Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Notices 32621 

Name of Committee: Advisory 

Committee for Pharmaceutical Science 

and Clinical Pharmacology. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held August 5, 2009, from 8 a.m. to 5 

p.m. 

Location: Hilton Washington DC/ 

Silver Spring, The Ballrooms, 8727 

Colesville Rd., Silver Spring, MD. The 

hotel telephone number is 301–589– 

5200. 

Contact Person: Paul Tran, Center for 

Drug Evaluation and Research (HFD– 

21), Food and Drug Administration, 

5600 Fishers Lane (for express delivery, 

5630 Fishers Lane, rm. 1093), Rockville, 

MD 20857, 301–827–7001, FAX: 301– 

827–6776, e-mail: 

paul.tran@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572) in the 

Washington, DC area), code 

3014512539. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: The committee will: (1) 

Receive a status update from the Office 

of Generic Drugs (OGD) on 

bioequivalence for highly variable drugs 

(highly variable means that the rate and 

amount of the drug entering blood 

varies significantly from one 

administration to another); (2) receive 

presentations from the Office of 

Pharmaceutical Science (OPS) on the 

scientific and regulatory challenges of 

Transdermal Drug Delivery Systems 

(TDDS); (3) receive presentations from 

OPS and discuss current thinking on 

‘‘Classifying Pre-Surgical Preparations 

as Sterile Products’’ in consideration of 

how these products are used; and (4) be 

updated by OPS on the current status of 

the International Conference on 

Harmonization (ICH) Quality Topics 

[i.e., those relating to chemical and 

pharmaceutical quality assurance 

(stability testing, impurity testing, etc.)], 

and outline the role of the ICH 

Implementation Work Group (Q IWG), 

its future activities, and any remaining 

gaps and challenges. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm, click on the year 2009 and 

scroll down to the appropriate advisory 

committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before July 21, 2009. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. Those desiring to make 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before July 13, 2009. Time allotted for 

each presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by July 14, 2009. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Paul Tran at 

least 7 days in advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: June 29, 2009. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E9–16136 Filed 7–7–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Office of Clinical and Preventive 

Services; Division of Behavioral 

Health; the Methamphetamine & 

Suicide Prevention Initiative for 

American Indian and Alaska Native 

Urban Programs 

Announcement Type: New. 

Funding Announcement Number: 

HHS–2009–IHS–METHU–0002. 

Catalog of Federal Domestic 

Assistance Number(s): 93.933. 

Key Dates: Application Deadline Date: 

July 31, 2009. 

Review Date: August 6–7, 2009. 

Earliest Anticipated Start Date: 

August 14, 2009. 

Table of Contents 

I. Funding Opportunity 

II. Award Information 

III. Eligibility 

IV. Application & Submission Information 

V. Application Review Information 

VI. Award Administration Information 

VII. Agency Contacts 

VIII. Other Information 

I. Funding Opportunity Description 

The Indian Health Service (IHS) 

announces competitive grant 

applications for the Methamphetamine 

& Suicide Prevention Initiative (MSPI) 

for American Indian and Alaska Native 

(AI/AN) Urban Program communities. 

This program is authorized under the 

Snyder Act, 25 U.S.C. 13, and 25 U.S.C. 

1602(a)(b)(9)(11)(12) of the Indian 

Health Care Improvement Act (IHCIA), 

as amended. This program is described 

at 93.933 in the Catalog of Federal 

Domestic Assistance. The purpose of the 

MSPI–U is to expand community-level 

access to effective, Urban AI/AN 

methamphetamine and/or suicide 

prevention and treatment programs. 

Resources will enhance evidence-based 

or practice-based methamphetamine 

and/or suicide prevention or treatment 

programs and/or community 

mobilization programs. The 

methamphetamine and suicide 

prevention or treatment funding will be 

used to: 

• Provide community-focused 

responses that enhance evidence-based 

or practice based methamphetamine 

and/or suicide prevention or treatment 

services or education programming; 

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32622 Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Notices 

• Coordinate services for 

communities to respond to their local 

methamphetamine and/or suicide 

crises; 

• Participate in a nationally 

coordinated program focusing 

specifically on increasing access to 

methamphetamine and/or suicide 

prevention or treatment related 

activities among the Federal partners, 

Areas, Tribes, States, and academic or 

not-for-profit programs; 

• Provide communities with needed 

resources to develop their own 

community-focused programs with 

preference for coordinated programming 

that maximizes the impact across 

communities and Tribal groups; 

• Establish baseline data information 

related to methamphetamine abuse/ 

suicides in the local communities; 

• Adequately document the level of 

need for the community; and 

• Promote programs that will ensure 

measureable impact. 

Awardees’ activities for this program 

are as follows: 

• Develop a three (3) year action plan. 

Applicants must document how their 

methamphetamine and/or suicide 

prevention or treatment activities will 

be implemented as soon as possible but 

no later than six (6) months after award. 

The remainder of Year One, Year Two, 

and Year Three will focus on 

implementation. The primary intent of 

the action plan should be to illustrate 

how the applicant will enhance 

community access to or support 

community delivery of evidence-based 

or practice-based methamphetamine 

and/or suicide prevention or treatment 

services. The action plan should 

describe the project implementation 

process. The action plan should include 

objectives that are specific, measurable, 

achievable, relevant, and time-phased. 

Objectives should demonstrate 

adherence to the Government 

Performance and Results Act of 1993 

(GPRA), where applicable. The 

implementation process may be guided 

by a community action organization, 

collaboration, or a group of partners to 

plan and implement a community-wide 

methamphetamine and/or suicide 

prevention or treatment project. If such 

partnerships or collaborations are 

already in place, provide a description 

of how they intend to expand their 

scope to include the implementation of 

the methamphetamine and/or suicide 

prevention or treatment project. 

Relevant partnerships working closely 

with and developing collaborations for 

the MSPI–U may include smaller urban 

organizations which combine their 

resources to implement this project. 

‘‘Relevant partnerships’’ can be defined 

as developing cooperative agreements 

and/or Memorandums of Agreement 

that clearly defines how the 

collaboration will be conducted. 

• Collaborations may also include 

other partners to share resources and 

information that could strengthen the 

program. 

• The action plan should focus on 

developing or enhancing and 

implementing community-based, 

evidence or practice-based 

methamphetamine and/or suicide 

prevention or treatment strategies. The 

action plan for the community 

prevention or treatment program should 

include the proposed best and 

promising practices being implemented, 

identify information sharing processes, 

and define and identify interactive 

group activities, data collection (i.e. 

Resource and Patient Management 

System), evaluation, and ongoing 

quality assurance improvement 

processes. The project should include 

culturally appropriate behavioral, 

policy, and community approaches to 

methamphetamine and/or suicide 

prevention or treatment. 

• Applicants must attend one (1) 

mandatory MSPI–U grantee meeting per 

year. The budget submitted should 

reflect travel costs for the project 

director and the local evaluator to 

attend this meeting. Location (city/ 

hotel) and time frame for this meeting 

will be provided after award; however 

the meeting will generally last two to 

three days and attendance is mandatory. 

At these meetings, grantees will present 

the results of their projects and Federal 

staff will be available to provide 

technical assistance. 

• Applicants must participate in a 

national evaluation of this project. Each 

grantee shall coordinate with their 

national MSPI project officer. The 

grantee shall work with the IHS staff 

and national MSPI project officer to 

develop a local process to measure 

specific outcome measures as consistent 

with national GPRA measures and IHS 

Division of Behavioral Health (DBH) 

program requirements. 

• Up to a maximum of 20 percent of 

grant funds may be used to develop or 

enhance the grantee’s local evaluation 

capacity for the purposes of meeting 

MSPI data collection requirements. All 

applicants will be required to employ 

the use of the Resource and Patient 

Management System (RPMS) and the 

RPMS behavioral health module or IHS 

Electronic Health Record. If applicant is 

unable to utilize the RPMS as an 

information management system, the 

applicant should demonstrate within 

the application how they will satisfy the 

data collection requirements. 

Applicants will also be required to 

adhere to any and all GPRA 

requirements, where applicable. 

• Other costs in conjunction with the 

evaluation of this project may include 

training (onsite and off-site), conference 

calls, and information sharing using email and/or faxing materials. 

• Applicants are expected to 

publicize their activities in the affected 

communities. The action plan may 

include: 

• Identification of one to three 

environmental issues that community 

members have stated need to be 

addressed in order to promote the 

prevention and/or treatment of 

methamphetamine abuse and/or 

suicide. There should be some record 

that this has been identified as an issue 

that needs to be addressed. This may 

include local newspapers, Tribal 

Council meetings, Town Hall meetings, 

or radio programs. 

• Community programs should 

inform their community about the 

program and its goals and the baseline 

data for the outcome indicators. The 

program should establish a time frame 

and setting to share their progress with 

the community. The settings could 

include regular programs on the radio 

station, monthly newspaper reports or 

newsletter mailings, or one or more 

graph or ‘thermometer’ type billboards 

or centrally placed posters that track 

progress. 

• The action plan should include a 

community gathering that is held to 

close out the project with an accounting 

of the progress by indicators and 

dialogue about next steps. 

II. Award Information 

Type of Awards: Grant. 

Estimated Funds Available: The total 

amount identified for fiscal year (FY) 

2008 is $1,103,000; FY 2009 is 

$1,103,000 Grand total of $2,206,000. 

The awards are for 12 months in each 

budget period. The awards are subject to 

the availability of funds. 

Anticipated Number of Awards: An 

estimated eleven (11) two-year awards 

will be approved for funding with the 

amounts identified for FY 2008 and FY 

2009. The existing awardees will apply 

for competing continuation awards for 

continued funding. Continuation 

awards will be made based on program 

performance. Contingent on 

appropriation of funds, the amount of 

awards in the third year will continue 

at the same level as year one and two 

under this Program Announcement. 

Project Period: Three (3) Years. 

Award Amount: $100,000, per year. 

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Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Notices 32623 

III. Eligibility Information 

1. Eligible applicants are: 

• Non-profit Urban Indian 

Organizations, as defined by 25 U.S.C. 

1603(h). 

Eligibility is limited to the 

aforementioned applicants because they 

have the necessary knowledge of, 

experience, and capability/capacity to 

work within the urban AI/AN 

communities to perform the required 

activities. 

Applicants must provide a letter of 

support from the board of the urban 

Indian Organization. If there is 

insufficient time to procure such a letter 

of support prior to submitting the 

application, the letter must be submitted 

within six months after award. Place 

this documentation behind the first page 

of your application form. 

2. Cost Sharing or Matching: The 

Methamphetamine & Suicide Prevention 

Initiative does not require matching 

funds or cost sharing. 

Other Requirements: 

A. If application budgets exceed the 

stated dollar amount that is outlined 

within this announcement; those 

applications will not be considered for 

funding. 

B. The budget should include a 

budget narrative and justification for all 

cost outlined in the application for the 

budget period and should explain why 

each line item is necessary or relevant 

to the proposed project. 

IV. Application and Submission 

Information 

1. Applicant packages may be found 

at the Grants.gov Web site (http:// 

www.grants.gov), or for a link to the 

package information go to the Grants 

Policy Staff Web site at http:// 

www.ihs.gov/NonMedicalPrograms/ 

gogp/gogp_funding.asp. Information 

regarding the electronic application 

process may be directed to Tammy G. 

Bagley, at (301) 443–6290. The entire 

application package and detailed 

application instructions are available at 

http://www.grants.gov/index.jsp. 

2. Content and Form of Application 

Submission 

a. You must submit a project narrative 

with your application package. The 

project narrative must be submitted in 

the following format: 

• Maximum number of pages: 25. If 

your narrative exceeds the page limit, 

only the first pages which are within the 

page limit will be reviewed. 

• Font size: 12 point unreduced. 

• Single spaced. 

• 81⁄2′′ x 11′′ paper. 

• Page margin size: One inch. 

Your narrative should address 

activities to be conducted over the 

entire project period. You must use the 

sections/headings listed below in 

developing your project narrative. Be 

sure to place the required information in 

the correct section, or it will not be 

considered. 

Your application will be scored 

according to how well you address the 

requirements for each section of the 

project narrative. Your project narrative 

must include the following items in the 

order listed: 

• Statement of Need 

• Describe the target population as 

well as the geographic area to be served, 

and justify the selection of both. The 

target population should include AI/AN 

youth who are currently residing within 

a youth regional/residential treatment 

center or who have been discharged 

from a residential treatment center 

within the previous sixty (60) days. 

Include the numbers to be served and 

demographic information. Discuss the 

target population’s language, beliefs, 

norms and values, as well as 

socioeconomic factors that must be 

considered in services to this 

population. Describe a brief history of 

the youth recidivism issues in the 

community and responses locally, 

within the Tribe and in the State. 

• Document clearly whether this 

project will address the transitional/ 

discharge or aftercare problem or 

decrease the rate of youth recidivism 

within the YRTC. 

• Document the need for a 

transitional/discharge or aftercare 

project in the selected community 

which is experiencing increases in the 

rate of recidivism. This documentation 

of need may come from a variety of 

sources, and applicants are encouraged 

to provide as much quantifiable data 

related information about the increases 

as may be available. 

• Show that identified needs are 

consistent with priorities of the Tribes, 

State, or county that has primary 

responsibility for the service delivery 

system. 

• Describe the local resource 

organizations in the community. 

• Depending on the type of project 

chosen, describe the local transitional/ 

discharge or aftercare resources 

available to the project. 

• Project Plan 

• Clearly state the purpose, goals and 

objectives of your proposed project and 

how it addresses the target population 

and the geographic area being served. 

• Describe how the project is to be 

implemented, including the roles of 

staff to be hired. 

• Provide a realistic timeline for the 

project (chart or graph) showing key 

activities, milestones, and responsible 

staff. [Note: The timeline should be part 

of the project narrative. It should not be 

placed in an appendix.] 

• If you plan to include an advisory 

body in your project, describe its 

membership, roles and functions, and 

frequency of meetings. 

• Describe how members of the target 

population help prepare the application 

and how they will help plan, 

implement, and evaluate the project. 

• Identify any other organizations 

that will participate in the proposed 

project. Describe their roles and 

responsibilities and demonstrate their 

commitment to the project. Include 

letters of commitment from community 

organizations supporting the project in 

the appendix. 

• Show that the necessary 

groundwork (e.g., planning, consensus 

development, development of 

memoranda of agreement) has been 

completed or is near completion so that 

the project can be implemented, and 

any prevention or treatment 

interventions can begin as soon as 

possible but no later than six (6) months 

after grant award. 

• Describe any potential barriers to 

successful conduct of the proposed 

project and how you will overcome 

them. 

• Describe your plan to ensure project 

sustainability when funding for this 

project ends. Also describe how 

program continuity will be maintained 

when there is a change in the 

operational environment (e.g., staff 

turnover, change in project leadership) 

to ensure stability over time. 

• Organizational Capacity 

• Discuss the capability and 

experience of the applicant organization 

and other participating organizations 

with the target population. Provide 

Memoranda of Understanding or Letters 

of Agreement specifically for the 

proposed project from participating 

organizations in the appendix. 

• Describe existing community 

infrastructure that addresses 

transitional/discharge or aftercare 

treatment. 

• Provide a list of staff and position 

descriptions for those who will 

participate in the project, showing the 

role of each and their level of effort and 

qualifications. Include the project 

director and other key personnel, such 

as the local evaluator and prevention or 

treatment personnel. 

• Describe the cultural characteristics 

of key staff and indicate if any are 

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32624 Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Notices 

members of the target population/ 

community. 

• Describe the resources available for 

the proposed project (e.g., facilities, 

equipment), and provide evidence that 

services will be provided in a location 

that is adequate, accessible, compliant 

with the Americans with Disabilities 

Act (ADA), and amenable to the target 

population. 

• Describe evidence of successful 

program management experience (see 

Criteria for more detail). 

• Describe experience with other 

Federal, state, or private grants. 

• Describe data collection experience 

and capacity for data storage. Clearly 

describe the project’s information 

management system capabilities and 

history of its use (if any). Describe any 

plans to utilize the RPMS information 

management system with the 

implementation of this project. If 

applicant currently utilizes an alternate 

information management system or is 

unable to utilize RPMS as an 

information management system, the 

applicant should demonstrate within 

the application how they plan to satisfy 

the data collection requirements. 

• Local Evaluation Capacity 

• Grantees must evaluate their 

projects and are required to describe 

their evaluation plans in their 

applications. The evaluation should be 

designed to provide regular feedback to 

the project to improve services. The 

evaluation must include both process 

and outcome components. Process and 

outcome evaluations must measure 

change relating to project goals and 

objectives over time compared to 

baseline information. Describe 

evaluation experience with current or 

past community projects. 

• State willingness to work with IHS 

evaluation consultant(s) in developing 

community-specific outcome measures 

for the local and national evaluation. 

• Demonstrate evidence of having 

secured or plans to secure a qualified 

local evaluation consultant and/or parttime employee to conduct data 

collection and data entry (e.g., resume 

position description). 

• Describe plans for data collection, 

management, analysis, interpretation 

and reporting. Describe the existing 

approach to the collection of data, along 

with any necessary modifications. Be 

sure to include data collection 

instruments/interview protocols in an 

appendix format. 

• Demonstrate how the evaluation 

will be integrated with requirements for 

collection and reporting of performance 

data (e.g., RPMS and GPRA indicators, 

performance measures). Explain: How 

you will ensure privacy and 

confidentiality? Where data will be 

stored? Who will or will not have access 

to information and how the identity of 

participants will be kept private, for 

example, through the use of a coding 

system on data records, limiting access 

to records, or storing identifiers 

separately from data? Describe adequate 

consent procedures. 

• Applicants must consider their 

evaluation plans when preparing the 

project budget. No more than 20% of the 

total grant award may be used for 

evaluation and data collection (this is 

not a research grant). 

The evaluation must include both 

process and outcome components. 

Process and outcome evaluations must 

measure change relating to project goals 

and objectives over time compared to 

baseline information. Control or 

comparison groups are not required. 

Process components should address 

issues such as: 

• How closely did the 

implementation match the plan? 

• What types of deviations from the 

plan occurred? 

• What led to the deviations? 

• What effect did the deviations have 

on the planned intervention and 

evaluation? 

• Who (program, staff) provided what 

services (modality, type, intensity, 

duration), to whom (individual 

characteristics), in what context 

(system, community), and at what cost 

(facilities, personnel, dollars)? 

Outcome components should address 

issues such as: 

FY 2008 FY 2009 FY 2010 

Outcome measure #1: 

The proportion of methamphetamine-using patients who enter a methamphetamine 

treatment program.

N/A ................... Baseline ............ Baseline. 

Outcome measure #2: 

Reduce the incidence of suicidal activities (ideation, attempts) in AI/AN communities through prevention, training, surveillance, & intervention programs.N/A ................... Baseline ............ Baseline. 

Outcome measure #3: 

Reduce the incidence of methamphetamine abuse in AI/AN communities through 

prevention, training, surveillance, & intervention programs.

N/A ................... Baseline ............ Baseline. 

Outcome measure #4: 

The proportion of youth who participate in evidence-based and/or promising practice prevention or intervention programs.N/A ................... Baseline ............ Baseline. 

Outcome measure #5: 

Establishment of trained suicide crisis response teams ............................................. N/A ................... Baseline ............ Baseline. 

Outcome measure #6: 

Increase tele-behavioral health encounters ................................................................ N/A ................... Baseline ............ Baseline. 

• Budget Justification (will not be 

counted in the stated page limit). You 

must provide a narrative justification of 

the items included in your proposed 

budget, as well as a description of 

existing resources and other support 

you expect to receive for the proposed 

project. Be sure to show that no more 

than 20% of the total grant award will 

be used for data collection and 

evaluation. 

Additional information shall be 

included in the application appendices. 

The appendices will not be counted 

toward the narrative page limit. This 

additional information includes: 

• Position descriptions for key 

personnel including local evaluator and 

data collection/data entry employees. If 

the evaluator will be subcontracted, 

include a letter of commitment with a 

current biographical sketch from the 

individual(s). Job descriptions should be 

no longer than one page each. 

• Curriculum Vitae/Resume of key 

personnel (project director, evaluator (if 

identified). Resumes should be no 

longer than two (2) pages in length. 

• Applicants must provide a letter of 

support from the board of the urban 

Indian organization. 

You are required to have a Dun and 

Bradstreet Data Universal Numbering 

System (DUNS) number to apply for a 

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Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Notices 32625 

grant or cooperative agreement from the 

Federal government. The DUNS number 

is a nine-digit identification number, 

which uniquely identifies business 

entities. Obtaining a DUNS number is 

easy and there is no charge. To obtain 

a DUNS number, access http:// 

www.dunandbradstreet.com or call 

(866) 705–5711. For more information, 

see the IHS Web site at: http:// 

www.ihs.gov/od/pgo/funding/ 

pubcommt.htm. 

If your application form does not have 

a DUNS number field, please write your 

DUNS number at the top of the first 

page of your application, and/or include 

your DUNS number in your application 

cover letter. 

3. Submission Dates and Times 

Applications must be submitted 

electronically through Grants.gov by 12 

a.m. midnight Eastern Daylight Time 

(E.D.T.) on the application deadline due 

date. If technical challenges arise and 

the applicant is unable to successfully 

complete the electronic application 

process, the applicant should contact 

Grants Policy Staff at (301) 443–6290 at 

least fifteen days prior to the application 

deadline and advise of the difficulties 

that your organization is experiencing. 

The grantee must obtain prior approval, 

in writing (e-mails are acceptable) 

allowing the paper submission. If 

submission of a paper application is 

requested and approved, the original 

and two copies may be sent to the 

Division of Grants Operations (DGO), 

801 Thompson Avenue, TMP, Suite 360, 

Rockville, MD 20852, (301) 443–5204 by 

12 midnight E.D.T. on the application 

deadline date. Applications not 

submitted through Grants.gov, without 

an approved waiver, may be returned to 

the applicant without review or 

consideration. Late applications will not 

be accepted for processing. They will be 

returned to the applicant and will not be 

considered for funding. 

4. Intergovernmental Review 

Executive Order 12372 requiring 

intergovernmental review is not 

applicable to this program. 

5. Funding Restrictions 

• Pre-award costs are allowable 

pending prior approval from the 

awarding agency. However, in 

accordance with 45 CFR part 74 all preaward costs are incurred at the 

recipient’s risk. The awarding office is 

under no obligation to reimburse such 

costs if for any reason the applicant 

does not receive an award or if the 

award to the recipient is less than 

anticipated. 

• The available funds are inclusive of 

direct and appropriate indirect costs. 

• IHS will not acknowledge receipt of 

applications. 

6. Other Submission Requirements 

Electronic Submission—The preferred 

method for receipt of applications is 

electronic submission through 

Grants.gov. However, should any 

technical challenges arise regarding the 

submission, please contact Grants.gov 

Customer Support at (800) 518–4726 or 

support@grants.gov. The Contact Center 

hours of operation are Monday–Friday 

from 7 a.m. to 9 p.m. E.D.T. The 

applicant must seek assistance at least 

fifteen days prior to the application 

deadline. Applicants that do not adhere 

to the timelines for Central Contractor 

Registry (CCR) and/or Grants.gov 

registration and/or requesting timely 

assistance with technical issues will not 

be a candidate for paper applications. 

To submit an application 

electronically, please use the http:// 

www.Grants.gov and select ‘‘Apply for 

Grants’’ link on the home page. 

Download a copy of the application 

package, on the Grants.gov Web site, 

complete it offline and then upload and 

submit the application via the 

Grants.gov site. You may not e-mail an 

electronic copy of a grant application to 

IHS. 

Please be reminded of the following: 

• Under the new IHS application 

submission requirements, paper 

applications are not the preferred 

method. However, if you have technical 

problems submitting your application 

online, please contact Grants.gov 

Customer Support at: http:// 

www.grants.gov/CustomerSupport. 

• Upon contacting Grants.gov obtain 

a tracking number as proof of contact. 

The tracking number is helpful if there 

are technical issues that cannot be 

resolved and a waiver request from 

Grants Policy must be obtained. 

• If it is determined that a formal 

waiver is necessary, the applicant must 

submit a request, in writing (e-mails are 

acceptable), to Michelle.Bulls@ihs.gov 

that includes a justification for the need 

to deviate from the standard electronic 

submission process. Upon receipt of 

approval, a hard copy application 

package must be downloaded by the 

applicant from Grants.gov, and sent 

directly to the DGO, 801 Thompson 

Avenue, TMP, Suite 360, Rockville, MD 

20852 on or before 12 midnight of the 

application deadline date. 

• Upon entering the Grants.gov site, 

there is information available that 

outlines the requirements to the 

applicant regarding electronic 

submission of an application through 

Grants.gov, as well as the hours of 

operation. We strongly encourage all 

applicants not to wait until the deadline 

date to begin the application process 

through Grants.gov as the registration 

process for CCR and Grants.gov could 

take up to fifteen working days. 

• To use Grants.gov, you, as the 

applicant, must have a DUNS Number 

and register in the CCR. You should 

allow a minimum of ten working days 

to complete CCR registration. See below 

for more information on how to apply. 

• You must submit all documents 

electronically, including all information 

typically included on the SF–424 and 

all necessary assurances and 

certifications. 

• Please use the optional attachment 

feature in Grants.gov to attach 

additional documentation that may be 

requested by IHS. 

• Your application must comply with 

any page limitation requirements 

described in the program 

announcement. 

• After you electronically submit 

your application, you will receive an 

automatic acknowledgment from 

Grants.gov that contains a Grants.gov 

tracking number. DGO will download 

your application from Grants.gov and 

provide necessary copies to the 

cognizant program office. The DGO will 

not notify applicants that the 

application has been received. 

• You may access the electronic 

application for this program on http:// 

www.Grants.gov. 

• You may search for the 

downloadable application package 

using either the CFDA number or the 

Funding Opportunity Number. Both 

numbers are identified in the heading of 

this announcement. 

• The applicant must provide the 

Funding Opportunity Number: HHS– 

2009–IHS–METHU–0002. 

E-mail applications will not be 

accepted under this announcement. 

DUNS Number 

Applicants are required to have a Dun 

and Bradstreet (DUNS) number to apply 

for a grant or cooperative agreement 

from the Federal Government. The 

DUNS number is a nine-digit 

identification number, which uniquely 

identifies business entities. Obtaining a 

DUNS number is easy and there is no 

charge. To obtain a DUNS number, 

access http:// 

www.dunandbradstreet.com or call 

(866) 705–5711. Interested parties may 

wish to obtain their DUNS number by 

phone to expedite the process. 

Applications submitted electronically 

must also be registered with the CCR. A 

DUNS number is required before CCR 

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32626 Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Notices 

registration can be completed. Many 

organizations may already have a DUNS 

number. Please use the number listed 

above to investigate whether or not your 

organization has a DUNS number. 

Registration with the CCR is free of 

charge. 

Applicants may register by calling 

(888) 227–2423. Please review and 

complete the CCR Registration 

Worksheet located on http:// 

www.grants.gov/CCRRegister. 

More detailed information regarding 

these registration processes can be 

found at http://www.grants.gov. 

V. Application Review Information 

1. Criteria 

Applicants are required to provide 

measures of effectiveness that will 

demonstrate the accomplishment of the 

various identified objectives of the 

cooperative agreement. Measures of 

effectiveness must relate to the 

performance goals stated in the 

‘‘Purpose’’ section of this 

announcement. Measures must be 

objective, qualitative and quantitative, 

and must measure the intended process 

and outcome. These measures of 

effectiveness must be submitted with 

the application and will be an element 

of evaluation. 

Your application will be evaluated 

against the following criteria: 

Project Plan (30) Points 

• Comprehensively describe the 

proposed three (3) year project—5 

Points; 

• Comprehensively describe the 

project’s objectives and activities—5 

Points; 

• Include a timeline of activities. Is 

the timeline provided comprehensive— 

5 Points; 

• Comprehensively describe and 

identify potential problem areas or 

barriers and propose solutions—5 

Points; 

• Provide community focused 

responses that enhance evidence-based 

or practice-based methamphetamine 

and/or suicide prevention or treatment 

services or education programming—5 

Points; 

• Provide communities with needed 

resources to develop their own 

community-focused programs with 

preference for coordinated programming 

that maximizes the impact across 

communities and Tribal groups—5 

Points. 

Statement of Need (15) Points 

• Provide an adequate baseline 

picture of the community—5 Points; 

• Provide a good description and 

justification for the identified project 

target population—10 points. 

Organizational Capacity (20) Points 

• Describe the community 

infrastructure addressing 

methamphetamine and/or suicide 

treatment or prevention—10 Points; 

• Comprehensively provide evidence 

of successful methamphetamine and/or 

suicide program management 

capability—5 Points; 

• Adequately describe the project 

staffing, their expected tasks/roles, 

experience and training, and time 

commitment—5 Points. 

Local Evaluation Capacity (25) Points 

• Address applicable outcomes/ 

output measures and how they relate to 

stated activities and objectives—10 

Points; 

• State a willingness to collaborate 

and submit data into the MSPI national 

evaluation process—2 Points; 

• Demonstrate evidence of 

commitment to securing a qualified 

local evaluation/data collection/entry 

capacity. Provide documentation—5 

Points; 

• Demonstrate how the program will 

use a portion of awarded funds (not to 

exceed 20 percent) to develop or 

enhance funding recipients’ local 

evaluation capacity—2 Points; 

• Describe how the funding recipients 

will establish baseline data and 

information related to 

methamphetamine abuse/suicides in the 

local communities—2 Points; 

• Demonstrate how the data 

collection and storage capacity 

adequately supports the program? If 

data collected is non-RPMS based, does 

the proposal describe how such data 

will be submitted to IHS/HQ—2 Points; 

• Describe the local evaluation 

process in sufficient detail—2 Points. 

National Evaluation Plan Capacity (10) 

Points 

• State a willingness to participate in 

a nationally coordinated program 

focusing on increasing access to 

methamphetamine and/or suicide 

prevention or treatment related 

activities—5 Points; 

• State a willingness to attend a 

minimum of one mandatory MSPI 

meeting per fiscal year—2 Points; 

• State a willingness to participate in 

monthly/quarterly MSPI awardees 

conferences—3 Points. 

2. Review and Selection Process 

Each application will be reviewed by 

the DGO for eligibility, compliance with 

the announcement, and completeness. 

Incomplete applications and 

applications that are non-responsive to 

the eligibility criteria will not advance 

through the review process. Applicants 

will be notified that their application 

did not meet submission requirements. 

Applications that meet eligibility 

requirements, are complete, and 

conform to this announcement will be 

subject to the competitive objective 

review and evaluation by an Ad Hoc 

Review Committee of Tribal, IHS, and 

other Federal or non-Federal reviewers. 

Applications will be reviewed against 

criteria. Reviewers will assign a 

numerical score to each application 

which will be used to rank applications. 

The review process will be directed by 

the DGO staff to ensure compliance with 

HHS and IHS grant review guidelines. 

In addition, the following factors may 

affect the funding decision: 

• Geographic diversity. 

IHS will provide justification for any 

decision to fund out of rank order. 

3. Anticipated Announcement and 

Award Dates 

Awards will start on August 14, 2009. 

VI. Award Administration Information 

1. Award Notices 

The Notice of Award (NoA) will be 

initiated by DGO and will be mailed via 

postal mail to each entity that is 

approved for funding under this 

announcement. The NoA will be signed 

by the Grants Management Officer and 

this is the authorizing document for 

which funds are dispersed to the 

approved entities. The NoA will serve 

as the official notification of the grant 

award and will reflect the amount of 

Federal funds awarded the purpose of 

the grant, the terms and conditions of 

the award, the effective date of the 

award, and the budget/project period. 

The NoA is the legally binding 

document. Applicants who are 

approved but unfunded or disapproved 

based on their Objective Review score 

will receive a copy of the Executive 

Summary which identifies the 

weaknesses and strengths of the 

application submitted. 

2. Administrative and National Policy 

Requirements 

Grants are administrated in 

accordance with the following 

documents: 

• This Program Announcement. 

• 45 CFR Part 92, ‘‘Uniform 

Administrative Requirements for Grants 

and Cooperative Agreements to State, 

Local and Tribal Governments,’’ or 45 

CFR part 74, ‘‘Uniform Administrative 

Requirements for Awards to Institutions 

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Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Notices 32627 

of Higher Education, Hospitals, Other 

Nonprofit Organizations, and 

Commercial Organizations.’’ 

• HHS Grants Policy Statement, 

January 2007. 

• OMB Circular A–87, ‘‘State, Local, 

and Indian Tribal Governments,’’ (Title 

2 Part 225) or OMB Circular A–122, 

‘‘Non-Profit Organizations.’’ (Title 2 Part 

230). 

• OMB Circular A–133, ‘‘Audits of 

States, Local Governments, and NonProfit Organizations.’’ 

3. Indirect-Cost Requirements 

This section applies to all grant 

recipients that request reimbursement of 

indirect costs in their grant application. 

In accordance with HHS Grants Policy 

Statement, Part II–27, IHS requires 

applicants to have a current indirect 

cost rate agreement in place prior to 

award. The rate agreement must be 

prepared in accordance with the 

applicable cost principles and guidance 

as provided by the agency or office. A 

current rate means the rate covering the 

applicable activities and the award 

budget period. If the current rate is not 

on file with the DGO at the time of 

award, the indirect cost portion of the 

budget will be restricted and not 

available to the recipient until the 

current rate is provided to DGO. 

Generally, indirect costs rates for IHS 

grantees are negotiated with the 

Division of Cost Allocation (DCA) 

http://rates.psc.gov/ and the Department 

of the Interior (National Business 

Center) http://www.nbc.gov/acquisition/ 

ics/icshome.html. If your organization 

has questions regarding the indirect cost 

policy, please contact the DGO at (301) 

443–5204. 

4. Reporting 

Progress Report. Semi-annual and 

annual report are required. A format 

will be provided. These reports will 

include a brief comparison of actual 

accomplishments to the goals 

established for the period, or, if 

applicable, provide sound justification 

for the lack of progress, and other 

pertinent information as required. 

Copies of any materials developed shall 

be attached. Semi-annual progress 

reports must be submitted within thirty 

(30) days of the end of the half year. An 

annual report must be submitted within 

thirty (30) days after the end of the 12 

month time period. 

Financial Status Report. Semi-annual 

financial status reports must be 

submitted within 30 days of the end of 

the half year. Final financial status 

reports are due within 90 days of 

expiration of the budget/project period. 

Standard Form 269 (long form) will be 

used for financial reporting. 

Reports. Grantees are responsible and 

accountable for accurate reporting of the 

Progress Reports and Financial Status 

Reports which are generally due semiannually. Financial Status Reports (SF– 

269) are due 90 days after each budget 

period and the final SF–269 must be 

verified from the grantee records on 

how the value was derived. Grantees 

must submit reports in a reasonable 

period of time. 

Failure to submit required reports 

within the time allowed may result in 

suspension or termination of an active 

grant, withholding of additional awards 

for the project, or other enforcement 

actions such as withholding of 

payments or converting to the 

reimbursement method of payment. 

Continued failure to submit required 

reports may result in one or both of the 

following: (1) The imposition of special 

award provisions; and (2) the nonfunding or non-award of other eligible 

projects or activities. This applies 

whether the delinquency is attributable 

to the failure of the grantee organization 

or the individual responsible for 

preparation of the reports. 

Telecommunication for the hearing 

impaired is available at: TTY (301) 443– 

6394. 

VII. Agency Contact(s) 

We encourage inquiries concerning 

this announcement. 

For program technical assistance, 

contact: Bryan E. Wooden, LICSW, 

LCSW–C, DCSW, Office of Clinical and 

Preventive Services, Director (Acting), 

Division of Behavioral Health, 801 

Thompson Avenue, Reyes Building, 

Suite 300, Rockville, Maryland 20852, 

Telephone: (301) 443–2038, e-mail: 

bryan.wooden@ihs.gov. 

For financial, grants management, or 

budget assistance, contact: Kimberly 

Pendleton, Senior Grants Management 

Officer, 801 Thompson Ave, Reyes Bldg, 

Suite 360, Rockville, MD 20852, 

Telephone: (301) 443–6290, e-mail: 

kimberly.pendleton@ihs.gov. 

VIII. Other Information 

This and other IHS funding 

opportunity announcements can be 

found on the IHS Web site, Internet 

address: http://www.ihs.gov. Click on 

‘‘Funding’’ then ‘‘Grants and 

Cooperative Agreements.’’ 

Dated: June 26, 2009. 

Yvette Roubideaux, 

Director, Indian Health Service. 

[FR Doc. E9–16045 Filed 7–7–09; 8:45 am] 

BILLING CODE 4165–16–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Office of Clinical and Preventive 

Services, Division of Behavioral 

Health; The Methamphetamine & 

Suicide Prevention Initiative for 

American Indian and Alaska Native 

Youth 

Announcement Type: New. 

Funding Announcement Number: 

HHS–2009–IHS–METHY–0001. 

Catalog of Federal Domestic 

Assistance Number(s): 93.933. 

DATES: Key Dates: Application Deadline 

Date: July 31, 2009. 

Review Date: August 6–7, 2009. 

Earliest Anticipated Start Date: 

August 14, 2009. 

Table of Contents 

I. Funding Opportunity 

II. Award Information 

III. Eligibility 

IV. Application and Submission Information 

V. Application Review Information 

VI. Award Administration Information 

VII. Agency Contacts 

VIII. Other Information 

I. Funding Opportunity Description 

The Indian Health Service (IHS) 

announces competitive grant 

applications for the Methamphetamine 

& Suicide Prevention Initiative (MSPI) 

for American Indian and Alaska Native 

(AI/AN) Youth (MSPI–Y). This program 

is authorized under the Snyder Act, 25 

U.S.C. 13, and 25 U.S.C. 1602(a) 

(b)(9)(11)(12); 25 U.S.C. 1621h(m) of the 

Indian Health Care Improvement Act 

(IHCIA), as amended. This program is 

described at 93.933 in the Catalog of 

Federal Domestic Assistance. The 

purpose of the MSPI–Y is to expand 

community-level access to effective 

methamphetamine and suicide 

prevention programs through Tribal, 

youth residential, transitional/ 

discharge, and aftercare services. 

Resources will enhance existing 

transitional/discharge and aftercare 

programs with a specific focus on 

methamphetamine and suicide 

prevention. Funding for the MSPIY will 

be used to: 

• Provide community-focused 

response grants that would allow Tribes 

and Tribal organizations to utilize the 

resources to enhance transitional/ 

discharge and aftercare programming 

focused on methamphetamine and 

suicide prevention for youth discharged 

or who have the expectation of 

discharge from a residential setting to 

maintain sobriety within their home 

community. 

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