GENETIC TESTING AND THE CLINICAL MANAGEMENT OF NONSYNDROMIC HEREDITARY
HEARING IMPAIRMENT
Release Date: December 20, 2000
PA NUMBER: PAS-01-036
National Institute on Deafness and Other Communication Disorders
(http://www.nidcd.nih.gov/)
National Human Genome Research Institute
(http://www.nhgri.nih.gov/)
Letter of Intent Receipt Dates: February 15, April 15, and August 15, 2001
Application Receipt Dates: March 14, 2001, June 26, 2001, October 26, 2001
THIS PA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED
WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA.
PURPOSE
The National Institute on Deafness and Other Communication Disorders (NIDCD)
and the National Human Genome Research Institute (NHGRI) invite research grant
applications to study genetic testing as it may relate to the clinical
management of nonsyndromic hereditary hearing impairment. There is a broad
range of issues that must be addressed to comprehensively determine the
clinical validity and utility of genetic testing for hereditary hearing
impairment. Such issues include the correlation of genetic and audiologic
information, the utilization of genetic information in clinical management and
outcomes, and the impact of genetic testing on the behaviors and attitudes of
individuals with hearing impairment and their families.
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 Program Announcement (PA), Genetic
Testing for Hereditary Hearing Impairment, 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/.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic and foreign, for-profit and non-
profit organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and eligible
agencies of the Federal government. Foreign institutions are eligible.
Racial/ethnic minority individuals, women, and persons with disabilities are
encouraged to apply as Principal Investigators.
MECHANISM OF SUPPORT
This PA will use the National Institutes of Health (NIH) R01 award mechanism.
Responsibility for the planning, direction, and execution of the proposed
project will be solely that of the applicant. The total project period for an
application submitted in response to this PA may not exceed four years. This
PA has three solicitation dates. Future unsolicited competing continuation
applications will compete with all investigator-initiated applications and be
reviewed according to the customary peer review procedures. The earliest
anticipated award date is September 28, 2001.
Specific application instructions have been modified to reflect "MODULAR
GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH.
Complete and detailed instructions and information on Modular Grant
applications can be found at
http://grants.nih.gov/grants/funding/modular/modular.htm
FUNDS AVAILABLE
The NIDCD intends to commit approximately $750,000 in FY 2001 and $750,000 in
FY 2002 to fund up to five new awards in response to this PA. The NHGRI will
also commit funds subject to availability. An applicant may request a project
period of up to four years. Because the nature and scope of the research
proposed may vary, it is anticipated that the size of each award will also
vary. Although the financial plans of the NIDCD and NHGRI provide support for
this program, awards pursuant to this PA are contingent upon the availability
of funds and the receipt of a sufficient number of meritorious applications.
At this time, there are no plans to reissue this PA.
RESEARCH OBJECTIVES
Background
In the last decade scientists have determined the chromosomal locations of
hundreds of genes that segregate in families with a history of deafness.
Approximately 20 of the genes whose mutations result in non-syndromic hearing
impairment have been identified and isolated. Mutations in one or a few of
these genes are important contributors to hearing impairment in some
population groups. One example is the GJB2 gene that encodes a gap junction
protein, Connexin 26. Mutations in this gene are reported to be the most
common cause of autosomal recessive non-syndromic deafness in several parts of
the world; however, the clinical phenotype may be variable. The degree of
hearing loss in persons with Connexin 26-related hearing impairment varies
even among individuals with the same GJB2 genotype, and there may be
variability in the time of initial onset of hearing loss as well as
variability in the rate of progression of hearing loss.
With the identification of genes that contribute to hearing function, genetic
testing becomes technically possible. This possibility does not necessarily
imply that genetic testing should be performed. Prior to clinical
implementation of genetic testing, several issues must be addressed to assess
the clinical validity and utility of such tests. There are many unresolved
issues regarding the prevalence and penetrance of mutations in various
populations, the clinical utility of knowing the specific genetic mutation
responsible for the hearing loss, and the short and long-term impact of
genetic testing and information on individuals and their families. There is
little information on the understanding of and attitudes about genetic testing
or the level of interest in such testing, particularly among families in which
hearing impairment has occurred. There are unique challenges pertaining to
genetic testing for deafness and hearing impairment because these conditions
are not considered to be disabling or undesirable by everyone.
The screening of newborns for hearing impairment (phenotypic) is being
initiated throughout the nation, identifying infants with hearing loss
immediately after birth. At present, thirty-two states have enacted
legislation that requires universal hearing screening for newborns.
Identification of hearing loss at birth is presenting unique challenges. Not
only are these infants with hearing impairment being identified much earlier
in life, but infants with varying degrees of hearing impairment are now being
identified, in contrast to the recent past where primarily only severe to
profound hearing impairment was detected in the second or third year of life.
Many unresolved issues remain for clinicians as they strive to characterize
the auditory performance in the newborn who fails hearing screening, design
intervention strategies to optimize communicative success, and ensure that a
medical home exists for the infant with hearing impairment.
The advances in the genetics of hereditary hearing impairment and the advances
in the early identification of hearing impairment have now converged. These
advances have led some to suggest genetic testing/evaluation for all infants
who are identified with a hearing loss at birth, and some organizations and
individuals have embraced this idea. For example, in January 2000 the
American College of Medical Genetics published a policy statement on universal
newborn hearing screening. In it, they noted that it is essential that all
children with confirmed hearing loss be referred for evaluation and genetic
counseling to a team which will typically include a qualified clinical
geneticist and a genetic counselor. These guidelines may be found at:
http://www.faseb.org/genetics/acmg/pol-35.htm.
The NIDCD has recently assembled two working groups in which the extramural
research communities have considered these issues. First was the NIDCD Working
Group on Considerations for Developing and Implementing Genetic Diagnostic
Tests for Hereditary Hearing Impairment and Other Communication Disorders.
The minutes may be found at
http://www.nidcd.nih.gov/funding/programs/hb/genetic.asp. Second was the Third
Workshop of the NIDCD Working Group on the Early Identification of Hearing
Impairment in which this topic was identified as a research need. Those
minutes may be found at
http://www.nidcd.nih.gov/funding/programs/hb/earlyid_00.asp.
This PA is designed to address the clinical relationship between genetic and
audiologic/otologic information as well as to address the clinical validity
and utility of genetic testing in the diagnosis, treatment and management of
nonsyndromic hereditary hearing impairment, as well as psychosocial effects.
Other
This PA is broad in scope and nature and it is likely that these applications
will be multidisciplinary. Responsive applications must have a clinical
research focus that seeks to investigate questions surrounding the use or
implementation of genetic testing for nonsyndromic hearing loss. There is a
broad range of issues that must be addressed to comprehensively determine the
utility of genetic testing for hereditary hearing impairment. Such issues
include the correlation of genetic and auditory information, the utilization
of genetic information in clinical management and outcomes, and the impact of
genetic testing on the behaviors and attitudes of individuals with hearing
impairment. Applications focusing solely on the prevalence and penetrance of
genetic mutations thought to be involved in hereditary hearing impairment are
not responsive to this PA; however, such applications are of interest to the
NIDCD and should be submitted to the NIH on the regular R01 submission dates.
The NIDCD and NHGRI are highly committed to furthering research on the
ethical, legal and social implications of human genetics and genomic research,
and have recently co-sponsored two NIH program announcements requesting
research applications in this area. The program announcement calling for
regular (R01) research grants in this area may be found at
http://grants.nih.gov/grants/guide/pa-files/PA-00-133.html and the program
announcement calling for small (R03) research grants in this area may be found
at http://grants.nih.gov/grants/guide/pa-files/PA-00-132.html.
Research objectives include, but are not limited to:
o Developing longitudinal studies of individuals with deafness/hearing
impairment to address genotype/phenotype correlations. This includes the
natural history of hearing loss in individuals with various mutations in
different populations. Necessary phenotypic information includes degree of
hearing loss as well as age of onset and rate of progression of hearing
loss.
o Examining the correlation and interaction of genetic information with
audiologic/auditory information beyond the audiogram, which includes
delineating auditory (sensory) thresholds as well as auditory perception
(speech and supra-threshold auditory abilities).
o Developing clinical studies to determine the value of genetic testing as a
complement to existing clinical screening procedures, diagnostic procedures
and management practices. Areas of study include understanding the
clinical validity and utility of genetic testing to screen for hearing
impairment as well as understanding the short and long term effects of
genetic testing for hearing impairment.
o Determining the role of genetic testing and the utilization of genetic
information in the optimization of models of service delivery for infants
and young children with hearing loss (i.e., screening, assessment and
habilitation/rehabilitation protocols, as well as medical management).
o Developing adequate informed consent procedures on the use of DNA specimens
for genetic testing and further genetic research related to hearing
impairment.
o Determining the impact of genetic testing and the utilization of genetic
information on attitudes and behaviors of individuals with hearing
impairment and their families.
o Evaluating the psychosocial effects of genetic testing in the context of
unique cultural issues associated with hearing impairment/deafness.
o Evaluating methods of providing education and counseling to facilitate
comprehension of genetic information and subsequent informed decision-
making following the provision of genetic information.
SPECIAL REQUIREMENTS
Attention to informed consent issues is required.
Informational materials to aid researchers in obtaining informed consent from
individuals with hearing impairment or deafness may be found at:
http://www.nidcd.nih.gov/news/releases/99/inform/toc.asp
Evidence of Clinical Laboratory Improvements Act (CLIA) certification is
required for all projects in which genetic testing results will be provided to
research participants.
In order to increase the scope and pace of the research, the NIDCD and NHGRI
will organize a consortium of studies. Such an arrangement will allow
researchers to compare findings on issues common to all the projects, to
reduce duplication of effort, and to promote sharing of information. To
facilitate such coordination, grantee workshops will be arranged on an annual
basis in the Bethesda area. The budget request should take into account the
need for funds for travel to these meetings for up to two investigators (the
PI and one other) per year.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
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 biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification are 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 research involving human subjects should read the
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research," published in the NIH Guide for Grants and Contracts on
August 2, 2000
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html);
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The
revisions relate to NIH defined Phase III clinical trials and require: a) all
applications or proposals and/or protocols to 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) all
investigators to report accrual, and to conduct and report analyses, as
appropriate, by sex/gender and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH 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 was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html
Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning the policy.
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. Reviewers are cautioned that their anonymity may
be compromised when they directly access an Internet site.
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes a
descriptive title of the proposed research, the name, address, and telephone
number of the Principal Investigator, the identities of other key personnel
and participating institutions, and the number and title of the PA. 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 NIDCD staff to estimate the potential review workload and plan the
review.
The letter of intent is to be sent to Amy Donahue, Ph.D., at the address
listed under INQUIRIES by the letter of intent receipt dates listed in
SUBMISSION OF APPLICATIONS.
APPLICATION PROCEDURES
The research grant application form PHS 398 (rev. 4/98) is to be used in
applying for these grants. These forms are available at most institutional
offices of sponsored research and from the Division of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge Drive,
MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email:
GrantsInfo@nih.gov.
The modular grant concept establishes specific modules in which direct costs
may be requested as well as a maximum level for requested budgets. Only
limited budgetary information is required under this approach. The just-in-
time concept allows applicants to submit certain information only when there
is a possibility for an award. It is anticipated that these changes will
reduce the administrative burden for the applicants, reviewers and Institute
staff. The research grant application form PHS 398 (rev. 4/98) is to be used
in applying for these grants, with the modifications noted below.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS
BUDGET INSTRUCTIONS
Modular Grant applications will request direct costs in $25,000 modules, up to
a total direct cost request of $250,000 per year. (Applications that request
more than $250,000 direct costs in any year must follow the traditional PHS
398 application instructions.) The total direct costs must be requested in
accordance with the program guidelines and the modifications made to the
standard PHS 398 application instructions described below:
PHS 398
FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in
$25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total
Direct plus Facilities and Administrative (F&A) costs] for the initial budget
period Items 8a and 8b should be completed indicating the Direct and Total
Costs for the entire proposed period of support.
DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of
the PHS 398. It is not required and will not be accepted with the application.
BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget table on Form Page 5 of the PHS 398. It is not required and
will not be accepted with the application.
NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative
page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample
pages.) At the top of the page, enter the total direct costs requested for
each year. This is not a Form page.
Under Personnel, list all project personnel, including their names, percent of
effort, and roles on the project. No individual salary information should be
provided. However, the applicant should use the NIH appropriation language
salary cap and the NIH policy for graduate student compensation in developing
the budget request.
For Consortium/Contractual costs, provide an estimate of total costs (direct
plus facilities and administrative) for each year, each rounded to the nearest
$1,000. List the individuals/organizations with whom consortium or contractual
arrangements have been made, the percent effort of all personnel, and the role
on the project. Indicate whether the collaborating institution is foreign or
domestic. The total cost for a consortium/contractual arrangement is included
in the overall requested modular direct cost amount. Include the Letter of
Intent to establish a consortium.
Provide an additional narrative budget justification for any variation in the
number of modules requested.
BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by
reviewers in the assessment of each individual's qualifications for a specific
role in the proposed project, as well as to evaluate the overall
qualifications of the research team. A biographical sketch is required for all
key personnel, following the instructions below. No more than three pages may
be used for each person. A sample biographical sketch may be viewed at:
http://grants.nih.gov/grants/funding/modular/modular.htm
- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on
research projects ongoing or completed during the last three years.
- List selected peer-reviewed publications, with full citations;
CHECKLIST - This page should be completed and submitted with the application.
If the F&A rate agreement has been established, indicate the type of agreement
and the date. All appropriate exclusions must be applied in the calculation of
the F&A costs for the initial budget period and all future budget years.
The applicant should provide the name and phone number of the individual to
contact concerning fiscal and administrative issues if additional information
is necessary following the initial review.
The Applicants planning to submit an investigator-initiated new (type 1),
competing continuation (type 2), competing supplement, or any amended/revised
version of the preceding grant application types requesting $500,000 or more
in direct costs for any year are advised that he or she must contact NIDCD
program staff before submitting the application, i.e, as plans for the study
are being developed. Furthermore, the application must obtain agreement from
the NIDCD staff that they will accept the application for consideration for
award. Finally, the applicant must identify, in a cover letter sent with the
application, the staff member and Institute who agreed to accept assignment of
the application.
This policy requires an applicant to obtain agreement for acceptance of both
any such application and any such subsequent amendment. Refer to the NIH
Guide for Grants and Contracts, March 20, 1998 at
http://grants.nih.gov/grants/guide/notice-files/not98-030.html
The title and number of the program announcement must be typed on line 2 of
the face page of the application form and the YES box must be marked.
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)
Send two additional copies of the application, and five sets of any appendices
to:
Chief, Scientific Review Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400-C, MSC 7180
Bethesda, MD 20892-7180
Rockville, MD 20852 (for express/courier service)
SUBMISSION OF APPLICATIONS
Applications will be accepted under these guidelines for three receipt dates
beginning with the March 2001 application receipt date through the October
2001 date.
Letter of Intent: February 15 April 15 August 15
Application Receipt Dates: March 14 June 26 October 26
NIDCD Committee Review: June October February 2002
Council Review: September January May
Earliest Funding: September 28 April 1 August 1
Applications must be received by the application receipt date listed above.
If an application is received after that date, it will be reviewed in the next
cycle.
The Center for Scientific Review (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 substantial
revisions of applications already reviewed, but such applications must include
an introduction addressing the previous critique.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by CSR. If the
application is not related to the goals of the PA, the applicant may be
contacted to determine whether to return the application to the applicant or
submit it for review in competition with unsolicited applications at the next
review cycle.
Applications that are complete will be evaluated for scientific and technical
merit by an appropriate peer review group convened by the NIDCD in accordance
with the review criteria stated below. As part of the initial merit review,
all applications will receive a written critique and 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,
assigned a priority score, and receive a second level review by the NDCD and
NHGRI Advisory Councils.
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. Each of these
criteria will be addressed and considered in assigning the overall score,
weighting them as appropriate for each application. Note that 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.
(1) 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?
(2) 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?
(3) 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?
(4) 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)?
(5) 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?
In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:
o The adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will also be
evaluated.
o The reasonableness of the proposed budget and duration in relation to the
proposed research.
o 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.
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o scientific merit (as determined by peer review)
o availability of funds
o programmatic priorities.
INQUIRIES
Inquiries concerning this PA are encouraged. The opportunity to clarify any
issues or answer questions from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Amy Donahue, Ph.D.
Chief, Hearing and Balance/Vestibular Section
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400-C, MSC-7180
Bethesda, MD 20892-7180
Telephone: (301) 402-3458
Fax: (301) 402-6251
Email: amy_donahue@nih.gov
Thomas Johnson, Ph.D.
Hearing Program Officer
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400-C, MSC-7180
Bethesda, MD 20892-7180
Telephone: (301) 402-3461
Fax: (301) 402-6251
Email: thomas_johnson@nih.gov
Jean McEwen, J.D., Ph.D.
Program Director
Ethical, Legal, and Social Implications Research Program
National Human Genome Research Institute
31 Center Drive
Building 31, MSC 2033, Room B2B07
Bethesda, MD 20892-2033
Telephone:(301) 402-4997
Fax: (301) 402-1950
Email: jm522n@nih.gov
http://www.nhgri.nih.gov/ELSI
Direct inquiries regarding review issues to:
Craig Jordan, Ph.D.
Chief, Scientific Review Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400-C, MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 496-8683
Fax: (301) 402-6250
Email: jordanc@nih.gov
Direct inquiries regarding fiscal matters to:
Ms. Sherry Dabney
Grants Management Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400-B, MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 402-0909
Fax: (301) 402-1758
Email: sherry_dabney@nih.gov
Ms. Jean Cahill
Division of Extramural Research
National Human Genome Research Institute
38 Library Drive, MSC 6050, Room 613
Bethesda, MD 20892-6050
Telephone: (301) 402-1733
Fax: (301) 402-1951
Email: cahillj@mail.nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.173. 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 92. This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and promote the non-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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