18414 Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–E–1657] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; JUXTAPID 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

JUXTAPID and is publishing this notice 

of that determination as required by 

law. FDA has made the determination 

because of the submission of an 

application to the Director of the U.S. 

Patent and Trademark Office (USPTO), 

Department of Commerce, for the 

extension of a patent which claims that 

human drug product. 

ADDRESSES: Submit electronic 

comments to http://

www.regulations.gov. Submit written 

petitions (two copies are required) and 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

Submit petitions electronically to 

http://www.regulations.gov at Docket 

No. FDA–2013–S–0610. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of 

Management, Food and Drug 

Administration, 10001 New Hampshire 

Ave., Hillandale Campus, Rm. 3180, 

Silver Spring, MD 20993, 301–796– 

7900. 

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

and the Generic Animal Drug and Patent 

Term Restoration Act (Pub, L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug product, animal drug product, 

medical device, food additive, or color 

additive) was subject to regulatory 

review by FDA before the item was 

marketed. Under these acts, a product’s 

regulatory review period forms the basis 

for determining the amount of extension 

an applicant may receive. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of the U.S. Patent and 

Trademark Office (USPTO) may award 

(for example, half the testing phase must 

be subtracted as well as any time that 

may have occurred before the patent 

was issued), FDA’s determination of the 

length of a regulatory review period for 

a human drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(1)(B). 

FDA has approved for marketing the 

human drug product JUXTAPID 

(lomitapide mesylate). JUXTAPID is 

indicated as an adjunct to a low-fat diet 

and other lipid-lowering treatments, 

including LDL apheresis where 

available, to reduce low-density 

lipoprotein cholesterol, total 

cholesterol, apolipoprotein B, and nonhigh-density lipoprotein cholesterol in 

patients with homozygous familial 

hypercholesterolemia. Subsequent to 

this approval, the USPTO received a 

patent term restoration application for 

JUXTAPID (U.S. Patent No. 5,712,279) 

from Aegerion Pharmaceuticals, Inc., 

and the USPTO requested FDA’s 

assistance in determining this patent’s 

eligibility for patent term restoration. In 

a letter dated January 31, 2014, FDA 

advised the USPTO that this human 

drug product had undergone a 

regulatory review period and that the 

approval of JUXTAPID represented the 

first permitted commercial marketing or 

use of the product. Thereafter, the 

USPTO requested that FDA determine 

the product’s regulatory review period. 

FDA has determined that the 

applicable regulatory review period for 

JUXTAPID is 6,002 days. Of this time, 

5,705 days occurred during the testing 

phase of the regulatory review period, 

while 297 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 355(i)) became effective: July 18, 

1996. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on July 18, 1996. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the FD&C Act: February 29, 

2012. FDA has verified the applicant’s 

claim that the new drug application 

(NDA) for Juxtapid (NDA 203–858) was 

submitted on February 29, 2012. 

3. The date the application was 

approved: December 21, 2012. FDA has 

verified the applicant’s claim that NDA 

203–858 was approved on December 21, 

2012. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 5 years of patent 

term extension. 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) either 

electronic or written comments and ask 

for a redetermination by June 5, 2015. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

October 5, 2015. To meet its burden, the 

petition must contain sufficient facts to 

merit an FDA investigation. (See H. 

Rept. 857, part 1, 98th Cong., 2d sess., 

pp. 41–42, 1984.) Petitions should be in 

the format specified in 21 CFR 10.30. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) electronic or written 

comments and written or electronic 

petitions. It is only necessary to send 

one set of comments. Identify comments 

with the docket number found in 

brackets in the heading of this 

document. If you submit a written 

petition, two copies are required. A 

petition submitted electronically must 

be submitted to http://

www.regulations.gov, Docket No. FDA– 

2013–S–0610. Comments and petitions 

that have not been made publicly 

available on http://www.regulations.gov 

may be viewed in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: April 1, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–07809 Filed 4–3–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Office of Direct Service and 

Contracting Tribes; National Indian 

Health Outreach and Education II 

Announcement Type: New Limited 

Competition. 


tkelley on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Notices 18415 

Funding Announcement Number: 

HHS–2015–IHS–NIHOE–0002. 

Catalog of Federal Domestic Assistance 

Number: 93.933. 

Key Dates 

Application Deadline Date: June 19, 

2015. 

Review Date: July 6–10, 2015. 

Earliest Anticipated Start Date: 

September 30, 2015. 

Proof of Non-Profit Status Due Date: 

July 3, 2015. 

I. Funding Opportunity Description 

Statutory Authority 

The Indian Health Service (IHS) is 

accepting competitive applications for 

two limited competition cooperative 

agreements under the National Indian 

Health Outreach and Education 

(NIHOE) program: the Behavioral 

Health—Methamphetamine and Suicide 

Prevention Intervention (MSPI) outreach 

and education award and the Human 

Immunodeficiency Virus/Acquired 

Immune Deficiency Syndrome (HIV/

AIDS) outreach and education award. 

The Behavioral Health—MSPI outreach 

and education award is funded by IHS 

and is authorized under the Snyder Act, 

codified at 25 U.S.C. § 13; the Transfer 

Act, codified at 42 U.S.C. § 2001; the 

Consolidated Appropriations Act, 2014, 

Public. Law 113–76. The HIV/AIDS 

outreach and education award is funded 

by the Office of the Secretary (OS), 

Department of Health and Human 

Services (HHS). Funding for the HIV/

AIDS award will be provided by OS via 

an Intra-Departmental Delegation of 

Authority dated to IHS to permit 

obligation of funding appropriated by 

the Consolidated Appropriations Act, 

2014, Public Law 113–76. Each award is 

funded through a separate funding 

stream by each respective Agency’s 

appropriations. The awardee is 

responsible for accounting for each of 

the two awards separately and must 

provide two separate financial reports 

(one for each award), as indicated 

below. This program is described in the 

Catalog of Federal Domestic Assistance 

under 93.933. 

Background 

The NIHOE program carries out 

health program objectives in the 

American Indian/Alaska Native (AI/AN) 

community in the interest of improving 

Indian health care for all 566 Federallyrecognized Tribes including Tribal 

governments operating their own health 

care delivery systems through Indian 

Self-Determination and Education 

Assistance Act (ISDEAA) contracts and 

compacts with the IHS and Tribes that 

continue to receive health care directly 

from the IHS. This program addresses 

health policy and health programs 

issues and disseminates educational 

information to all AI/AN Tribes and 

villages. The NIHOE IIMSPI and HIV/

AIDS awards require that public forums 

be held at Tribal educational consumer 

conferences to disseminate changes and 

updates in the latest health care 

information. These awards also require 

that regional and national meetings be 

coordinated for information 

dissemination as well as for the 

inclusion of planning and technical 

assistance and health care 

recommendations on behalf of 

participating Tribes to ultimately inform 

IHS and the Department of Health and 

Human Services (HHS) based on Tribal 

input through a broad based consumer 

network. 

Purpose 

The purpose of these cooperative 

agreements is to further IHS health 

program objectives in the AI/AN 

community with expanded outreach 

and education efforts for the MSPI and 

HIV/AIDS programs on a national scale 

and in the interest of improving Indian 

health care. This announcement 

includes two separate awards, each of 

which will be awarded as noted below. 

The purpose of the MSPI award is to 

further the goals of the national MSPI 

program. The MSPI is a national 

demonstration project aimed at 

addressing the dual problems of 

methamphetamine use and suicide in 

Indian Country. The MSPI supports an 

AI/AN community driven focus on the 

utilization and development of 

evidence-based and practice-based 

intervention models that promote a 

culturally appropriate prevention, 

treatment, and postvention approach to 

methamphetamine use and suicide. The 

six goals of the MSPI are to effectively 

prevent, reduce, or delay the use and/ 

or spread of methamphetamine use; 

build on the foundation of prior 

methamphetamine and suicide 

prevention and treatment efforts in 

order to support the IHS, Tribes, and 

urban Indian health organizations in 

developing and implementing Tribal 

and/or culturally appropriate 

methamphetamine and suicide 

prevention and early intervention 

strategies; increasing access to 

methamphetamine and suicide 

prevention services; improving services 

for behavioral health issues associated 

with methamphetamine use and suicide 

prevention; promoting the development 

of new and promising services that are 

culturally and community relevant; and 

demonstrating efficacy and impact. 

[Note: While the national MSPI program 

includes outreach to urban Indian 

organizations, outreach aimed specifically at 

urban Indian organizations will be addressed 

in a separate award announcement. However, 

materials developed by the grantee in the 

(NIHOE–II) MSPI award described in this 

announcement may be distributed by IHS to 

urban Indian organizations, at the discretion 

of the Agency.] 

The purpose of the HIV/AIDS award 

is to further the goals of the national 

HIV/AIDS program. HIV and AIDS are a 

critical and growing health issue within 

the AI/AN population. The IHS National 

HIV/AIDS Program seeks to avoid 

complacency and to increase awareness 

of the impact of HIV/AIDS on AI/ANs. 

All activities are part of the IHS’s 

implementation plan to meet the three 

goals of the President’s National HIV/

AIDS Strategy (NHAS) to reduce the 

number of people who become infected 

with HIV, increase access to care and 

optimize health outcomes for people 

living with HIV, and reduce HIV-related 

disparities. This population faces 

additional health disparities that 

contribute significantly to the risk of 

HIV transmission such as substance 

abuse and sexually transmitted 

infections. Amongst AI/AN people, 

HIV/AIDS exists in both urban and rural 

populations (and on or near Tribal 

lands); however, many of those living 

with HIV are not aware of their status. 

These statistics, risk factors, and missed 

opportunities for screening illuminate 

the need to go beyond raising awareness 

about HIV and begin active integration 

of initiatives that will help routinize 

HIV services. If the status quo is 

unchanged, prevalence will continue to 

increase and AI/AN communities may 

face an irreversible problem. Therefore, 

the National HIV/AIDS Program is 

working to change the way HIV is 

discussed, to change and improve the 

way HIV testing is integrated into health 

services, and to firmly establish linkages 

and access to care. The IHS HIV/AIDS 

Program is implemented and executed 

via an integrated and comprehensive 

approach through collaborations across 

multi-health sectors, both internal and 

external to the agency. It attempts to 

encompass all types of service delivery 

‘systems’ including IHS/Tribal/Urban 

facilities. The IHS HIV/AIDS Program is 

committed to realizing the goals of the 

President’s NHAS and has bridged the 

objectives and implementation to the 

IHS HIV/AIDS Strategic Plan. 

Limited Competition Justification 

Competition for both of the awards 

included in this announcement is 

limited to national Indian health care 

organizations with at least ten years of 


tkelley on DSK4VPTVN1PROD with NOTICES
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experience providing education and 

outreach on a national scale. This 

limitation ensures that the awardee will 

have: (1) A national information-sharing 

infrastructure which will facilitate the 

timely exchange of information between 

HHS and Tribes and Tribal 

organizations on a broad scale; (2) a 

national perspective on the needs of AI/ 

AN communities that will ensure that 

the information developed and 

disseminated through the projects is 

appropriate, useful and addresses the 

most pressing needs of AI/AN 

communities; and (3) established 

relationships with Tribes and Tribal 

organizations that will foster open and 

honest participation by AI/AN 

communities. Regional or local 

organizations will not have the 

mechanisms in place to conduct 

communication on a national level, nor 

will they have an accurate picture of the 

health care needs facing AI/ANs 

nationwide. Organizations with less 

experience will lack the established 

relationships with Tribes and Tribal 

organizations throughout the country 

that will facilitate participation and the 

open and honest exchange of 

information between Tribes and HHS. 

With the limited funds available for 

these projects, HHS must ensure that the 

education and outreach efforts 

described in this announcement reach 

the widest audience possible in a timely 

fashion, are appropriately tailored to the 

needs of AI/AN communities 

throughout the country, and come from 

a source that AI/ANs recognize and 

trust. For these reasons, this is a limited 

competition announcement. 

II. Award Information 

Type of Award 

Cooperative Agreement. 

Estimated Funds Available 

The total amount of funding 

identified for the current fiscal year (FY) 

2015 is approximately $250,000 to fund 

two cooperative agreements for one 

year; $150,000 will be awarded for the 

Behavioral Health—MSPI award and 

$100,000 will be awarded for the HIV/ 

AIDS award. The amount of funding 

available for competing awards issued 

under this announcement is subject to 

the availability of appropriations and 

budgetary priorities of the Agency. The 

IHS is under no obligation to make 

awards that are selected for funding 

under this announcement. 

Anticipated Number of Awards 

Two awards will be issued under this 

program announcement. It is the 

intention of IHS and the Office of the 

Secretary (OS) that one entity will 

receive both awards. OS and IHS will 

concur on the final decision as to who 

will receive both awards. 

Project Period 

The project periods for each award 

will be for one year and will run from 

September 30, 2015 with completion by 

September 29, 2016. 

Cooperative Agreement 

Cooperative agreements awarded by 

the Department of Health and Human 

Services (HHS) are administered under 

the same policies as a grant. The 

funding agency (IHS) is required to have 

substantial programmatic involvement 

in the project during the entire award 

segment. Below is a detailed description 

of the level of involvement required for 

both IHS and the grantee. IHS will be 

responsible for activities listed under 

section A and the grantee will be 

responsible for activities listed under 

section B as stated: 

Substantial Involvement Description for 

Cooperative Agreement 

A. IHS Programmatic Involvement 

The IHS assigned program official 

will monitor the overall progress of the 

awardee’s execution of the requirements 

of the two awards: IHS award and OS 

award noted below as well as their 

adherence to the terms and conditions 

of the cooperative agreements. This 

includes providing guidance for 

required reports, developing of tools, 

and other products, interpreting 

program findings, and assisting with 

evaluations and overcoming any 

difficulties or performance issues 

encountered. The IHS assigned program 

official must approve all presentations, 

electronic content, and other materials, 

including mass emails, developed by 

awardee pursuant to these awards and 

any supplemental awards prior to the 

presentation or dissemination of such 

materials to any party. 

(1) Behavioral Health—MSPI Award 

i. The IHS assigned program official 

will work in partnership with the 

awardee to identify and provide 

presentation topics on MSPI for the 

National Tribal Advisory Committee 

meetings; the Behavioral Health Work 

Group; webinars; and IHS Area 

conference calls. 

ii. The IHS assigned program official 

will work in partnership with the 

awardee to identify MSPI projects in 

need of technical assistance. 

(2) HIV/AIDS Award 

IHS staff will provide support for the 

HIV/AIDS award as follows: 

i. The IHS assigned program official 

will work in partnership with the 

awardee in all decisions involving 

strategy, hiring of grantee personnel, 

deployment of resources, release of 

public information materials, quality 

assurance, coordination of activities, 

training, reports, budgets, and 

evaluations. Collaboration includes data 

analysis, interpretation of findings, and 

reporting. 

ii. The IHS assigned program official 

will work closely with OS and all 

participating IHS health services/

programs, as appropriate, to coordinate 

award activities. 

iii. The IHS assigned program official 

will coordinate the following for OS and 

the participating IHS program offices 

and staff: 

• Discussion and release of any and 

all special grant conditions upon 

fulfillment. 

• Monthly scheduled conference 

calls. 

• Appropriate dissemination of 

required reports to each participating 

program. 

iv. The IHS will, jointly with the 

awardee, plan and set an agenda for 

each of the conferences mentioned in 

this announcement that: 

• Shares the training and/or 

accomplishments. 

• Fosters collaboration amongst the 

participating program offices, agencies, 

and/or departments. 

• Increases visibility for the 

partnership between the awardee and 

the IHS and OS. 

v. IHS will provide guidance in 

addressing deliverables and 

requirements. 

vi. IHS will provide guidance in 

preparing articles for publication and/or 

presentations of program successes, 

lessons learned, and new findings. 

vii. IHS will communicate via 

monthly conference calls, individual or 

collective site visits, and monthly 

meetings. 

viii. IHS staff will review articles 

concerning the HHS, OS, and the 

Agency for accuracy and may, as 

requested by the awardee, provide 

relevant articles. 

ix. IHS will provide technical 

assistance to the entity as requested. 

x. IHS staff may, at the request of the 

entity’s board, participate on study 

groups and may recommend topics for 

analysis and discussion. 

B. Grantee Cooperative Agreement 

Award Activities 

The awardee must comply with 

relevant Office of Management and 

Budget (OMB) Circular provisions 

regarding lobbying, any applicable 


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lobbying restrictions provided under 

other law and any applicable restriction 

on the use of appropriated funds for 

lobbying activities. 

The awardee is responsible for the 

following in addition to fulfilling all 

requirements noted for each award 

component: Behavioral Health—MSPI 

and HIV/AIDS. 

i. To succinctly and independently 

address the requirements for each of the 

two awards listed below: Behavioral 

Health—MSPI and HIV/AIDS. 

ii. To facilitate a forum or forums at 

which concerns can be heard that are 

representative of all Tribal governments 

in the area of health care policy analysis 

and program development for each of 

the two components listed above. 

iii. To assure that health care outreach 

and education is based on Tribal input 

through a broad-based consumer 

network involving the Area Indian 

health boards or health board 

representatives from each of the 12 IHS 

Areas. 

iv. To establish relationships with 

other national Indian organizations, 

professional groups, and Federal, State, 

and local entities supportive of AI/AN 

health programs. 

v. To improve and expand access for 

AI/AN Tribal governments to all 

available programs within the HHS. 

vi. To disseminate timely health care 

information to Tribal governments, AI/ 

AN health boards, other national Indian 

organizations, professional groups, 

Federal, State, and local entities. 

vii. To provide periodic 

dissemination of health care 

information, including publication of a 

newsletter four times a year that features 

articles on MSPI and HIV/AIDS health 

promotion/disease/behavioral health 

prevention activities and models of best 

or promising practices, health policy, 

and funding information relevant to AI/ 

AN, etc. 

The following schedule of 

deliverables outlines the requirements 

necessary to effectuate timely and 

effective support services to Tribal MSPI 

projects: 

Summary of Tasks To Be Performed 

MSPI: 

• At a minimum, the awardee shall 

provide Tribal MSPI program updates at 

the National Tribal Advisory Committee 

meetings and conference calls; and the 

Behavioral Health Work Group meetings 

and conference calls. 

• At a minimum, the awardee shall 

serve as a committee member for the 

National Action Alliance for Suicide 

Prevention’s American Indian/Alaska 

Native Task Force. 

• The awardee shall participate in 

MSPI Area conference calls requested 

by the IHS assigned program official. 

The awardee must be included on the 

agenda and provide presentations on 

specific areas of interest identified by 

the Tribal MSPI programs and IHS 

assigned program official. 

Outreach and Education 

• The awardee shall provide 

information and education via multimedia venues, including but not limited 

to teleconference, webinar workshops, 

and/or online training modules on 

topics of particular importance to Tribal 

MSPI projects. The awardee will work 

with MSPI Tribal projects and the IHS 

assigned program official to identify 

topics. Topics will be discussed prior to 

the teleconference or webinar and will 

be subject to approval from the IHS 

assigned program official. PowerPoint 

slides must be submitted for approval 

two weeks prior to the presentation and 

will be made available on the IHS MSPI 

Web sites. Awardee’s organizational 

Web site will link to IHS MSPI Web 

sites. 

• The awardee shall conduct 

workshops and/or presentations 

including, but not limited to, the 

successes of the MSPI and promising 

practices and/or best practices of Tribal 

MSPI programs at three national 

conferences (venue and content of 

presentations to be agreed upon by the 

awardee and the IHS assigned program 

official). 

• The awardee shall maintain a booth 

at identified meetings and conferences 

to provide comprehensive information 

on Tribal MSPI programs, curricula, 

findings, and strategies to local, 

regional, state, and Federal agencies and 

organizations. 

• The awardee shall conduct site 

visits at Tribal MSPI programs, as 

funding is available, with two weeks 

advanced notification to the IHS 

assigned program official. 

Technical Assistance 

• The awardee shall review progress 

reports of MSPI projects identified by 

the program official. 

• The awardee will develop and 

maintain orientation materials for MSPI 

projects including but limited to 

factsheets and guides. 

• The awardee will provide training 

and technical assistance to increase AI/ 

AN specific culture- or tradition-based 

interventions to be listed on the IHS 

Best and Promising Practice Registry. 

Information Sharing 

• The awardee shall develop, 

maintain, and disseminate 

comprehensive information on Tribal 

MSPI programs, curricula, findings, 

articles, and strategies to all Tribal MSPI 

programs, and present the information 

at conference and meeting booths as 

described above. 

• The awardee will provide postings 

on MSPI related information for the IHS 

MSPI Web site. 

• The awardee will develop and/or 

maintain a comprehensive list of 

evidence-based and practice-based 

program development and business 

practice guidelines for use by Tribal 

MSPI programs. 

• The awardee will develop and 

publish a semi-annual MSPI newsletter 

focusing on the impact and outcomes of 

the MSPI projects in Tribal communities 

to be cleared by IHS and then published 

on the IHS MSPI Web site. 

Reporting 

• The awardee shall provide semiannual reports documenting and 

describing progress and 

accomplishment of the activities 

specified above, attaching any necessary 

documentation to adequately document 

accomplishments. 

• The awardee shall attend bi-weekly, 

regularly scheduled, in-person and 

conference call meetings with the IHS 

assigned program official team to 

discuss the awardee’s services and 

MSPI/related issues. The awardee must 

provide meeting minutes that highlight 

the awardee’s specific involvement and 

participation. 

• The awardee shall obtain approval 

from the IHS assigned program official 

for all PowerPoint presentations, 

electronic content, and other materials, 

including mass emails, developed by 

awardee pursuant to this award and any 

supplemental awards prior to the 

presentation or dissemination of such 

materials to any party, allowing for a 

reasonable amount of time for IHS 

review. 

Deliverables 

• Attendance at regularly scheduled 

meetings between awardee and the IHS 

assigned program official, evidenced by 

meeting minutes which highlight the 

awardee’s specific involvement and 

participation. 

• Participation on MSPI Area 

conference calls identified by the IHS 

assigned program official, evidenced by 

meeting agenda and minutes as needed. 

• Report of outcomes at the following 

(meeting booths, workshops, site 

visitations and/or presentations 

provided): 

(a) National Tribal Advisory 

Committee conference calls and 

meetings. 


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(b) Behavioral Health Work Group 

conference calls and meetings. 

(PowerPoint slides in electronic form 

and one hard copy are to be submitted 

to the program official and the IHS 

assigned program official as required). 

(c) IHS Area conference calls. 

(d) IHS Area and national webinars. 

(e) MSPI Project site visitations. 

(f) Other AI/AN national conferences. 

• Completed programmatic reviews of 

semi and annual progress reports of 

Tribal MSPI projects in order to identify 

projects that require technical 

assistance. 

[Note: This review is not to replace IHS 

review of MSPI programs. The programmatic 

reviews to be conducted by grantee are 

secondary reviews intended solely to identify 

programs in need of technical assistance.] 

Æ The awardee shall help the IHS 

assigned program official identify 

challenges faced by participating Tribal 

communities and assist in developing 

solutions. 

• Copies of educational and practicebased information provided to Tribal 

MSPI programs (electronic form and one 

hard copy). 

• Copies of all promotional and 

educational materials provided to Tribal 

MSPI programs and other projects 

(electronic form and one hard copy). 

• Copies of all promotional materials 

provided to media and other outlets 

(electronic form and one hard copy). 

• Copies of all articles published 

(electronic form and one hard copy). 

Submit semi-annual and annual 

progress reports to Division of 

Behavioral Health (DBH), due no later 

than 30 days after the reporting cycle, 

attaching any necessary documentation. 

For example: meeting minutes, 

correspondence with Tribal MSPI 

projects, samples of all written materials 

developed including brochures, news 

articles, videos, radio and television ads 

to adequately document 

accomplishments. 

• The awardee will submit a 

deliverable schedule to the program 

official no later than 30 days after the 

start date. 

HIV/AIDS 

In alignment with the above program 

and independent from MSPI activities 

(both via fiscal resources and 

programmatic implementation), the 

awardee shall: 

• Disseminate existing HIV/AIDS 

messages to AI/AN audiences in a 

format designed to solicit, collect, and 

report on community-level feedback and 

generate discussion regarding the 

disease and its prevention. This may 

include electronic and emerging means 

of communication. At least four distinct 

audiences (such as women, young 

people, etc.) will be addressed and 

engaged. Preference will be given to 

reaching audiences with the highest HIV 

burden or potential increases as 

supported by the NHAS. 

• Disseminate existing IHS HIV/AIDS 

program and other HIV/AIDS training 

materials to educators, health care 

providers, and other key audiences. 

Collect and report on relevant 

evaluation criteria, including impacts 

on underlying knowledge, attitudes, or 

beliefs about HIV acquisition, testing, or 

treatment. 

• Deliver HIV/AIDS technical 

assistance and activity support program. 

Engage in documented partnerships 

with AI/AN communities to expand 

their capacity relevant to HIV/AIDS 

education and prevention efforts. Local 

activity support may include subawards of resources and distribution of 

incentives to qualified AI/AN-serving 

community organizations increasing 

HIV/AIDS education and prevention in 

their populations. Sub-award eligibility 

standards and management controls will 

be proposed by the awardee and will be 

subject to IHS approval. These activities 

must be conducted in accordance with 

Federal grant policies and procedures. 

Awardee will collect and maintain 

relevant evaluation materials and 

generate reports that highlight progress 

towards the President’s NHAS goals on 

the community level and that collect 

best practices for dissemination to other 

communities. 

• Contribute technical expertise to 

the IHS HIV/AIDS program and develop 

formal written documents responding to 

information requests from the public 

regarding HIV/AIDS initiatives. 

• Develop and launch anti-stigma 

messaging for at least one audience, 

coordinated with other local activities to 

increase HIV screening and increase 

access to services, or increase positive 

role modeling for people living with, or 

at risk of, acquiring HIV/AIDS. 

• Support and document issuespecific discussions with Tribal Leaders 

as needed to address effective 

prevention interventions for AI/AN 

populations as noted in the President’s 

NHAS. 

• Obtain approval from the IHS 

assigned program official of all 

presentations, electronic content, and 

other materials, including mass emails, 

developed by awardee pursuant to this 

award and any supplemental awards 

prior to the presentation or 

dissemination of such materials to any 

party, allowing for a reasonable amount 

of time for IHS review. 

III. Eligibility Information 

1. Eligibility 

To be eligible for this ‘‘New/

Competing Continuation Limited 

Competition Announcement’’, an 

applicant must: 

Provide proof of non-profit status 

with the application, e.g., 501(c)(3). 

Eligible applicants that can apply for 

this funding opportunity are national 

Indian organizations. 

The national Indian organization must 

have the infrastructure in place to 

accomplish the work under the 

proposed program. 

Eligible entities must have 

demonstrated expertise in the following 

areas: 

• Representing all Tribal governments 

and providing a variety of services to 

Tribes, Area health boards, Tribal 

organizations, and Federal agencies, and 

playing a major role in focusing 

attention on Indian health care needs, 

resulting in improved health outcomes 

for AI/ANs. 

• Promotion and support of Indian 

education and coordinating efforts to 

inform AI/AN of Federal decisions that 

affect Tribal government interests 

including the improvement of Indian 

health care. 

• National health policy and health 

programs administration. 

• Have a national AI/AN constituency 

and clearly support critical services and 

activities within the IHS mission of 

improving the quality of health care for 

AI/AN people. 

• Portray evidence of their solid 

support of improved health care in 

Indian Country. 

• Provide evidence of at least ten 

years of experience providing education 

and outreach on a national scale. 

Note: Please refer to Section IV.2 

(Application and Submission Information/

Subsection 2, Content and Form of 

Application Submission) for additional proof 

of applicant status documents required such 

as Tribal resolutions, proof of non-profit 

status, etc. 

2. Cost Sharing or Matching 

The IHS does not require matching 

funds or cost sharing for grants or 

cooperative agreements. 

3. Other Requirements 

If application budgets exceed the 

highest dollar amount outlined under 

the ‘‘Estimated Funds Available’’ 

section within this funding 

announcement, the application will be 

considered ineligible and will not be 

reviewed for further consideration. If 

deemed ineligible, IHS will not return 

the application. The applicant will be 


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notified by email by the Division of 

Grants Management (DGM) of this 

decision. 

Proof of Non-Profit Status 

Organizations claiming non-profit 

status must submit proof. A copy of the 

501(c)(3) Certificate must be received 

with the application submission by the 

Application Deadline Date listed under 

the Key Dates section on page one of 

this announcement. 

An applicant submitting any of the 

above additional documentation after 

the initial application submission due 

date is required to ensure the 

information was received by the IHS by 

obtaining documentation confirming 

delivery (i.e., FedEx tracking, postal 

return receipt, etc.). 

IV. Application and Submission 

Information 

1. Obtaining Application Materials 

The application package and detailed 

instructions for this announcement can 

be found at http://www.Grants.gov or 

https://www.ihs.gov/dgm/

index.cfm?module=dsp_dgm_funding. 

Questions regarding the electronic 

application process may be directed to 

Mr. Paul Gettys at (301) 443–2114. 

2. Content and Form Application 

Submission 

Two complete separate signed 

applications are required. Both 

applications should address all the 

following components separately in 

each application. Each separate 

application must include the project 

narrative as an attachment to the 

application package. Mandatory 

documents for all applicants include: 

• Table of contents. 

• Abstract (one page) summarizing 

the project. 

• Application forms: 

Æ SF–424, Application for Federal 

Assistance. 

Æ SF–424A, Budget Information— 

Non-Construction Programs. 

Æ SF–424B, Assurances—NonConstruction Programs. 

• Budget Justification and Narrative 

(must be single spaced and not exceed 

five pages). 

• Project Narrative (must be single 

spaced and not exceed 20 pages). 

Æ Background information on the 

organization. 

Æ Proposed scope of work, objectives, 

and activities that provide a description 

of what will be accomplished, including 

a one-page Timeframe Chart. 

• Letter of Support from 

Organization’s Board of Directors. 

• 501(c)(3) Certificate (if applicable). 

• Position Descriptions for all key 

personnel. 

• Contractor/Consultant resumes or 

qualifications and scope of work. 

• Disclosure of Lobbying Activities 

(SF–LLL). 

• Certification Regarding Lobbying 

(GG-Lobbying Form). 

• Copy of current Negotiated Indirect 

Cost rate (IDC) agreement (required) in 

order to receive IDC. 

• Organizational Chart (optional). 

• Documentation of current Office of 

Management and Budget (OMB) A–133 

required Financial Audit (if applicable). 

Acceptable forms of documentation 

include: 

Æ Email confirmation from Federal 

Audit Clearinghouse (FAC) that audits 

were submitted; or 

Æ Face sheets from audit reports. 

These can be found on the FAC Web 

site: http://harvester.census.gov/sac/

dissem/accessoptions.html?submit=

Go+To+Database 

Public Policy Requirements 

All Federal-wide public policies 

apply to IHS grants and cooperative 

agreements with exception of the 

Discrimination policy. 

Requirements for Project and Budget 

Narratives 

A. Project Narrative: This narrative 

should be a separate Word document 

that is no longer than 20 pages and 

must: Be single-spaced, be type written, 

have consecutively numbered pages, use 

black type not smaller than 12 

characters per one inch, and be printed 

on one side only of standard size 81⁄2′′ 

x 11′′ paper. 

Be sure to succinctly address and 

answer all questions listed under the 

narrative and place them under the 

evaluation criteria (refer to Section V.1, 

Evaluation criteria in this 

announcement) and place all responses 

and required information in the correct 

section (noted below), or they shall not 

be considered or scored. These 

narratives will assist the ORC in 

becoming familiar with the applicant’s 

activities and accomplishments prior to 

this cooperative agreement award. If the 

narrative exceeds the page limit, only 

the first 20 pages will be reviewed. The 

20-page page limit for the narrative does 

not include the work plan, standard 

forms, Tribal resolutions, table of 

contents, budget, budget justifications, 

narratives, and/or other appendix items. 

There are three parts to the narrative: 

Part A—Program Information; Part B— 

Program Planning and Evaluation; and 

Part C—Program Report. See below for 

additional details about what must be 

included in the narrative. 

Reminder: You are required to submit 

two separate complete and signed 

application packages. One for the 

Behavioral Health—MSPI cooperative 

agreement and one complete signed 

application package for the HIV/AIDS 

cooperative agreement. This applies to 

the narratives and budgets as well and 

all components listed below. Be sure to 

address each component separately in 

its respective application package. The 

page limitations below are for each 

narrative and budget submitted. 

Part A: Program Information (8 page 

limitation) 

Section 1: Needs 

Describe how the national Indian 

organization has the experience to 

provide outreach and education efforts 

regarding the pertinent changes and 

updates in health care for each of the 

two components listed herein: 

Behavioral Health—MSPI and HIV/

AIDS. 

Part B: Program Planning and 

Evaluation (7 page limitation) 

Section 1: Program Plans 

Describe fully and clearly how the 

national Indian organization plans to 

address the NIHOE II MSPI and HIV/

AIDS requirements, including how the 

national Indian organization plans to 

demonstrate improved health education 

and outreach services to all 566 

Federally-recognized Tribes for each of 

the two components described herein. 

Section 2: Program Evaluation 

Describe fully and clearly how the 

outreach and education efforts will 

impact changes in knowledge and 

awareness in Tribal communities 

regarding both components. Identify 

anticipated or expected benefits for the 

Tribal constituency. 

Part C: Program Report (5 page 

limitation) 

Section 1: Describe Major 

Accomplishments Over the Last 24 

Months 

Identify and describe significant 

program achievements associated with 

the delivery of quality health outreach 

and education. Provide a comparison of 

the actual accomplishments to the goals 

established for the project period for 

both components, or if applicable, 

provide justification for the lack of 

progress. 

Section 2: Describe Major Activities 

Over the Last 24 Months 

Identify and summarize recent major 

health related outreach and education 

project activities of the work performed 


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18420 Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Notices 

for both components during the last 

project period. 

B. Budget Narrative: This narrative 

must include a line item budget with a 

narrative justification for all 

expenditures identifying reasonable and 

allowable costs necessary to accomplish 

the goals and objectives as outlined in 

the project narrative. Budget should 

match the scope of work described in 

the project narrative. The budget 

narrative should not exceed five pages. 

3. Submission Dates and Times 

Applications must be submitted 

electronically through Grants.gov by 

11:59 p.m. Eastern Standard Time (EST) 

on the Application Deadline Date listed 

in the Key Dates section on page one of 

this announcement. Any application 

received after the application deadline 

will not be accepted for processing, nor 

will it be given further consideration for 

funding. Grants.gov will notify the 

applicant via email if the application is 

rejected. 

If technical challenges arise and 

assistance is required with the 

electronic application process, contact 

Grants.gov Customer Support via email 

to support@grants.gov or at (800) 518– 

4726. Customer Support is available to 

address questions 24 hours a day, 7 days 

a week (except on Federal holidays). If 

problems persist, contact Mr. Paul 

Gettys, DGM (Paul.Gettys@ihs.gov) at 

(301) 443–2114. Please be sure to 

contact Mr. Gettys at least ten days prior 

to the application deadline. Please do 

not contact the DGM until you have 

received a Grants.gov tracking number. 

In the event you are not able to obtain 

a tracking number, call the DGM as soon 

as possible. 

If the applicant needs to submit a 

paper application instead of submitting 

electronically through Grants.gov, a 

waiver must be requested. Prior 

approval must be requested and 

obtained from Ms. Tammy Bagley, 

Acting Director of DGM, (see Section 

IV.6 below for additional information). 

The waiver must: (1) Be documented in 

writing (emails are acceptable), before 

submitting a paper application, and (2) 

include clear justification for the need 

to deviate from the required electronic 

grants submission process. A written 

waiver request must be sent to 

GrantsPolicy@ihs.gov with a copy to 

Tammy.Bagley@ihs.gov. Once the 

waiver request has been approved, the 

applicant will receive a confirmation of 

approval email containing submission 

instructions and the mailing address to 

submit the application. A copy of the 

written approval must be submitted 

along with the hardcopy of the 

application that is mailed to DGM. 

Paper applications that are submitted 

without a copy of the signed waiver 

from the Acting Director of the DGM 

will not be reviewed or considered for 

funding. The applicant will be notified 

via email of this decision by the Grants 

Management Officer of the DGM. Paper 

applications must be received by the 

DGM no later than 5:00 p.m., EST, on 

the Application Deadline Date listed in 

the Key Dates section on page one of 

this announcement. Late applications 

will not be accepted for processing or 

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 not allowable. 

• The available funds are inclusive of 

direct and appropriate indirect costs. 

• Only one grant/cooperative 

agreement will be awarded per 

component. 

• IHS will not acknowledge receipt of 

applications. 

6. Electronic Submission Requirements 

All applications must be submitted 

electronically. Please use the http://

www.Grants.gov Web site to submit an 

application electronically and select the 

‘‘Find Grant Opportunities’’ link on the 

homepage. Download a copy of the 

application package, complete it offline, 

and then upload and submit the 

completed application via the http://

www.Grants.gov Web site. Electronic 

copies of the application may not be 

submitted as attachments to email 

messages addressed to IHS employees or 

offices. 

If the applicant receives a waiver to 

submit paper application documents, 

they must follow the rules and timelines 

that are noted below. The applicant 

must seek assistance at least ten days 

prior to the Application Deadline Date 

listed in the Key Dates section on page 

one of this announcement. 

Applicants that do not adhere to the 

timelines for System for Award 

Management (SAM) and/or http://

www.Grants.gov registration or that fail 

to request timely assistance with 

technical issues will not be considered 

for a waiver to submit a paper 

application. 

Please be aware of the following: 

• Please search for the application 

package in http://www.Grants.gov by 

entering the CFDA number or the 

Funding Opportunity Number. Both 

numbers are located in the header of 

this announcement. 

• If you experience technical 

challenges while submitting your 

application electronically, please 

contact Grants.gov Support directly at: 

support@grants.gov or (800) 518–4726. 

Customer Support is available to 

address questions 24 hours a day, 7 days 

a week (except on Federal holidays). 

• 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 from the agency 

must be obtained. 

• If it is determined that a waiver is 

needed, the applicant must submit a 

request in writing (emails are 

acceptable) to GrantsPolicy@ihs.gov 

with a copy to Tammy.Bagley@ihs.gov. 

Please include a clear justification for 

the need to deviate from the standard 

electronic submission process. 

• If the waiver is approved, the 

application should be sent directly to 

the DGM by the Application Deadline 

Date listed in the Key Dates section on 

page one of this announcement. 

• Applicants are strongly encouraged 

not to wait until the deadline date to 

begin the application process through 

Grants.gov as the registration process for 

SAM and Grants.gov could take up to 

fifteen working days. 

• Please use the optional attachment 

feature in Grants.gov to attach 

additional documentation that may be 

requested by the DGM. 

• All applicants must comply with 

any page limitation requirements 

described in this Funding 

Announcement. 

• After electronically submitting the 

application, the applicant will receive 

an automatic acknowledgment from 

Grants.gov that contains a Grants.gov 

tracking number. The DGM will 

download the application from 

Grants.gov and provide necessary copies 

to the appropriate agency officials. 

Neither the DGM nor the Office of Direct 

Service and Contracting Tribes (ODSCT) 

will notify the applicant that the 

application has been received. 

• Email applications will not be 

accepted under this announcement. 

Unique Entity Identifier (UEI) 

Numbering System 

All IHS applicants and grantee 

organizations are required to obtain a 

UEI number and maintain an active 

registration in the SAM database. The 

UEI number is a unique 9-digit 

identification number provided to each 

entity. The UEI number is site specific; 

therefore, each distinct performance site 

may be assigned a UEI number. 

Obtaining a UEI number is easy, and 

there is no charge. To obtain a UEI 


tkelley on DSK4VPTVN1PROD with NOTICES
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number, please contact Mr. Paul Gettys 

at (301) 443–2114. 

All HHS recipients are required by the 

Federal Funding Accountability and 

Transparency Act of 2006, as amended 

(‘‘Transparency Act’’), to report 

information on subawards. Accordingly, 

all IHS grantees must notify potential 

first-tier subrecipients that no entity 

may receive a first-tier subaward unless 

the entity has provided its DUNS 

number to the prime grantee 

organization. This requirement ensures 

the use of a universal identifier to 

enhance the quality of information 

available to the public pursuant to the 

Transparency Act. 

System for Award Management (SAM) 

Organizations that were not registered 

with Central Contractor Registration 

(CCR) and have not registered with SAM 

will need to obtain a DUNS number first 

and then access the SAM online 

registration through the SAM home page 

at https://www.sam.gov (U.S. 

organizations will also need to provide 

an Employer Identification Number 

from the Internal Revenue Service that 

may take an additional 2–5 weeks to 

become active). Completing and 

submitting the registration takes 

approximately one hour to complete 

and SAM registration will take 3–5 

business days to process. Registration 

with the SAM is free of charge. 

Applicants may register online at 

https://www.sam.gov. 

Additional information on 

implementing the Transparency Act, 

including the specific requirements for 

DUNS and SAM, can be found on the 

IHS Grants Management, Grants Policy 

Web site: https://www.ihs.gov/dgm/

index.cfm?module=dsp_dgm_policy_

topics. 

V. Application Review Information 

The instructions for preparing the 

application narrative also constitute the 

evaluation criteria for reviewing and 

scoring the application. Weights 

assigned to each section are noted in 

parentheses. The 20 page narrative 

should include only the first year of 

activities; information for multi-year 

projects should be included as an 

appendix. See ‘‘Multi-year Project 

Requirements’’ at the end of this section 

for more information. The narrative 

section should be written in a manner 

that is clear to outside reviewers 

unfamiliar with prior related activities 

of the applicant. It should be well 

organized, succinct, and contain all 

information necessary for reviewers to 

understand the project fully. Points will 

be assigned to each evaluation criteria 

adding up to a total of 100 points. A 

minimum score of 60 points is required 

for funding. Points are assigned as 

follows: 

1. Criteria 

A. Introduction and Need for Assistance 

(15 points) 

(1) Describe the organization’s current 

health, education and technical 

assistance operations as related to the 

broad spectrum of health needs of the 

AI/AN community. Include what 

programs and services are currently 

provided (i.e., Federally-funded, Statefunded, etc.), and identify any 

memorandums of agreement with other 

national, Area or local Indian health 

board organizations. This could also 

include HHS’ agencies that rely on the 

applicant as the primary gateway 

organization that is capable of providing 

the dissemination of health information 

to Tribes. Include information regarding 

technologies currently used (i.e., 

hardware, software, services, Web sites, 

etc.), and identify the source(s) of 

technical support for those technologies 

(i.e., in-house staff, contractors, vendors, 

etc.). Include information regarding how 

long the applicant has been operating 

and its length of association/

partnerships with Area health boards, 

etc. [historical collaboration]. 

(2) Describe the organization’s current 

technical assistance ability. Include 

what programs and services are 

currently provided, programs and 

services projected to be provided, and 

describe any memorandums of 

agreement with other national Indian 

organizations that deem the applicant as 

the primary source of health policy 

information for AI/ANs, or any other 

memorandums of agreement with other 

Area Indian health boards, etc. 

(3) Describe the population to be 

served by the proposed projects. Are 

they hard to reach? Are there barriers? 

Include a description of the number of 

Tribes who currently benefit from the 

technical assistance provided by the 

applicant. 

(4) Describe the geographic location of 

the proposed project including any 

geographic barriers experienced by the 

recipients of the technical assistance to 

the health care information provided. 

(5) Identify all previous IHS 

cooperative agreement awards received, 

dates of funding and summaries of the 

projects’ accomplishments. State how 

previous cooperative agreement funds 

facilitated education, training and 

technical assistance nationwide for 

AI/ANs. (Copies of reports will not be 

accepted.) 

(6) Describe collaborative and 

supportive efforts with national, Area, 

and local Indian health boards. 

(7) Explain the need/reason for the 

proposed projects by identifying 

specific gaps or weaknesses in services 

or infrastructure that will be addressed 

by the proposed projects. Explain how 

these gaps/weaknesses have been 

assessed. 

(8) Explain what measures were taken 

or will be taken to ensure the proposed 

projects will not create new gaps or 

weaknesses in services or infrastructure. 

(9) Describe the effect of the proposed 

project on current programs (i.e., 

Federally-funded, State funded, etc.) 

and, if applicable, on current equipment 

(i.e., hardware, software, services, etc.). 

Include the effect of the proposed 

projects on planned/anticipated 

programs and/or equipment. 

(10) Describe how the projects relate 

to the purpose of the cooperative 

agreement by identifying how the 

proposed project will address national 

Indian health care outreach and 

education regarding various health data 

listed, e.g., MSPI and HIV and AIDS, 

dissemination, training, and technical 

assistance, etc. 

B. Project Objective(s), Work Plan and 

Approach (40 points) 

(1) Identify the proposed project 

objective(s) for each of the two projects, 

as applicable, addressing the following: 

• Measurable and (if applicable) 

quantifiable. 

• Results oriented. 

• Time-limited. 

Example: Issue four quarterly 

newsletters, provide alerts and quantify 

number of contacts with Tribes. Goals 

must be clear and concise. 

(2) Address how the proposed 

projects will result in change or 

improvement in program operations or 

processes for each proposed project 

objective for the selected projects. Also 

address what tangible products, if any, 

are expected from the project, (i.e., 

legislative analysis, policy analysis, 

annual conferences, mid-year 

conferences, summits, etc.). 

(3) Address the extent to which the 

proposed projects will provide, 

improve, or expand services that 

address the need(s) of the target 

population. Include a strategic plan and 

business plan currently in place that are 

being used that will include the 

expanded services. Include the plan(s) 

with the application submission. 

(4) Submit a work plan in the 

Appendix that: 

• Provides the action steps on a 

timeline for accomplishing each of the 

projects’ proposed objective(s). 


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• Identifies who will perform the 

action steps. 

• Identifies who will supervise the 

action steps taken. 

• Identifies what tangible products 

will be produced during and at the end 

of the proposed project objective(s). 

• Identifies who will accept and/or 

approve work products during the 

duration of the proposed projects and at 

the end of the proposed projects. 

• Identifies any training that will take 

place during the proposed projects and 

who will be attending the training. 

• Identifies evaluation activities 

proposed in the work plans. 

(5) If consultants or contractors will 

be used during the proposed project, 

please include the following 

information in their scope of work (or 

note if consultants/contractors will not 

be used): 

• Educational requirements. 

• Desired qualifications and work 

experience. 

• Expected work products to be 

delivered on a timeline. 

If a potential consultant/contractor 

has already been identified, please 

include a resume in the Appendix. 

(6) Describe what updates will be 

required for the continued success of 

the proposed project. Include when 

these updates are anticipated and where 

funds will come from to conduct the 

update and/or maintenance. 

C. Program Evaluation (20 points) 

Each proposed objective requires an 

evaluation component to assess its 

progress and ensure its completion. 

Also, include the evaluation activities in 

the work plan. 

Describe the proposed plan to 

evaluate both outcomes and process. 

Outcome evaluation relates to the 

results identified in the objectives, and 

process evaluation relates to the work 

plan and activities of the project. 

(1) For outcome evaluation, describe: 

• What will the criteria be for 

determining success of each objective? 

• What data will be collected to 

determine whether the objective was 

met? 

• At what intervals will data be 

collected? 

• Who will collect the data and their 

qualifications? 

• How will the data be analyzed? 

• How will the results be used? 

(2) For process evaluation, describe: 

• How will the projects be monitored 

and assessed for potential problems and 

needed quality improvements? 

• Who will be responsible for 

monitoring and managing project 

improvements based on results of 

ongoing process improvements and 

what are their qualifications? 

• How will ongoing monitoring be 

used to improve the projects? 

• Describe any products, such as 

manuals or policies, that might be 

developed and how they might lend 

themselves to replication by others. 

• How will the organization 

document what is learned throughout 

the projects’ grant periods? 

(3) Describe any evaluation efforts 

planned after the grant period has 

ended. 

(4) Describe the ultimate benefit to the 

AI/AN population served by the 

applicant organization that will be 

derived from these projects. 

D. Organizational Capabilities, Key 

Personnel and Qualifications (15 points) 

This section outlines the broader 

capacity of the organization to complete 

the project outlined in the work plan. It 

includes the identification of personnel 

responsible for completing tasks and the 

chain of responsibility for successful 

completion of the projects outlined in 

the work plans. 

(1) Describe the organizational 

structure of the organization beyond 

health care activities, if applicable. 

(2) Describe the ability of the 

organization to manage the proposed 

projects. Include information regarding 

similarly sized projects in scope and 

financial assistance, as well as other 

cooperative agreements/grants and 

projects successfully completed. 

(3) Describe what equipment (i.e., fax 

machine, phone, computer, etc.) and 

facility space (i.e., office space) will be 

available for use during the proposed 

projects. Include information about any 

equipment not currently available that 

will be purchased through the 

cooperative agreement/grant. 

(4) List key personnel who will work 

on the projects. Include title used in the 

work plans. In the Appendix, include 

position descriptions and resumes for 

all key personnel. Position descriptions 

should clearly describe each position 

and duties, indicating desired 

qualifications and experience 

requirements related to the proposed 

project. Resumes must indicate that the 

proposed staff member is qualified to 

carry out the proposed project activities. 

If a position is to be filled, indicate that 

information on the proposed position 

description. 

(5) If personnel are to be only partially 

funded by this cooperative agreement, 

indicate the percentage of time to be 

allocated to this project and identify the 

resources used to fund the remainder of 

the individual’s salary. 

E. Categorical Budget and Budget 

Justification (10 points) 

This section should provide a clear 

estimate of the program costs and 

justification for expenses for the entire 

cooperative agreement period for each 

award. The budgets and budget 

justifications should be consistent with 

the tasks identified in the work plans. 

Because each of the two awards 

included in this announcement are 

funded through separate funding 

streams, the applicant must provide a 

separate budget and budget narrative for 

each of the two components and must 

account for costs separately. 

(1) Provide a categorical budget for 

each of the 12-month budget periods 

requested for each of the two projects. 

(2) If IDC are claimed, indicate and 

apply the current negotiated rate to the 

budget. Include a copy of the rate 

agreement in the Appendix. See Section 

VI. Award Administration Information, 

3. Indirect Costs. 

(3) Provide a narrative justification 

explaining why each line item is 

necessary or relevant to the proposed 

project. Include sufficient costs and 

other details to facilitate the 

determination that the cost is allowable 

(i.e., equipment specifications, etc.). 

Additional Documents Can Be 

Uploaded as Appendix Items in 

Grants.gov 

• Work plan, logic model and/or time 

line for proposed objectives. 

• Position descriptions for key staff. 

• Resumes of key staff that reflect 

current duties. 

• Consultant or contractor proposed 

scope of work and letter of commitment 

(if applicable). 

• Current Indirect Cost Agreement. 

• Organizational chart. 

• Map of area identifying project 

location(s). 

• Additional documents to support 

narrative (i.e. data tables, key news 

articles, etc.). 

2. Review and Selection 

Each application will be prescreened 

by the DGM staff for eligibility and 

completeness as outlined in the funding 

announcement. Applications that meet 

the eligibility criteria shall be reviewed 

for merit by the ORC based on 

evaluation criteria in this funding 

announcement. The ORC could be 

composed of both Tribal and Federal 

reviewers appointed by the ODSCT to 

review and make recommendations on 

these applications. The technical review 

process ensures selection of quality 

projects in a national competition for 

limited funding. Incomplete 


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Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Notices 18423 

applications and applications that are 

non-responsive to the eligibility criteria 

will not be referred to the ORC. The 

applicant will be notified via email of 

this decision by the Grants Management 

Officer of the DGM. Applicants will be 

notified by DGM, via email, to outline 

minor missing components (i.e., budget 

narratives, audit documentation, key 

contact form) needed for an otherwise 

complete application. All missing 

documents must be sent to DGM on or 

before the due date listed in the email 

of notification of missing documents 

required. 

To obtain a minimum score for 

funding by the ORC, applicants must 

address all program requirements and 

provide all required documentation. 

VI. Award Administration Information 

1. Award Notices 

The Notice of Award (NoA) is a 

legally binding document signed by the 

Grants Management Officer and serves 

as the official notification of the grant 

award. The NoA will be initiated by the 

DGM in our grant system, 

GrantSolutions (https://

www.grantsolutions.gov). Each entity 

that is approved for funding under this 

announcement will need to request or 

have a user account in GrantSolutions 

in order to retrieve their NoA. The NoA 

is the authorizing document for which 

funds are dispersed to the approved 

entities and reflects 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. 

Disapproved Applicants 

Applicants who received a score less 

than the recommended funding level for 

approval, 60 points, and were deemed 

to be disapproved by the ORC, will 

receive an Executive Summary 

Statement from the ODSCT within 30 

days of the conclusion of the ORC 

outlining the strengths and weaknesses 

of their application submitted. The 

ODSCT will also provide additional 

contact information as needed to 

address questions and concerns as well 

as provide technical assistance if 

desired. 

Approved But Unfunded Applicants 

Approved but unfunded applicants 

that met the minimum scoring range 

and were deemed by the ORC to be 

‘‘Approved’’, but were not funded due 

to lack of funding, will have their 

applications held by DGM for a period 

of one year. If additional funding 

becomes available during the course of 

FY 2015 the approved but unfunded 

application may be re-considered by the 

awarding program office for possible 

funding. The applicant will also receive 

an Executive Summary Statement from 

the IHS program office within 30 days 

of the conclusion of the ORC. 

Note: Any correspondence other than the 

official NoA signed by an IHS Grants 

Management Official announcing to the 

Project Director that an award has been made 

to their organization is not an authorization 

to implement their program on behalf of IHS. 

2. Administrative Requirements 

Cooperative agreements are 

administered in accordance with the 

following regulations, policies, and 

OMB cost principles: 

A. The criteria as outlined in this 

Program Announcement. 

B. Administrative Regulations for 

Grants: 

45 CFR part 75, Administrative 

Requirements. 

C. Grants Policy: 

• HHS Grants Policy Statement, 

Revised 01/07. 

D. Cost Principles: 

45 CFR part 75, subpart E. Cost 

Principles. 

E. Audit Requirements: 

• 45 CFR part 75, subpart F. Audit 

Requirements. 

3. Indirect Costs 

This section applies to all grant 

recipients that request reimbursement of 

indirect costs (IDC) in their grant 

application. In accordance with HHS 

Grants Policy Statement, Part II–27, IHS 

requires applicants to obtain a current 

IDC rate agreement prior to award. The 

rate agreement must be prepared in 

accordance with the applicable cost 

principles and guidance as provided by 

the cognizant agency or office. A current 

rate covers the applicable grant 

activities under the current award’s 

budget period. If the current rate is not 

on file with the DGM at the time of 

award, the IDC portion of the budget 

will be restricted. The restrictions 

remain in place until the current rate is 

provided to the DGM. 

Generally, IDC rates for IHS grantees 

are negotiated with the Division of Cost 

Allocation (DCA) https://rates.psc.gov/ 

and the Department of Interior (Interior 

Business Center). http://www.doi.gov/

ibc/services/Indirect_Cost_Services/

index.cfm. For questions regarding the 

indirect cost policy, please call the 

Grants Management Specialist listed 

under ‘‘Agency Contacts’’ or the main 

DGM office at (301) 443–5204. 

4. Reporting Requirements 

The grantee must submit required 

reports consistent with the applicable 

deadlines. 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 non-funding or non-award of 

other eligible projects or activities. This 

requirement applies whether the 

delinquency is attributable to the failure 

of the grantee organization or the 

individual responsible for preparation 

of the reports. Reports must be 

submitted electronically via 

GrantSolutions. Personnel responsible 

for submitting reports will be required 

to obtain a login and password for 

GrantSolutions. Please see the Agency 

Contacts list in section VII for the 

systems contact information. 

The reporting requirements for this 

program are noted below. 

A. Progress Reports 

Program progress reports are required 

semi-annually within 30 days after the 

budget period ends. These reports must 

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. A 

final report must be submitted within 90 

days of expiration of the budget/project 

period. 

B. Financial Reports 

Federal Financial Report FFR (SF– 

425), Cash Transaction Reports are due 

30 days after the close of every calendar 

quarter to the Payment Management 

Services, HHS at: http://

www.dpm.psc.gov. It is recommended 

that the applicant also send a copy of 

the FFR (SF–425) report to the Grants 

Management Specialist. Failure to 

submit timely reports may cause a 

disruption in timely payments to the 

organization. 

Grantees are responsible and 

accountable for accurate information 

being reported on all required reports: 

the Progress Reports and Federal 

Financial Report. 

C. Federal Subaward Reporting System 

(FSRS) 

This award may be subject to the 

Transparency Act subaward and 

executive compensation reporting 

requirements of 2 CFR part 170. 


tkelley on DSK4VPTVN1PROD with NOTICES
18424 Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Notices 

The Transparency Act requires the 

OMB to establish a single searchable 

database, accessible to the public, with 

information on financial assistance 

awards made by Federal agencies. The 

Transparency Act also includes a 

requirement for recipients of Federal 

grants to report information about firsttier subawards and executive 

compensation under Federal assistance 

awards. 

IHS has implemented a Term of 

Award into all IHS Standard Terms and 

Conditions, NoAs and funding 

announcements regarding the FSRS 

reporting requirement. This IHS Term of 

Award is applicable to all IHS grant and 

cooperative agreements issued on or 

after October 1, 2010, with a $25,000 

subaward obligation dollar threshold 

met for any specific reporting period. 

Additionally, all new (discretionary) 

IHS awards (where the project period is 

made up of more than one budget 

period) and where: 1) The project period 

start date was October 1, 2010 or after 

and 2) the primary awardee will have a 

$25,000 subaward obligation dollar 

threshold during any specific reporting 

period will be required to address the 

FSRS reporting. For the full IHS award 

term implementing this requirement 

and additional award applicability 

information, visit the DGM Grants 

Policy Web site at: https://www.ihs.gov/ 

dgm/index.cfm?module=dsp_dgm_

policy_topics. 

Telecommunication for the hearing 

impaired is available at: TTY (301) 443– 

6394. 

VII. Agency Contacts 

1. Questions on the programmatic 

issues may be directed to: 

Mr. Chris Buchanan, Director, ODSCT, 

801 Thompson Avenue, Suite 220, 

Rockville, Maryland 20852. 

Telephone: (301) 443–1104. E-Mail: 

Chris.Buchanan@ihs.gov. 

2. Questions on grants management 

and fiscal matters may be directed to: 

Mr. John Hoffman, DGM, Grants 

Management Specialist, 801 

Thompson Avenue, TMP Suite 360, 

Rockville, Maryland 20852. 

Telephone: (301) 443–2116 Fax: (301) 

443–9602. E-Mail: John.Hoffman@

ihs.gov. 

3. Questions on systems matters may 

be directed to: 

Paul Gettys, Grant Systems Coordinator, 

DGM, 801 Thompson Avenue, TMP 

Suite 360, Rockville, MD 20852. 

Phone: 301–443–2114; or the DGM 

main line 301–443–5204. Fax: 301– 

443–9602. E-Mail: Paul.Gettys@

ihs.gov. 

VIII. Other Information 

The Public Health Service strongly 

encourages all cooperative agreement 

and contract recipients to provide a 

smoke-free workplace and promote the 

non-use of all tobacco products. In 

addition, Public Law 103–227, the ProChildren Act of 1994, prohibits smoking 

in certain facilities (or in some cases, 

any portion of the facility) in which 

regular or routine education, library, 

day care, health care, or early childhood 

development services are provided to 

children. This is consistent with the 

HHS mission to protect and advance the 

physical and mental health of the 

American people. 

Dated: March 29, 2015. 

Robert G. McSwain, 

Acting Director, Indian Health Service. 

[FR Doc. 2015–07780 Filed 4–3–15; 8:45 am] 

BILLING CODE 4165–16–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Solicitation of Written Comments on 

the National Vaccine Advisory 

Committee’s Draft Report and Draft 

Recommendations for Consideration 

for Addressing the State of Vaccine 

Confidence in the United States 

AGENCY: Office of the Secretary, Office 

of the Assistant Secretary for Health, 

National Vaccine Program Office, 

Department of Health and Human 

Services 

ACTION: Notice. 

SUMMARY: The National Vaccine 

Advisory Committee (NVAC) was 

established in 1987 to comply with Title 

XXI of the Public Health Service Act 

(Pub. L. 99–660) (§ 2105) (42 U.S. Code 

300aa–5 (PDF–78 KB)). Its purpose is to 

advise and make recommendations to 

the Director of the National Vaccine 

Program on matters related to program 

responsibilities. The Assistant Secretary 

for Health (ASH) has been designated by 

the Secretary of Health and Human 

Services (HHS) as the Director of the 

National Vaccine Program. The National 

Vaccine Program Office (NVPO) is 

located within the Office of the 

Assistant Secretary for Health (OASH), 

Office of the Secretary, U.S. Department 

of Health and Human Services (HHS). 

NVPO provides leadership and fosters 

collaboration among the various federal 

agencies involved in vaccine and 

immunization activities. The NVPO also 

supports the National Vaccine Advisory 

Committee (NVAC). The NVAC advises 

and makes recommendations to the 

ASH in her capacity as the Director of 

National Vaccine Program on matters 

related to vaccine program 

responsibilities. 

Recognizing that immunizations are 

given across the lifespan and there are 

likely to be important differences in 

vaccine acceptance at different stages of 

life, in February of 2013 the National 

Vaccine Advisory Committee accepted 

an initial charge from the Assistant 

Secretary for Health (ASH) to report on 

how confidence in vaccines impacts the 

optimal use of recommended childhood 

vaccines in the United States, including 

reaching Healthy People 2020 

immunization coverage targets. Focus of 

such a report may include 

understanding the determinants of 

vaccination acceptance among parents, 

what HHS should be doing to improve 

parental confidence in vaccine 

recommendations and how to best 

measure confidence in vaccine and 

vaccination to inform and evaluate 

interventions in the future. 

Through a series of teleconferences, 

electronic communications, 

presentations and public discussions 

during the NVAC meetings, a working 

group identified a number of draft 

recommendations to further understand 

and address issues of vaccine 

confidence in the United States. 

On behalf of NVAC, NVPO is 

soliciting public comment on the draft 

report and draft recommendations from 

a variety of stakeholders, including the 

general public, for consideration by the 

NVAC as they develop their final 

recommendations to the ASH. It is 

anticipated that the draft report and 

draft recommendations, as revised with 

consideration given to public comment 

and stakeholder input, will be presented 

to the NVAC for adoption in June 2015 

at the quarterly NVAC meeting. 

DATES: Comments for consideration by 

the NVAC should be received no later 

than 5:00 p.m. EDT on May 6, 2015. 

ADDRESSES: 

(1) The draft report and draft 

recommendations are available on the 

Web at http://www.hhs.gov/nvpo/nvac/

subgroups/nvac-vaccine-confidencewg.html. 

(2) Electronic responses are preferred 

and may be addressed to: vcwg@

hhs.gov. 

(3) Written responses should be 

addressed to: National Vaccine Program 

Office, U.S. Department of Health and 

Human Services, 200 Independence 

Avenue SW., Room 733G, Washington, 

DC 20201. Attn: Vaccine Confidence 

Working Group. 

FOR FURTHER INFORMATION CONTACT: 

National Vaccine Program Office, Office 

of the Assistant Secretary for Health, 


tkelley on DSK4VPTVN1PROD with NOTICES