State 

protection and advocacy (P&A) system 

is required to prepare a report that 

describes its activities, 

accomplishments, and expenditures to 

protect the rights of individuals with 

mental illness supported with payments 

from PAIMI Program allotments during 

the most recently completed fiscal year. 

The PAIMI Act at 42 U.S.C. 10824(a) 

requires that each P&A system transmit 

a copy of its annual report to the 

Secretary (via SAMHSA/CMHS) and to 

the State Mental Health Agency where 

the system is located. These annual 

PAIMI Program Performance Reports 

(PPR) to the Secretary must include the 

following information: 

• The number of (PAIMI-eligible) 

individuals with mental illness served; 

• A description of the types of 

activities undertaken; 

• A description of the types of 

facilities providing care or treatment to 

which such activities are undertaken; 

• A description of the manner in 

which the activities are initiated; 

• A description of the 

accomplishments resulting from such 

activities; 

• A description of systems to protect 

and advocate the rights of individuals 

with mental illness supported with 

payments from PAIMI Program 

allotments; 

• A description of activities 

conducted by States to protect and 

advocate such rights; 

• A description of mechanisms 

established by residential facilities for 

individuals with mental illness to 

protect such rights; and 

• A description of the coordination 

among such systems, activities and 

mechanisms; 

• Specification of the number of 

systems that are public and nonprofit 

systems established with PAIMI 

Program allotments; 

• Recommendations for activities and 

services to improve the protection and 

advocacy of the rights of individuals 

with mental illness and a description of 

the need for such activities and services 

that were not met by the State P&A 

systems established under the PAIMI 

Act due to resource or annual program 

priority limitations. 

** [The PAIMI Rules at 42 CFR Part 

51 at section 51.32(b), state that P&A 

systems may place restrictions on case 

or client acceptance criteria developed 

as part of its annual PAIMI priorities. 

Each P&A system is required to inform 

prospective clients of any such 

restrictions when he/she requests a 

service]. 

This PAIMI PPR summary must 

include a separate section, prepared by 

the PAIMI Advisory Council (PAC) that 

describes the council’s activities and its 

assessment of the operations of the State 

P&A system at 42 U.S.C. 10805(7). 

The burden estimate for the annual 

State P&A system reporting 

requirements for these regulations is as 

follows: 

42 CFR citation Number of 

respondents 

Responses 

per 

respondent 

Burden per 

response 

(hrs.) 

Total annual 

burden 

51.(8)(a)(2) Program Performance Report ...................................................... 57 1 26.0 1 1,482 

51.8(8)(a)(8) Advisory Council Report ............................................................. 57 1 10.0 1 570 

51.10 Remedial Actions.

Corrective Action Plans Implementation Status Report ........................... 6 

6 

1 

3 

8.0 

2.0 

56 

42 

51.23(c) Reports, materials and fiscal data provided to the PAC ................... 57 1 1.0 57 

51.25(b)(2) Grievance Procedures .................................................................. 57 1 .5 29 

Total ................................................................................................... 126 ........................ ........................ 184 

1Burden hours associated with these reports are approved under OMB Control No. 0930–0169. 

Send comments to Summer King, 

SAMHSA Reports Clearance Officer, 

Room 7–1044, One Choke Cherry Road, 

Rockville, MD 20857 and e-mail her a 

copy at summer.king@samhsa.hhs.gov. 

Written comments should be received 

within 60 days of this notice. 

Dated: September 28, 2009. 

Elaine Parry, 

Director, Office of Program Services. 

[FR Doc. E9–24019 Filed 10–5–09; 8:45 am] 

BILLING CODE 4162–20–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) 


jlentini on DSKJ8SOYB1PROD with NOTICES
51284 Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Notices 

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. 

Project: Addiction Technology Transfer 

Centers (ATTC) Network Program 

Monitoring (OMB No. 0930–0216)— 

Revision 

The Substance Abuse and Mental 

Health Administration’s (SAMHSA) 

Center for Substance Abuse Treatment 

(CSAT) will continue to monitor 

program performance of its Addiction 

Technology Transfer Centers (ATTCs). 

The ATTCs disseminate current health 

services research from the National 

Institute on Drug Abuse, National 

Institute on Alcohol Abuse and 

Alcoholism, National Institute of Mental 

Health, Agency for Health Care Policy 

and Research, National Institute of 

Justice, and other sources, as well as 

other SAMHSA programs. To 

accomplish this, the ATTCs develop 

and update State-of-the-art, researchbased curricula and professional 

development training. 

Each of the forms is described below. 

SAMHSA/CSAT is proposing to revise 

the Event Description and Post-Event 

forms currently used by the ATTCs. The 

Follow-Up forms will not be changed. 

The Pre-Events forms currently in use 

will be eliminated. 

Sixty percent of the forms are 

administered in person to participants 

at educational and training events, who 

complete the forms by paper and pencil. 

Ten percent of the training courses are 

online, and thus, those forms are 

administered online. The remaining 

thirty percent is made up of 30-day 

follow-up forms that are distributed to 

consenting participants via electronic 

mail using an online survey tool. 

(1) The Event Description Form will 

be revised. The form collects event 

information. It includes questions 

regarding the SAMHSA priority areas 

and cross-cutting principles covered by 

the content of the event. SAMHSA’s 

priority areas and cross-cutting 

principles have been revised since this 

form was approved, so the form will be 

revised to match the updated priorities 

and principles. In addition, the Event 

Description Form asks which of 

SAMHSA’s Technical Assistance 

Publications (TAPs) and Treatment 

Improvement Protocols (TIPs) were used 

during the event. New TIPs and TAPs 

have been published since the form was 

approved. Those new TIPs and TAPs 

will be added to the form. 

(2) The Pre-Event Form for meetings, 

technical assistance events, and training 

events will be eliminated. The 

demographic information that was 

collected on this form will be added to 

the Post-Event Forms. By incorporating 

this demographic information on the 

Post-Event Forms, the Pre-Event Form 

can be eliminated, thereby reducing the 

response burden for participants. 

(3) The Post-Event Form for all events 

will be revised. The five current 

demographic questions will be revised 

to reflect a more current understanding 

of the field, and five additional 

demographic questions will be 

included. 

(4) The Follow-Up Form for all events 

will remain the same as the ones 

currently in use by the ATTCs. 

Event Description: The event 

description form asks approximately 10 

questions of the ATTC faculty/staff for 

each of the ATTC events. The approved 

form asks the event focus, format, and 

publications to be used in the event. As 

noted above, it will be revised to reflect 

updates to SAMHSA’s priority areas and 

cross-cutting principles and the 

publication of new TIPs and TAPs. 

Technical Assistance and Meeting 

Events Forms 

The ATTCs provide technical 

assistance, which is a jointly planned 

consultation generally involving a series 

of contacts between the ATTC and an 

outside organization/institution during 

which the ATTC provides expertise and 

gives direction toward resolving a 

problem or improving conditions. The 

ATTCs hold meetings, which are ATTC 

sponsored or co-sponsored events in 

which a group of people representing 

one or more agencies other than the 

ATTC work cooperatively on a project, 

problem, and/or a policy. The ATTCs 

will collect satisfaction measures after 

each technical assistance and meeting 

event. The ATTCs will base the PostEvent Form on the approved CSAT 

Government Performance and Results 

Act (GPRA) Customer Satisfaction form 

(OMB #0930–0197). The only revision 

to this GPRA form will be that the 

ATTCs will revise the five current 

demographic questions asked on this 

form and include five additional 

demographic questions. The ATTCs will 

collect satisfaction measures 30 days 

after each event by using the approved 

CSAT Government Performance and 

Results Act (GPRA) Customer 

Satisfaction form (OMB #0930–0197). 

The ATTCs are eliminating the 

Technical Assistance and Meeting PreEvent Forms currently in use. 

Post-Event Form for Technical 

Assistance and Meetings: The PostEvent Information form for technical 

assistance and meetings asks 

approximately 25 questions of each 

individual that participated in the 

event. The current form asks the 

participants to report satisfaction with 

the quality of the event and event 

materials, and to assess their level of 

skills in the topic area. The five current 

demographic questions on the form will 

be revised to reflect a more current 

understanding of the field, and five 

additional demographic questions will 

be included. The form will ask 

participants to report demographic 

information, education, profession, field 

of study, status of certification or 

licensure, workplace role, and 

employment setting. 

30-Day Follow-Up Form for Technical 

Assistance and Meetings: The Followup Information Form for technical 

assistance and meetings asks about 20 

questions of about 25% of consenting 

participants. The approved form asks 

the participants to report satisfaction 

with the quality of the event materials, 

to assess their level of skills in the topic 

area, and to report whether or not they 

have shared information from the event 

at their place of work. This form is 

already approved by OMB and will not 

be revised (OMB #0930–0197). 

Training Forms 

Trainings are defined as ATTC 

sponsored or co-sponsored events, 

mainly focusing on the enhancement of 

knowledge and/or skills of counselors 

and other professionals who work with 

individuals with substance use 

disorder-related problems. The ATTCs 

will collect information from training 

participants at the end of the training 

event by using a revised version of the 

currently approved Post-Event Form for 

training. The current approval for this 

form is under OMB #0930–0216. The 

only revision to this Post-Event Form 

will be that the ATTCs will revise the 

five current demographic questions 

asked and include five additional 

demographic questions. The ATTCs will 

collect information from training 

participants 30 days after the training 

event by using the same form currently 

approved for this purpose under OMB 

#0930–0216. The Pre-Event Form for 

training will be eliminated. 

Post-Event Form for Training: The 

Post- Form for Training asks 

approximately 25 questions of each 

individual that participated in the 

training. The approved form asks the 

participants to report satisfaction with, 

usefulness of, and quality of the training 

and training materials as well as to 

assess their level of skills in the topic 

area. The five current demographic 

questions on the form will be revised to 

reflect a more current understanding of 

the field, and five additional 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Notices 51285 

demographic questions will be 

included. The form will ask participants 

to report demographic information, 

education, profession, field of study, 

status of certification or licensure, 

workplace role, and employment 

setting. 

Follow-up Form for Training: The 

Follow-up Information Form for 

Training asks about 25 questions of 

about 25% of consenting participants. 

The approved form asks the participants 

to report satisfaction with, usefulness of, 

and quality of the training and training 

materials as well as to assess their level 

of skills in the topic area. The form also 

asks participants to report whether or 

not they have shared information from 

the event at their place of work and 

which, if any, barriers they have 

encountered to applying the information 

gained from the training. This form is 

already approved by OMB and will not 

be revised (OMB #0930–0216). 

The information collected on the 

ATTC forms will assist CSAT in 

documenting the numbers and types of 

participants in ATTC events, describing 

the extent to which participants report 

improvement in their clinical 

competency, and which method is most 

effective in disseminating knowledge to 

various audiences. This type of 

information is crucial to support CSAT 

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 

Hours per 

response 

Total annual 

burden hours 

Faculty/staff Event Description Form ............................................................... 250 1 .25 62.50 

Meeting and Technical Assistance Participants: 

Post-Event Form ....................................................................................... 5,000 1 .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 .16 4,800 

Follow-up Form ......................................................................................... 7,500 1 .16 1,200 

Total ................................................................................................... 42,750 6,662.50 

Send comments to Summer King, 

SAMHSA Reports Clearance Officer, 

Room 7–1044, One Choke Cherry Road, 

Rockville, MD 20857 and e-mail her a 

copy at summer.king@samhsa.hhs.gov. 

Written comments should be received 

within 60 days of this notice. 

Dated: September 28, 2009. 

Elaine Parry, 

Director, Office of Program Services. 

[FR Doc. E9–24017 Filed 10–5–09; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0163] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Draft Guidance, 

Emergency Use Authorization of 

Medical Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by November 

5, 2009. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB Control Number 0910–0595. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794, 

JonnaLynn.Capezzuto@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Draft Guidance, Emergency Use 

Authorization of Medical Products— 

(OMB Control Number 0910–0595)— 

Extension 

The draft guidance describes the 

agency’s general recommendations and 

procedures for issuance of emergency 

use authorizations (EUA) under section 

564 of the Federal Food, Drug, and 

Cosmetic Act (the act) (21 U.S.C. 

360bbb–3), which was amended by the 

Project BioShield Act of 2004 (Pub. L. 

108–276). The act permits the FDA 

Commissioner (the Commissioner) to 

authorize the use of unapproved 

medical products or unapproved uses of 

approved medical products during an 

emergency declared under section 564 

of the act. The data to support issuance 

of an EUA must demonstrate that, based 

on the totality of the scientific evidence 

available to the Commissioner, 

including data from adequate and wellcontrolled clinical trials (if available), it 

is reasonable to believe that the product 

may be effective in diagnosing, treating, 

or preventing a serious or lifethreatening disease or condition (21 

U.S.C. 360bbb–3(c)). Although the exact 

type and amount of data needed to 

support an EUA may vary depending on 

the nature of the declared emergency 

and the nature of the candidate product, 

FDA recommends that a request for 

consideration for an EUA include 

scientific evidence evaluating the 

product’s safety and effectiveness, 

including the adverse event profile for 

diagnosis, treatment, or prevention of 

the serious or life-threatening disease or 

condition, as well as data and other 

information on safety, effectiveness, 

risks and benefits, and (to the extent 

available) alternatives. 

Under section 564 of the act, the FDA 

Commissioner may establish conditions 

on the approval of an EUA. Section 

564(e) requires the FDA Commissioner 

(to the extent practicable given the 


jlentini on DSKJ8SOYB1PROD with NOTICES