MANUFACTURING PROCESSES OF MEDICAL, DENTAL, AND BIOLOGICAL TECHNOLOGIES (SBIR/STTR)

RELEASE DATE:  September 29, 2004

PA NUMBER:   PA-04-161 (This PA has been reissued, see PA-06-012 and PA-06-013)
                       (Contact change for NLM, see NOT-LM-05-006)

EXPIRATION DATE:  October 20, 2005 

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATIONS:  
National Institutes of Health (NIH) 
 (http://www.nih.gov)
Center for Disease Control and Prevention (CDC) 
 (http://www.cdc.gov)
Food and Drug Administration (FDA) 
 (http://www.fda.gov)

COMPONENTS OF PARTICIPATING ORGANIZATIONS: 
National Institute on Aging (NIA)
 (http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 (http://www.niaaa.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID)
 (http://www.niaid.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
 (http://www.nibib.nih.gov/)
National Cancer Institute (NCI)
 (http://www.nci.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD)
 (http://www.nidcd.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR)
 (http://www.nidr.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 (http://www.niddk.nih.gov/)
National Institute on Drug Abuse (NIDA)
 (http://www.nida.nih.gov)
National Institute of Environmental Health Sciences (NIEHS)
 (http://www.niehs.nih.gov/)
National Eye Institute (NEI)
 (http://www.nei.nih.gov/)
National Institute of General Medical Sciences (NIGMS)
 (http://www.nigms.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI)
 (http://www.nhlbi.nih.gov/)
National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS)
  (http://www.ninds.nih.gov)
National Institute of Nursing Research (NINR)
 (http://www.ninr.nih.gov/)
National Center for Research Resources (NCRR)
  (http://www.ncrr.nih.gov)
National Center for Complementary and Alternative Medicine (NCCAM)
  (http://nccam.nih.gov)
National Library of Medicine (NLM)
 (http://www.nlm.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  
93.394 (NCI); 93.867 (NEI); 93.233, 93.837,93.838, 93.839 (NHLBI); 93.866 
(NIA); 93.273 (NIAAA); 93.856; (NIAID); 93.286, 93.287 (NIBIB); 93.173 
(NIDCD); 93.121; (NIDCR); 93.849, 93.848 and 93.847 (NIDDK); 93.279 (NIDA); 
93.113, 93.114, 93.115 (NIEHS); 93.859 (NIGMS); 93.242 (NIMH); 93.853 
(NINDS); 93.361 (NINR); 93.879 (NLM); 93.103 (FDA); 93.061 (CDC) 

APPLICATION RECEIPT DATE(S):  Applications submitted in response to this 
program announcement will be accepted at the standard application deadlines 
[April 1, August 1, December 1]

THIS PA CONTAINS THE FOLLOWING INFORMATION:

o  Purpose of the PA
o  Research Objectives
o  Mechanism(s) of Support
o  Funds Available (include for PAS only)
o  Project Period and Amount of Award
o  Eligible Institutions
o  Individuals Eligible to Become Principal Investigators
o  Where to Send Inquiries
o  Submitting an Application
o  Supplementary Instructions
o  Peer Review Process
o  Review Criteria
o  Award Criteria
o  Receipt and Review Schedule 
o  Required Federal Citations

NOTICE: This program announcement (PA) must be read in conjunction with the 
current Omnibus Solicitation of the National Institutes of Health, Centers 
for Disease Control and Prevention, and Food and Drug Administration for 
Small Business Innovation Research (SBIR) and Small Business Technology 
Transfer (STTR) Grant Applications. The solicitation (see 
http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf [PDF] or 
http://grants.nih.gov/grants/funding/sbirsttr1/index.doc (MS Word] contains 
information about the SBIR and STTR programs, regulations governing the 
programs, and instructional information for submission. All of the 
instructions and review criteria within the current SBIR/STTR Omnibus 
Solicitation apply.

PURPOSE OF THE PA 

On February 26, 2004, Executive Order 13329 
(http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov
/2004/pdf/04-4436.pdf)was signed by President George W. Bush requiring 
SBIR/STTR agencies, to the extent permitted by law and in a manner consistent 
with the mission of the Department, to give high priority within the SBIR and 
STTR programs to manufacturing-related research and development (R&D).  In 
response to this Executive Order, NIH, CDC, and the FDA are expanding their 
foci by encouraging biomedical research related to advanced processing, 
manufacturing processes, equipment and systems, and manufacturing workforce 
skills and protection.  

RESEARCH OBJECTIVES 

The NIH, CDC, and FDA encourage research related to advanced processing in 
the manufacture of biomedical products and the implementation of new 
technologies in medical care.  New methods, procedures, measures, and 
controls are needed for manufacturing a broad range of technologies and 
products with unsurpassed quality and to lower manufacturing costs for 
existing and/or new processes.  Research is also encouraged that can 
contribute to the containment and reduction of health care costs and that can 
improve the cost effectiveness, quality, and accessibility of the health care 
system.

Manufacturing-related R&D is defined as:

Manufacturing innovation is fostered by research and development of 
technologies that are aimed at increasing the competitive capability of 
manufacturing concerns.  Broadly speaking, manufacturing-related R&D 
encompasses improvements in existing methods or processes, or wholly new 
processes, machines or systems.  Four main areas include:

Unit process level technologies that create or improve manufacturing 
processes, including (1) fundamental improvements in existing manufacturing 
processes that deliver substantial productivity, quality, or environmental 
benefits, and (2) development of new manufacturing processes, including new 
materials, coatings, methods, and practices associated with these processes.

Machine level technologies that create or improve manufacturing equipment, 
including (1) improvements in capital equipment that create increased 
capability (such as accuracy or repeatability), increased capacity (through 
productivity improvements or cost reduction), or increased environmental 
efficiency (safety, energy efficiency, environmental impact), and (2) new 
apparatus and equipment for manufacturing, including additive and subtractive 
manufacturing, deformation and molding, assembly and test, semiconductor 
fabrication, and nanotechnology.

Systems level technologies for innovation in the manufacturing enterprise, 
including (1) advances in controls, sensors, networks, and other information 
technologies that improve the quality and productivity of manufacturing 
cells, lines, systems, and facilities; (2) innovation in extended enterprise 
functions critical to manufacturing, such as quality systems, resource 
management, supply chain integration, and distribution, scheduling and 
tracking; and (3) technologies that enable integrated and collaborative 
product and process development, including computer-aided and expert systems 
for design, tolerancing, process and materials selection, life-cycle cost 
estimation, rapid prototyping, and tooling.

Environment or societal level technologies that improve workforce abilities 
and manufacturing competitiveness, including (1) technologies for improved 
workforce health and safety, such as human factors and ergonomics; and (2) 
technologies that aid and improve workforce manufacturing skills and 
technical excellence, such as educational systems incorporating improved 
manufacturing knowledge and instructional methods

Because manufacturing-related R&D is extremely broad in scope, the following 
examples of research topics may be of interest but are not meant to be 
exhaustive. 

o Flexible computer-assisted integrated manufacturing equipment and 
intelligent processing equipment adaptable to the varied needs of biomedical 
research and medical care device and material production.

o Systems engineering and management tools needed for the development of 
biomedical product manufacturing plants with particular emphasis on the 
requirements to meet GMP requirements for FDA approvals.

o Technology for the manufacture of research instrumentation, such as highly 
sensitive, high resolution spectrometers, highly selective electrodes, 
microarray devices, and microfluidic devices.

o Technology for the manufacture of clinical diagnostic devices and reagents.
Technology for the manufacture of novel diagnostic imaging devices for both 
invasive and non-invasive techniques.

o Technology for the manufacture and delivery of therapeutic drugs, including 
for example, synthetic process chemistry, separations methods, formulation, 
and dosage delivery.

o Technology for the manufacture of implantable devices and materials, 
including drug delivery pumps, prosthetic organs, artificial tissues, 
electronic sensors and electrical stimulators. 

o Technology for the production of natural products derived from plant, 
animal, and microbial sources, such as antibiotics, anticancer drugs, and 
other therapeutic agents, and useful synthetic starting materials.

o Technology for the production and isolation of biotechnology products, such 
as proteins, antibodies, nucleic acids, vaccines, and vectors for genetic 
engineering and gene therapy.

o Technology for the production of new materials relevant to biomedical 
research and medical care delivery, including nanomaterials, carbon fibers, 
polymeric materials, self-assembled monolayers, controlled size, shape, and 
porosity particles, filters, membranes, silicon substrates for microarrays, 
superconducting materials for NMR and MRI magnets, and implantable magnetic 
materials for external magnetic manipulation.

o Technology for manufacture of medical device power sources, such as high 
energy density, long life-time batteries, solar cells, and fuel cells.

o Technology for the fabrication of medical care instruments and devices such 
as minimally invasive and magnetic field tolerant surgical instruments, 
orthopedic implants, prostheses, and enabling devices for the injured and 
disabled.  

o Rapid prototyping and manufacture technology suitable for remote site and 
on demand production processes.  

o Technology to promote the recovery, reuse, and remanufacture (recycling) of 
medical materials and equipment.

o Technology for the manufacture of biomedically specialized computational 
and information technology equipment and software.

o Development of innovative products that facilitate the safety and health 
training of hazardous materials workers, emergency responders, and skilled 
support personnel.  (See also NIEHS Worker Education and Training Program at 
http://www.niehs.nih.gov/wetp/home.htm.

Many specific topics listed in Part II of the NIH SBIR/STTR Omnibus 
Solicitation of the National Institutes of Health, Centers for Disease 
Control and Prevention, and Food and Drug Administration 
(http://grants.nih.gov/grants/funding/sbirsttr1/2005-2_SBIR-STTR-topics.pdf) 
could also be considered relevant to manufacturing.  Potential applicants are 
encouraged to review this material for additional indications of NIH areas of 
interest.

MECHANISM(S) OF SUPPORT

This PA uses the SBIR and STTR mechanisms, which are set-aside programs. As 
an applicant, you will be solely responsible for planning, directing, and 
executing the proposed project. Future unsolicited, competing- continuation 
applications based on this project will compete with all SBIR/STTR 
applications and will be reviewed according to the customary peer review 
procedures.
This PA uses just-in-time concepts. It also uses the modular budgeting 
format. Specifically, if you are submitting an application budget of $100,000 
total costs (direct, F&A and fee) or less, use the modular format and 
instructions as described in the current SBIR/STTR Omnibus Solicitation. 
Otherwise follow the instructions for non-modular budget research grant 
applications.  This program does not require cost sharing as defined in the 
current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm#matching_or
_cost_sharing
Applications may be submitted for support as Phase I STTR (R41) or Phase I 
SBIR (R43) grants; Phase II STTR (R42) or Phase II SBIR (R44) grants; or the 
SBIR/STTR FAST-TRACK option as described in the SBIR/STTR Omnibus 
Solicitation.  Phase II applications in response to this PA will only be 
accepted as competing continuations of previously funded NIH Phase I 
SBIR/STTR awards.  The Phase II application must be a logical extension of 
the Phase I research but not necessarily a Phase I project supported in 
response to this PA.
  
PROJECT PERIOD AND AMOUNT OF AWARD

The SBIR/STTR Omnibus Solicitation indicates the statutory guidelines of 
funding support and project duration periods for SBIR and STTR Phase I and 
Phase II awards.  

ELIGIBLE INSTITUTIONS:

Eligibility requirements are described in the SBIR/STTR Omnibus Solicitation.  
Only small business concerns are eligible to submit applications. A small 
business concern is one that, on the date of award for both Phase I and Phase 
II agreements, meets ALL of the criteria as described in the SBIR/STTR 
Omnibus Solicitation.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.  On an SBIR application, the principal 
investigator must have his/her primary employment (more than 50%) with the 
small business at the time of award and for the duration of the project. The 
PI on an STTR application may be employed with the small business concern or 
the participating non-profit research institution as long as s/he has a 
formal appointment with or commitment to the applicant small business 
concern, which is characterized by an official relationship between the small 
business concern and that individual. 

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into two 
areas:  scientific/research and financial or grants management issues:

o Direct your questions about scientific/research issues to:

Michael-David Kerns, Ph.D. 
National Institute on Aging 
Gateway Building, Room 2C218, 
7201 Wisconsin Avenue, Bethesda, MD 20892-9205; 
Telephone: (301) 496-9322 
FAX: (301) 402-2945 
Email: kernsm@mail.nih.gov

Karen P. Peterson, Ph.D. 
National Institute on Alcohol Abuse and Alcoholism 
5635 Fishers Lane, MSC 9304 
Bethesda, MD 20892-9304 
Telephone: (301) 451-3883 
FAX: (301) 443-7043 
Email: kpeterso@mail.nih.gov

Gregory Milman, Ph.D. 
National Institute of Allergy and Infectious Diseases 
Division of Extramural Activities 
Room 2153, MSC-7610 
6700-B Rockledge Drive 
Bethesda, MD 20892-7610 
Telephone (301) 496-8666 
FAX: (301) 402-0369 
Email: gm16s@nih.gov

Todd Merchak 
National Institute of Biomedical Imaging and Bioengineering 
6707 Democracy Blvd., MSC 5477 
Bethesda, MD 20892-5477 
Telephone: (301) 496-8592 
FAX: (301) 480-1614 
Email: merchakt@mail.nih.gov

Greg Downing, Ph.D. 
National Cancer Institute 
Office of Technology and Industrial Relations 
31 Center Drive; Room 10A52, MSC 2580 
Bethesda, MD 20852 
Telephone: (301) 496-1550 
FAX:  496-7807 
Email: downing@mail.nih.gov

Cathrine Sasek, Ph.D. 
National Institute on Drug Abuse 
6001 Executive Blvd, MSC 9591 
Bethesda, MD 20892-9591 
Telephone: (301) 443-6071 
FAX: (301) 443-6277 
Email: csasek@nih.gov

Lynn E. Luethke, Ph.D. 
National Institute on Deafness and Other Communication Disorders 
6120 Executive Blvd., MSC 7180 
Bethesda, MD 20892-7180 
Telephone: (301) 402-3458 
FAX: (301) 402-6251 
Email: lynn_luethkel@nidcd.nih.gov

Rosemarie Hunziker, Ph.D. 
National Institute of Dental and Craniofacial Research 
45 Center Drive, Room 4An.24K 
Bethesda, MD  20892-6402 
Telephone:  (301) 451-3888 
FAX: (301) 480-8318 
E-mail: hunzikerr@nidcr.nih.gov 

Sanford A. Garfield, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases 
6707 Democracy Blvd., Room 685 
Bethesda, MD 20892 
Telephone: (301) 594-8803 
FAX: (301) 402-6271 
Email: sg50o@nih.gov

Jerry Heindel, Ph.D. 
National Institute of Environmental Health Sciences 
79 T.W. Alexander Drive,4401 Bldg, 3rd Floor 
Research Triangle Park, NC, 27709 
Telephone: (919) 541-0781 
FAX (919)541-5064 
Email: heindelj@niehs.nih.gov

Ralph J. Helmsen, Ph.D. 
National Eye Institute 
Suite 1300, 5635 Fishers Lane, MSC 9300 
Bethesda, MD 20892-9300 
Telephone: (301) 451-2020 
FAX: (301) 402-0528 
Email: rjh@nei.nih.gov

Peter Preusch, Ph.D. 
National Institute of General Medical Sciences 
45 Center Drive; Room 2As.43j; MSC 6200 
Bethesda, MD 20892 
Telephone: (301) 594-5938 
FAX:  (301) 480-2802 
Email: preuschp@nigms.nih.gov

Bishow Adhikari, Ph.D. 
National Heart, Lung and Blood Institute  
6701 Rockledge Dr, Room 9161; MSC 7940 
Bethesda, MD 20892 
Telephone: (301) 435-0513 
FAX: 301-480-1335 
Email: adhikarb@mail.nih.gov

Margaret Grabb, Ph.D. 
National Institute of Mental Health 
6001 Executive Blvd., Room 7204, MSC 9645 
Bethesda, MD 20892 
Telephone: (301) 443-3563 
FAX: (301) 443-1731 
Email: mgrabb@mail.nih.gov

Thomas Miller, Ph.D. 
National Institute of Neurological Disorders and Stroke 
6001 Executive Blvd., Room 2139 
Bethesda, MD 20892-9527 
Telephone: (301) 496-1779 
FAX: (301) 402-1501 
Email: millert@ninds.nih.gov 

Yvonne Bryan, Ph.D. 
National Institute of Nursing Research 
6701 Democracy Blvd., Room 710; MSC 4870 
Bethesda, MD 20892-0001 
Telephone: (301) 594-6908 
FAX:  (301) 480-8260 
Email: bryany@mail.nih.gov

Amy L. Swain, Ph.D. 
National Center for Research Resources 
6701 Democracy Blvd., MSC 4874 
Bethesda, MD  20879-4874 
Telephone:  (301) 435-0752 
FAX: 301-402-3659 
Email: swaina@mail.nih.gov

Shan S. Wong, Ph.D. 
National Center for Complementary and Alternative Medicine 
6707 Democracy Blvd., MSC 5475 
Bethesda, MD 20892-5475 
Telephone: (301) 496-7498 
FAX: (301) 480-3621 
Email: sw196c@nih.gov.

Charles Friedman, Ph.D. 
National Library of Medicine 
6705 Rockledge Drive, Room 301 
Bethesda, MD 20892 
Telephone: (301) 594-4927 
FAX: 301-402-2951 
Email: friedmc1@mail.nih.gov

Curtis L. Bryant 
Centers for Disease Control and Prevention 
Procurement & Grants Office 
2920 Brandywine Road 
Atlanta, GA 30341 
Telephone: (770) 488-2806 
FAX: (770) 488-2828
Email: ckb9@cdc.gov

Rosemary Springer 
Food and Drug Administration 
Division of Contracts and Grants Management 
5600 Fishers Lane, HFA-531 
Rockville, MD  20857 
Telephone: (301) 827-7182 
FAX: (301) 827-7101 
Email: rspringe@oc.fda.gov

o Direct your questions about financial or grants management matters to:

Ms. Linda Whipp 
National Institute on Aging 
Gateway Building, Room 2N212 
Bethesda, MD 20892 
Telephone: (301) 496-1472 
FAX: (301) 402-3672 
Email: whippl@mail.nih.gov 

Ms. Judy Fox 
National Institute on Alcohol Abuse and Alcoholism 
5635 Fishers Lane, MSC 9304 
Bethesda, MD 20892-9304 
Telephone: (301) 443-4704 
FAX: (301) 443-3891 
Email: jfox@mail.nih.gov

Ms. Pamela Fleming 
National Institute of Allergy and Infectious Diseases 
Division of Extramural Activities 
Room 2119, MSC 7614 
6700-B Rockledge Drive 
Bethesda, MD 20892-7614 
Telephone: (301) 402-6580 
FAX: (301) 480-3780
Email: pf49e@nih.gov

Ms. Florence Turska 
National Institute of Biomedical Imaging and Bioengineering 
6707 Democracy Blvd., MSC 5469 
Bethesda, MD 20892-5469 
Telephone: (301) 496-9314 
FAX: (301) 480-5735 
Email: turskaf@mail.nih.gov

Mr. Ted Williams 
National Cancer Institute 
6120 Exec Blvd, Room 243; MSC 7150 
Bethesda, MD 20892 
Telephone: (301) 496-8785 
FAX: (301) 496-8601 
Email: williate@mail.nih.gov

Mr. Gary Fleming 
National Institute on Drug Abuse 
6101 Executive Blvd, MSC 8403 
Bethesda, MD 20892-8403 
Telephone: (301) 443-6710 
FAX: (301) 594-6849 
Email: gf6s@nih.gov.

Mr. Christopher Myers 
National Institute on Deafness and Other Communication Disorders 
6120 Executive Blvd., Room 400B, MSC 7180 
Bethesda, MD 20892 
Telephone: (301) 402-0909 
FAX: (301) 402-1758 
Email: myers@mail.nih.gov

Ms. Mary Daley 
National Institute of Dental and Craniofacial Research 
45 Center Drive Bldg. 45, Rm. 4AN44B; MSC 6402
Bethesda, MD  20892-6402 
Telephone: (301) 594-4808 
FAX: (301) 480-3562 
Email: md74u@nih.gov 

Ms. Helen Y. Ling 
National Institute of Diabetes and Digestive and Kidney Diseases 
6707 Democracy Blvd., Room 732 
Bethesda, MD 20892 
Telephone: (301) 594-8857 
FAX: (301) 480-3504 
Email: lingh@extra.niddk.nih.gov

Mr. Dwight Dolby 
National Institute of Environmental Health Sciences 
79 T.W. Alexander Drive, 4401 Bldg, 3rd Floor 
Research Triangle Park, NC, 27709 
Telephone: (919) 541-7824 
FAX: (919) 541-2860 
Email: dolby@niehs.nih.gov

Mr. William Darby 
National Eye Institute 
Suite 1300, 5635 Fishers Lane, MSC 9300 
Bethesda, MD 20892-9300 
Telephone: (301) 451-2020 
FAX: (301) 496-9997 
Email: wwd@nei.nih.gov

Ms. Patrice Molnar 
National Institute of General Medical Sciences 
45 Center Drive MSC 6200 
Bethesda, MD 20892-6200 
Telephone: (301) 534-5136 
FAX: (301) 480-2554 
E-Mail: molnarp@nigms.nih.gov

Ms. Suzanne White 
National Heart, Lung and Blood Institute 
6701 Rockledge Dr.; MSC 7926 
Bethesda, MD 20892 
Telephone: (301) 435-0144 
FAX: (301) 480-3310 
Email: sw52h@nih.gov

Mr. Brian Albertini
National Institute of Mental Health 
6001 Executive Blvd., MSC 9605 
Bethesda, MD  20892-9605 
Telephone: (301) 443-0004 
FAX: (301) 443-6885 
Email: albertib2@mail.nih.gov

Ms. Kathleen Howe 
National Institute of Neurological Disorders and Stroke
6001 Exec Blvd.; MSC 9531 
Bethesda, MD 20892 
Telephone: (301) 496-9231 
FAX: (301) 402-0219 
Email: howek@ninds.nih.gov 

Ms. Teresa Farris Marquette 
National Institute of Nursing Research 
6701 Democracy Blvd, Room 710; MSC 4870 
Bethesda, MD 20892 
Telephone: (301) 594-2177 
FAX: (301) 402-4502 
Email: tm275a@nih.gov

Ms. Alice Chi 
National Center for Research Resources 
6701 Democracy Blvd., MSC 4874 
Bethesda, MD  20879-4874 
Telephone: (301) 435-0857 
FAX: (301) 435-480-3777 
Email: ChiA@mail.nih.gov

Mr. George Tucker 
National Center for Complementary and Alternative Medicine 
6707 Democracy Blvd.; MSC 5475 
Bethesda, MD 20892-5475 
Telephone: (301) 594-9102 
FAX: (301) 480-1552 
Email: gt35v@nih.gov.

Mr. Dwight Mowery 
National Library of Medicine 
6705 Rockledge Drive, Suite 301 
Bethesda, MD 20892
Telephone: (301) 496-4221 
FAX 301 402-0421 
Email: moweryd@mail.nih.gov

Ms. Sharron Orum 
Centers for Disease Control and Prevention 
2920 Brandywine Road 
Atlanta, GA 30341 
Telephone: (770) 488-2716 
FAX: (770) 488-2777 
Email: sorum@cdc.gov

Ms. Rosemary Springer 
Food and Drug Administration 
Division of Contracts and Grants Management 
5600 Fishers Lane, HFA-531 
Rockville, MD  20857
Telephone: (301) 827-7182  
FAX: (301) 827-7101 
Email: rspringe@oc.fda.gov

SUBMITTING AN APPLICATION

The PHS 398 research grant application must be used for all SBIR/STTR Phase 
I, Phase II and Fast-Track applications (new and revised.)  Effective October 
1, 2003, applications must have a DUN and Bradstreet (D&B) Data Universal 
Numbering System (DUNS) number as the Universal Identifier when applying for 
Federal grants or cooperative agreements. The DUNS number can be obtained by 
calling (866) 705-5711 or through the web site at 
http://www.dunandbradstreet.com/. The DUNS number should be entered on line 
11 of the face page of the PHS 398 form. The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html.  Prepare your 
application in accordance with the SBIR/STTR Omnibus Solicitation and the PHS 
398. Helpful information for advice and preparation of the application can be 
obtained at: http://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf. The 
NIH will return applications that are not submitted on the 5/2001 version of 
the PHS 398.  For further assistance contact GrantsInfo, Telephone: (301) 
435-0714, Email: GrantsInfo@nih.gov. 

The title and number of this PA must be typed on line 2 of the face page of 
the application.

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and five 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 (FOR USPS EXPRESS or REGULAR MAIL)
Bethesda, MD  20817 (FOR EXPRESS/COURIER NON-USPS SERVICE)

APPLICATION PROCESSING:  Applications must be mailed on or before the receipt 
dates described on the first page of this program announcement. The 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 a substantial revision of an unfunded version of an application 
already reviewed, but such application must include an Introduction 
addressing the previous critique.  

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

PEER REVIEW PROCESS

Applications submitted for this PA that are complete will be assigned on the 
basis of established PHS referral guidelines.  Appropriate scientific review 
groups convened in accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific 
and technical merit.  

As part of the initial merit review, all applications will:

o Undergo a selection 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
o Receive a written critique
o Receive a second level review by the appropriate national advisory council 
or board  

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: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

ALL SBIR/STTR APPLICATIONS

1. Significance:  Does the proposed project have commercial potential to lead 
to a marketable product or process? Does this study address an important 
problem? What may be the anticipated commercial and societal benefits of the 
proposed activity? If the aims of the application are achieved, how will 
scientific knowledge be advanced? Does the proposal lead to enabling 
technologies (e.g., instrumentation, software) for further discoveries? Will 
the technology have a competitive advantage over existing/alternate 
technologies that can meet the market needs? 

2. Approach:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project? Is the proposed plan a sound approach for establishing technical and 
commercial feasibility? Does the applicant acknowledge potential problem 
areas and consider alternative strategies? Are the milestones and evaluation 
procedures appropriate? 

3. Innovation:  Does the project challenge existing paradigms or employ novel 
technologies, approaches or methodologies? Are the aims original and 
innovative? 

4. Investigators: Is the Principal Investigator capable of coordinating and 
managing the proposed SBIR/STTR? Is the work proposed appropriate to the 
experience level of the Principal Investigator and other researchers, 
including consultants and subcontractors (if any)? Are the relationships of 
the key personnel to the small business and to other institutions appropriate 
for the work proposed? 

5. Environment:  Is there sufficient access to resources (e.g., equipment, 
facilities)? Does the scientific and technological 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? 
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following 
items will be applied to ALL applications in the determination of scientific 
merit and the priority score:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their participation 
in the proposed research will be assessed. (See additional information and 
criteria included in the section on Federal Citations, below). 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of 
plans to include subjects from both genders, all racial and ethnic groups 
(and subgroups), and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will also be 
evaluated. (See additional information and Inclusion Criteria in the sections 
on Federal Citations, below).

Human Subjects:
 
1. Protection of Human Subjects from Research Risks - for all studies 
involving human subjects. See instructions and "Guidance for Preparing the 
Human Subjects Research Section.” If an exemption is claimed, is it 
appropriate for the work proposed? If no exemption is claimed, are the 
applicant's responses to the six required points appropriate? Are human 
subjects placed at risk by the proposed study? If so, are the risks 
reasonable in relation to the anticipated benefits to the subjects and 
others? Are the risks reasonable in relation to the importance of the 
knowledge that reasonably may be expected to be gained? Are the plans 
proposed for the protection of human subjects adequate? 

2. Inclusion of Women Plan - for clinical research only.  Does the applicant 
propose a plan for the inclusion of both genders that will provide their 
appropriate representation? Does the applicant provide appropriate 
justification when representation is limited or absent? Does the applicant 
propose appropriate and acceptable plans for recruitment/outreach and 
retention of study participants? 

3. Inclusion of Minorities Plan - for clinical research only.  Does the 
applicant propose a plan for the inclusion of minorities that will provide 
their appropriate representation? Does the applicant provide appropriate 
justification when representation is limited or absent? Does the applicant 
propose appropriate and acceptable plans for recruitment/outreach and 
retention of study participants? 

4. Inclusion of Children Plan- for all studies involving human subjects.  
Does the applicant describe an acceptable plan in which the representation of 
children of all ages (under the age of 21) is scientifically appropriate and 
recruitment/retention is addressed realistically? If not, does the applicant 
provide an appropriate justification for their exclusion? 
5. Data and Safety Monitoring Plan – for clinical trials only.  Does the 
applicant describe a Data and Safety Monitoring Plan that defines the general 
structure of the monitoring entity and mechanisms for reporting Adverse 
Events to the NIH and the IRB? 

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to 
be used in the project, the required five items described under Vertebrate 
Animals (section f of the Research Plan instructions) will be assessed. 

BIOHAZARDS:  Is the use of materials or procedures that are potentially 
hazardous to research personnel and/or the environment proposed? Is the 
proposed protection adequate? 

ADDITIONAL REVIEW CONSIDERATIONS: The following items may be also be 
considered by reviewers but will not be included in the determination of 
scientific merit.

SHARING RESEARCH DATA:  Applicants requesting $500,000 or more in direct 
costs in any year of the proposed research must include a data sharing plan 
in their application. The reasonableness of the data sharing plan or the 
rationale for not sharing research data will be assessed by the reviewers. 
However, reviewers will not factor the proposed data sharing plan into the 
determination of scientific merit or priority score. 
(http://grants.nih.gov/grants/policy/data_sharing)

BUDGET:  The reasonableness of the proposed budget may be considered.
For all applications, is the percent effort listed for the PI appropriate for 
the work proposed? On applications requesting up to $100,000 total costs, is 
the overall budget realistic and justified in terms of the aims and methods 
proposed? On applications requesting over $100,000 in total costs, is each 
budget category realistic and justified in terms of the aims and methods? 

PERIOD OF SUPPORT: The appropriateness of the requested period of support in 
relation to the proposed research.
PHASE II APPLICATIONS: In addition to the above review criteria:
1. How well did the applicant demonstrate progress toward meeting the Phase I 
objectives, demonstrating feasibility, and providing a solid foundation for 
the proposed Phase II activity? 
2. Did the applicant submit a concise Commercialization Plan that adequately 
addresses the seven areas described in the Research Plan item J? 
3. Does the project carry a high degree of commercial potential, as described 
in the Commercialization Plan? 
AMENDED APPLICATIONS

In addition to the above criteria, the following criteria will be applied to 
revised applications.

1. Are the responses to comments from the previous SRG review adequate? 

2. Are the improvements in the revised application appropriate? 
PHASE I/PHASE II FAST-TRACK APPLICATION REVIEW CRITERIA

For Phase I/Phase II Fast Track applications, the following criteria also 
will be applied:

1. Does the Phase I application specify clear, appropriate, measurable goals 
(milestones) that should be achieved prior to initiating Phase II? 

2. Did the applicant submit a concise Commercialization Plan that adequately 
addresses the seven areas described in the Research Plan, item J? 

3. To what extent was the applicant able to obtain letters of interest, 
additional funding commitments, and/or resources from the private sector or 
non-SBIR/ STTR funding sources that would enhance the likelihood for 
commercialization? 

4. Does the project carry a high degree of commercial potential, as described 
in the Commercialization Plan? 

Phase I and Phase II Fast-Track applications that satisfy all of the review 
criteria will receive a single rating. Failure to provide clear, measurable 
goals may be sufficient reason for the scientific review group to exclude the 
Phase II application from Fast-Track review.

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds 
with all other recommended SBIR and STTR applications.  The following will be 
considered in making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities

For FAST-TRACK applications, the Phase II portion may not be funded until a 
Phase I final report and other documents necessary for continuation have been 
received and assessed by program staff that the Phase I milestones have been 
successfully achieved.

RECEIPT AND REVIEW SCHEDULE  
See http://grants1.nih.gov/grants/funding/sbirsttr_receipt_dates.htm 

REQUIRED FEDERAL CITATIONS 

HUMAN SUBJECTS PROTECTION:  Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained. 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for 
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II), efficacy, 
effectiveness and comparative trials (phase III). The establishment of data 
and safety monitoring boards (DSMBs) is required for multi-site clinical 
trials involving interventions that entail potential risk to the 
participants.    (NIH Policy for Data and Safety Monitoring, NIH Guide for 
Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

SHARING RESEARCH DATA:  Investigators submitting an NIH application seeking 
$500,000 or more in direct costs in any single year are expected to include a 
plan for data sharing or state why this is not possible. 
http://grants.nih.gov/grants/policy/data_sharing 
Investigators should seek guidance from their institutions, on issues related 
to institutional policies, local IRB rules, as well as local, state and 
Federal laws and regulations, including the Privacy Rule. Reviewers will 
consider the data sharing plan but will not factor the plan into the 
determination of the scientific merit or the priority score.

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of 
the research. This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43).

All investigators proposing clinical research should read the "NIH Guidelines 
for Inclusion of Women and Minorities as Subjects in Clinical Research - 
Amended, October, 2001," published in the NIH Guide for Grants and Contracts 
on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-
02-001.html); a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.  
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. 

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects. You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research 
on hESCs can be found at http://stemcells.nih.gov/index.asp and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide, in the project 
description and elsewhere in the application as appropriate, the official NIH 
identifier(s) for the hESC line(s) to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA 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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The 
Department of Health and Human Services (DHHS) issued final modification to 
the “Standards for Privacy of Individually Identifiable Health Information”, 
the “Privacy Rule,” on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on “Am I a covered 
entity?”  Information on the impact of the HIPAA Privacy Rule on NIH 
processes involving the review, funding, and progress monitoring of grants, 
cooperative agreements, and research contracts can be found at 
http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals 
for NIH funding must be self-contained within specified page limitations. 
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites.   Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of "Healthy 
People 2010," a PHS-led national activity for setting priority areas. This PA 
is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All 
awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm. 

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the use of all tobacco products.  In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care, or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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