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
https://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
(https://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: blithed@nih.gov
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: kathy.hancock@nih.gov
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: blithed@nih.gov
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
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone 301-710-0267,
E-mail: GrantsInfo@nih.gov.
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:
https://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: https://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
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete
copy of the updated Guidelines is 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. You will find this policy announcement 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 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
https://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.