eh11-001 foa final amendment i 05.02.11.doc

Amendment I 05/02/2011

This is a budget clarification for RFA-EH-11-001. The amount budgeted is $450,000 per year, per award for a project period of up to 2 years.

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Department of Health and Human Services

Part 1. Overview Information

limited use, and CIO may or may not have authority for each activity code. Add the relevant activity code, if not listed above. Please see the Activity Codes, Organizational Codes, and Definitions Used in Extramural Programs for more information.

Announcement Type

New Keep relevant text; enter previous FOA Number if a reissuance

Delete the non-relevant choices (RFA/PA. Fill in Fiscal Year (FY). For a CIO RFA, insert the RFA number for NNN. Leave the FOA number as NNN and it will be assigned by PGO staff.

http://www.grants.gov/search/category.do e.g.:

Health

Please limit this field to a brief description of ¼ to ½ page in length. Brevity is appreciated.

Key Dates Publication Date

PGO will add this information when posted. This field is not available for CIO edit.

by 5:00 PM Eastern Time.

On-time submission requires that electronic applications be error-free and made available to CDC for processing from eRA Commons on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov/eRA Commons no later than 5:00 PM Eastern Time. Note: HHS/CDC grant submission procedures do not provide a period of time beyond the application due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Date is expected to be three months (minimum two months) after publication of the announcement (assume 30 days in one month).

The expiration date will be the day after the last due date. (Enter date above).

Required Application Instructions It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Insert as applicable and include the page limits:

Note: The Research Strategy component of the Research Plan is limited to 10 pages.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348 “Apply Electronically” Text and link inserted here by PGO.

Table of Contents

Part 1. Overview Information Part 2. Full Text of the Announcement Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement

Section I. Funding Opportunity Description The National Center for Environmental Health (NCEH) of CDC within HHS is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2020" and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA). This FOA addresses “Healthy People 2020” priority area(s) of Maternal, Infant and Child Health to “reduce fetal and infant deaths and to ensure appropriate newborn bloodspot screening” and Public Health Infrastructure, and is in alignment with NCEH performance goal(s) to “develop new laboratory methods…,” “to provide laboratory measurements for studies of… genetic susceptibility related to disease, and risk factors for selected chronic diseases,” “and to ensure that laboratory quality standards are maintained for newborn screening.” For more information, www.healthypeople.gov. www.cdc.gov/nceh/ and http://intra-apps.cdc.gov/fmo/ Background

Newborn bloodspot screening (NBS) is a vital public health program to test newborns for congenital disorders that are not apparent at birth. More than 4 million newborns are screened annually in the United States, and thousands of newborns and children are saved from disability and death through early detection and treatment. Although the conditions for which newborns are screened vary from state to state, a core panel of tests for congenital disorders detectable by NBS has been recommended to the Department of Health and Human Services by the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC). In January 2010, SACHDNC made its first-ever recommendation to expand the uniform national panel to include Severe Combined Immune Deficiency (SCID). In a landmark decision in May 2010, Secretary Sebelius approved the adoption of the SACHDNC’s 29 recommended core conditions (including the 25 secondary conditions) to the Uniform Screening Panel and also adopted SCID as the 30th core condition to be screened for by all State newborn screening programs.

SCID is a group of disorders characterized by severe defects in both cellular and humoral immunity. At birth SCID newborns appear healthy and are not typically identified until clinical symptoms of opportunistic infection develop. Hematopoietic stem cell transplantion is a highly effective treatment, but only if infants are identified early in life (within 3.5 months of birth), prior to the onset of severe infections. Without medical intervention, the disease is fatal and affected individuals typically die before the age of one.

Presymptomatic diagnosis of newborns offers the best opportunity for successful treatment of SCID. Effective laboratory screening methodology has been developed utilizing dried bloodspots collected at birth. In addition, studies and pilot programs supported by both the CDC and the National Institutes of Health (NIH) have demonstrated the cost effectiveness and feasibility of population-based NBS for SCID. As of November 2010, screening of more than 400,000 newborns has successfully identified patients with classical SCID and other primary immune deficiencies. Such progress in SCID detection, along with the endorsement of the SACHDNC and approval by the HHS Secretary provides the foundation for continued support for the implementation of new SCID NBS programs throughout the United States and its Territories.

Purpose

The purpose of this funding opportunity is to promote research in support of the implementation of first time newborn bloodspot screening programs for SCID and is targeted to programs which were not fully operational before January 2011.

Objectives:

· To expand laboratory capacity for SCID newborn screening in the US by the funding of capital costs for purchases (such as laboratory equipment, reagents, etc) in order to implement SCID testing

· To increase the pool of laboratory scientists with knowledge and skill in conducting newborn screening for SCID

· To provide training for the public health community (e.g., laboratory scientists, healthcare providers, NBS program officials, primary care physicians) about NBS tests for SCID and to foster its integration into the standard of care for communities

· To encourage participation in collaborative ventures to explore data analysis and statistical algorithms that can improve the predictive values of primary SCID NBS tests

Note: Awards are intended as seed funding, and applicants must demonstrate a commitment to secure and sustain funds from other sources for routine program operation beyond the project period.

Recommended length: 1-5 pages. Present the purpose of the funding opportunity in paragraph form, addressing all of the items below. Please keep in mind that readers will appreciate clarity and brevity. The following headers may be useful in preparing this section:

Purpose/Research objectives (describe the nature and need of the research opportunity)

Specific Areas of Research Interest (include examples of research topics. In such cases, add a statement indicating that appropriate topics “include but are not limited to those listed below.”

This section may also address scientific knowledge to be achieved through research supported by the special program and types of research and experimental approaches that are being sought to achieve the objectives.

Add information.

Section II. Award Information

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

Choose one of the following:.

New

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

Indicate the total funds available for the entire program.

$900,000 for 2 Awards

Awards issued under this FOA are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

INSERT maximum $ amount; amount that you will not exceed OR INSERT "None." This ceiling is for the first 12-month budget period. Indicate if this is direct cost only or total cost, which would include indirect costs.

INSERT any minimum $ amount, if you will not make an award smaller than a floor amount OR INSERT "None."

The total project period for an application submitted in response to this funding opportunity will be for two years. If the project period is more than two years, approval is required.

Add Information Here (Example: Scope of the proposed project should determine the project period. The maximum period is 5 years.)

If project period is more than five years, approval is required.

Throughout the project period, CDC's commitment to continuation of awards will be conditional on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants Eligible Organizations

Delete organizations that are not eligible to apply.

· Eligible applicants are State or Territorial Public Health Newborn Bloodspot Screening Programs. Eligible applicants may apply either as: an individual organization, or as the lead member of a consortium of multiple State Public Health laboratories with an existing Newborn Bloodspot Screening program, or in partnership with an organization from the following list: Public nonprofit organizations; private nonprofit organizations; for profit organizations; small, minority, and women-owned businesses; universities; colleges; research institutions; hospitals; community-based organizations; faith-based organizations; federally recognized or state-recognized American Indian/Alaska Native tribal governments; American Indian/Alaska Native tribally designated organizations; Alaska Native health corporations; urban Indian health organizations; tribal epidemiology centers; state and local governments or their Bona Fide Agents (this includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau); and political subdivisions of states (in consultation with states).

A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms" when submitting via www.grants.gov.

If foreign organizations are eligible to apply, then delete the following sentence Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are not if foreign components are not allowed, delete “not” allowed.

Add additional eligibility requirements here for institutions.

Required Registrations Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

· Central Contractor Registration (CCR) – must be renewed annually

· Grants.gov

· eRA Commons

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for HHS/CDC support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

Add additional eligibility requirements here for individuals.

2. Cost Sharing

This FOA does not require cost sharing as defined in the HHS Grants Policy Statement.

3. Additional Information on Eligibility Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

If the sentence above is not true, , CIO must insert a comment to change the sentence above to “Only one application per institution (normally identified by having a unique DUNS number) is allowed.”

HHS/CDC will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. HHS/CDC will not accept any application that is essentially the same as one already reviewed.

This FOA is specifically targeted to the implementation of first time SCID newborn screening programs which were not fully operational before January 2011.

Add Information Here related to eligibility and number of applications.

Section IV. Application and Submission Information

1. Obtaining an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity from Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent The only acceptable modifications to this section are those related to the staff contact information. Current policy does not allow any changes to the type of information requested in the Letter of Intent. If Letter of Intent is not applicable for this FOA, delete the heading above and the section below.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research Name, address, and telephone number of the PD(s)/PI(s) Names of other key personnel Participating institutions Number and title of this funding opportunity

The letter of intent should be sent to:

J. Felix Rogers, Ph.D., M.P.H.

Scientific Review Officer

Extramural Research Program Office Coordinating Center for Environmental Health and Injury Prevention

Centers for Disease Control and Prevention (CDC)

U.S. Department of Health and Human Services 4770 Buford Highway, MS F62

Atlanta, Georgia 30341

Telephone: 770-488-4334 (office) Fax: 404-929-2741 Email: FRogers@cdc.gov Required and Optional Components A complete application has many components, both required and optional. The forms package associated with this FOA in Grants.gov includes all applicable components for this FOA, required and optional.

Page Limitations

All page limitations described in this individual FOA must be followed.

For this FOA, the Research Strategy section is limited to 10 pages. If the 10 page limit is exceeded, the application will be deemed nonresponsive and returned to applicant.

Research Plan Components All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Add text in the space below (before Appendix) to supply any additional instructions related to the Research Plan, but only include information that is different from application guide.

Research Plan Section - Individual NBS Applications and NBS Research Consortium Applications

The Research Plan section needs to be uploaded separately as a PDF attachment. Applicants for a NBS research consortium should construct the Research Plan for the consortium as a single document, separating each individual NBS Laboratory component into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to HHS/CDC in PDF format, filenames must be included with no spaces or special characters, and a PDF extension must be used. Do not include any information in a header or footer of the attachments. A header will be system-generated that references the PD/PI. Page numbers for the footer will be system-generated in the complete application, with all pages sequentially numbered; therefore, do not number the pages of your attachments. Your research plan for an individual NBS research application must not exceed 25 pages. The research plan for a NBS research consortium application must not exceed the 15 pages limit for each NBS Laboratory component and 10 page limit for the research strategy/overview. For example, the page limit for a NBS research consortium with 5 NBS Laboratory components is 85 pages. If your research plan exceeds the page limitation, your application will be considered nonresponsive and ineligible for review.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide, with the following modifications:

Delete the text block above and bullet below if not adding any changes to the Appendix instructions. If you are making changes, fill in text below.

Up to five publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to the proposed project. Do not include manuscripts submitted for publication. Applicants should refer to instruction guides and specific Funding Opportunity Announcements (FOAs) to determine the appropriate limit on the number of publications that may be submitted for a particular program. Note that not all grant activity codes allow the inclusion of publications.

· Publications in press: Include only a publication list with a link to the publicly available on-line journal article or the NIH Pub Med Central (PMC) submission identification number. Do not include the entire article.

· Manuscripts accepted for publication but not yet published: The entire article may be submitted electronically as a PDF attachment.

· Manuscripts published but a publicly available online journal link is not available: The entire article may be submitted electronically as a PDF attachment.

· Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents.

· Graphic images of gels, micrographs, etc. provided that the image (may be reduced in size) is also included within the (stated) page limit of Items 2-5 of the Research Plan component. No images may be included in the Appendix that are not also represented within the Research Plan.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process is provided in the SF424 (R&R) Application Guide.

Note: HHS/CDC grant submission procedures do not provide a period of time beyond the grant application due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e. error correction window).

The application package is not complete until it has passed the Grants.gov/eRA Commons validation process. This process and email notifications of receipt and validation or rejection may take two (2) business days. Applicants are strongly encouraged to allocate additional time prior to the submission deadline to submit their applications and to correct errors identified in the validation process. Applicants are encouraged also to check the status of their application submission to determine if the application packages are complete and error-free. Applicants who encounter system errors when submitting their applications must attempt to resolve them by contacting the Grants.gov Contact Center (1-800-518-4726; support@grants.gov). If the system errors cannot be resolved, applicants must contact PGO TIMS for guidance at least 3 calendar days before the deadline date.

Please note the following restriction on appendix attachments: The Research Plan Appendix attachments are limited to 10 attachments. Appendices are uploaded as attachments in the PHS 398 Research Plan form, in field #18, within the electronic application package. An applicant will receive an error message if the number of appendix attachments exceeds 10, which will result in an unsuccessful submission of the application. You may include more than one publication, or other allowable appendix material, within one attachment; however, do not let your attachments exceed 10.”

4. Intergovernmental Review (E.O. 12372) This initiative is not subject to intergovernmental review.

Or:

5. Funding Restrictions

All HHS/CDC awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Pre-award costs are unallowable as described in the HHS Grants Policy Statement.

Funds for human subjects research will be restricted until Federal wide assurances and institutional review board approvals are in place. Add additional information about funding restrictions. If any of these restrictions become part of the terms of award, that must be stated in Section VI.1. Delete this block if there is no additional information.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:

All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to CDC.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the CDC Procurement and Grants Office (PGO) and responsiveness by PGO and the Center, Institute or Office of the CDC. Applications that are incomplete and/or nonresponsive will not be reviewed.

Add information here related to responsiveness if applicable.

Add any other Submission Requirements and Information; include heading (and description. Do not include information about the CONTENT and FORM of the application, which should instead be placed above in Section IV.2. Content and Form, Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the CDC mission, all applications submitted to the CDC in support of public health research are evaluated for scientific and technical merit through the CDC peer review system.

Overall Impact

This FOA is specifically targeted to the implementation of first time SCID newborn screening programs which were not fully operational before January 2011. Is the applicant proposing a new or first time SCID newborn screen program? Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Overall Impact is not editable.

Streamlining/Triaging

Streamlining is a practice through which less competitive grant applications, as judged by the study section members, are not discussed at the review meeting. In order for an application to be streamlined, there must be unanimous agreement amongst study section members. These applications do not receive an overall impact score. For the "NOT DISCUSSED" applications, the summary statement integrates all of the written reviews from the assigned reviewers.

Scored Review Criteria Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? How will successful completion of the aims change the concepts, newborn screening methods and technologies, preventative interventions, treatments, available services and standards of care this field? To what extent will the proposed research develop, evaluate, implement, and/or improve NBS tests for SCID, through for example: decreased false-positive results without increased false-negative results, increased sample throughput, reduced test costs, improved “ease of testing, etc?

Additional Questions may be added.

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? Have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? To what extent does the applicant demonstrate the capacity to access a sufficiently large population of newborns necessary to detect SCID? How well are plans for Quality Control/Quality Assurance (QA/QC) developed, including knowledge of and plans for participation in the CDC/NCEH Newborn Screening Quality Assurance Program (NSQAP)? To what extent does the applicant describe how they will address the impact of the new NBS test on current NBS laboratory operations, e.g., resources, instrumentation requirements, run-times, etc?

Additional Questions may be added.

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, justified in terms of the scientific goals and research strategy proposed? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area in order to expand SCID testing to other areas?

Additional Questions may be added.

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves research involving human subjects or a clinical investigation, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Are essential facilities and instrumentation available and adequate for conducting the research and to continue with the same level of output for ongoing NBS bloodspot testing? Does the applicant demonstrate that they have the capacity to manage the volume of NBS bloodspot screening for a large population as necessary for the detection of SCID?

Additional Questions may be added.

IMPORTANT: Any reordering or rewording of the existing text above (this does not include any information you have added) should be discussed and cleared with the Scientific Review Officer, the GMO, and PGO TIMS before publication as it may require technical changes in the eRA review modules.

Additional Scored Review Criteria may be added but criterion scores for these criteria will not be captured by IAR and must instead be calculated by Review Staff..

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

· The relevance and balance of proposed research relative to the HHS/CDC/NCEH programs and priorities, for example, to promote research in support of the implementation of first time newborn bloodspot screening programs for SCID.

· Consideration for funding to achieve geographic diversity (regional balance), broad national coverage (screening that can be effectively implemented in other parts of the country) and/or balance among State Public Health NBS Laboratories serving large or small populations.

· Preference for funding applicants with demonstrated experience and/or ongoing efforts for the development of methods and NBS screening programs for SCID and applicants that can demonstrate a commitment to secure and sustain funds from other sources for program operation beyond the project period.

· Only first-time newborn screening programs for SCID will be considered. Applicants cannot have submitted a funded application under RFA EH08-002.

· Availability of funds.

Additional Review Criteria may be added.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the HHS/CDC Requirements under AR-1 Human Subjects Requirements.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Inclusion of Women and Racial and Ethnic Minorities in Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Revisions Revisions (formerly called competing supplement applications), are a request for an increase in support in a current budget period for expansion of the scope of the approved project or program or to meet an unforeseen increase in costs. The request may specify budgetary changes required for the remainder of the project period as well as for the current budget period. Supplemental applications requesting a programmatic expansion (change in scope) must undergo objective review and generally are required to compete for support; requests for administrative supplements may be awarded without objective review or competition.

Additional Review Considerations As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score. Additional Review Considerations may be added.

If Foreign Organizations are not allowed to apply for this FOA, delete the text. Otherwise, do not change.

Resource Sharing Plans

HHS/CDC policy requires that recipients of grant awards make unique research resources and data readily available for research purposes to qualified individuals within the scientific community after publication. Please see:

http://www.cdc.gov/od/foia/policies/sharing.htm. Investigators responding to this funding opportunity should include a plan on sharing research resources and data.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process Applications will be evaluated for scientific and technical merit by an appropriate peer review group, in accordance with CDC peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications will: Delete first bullet if all applications will be discussed (no streamlining of applications); otherwise do not modify the bullet.

· Undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review), will be discussed and assigned an overall impact/priority score.

· Receive a written critique.

Following initial peer review, recommended applications will receive a second level of review. The secondary review will provide recommendations to the HHS/CDC/CIO Director regarding the relevance and balance of the proposed research to the HHS/CDC/CIO programs and priorities and the research objectives identified in this FOA.

The following will be considered in making funding decisions:

· Scientific and technical merit of the proposed project as determined by scientific peer review.

· Availability of funds.

· Relevance of the proposed project to program priorities.

For any additional considerations in funding decisions, add a bullet and enter text such as “Compliance with resource sharing policies.”

Indicate if this award will include special terms and conditions that differ from the agency’s usual terms and conditions. Include Programmatic Priorities and Other Cost Limitations (e.g., excluding Facilities & Administrative costs for R13s). See also Section IV.5. “Funding Restrictions.”

3. Anticipated Announcement and Award Dates After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Information regarding the disposition of applications is available in the HHS Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, HHS/CDC will request "just-in-time" information from the applicant as described in the HHS Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs specified in the FOA document.

2. Administrative and National Policy Requirements

All HHS/CDC grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA. For these terms of award, see the HHS Grants Policy Statement Part II: Terms and Conditions of Award, Overview of Terms and Conditions of Award and Requirements for Specific Types of Grants. Additional requirements are available at the following internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

Cooperative Agreement Terms and Conditions of Award Indicate if this FOA is not for a cooperative agreement and this section (from here to Reporting) can be removed.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and CDC grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial CDC programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the HHS/CDC purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and HHS/CDC as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

· Build sufficient capacity to assure the reliable implementation of SCID newborn screening technology as part of routine laboratory testing at the state level.

· To expand the number of laboratory scientists with the knowledge and skill necessary for conducting newborn screening for SCID

· Provide training for the public health community, e.g., laboratory scientists, healthcare providers, NBS program officials, primary care physicians, about the improved NBS test(s) to foster its integration into the standard of care for communities.

· To participate in collaborative ventures to explore data analysis and statistical algorithms that can improve the predictive values of primary SCID NBS tests. The recipient will work collaboratively with the CDC to review public or private requests for data.

· Add any additional bulleted information.Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and CDC policies.

· Obtain the appropriate IRB approvals for research involving human subjects for all participating sites CDC staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

· Foster relationships among State Public Health NBS Laboratory programs and other partners by assisting in the sharing of information, seminars, an annual stakeholder meeting, quarterly conference calls, and other direct interactions.

· Assist each project to integrate, as appropriate, the six components of the NBS system: Education, Laboratory Screening, Follow-Up, Diagnosis, Management, and Evaluation.

· Convene workgroups as appropriate to cross-fertilize efforts among different partners.

· Assist in designing, developing, and evaluating laboratory methods and pilot studies, especially with respect to Quality Assurance/Quality Control (QA/QC) and integration with CDC NSQAP.

· Assure compatibility of laboratory data from multiple sources by providing common reference materials.

· Assist in the protocol development, implementation, data analysis, interpretation of results, and dissemination of laboratory and pilot demonstration findings including report writing and oral presentation.

· Maintain a central repository of newborn dried bloodspot specimens that were classified as screen-positive for future assay comparisons and evaluations.

· Provide assistance in development of training materials on laboratory methods, evaluations, risk communication, and other topics for State Public Health NBS programs.

· Add any additional bulleted information. Additionally, an agency program official or CIO program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

· Obtain IRB approvals as required by CDC when CDC is engaged in research involving human subjects.

Areas of Joint Responsibility include:

· None; all responsibilities are divided between awardees and CDC staff as described above. If there areas of joint responsibility (examples include membership, duties, voting, steering committee, etc.), revise text as appropriate.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the HHS Grants Policy Statement.

If additional reporting requirements need to be added, please insert a comment indicating what reporting requirements are desired. Note that additions likely will require approval by PGO.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated, no more than 90 days after the end of the project period.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

CIO cannot require prior approvals in this section.

Scientifi…