6686 Federal Register / Vol. 70, No. 25 / Tuesday, February 8, 2005 / Notices 

the appropriate and only qualified 

organization to address the activities 

described under this program 

announcement. 

ATPM is the only association that has 

an established membership of diverse 

professionals that includes teachers, 

practitioners, administrators, and 

residents in the specialty of preventive 

medicine, and graduate students from 

schools of medicine and public health, 

as well as from public health agencies. 

For 62 years, ATPM and its members 

have been in the forefront of advancing, 

promoting, and supporting health 

promotion and disease prevention in the 

education of physicians and other 

health professionals. ATPM provides an 

essential connection to individuals and 

institutions devoted to health promotion 

and disease prevention education. 

C. Funding 

Approximately $15,000,000 is 

available in FY 2005 to fund this award. 

It is expected that the award will begin 

on or before September 1, 2005 and will 

be made for a 12-month budget period 

within a project period of up to 5 years. 

Funding estimates may change. 

D. Where To Obtain Additional 

Information 

For general comments or questions 

about this announcement, contact: 

Technical Information Management, 

CDC Procurement and Grants Office, 

2920 Brandywine Road, Atlanta, GA 

30341–4146, telephone: 770–488–2700. 

For technical questions about this 

program, contact: John (Jack) Rogers, 

Technical Review Administrator, The 

Coordinating Center for Health 

Information and Services (CoCHIS), 

4770 Buford Hwy, Mailstop K–38, 

Atlanta, GA 30341, telephone: 770–488–

2516, e-mail: JJRogers@cdc.gov.

Dated: February 2, 2005. 

William P. Nichols, 

Director, Procurement and Grants Office, 

Centers for Disease Control and Prevention.

[FR Doc. 05–2372 Filed 2–7–05; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

National Center for Environmental 

Health/Agency for Toxic Substances 

and Disease Registry; The Community 

and Tribal Subcommittee of the Board 

of Scientific Counselors (BSC), 

Centers for Disease Control and 

Prevention (CDC), National Center for 

Environmental Health (NCEH)/Agency 

for Toxic Substances and Disease 

Registry (ATSDR): Teleconference 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention, NCEH/ATSDR 

announces the following subcommittee 

meeting:

Name: Community and Tribal 

Subcommittee (CTS). 

Time and Date: 3 p.m.–4:30 p.m., February 

28, 2005. 

Place: The teleconference will originate at 

the National Center for Environmental 

Health/Agency for Toxic Substances and 

Disease Registry in Atlanta, Georgia. Please 

see SUPPLEMENTARY INFORMATION for details 

on accessing the teleconference. 

Status: Open to the public, teleconference 

access limited only by availability of 

telephone ports. 

Purpose: Under the charge of the Board of 

Scientific Counselors, NCEH/ATSDR the 

Community and Tribal Subcommittee will 

provide the BSC, NCEH/ATSDR with a forum 

for community and tribal first-hand 

perspectives on the interactions and impacts 

of the NCEH/ATSDR’s national and regional 

policies, practices and programs. 

Matters to be Discussed: The 

teleconference agenda will include 

discussions on obtaining directions from the 

BSC on their expectations from the CTS; the 

community tool kit; faith-based initiative/

emergency preparedness; partnering with the 

Program Review Committee; and an open 

discussion for other important issues. 

Agenda items are subject to change as 

priorities dictate. 

Supplementary Information: This 

conference call is scheduled to begin at 3 

p.m. eastern standard time. To participate in 

the teleconference, please dial (877) 315–

6535 and enter conference code 383520. 

For Further Information Contact: Sandra 

Malcom, Committee Management Specialist, 

Office of Science, NCEH/ATSDR, M/S E–28, 

1600 Clifton Road, NE., Atlanta, Georgia 

30333, telephone 404/498–0003. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities for 

both CDC and the Agency for Toxic 

Substances and Disease Registry.

Dated: February 1, 2005. 

Alvin Hall, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention.

[FR Doc. 05–2376 Filed 2–7–05; 8:45 am] 

BILLING CODE 4163–70–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Notice of Issuance of Final Policy 

Directive

AGENCY: Administration for Native 

Americans (ANA), HHS.

SUMMARY: The Administration for 

Native Americans (ANA) herein 

describes its issuance of final 

interpretive rules, general statements of 

policy and rules of agency procedure or 

practice relating to the Social and 

Economic Development Strategies 

(SEDS), Language Preservation and 

Maintenance (hereinafter referred to as 

Native Language), and Environmental 

Regulatory Enhancement (hereinafter 

referred to as Environmental) programs.

DATES: January 28, 2005.

FOR FURTHER INFORMATION CONTACT:

Sheila Cooper, Director of Program 

Operations at (877) 922–9262.

SUPPLEMENTARY INFORMATION: 

Background 

Pursuant to section 814 of the Native 

American Programs Act of 1974, as 

amended, 42 U.S.C. 2991b–1, ANA is 

required to provide members of the 

public an opportunity to comment on 

proposed changes in interpretive rules, 

statements of general policy, and rules 

of agency procedure or practice, and to 

give notice of the final adoption of such 

changes at least 30 days before the 

changes become effective. 

The Administration for Native 

Americans (ANA) published a Notice of 

Public Comment (NOPC) in the Federal 

Register on December 27, 2004 (69 FR 

77251), on the proposed ANA policy 

and program clarifications, 

modifications, and activities for the FY 

2005 Program Announcements. The 

NOPC closed January 25, 2005. ANA 

received two public comments: One 

submitted by an inter-tribal non-profit 

organization and one from a federallyrecognized tribe. The comments in 

response to the notice have been 

considered and one has been accepted. 

The clarification will appear in the FY 

2005 SEDS, Native Language and 

Environmental program 

announcements. This notice shall 

Federal Register / Vol. 70, No. 25 / Tuesday, February 8, 2005 / Notices 6687

suffice as the response to comments and 

any public recommendations accepted 

by ANA will be reflected in the FY 05 

program announcements to be 

published in the Federal Register.

Comment and Response 

I. ANA Application Format 

ANA has revised Part Two, 

‘‘Application Review Criteria’’ of the FY 

2005 Program Announcement, 

specifically the Application Submission 

Requirements. Previously, ANA 

required applicants to include and 

count the Objective Work Plan (OWP) 

form (OMB Control Number 0980–

0204), and the Federal and non-Federal 

share line-item budget and budget 

justification narrative in the page 

limitation. In FY 2005, ANA has 

removed the OWP and the line-item 

budget and budget justification narrative 

from the page limitation. With the 

exemption of the OWP and the budget 

section from the page limitation, ANA 

has reduced in the FY 2005 program 

announcements the Application 

Submission Requirements to 40 pages. 

The exemption of the OWP and the 

budget from the page limitation will 

enable applicants applying for multiyear awards to provide more 

information on the proposed project. 

(Legal authority: Section 803(a) and (d) 

and 803C of the Narrative American 

Programs Act of 1974, as amended, 42 

U.S.C. 2991b and 2991b–3.) 

II. Required Forms 

The Grant Application Data Summary 

(GADS) form (OMB Clearance Number 

0970 0261 exp. 03/31/2007) is a new 

ANA form. The Commissioner for the 

Administration for Native Americans is 

required to collect and disseminate 

information related to the social and 

economic conditions of Native 

Americans for inclusion in its Annual 

Report to Congress. The data collected 

on the GADS is required to assist in 

gathering that data. The information is 

also used to ensure that ANA obtains 

the proper number of reviewers to 

review each category of grant 

applications. Although not included in 

prior announcements, GADS received 

OMB approval after the publication of 

the FY 2004 announcement. It will be 

included in this announcement and 

future announcements to be submitted 

as a part of the application package. 

(Legal authority: Section 803B of the 

Native American Programs Act of 1974, 

as amended, 42 U.S.C. 2991B–2.) 

III. Evaluation Criteria 

(a) ANA has modified five evaluation 

criteria titles and adjusted the point 

values and weight of three criteria. In 

ANA’s FY 2004 grant competitions, 

ANA did not rate applications on how 

closely they followed the prescribed 

format. This year, ANA is proposing to 

revise the Evaluation Criteria to provide 

for the award of points in rating 

applications based on whether the 

applicant complied with the 

requirements in the announcement with 

regard to the organization of the 

application. ANA will maintain six 

evaluation criteria. The title and merit 

weights will apply to all three ANA 

program areas. Criterion One was 

retitled from ‘‘Project Introduction and 

Summary/Abstract’’ to ‘‘Introduction 

and Project Summary/Application 

Format’’ and modified to add points for 

the Application Format to clarify the 

importance of adhering to the 

application requirements. Criterion Two 

was retitled from ‘‘Objectives and Need 

for Assistance’’ to ‘‘Need for 

Assistance’’. Criterion Three was 

retitled for clarity from ‘‘Approach’’ to 

‘‘Project Approach’’. Criterion Four was 

retitled from ‘‘Organizational Profiles’’

to ‘‘Organizational Capacity’’ and the 

point value was reduced to allow for the 

increase in weight and points awarded 

under Criterion One. Criterion Five was 

retitled for clarity from ‘‘Results or 

Benefits Expected’’ to ‘‘Project Impact/

Evaluation’’ and the point value was 

reduced to allow for the increase in 

weight and points awarded under 

Criterion Six. For FY 2005 program 

announcements the titles and assigned 

point criteria values are: Criterion 

One—Introduction and Project 

Summary/Application Format (10 pts.); 

Criterion Two—Needed for Assistance 

(20 pts.); Criterion Three—Project 

Approach (25 pts.); Criterion Four—

Organizational Capacity (15 pts.); 

Criterion Five—Project Impact/

Evaluation (15 pts.); Criterion Six—

Budget and Budget Justification/Cost 

Effectiveness (15 pts.). (Legal authority: 

Section 803(a) and (d) and 803C of the 

Native American Programs Act of 1974, 

as amended, 42 U.S.C. 2991b and 

2991b–3.)

(b) In the FY 2004 Program 

Announcement within the ANA 

Criterion Five, ANA used the term 

‘‘Performance’’ Indicator. In the FY 2005 

Program Announcement this term will 

be changed to ‘‘Impact’’ Indicator to be 

consistent with the Native American 

Programs Act of 1974, as amended. 

(Legal authority: Section 803(a) and (d) 

and 803C of the Native American 

Programs Act of 1974, as amended, 42 

U.S.C. 2991b and 2991b–3.) 

(c) Standard and Required Impact 

Indicators: As ANA continues to 

improve its competitive grant program 

ANA has modified (through addition or 

deletion) its collection of impact 

indicators under each of its programs 

(SEDS, Native Language and 

Environmental). The modified impact 

indicators will continue to be used to 

inform Congress and the public on the 

effectiveness, success and impact that 

ANA programs have in Native American 

communities and on behalf of Native 

American families. Two impact 

indicators will be required across all 

three program areas to serve as a 

common baseline of data that is 

required to be reported in ANA’s 

legislation to demonstrate the diversity 

of projects and to monitor the impact of 

projects on the community. The FY 

2005 program announcements still 

require five impact indicators to be 

submitted by the applicant under 

Criterion Five. ANA has standardized 

for consistency and program 

performance data collection two of the 

required impact indicators across all 

three program areas (SEDS, Native 

Language and Environmental). The two 

standard required impact indicators are: 

(1) Number of partnerships formed and 

(2) the amount of dollars leveraged 

beyond the required NFS match. In 

addition to the two standard required 

impact indicators, an applicant must 

also submit three additional indicators 

either selected from a suggested list in 

each program announcement or 

applicant project-specific impact 

indicators. (Legal authority: Section 

803(a) and (d), 803B and 803C of the 

Native American Programs Act of 1974, 

as amended, 42 U.S.C. 2991b, 2991b–2 

and 2991b–3.) 

Discussion on Comment: A comment 

was received that expressed concern 

about how ANA’s peer reviewers would 

interpret ANA’s standard impact 

indicator (2) ‘‘amount of dollars 

leveraged beyond the required nonfederal share match’’. The commenter is 

concerned that peer reviewers will 

negatively perceive any leveraged 

resources identified by the applicant in 

the request for federal funds as an 

indication that the ANA project funds 

are not needed by the applicant. The 

commenter requested that ANA add a 

disclaimer to the program 

announcements indicating that 

information pertaining to leveraged 

resources will not be a negative factor in 

the review process.

Response: ANA annually trains peer 

reviewers and provides specific 

guidance on how to analyze proposed 

projects and the application scoring 

process as it relates to the evaluation 

criteria. ANA selected the ‘‘leveraged 

resource’’ indicator as a standard for all 

three ANA program areas because it will 

6688 Federal Register / Vol. 70, No. 25 / Tuesday, February 8, 2005 / Notices 

yield useful information to support an 

analysis of how ANA’s limited funding 

impacts native communities. The 

applicant’s response to this indicator 

will also demonstrate how the leveraged 

resources contribute to the impact an 

ANA funded project has in a 

community. The ANA definition for 

‘‘leveraged resources’’ is the total dollar 

value of all non-ANA resources that are 

committed to a proposed ANA project 

and are supported by documentation 

that exceed the 20% non-Federal match 

required for an ANA grant. Such 

resources may include any natural, 

financial and physical resources 

available within the tribe, organization, 

or community to assist in the successful 

completion of the project. An example 

would be a letter from an organization 

that agrees to provide a supportive 

action, product, and service, human or 

financial contribution that will add to 

the potential success of the project. 

ANA has considered the comment to 

add a disclaimer to the program 

announcements and has determined 

that ANA guidance and peer review 

procedures are sufficient to ensure a fair 

and reasonable review is conducted on 

all applications requesting federal 

funds. The required ANA impact 

indicator will remain as a standard data 

element to be used for ANA program 

data collection purposes. 

The optional impact indicators for 

SEDS are: (1) Number of infrastructures 

and administrative systems, including 

policies and procedures developed and 

implemented; (2) number of codes or 

ordinances developed and 

implemented; (3) number of people to 

successfully complete a workshop/

training; (4) number of children, youth, 

families or elders assisted or 

participating; (5) number of volunteer 

hours; (6) number of faith-based or 

community-based partnerships; (7) 

number of jobs created; (8) number of 

community-based small businesses 

established or expanded; (9) 

identification of Tribal or Village 

government business, industry, energy 

or financial codes or ordinances that 

were adopted or enacted; and (10) 

number of micro-businesses started. The 

optional impact indicators for Language, 

Category I are: (1) Number of surveys 

completed; (2) percent and number of 

community members assessed; (3) the 

rate of language loss or gain; (4) number 

of elders consulted; (5) number of 

language experts consulted; (6) number 

of community goals developed to 

preserve the native language; and (7) 

number of infrastructure and 

administrative systems, including 

policies and procedures developed and 

implemented. (Legal authority: Section 

803(a) and (d), 803B and 803C of the 

Native American Programs Act of 1974, 

as amended, 42 U.S.C. 2991b, 2991b–2 

and 2991b–3.)

The optional impact indicators for 

Language, Category II are: (1) Number of 

people involved in establishment or 

operation of project; (2) number of 

training classes or workshops held to 

teach language; (3) number and type of 

materials developed; (4) number of 

media products developed; (5) number 

of translations achieved; (6) number of 

individuals who increased in ability to 

speak the language; (7) number of 

participants who achieve fluency; (8) 

number of settings the language is 

spoken in; and (9) number of 

infrastructure and administrative 

systems, including policies and 

procedures developed and 

implemented. (Legal authority: Section 

803(a) and (d), 803B and 803C of the 

Native American Programs Act of 1974, 

as amended, 42 U.S.C. 2991b, 2991b–2 

and 2991b–3.) 

The optional impact indicators for 

Environmental are: (1) Number of 

environmental regulations, codes or 

ordinances created; (2) number of 

people to successfully complete a 

workshop/training; (3) number of 

workshops/trainings provided; (4) types 

of capacity building systems created and 

implemented to support environmental 

program functions; (5) identification of 

Tribal or Village government 

regulations, codes or ordinances that 

were enacted and adopted; (6) number 

of regulations, codes or ordinances 

successfully enforced; and (7) number of 

infrastructure and administrative 

systems, including policies and 

procedures developed and 

implemented. ANA may add/delete 

optional impact indicators to program 

announcements as necessary to support 

ANA initiatives. (Legal authority: 

Section 803(a) and (d), 803B and 803C 

of the Native American Programs Act of 

1974, as amended, 42 U.S.C. 2991b, 

2991b–2, and 2991b–3.) 

Discussion on Comment: One 

comment was received that pertained to 

this section. The commenter suggested 

that ANA clarify in the evaluation 

criteria section the request to submit 

five impact indicators. The commenter 

offered text to clearly define the 

applicant’s option to select three 

indicators from the suggested program 

announcement list or to submit 

applicant defined project indicators or 

to submit a combination of ANA 

suggested indicators and applicant 

defined indicators. 

Response: ANA has reviewed the 

comment and concurs there is a need to 

clearly describe the optional impact 

indicators. ANA will incorporate the 

following text in the three FY 2005 ANA 

program announcements. The following 

paragraph will precede the discussion 

on impact indicators: 

In addition to the two standard 

required impact indicators, an applicant 

must also submit three additional 

impact indicators. These three impact 

indicators may be selected from the 

suggested list given below, or they may 

be developed for the specific proposed 

project, or the applicant may submit a 

combination of both the ANA suggested 

indicators and applicant project-specific 

indicators. (Legal authority: Section 

803(a) and (d), 803B and 803C of the 

Native American Programs Act of 1974, 

as amended, 42 U.S.C. 2991b, 2991b–2 

and 2991b–3.) 

(d) ANA corrected the timeframe for 

use of research data in an application 

from 48 to 36 months under the 

Language, Category II program.

IV. ANA Funding Restrictions 

In ANA’s effort to streamline its 

program announcements and to clarify 

Funding Restriction Policies for 

applicants, ANA has relocated general 

policy statements from the criterion 

section of the program announcement 

text to the Funding Restrictions Policies 

section. Formerly listed under ‘‘ANA 

Administrative Policies’’, the bullet 

point on funding requests for feasibility 

studies, business plans, marketing plans 

or written materials and the bullet point 

on proposals from consortia of Tribes 

were moved to the section entitled 

‘‘ANA Funding Restrictions’’. These 

restrictions are already reflected in the 

ANA eligibility restrictions at 45 CFR 

1336.33(b)(2) and (b)(6). The bullet 

point on the social service delivery 

programs was inadvertently omitted 

from previous announcements, but ANA 

is statutorily required to address these 

programs. The restriction already 

appears in the ANA eligibility 

regulation at 45 CFR 1336.33(b)(3). ANA 

will include the following funding 

restrictions in all program 

announcements in compliance with 

sections 803(a) and (d) and 803C of the 

Native American Programs Act of 1974 

as amended, 42 U.S.C. 2991b and 

2991b–3 and 45 CFR 1336: 

• Projects that request funds for 

feasibility studies, business plans, 

marketing plans or written materials, 

such as manuals, that are not an 

essential part of the applicant’s project 

or SEDS long-rage development plan. 

(Legal authority: Sections 803(a) and (d) 

and 803C of the Native American 

Programs Act of 1974 as amended, 42 

Federal Register / Vol. 70, No. 25 / Tuesday, February 8, 2005 / Notices 6689

U.S.C. 2991b and 2991b–3 and 45 CFR 

1336.33.) 

• The support of ongoing social 

service delivery programs or the 

expansion, or continuation, of existing 

social service delivery programs. (Legal 

authority: Sections 803(a) and (d) and 

803C of the Native American Programs 

Act of 1974 as amended, 42 U.S.C. 

2991b and 2991b–3 and 45 CFR 

1336.33.) 

• Proposals from consortia of Tribes 

that are not specific to support from and 

roles of member Tribes. An application 

from a consortium must have goals and 

objectives that will create positive 

impacts and outcomes in the 

communities of its members. ANA will 

not fund activities by a consortium of 

Tribes that duplicates activities for 

which member Tribes also receive 

funding from ANA. (Legal authority: 

Sections 803(a) and (d) and 803C of the 

Native American Programs Act of 1974 

as amended, 42 U.S.C. 2991b and 

2991b–3 and 45 CFR 1336.33.) 

V. Initial Screening 

Prior to competitive panel review, all 

applications are pre-screened for 

completeness. Previously, each 

application submitted to ANA in 

response to a program announcement 

was pre-screened to ensure that (a) the 

application was received by the program 

announcement closing date; (b) the 

application was submitted in 

accordance with Section IV, 

‘‘Application and Submission 

Information’’; (c) the applicant is 

eligible for funding in accordance with 

Section III, ‘‘Eligibility Information’’; (d) 

the applicant submitted the proper 

supporting documentation such as proof 

of non-profit status, resolutions, and 

required government forms; (e) an 

authorized representative has signed the 

application; and (f) the applicant has a 

DUNS number. An application that does 

not meet (a) through (f) immediately 

above is determined to be incomplete 

and is excluded from the competitive 

review process. 

In an effort to ensure consistency with 

the way ACF evaluates competitive 

discretionary grant applications, ACF 

has changed its policy to include only 

two enforceable screen-out criteria: 

Timeliness and compliance with stated 

funding limitations. Additionally, ACF 

has approved ANA’s request to include 

two additional screen-out criteria: 

Inclusion of a signed and dated 

resolution by the governing body and, 

for applicants that are not Tribes or 

Alaska Native Village governments, 

submission of a resolution and proof 

that a majority of the governing board of 

directors is representative of the 

community to be served. 

Consequently, ANA will screen 

applications for completeness prior to 

the competitive panel review using the 

following elements: (a) The application 

is received by ANA on or before the 

published program announcement 

closing date; (b) the federal request does 

not exceed the ceiling award amount as 

published in the program 

announcement; (c) the application 

includes a signed and dated resolution 

of the governing body; and (d) if the 

applicant is not a Tribe or Alaska Native 

Village government, the native nonprofit organization submits a resolution 

and proof that a majority of the 

governing board of directors is 

representative of the community to be 

served. An application that does not 

contain these elements will be 

considered incomplete and excluded 

from the competitive review process.

VI. Administrative Policies 

In ANA’s effort to streamline its 

program announcements and to clarify 

administrative policies for applicants, 

ANA has relocated general policy 

statements from the Criterion section of 

the program announcement text to the 

Administrative Policies section. ANA 

has also clarified administrative policies 

that have historically prompted 

numerous questions and created 

application and project development 

inconsistencies. For example, ANA 

removed ‘‘Organizational Capacity’’ and 

reworded the first bullet below for 

clarity. The second bullet below 

clarifies the administrative policy on the 

funding of projects versus programs to 

include the term ‘‘short-term’’ to 

communicate that projects will not be 

awarded for longer than three years in 

most program areas. The third and 

fourth bullets were moved from 

Definitions to Administrative Policies to 

establish the policy to determine project 

progress before additional funding is 

committed. For the purposes of clarify, 

the fifth bullet combined and reworded 

the requirement for community 

involvement under the definition for 

‘‘Community Involvement’’ with a 

similar paragraph under ‘‘Need for 

Assistance’’. The sixth bullet supports 

the needs of ANA and was reworded for 

clarity. The seventh bullet was also 

reworded for clarity. The policy on the 

treatment of multiple applications and 

applications from Tribal components 

has been reworded for clarity and 

broken into two separate points to 

ensure application to both Tribes and 

non-profit organizations. The revised 

policy is contained in the eighth and 

ninth bullet points on the list below. 

The ninth bullet corrects the inadvertent 

omission of the categories that apply to 

the board of directors for non-profit 

applicants. ANA will now include the 

following administrative policies in 

each program announcement (legal 

authority: Sections 803(a) and (d) and 

803C of the native American Programs 

Act of 1974, as amended, and 45 U.S.C. 

2991b and 2991b–3): 

Applicants must comply with the 

following administrative policies: 

• All funded applications will be 

reviewed to ensure that the applicant 

has provided a positive statement to 

give credit to ANA on all material 

developed using ANA funds. 

• ANA funds short-term projects, not 

programs. Proposed projects must have 

definitive goals and objectives that will 

be achieved by the end of the project 

period. All projects funded by ANA 

must be completed, or self-sustaining or 

supported by other-than-ANA funding 

at the end of the project period. 

• Before funding the second or third 

year of a multi-year grant, ANA will 

require verification and support 

documentation from the grantee that 

objectives and outcomes proposed in 

the preceding year were accomplished 

and that the non-federal share was met. 

• ANA reviews the quarterly and 

annual reports of grantees to determine 

if the grantee is meeting its goals, 

objectives and activities identified in 

the Objective Work Plan (OWP). 

• Applications from national and 

regional organizations must clearly 

demonstrate a need for the project, 

explain how the project originated, 

discuss the community-based delivery 

strategy of the project, identify and 

describe the intended beneficiaries, 

describe and relate the actual project 

benefits to the community and 

organization and describe a communitybased delivery system. National and 

regional organizations must describe 

their membership, define how the 

organization operates and demonstrate 

Native community and/or Tribal 

government support for the project. The 

type of community to be served will 

determine the type of documentation 

necessary to support the project.

• Applicants proposing an Economic 

Development project must address the 

project’s viability. A business plan, if 

applicable, must be included to describe 

the projects feasibility, cash flow and 

approach for the implementation and 

marketing of the business. 

• ANA will review proposed projects 

to ensure applicants have considered all 

resources available to the community to 

support the project. 

• ANA will not accept applications 

from Tribal components that are 

6690 Federal Register / Vol. 70, No. 25 / Tuesday, February 8, 2005 / Notices 

Tribally authorized divisions unless the 

ANA application includes a Tribal 

resolution. 

• ANA will only accept one 

application per eligible entity. The first 

application received by ANA will be the 

application considered for competition 

unless ANA is notified in writing which 

application should be considered for 

competitive review. 

• If the applicant, other than a Tribe 

or an Alaska Native Village government, 

is proposing a project benefiting Native 

Americans, Alaska Natives, or both, the 

applicant must provide assurance that 

its duly elected or appointed board of 

directors is representative of the 

community to be served. Applicants 

must provide information that at least a 

majority of the individuals serving on a 

non-profit applicant’s board fall into 

one or more of the following categories: 

(1) A current or past member of the 

community to be served; (2) a 

prospective participant or beneficiary of 

the project to be funded; or (3) have a 

cultural relationship with the 

community to be served. (Legal 

authority: 45 CFR 1336.33 (a).) 

VII. Funding Thresholds 

This is a clarification to the ANA 

Environmental Regulatory Enhancement 

program announcement funding 

threshold. The funding threshold for the 

Environmental Regulatory Enhancement 

program will be $50,000.00 (floor 

amount) to $250,000.00 (ceiling amount) 

per budget period. Applications 

exceeding the $250,000.00 threshold 

will be considered non-responsive and 

will not be considered for funding 

under this announcement. (Legal 

authority: Sections 803(a) and (d) and 

803C of the Native American Programs 

Act of 1974, as amended 42 U.S.C. 

2991b and 2991b–3.) 

VIII. Definitions

The following definitions will be used 

in the appropriate program-specific FY 

2005 program announcements. ANA has 

clarified many areas that applicants 

have historically found difficult to 

understand and that have previously 

prompted numerous questions and 

created application and project 

development inconsistencies. The ANA 

program announcements will now 

include additional definitions for the 

following terms: 

Consortium/Tribal Village: A group of 

Tribes or Villages that join together for 

long-term purposes or for the purpose of 

an ANA grant. 

Impact Indicators: Measurement 

descriptions used to identify the 

outcomes or results of the project. 

Outcomes or results must be 

quantifiable, measurable, verifiable and 

related to the outcome of the project to 

determine that the project has achieved 

its desired objective and can be 

independently verified through ANA 

monitoring and evaluation. 

Objective Work Plan (OWP): The 

project plan the applicant will use in 

meeting the results and benefits 

expected for the project. The results and 

benefits are directly related to the 

Impact Indicators. The OWP provides 

detailed descriptions of how, when, 

where, by whom and why activities are 

proposed for the project and is 

complemented and condensed in the 

OWP. ANA will require separate OWPs 

for each year of the project. (Form 

OMB# 0980–0204 exp 10/31/2006.) 

Minor Renovation or Alteration: Work 

required to change the interior 

arrangements or other physical 

characteristics of an existing facility, or 

install equipment so that it may be more 

effectively used for the project. Minor 

alteration and renovation may include 

work referred to as improvements, 

conversion, rehabilitation, remodeling 

or modernization, but is distinguished 

from construction and major 

renovations. A minor alteration and/or 

renovation must be incidental and 

essential for the project (‘‘incidental’’

meaning the total alteration and 

renovation budget must not exceed the 

lesser of $150,000 or 25 percent of total 

direct costs approved for the entire 

project period). 

Total Approved Project Costs: The 

sum of the Federal request plus the nonFederal share. (Legal authority: Section 

803(a) and (d) and 803C of the Native 

American Programs Act of 1974, as 

amended, 42 U.S.C. 2991b and 2991b–

3). 

IX. Application Review Information 

To ensure that grantees fulfill their 

obligations to ANA, ANA is including a 

review of grantees’ past performance 

when considering the applicant for a 

new or ongoing award under all three 

program areas. The inclusion of this 

item in the application consideration 

process will assist ANA in making its 

funding decisions on whether or not to 

award to a particular grant applicant. 

Factors that may impact a grantee’s past 

performance are their timeliness to 

report submission requirements, timely 

use and proper expenditure of the grant 

award funds and the administrative ease 

of closing out the grantee at the end of 

the award period.

The following statement is included 

under the Application Consideration for 

the Review and Selection Process: 

Application Consideration: The 

Commissioner’s funding decision is 

based on an analysis of the application 

by the review panel, panel review scores 

and recommendations; an analysis by 

ANA staff; review of previous ANA 

grantee’s past performance; comments 

from the State and Federal agencies 

having contract and grant performancerelated information; and other interested 

parties. 

X. Native Language Program Area 

The title for Native Language Category 

I grants has been changed from ‘‘Native 

Language Category I Planning’’ to 

‘‘Native Language Category I 

Assessment’’. The change clarifies the 

purpose of the 12-month Category I 

grant. (Legal authority: Section 803(a) 

and (d) and 803C of the Native 

American Programs Act of 1974, as 

amended, 42 U.S.C. 2991b and 2991b–

3.) 

The FY 2005 Native Language 

Program Announcement expands the 

Category I-Program Area of Interest and 

the necessary assessment data to be 

collected. ANA recommends each 

applicant consider the Program Area of 

Interest in the development of a project. 

The Program Area of Interest under 

Category I is ‘‘A project for data 

collection and compilation that surveys 

the current language status through a 

‘‘formal’’ method (e.g., work performed 

by a linguist and/or a language survey 

conducted by community members) or 

an ‘‘informal’’ method (e.g., a 

community consensus of the language 

status based on elders, Tribal scholars 

and/or other community members) with 

the development of long-range language 

preservation goals and uses elders in the 

development of these goals. This 

assessment data should capture, at a 

minimum, the following data: Number 

of speakers; age of speakers; gender of 

speakers; level(s) of fluency; number of 

first language speakers (native language 

as the first language acquired); number 

of second language speakers (native 

language as the second language 

acquired); where native language is used 

(e.g., home, court system, religious 

ceremonies, church, media, school 

governance or cultural activities); source 

of data (formal and/or informal); and 

rate of language loss or gain. (Legal 

authority: Section 803(a) and (d) and 

803C of the Native American Programs 

Act of 1974, as amended, 42 U.S.C. 

2991b and 2991b–3.) 

Additional Information 

Technical Correction: Upon general 

review of the Notice, Section V: 

Screening Elements, item ‘‘d’’ will be rewritten as ‘‘Each application submitted 

under an ANA program announcement 

will undergo a pre-review screening for: 

Federal Register / Vol. 70, No. 25 / Tuesday, February 8, 2005 / Notices 6691

* * * (d) if the applicant is not a Tribe 

or Alaska Native Village government, 

the applicant must submit proof that a 

majority of the governing board of 

directors is representative of the 

community to be served.’’ The reference 

to Native non-profit organizations was 

inadvertently placed in the text. This 

correction will be reflected in all three 

FY 05 ANA program announcements. 

Technical Correction: Upon general 

review of the Notice, Section II. 

Evaluation Criteria (a) additional text is 

needed to clarify the use of the ANA 

Project Abstract form in relation to 

Criteria One: Introduction and Project 

Summary/Application Format. 

Instructional text will be inserted in the 

ANA evaluation Criterion One to state 

‘‘In addition to using the ANA Project 

Abstract form, applicants will submit a 

brief narrative summary of the project 

that provides more information on the 

applicant and proposed project.’’ The 

additional text will provide clarity to 

the applicant as they respond to the 

program announcement.

Dated: January 31, 2005. 

Quanah Crossland Stamps, 

Commissioner, Administration for Native 

Americans.

[FR Doc. 05–2325 Filed 2–7–05; 8:45 am] 

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N–0016]

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Evaluation of 

Consumer-Friendly Formats for Brief 

Summary in Direct-to-Consumer Print 

Advertisements for Prescription 

Drugs: Study 1

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on a 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register

concerning each proposed collection of 

information and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

a study of consumer evaluations of 

various consumer-friendly formats for 

the brief summary in direct-to-consumer 

(DTC) prescription drug print 

advertisements.

DATES: Submit written or electronic 

comments on the collection of 

information by April 11, 2005.

ADDRESSES: Submit electric comments 

on the collection of information to: 

http://www.fda.gov/dockets/ecomments. 

Submit written comments on the 

collection of information to the Division 

of Dockets Management (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, rm. 1061, Rockville, MD 

20852. All comments should be 

identified with the docket number 

found in brackets in the heading of this 

document.

FOR FURTHER INFORMATION CONTACT:

Karen Nelson, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1482.

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document.

With respect to each of the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology.

Evaluation of Consumer-Friendly 

Formats for Brief Summary in Directto-Consumer (DTC) Print 

Advertisements for Prescription Drugs: 

Study 1

Section 1701(a)(4) of the Public 

Health Service Act (42 U.S.C. 

300u(a)(4)) authorizes FDA to conduct 

research relating to health information. 

Section 903(b)(2)(c) of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 393(b)(2)(c)) authorizes FDA to 

conduct research relating to drugs and 

other FDA regulated products in 

carrying out the provisions of the act. 

Under the act, a drug is misbranded if 

its labeling or advertising is false or 

misleading. In addition, section 502(n) 

of the act (21 U.S.C. 352(n)) specifies 

that advertisements for prescription 

drugs and biological products must 

provide a true statement of information 

‘‘***in brief summary***’’ about the 

advertised product’s ‘‘***side effects, 

contraindications and 

effectiveness***.’’ Generally, the 

display text of an advertisement 

presents a fair and balanced disclosure 

of the product’s indication and benefits 

and the product’s side effects and 

contraindications. The prescription drug 

advertising regulations (§ 202.1(e)(3)(iii) 

(21 CFR 202.1(e)(3)(iii))) specify that the 

information about risks must include 

each specific side effect and 

contraindication’’ from the advertised 

drug’s approved labeling. The regulation 

also specifies that the phrase ‘‘side 

effect and contraindication’’ refers to all 

of the categories of risk information 

required in the approved product 

labeling written for health professionals, 

including the Warnings, Precautions, 

and Adverse Reactions sections. Thus, 

every risk in an advertised drug’s 

approved labeling must be addressed to 

meet these regulations.

In recent years, FDA has become 

concerned about the adequacy of the 

brief summary in DTC print 

advertisements. Although advertising of 

prescription drugs was once primarily 

addressed to health professionals, 

consumers increasingly have become a 

primary target audience, and DTC 

advertising has dramatically increased 

in the past few years. Results of the FDA 

2002 survey on DTC advertising 

(available at www.fda.gov/cder/ddmac/

researchka.htm) provide some 

information regarding the extent to 

which consumers read these ads and the 

brief summary that accompanies the 

main ad—41 percent of respondents in 

2002 reported they do not usually read 

any of the brief summary. Use of the 

brief summary was a function of 

whether they have an interest in the