Federal Register / Vol. 69, No. 210 / Monday, November 1, 2004 / Notices 63403

conducting pharmacokinetic (PK) 

studies in pregnant women and, 

specifically, on how to assess the 

influence of pregnancy on the PKs, and 

where appropriate, the 

pharmacodynamics (PD) of drugs or 

biologic products. The goals of this 

guidance are to recommend a 

framework for designing and conducting 

PK studies in pregnant women and 

stimulate further study and research to 

assist in rational therapeutics for 

pregnant patients.

DATES: Submit written or electronic 

comments on the draft guidance by 

January 3, 2005. General comments on 

agency guidance documents are 

welcome at any time.

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, or the Office of 

Communications, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research (CBER), 1401 Rockville Pike, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

that office in processing your requests. 

Submit written comments on the draft 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http://

www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document.

FOR FURTHER INFORMATION CONTACT:

Kathleen Uhl, Center for Drug 

Evaluation and Research (HFD–020), 

Food and Drug Administration, 5515 

Security Lane, Rockville, MD 20852, 

301–443–5157.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Draft Guidance for Industry on 

Pharmacokinetics in Pregnancy—Study 

Design, Data Analysis, and Impact on 

Dosing and Labeling.’’ This guidance is 

intended to provide recommendations 

to sponsors and investigators on how to 

design, conduct, and assess studies 

investigating the influence of pregnancy 

on the pharmacokinetics, and where 

appropriate, the pharmacodynamics of 

drugs or biologic products. During the 

clinical development of most products, 

pregnant women are actively excluded 

from trials, and, if pregnancy does occur 

during a trial, the usual procedure is to 

discontinue treatment and drop the 

patient from the study. Consequently, at 

the time of a drug’s initial marketing, 

except for products developed to treat 

conditions specific to pregnancy, there 

are seldom meaningful human data on 

the appropriate dosage and frequency of 

administration during pregnancy. Even 

after years of marketing, data in product 

labels regarding PK and dose 

adjustments during pregnancy rarely 

provide more information for 

appropriate prescribing in pregnancy 

than what was available at the time of 

initial marketing.

The information in this guidance is 

intended to promote an increase in the 

amount of useful data concerning how 

drug kinetics are affected by pregnancy 

and to further encourage the 

development of appropriate therapeutic 

treatments for pregnant women. Topics 

covered include ethical considerations 

associated with conducting PK studies 

in pregnant women, study design, data 

analysis, labeling, and considerations 

for future research. The agency 

recommends using this guidance in 

conjunction with other pharmacological 

and clinical literature on the design, 

conduct, and interpretation of PK 

studies. Because the conduct of studies 

in pregnant women requires specialized 

knowledge in a variety of areas, 

investigators designing such studies are 

encouraged to obtain advice from 

experts in fields such as obstetrics, 

pediatrics, pharmacology, clinical 

pharmacology, pharmacometrics, 

statistics, and other applicable 

disciplines.

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on this topic. It does not create or confer 

any rights for or on any person and does 

not operate to bind FDA or the public. 

An alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations.

II. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the draft guidance. Two 

copies of mailed comments are to be 

submitted, except that individuals may 

submit one copy. Comments are to be 

identified with the docket number 

found in brackets in the heading of this 

document. The draft guidance and 

received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet 

may obtain the document at either http:/

/www.fda.gov/cder/guidance/index.htm

or http://www.fda.gov/ohrms/dockets/

default.htm.

Dated: October 21, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–24308 Filed 10–29–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Funding Opportunity Title: Historically 

Black Colleges and Universities 

National Resource Center for 

Substance Abuse and Mental Health 

Service System Infrastructure 

Development (Short Title: HBCU–NRC) 

Announcement Type: Initial. 

Funding Opportunity Number: TI 05–

002. 

Catalog of Federal Domestic 

Assistance (CFDA) Number: 93.243.

DATES: Due Date for Applications:

January 18, 2005.

(Note: Letters from State Single Point of 

Contact (SPOC) in response to E.O. 12372 are 

due March 21, 2005.)

SUMMARY: The Substance Abuse and 

Mental Health Services Administration 

(SAMHSA), Center for Substance Abuse 

Treatment (CSAT) and Center for 

Mental Health Services (CMHS), 

announce the availability of FY 2005 

funds for a Historically Black Colleges 

and Universities National Resource 

Center (HBCU–NRC) for Substance 

Abuse and Mental Health Service 

System Infrastructure Development. A 

synopsis of this Notice of Funding 

Availability (NOFA), as well as many 

other Federal government funding 

opportunities, are also available at the 

Internet site: http://www.grants.gov.

For complete instructions, potential 

applicants must obtain a copy of 

SAMHSA’s standard Infrastructure 

Grants Program Announcement, INF–05 

PA, and the PHS 5161–1 (Rev. 7/00) 

application form before preparing and 

submitting an application. The INF–05 

PA describes the general program design 

and provides instructions for applying 

for all SAMHSA Infrastructure Grants, 

including the Historically Black 

Colleges and Universities National 

Resource Center for Substance Abuse 

and Mental Health Service System 

Infrastructure Development. SAMHSA’s 

Infrastructure Grants provide funds to 

63404 Federal Register / Vol. 69, No. 210 / Monday, November 1, 2004 / Notices 

increase the capacity of mental health 

and substance abuse service systems to 

support effective programs and services. 

Additional instructions and specific 

requirements for this funding 

opportunity are described below. 

I. Funding Opportunity Description

Authority: Sections 509 and 520A of the 

Public Health Service Act, as amended and 

subject to the availability of funds.

The Historically Black Colleges and 

Universities National Resource Center for 

Substance Abuse and Mental Health Service 

System Infrastructure Development (HBCU–

NRC) is one of SAMHSA’s Infrastructure 

Grants. The purpose of the HBCU–NRC 

cooperative agreement is to provide funds to 

support an innovative national resource 

center dedicated to the following 3 goals: (1) 

Establishing a national network of HBCUs to 

facilitate collaboration among the 104 HBCU 

institutions; (2) supporting culturally 

appropriate substance abuse treatment and 

mental health disorders prevention and 

treatment student health services and 

wellness needs on HBCU campuses; and (3) 

facilitating the design of accredited courses, 

minors/majors and undergraduate and 

graduate degree programs that adapt State 

requirements and encourage student interest 

in substance abuse and mental health.

Applications should reflect a program 

that achieves these goals and may 

propose any of the activities listed 

under Section I–2.1 Allowable 

Activities of the INF–05 PA. However, 

the successful applicant must undertake 

the following required activities: 

• Establish and manage a viable 

structure to serve all 104 HBCU 

institutions. 

• Support the annual Dr. Lonnie E. 

Mitchell Substance Abuse Conference 

with tracks on substance abuse and 

mental health treatment and prevention. 

• Establish a database to measure 

student participation and impact of the 

Dr. Lonnie E. Mitchell Substance Abuse 

Conference. 

• Develop a strategic plan for the 

HBCU–NRC. 

• Convene the HBCU–NRC steering 

committee at least twice a year. 

• Coordinate technical assistance 

efforts with SAMHSA’s Addiction 

Technology Transfer Centers (ATTCs), 

the Mental Health Information Network, 

and other appropriate SAMHSA-funded 

activities. 

• Establish and maintain a data base 

of HBCUs with substance abuse and 

mental health curricula, programs, and 

faculty. 

• Develop assessment models for 

evaluating substance abuse and mental 

health curricula and/or programs at 

HBCUs and in communities at large.

• Disseminate information about 

effective practices within the mental 

health services and substance abuse 

treatment fields and promote/encourage 

career opportunities for HBCU students 

in the substance abuse and mental 

health fields. 

• Conduct on-site and distance 

learning opportunities to promote 

awareness of mental health and 

associated evidence-based practices. 

• Pilot campus-based suicide 

screenings and referrals to appropriate 

mental health treatment. 

Background: The National Institute on 

Drug Abuse (NIDA), in conjunction with 

the Center for Substance Abuse 

Treatment (CSAT) and in collaboration 

with the Morehouse School of Medicine 

and the Cork Institute-Southeast ATTC, 

helped to create the National HBCU 

Substance Abuse Consortium 

(NHBCUSAC) to address the shortage of 

qualified, trained, and licensed 

professionals, especially ethnic 

minorities, who are capable of treating 

and preventing substance abuse 

disorders. 

In 1995, CSAT began providing 

funding to the NHBCUSAC to develop 

curriculum models and enhance the 

expansion of college degrees being 

offered at HBCUs that led to licensure 

in substance abuse and health-related 

academic programs. CSAT and the 

Center for Substance Abuse Prevention 

(CSAP) supported the initiation of the 

National Dr. Lonnie E. Mitchell 

Substance Abuse Conference that 

brought together researchers, 

practitioners, faith communities, 

treatment providers, government 

officials, and most importantly, students 

from HBCUs across the country to 

introduce them to the substance abuse 

field and stimulate increased awareness 

and capacity building in substance 

abuse curricula and services among the 

faculty. Since that time, CSAT and the 

NHBCUSAC have expanded their 

interests to include mental health 

disorders affecting HBCUs and 

surrounding communities. Accordingly, 

CMHS is joining as a cosponsor of this 

initiative. 

Outreach is critical to helping HBCUs 

develop the capacity to address 

substance abuse treatment and mental 

health wellness, as well as improve 

academic programs and curricula to 

prepare students to earn degrees and 

work towards careers in the fields of 

substance abuse treatment and mental 

health. For the past several years, 

CSAT’s support for NHBCUSAC 

activities has been provided on a yearto-year basis under an interagency 

agreement with various National 

Institutes of Health. Based on the 

growing needs within HBCU campuses 

to develop capacities to address 

substance abuse treatment and mental 

health, formalizing the network of 

HBCUs with CSAT and CMHS support 

is expected to improve student access to 

information and training, thereby 

furthering support efforts to establish a 

culturally appropriate workforce. 

II. Award Information 

1. Estimated Funding Available/

Number of Awards: It is expected that 

up to $1.075 million will be available to 

fund one (1) award in FY 2005. The 

maximum allowable award is $1.075 

million in total costs (direct and 

indirect) per year for up to 3 years. 

Proposed budgets cannot exceed the 

allowable amount in any year of the 

proposed project. The actual amount 

available for the awards may vary, 

depending on unanticipated program 

requirements and the number and 

quality of the applications received. 

Annual continuations will depend on 

the availability of funds, grantee 

progress in meeting program goals and 

objectives, and timely submission of 

required data and reports. 

This is a Category 2—Comprehensive 

Infrastructure Grant; the total award 

may be used for infrastructure 

development and implementation 

pilots. The allowance of 15 percent of 

the total grant award for implementation 

pilots specified in INF–05 PA is not 

applicable to this program. Funding 

requested for pilot campus-based 

suicide screening and referral to 

appropriate mental health treatment 

may not exceed $150,000 per year. 

Funding requested for the annual Dr. 

Lonnie E. Mitchell Substance abuse 

Conference may not exceed $500,000 

per year. The $500,000 set aside for the 

conference includes a contribution from 

SAMHSA’s Center for Substance Abuse 

Prevention. 

This program is being announced 

prior to the annual appropriation for FY 

2005 for SAMHSA’s programs, with 

funding estimates based on the 

President’s budget request for FY 2005. 

Applications are invited based on the 

assumption that sufficient funds will be 

appropriated for FY 2005 to permit 

funding of an award. All applicants are 

reminded, however, that we cannot 

guarantee that sufficient funds will be 

appropriated to permit SAMHSA to 

fund any applications. 

2. Funding Instrument: Cooperative 

Agreement.

Because of the complexity of this 

cross-center initiative, and the 

anticipation of ongoing involvement of 

the Federal government in the 

development of the program guidelines, 

this award will be made as a cooperative 

agreement. The grantee will establish a 

Federal Register / Vol. 69, No. 210 / Monday, November 1, 2004 / Notices 63405

steering committee for this initiative, 

and will manage the steering 

committee’s logistical and programmatic 

needs. The steering committee will 

consist of the HBCU–NRC Project 

Director; members of the Executive 

Board of the NHBCUSAC; two 

representatives selected by the grantee 

from among the HBCU institutions that 

are not current members of the 

NHBCUSAC; and the CSAT and CMHS 

Project Officers. All steering committee 

members will have a vote. Non-voting 

representatives of professional 

organizations that have expertise in the 

fields of substance abuse treatment and 

mental health may be invited to steering 

committee meetings on an as-needed 

basis. 

Role of Grantee:

• Comply with the terms and 

conditions of the cooperative agreement 

and collaborate with SAMHSA staff in 

project implementation. 

• Provide SAMHSA with data 

required to comply with the 

Government Performance and Results 

Act (GPRA). The grantee must meet 

with SAMHSA Project Officers within 

two months after the award of the 

cooperative agreement to begin 

discussing the grantee’s evaluation 

strategy and how it will meet SAMHSA 

GPRA requirements. 

• Participate with SAMHSA staff in 

any necessary development and 

refinement of HBCU–NRC policies, 

evaluation designs, measures, and 

databases. 

• Keep policies consistent with 

SAMHSA policies on data sharing, 

access to data and materials, and 

publications. 

• Attend meetings with SAMHSA as 

typically required of cooperative 

agreement grantees. These may be 

conducted in person, electronically, or 

by conference call. 

• Provide funds for HBCU–NRC staff 

to attend relevant national meetings and 

conferences. 

• Collaborate in planning and 

participate in any joint learning 

workshops with the ATTCs and other 

appropriate SAMHSA-funded activities. 

Role of SAMHSA Staff:

• Work with the HBCU–NRC to help 

coordinate activities. 

• Provide guidance and technical 

assistance across all the project’s 

components, and conduct site visits as 

needed. 

• Approve project implementation 

plan. 

• Monitor and review progress of the 

HBCU–NRC project and make 

recommendations regarding moving 

through successive stages including its 

potential continuance. 

• Participate in any necessary 

development and refinement of the 

HBCU–NRC policies, evaluation 

designs, measures, and databases. 

• Facilitate the coordination of this 

program with other SAMHSA policies 

and activities, as appropriate. 

• Participate as voting members of the 

HBCU–NRC steering committee. 

• Approve steering committee 

structure and membership. 

• Review and approve products prior 

to publication and dissemination. 

• Approve proposed pilots and 

subawards. 

The HBCU–NRC Steering Committee 

will:

• Consist of the HBCU–NRC Project 

Director, members of the Executive 

Board of the NHBCUSAC; two 

representatives selected by the grantee 

from among the HBCU institutions that 

are not current members of the 

NHBCUSAC; and the CSAT and CMHS 

Project Officers who will participate in 

but will not chair meetings. 

• Meet at least twice annually. The 

first meeting of the steering committee 

may be convened at the request of 

SAMHSA Project Officers; the HBCU–

NRC Steering Committee will 

coordinate with the SAMHSA Project 

Officers in scheduling, planning, and 

carrying out future meetings. 

• Assist in the development and 

refinement of HBCU–NRC policies, 

evaluation designs, measures, and 

databases. 

• Collaborate with SAMHSA in 

designing and implementing evaluation 

plans that will include SAMHSA GPRA 

goals and program specific goals. 

III. Eligibility Information 

1. Eligible Applicants are the 104 

nationally recognized Historically Black 

Colleges and Universities (HBCUs) or a 

consortium of HBCUs with a lead 

college/university as the applicant. The 

recipient of the award will be the entity 

legally responsible for satisfying the 

grant requirements. The applicant must 

agree to involve and serve all 104 

HBCUs in the United States.

Eligibility is limited to the nationally 

recognized HBCUs or a consortium of 

HBCUs because the target audiences for 

activities supported under this initiative 

are HBCUs and HBCU students. Since 

there is a high concentration of African 

American students on these campuses, 

HBCUs are uniquely situated to provide 

the perspective regarding the substance 

abuse and mental health needs and 

issues surrounding the African 

American population in and around 

these college campuses. This initiative 

also supports Executive Orders 12320 

and 12876 to ‘‘strengthen the capacity of 

historically Black colleges and 

universities to provide quality 

education, to overcome the effects of 

discriminatory treatment, and to 

provide advice to the President 

regarding the needs in the areas of 

infrastructure, academic programs, and 

faculty and institutional development.’’

These eligibility criteria supersede the 

criteria specified in Section III–1 of the 

INF–05 PA. 

2. Cost Sharing or Matching is not 

required. 

3. Other: Applicants must also meet 

certain application formatting and 

submission requirements or the 

application will be screened out and 

will not be reviewed. These 

requirements are described in Section 

IV–2 below as well as in the INF–05 PA. 

IV. Application and Submission 

Information 

1. Address to Request Application 

Package: Complete application kits may 

be obtained from the National 

Clearinghouse for Alcohol and Drug 

Information (NCADI) at 1–800–729–

6686, or the National Mental Health 

Information Center at 1–800–789–2647. 

When requesting an application kit for 

this program, the applicant must specify 

the funding opportunity title ‘‘HBCUNRC’’ and the funding opportunity 

number (TI 05–002). All information 

necessary to apply, including where to 

submit applications and application 

deadline instructions, is included in the 

application kit. The PHS 5161–1 

application form is also available 

electronically via SAMHSA’s World 

Wide Web home page: http://

www.samhsa.gov/Grants/generalinfo/

useful_Info.aspx and the INF–05 PA is 

available electronically at http://

www.samhsa.gov/grants/standard/

Infrastructure/index.aspx.

When submitting an application, be 

sure to type ‘‘TI 05–002/HBCU–NRC’’ in 

Item Number 10 on the face page of the 

application form. Also, SAMHSA 

applicants are required to provide a 

DUNS Number on the face page of the 

application. To obtain a DUNS Number, 

access the Dun and Bradstreet web site 

at http://www.dunandbradstreet.com or 

call 1–866–705–5711. 

2. Content and Form of Application 

Submission: Information including 

required documents, required 

application components, and 

application formatting requirements is 

available in the INF–05 PA in Section 

IV–2. 

Checklist for Application Formatting 

Requirements 

SAMHSA’s goal is to review all 

applications submitted for grant 

63406 Federal Register / Vol. 69, No. 210 / Monday, November 1, 2004 / Notices 

funding. However, this goal must be 

balanced against SAMHSA’s obligation 

to ensure equitable treatment of 

applications. For this reason, SAMHSA 

has established certain formatting 

requirements for its applications. If you 

do not adhere to these requirements, 

your application will be screened out 

and returned to you without review. 

b Use the PHS 5161–1 application. 

b Applications must be received by 

the application deadline or have proof 

of timely submission, as detailed in 

Section IV–3 of the INF–05 PA. 

b Information provided must be 

sufficient for review. 

b Text must be legible. 

• Type size in the Project Narrative 

cannot exceed an average of 15 

characters per inch, as measured on the 

physical page. (Type size in charts, 

tables, graphs, and footnotes will not be 

considered in determining compliance.) 

• Text in the Project Narrative cannot 

exceed 6 lines per vertical inch. 

b Paper must be white paper and 8.5 

inches by 11.0 inches in size. 

b To ensure equity among 

applications, the amount of space 

allowed for the Project Narrative cannot 

be exceeded.

• Applications would meet this 

requirement by using all margins (left, 

right, top, bottom) of at least one inch 

each, and adhering to the page limit for 

the Project Narrative stated in the INF–

05 PA. 

• Should an application not conform 

to these margin or page limits, SAMHSA 

will use the following method to 

determine compliance: The total area of 

the Project Narrative (excluding 

margins, but including charts, tables, 

graphs and footnotes) cannot exceed 

58.5 square inches multiplied by the 

page limit. This number represents the 

full page less margins, multiplied by the 

total number of allowed pages. 

• Space will be measured on the 

physical page. Space left blank within 

the Project Narrative (excluding 

margins) is considered part of the 

Project Narrative, in determining 

compliance. 

To facilitate review of your 

application, follow these additional 

guidelines. Failure to adhere to the 

following guidelines will not, in itself, 

result in your application being 

screened out and returned without 

review. However, the information 

provided in your application must be 

sufficient for review. Following these 

guidelines will help ensure your 

application is complete, and will help 

reviewers to consider your application. 

b The 10 application components 

required for SAMHSA applications 

should be included. These are: 

• Face Page (Standard Form 424, 

which is in PHS 5161–1). 

• Abstract. 

• Table of Contents. 

• Budget Form (Standard Form 424A, 

which is in PHS 5161–1). 

• Project Narrative and Supporting 

Documentation. 

• Appendices. 

• Assurances (Standard Form 424B, 

which is in PHS 5161–1). 

• Certifications (a form in PHS 5161–

1). 

• Disclosure of Lobbying Activities 

(Standard Form LLL, which is in PHS 

5161–1). 

• Checklist (a form in PHS 5161–1). 

b Applications should comply with 

the following requirements: 

• Provisions relating to 

confidentiality, participant protection 

and the protection of human subjects, as 

indicated in the INF–05 PA. 

• Budgetary limitations as indicated 

in Sections I, II, and IV–5 of the INF–

05 PA. 

• Documentation of nonprofit status 

as required in the PHS 5161–1. 

b Pages should be typed singlespaced in black ink with one column 

per page. Pages should not have printing 

on both sides. 

b Please number pages consecutively 

from beginning to end so that 

information can be located easily during 

review of the application. The cover 

page should be page 1, the abstract page 

should be page 2, and the table of 

contents page should be page 3. 

Appendices should be labeled and 

separated from the Project Narrative and 

budget section, and the pages should be 

numbered to continue the sequence. 

b The page limits for Appendices 

stated in the specific funding 

announcement should not be exceeded. 

b Send the original application and 

two copies to the mailing address in the 

funding announcement. Please do not 

use staples, paper clips, and fasteners. 

Nothing should be attached, stapled, 

folded, or pasted. Do not use heavy or 

lightweight paper, or any material that 

cannot be copied using automatic 

copying machines. Odd-sized and 

oversized attachments such as posters 

will not be copied or sent to reviewers. 

Do not include videotapes, audiotapes, 

or CD–ROMs. 

3. Submission Dates and Times:

Applications must be received by 

January 18, 2005. You will be notified 

by postal mail that your application has 

been received. Additional submission 

information is available in the INF–05 

PA in Section IV–3. 

4. Intergovernmental Review:

Applicants for this funding opportunity 

must comply with Executive Order 

12372 (E.O.12372). E.O.12372, as 

implemented through Department of 

Health and Human Services (DHHS) 

regulation at 45 CFR part 100, sets up 

a system for State and local review of 

applications for Federal financial 

assistance. Instructions for complying 

with E.O. 12372 are provided in the 

INF–05 PA in Section IV–4. A current 

listing of State Single Points of Contact 

(SPOCs) is included in the application 

kit and is available at http://

www.whitehouse.gov/omb/grants/

spoc.html.

5. Funding Restrictions: Information 

concerning funding restrictions is 

available in the INF–05 PA in Section 

IV–5. 

V. Application Review Information 

1. Evaluation Criteria: Applications 

will be reviewed against the Evaluation 

Criteria and requirements for the Project 

Narrative specified in Section V. 

Application Review Information in the 

INF–05 PA. The following information 

describes exceptions or limitations to 

the INF–05 PA and provides special 

requirements that pertain only to HBCUNRC grants. Applicants must discuss 

the following requirements in their 

applications, in addition to the 

requirements specified in the INF–05 

PA:

1.1 In ‘‘Section A: Statement of Need,’’

the 4th bullet is deleted. 

1.2 Performance Measurement: All 

SAMHSA grantees are required to 

collect and report certain data so that 

SAMHSA can meet its obligations 

under the Government Performance 

and Results Act (GPRA) and the 

grantees can meet their requirements 

to provide quarterly progress reports 

to SAMHSA as outlined below. All 

applicants must document their 

ability to collect and report data using 

the Knowledge Application Customer 

Satisfaction GPRA tool in ‘‘Section D. 

Evaluation and Data’’. This tool can 

be found at http://www.csatgpra.samhsa.gov (click on ‘Data 

Collection Tools/Instruments’), along 

with instructions for completing it. 

GPRA data must be collected at the 

end of each event and thirty days 

post-event. GPRA data must be 

entered into the GPRA Web system 

within 7 business days of the forms 

being completed. In addition, 80% of 

the participants must be followed up 

on. GPRA data are to be collected and 

then entered into CSAT’s GPRA Data 

Entry and Reporting System (http://

www.csat-gpra.samhsa.gov). Training 

and technical assistance on data 

collecting, as well as data entry, will 

be provided by CSAT.

Federal Register / Vol. 69, No. 210 / Monday, November 1, 2004 / Notices 63407

The HBCU–NRC grantee will be 

required to report quarterly on their 

progress in meeting the Required 

Activities in Section I. Funding 

Opportunity Description of this NOFA 

as well as any other activities proposed 

in the application. At present, 

performance measures for these 

required activities have not been 

established. In ‘‘Section D. Evaluation 

and Data,’’ applicants must describe 

their current ability to collect and report 

data on their progress in meeting the 

Required Activities and any other 

proposed activities. Applicants may also 

propose performance measures to be 

considered by SAMHSA. The HBCU–

NRC steering committee will work to 

build consensus around a common set 

of performance measures aligned with 

the Required Activities and program 

goals in Section I. Funding Opportunity 

Description of this NOFA. The grantee 

will be required to report in narrative 

format on the broad themes around their 

progress in their quarterly reports. Once 

SAMHSA has obtained necessary 

approval from the Office of Management 

and Budget (OMB), further data 

requirements will be mandated based on 

the consensus from the steering 

committee. The grantee may choose at 

any time to begin collecting more 

specific data related to the agreed upon 

measures to assist in building local 

support for continued sustainability for 

their activities once the period of 

Federal funding ends. SAMHSA will 

work with the grantee to assist them in 

building performance measurement 

systems that will provide needed local 

policy information. 

Program activities may be used to 

demonstrate SAMHSA’s contribution to 

the White House Initiative for 

Historically Black Colleges and 

Universities. 

Outcome measures expected from the 

HBCU–NRC: 

• Program reports and evaluations 

that include client satisfaction and 

performance with relevant Government 

Performance and Results Act (GRPA) 

measures. 

• Practice changes resulting from 

participating in the substance abuse and 

HIV prevention, substance abuse 

treatment, and mental health wellness 

tracks at the Dr. Lonnie E. Mitchell 

Substance Abuse Conference. 

• An increase in the number of 

HBCUs that will make substance abuse 

and mental health a major part of their 

student orientations by 25% in year 2 

and 50% in year 3 relative to the 

baseline estimate in year 1 of the 

project. 

• An increase in the number of 

HBCUs that offer courses, 

concentrations, minors and/or majors in 

the fields of substance abuse and/or 

addiction and mental health by 15% in 

year 2 and 30% in year 3 relative to the 

baseline estimate in year 1 of the 

project.

• Number of referrals to mental 

health treatment as a result of suicide 

screenings. 

2. Review and Selection Process:

Information about the review and 

selection process is available in the 

INF–05 PA in Section V–2. 

VI. Award Administration Information 

Award administration information, 

including award notices, administrative 

and national policy requirements, and 

reporting requirements are available in 

the INF–05 PA in Section VI. 

SAMHSA’s standard terms and 

conditions are available at http://

www.samhsa.gov/Grants/generalinfo/

grants_management.aspx.

The HBCU–NRC program requires 

reporting in addition to that outlined in 

Section VI–3 Reporting Requirements of 

the INF–05 PA. The HBCU–NRC is 

expected to provide the following types 

of reports: 

• Quarterly progress reports. 

• Annual progress and fiscal reports. 

• Final summary report at the end of 

the 3-year cycle. 

• Periodic delivery of electronic 

copies of contact and service data. 

Additional reports may be required on 

special projects and activities (e.g., 

collaborative services delivered with 

supplemental funding by another 

Federal agency partnering with 

SAMHSA in this program). 

VII. Agency Contacts for Additional 

Information 

For questions concerning program 

issues contact: 

CSAT: Shannon Taitt, SAMHSA/

CSAT/OPAC, 1 Choke Cherry Road, 

Room 5–1037, Rockville, MD 20857. 

240–276–1691; e-mail: 

shannon.taitt@samhsa.hhs.gov.

CMHS: Roslyn Holliday Moore, 

SAMHSA/CMHS/OPAC, 1 Choke 

Cherry Road, Room 6–1077, Rockville, 

MD 20857. 240–276–1825; e-mail: 

roslyn.moore@samhsa.hhs.gov.

For questions on grants management 

issues contact: Kimberly Pendleton, 

SAMHSA/Division of Grants 

Management, 1 Choke Cherry Road, 

Room 7–1097, Rockville, MD 20857. 

240–276–1421; e-mail: 

kimberly.pendleton@samhsa.hhs.gov.

Dated: October 22, 2004. 

Daryl Kade, 

Director, Office of Policy Planning and 

Budget, Substance Abuse and Mental Health 

Services Administration.

[FR Doc. 04–24300 Filed 10–29–04; 8:45 am] 

BILLING CODE 4162–20–P

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

Open Meeting of the Federal 

Interagency Committee on Emergency 

Medical Services (FICEMS)

AGENCY: Federal Emergency 

Management Agency (FEMA), 

Emergency Preparedness and Response 

Directorate, Department of Homeland 

Security.

ACTION: Notice of open meeting.

SUMMARY: FEMA announces the 

following open meeting. 

Name: Federal Interagency Committee 

on Emergency Medical Services 

(FICEMS). 

Date of Meeting: December 2, 2004. 

Place: Room 2029, National Technical 

Information Service (NTIS), 5285 Port 

Royal Road, Springfield, VA 22161. 

Times: 10:30 a.m.—Main FICEMS 

Meeting; 1 p.m.—FICEMS CounterTerrorism Subcommittee and 

Ambulance Safety Subcommittee. 

Proposed Agenda: Review and 

submission for approval of previous 

FICEMS Committee Meeting Minutes; 

Ambulance Safety Subcommittee and 

Counter-terrorism Subcommittee report; 

Action Items review; presentation of 

member agency reports; and reports of 

other interested parties.

SUPPLEMENTARY INFORMATION: This 

meeting will be open to the public with 

limited seating available on a first-come, 

first-served basis. See the Response and 

Security Procedures below. For those 

driving, parking is complimentary. If 

you are interested in taking METRO, 

blue line, and need shuttle service from/

to METRO/NTIS, please notify Ms. Patti 

Roman when following the response 

procedures below. 

Response Procedures: Committee 

Members and members of the general 

public who plan to attend the meeting 

should contact Ms. Patti Roman, on or 

before Tuesday, November 30, 2004, via 

mail at NATEK Incorporated, 21355 

Ridgetop Circle, Suite 200, Dulles, 

Virginia 20166–8503, or by telephone at 

(703) 674–0190, or via facsimile at (703) 

674–0195, or via e-mail at 

proman@natekinc.com. This is