INNOVATION GRANT PROGRAM: APPROACHES IN HIV VACCINE RESEARCH 

RELEASE DATE:  March 20, 2003

PA NUMBER: PA-03-082  (This PA has been reissued and modified, see PA-06-109)

RECEIPT DATE Standard AIDS Receipt Date

EXPIRATION DATE: December 23, 2005

National Institute of Allergy and Infectious Diseases (NIAID)
 (http://www.niaid.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR)
 (http://www.nidcr.nih.gov/)
 
CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:
No. 93.855, Immunology, Allergy, and Transplantation Research
No. 93.856, Microbiology and Infectious Diseases Research
No. 93.121, Oral Diseases and Disorders Research

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA 

This program announcement (PA) is a continuation of the Innovation Grant 
Program for AIDS Vaccine Research, implemented by the National Institute of 
Allergy and Infectious Diseases (NIAID) and the National Institute of Dental 
and Craniofacial Research (NIDCR), National Institutes of Health (NIH), 
Department of Health and Human Services (DHHS), on the recommendation of the 
AIDS Vaccine Research Working Group (AVRWG).  This program encourages the 
entrance of novel and innovative vaccine discovery and development concepts 
into the research pipeline.  As such, the emphasis of this program is on 
supporting prophylactic vaccine research projects that are particularly 
innovative, novel, may be high risk/high impact, and that exhibit the 
potential to advance AIDS prophylactic vaccine design or evaluation.  
Applications are especially welcome from both experienced investigators not 
currently active in the field of AIDS research, and from young investigators 
beginning their work in this field.  The Innovation Grant Program uses a 
grant mechanism that provides funding for projects that are exploratory and 
that are intended to generate preliminary data for further studies.

Applications targeting any scientific area(s) related to AIDS prophylactic 
vaccine research are encouraged.  Before application receipt dates, 
scientific areas of particular programmatic interest may be posted on the 
NIAID website http://www.niaid.nih.gov/daids/vaccine/innovation.htm.  
Periodically, these areas are chosen based on advice received from the AIDS 
Vaccine Research Working Group (AVRWG), and emerge from meetings, workshops, 
and discussions with program staff.  Applicants are strongly encouraged to 
contact program staff and visit the website before submitting an application.  
Applications for research aimed at targeted areas are especially encouraged, 
but applicants are not required to focus on only those areas.

RESEARCH OBJECTIVES

All pertinent areas of investigation contributing to the development of an 
efficacious HIV/AIDS vaccine are welcome.  These might include but are not 
limited to: methods to enhance antigen presentation/ processing; structural 
studies of HIV proteins as related to their antigenicity; nucleic acid 
vaccination; recombinant virus vectors; pseudovirion approaches; analyses of 
correlates of immunity; approaches to enhance HIV vaccine-induced immunologic 
memory; development of improved assays for antibody neutralization, CTL or 
other immune responses; vaccine approaches that target developing stronger 
mucosal immunity; strategies that use oral or nasal mucosa as the vaccination 
route; mobilizing antigen presenting cells to vaccination sites; strategies 
to induce broadly reactive neutralizing antibodies to primary isolates; 
determining vaccine effects during concurrent/inter-current infections (e.g., 
TB and malaria) common in HIV endemic areas; vaccine approaches exploring 
innate immunity, the use of biological adjuvants, and regulatory T cell 
responses.  Research applications intended to produce preliminary data or 
precedent for a new idea or concept are particularly encouraged.  Vaccine 
research focused solely on therapeutic applications is not within the scope 
of this program announcement.  The safety evaluation of immunogens in 
infected animals or people can be included if these studies directly support 
the development of a prophylactic vaccine.  For information on programs that 
support therapeutic vaccine development please contact program staff.

MECHANISM OF SUPPORT

This PA will use the NIH Exploratory/Developmental Research Project Grant 
(R21) award mechanism.  The total requested project period for an application 
submitted in response to this PA may not exceed two years.  The applicant 
will be solely responsible for planning, directing, and executing the 
proposed project.  

NIAID uses R21 grants to provide short-duration support for preliminary 
studies of a highly speculative nature, which are expected to yield, within 
this time frame, sufficient information upon which to base a well-planned and 
rigorous series of further investigations.

This PA uses the just-in-time procedure for certain information.  It also 
uses the modular budgeting format (see 
https://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, 
applications with direct cost budgets of $250,000 or less in each year must 
use the modular budget format.  This program does not require cost sharing as 
defined in the current NIH Grants Policy Statement at 
https://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm. 

Applicants to this specific PA may request up to two years of support limited 
to $150,000 per annum in direct cost.  Thus, applicants will request direct 
costs in $25,000 modules, up to a total of $150,000 direct cost per year.

Current policy limits support of R21 grants to two years with no extensions 
or supplements.  However, awardees may request no-cost extensions, if 
appropriate, nearing completion of the second year.  A typical modular grant 
application requests the same number of modules in each year.  The applicant 
is solely responsible for planning, directing, and executing the proposed 
project.

Though applicants may request up to two years of support and up to $150,000 
per annum in direct costs, exceptions can be made, with compelling 
justification.  Examples of what might warrant exception would be the 
necessity for specific costly reagents, animals, specimens, or laboratory 
modifications to perform the studies.  Program staff may be able to advise 
prospective applicants concerning NIAID- and NIDCR-sponsored resources that 
may be available to them.  Contact the program staff listed under WHERE TO 
SEND INQUIRIES for further information.

This award is non-renewable.  However, it is hoped that successful grantees 
funded through this exploratory/developmental research program will elect to 
seek continuing support for research further along the development pipeline 
through R01or P01 grant mechanisms utilized by the HIV Vaccine Research and 
Development Program and/or the Integrated Preclinical/Clinical AIDS Vaccine 
Development Program.

ELIGIBLE INSTITUTIONS

The applicant may submit (an) application(s) if the institution has any of 
the following characteristics: 

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
  and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government 
o Domestic or foreign
o Faith-based or community-based organizations 

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support. Individuals from under-represented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.

SPECIAL REQUIREMENTS 

Awardees may be expected to attend a meeting convened by NIAID and NIDCR to 
showcase the progress of the work funded under this program.  Details of this 
meeting will be provided post-award.  Thus, applicants should include in 
their budget request funds for the PI to attend one two-day meeting in the 
Washington, DC area over the two-year performance period of the award.

When clinical studies or trials are a component of the research proposed, 
NIAID policy requires that studies be monitored commensurate with the degree 
of potential risk to study subjects and the complexity of the study.  AN 
UPDATED NIAID policy was published in the NIH Guide on July 8, 2002 and is 
available at: https://grants.nih.gov/grants/guide/notice-files/
NOT-AI-02-032.html.  The full policy, including terms and conditions of 
award, is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf.

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into three 
areas: scientific/research, peer review, and financial or grants management 
issues.

The NIAID Division of AIDS (DAIDS) has a website 
(http://www.niaid.nih.gov/daids/vaccine) for AIDS vaccine research with an 
emphasis on facilitating applications for AIDS vaccine research funds and 
access to other resources available to AIDS vaccine investigators through the 
Division.  The website has information describing the various programs 
targeting AIDS vaccine research and listings of currently active AIDS 
vaccine-related program announcements and contracts and their associated 
deadlines.  Updates concerning the continuing Innovation Grant Program: 
Approaches in HIV Vaccine Research will also be posted there.

Applicants are encouraged to explore the NIH AIDS Research and Reference 
Reagent Program (http://www.niaid.nih.gov/reposit) for the availability of 
various human and animal specimens, as well as small quantities of viruses, 
antibodies, HIV and SIV proteins and peptides, plasmids, and other reagents. 

o Direct questions about scientific/research issues to:

NIAID

Jon Warren, Ph.D.
Division of AIDS (DAIDS)
National Institute of Allergy and Infectious Diseases
Room 4104, MSC-7628
6700-B Rockledge Drive
Bethesda, MD 20892-7628
Telephone: (301) 402-0633
FAX: (301)402-3684
Email: jw374e@nih.gov

NIDCR

Mostafa Nokta, M.D., Ph.D. 
Division of Basic and Translational Sciences 
National Institute of Dental and Craniofacial Research
45 Center Drive
Building 45, Room 4AN-18H, MSC-6402
Bethesda, MD 20892-6402
Telephone: (301) 594-7985
FAX: (301) 480-8319
Email: Mostafa.Nokta@nih.gov

o Direct questions about peer review issues to:

Maryclare Walker, Ph.D.
Center for Scientific Review
Room 5104, MSC-7710
6701 Rockledge Drive
Bethesda, MD  20892-7710
Telephone: (301) 435-1165
FAX: (301) 480-2241
Email: mw31y@nih.gov

o Direct questions about financial or grants management matters to:

NIAID

Jeannette Gordon
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2122, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 402-5065
FAX: (301) 493-0597
Email: jg82s@nih.gov

NIDCR

Mary Daley
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
Building 45, Room 4AN44B, MSC-6402
45 Center Drive
Bethesda, MD  20892-6402
Phone: (301) 594-4808
FAX: (301) 480-3562
Email: md74u@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 
Email: GrantsInfo@nih.gov.

APPLICATION RECEIPT DATES:  Applications submitted in response to this 
program announcement will be accepted at the standard AIDS-related 
application deadlines (typically May 1, September 1, and January 2).  It is 
advisable to verify these deadlines at 
https://grants.nih.gov/grants/dates.htm.  Application deadlines are also 
indicated in the PHS 398 application kit.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:  Applications requesting 
up to $250,000 per year in direct costs must be submitted in a modular grant 
format.  The modular grant format simplifies the preparation of the budget in 
these applications by limiting the level of budgetary detail.  Applicants 
request direct costs in $25,000 modules.  Section C of the research grant 
application instructions for the PHS 398 (rev. 5/2001) at 
https://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at 
https://grants.nih.gov/grants/funding/modular/modular.htm.

SUPPLEMENTAL INSTRUCTIONS FOR R21 APPLICATIONS:  

To apply, please follow the PHS 398 instructions for submission of a single 
project (R01) research grant application, modified for submission of an R21 
application as listed below: 

1) The description (abstract) must include a brief explanation of the 
proposed activity, and how it is consistent with the 
exploratory/developmental nature of the R21 mechanism as described in this 
notice. 

2) Although preliminary data are neither expected nor required for an R21 
application, they may be included. 

3) Sections a-d of the Research Plan may not exceed 10 pages, including 
tables and figures. 

4) Appendix materials should be limited, as is consistent with the 
exploratory nature of the R21 mechanism, and should not be used to circumvent 
the page limit for the research plan.  Copies of appendix material will only 
be provided to the primary reviewers of the application and will not be 
reproduced for wider distribution.  The following materials may be included 
in the appendix: 

o Up to five publications, including manuscripts (accepted for publication), 
abstracts, patents, or other printed materials directly relevant to the 
project.  These may be stapled as sets. 

o Surveys, questionnaires, data collection instruments, and clinical 
protocols.  These may be stapled as sets. 

o Original glossy photographs or color images of gels, micrographs, etc., 
provided that a photocopy (may be reduced in size) is also included within 
the 10-page limit of items a-d of the research plan. 

Include five collated sets of all appendix material, in the same package with 
the application, following all copies of the application.  Identify each item 
with the name of the principal investigator. 

SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original of 
the application, including the checklist, and five signed photocopies in one 
package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

APPLICATION PROCESSING:  Applications must be received by or mailed before 
the receipt dates described at 
https://grants.nih.gov/grants/funding/submissionschedule.htm.  The CSR will 
not accept any application in response to this PA that is essentially the 
same as one currently pending initial review unless the applicant withdraws 
the pending application.  The CSR will not accept any application that is 
essentially the same as one already reviewed.  This does not preclude the 
submission of a substantial revision of an application already reviewed, but 
such application must include an Introduction addressing the previous 
critique.

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
convened in accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific 
and technical merit.  

As part of the initial merit review, all applications will:

o Receive a written critique
o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the appropriate advisory council or board.

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following 
aspects of the application in order to judge the likelihood that the proposed 
research will have a substantial impact on the pursuit of these goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

The scientific review group will address and consider each of these criteria 
in assigning the application's overall score, weighting them as appropriate 
for each application.  The application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score.  For example, an investigator may propose to 
carry out important work that by its nature is not innovative but is 
essential to move a field forward.

SIGNIFICANCE:  Does this study address an important problem? If the aims of 
the application are achieved, how will scientific knowledge be advanced?  
What will be the effect of these studies on the concepts or methods that 
drive this field?

APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?

INNOVATION:  Does the project employ novel concepts, approaches or methods? 
Are the aims original and innovative?  Does the project challenge existing 
paradigms or develop new methodologies or technologies?

INVESTIGATOR:  Is the investigator appropriately trained and well-suited to 
carry out this work?  Is the work proposed appropriate to the experience 
level of the principal investigator and other researchers (if any)?

ENVIRONMENT:  Does the scientific environment in which the work will be done 
contribute to the probability of success?  Do the proposed experiments take 
advantage of unique features of the scientific environment or employ useful 
collaborative arrangements?  Is there evidence of institutional support?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and the 
priority score:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their participation 
in the proposed research will be assessed. (See criteria included in the 
section on Federal Citations, below).
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of 
plans to include subjects from both genders, all racial and ethnic groups 
(and subgroups), and children as appropriate for the scientific goals of the 
research will be assessed.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the sections on 
Federal Citations, below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to 
be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.  

ADDITIONAL CONSIDERATIONS 

DATA SHARING:  The adequacy of the proposed plan to share data.

BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities

REQUIRED FEDERAL CITATIONS 

HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained.

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of 
the research. This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43).

All investigators proposing clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 (https://grants.nih.gov/grants/guide/notice-
files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are 
available at https://grants.nih.gov/grants/funding/women_min/
guidelines_amended_10_2001.htm.  The amended policy incorporates: the use 
of an NIH definition of clinical research; updated racial and ethnic categories 
in compliance with the new OMB standards; clarification of language governing 
NIH-defined Phase III clinical trials consistent with the new PHS Form 398; 
and updated roles and responsibilities of NIH staff and the extramural 
community.  The policy continues to require for all NIH-defined Phase III 
clinical trials that: a) all applications or proposals and/or protocols must
provide a description of plans to conduct analyses, as appropriate, to address 
differences by sex/gender and/or racial/ethnic groups, including subgroups if 
applicable; and b) investigators must report annual accrual and progress in 
conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
https://grants.nih.gov/grants/funding/children/children.htm.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  This policy announcement is in the NIH Guide for Grants and 
Contracts Announcement, dated June 5, 2000, at 
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research 
on hESCs can be found at https://grants.nih.gov/grants/stem_cells.htm and at  
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals 
for NIH funding must be self-contained within specified page limitations. 
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites.   Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of "Healthy 
People 2010," a PHS-led national activity for setting priority areas. This PA 
is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. 

AUTHORITY AND REGULATIONS

This program is described in the Catalogue of Federal Domestic Assistance at 
http://www.cfda.gov/ in the following citations: No. 93.855, Immunology, 
Allergy, and Transplantation Research and No. 93.856, Microbiology and 
Infectious Diseases Research. Awards are made under authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and administered under NIH grants policies and Federal Regulations 42 CFR 52 
and 45 CFR Parts 74 and. This program is not subject to the intergovernmental 
review requirements of Executive Order 12372 or Health Systems Agency review.

The NIH Grants Policy Statement is available at 
https://grants.nih.gov/grants/policy/policy.htm. This document includes 
general information about the grant application and review process; 
information on the terms and conditions that apply to NIH Grants and 
cooperative agreements; and a listing of pertinent offices and officials at 
the NIH.  All awards are subject to the terms and conditions, cost 
principles, and other considerations described in the NIH Grants Policy 
Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the use of all tobacco products.  In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities (or in some cases, any portion of a 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 PHS mission to protect and advance the physical and mental health of 
the American people.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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