5161-SS-2010 [8-30-2010]ver3

5161-SS-2010 [8-30-2010]ver3.doc

HHS Supplemental Form to the SF-424 (HHS 5161-1)

OMB: 0990-0317

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SUPPORTING STATEMENT



A. JUSTIFICATION


1. Circumstances of Information Collection

The Office of the Secretary (OS) at the U.S. Department of Health and Human Services (HHS), on behalf of the former Public Health Service (PHS) agencies, is requesting a 3-year extension with change (revision) of the HHS 5161-1 form. During this 3 year clearance HHS will conduct a Departmental wide evaluation to decide if HHS will continue to use this form and if so, allow the users of the form to make changes that will be make the form more efficient for future use. The revised checklist and other forms as listed below will be utilized until a final decision is made. Only the checklist and assurances/certification page were revised. The checklist will include the citation, “Trafficking Victims Protection Act of 2000 (Section 106), as amended (22 U.S.C. 7104(g).”


HHS is requesting clearance for a Checklist (revised), Program Narrative, the Public Health System Impact Statement (PHSIS), used by several former PHS agencies within HHS; CDC 0.1113 supplemental forms used exclusively by the Centers for Disease Control and Prevention (CDC); and the Single Source Agency (SSA) notification form, a supplement form used exclusively by Substance Abuse Mental Health Services Administration (SAMHSA), The Project Abstract form is being added as a component to the HHS 5161-1 package, but the form is approved by the Agency for Children and Families (ACF) . In addition, HHS will continue to include the use of the 5161-1 form for several emergency acts as necessary.


The approved forms are part of the standard application for State and local governments and for private non-profit and for-profit organizations when applying for health services projects. SAMHSA is requesting continued use of the SSA notification for its programs when the applicant is not the SSA. CDC requests continued use of the CDC 0.1113 form, which is an assurance to CDC that the grantee will comply with the guidelines and specifications related to the contents of AIDS-related written materials, pictorials, audiovisuals, questionnaires, survey-instruments, and educational sessions in CDC funded programs.


The Checklist and Program Narrative assists applicants to ensure that they have included all required information necessary to process the application as well as the name, title, and phone number of the business official and project officer responsible for carrying out the project. Checklist information concerning the type of application is also needed since new, competing continuation, noncompeting continuation, and supplemental applications are separated and reviewed differently. The checklist data helps to reduce the time required to process and review grant applications, expediting the issuance of grant awards. A copy of the document is included in Attachment A.


The Project Abstract form was added to the HHS 5161 packet because many agencies use for applicants that submit through Grants.gov and it is utilized in internal HHS grants management systems.  The Project Abstract form is also utilized by many agencies to post summaries of funded grant projects on their websites so that the public is better informed of how taxpayer dollars are being spent to provide services in their communityIt is incorporated into the HHS 5161-1 form. This form will not affect the burden for the 5161 form because ACF clears this form under OMB number 0980-2040. See Attachment A.


With the addition of the Project Abstract Form, reference to the core HHS 5161-1 form will include will include the Check List, Program Narrative, and the Project Abstract Form. The PHSIS, SAMHSA SSA, and CDC.01113 forms are supplemental forms based on a predetermined need determined by the specific HHS Agency requesting the form.


The Public Health System Impact Statement (PHSIS), Third Party Notification, informs State and local health agencies of community-based proposals submitted by non-governmental applicants for Federal funding. The statement includes a description of the population to be served and that portion of the population whose needs would be met under the proposal, a summary of the services to be provided and the level of such services, and the nature of any coordination planned with the appropriate State or local health agencies.


The PHSIS is one page or less and is included as the first page of the application program narrative. The notification procedure consists of sending a copy of the PHSIS and a copy of the application face page SF424 (both of which are developed as part of the application) to relevant local and state health agencies. A copy of the document is included in Attachment B.


SAMHSA has a statutory mandate in section 501(d)(13)(B) of the Public Health Service Act to Aassure that...all grants that are awarded to entities other than States are awarded only after the State in which the entity intends to provide services...is afforded an opportunity to comment on the merits of the application@. Because of the importance of coordination with the SSA to help ensure communication, reduce duplication and facilitate continuity, SAMHSA has developed a third party notification requirement for SSA Coordination which is comparable to the Public Health System Impact Statement. The SSA Coordination requirement directs applicants who are not the SSA to include with the application a copy of a letter sent to the SSA transmitting the face page of Standard Form 424 and a copy of the project abstract, and informing the SSA that comments on the proposal should be sent to SAMHSA not later than 60 days after the deadline date for receipt of applications. A copy of the Single State Agency Coordination statement is provided in Attachment C.



CDC 0.1113 form is used exclusively by CDC for several grantees once funding has been awarded. The form’s purpose is to assure CDC that the grantee will comply with the guidelines and specifications related to the contents of AIDS-related written materials, pictorials, audiovisuals, questionnaires, survey-instruments, and educational sessions in CDC assistance programs. When the grantees sign and submit this form they are assuring that they agree to a panel review and approval of all applicable materials prior to their distribution and use in any activities funded in any part with CDC assistance funds. A copy of the form is located in Attachment D.


The legal authorities for the programs requesting use of these supplements are listed below.


Public Health Service Act, Section:

301: Research and Investigation; Rural Health Services Outreach Program; Rural Telemedicine Grant Program; Rural Health Research Centers; Integrated Community-Based Primary Care and Drug Abuse Treatment Services; Junior National Health Services Corps; Orphan Product Development

303: Minority Fellowship Program

303(a)(1): Mental Health Care Provider Education in HIV/AIDS

319: Disaster Assistance (42 U.S.C. 247d)

319B, C, F Public Health Threats and Emergencies Act

320(a)(2): Hansen’s Disease

329: Migrant Health Centers including Infant Mortality

329(e): Migrant Health Environmental Program

329(f): Capitol Improvements Projects

329(g)(1): Technical and Non-Financial Assistance, Migrant Health Centers

330: Community Health Centers, Including Infant Mortality; Healthy Start

330(e): Capitol Improvements Projects

330(f)(1): Technical and Non-Financial Assistance, Community Health Centers

333(d): Primary Care Services Resource Coordination and Development Agreements

338(I): Nat. Health Service Corps State Loan Repayment Program

338(J): Grants to States for Operation of Offices of Rural Health

338(K): Native Hawaiian Health Care Scholarships

338(L): Demo. Grants to States for Community Scholarship Programs

340: Health Services to the Homeless; Healthy Schools, Healthy Communities

340(A): Health Services for Residents of Public Housing

371: Organ Procurement Organizations

374: Grants to Increase Organ Donation

379: National Bone Marrow Donor Registry

398/398A/398B: Demonstration Grants to States with Respect to Alzheimer’s Disease

413(b) (6) (B) and 414(b)PHS Act, as amended (42 U.S.C.'' 285a -2(b) 6(B), 285a-3(b): NCI construction grants

421(b)(2)(B) and 422(c)(3)PHS Act, as amended (42 U.S.C.'' 285b - 3(b)(2)(B), 285b-4(c)(3):NHLBI construction

441(a)PHS Act, as amended (42 U.S.C.'285d-6(a)): NIAMS construction

455 PHS Act, as amended (42 U.S.C. '285i): NEI construction

464C(a)PHS Act, as amended (42 U.S.C. '285m-3(a)): NIDCD construction

464P(b) PHS Act, as amended (42 U.S.C. '285o-4(b)(3): NIDA construction

481A(a) PHS Act, as amended (42 U.S.C. '487a-2(a)): NIH Director, acting through NCRR; construction of biomedical and behavior research facilities.

481B(a) PHS Act, as amended (42 U.S.C. '287a-3(a)): NIH Director, re NCRR activities, construction of regional primate centers

501(d)(5): Improved Provision of Mental Health and Substance Abuse Treatment, Prevention and Related Services

507(b)(11), and 511: Demonstration Cooperative Agreements for Development and Implementation of Criminal Justice-Treatment Networks

508: Services Grant Program for Residential Treatment for Pregnant and Postpartum Women

510 (b)(1): Demonstration Grant Program for Residential Treatment for Women and Their Children

510(b)(6): Community-Based Comprehensive HIV/STD/TB Outreach Services for High Risk Substance Abusers Demo. Pgm.

515: Knowledge Dissemination Conference Grants

515(b)(3)and(9): Communications Programs Aimed at Preventing Alcohol and Other Drug

Programs

517: Substance Abuse Prevention Demonstration Grants for High Risk Youth

520(A): Evaluating Innovative Children’s Mental Health Services; Community Support Program - Mental Health Systems Improvement Demonstration Grants for Consumer and Family Networks; Cooperative Agreements for Employment Intervention Demonstration Program; National Consumer Technical Assistance Centers

561: Comprehensive Community Mental Health Services for Children with Serious Emotional Disturbances

901: AHCPR Research Grants Program

1003: Training Grants (Population Research and Voluntary Family Planning)

1252: State Grants for Demonstration Projects Regarding Traumatic Brain Injury

1610(b): Renovation or Construction of Non-Acute Facilities

1707(d)(1): Minority Health

1910: Emergency Medical Services for Children Demonstration

1935(b)(1)(C): Evaluations of Substance Abuse Data Activities

1948(a): Provision of Technical Assistance to States, Public or Nonprofit Private Entities Receiving Funding Under the Community Mental Health Services and Substance Abuse Prevention and Treatment Block Grants

2003: Authority for Demonstration Grants (Population Affairs)

2354B(a) PHS Act, as amended (42 U.S.C. '300cc-41(a)(5)(B): Director for Office of AIDS Research; construction of AIDS research facilities

2601: Ryan White Title I - Emergency Relief for Areas with Substantial Need for Services

2611: Ryan White Title II, Part B, Care Grant Program

2618(a): Ryan White C.A.R.E. Act of 1990; Special Projects of National Significance

2651: Ryan White Title III: Outpatient Early Intervention

Services--Supbart II

2671: Ryan White Title IV - Pediatric AIDS Demo. Projects


Other Authorities:

Title V, Social Security Act, Sec. 502(a): Maternal & Child Health Federal Consolidated Programs (SPRANS)

Title V, Social Security Act, Sec. 502(b)(1)(a): Maternal & Child Health Community Integrated Service Systems Set-Aside Pgm.

Coal Mine Health and Safety Act, Sec. 427(a): Coal Miners Respiratory Impairment Treatment Clinics and Services

Title X Section 1003, 42 U.S.C. 300a-1; Family Planning Services and Population Research Act of 1970, Section 6(c), Public Law 91-572, 84 Stat.1507, as amended.

Title XVII, Section 1707 (d)(I), 42 U.S.C. 300u et seq.: Disadvantaged Minority Health Improvement Act of 1990, Public Law 101-527

Title XXVI HIV Health Care Services Program

Title XX, Section 2003, Public Law 98-512, 42 U.S.C. 300z-2 as amended

P.L. 93-638, Sec. 103: Navajo Grants; Tribal Demonstration (Diabetes & Mental Health): Child Protection and Child Abuse

P.L. 93-638, Sec. 104: Tribal Management

P.L. 93-638, Title III, Sec. 302: Tribal Self-Governance Planning and Negotiation

P.L. 94-437: Tribal Recruitment and Retention - Coop. Agmnts; Preparatory Scholarships; Indian Health Scholarships

P.L. 94-437: Sec. 110: Tribal Recruitment and Retention

Sec. 120: Tribal Matching Scholarships

P.L. 96-537: Indian Health Professions, Pregraduate

P.L. 100-202: State-Based Projects for Disability Prevention

P.L. 100-579: Native Hawaiian Health Centers

P.L. 100-690, Sec. 4231: Urban Alcohol and Substance Abuse

P.L. 100-713, Sec. 208: IHS Research Program

P.L. 101- 527, Sec. 10: Health Services in the Pacific Basin

P.L. 101-616: Grants to Increase Organ Donation

P.L. 101-630: Health Care Services for Urban Indians - Health Promotion and Disease Prevention

Sec. 307: Indian Health Delivery Demonstration

Sec. 505(b): Health Care Services for Urban Indians (Immunization)

Sec. 511: Indian Urban Mental Health

P.L. 102-573, Sec. 112 & 114: Health Professions Recruitment for Indians (INMED, Nursing)

Sec. 216: Indian Adolescent Health Centers

Sec. 122: Health Professions Recruitment & Placement for Indians - Cooperative Agreements

P.L. 103-183: State Trauma; Rural Trauma; Special State Projects

8 USC 1101(a)(42): Health Programs for Refugees

29 USC 669(a): Centers for Agricultural Research, Education, and Disease and Injury Prevention; Occupational Respiratory Disease and Musculoskeletal Disorders Evaluation and Rehabilitation

29 USC 670(a)(1): Occupational Health and Safety Programs

42 USC 201: Public Health Service Act

42 USC 290aa: Public Health Service Act

Title V Substance Abuse and Mental health Services Administration

Sec. 501 (m)(n)

42 USC 241: Grants for Radiation Studies and Research; Public Health Programs Impacted by Hurricane

42 USC 290cc-11: Projects for Transition From Homelessness (PATH)

42 USC 290bb-31: Protection and Advocacy for Individuals with Mental Illness (PAIMI)

42 USC 241(a): EPI Research Studies and Prevention Projects (AIDS and HIV); Sexually Transmitted Disease Control Program; HIV Conference Support; Hemophilia Centers; Emergency Flood Relief; Advancement of Understanding of Health of Racial and Ethnic Populations

42 USC 242(n): CDC General Conference Grant Program

42 USC 247(b): Minority HIV Demonstration Projects

42 USC 247b-1: Childhood Lead Poisoning Prevention Program

42 USC 247(b)&(k): State Demonstration Projects: Comprehensive School Health Programs; Capacity Building for Tobacco Prevention and Control Programs

42 USC 247(b)(k)(3): Health Promotion and Disease Prevention

Research; State-Based Diabetes Control Program; National

Laboratory Training Network for State Laboratories

42 USC 280(b): Injury Prevention Research Centers; State and Community-Based Injury Control

42 USC 287b and 280b-1: Development of Educational Materials for Prevention of Youth Violence

42 USC 287a-2: Construction of Vision Research; Construction for Cancer Research; Construction Projects for Extramural Research Facilities

42 USC 300aa-zz: Immunization Program

42 USC 300(k), 300(n)(3), and 300(n)(5): Breast and Cervical Cancer Control Program

42 USC 300u-3: The Public Health Leadership Institute; Enhancement of Capacity of Assess Progress Towards Healthy People 2000 Objectives

42 USC 300u-5: Chronic Disease Prevention and Control

42 USC 341(a): Tuberculosis and HIV Risk Factor Data and Serostatus Surveillance

42 USC 347(b)(1): State-Based Program for Lead Poisoning Prevention

42 USC 9604(a)(5), (i)(5), (9) and (15): Respiratory Effects of Waste Incinerators; Great Lakes Research Program

42 USC 9604(I)(4), (6), & (15): Surveillance of Hazardous Substance Emergency Events


2. Purpose and Use of Information

Each agency’s financial assistance program evaluates the information provided by the applicants to select the ones most likely to meet program objectives and to determine that satisfactory progress is being made on funded projects.


3. Use of Improved Technology

The information requested in the program narrative is based on model instructions provided in OMB Circular A-102 and 2 CFR Part 215.  Although all government-wide funding opportunities and many grant application packages are now available on Grants.gov, there is currently no mandate that all grant application submissions must be made via Grants.gov.   Incoming application packages are managed by each awarding agency.  As a consequence, there is no consolidated system or portal to handle all incoming grant applications although it is an ongoing goal to streamline the grants submission process.  Toward that end, efforts will be made to convert the HHS-5161-1 package into an electronic format for a variety of grant systems, including Grants.gov, the HHS Public Forms Website, and the two grants management systems used by HHS.  It is our hope and intention that the conversion of the entire application package into an electronic format will lessen the burden of forms completion for the applicant.  The Checklist was recently converted into a fillable and printable form, but data cannot be stored. Every effort is made to hold to a minimum the burden imposed on applicants while requesting sufficient information to adequately evaluate and rank the application. 


4. Efforts to Identify Duplication

No other application forms are authorized for the covered programs. No other similar information is available.


5. Involvement of Small Entities

The information requested is the minimum amount needed to meet program requirements. It cannot be reduced for small entities.


6. Consequences if Information is Collected Less Frequently

If this information is not collected, the programs will not have adequate data to select appropriate grantees or to evaluate which grants should be continued. Reduced frequency is not possible as the annual frequency of applications and awards coincides with the annual appropriate of funds. Information is collected once as needed. There are no legal obstacles to reduce the burden.


7. Special Circumstances

These supplements fully comply with the guidelines at 5 CFR 1320.6.


8. Consultation Outside of the Agency

A. The 60-Day Federal Register Notice announcing this data collection was published in the Federal Register on April 27, 2010 Vol. 75, No. 80, page 22136. There were no public comments.


B. The information requested in the Program Narrative follows that which is set forth in OMB Circulars A-102 and 2 CFR Part 215.


In the past, the Association of State and Territorial Health Officials (ASTHO) has been consulted regarding the PHSIS, and that organization is very much in favor of continuing the third-party notification requirement for specified projects. In his letter of May 8, 1995, Christopher G. Atchison, President of ASTHO, states, “Health funding consolidations at the federal level, as well as changes in the Medicaid program, make it essential to integrate and coordinate funding streams for most effective use. It is critical that the state health agency have information on federal health funding targeting both the state and local levels. ... As the President of ASTHO and the Director of the Iowa Department of Health, I believe that the Public Health (System) Impact Statement program is an important element of efforts to increase accountability for federal funds. I offer both the support of ASTHO, and its assistance in working with state health department directors to ensure that the program is functioning effectively.”


There were several meetings among the HHS agencies to discuss these forms to ensure that the forms will be of benefit to all.



9. Payments to Respondents

There are no payments or gifts to the respondents.


10. Assurance of Confidentiality

No assurance of confidentiality is given.



11. Questions of a Sensitive Nature

No questions of a sensitive nature are asked.



12. Estimates of Annualized Burden Hours and Costs


A. Annualized Burden Hours


A. Program Narrative and Checklist: The total response burden for the HHS Supplements to the Application for Federal Assistance is 40,819 hours. The burden was calculated on the basis of the estimated number of applications received for the covered programs. Applications are requested annually. In consultation with the 10 PHS regional offices and the PHS awarding offices, an estimate of 4 - 50 hours was established for the information required to complete the Program Narrative and Checklist. The total includes the amount for the CDC and HRSA narratives.


PHSIS: The total response burden for the PHSIS is 1,185 hours. For covered programs, applicants are directed by the Program Announcement to forward the PHSIS and the SF 424 to state proposal. Each applicant sends statements to an average of 2 to 3 local and state health agencies. The burden, estimated at 10 minutes each, is limited to the time required to copy and mail the two pages.


CDC 0.1113: The total response burden for CDC 0.1113 is 500 hours. The response time is 30 minutes.


SSA: The total response burden for SSA is 187 hours. The 10 minutes response time is the same as the PHSIS.


Total: The total response burden for the Program Narrative, Checklist, Public Health System Impact Statement, SSA, and CDC 0.1113 is 42,691 hours per year.


The programs requiring the use of the HHS Form 5161-1 and the estimated number of applicants per year are listed below.


Programs requiring a PHSIS are indicated by an asterisk *.

Public Health Preparedness and Response for Bioterrorism Programs administered by CDC and HRSA reflect a unique number of responses per respondent and/or the response burden as required by the authorizing legislation. Both programs are identified by **.


Only SAMHSA programs will use the SSA forms.



Programs, by Agency No. Of Applications


SAMHSA

Knowledge Development and Application 1,205

Services Program 45*

Projects for Transition from Homelessness

Protection and Advocacy

Projects for Transition from Homelessness

(PATH) 56

Protection and Advocacy for Individuals

with Mental Illness (PAIMI) 56

Immediate Emergency Response Grants 3

Intermediate Emergency Response Grants 3

_____

1,368

(Subject to SSA: 1,125)

(Subject to PHSIS: 10)

AHCPR

AHCPR Research Grants Program 3



CDC

Conduct Research on the Diagnosis and Pathogenesis of

Lyme Disease in U.S. 27

Conduct Research and Education Programs on Lyme Disease

in the U.S. 55

Public Health Conference Support Coop. Agreement Program

for HIV Prevention 54

Public Health Conference Support Grant Program 104

HIV Prevention Project 113*

School Health Programs to Prevent Serious Health Problems

and Improve Education 158

Mining Occupational Safety and Health Research Grants 15

Chronic Disease Control and Prevention: World Health

Organization (WHO) 1

Grants for Injury Control Research Centers 11

Demonstration Projects to Promote Integrated Public Health Information 39

Development & Distribution of American Red Cross Aids Educ. Materials 1

Research Studies Evaluating Projects on Feasibility of STD Treatment 4

Applied Research in Emerging Infections HCV Infection‑sexual Transmission 11

FACE 8

Grants for Injury Research 67

Childhood Agricultural Safety and Health Research 32

Childhood Agricultural Safety and Health Research 38

Pfiesteria‑Related Illness Surveillance and Prevention 6

Dengue Prevention and Mosquito Control Educational Exhibit 1

Fellowship Program in Violence Prevention for Minority

Medical Students 2

Applied Research for Traumatic Brain Injury Surv.& TBI

Follow‑up Registry 8

HIV, STDS, & TB Related Applied Research Projects 35

Creating Healthy Work Organizations 9

Program for Playground Safety 1

Research Program for Exposure‑Dose Reconstruction 1

Development & Testing for Populations at High Risk

for Gonorrhea Stage 1 5

Grants for Violence‑related Injury Prevention Research 43

Occupational Radiation and Energy‑Related Health Research

Grants 23

Establishment of Medical Monitoring Program ‑ The Bunker

Hill Superfund Site 1

Prevention of Violence Against Women Electronic Networking Program 1

State‑based Diabetes Programs: Comprehensive Program

Approach 22

Epidemiological Research Studies of AIDS & HIV Infection 14

Violence Against Women Prevention Research Center 9

Initiatives by Organizations to Strengthen National

Tobacco Control Activities 9

Programs to Prevent the Emergence and Spread of

Antimicrobial Resistance 28

Waterborne Disease Occurrence Studies 5

National Partnerships for Human Immunodeficiency Virus

(HIV) Prevention 20*

Educational Resource Center Training Grants 18

National Partnerships for Human Immunodeficiency Virus

(HIV) Prevention 1

Health Promotion and Disease Prevention Research Centers 43

The National Blood Data Resource Center 1

Evaluation of Toxicologic Risk Assessment Models Using Epidemiology Data 5

A Young Worker Community‑Based Health Education Project 4

Enhanced State‑Based Birth Defect Surveillance and Use of Surveillance Data 36

Deep South Center for Aging Disease and Injury Research,

Education and Prevention 3

Programs for the Prevention of Fire-Related Injuries 21

Prevention of Birth Defects through Surveillance, Training,

& Epi Research 1

Mining Occupational Safety and Health 32

National Sexual Violence Resource Center 1

Identify the Incidence of Occupational Asthma 6

HIV/AID Prevention Program Development & Technical Assist. Collaboration 1

Plant Delivered Oral Vaccines 1

Cooperative Agreement for Asthma Education 2

Hepatitis B Immunization Program with Focus on Asians

and Pacific Islanders 1

Building State Capacity to Conduct Site‑specific Activities 6

Study a Healthy Home/healthy Community Intervention 3

Model Hearing Conservation Program for Coal Miners 3

Suicide Prevention Research Center 2

Grants for Radiation Studies and Research 11

Thyroid Disease in Persons Exposed to Radiation Fallout

from Atomic Weapons Testing 1

Evaluation of Violence Prevention Programs for High‑Risk

Youth 27

Demonstration of School‑based Violence Prevention 123

The Evaluation of Interventions to Prevent Suicide 11

Coop Agreement. to Enhance Efforts to Eradicate Polio

& Improve Immunization Levels Globally 1

The Great Lakes Research Program 10

Surveillance, Research, Services, & Evaluation Directed

Toward the Prevention of Birth Defects 1

Programs to Prevent the Emergence & Spread. of

Antimicrobial Resist/Food Animals 2

State Grants to Support the Evaluation of 5-a-Day

Nutrition Programs 10

North American Association of Central Cancer Registries 1

National Diabetes Prevention Center 1

NMO Strategies for the Prevention and Control of

Diabetes (NDE Program) 9

Oral Disease Prevention in School‑Aged Children Using School‑Based/Linked

State Cardiovascular Health Programs 6

Young People in Alternative Education Settings:

Preventing HIV & Other STDS 17

Translational Research Centers for Diabetes Control

Within Managed‑Care 11

Resource Center for Unintentional Injury Prevention

among Older Americans 16

Building Environmental Health Response Capacity in Arctic Communities 1

Evaluation of Health‑Care Worker Glove Protection During

Surgery & Effects 11

Epidemiology of Opportunistic Infection in Bone Marrow

Transplant Recipient 6

Measuring the Risk for Transmission and Sequelae

from Chlamydial Disease 7

Enhancement of Local Public Health Dept. Participation

in Brownfields Dec. 10

Behavioral Intervention Research 3

Technology Translation and Transfer of Effective HIV

Prevention Interventions 1

Grants for Minority Health Statistics Dissertation Research 7

Expanded Use of Rapid HIV Testing, & Barriers to HIV Testing 28

National Heart, Lung, & Blood Institute Asthma Surveillance

with an Emphasis on Children 13

Cooperative Agreement to Study Consumer Demand for

Food Safety 10

Research Program to Study the Dermal Toxicokinetics

of Methyl Parathion 1

Coop. Agreement to Expand International Program Regarding Disability & Health 1

Cooperative Agreement for Enhancement of Poison Control

Centers 1

Studies to Evaluation, Epidemiology, and Laboratory Characteristics of

HIV Infection among U.S. Blood Donors 1

Public Health Preparedness and Response for Bioterrorism 59**


Total Competing Applications 1,545

Non-Competing Continuation Application for all Programs 495 _____

2,040

(Subject to PHSIS: 133)



FDA

Orphan Product Development 1


NIH

Construction Grants:

National Cancer Institute 1

National Center for Research Resources 70

____

71


HRSA

Rural Telemedicine Grant Program 70*

Rural Network Development Grant Program 50*

Rural Health Services Outreach Program 500*

Grants to States for Operation of Offices of

Rural Health 50

Emergency Medical Services for Children

Demonstration Grants 89*

Healthy Start 72*

Maternal & Child Health Community Integrated Service

System Set-Aside Program 114*

Maternal & Child Health Block Grant 59

Maternal & Child Health SPRANS 334*

Traumatic Brain Injury Program 21

Abstinence Education Program 53

Primary Care Cooperative Agreements 65

Health Care for the Homeless 175*

Health Services for Pacific Islanders 15*

National Health Service Corps State Loan

Repayment Program 30

Community Health Centers, including Infant

Mortality 630*

Technical and Non-financial Assistance to

Health Centers 55*

Migrant Health Centers including Infant Mortality 35*

Migrant Health Environment Program 10*

Health Services for Residents of Public Housing 10*

Black Lung Clinics 25*

Native Hawaiian Health Care 14*

Scholarships 1*

Health Centers 8*

Demonstration Grants to States for Community Scholarship

Programs 15

Hansens’ Disease 10*

Demonstration Grants to States for Alzheimer’s 20

Junior National Health Service Corps 15*

Capital Improvements Projects 35*

HIV Emergency Relief Program (Part A) 84

HIV Care Grants to States (Part B) 51

HIV Early Intervention Services (Part C) 150*

HIV Pediatrics Grants 49*

AIDS Special Projects of national Significance 46*

AIDS Education and Training Centers 15

Grants to Increase Organ Donation 5

Renovation or Construction of Non-acute Facilities 10

Disaster Assistance 18*

Public Health Preparedness and Response for Bioterrorism 59**

(Hospital Preparedness) _____

3,057

(Subject to PHSIS: 2,520)


IHS

Navajo Grants 21

Tribal Management 81

Tribal Demonstration (Mental Health) 7

Tribal Demonstration (Diabetes) 64

Health Professions Recruitment for Indians 14

Indian Child Protection and Child Abuse 50

Tribal Recruitment and Retention 12

Adolescent Health Centers 25

IHS Research Program 34

Tribal Self-Governance Planning and Negotiation 28

Tribal Matching Scholarship 4

Urban Immunization and Health Promotion/Disease Prevention 33*

Urban Indian Alcohol & Substance Abuse &

Urban Mental Health 33*

Health Professions Recruitment and Placement

for Indians: Cooperative Agreements 4

Tribal Recruitment and Retention - Coop. Agreements 10

____

420

(Subject to PHSIS: 66)


Office of Minority Health

Bilingual/Bicultural Service Demonstration Projects

in Minority Health 50*

Minority Community Health Coalition Demonstration Program 66*

Family and Community Violence Prevention Program. 4

Construction Grants 1

Cooperative Agreements to Improve Minority Health 10 _____

131

(Subject to PHSIS: 116)



Office of Population Affairs

Adolescent Family Life - Demonstration Projects 250

Family Planning - Personnel Training Program 16

Family Planning Services 100

___

366

Respondents Grand Total: 7,456


(Total Subject to PHSIS: 2,845)

(Total Subject to SSA: 1,125)






The total estimated burden is 42,691 hours per year.






Forms


No. Of Respondents


Response per Respondent


Avg. Burden Per Response

(in hours)


Total

Burden

(in hours)


Program Narrative and Checklist,



7,338



1



4



29,373


Program Narrative and Checklist (CDC)


59


6


24


8,496


Program Narrative and Checklist, (HRSA)


59


1


50


2,950


CDC Form 0.1113


1,000


1


30/60


500


Public Health Impact Statement (PHSIS)



2,845




2.5





10/60




1,185


SSA (SAMHSA)


1,125


1


10/60


187


Total




42,691


B. Annualized Cost to the Respondent



Program Narrative and Checklist :


We estimate that an applicant can complete the required narrative and checklist in an average of 4 hours. Salaries are estimated at $25/hour plus an additional $13/hour for fringe benefits and overhead.


Salary/fringe cost of $38/hr. x 4 hours = $152 per application. $152 x 7338 respondents annually = $1,115,376 per year.




Program Narrative and Checklist, (CDC):


We estimate that an applicant can complete the required narrative and checklist in an average of 4 hours. Salaries are estimated at $25/hour plus an additional $13/hour for fringe benefits and overhead.



Salary/fringe cost of $38/hr. x 24 hours = $912 x 6 applications = $5,472 x 59 respondents annually = $322,848 per year.



Program Narrative and Checklist (HRSA):


We estimate that an applicant can complete the required narrative and checklist in an average of 50 hours. Salaries are estimated at $25/hour plus an additional $13/hour for fringe benefits and overhead.


Salary/fringe cost of $38/hr. x 50 hours = $1,900 per application. $1,900 x 59 respondents annually = $112,100 per year.



CDC Form 0.1113:


We estimate that an applicant can complete the required CDC Form 0.1113 in an average of 30 minutes. Salaries are estimated at $25/hour plus an additional $13/hour for fringe benefits and overhead.



Salary/fringe cost of $38/hr. x 30 minutes = $19 per application. $19 x 1,000 respondents annually = $19,000 per year.



Public Health System Impact Statement:


The direct cost to the applicant is negligible. It is limited to the cost of copying and mailing two pages of the application to relevant state and local health agencies, which is estimated to require 10 minutes. Since the services provided by most community-based organizations focus on specific populations and geographic areas, the number of health agencies affected is few. It is estimated that each affected applicant sends an average of two to three statements to such agencies.

The annualized cost is estimated to be $17,220, which is calculated on the basis of 2,845 respondents, times an average of 2.5 responses, times 10 minutes, times $12 per hour, plus $3,000 estimated cost for postage and copying.


2,845 x 2.5 x 10 minutes = 1,185 hours

1,185 x $12 = $14,220 + $3,000 = $17,220



SAMHSA Single State Agency Coordination:


SAMHSA Single State Agency Coordination (SSA) - The total response burden for this notification is 187 hours. For covered programs, applicants are directed by the Program Announcement to forward the materials to the SSA. Each applicant sends statements to an average of one SSA. The burden, estimated at 10 minutes, is limited to the time required to copy and mail the two pages and include a copy of the transmittal with the application.


The annualized cost is estimated to be $5,244 which is calculated on the basis of 1,125 respondents, times 10 minutes, times $12 per hour, plus $3,000 estimated cost for postage and copying.


1,125 x 10 minutes = 187 hours

187 x $12 = $2,244 + $3,000 = $5,244



Total Annual Cost to Respondents


$1,115,376 (Program Narrative and Checklist,)

322,848 (CDC Program Narrative and Checklist)

112,100 (HRSA Program Narrative and Checklist) 19,000 (CDC Form 0.1113)

17,220 (PHSIS)

5,244 (SSA)

__________

$1,591,788 Total



13. Estimates of Annualized Respondent Capital and Maintenance Costs

There are no capital or maintenance costs.




14. Estimates of Annualized Cost-Government


Copy Preparation 2,500

Printing 50,500

Mailing and Handling 4,000


Total: $ 57,000


The third-party notification constitutes no cost to the Government.



15. Changes in Hour Burden

The revision is due to the addition of the Trafficking Victims Protection Act of 2000 (Section 106), as amended (22 U.S.C. 7104(g) to the certifications modifications made to the Checklist. This did not result in changes to the burden hours.


16. Time Schedule, Publication, and Analysis Plans

These are recurring data collections, and collections are done on an as needed basis. Each agency has different time-lines for the receipt and processing of their applications. Data is not collected for statistical use. There are no current plans to publish any information received from this application process.


17. Expiration Date Display Exemption

We are requesting an expiration date display exemption. The enclosed forms are used by many state and local governments, private non-profit organizations, and for-profit organizations for federally funded health services projects. Applicants can download, complete, review, and/or or print the 5161 application forms from the HHS or the SAMHSA websites. However, at this time the data cannot be saved . Although having access to the forms over the Internet is convenient for some it is not available for most, the majority continues to use hard copies.


Applicants can contact a Clearinghouse and receive a hard copy ‘application kit’ containing all relevant application information, including the 5161 forms package. The Clearinghouse does maintain a supply of printed forms. Therefore we are requesting to continue to have the ability to print large quantities of the forms without expiration dates, at one time. This would be very cost effective for the agencies and the applicants. Expiration dates require that perfectly useful forms be discarded because the expiration date is not current.


If a significant change were ever made we could easily cite the new date of revision in the grants/cooperative agreement application instructions. That way the organizations could request and receive the revised version as needed.



18. Exceptions to Certification

No exceptions are requested.




B. Collections of Information Employing Statistical Methods


This information will not be used for statistical purposes.


List of Attachments (Located in ROCIS)






Attachment A Supplemental Form HHS 5161-1 (Part II IC form)



Attachment B Public Health System Impact Statement (Part I file)



Attachment C Substance Abuse/Mental Health Single State Agency Coordination (Part I file)



Attachment D CDC Supplemental Form [CDC 0.113] (Part I file)





























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File Modified2010-08-31
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