Release Date:  October 22, 2001

RFA:  RFA-OH-02-003

National Institute for Occupational Safety and Health, (NIOSH)

Letter of Intent Receipt Date:  November 7, 2001
Application Receipt Date:       December 27, 2001



The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2002 funds for research grant 
applications on occupational hearing loss.  Applications are 
sought that investigate the etiology of and prevention and 
intervention strategies for occupational hearing loss through 
population-based or laboratory research that is focused on changes 
in hearing due to: (1) exposure to noise or (2) exposure to noise 
and chemicals. This program addresses the AHealthy People 2010" 
focus area Occupational Health and Safety.

The research needs identified in this announcement are consistent 
with the National Occupational Research Agenda (NORA) developed by 
NIOSH and partners in the public and private sectors to provide a 
framework to guide occupational safety and health research in the 
new millennium towards topics which are most pressing and most 
likely to yield gains to the worker and the nation.  The agenda 
identifies 21 research priorities.  NORA priorities with specific 
relevance to this announcement is hearing loss.  Information about 
NORA is available through the NIOSH Home Page; 
http://www.cdc.gov/niosh/norhmpg.html.  You may also refer to 


CDC is committed to achieving the health promotion and disease 
prevention objectives of Healthy People 2010, a national 
activity to reduce morbidity and mortality and improve the quality 
of life.  For the conference copy of AHealthy People 2010", visit 
the internet site:  http://www.health.gov/healthypeople/.


Applications may be submitted by domestic and foreign, public and 
private nonprofit and for-profit organizations and by governments 
and their agencies; that is, universities, colleges, research 
institutions, hospitals, other public and private nonprofit and 
for-profit organizations, State and local governments or their 
bona fide agents, including the District of Columbia, the 
Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth 
of the Northern Mariana Islands, American Samoa, Guam, the 
Federated States of Micronesia, the Republic of the Marshall 
Islands, and the Republic of Palau, federally recognized Indian 
tribal governments, Indian tribes, or Indian tribal organizations, 
and small, minority, and women-owned businesses that meet the 
above criteria.  Racial/ethnic minority individuals, women, and 
persons with disabilities are encouraged to apply as Principal 

Note: Title 2 of the United States Code section 1611 states that 
an organization described in section 501(c)(4) of the Internal 
Revenue Code that engages in lobbying activities is not eligible 
to receive Federal funds constituting an award, grant, or loan.


The mechanism of support will be the individual research project 
grant (R01).  Responsibility for the planning, direction, and 
execution of the proposed project will be solely that of the 
applicant.  The total requested project period for an application 
submitted in response to this RFA may not exceed three (3) years 
for laboratory studies and five (5) years for population-based 
studies. Note: Foreign grants are limited to 3 years.  This RFA is 
a one-time solicitation.


Approximately $1,000,000 is available in FY 2002 to fund 4-5 
awards under this RFA.  The maximum amount that may be requested 
is $200,000 direct cost per year for laboratory-based studies and 
$400,000 direct cost per year for population-based studies.  
Awards are expected to begin May 1, 2002. Funding estimates may change.

Awards will be made for a 12-month budget period within a project 
period up to three (3) years for laboratory-based studies and five 
(5) years for population-based studies.  Continuation awards 
within the project period will be made on the basis of 
satisfactory progress and availability of funds in future years.

Use of Funds

Applicants should include in their budgets funds for one trip per 
year for an annual meeting of grantees to be held in Washington, 
D.C. The purpose of this meeting is to provide an opportunity for 
the exchange and dissemination of scientific information.



In 1995, the National Institute on Deafness and Other 
Communication Disorders estimated that of the 28 million Americans 
with hearing loss, nearly half had work-related, noise-induced 
hearing loss.  NIOSH estimates that almost 10 million American 
workers are exposed to occupational combinations of noise and 
chemicals that pose a hazard to their hearing.  These chemicals 
include metals, solvents, insecticides, herbicides, and 
asphyxiants.  Some recent studies have indicated the combined 
effects of noise and chemicals on hearing are synergistic in that 
the prevalence or severity of hearing loss is increased over what 
would be observed for exposure to the noise or ototoxic chemical 
alone.  The effects have been observed even below the recommended 
exposure limits for the individual agents.  Further research in 
occupational hearing loss is needed to develop exposure guidelines 
that are sensitive to the effects of noise and to the combined 
effects of noise and chemicals on the auditory system.

Research Goals

Work-related hearing loss from noise exposure has long been 
recognized.  However, job-related hearing loss from exposure to 
chemicals in combination with noise has been recognized only 
recently.  Research from the 1990s showed that some workers 
exposed only to chemicals have more risk of occupational hearing 
loss than workers exposed to noise alone.  In addition, studies 
have found that workers exposed to both noise and chemicals were 
at much greater risk of hearing loss than workers exposed to 
either noise or chemicals alone.  There is a need for studies that 
will support development of dose-response relationships so that 
exposure limits can be established to protect workers= hearing 
from combined noise and chemical exposures.  

Noise exposure parameters of interest include, but are not limited 
to steady state, fluctuating, intermittent and impulse/impact.  
The chemicals of interest include solvents, metals, insecticides, 
herbicides, pesticides, and asphyxiants.  Populations of interest 
include, youths, miners, construction and agricultural workers.

Types of research applications that are appropriate for this topic 
include but are not limited to the following areas:
(1) biological effects and biological responses induced by noise 
in combination with other ototoxic agents;(2)individual 
susceptibility to hearing loss induced by noise and chemicals; 
(3)the role of free-radicals and antioxidants in the auditory 
system=s response to noise and ototoxic chemicals; (4) evaluation 
of the dose-response relationships between hearing loss and 
exposure to noise and chemicals; and (5)laboratory studies that 
mimic work place noise/chemical exposures are appropriate as long 
as the results are directly applicable to the work place.  Studies 
that focus on the systematic evaluation of the effectiveness of 
interventions or develops new interventions are of interest.  
Note, if a study is for the development of a new intervention, it 
must contain a comprehensive evaluation of the new intervention.  
Projects will not be supported that only develop an intervention.

Useful References

Morata TC, et al., Occupational exposure to organic solvents and 
noise: effects on hearing. Scandinavian Journal of Work, 
Environment and Health, 19 (4):245-254 (1993) 

Morata TC, et al., Toluene-induced hearing loss among rotogravure 
printing workers. Scandinavian Journal of Work, Environment and 
Health, 23:289-298 (1997).


It is the policy of the CDC to ensure that individuals of both 
sexes and the various racial and ethnic groups will be included in 
CDC-supported research projects involving human subjects, whenever 
feasible and appropriate. Racial and ethnic groups are those 
defined in OMB Directive No. 15 and include American Indian or 
Alaska Native, Asian, Black or African American, Hispanic or 
Latino, Native Hawaiian or other Pacific Islander.  Applicants 
shall ensure that women, racial and ethnic minority populations 
are appropriately represented in applications for research 
involving human subjects.  Where clear and compelling rationale 
exist that inclusion is inappropriate or not feasible, this 
situation must be explained as part of the application.  This 
policy does not apply to research studies when the investigator 
cannot control the race, ethnicity, and/or sex of subjects.  
Further guidance to this policy is contained in the Federal 
Register, Vol. 60, No. 179, pages 47947-47951, and dated Friday, 
September 15, 1995.

All investigators proposing research involving human subjects 
should read the "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 
a complete copy of the updated Guidelines are available at 


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.  This policy will be followed by NIOSH for this 

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: 

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.


If the proposed project involves research on human subjects, the 
applicant must comply with the Department of Health and Human 
Services (DHHS) Regulations (Title 45 Code of Federal Regulations 
Part 46) regarding the protection of human research subjects.  All 
awardees of CDC grants and cooperative agreements and their 
performances sites engaged in human subjects research must file an 
assurance of compliance with the regulations and have continuing 
reviews of the research protocol by appropriate institutional 
review boards.

In order to obtain a federal-wide Assurance (FWA) of Protection 
for Human Subjects, the applicant must complete an on-line 
application at the Office for Human Research Protections (OHRP) 
website or write to the OHRP for an application.  OHRP will verify 
that the signatory official and the Human Subjects Protections 
Administrator have completed the OHRP Assurance Training/Education 
Module before approving the FWA.  Existing Multiple Project 
Assurances (MPAs), Cooperative Project Assurances (CPAs), and 
Single Project Assurances (SPAs) remain in full effect until they 
expire or until December 31, 2003, whichever comes first.

To obtain a FWA contact the OHRP at:

http://www.hhs.gov/ohrp/assurances/assurances_index.html or write to:
Office for Human Research Protections (OHRP)
Department of Health and Human Services
6100 Executive Boulevard, Suite 3B01, MSC 7501
Rockville, Maryland  20892-7507
(Note:  For Express or Hand Delivered Mail, Use Zip Code 20852)

Note: In addition to other applicable committees, Indian Health 
Service (IHS) institutional review committees must also review the 
project if any component of IHS will be involved with or will 
support the research.  If any American Indian community is 
involved, its tribal government must also approve the applicable 
portion of that project.


NIH policy requires education on the protection of human subject 
participants for all investigators submitting NIH proposals for 
research involving human subjects.  This policy announcement is 
found in the NIH Guide for Grants and Contracts Announcement dated 
June 5, 2000, at the following website: 


If the proposed project involves research on animal subjects, 
compliance with the PHS Policy on Humane Care and Use of 
Laboratory Animals by Awardee Institutions is required.  An 
applicant (as well as each subcontractor or cooperating 
institution that has immediate responsibility for animal subjects) 
proposing to use vertebrate animals in CDC-supported activities 
must file (or have on file) the Animal Welfare Assurance with the 
Office of Laboratory Animal Welfare (OLAW) at the National 
Institutes of Health. The applicant must provide in the 
application the assurance of compliance number and evidence of 
review and approval (including the date of the most recent 
approval) by the Institutional Care and Use Committee (IACUC). Web 
page https://grants.nih.gov/grants/olaw/olaw.htm.


All applications must be self-contained within specified page 
limitations.  Unless otherwise specified, 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.


By regulation (45 CFR 74.36), grantees that are institutions of 
higher education, hospitals, or non-profit organizations are 
required to provide public access to research data through the 
Freedom of Information Act (FOIA) under some circumstances (OMB 
Circular A-110).  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.  For further 
information on this policy refer to page 52 in the PHS 398 grant 
application or access the NIH Guide for Grants and Contracts 
Announcement at: 
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.  


Prospective applicants are asked to submit, by November 7, 2001, a 
letter of intent that includes the number and title of the RFA, a 
descriptive title of the proposed research, the name, address, and 
telephone number of the Principal Investigator, and the identities 
of other key personnel and participating institutions.  Although a 
letter of intent is not required, is not binding, and is not used 
in the review of an application, the information that it contains 
is used to estimate the potential review workload and plan the review.

The letter of intent is to be submitted to: 

Price Connor, Ph.D.
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention (CDC)
1600 Clifton Road, N.E.
Building 1, Room 3061, MS D-28
Atlanta, GA  30333
Telephone:  404-639-2383
Fax:  404-639-2196
Email:  pconnor@cdc.gov 


The PHS 398 research grant application instructions and forms 
(rev. 5/2001) at https://grants.nih.gov/grants/funding/phs398/phs398.pdf 
must be used in applying for these grants. This version of PHS 398 is 
available in an interactive, searchable format. Although 
applicants are strongly encouraged to begin using the 5/2001 
revision of the PHS 398 as soon as possible, the NIOSH will 
continue to accept applications prepared using the 4/1998 revision 
until January 9, 2002. Beginning January 10, 2002, however, the 
NIOSH will return applications that are not submitted on the 
5/2001 version.  For further assistance contact GrantsInfo, 
Telephone 301/710-0267, 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 NIH staff. 
 The research grant application form PHS 398 (rev. 5/2001) at 
https://grants.nih.gov/grants/funding/phs398/phs398.html is to be 
used in applying for these grants, with modular budget 
instructions provided in Section C of the application 
instructions.  Applicants are permitted, however, to use the 
4/1998 revision of the PHS 398 for scheduled application receipt 
dates until January 9, 2002.  If you are preparing an application 
using the 4/1998 version, please refer to the step-by-step 
instructions for Modular Grants available at 

Additional information about Modular Grants is also available on 
this site.

The RFA label available in the PHS 398 (rev. 5/2001) application 
form (https://grants.nih.gov/grants/funding/phs398/labels.pdf) 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.  

Submit a signed, typewritten original of the application, 
including the Checklist, and three signed photocopies, in one 
package to:  

Center for Scientific Review (CSR)
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 also be sent to:

Price Connor, Ph.D.
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention (CDC)
1600 Clifton Road, N.E.
Building 1, Room 3061, MS D-28
Atlanta, GA  30333
Telephone:  404-639-2383
Fax:  404-639-2196
Email:  pconnor@cdc.gov 

Applications must be received by December 27, 2001.  If an 
application is received after that date, it will be returned to 
the applicant without review.  CSR and NIOSH 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.  CSR and NIOSH will not accept 
any application that is essentially the same as one already 
reviewed.  This does not preclude the submission of a substantial 
revision of an application already reviewed, but such an 
application must follow the guidance in the PHS Form 398 
application instructions for the preparation of revised 
applications, including an Introduction addressing the 
previous critique.


Upon receipt, applications will be reviewed for completeness by 
CSR and responsiveness by NIOSH. Applications determined to be 
incomplete or unresponsive to this RFA will be returned to the 
applicant without further consideration.  Applications that are 
complete and responsive to the RFA will be reviewed for technical 
merit by a scientific review group convened by NIOSH.

All applications will be judged on the basis of the scientific 
merit of the proposed project and the documented ability of the 
investigators to meet the RESEARCH OBJECTIVES of the RFA.  As part 
of the scientific 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 applications under review, will be 
discussed and assigned a priority score.

The criteria that will be used to review applications for 
scientific merit and for meeting program objectives are 
provided below.

Scientific Review Criteria

o  Significance - Does this study address an important problem 
related to the topical research issues outlined in this 
announcement?  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?

o  Approach - Are the conceptual framework, design (including 
composition of study population), 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?

o  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?

o  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?

o  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 documentation of cooperation from 
industry, unions, communities, or other participants in the 
project, where applicable?  Is there evidence of institutional 
support and availability of resources necessary to perform the 

o 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 to the 
proposed research.  

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

o Availability of special opportunities for furthering research 
programs through the use of unusual talent resources, populations, 
or environmental conditions in other countries which are not 
readily available in the United States or which provide 
augmentation of existing U.S. resources.  

Programmatic Review Criteria

o  Magnitude of the problem in terms of numbers of workers 

o  Severity of the disease or injury in the worker population.

o  Likelihood of developing applied technical knowledge for the 
prevention of occupational safety and health hazards on a national 
or regional basis.


Letter of Intent Receipt Date:  November 7, 2001
Application Receipt Date:       December 27, 2001
Anticipated Award Date:         May 1, 2002


Applications will be considered for award based upon (a) 
scientific merit, (b) program importance, (c) program balance in 
research areas, and (d) availability of funds.  


Inquiries concerning this RFA are encouraged.  The opportunity to 
clarify any issues or questions from potential applicants is 
welcome.  This RFA and other CDC Announcements can be found on the 
CDC HomePage (http://www.cdc.gov) under the "Funding" section (see 
"Grants and Cooperative Agreements" scroll down to "Occupational 
Safety and Health").  This RFA can also be found on the NIOSH 
HomePage (http://www.cdc.gov/niosh) under "Extramural Programs", "Current 
Funding Opportunities".

Direct inquiries regarding programmatic issues to:

Adele M. Childress, Ph.D., M.S.P.H.
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road, N.E.
Building 1, Room 3066, MS D-28
Atlanta, GA  30333
Telephone:  404/639-1493
FAX:  404/639-0035
Email:  ahc0@cdc.gov

Direct inquiries regarding grants business management matters to:

Joanne Wojcik
Grants Management Branch
Procurement and Grants Office
CDC Announcement Number CDC02017
Centers for Disease Control and Prevention
2920 Brandywine Road, Suite 3000
Atlanta, GA  30341-4146
Telephone:  770/488-2717
Email:  jcw6@cdc.gov


The Catalog of Federal Domestic Assistance number is: 93.262 for 
the National Institute for Occupational Safety and Health (NIOSH). 
This program is authorized under the Public Health Service Act, as 
amended, Section 301(a) [42 U.S.C. 241(a)], and the Occupational 
Safety and Health Act of 1970, Section 20(a) [29 U.S.C. 669(a)].  
The applicable program regulation is 42 CFR Part 52.  This program 
is not subject to the intergovernmental review requirements of 
executive order 12372 or Health Systems Agency Review.


Applicants should be aware of restrictions on the use of Health 
and Human Services (DHHS) funds for lobbying of Federal or State 
legislative bodies.  Under the provisions of 31 U.S.C. Section 
1352, recipients (and their subtier contractors) are prohibited 
from using appropriated Federal funds (other than profits from a 
Federal contract) for lobbying congress or any Federal agency in 
connection with the award of a particular contract, grant, 
cooperative agreement, or loan.  This includes grants/cooperative 
agreements that, in whole or in part, involve conferences for 
which Federal funds cannot be used directly or indirectly to 
encourage participants to lobby or to instruct participants on how 
to lobby.

In addition, no part of the Center for Disease Control and 
Prevention (CDC) appropriated funds shall be used, other than for 
normal and recognized executive-legislative relationships, for 
publicity or propaganda purposes, for the preparation, 
distribution, or use of any kit, pamphlet, booklet, publication, 
radio, television, or video presentation designed to support or 
defeat legislation pending before the Congress or any State or 
local legislature, except in presentation to the Congress or any 
State or local legislature itself.  No part of the appropriated 
funds shall be used to pay the salary or expenses of any grant or 
contract recipient, or agent acting for such recipient, related to 
any activity designed to influence legislation or appropriations 
pending before the Congress or any State or local legislature.

Any activity designed to influence action in regard to a 
particular piece of pending legislation would be considered 
"lobbying."  That is lobbying for or against pending legislation, 
as well as indirect or "grass roots" lobbying efforts by award 
recipients that are directed at inducing members of the public to 
contact their elected representatives at the Federal or State 
levels to urge support of, or opposition to, pending legislative 
proposals is prohibited.  As a matter of policy, CDC extends the 
prohibitions to lobbying with respect to local legislation and 
local legislative bodies.

The provisions are not intended to prohibit all interaction with 
the legislative branch, or to prohibit educational efforts 
pertaining to public health.  Clearly there are circumstances when 
it is advisable and permissible to provide information to the 
legislative branch in order to foster implementation of prevention 
strategies to promote public health.  However, it would not be 
permissible to influence, directly or indirectly, a specific piece 
of pending legislation.

It remains permissible to use CDC funds to engage in activity to 
enhance prevention; collect and analyze data; publish and 
disseminate results of research and surveillance data; implement 
prevention strategies; conduct community outreach services; 
provide leadership and training; and foster safe and healthful 

Recipients of CDC grants and cooperative agreements need to be 
careful to prevent CDC funds from being used to influence or 
promote pending legislation.  With respect to conferences, public 
events, publication, and "grassroots" activities that relate to 
specific legislation, recipients of CDC funds should give 
attention to isolating and separating the appropriate use of CDC 
funds from non-CDC funds.  CDC also cautions recipients of CDC 
funds to be careful not to give the appearance that CDC funds are 
being used to carry out activities in a manner that is prohibited 
under Federal law.


CDC strongly encourages all grant recipients to provide a 
smoke-free workplace and promote the non-use of all tobacco 
products, and Public Law 103-227, the Pro-Children Act of 1994, 
prohibits smoking in certain facilities that receive Federal funds 
in which education, library, day care, health care, and early 
childhood development services are provided to children.


It is a national policy to place a fair share of purchases with 
small, minority and women-owned business firms. The Department of 
Health and Human Services is strongly committed to the objective 
of this policy and encourages all recipients of its grants and 
cooperative agreements to take affirmative steps to ensure such 
fairness. In particular, recipients should:

1. Place small, minority, women-owned business firms on bidders 
mailing lists.

2. Solicit these firms whenever they are potential sources of 
supplies, equipment, construction, or services.

3. Where feasible, divide total requirements into smaller needs, 
and set delivery schedules that will encourage participation by 
these firms.

4. Use the assistance of the Minority Business Development Agency 
of the Department of Commerce, the Office of Small and 
Disadvantaged Business Utilization, DHHS, and similar state and 
local offices.


The signature of the institution official on the face page of the 
application submitted under this Program Announcement is 
certifying compliance with the Department of Health and Human 
Services (DHHS) regulations in Title 42 Part 50, Subpart A, 
entitled "Responsibility of PHS Awardee and Applicant Institutions 
for Dealing with and Reporting Possible Misconduct in Science."

The regulation places several requirements on institutions 
receiving or applying for funds under the PHS Act that are 
monitored by the DHHS Office of Research Integrity's (ORI) 
Assurance Program.

For examples:

Section 50.103(a) of the regulation states: "Each institution that 
applies for or receives assistance under the Act for any project 
or program which involves the conduct of biomedical or behavioral 
research must have an assurance satisfactory to the Secretary 
(DHHS) that the applicant: (1) Has established an administrative 
process, that meets the requirements of this subpart, for 
reviewing, investigating, and reporting allegations of misconduct 
in science in connection with PHS-sponsored biomedical and 
behavioral research conducted at the applicant institution or 
sponsored by the applicant; and (2) Will comply with its own 
administrative process and the requirements of this Subpart."
Section 50.103(b) of the regulation states that: "an applicant or 
recipient institution shall make an annual submission to the [ORI] 
as follows: (1) The institution's assurance shall be submitted to 
the [ORI], on a form prescribed by the Secretary,...and updated 
annually thereafter...(2) An institution shall submit, along with 
its annual assurance, such aggregate information on allegations, 
inquiries, and investigations as the Secretary may prescribe."

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