IN VITRO INACTIVATION OF VIRUSES IN BLOOD COMPONENTS

Release Date:  January 18, 2000

RFA:  HL-00-010

National Heart, Lung, and Blood Institute

Letter of Intent Receipt Date: March 1, 2000
Application Receipt Date: April 12, 2000

THIS RFA USES "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 RFA. 

PURPOSE

The objective of this program is to encourage basic and applied research on the 
development and evaluation of procedures to remove or destroy the infectivity of 
transfusion-transmitted viruses and other pathogens in blood components, while 
maintaining the therapeutic effectiveness of these preparations.
 
HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health promotion and 
disease prevention objectives of Healthy People 2000, a PHS-led national activity for 
setting priority areas.  This Request for Applications (RFA), AIn Vitro Inactivation of 
Viruses in Blood Components,@ is related to the priority areas of HIV Infection, 
Immunization and Infectious Diseases.  Potential applicants may obtain a copy of 
"Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or Summary Report: Stock 
No. 017-001-00473-1 through the Superintendent of Documents, Government Printing 
Office, Washington, D.C. 20402-9325 (telephone 202-512-1800 or at ).
http://odphp.osophs.dhhs.gov/pubs/hp2000/

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 or local governments, and eligible agencies of the Federal 
government.  Racial/ethnic minority individuals, women, and persons with disabilities 
are encouraged to apply as Principal Investigators.  All current policies and 
requirements that govern the research grant programs of the National Institutes of 
Health (NIH) will apply to grants awarded under this RFA.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) research project grant (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 of this RFA may not exceed 5 years.  This RFA is one-
time solicitation.  Future unsolicited competing continuation applications will compete 
with all investigator-initiated applications and be reviewed according to the customary 
peer review procedures.  The anticipated award date is September 30, 2000.

FUNDS AVAILABLE

The NHLBI intends to commit approximately $1.5 million in FY 2000 to fund four (4) to 
six (6) new grants in response to this RFA.  An applicant may request a project period 
up to five (5) years and a budget for direct costs for up to ten (10) modules of 
$25,000 each per year, including Facilities and Administrative Costs on consortium 
arrangements.  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 NHLBI 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 
applications of outstanding scientific and technical merit.  At this time, it is not 
known if competing renewal applications will be accepted and/or if this RFA will be 
reissued.  

RESEARCH OBJECTIVES

BACKGROUND

Annually, an estimated 3.8 million Americans are transfused with 28.2 million blood 
components derived from 12.8 million units of blood donated by apparently healthy 
volunteers.  A rigorous scrutiny of blood donors and the screening of donated blood for 
various serological markers of asymptomatic infection have significantly reduced the 
morbidity and mortality due to transfusion-associated infectious agents.  The enzyme 
immunoassays used for routine screening may detect viral antigens or antibodies, but 
not the infectious agents themselves.  Thus, there could be an asymptomatic window-
period of infectivity responsible for a residual risk of post-transfusion infections.  

Recent progress in inactivating viruses in plasma derivatives has been substantial.  
Safe and efficient inactivation procedures have been developed and are now widely 
available.  One of these methods, developed with NHLBI support, involves treatment of 
material with organic solvent and detergent.  This approach, which destroys viruses 
with phospholipid envelopes,  has been applied successfully to coagulation factor 
concentrates, immune globulins, lymphokines, and other growth factors.  Plasma 
derivatives treated with solvent/detergent mixtures are now prepared in many countries 
around the world.  Derivatives that are manufactured using this method have shown no 
evidence of transmission of hepatitis B virus (HBV), hepatitis C virus (HCV), or human 
immunodeficiency virus (HIV).  An important scientific and technical challenge is to 
achieve similar safety in cellular blood products such as platelet concentrates and 
packed red cells.

Attempts to develop inactivation procedures to destroy the infectivity of viruses in 
blood components have been uniformly unsuccessful despite considerable research 
activity in this area.  The difficult problem of virus inactivation is exacerbated in 
cellular products due to the inherent lability of membranes and sensitive proteins in 
cells.  As a result, the destruction of viral activity is often accompanied by loss of 
cellular function.  Consequently, whole blood and cellular components including red 
cells, platelets, and leukocytes continue to carry a risk of virus transmission.  In 
addition, although the risk of acquiring identified pathogens through transfusion is 
lower than ever, world-wide travel and changing demographics have in the past and most 
certainly will continue to spread new pathogens into the U.S. blood donor population in 
the future.  Therefore, the prevention of transfusion-transmitted diseases remains a 
top priority of transfusion medicine research. 

Current estimated risks of being infected with a unit of screened blood are 1/1,000,000 
for hepatitis A virus (HAV), 1/30,000 - 1/250,000 for HBV, 1/30,000 - 1/150,000 for 
HCV, 1/200,000 - 1/2,000,000 for HIV, 1/250,000 - 1/2,000,000 for human T-cell 
lymphotropic viruses (HTLV) types I and II, and 1/10,000 for parvovirus B19.  In 
addition, viruses such as  cytomegalovirus (CMV) and Epstein-Barr virus (EBV) also pose 
potential risks following the transfusion of blood or blood components.  Also, new and 
emerging agents are constantly posing  new threats to the blood supply.  Recent 
examples are HHV-8, HGV, and TTV.  Their transmissibility via blood and clinical 
significance are being investigated.  Furthermore, the estimated frequency of bacterial 
contamination of red blood cells is 1/500,000 units, and the risk of platelet-related 
sepsis is estimated to be 1/12,000.  Despite advances in donor selection and blood 
donor screening, it is unlikely that the risk of transmission of these viruses and 
bacteria will be completely eliminated without the introduction of efficient virucidal 
or virus-removal procedures that maintain cellular function.  

Over the past 5 years, investigators supported under an NHLBI RFA program have explored 
a number of different approaches to inactivate or remove viruses from blood and blood 
components including the use of UV-C irradiation, filtration, hydrolyzed diol epoxides, 
ozone, halogenated oxidizing agents, and photoactive dyes for viral sterilization of 
fresh frozen plasma, red blood cell concentrates, and platelet concentrates.  Removal 
of leukocytes by filtration was shown to reduce CMV transmission to susceptible 
patients; however, elimination of HIV-infected cells by this method was incomplete, as 
filtration could not be expected to remove cell-free virus.  The use of UV or ionizing 
irradiation is attractive because of its simplicity; however, the dose of gamma-
irradiation used to inactivate lymphocytes is not sufficiently virucidal, and the 
virucidal doses are generally cell-destructive.  UV irradiation was found to inactivate 
HIV under conditions generally favorable to platelets.  However, important caveats on 
the use of UV remain; viral sensitivity to UV treatment seems to depend on the size of 
the viral genome and whether it is single or double stranded. Furthermore, it appears 
that suboptimal doses for viral inactivation induce virus activation and/or 
replication.  Hydrolyzable compounds such as beta-propriolactone have proved highly 
virucidal but fail to destroy sufficient virus under conditions tolerated by cellular 
components.  Ozone has been shown to inactivate HIV but virucidal doses often cause 
hemolysis.  The most promising results have been obtained with the treatment of 
platelet concentrates with photodynamically active dyes.  The precise biologic 
mechanisms of in vitro photochemical inactivation of pathogens are poorly understood. 
An investigator supported under this RFA developed a photochemical decontamination 
technique using a synthetic psoralen and long wavelength UV light to form covalent 
adducts between viral nucleic acids and the psoralens. 
This method effectively inactivates a number of viruses and also destroys the bacteria 
often associated with platelets without significant adverse effects in in vitro 
platelet function.  In order  to minimize the damage to platelets caused by 
irradiation, however, the process must be conducted in the absence of oxygen or in the 
presence of agents that remove damaging reactive intermediate compounds.  Also, the 
potential toxicity of a virucidal process that adds photoreactive dyes or other 
potentially carcinogenic or teratogenic compounds will require careful assessment. The 
procedure has been tested in animal models and it is currently being evaluated in 
clinical trials. 

While significant progress has been made under the previous RFA program toward the 
development of inactivation procedures, additional research is urgently needed to 
better understand the mode of action of these as well as other virucidal reagents and 
procedures so as to apply and optimize their use in a blood banking environment.  
Furthermore, studies on the removal of viruses from biological materials in ways that 
permit the treated products to be used clinically are also needed and constitute the 
ultimate goal of this RFA.  Possible approaches include viral adherence to affinity 
columns; use of monoclonal antibodies for in vitro neutralization; absorption-
filtration procedures; centrifugal removal of viruses; and use of filters for 
leukodepletion. Other innovative strategies for in vitro inactivation or removal of 
blood-borne agents that maintain the functional integrity of blood components also need 
to be pursued.  For example, in view of the enhanced antigen neutralizing capability 
imparted by  catalytic function, it is possible that the development of catalytic 
antibodies to specific pathogen epitopes may lead to catalytic cleavage of the agent=s 
targeted polypeptides, resulting in the elimination of infectivity.  A similar approach 
may be to use ribozymes, which exhibit catalytic activity.  Synthesis of a ribozyme 
with flanking segments that contain nucleotide sequences complementary to portions of a 
viral mRNA target could bind and degrade the intracellular viral mRNA with consequent 
virus inhibition.  Strategies to deliver such large therapeutic molecules 
intracellularly are also within the scope of this RFA.

In summary, transfusion practices continue to carry a small but unacceptable risk of 
infection from transfusion-transmitted viruses.  The solution to this problem is the 
development of inactivation or virus removal procedures that do not destroy the 
functional integrity of blood or blood components.  Some procedures are currently 
available such as the use of photochemicals that inactivate nucleic acids and destroy 
virus infectivity with minimal effects on nucleic acid-free red cells and platelets.  
Technological advances are needed that would permit the use of photochemicals as well 
as other inactivation procedures in an efficient cost-effective  fashion that is 
compatible with the operation of a large-scale blood center.

This program encourages basic and applied research on the development and evaluation of 
procedures to remove or destroy the infectivity of transfusion-transmitted viruses in 
blood components while maintaining the therapeutic effectiveness of these preparations. 
Applicants must delineate a research plan that focuses on completing a Phase I clinical 
trial (safety and pharmacokinetics) during the final year of this RFA program.

PROPOSED RESEARCH

The objective of this program is to encourage basic and applied research on the 
development and evaluation of procedures to remove or destroy the infectivity of 
transfusion-transmitted viruses and other pathogens in blood components, while 
maintaining the therapeutic effectiveness of these preparations.  Possible approaches 
include viral adherence to affinity columns; use of monoclonal antibodies for in vitro 
neutralization; absorption-filtration procedures; centrifugal removal of viruses; and 
use of filters for leukodepletion. Other innovative strategies for in vitro 
inactivation or removal of blood-borne agents that maintain the functional integrity of 
blood components also need to be pursued.  For example, in view of the enhanced antigen 
neutralizing capability imparted by  catalytic function, it is possible that the 
development of catalytic antibodies to specific pathogen epitopes may lead to catalytic 
cleavage of the agent=s targeted polypeptides, resulting in the elimination of 
infectivity.  A similar approach may be to use ribozymes, which exhibit catalytic 
activity.  Synthesis of a ribozyme with flanking segments that contain nucleotide 
sequences complementary to portions of a viral mRNA target could bind and degrade the 
intracellular viral mRNA with consequent virus inhibition.  Strategies to deliver such 
large therapeutic molecules intracellularly are also within the scope of this RFA.

SPECIAL REQUIREMENTS

Upon initiation of the program, the NHLBI will sponsor annual meetings to encourage the 
exchange of information among investigators who participate in this program.  Travel 
funds for a one day meeting each year, most likely to be held in Bethesda, Maryland, 
should be included in the modules.  Applicants should also include a statement in the 
application indicating their willingness to participate in such meetings.

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 
subpopulations must be included in all NIH supported biomedical and behavioral research 
projects involving human subjects, unless a clear and compelling rationale and 
justification is provided that inclusion is inappropriate with respect to the health of 
the subjects or the purpose of 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 "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research", 
which have been published in the Federal Register of March 28, 1994 (FR 59 14508-
14513), and in the NIH GUIDE FOR GRANTS AND CONTRACTS, Volume 23, Number 11, March 18, 
1994, available on the Web at: 
https://grants.nih.gov/grants/guide/notice-files/not94-100.html

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the 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: 
https://grants.nih.gov/grants/guide/notice-files/not98-024.html

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 RFA in response to which the application 
may be submitted.  Although the 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 the NHLBI staff to estimate the potential review workload and to avoid 
conflict of interest in the review.

The letter of intent is to be mailed, or faxed by the letter of intent receipt date 
listed in the heading of this RFA to:

Dr. C. James Scheirer
Division of Extramural Affairs, NHLBI
6701 Rockledge Drive, Room 7220, MSC 7924
Bethesda, Maryland  20892-7924
Tel:  (301) 435-0266
FAX:  (301) 480-3541
E-Mail Address: js110j@nih.gov

APPLICATION PROCEDURES  

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  
https://grants.nih.gov/grants/funding/modular/modular.htm    
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.  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 301/710-0267, email: 
GrantsInfo@nih.gov .  

 The RFA label available in the PHS 398 (rev. 4/98) 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 of the face page of the 
application for and the YES box must be marked.

The sample RFA label available at:  
https://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for 
this change.  Please note this is in pdf format.  

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:

Dr. C. James Scheirer
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7220, MSC 7924
Bethesda, MD 20892-7924
Telephone: (301) 435-0266
FAX: (301) 480-3541
Email: js110j@nih.gov

Applications must be received by the application receipt date listed in 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.

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. 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   o 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.   

o 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.   

o 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.   

o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See 
https://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.   

o Under Personnel, List key 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 key 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.   

o 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:  
https://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.   

o 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.   

o 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. 

REVIEW CONSIDERATIONS   Upon receipt, applications will be reviewed for completeness by 
the CSR and responsiveness by the NHLBI.  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 the 
NHLBI in accordance with the review criteria stated below.  As part of the initial 
merit review, a process will be used by the initial review group in which applications 
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 NHLBI National Advisory 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 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 method? 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. 

Schedule   

Letter of Intent Receipt Date: March 1, 2000  
Application Receipt Date: April 12, 2000  
Peer Review Date: May/June 2000  
Council Review: September 7-8, 2000  
Earliest Anticipated Start Date: September 29, 2000   

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 RFA are encouraged.  The opportunity to clarify 
any issues or questions from potential applicants is welcome.  

Direct inquiries regarding programmatic issues and requests for sample budget pages to:

Luiz H. Barbosa, D.V.M.
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 10146, MSC 7950
Bethesda, MD  20892-7950
Telephone:  (301) 435-0075
FAX:  (301) 480-0868
Email: lb30o@nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Jane Davis
Grants Operations Branch
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Suite 7174, MSC 7926
Bethesda, MD  20892-7926
Telephone:  (301) 435-0166
FAX:  (301) 480-3310
Email: jd53j@nih.gov

This program is described in the Catalog of Federal Domestic Assistance No. 93.839.  
Awards are made under authorization of the Public Health Service Act, Title IV, Part A 
(Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and 
administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR 
Part 74.  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 and contract 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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