NOVEL APPROACHES TO MALE FERTILITY REGULATION

RELEASE DATE:  October 17, 2002							

RFA:  HD-02-028 (Reissued as RFA-HD-08-005)

National Institute of Child Health and Human Development (NICHD) 
 (http://www.nichd.nih.gov) 

Letter of Intent Receipt Date:  February 12, 2003
Application Receipt Date:  March 12, 2003

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

The National Institute of Child Health and Human Development (NICHD) invites 
applications from investigators interested in participating with NICHD in a 
cooperative research program to explore novel approaches to male fertility 
regulation.  The NICHD has identified development of novel male 
contraceptives as a high priority goal within its Strategic Plan 
http://www.nichd.nih.gov/.  The aim of the program is to conduct a wide range 
of research, both basic and applied, with the ultimate goal of developing 
knowledge that may lead to clinically useful products to regulate male 
fertility.  The proposed research involves exploration of the epididymis and 
testis to identify specific targets that can be exploited for fertility 
regulation.  The RFA will support research on novel approaches to male 
contraception including, but not limited to, research on epididymal function, 
spermatogenesis, and regulation of germ cell apoptosis.  

RESEARCH OBJECTIVES

Background

Over 50 percent of pregnancies in the United States are unintended.  Other 
than condoms, withdrawal and vasectomy, there are no male methods available 
for use in the United States.  The NICHD has identified development of novel 
male contraceptives as a high priority goal within the Strategic Plan for the 
Institute.  Toward that goal, the Center for Population Research (CPR) has 
held meetings internally as well as with outside advisors to develop the 
mechanisms that would most efficiently accomplish the task.  As a result of 
the meetings, we have proposed a plan to bring together investigators and 
resources to explore novel approaches to male contraception.  The ideal 
contraceptive should be safe and highly effective.  A variety of 
contraceptive methods are needed to address the needs of people of different 
ethnic, cultural, and religious values; those with inadequate access to 
services; and those with changing needs related to age.

Research Scope

The purpose of the RFA is to identify new targets that could lead to the 
development of safe and effective contraceptive products for males.  Research 
projects proposed in response to this RFA can be directed to male targets of 
fertility regulation, including spermatogenesis, testicular or epididymal 
function, and regulation of germ cell apoptosis, etc.  Examples of possible 
projects include, but are not limited to: 

o  Research on a particular sperm-specific target for drug design.

o  Development of genomic or proteomic screens designed to identify and 
define the functional role of proteins in spermatogenesis, epididymal, 
testicular, seminal or sperm function.

o  The characterization of a macromolecule(s) involved in spermatogenesis or 
sperm, epididymal or testicular function, the perturbation of which with a 
pharmacological agent results in reversible infertility.

o  Research on the nature of the sperm-testis or blood-epididymal barriers 
with the goal of delivering agents to specific targets involved in control of 
fertility.

o  Research on the processes of sperm maturation with the goal of defining 
specific targets involved in control of fertility.

Guidance and Management Structure

A steering committee composed of participating Principal Investigators and 
NICHD program staff, will meet at least once yearly.  The purpose of these 
meetings is to assess scientific progress, identify new research 
opportunities, establish priorities, and discuss strategies that will 
accelerate the translation of preclinical findings into clinical 
applications. Outside consultants/experts may be asked to participate in 
these discussions as nonvoting advisors. Periodic workshops will be held to 
allow the investigators to exchange information and advice.  

Research Resource

A program supporting phenotyping of male fertility defects in knock-out mouse 
models has been initiated under a separate RFA 
http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-01-020.html>. The support 
of the phenotyping facilities that are geared toward identifying mutants with 
impaired fertility is to help pinpoint genes involved with male fertility 
regulation. Investigators supported by the present RFA will have the 
opportunity to utilize the mutant mice developed under that program that 
present with male fertility defects. The gene targets identified through this 
research will be further characterized with respect to function and 
suitability for fertility regulation. The Steering Committee, as part of its 
annual meeting, will develop a plan for use of mutants by the investigators 
within this cooperative agreement.  The investigators will work together to 
minimize overlap and to facilitate research efforts, depending upon the 
research goals of the various funded projects.  In the event that potential 
products emerge from the research, further development will be carried out 
through the use of NICHD service contracts that conduct toxicology, 
formulation, and clinical trials.  Use of these contracts will be directed by 
project officers within the Contraception and Reproductive Health Branch of  
NICHD to provide assistance toward obtaining FDA approval of a product for 
male contraception.

MECHANISM OF SUPPORT

The RFA will use the National Institutes of Health (NIH) Cooperative Research 
Project (U01) award mechanism.  The NIH (U01) is a cooperative agreement 
award mechanism in which the Principal Investigator retains the primary 
responsibility and dominant role for planning, directing, and executing the 
proposed project, with NIH staff being substantially involved as a partner 
with the Principal Investigator, as described under the section "Cooperative 
Agreement Terms and Conditions of Award."

FUNDS AVAILABLE

The NICHD intends to commit approximately $1.5 million in total costs [Direct 
plus Facilities and Administrative (F & A) costs] in FY 2003 to fund new 
and/or competing continuation awards in response to this RFA.  Applicants may 
request a period of support of up to five years. Because the nature and scope 
of the research proposed may vary, it is probable that the size of the awards 
will also vary. Applicants may request a budget up to $200,000 direct costs 
in the first year. Although the financial plans of the NICHD provide support 
for this program, awards pursuant to this RFA are contingent upon the 
availability of funds and the receipt of a sufficient number of meritorious 
applications. Depending on the number, size and quality of the applications 
received it is anticipated that 4-7 grants may be funded. At this time, it is 
not known if the RFA will be reissued.  

ELIGIBILE INSTITUTIONS

You may submit an application if your 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.  

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 underrepresented racial 
or ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.  

SPECIAL REQUIREMENTS

Minimum Application Requirements

The minimal requirements for a successful applicant to this RFA are as 
follows:

o  An innovative proposal by the Principal Investigator;

o  Availability of the technical resources and facilities for the conduct of 
the proposed project, including appropriate animal facilities, if applicable;

o  Research environment conducive for contraceptive research;

o  Willingness to engage in a coordinated, cooperative research program with 
multiple interacting research projects.

The investigators funded by this RFA are expected to work together in a 
cooperative manner.  The Steering Committee, as part of its annual meeting, 
will facilitate the development of a plan for use of resources from the mouse 
phenotyping program 
(http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-01-020.html) by the members.  
The investigators will work together to minimize overlap and to facilitate 
research efforts, depending upon the research goals of the various funded projects. 

A response to this RFA must consist of an application that includes:

o  A description of the research project. 
o  A description of the capabilities of the Investigator.
o  A proposed five-year research plan that presents the applicant's 
perception of the organization and component functions of the program.  The 
plan should identify the applicant's knowledge, ingenuity, practicality, and 
commitment in organizing a project aimed at developing new male 
contraceptives.

Meetings

An annual meeting of the Investigators will be conducted and applicants are 
advised to include such a plan in the budget request.  The purpose of the 
meeting is to exchange scientific information and to discuss collaborations 
between investigators.  It is expected that the Principal Investigator will 
attend the annual meeting.  In addition, research fellows participating in 
the projects should attend the meeting.  For budgeting purposes, assume that 
the meeting will be held in Bethesda, MD.
 
Cooperative Agreement Terms and Conditions of Award

The following terms and conditions of the cooperative agreement award and 
details of the arbitration procedures pertaining to the scope and nature of 
the interaction between the NICHD and the participating awardees will be 
incorporated into the Notice of Grant Award and provided to the Principal 
Investigator and the institutional official at the time of award. The special 
Terms and Conditions of Award are in addition to, not in lieu of, otherwise 
applicable OMB administrative guidelines, HHS grant administration 
regulations at 42 CFR Parts 74 and 92, and other HHS, PHS and NIH grant 
administration policies. 

The administrative and funding instrument used for this program is a 
Cooperative Agreement (U01), an "assistance" mechanism (rather than an 
"acquisition" mechanism) in which substantial NIH scientific and/or 
programmatic involvement with the awardee is anticipated during performance 
of the activity.  Under the cooperative agreement, the NIH purpose is to 
support and/or stimulate the recipient's activity by involvement in and 
otherwise working jointly with the award recipient in a partner role, but it 
is not to assume direction, prime responsibility, or a dominant role in the 
activity. Consistent with this concept, the dominant role and prime 
responsibility for the activity resides with the awardee(s) for the project 
as a whole, although specific tasks and activities in carrying out the 
studies will be shared among the awardees and the NICHD Research Coordinator.  

1.  Awardee Rights and Responsibilities

Awardees have primary authorities and responsibilities to define objectives 
and approaches, and to plan, conduct, analyze, and publish results, 
interpretations, and conclusions of their studies.  The primary 
responsibilities of the awardees are to:

o  Define the research objectives;

o  Design the necessary research protocols;

o  Conduct specific studies;

o  Analyze and interpret research data;

o  Modify protocols as required;

o  Interact with the FDA concerning clinical investigations;

o  Provide information to the NICHD Research Coordinator concerning progress.
 
Awardees will retain custody of and primary rights to their data and 
intellectual property developed under the award subject to current government 
policies regarding rights of access as consistent with current HHS, PHS, and 
NIH policies. 

2.  NICHD Staff Responsibilities

NICHD Research Coordinator:

The NICHD Research Coordinator will have substantial scientific-programmatic 
involvement during the conduct of this activity, through technical 
assistance, advice and coordination above and beyond normal program 
stewardship for grants.  The responsibilities of the NICHD Research 
Coordinator will include the following:

o  Assist in setting research priorities and in avoiding unwarranted 
duplication of effort;

o  Serve on the Steering Committee as a voting member;

o  Review and comment on critical stages in the research program before 
subsequent stages are implemented;

o  Assist in the interaction between the awardee and the FDA, investigators 
at other institutions, and potential commercial sponsors;

o  Retain the option to recommend additional research endeavors within the 
constraints of the approved research and negotiated budget;

NICHD Project Officer:

NICHD will appoint a Project Officer, apart from the Research Coordinator, 
who will:

o ensure that all regulatory, fiscal and administrative matters are handled 
according to NIH guidelines;

o will evaluate requests for additional funds or for rebudgeting; 

o carry out continuous review of individual projects to evaluate progress;

o serve as a non-voting advisor to the Steering Committee; 

o perform other duties required for normal program stewardship of grants.

3. Collaborative Responsibilities

Overall coordination of the Program, consistent with the stated intent of the 
RFA, will be provided by a Steering Committee consisting of the Principal 
Investigators of each of the awarded grants and the NICHD Research 
Coordinator.  The NICHD Project Officer and a member of the NICHD grants 
management staff will serve as nonvoting advisors to the Committee.  The 
Steering Committee meetings will be convened at least once yearly.  The 
purpose of these meetings is to assess scientific progress, identify new 
research opportunities, establish priorities, and discuss strategies that 
will accelerate the translation of preclinical findings into clinical 
applications.  Outside consultants/experts may be asked to participate in 
these discussions as nonvoting advisors.

4. Arbitration Process

When agreement between an awardee and NICHD staff cannot be reached on 
scientific/programmatic issues that may arise after the award is made, an 
arbitration panel will be formed.  The arbitration panel will consist of one 
person selected by the Principal Investigators on the Steering Committee, one 
person selected by the NICHD, and a third person selected by both NICHD staff 
and the Principal Investigators.  The decision of the arbitration panel, by 
majority vote, will be binding.  The special arbitration procedure in no way 
affects the right of an awardee to appeal adverse action in accordance with 
PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR 
Part 16.

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA 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: encouraged. The opportunity to clarify any issues or answer questions 
is welcome.

Direct your questions about scientific/research issues to:

Diana Blithe, Ph.D.
Contraception and Reproductive Health Branch,
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B13, MSC 7510
Bethesda, MD 20892-7510
Telephone:  (301) 435-6990
FAX:  (301) 480-1972
Email:  [email protected] 

Direct your questions about peer review issues to:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Telephone:  (301) 496-1485
FAX:  (301) 402-4104

Direct your questions about financial or grants management matters to:

Kathy Hancock
Grants Management Branch
National Institute of Child Health and Human Development 
6100 Executive Boulevard, Room 8A17M, MSC 7510
Bethesda, MD 20892-7510
Telephone:  (301) 496-5482
FAX:  (301) 402-0915
Email:  [email protected] 

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes 
the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

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 NICHD staff to estimate the potential review workload and 
plan the review.

The letter of intent is to be sent by the date listed at the beginning of 
this document.  The letter of intent should be sent to:

Diana Blithe, Ph.D.
Contraception and Reproductive Health Branch,
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B13, MSC 7510
Bethesda, MD 20892-7510
Telephone:  (301) 435-6990
FAX:  (301) 480-1972
Email:  [email protected] 

SUBMITTING AN APPLICATION

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

SUPPLEMENTAL INSTRUCTIONS:

The application should address the items listed above under SPECIAL 
REQUIREMENTS/Minimum Application Requirements.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  Failure to use this label 
could result in delayed processing of the application such that it may not 
reach the review committee in time for review.  In addition, the RFA title 
and number must be typed on line 2 of the face page of the application form 
and the YES box must be marked. The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the Checklist, and three 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)
 
At the time of submission, two additional copies of the application must be 
sent to:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E03, MSC 7510
Bethesda, MD 20892-7510
Rockville MD 20852 (for express/courier service)

APPLICATION PROCESSING:  Applications must be received by the application 
date listed at the heading of this RFA.  If an application is received after 
that date, it will be returned to the applicant without review.

The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA 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 substantial 
revisions of applications already reviewed, but such applications must 
include an introduction addressing the previous critique.  

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by NICHD. Incomplete and/or non-responsive applications will 
be returned to the applicant without further consideration. Applications that 
are complete and responsive to the RFA will be evaluated for scientific and 
technical merit by an appropriate peer review group convened by NICHD in 
accordance with the review criteria stated below.  As part of the initial 
merit review, all applications will:

o Receive a written critique
o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the National Advisory Child Health and 
Human Development Council

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 your 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 your application's overall score, weighting them as appropriate 
for each application.  Your 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, you may propose to carry out 
important work that by its nature is not innovative but is essential to move 
a field forward.

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

(2) APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Do you acknowledge potential problem areas and consider alternative 
tactics?

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

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

(5) ENVIRONMENT:  Does the scientific environment in which your 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, your 
application will also be reviewed with respect to the following:

o PROTECTIONS:  The adequacy of the proposed protection for humans, animals, 
or the environment, to the extent they may be adversely affected by the 
project proposed in the application.

o INCLUSION:  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.  Plans for the recruitment and 
retention of subjects will also be evaluated. (See Inclusion Criteria 
included in the section on Federal Citations, below)

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

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

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  February 12, 2003
Application Receipt Date: March 12, 2003
Peer Review Date:  May 2003 
Council Review:  September 2003
Earliest Anticipated Start Date:  September 2003

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

Scientific merit (as determined by peer review)
Availability of funds
Programmatic priorities.

REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD:  Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

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 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete 
copy of the updated Guidelines is available at 
http://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 
http://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.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://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 http://grants.nih.gov/grants/stem_cells.htm and at 
http://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 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this RFA 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 
RFA 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 Catalog of 
Federal Domestic Assistance No. 93.864, Population Research, and is not 
subject to the intergovernmental review requirements of Executive Order 12372 
or Health Systems Agency review.  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 described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92. 

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.

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