[Federal Register Volume 68, Number 153 (Friday, August 8, 2003)]
[Notices]
[Pages 47340-47344]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-20198]



[[Page 47340]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Clinical Studies of Safety and Effectiveness of Orphan Products; 
Availability of Grants; Request for Applications (Catalog of Federal 
Domestic Assistance No. 93.103)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing changes 
to its Office of Orphan Products Development (OPD) grant program for 
fiscal years (FY) 2004 and 2005. This announcement supercedes the 
previous announcement of this program, which was published in the 
Federal Register of August 27, 2002 (67 FR 55020).

DATES: For FY 2004, the application receipt date is October 13, 2003. 
For FY 2005, the application receipt dates are April 7, 2004, and 
October 6, 2004.

ADDRESSES: Application requests and completed applications should be 
submitted to Maura Stephanos, Grants Management Officer, Grants and 
Assistance Agreements, Division of Contracts and Grants Management 
(HFA-531), Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857, 301-827-7183, e-mail: [email protected]. Applications that 
are hand-carried or commercially delivered should be addressed to 5630 
Fishers Lane, rm. 2129, Rockville, MD 20857.\1\ Applications may also 
be obtained from the OPD on the Internet at http://www.fda.gov/orphan 
or http://grants.nih.gov/grants/funding/phs398/phs398.html.\2\
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    \1\ Do not send applications to the Center for Scientific 
Research (CSR), National Institutes of Health (NIH).
    \2\ FDA has verified the Web site address, but we are not 
responsible for subsequent changes to the Web site after this 
document publishes in the Federal Register.

FOR FURTHER INFORMATION CONTACT: 
    Regarding the administrative and financial management issues of 
this notice: Maura Stephanos (see ADDRESSES).
    Regarding the programmatic issues of this notice: Debra Y. Lewis, 
Director, Orphan Products Grants Program, Office of Orphan Products 
Development (HF-35), Food and Drug Administration, 5600 Fishers Lane, 
rm. 6A-55, Rockville, MD 20857, 301-827-3666, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Except for applications for studies of 
medical foods that do not need premarket approval, FDA will only award 
grants to support premarket clinical studies to determine whether the 
products are safe and effective for approval under section 301 of the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 331 et seq.) 
or under section 351 of the Public Health Service Act (the PHS Act) (42 
U.S.C. 262).
    FDA will support the clinical studies covered by this notice under 
the authority of section 301 of the PHS Act. FDA's research program is 
described in the Catalog of Federal Domestic Assistance, No. 93.103.
    Applicants for Public Health Service (PHS) clinical research grants 
are encouraged to include minorities and women in study populations so 
research findings can be of benefit to all people at risk of the 
disease or condition under study. It is recommended that applicants 
place special emphasis on including minorities and women in studies of 
diseases, disorders, and conditions that disproportionately affect 
them. This policy applies to research subjects of all ages. If women or 
minorities are excluded or poorly represented in clinical research, the 
applicant should provide a clear and compelling rationale that shows 
inclusion is inappropriate.
    The PHS strongly encourages all grant recipients to provide a 
smoke-free workplace and to discourage the use of all tobacco products. 
This is consistent with the PHS mission to protect and advance the 
physical and mental health of the American people.
    FDA is committed to achieving the health promotion and disease 
prevention objectives of ``Healthy People 2010,'' a national effort 
designed to reduce morbidity and mortality and to improve quality of 
life. Applicants may obtain a paper copy of the ``Healthy People 2010'' 
objectives, vols. I and II, for $70 ($87.50 foreign) S/N 017-000-00550-
9, by writing to the Superintendent of Documents, P.O. Box 371954, 
Pittsburgh, PA 15250-7954. Telephone orders can be placed to 202-512-
2250. The document is also available in CD-ROM format, S/N 017-001-
00549-5 for $19 ($23.50 foreign) as well as on the Internet at http://www.healthypeople.gov/. (FDA has verified the Web site address, but we 
are not responsible for subsequent changes to the Web site after this 
document publishes in the Federal Register.) Internet viewers should 
proceed to ``Publications.''

I. Program Research Goals

    The OPD was created to identify and promote the development of 
orphan products. Orphan products are drugs, biologics, medical devices, 
and foods for medical purposes that are indicated for a rare disease or 
condition (that is, one with a prevalence, not incidence, of fewer than 
200,000 people in the United States). Diagnostic tests and vaccines 
will qualify only if the U.S. population of intended use is fewer than 
200,000 people a year.
    The goal of FDA's OPD grant program is to support the clinical 
development of products for use in rare diseases or conditions where no 
current therapy exists or where the product will improve the existing 
therapy. FDA provides grants for clinical studies on safety and/or 
effectiveness that will either result in, or substantially contribute 
to, market approval of these products. Applicants must include in the 
application's ``Background and Significance'' section an explanation of 
how the proposed study will either help gain product approval or 
provide essential data needed for product development. All funded 
studies are subject to the requirements of the act and regulations 
issued under it.

II. Mechanism of Support

A. Award Instrument

    Support will be in the form of a grant. All awards will be subject 
to all policies and requirements that govern the research grant 
programs of the PHS, including the provisions of 42 CFR part 52 and 45 
CFR parts 74 and 92. The regulations issued under Executive Order 12372 
do not apply to this program. The NIH modular grant program does not 
apply to this FDA grant program. All grant awards are subject to 
applicable requirements for clinical investigations imposed by sections 
505, 512, and 515 of the act (21 U.S.C. 355, 360b, and 360e), section 
351 of the PHS Act (42 U.S.C. 262), and regulations issued under any of 
these sections.

B. Award Amount

    Of the estimated FY 2004 funding ($13.2 million), approximately 
$9.2 million will fund noncompeting continuation awards, and 
approximately $4 million will fund 10 to 12 new awards. The expected 
start date for the FY 2004 awards will be April 1, 2004. The estimated 
FY 2005 funding is anticipated to be the same as FY 2004. The expected 
start date for the FY 2005 awards will begin January 1, 2005.
    All applications received for the October 13, 2003, due date that 
are

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recommended for approval but not funded using FY 2004 funds will remain 
in competition for FY 2005 funds along with those applications received 
for the April 7, 2004, and October 6, 2004, due dates. Applications 
submitted for the first due date may be withdrawn and resubmitted for 
the second due date.
    Grants will be awarded for $150,000 or $300,000 in direct costs a 
year, plus applicable indirect costs, for up to 3 years. Applications 
for the smaller grants ($150,000) may be for phase 1, 2, or 3 studies. 
Study proposals for the larger grants ($300,000) must be for studies 
continuing in phase 2 or phase 3 of investigation. Phase 1 studies 
include the initial introduction of an investigational new drug or 
device into humans, are usually conducted in healthy volunteer 
subjects, and are designed to determine the metabolic and 
pharmacological actions of the product in humans, the side effects 
including those associated with increasing drug doses and, if possible, 
to gain early evidence on effectiveness. Phase 2 studies include early 
controlled clinical studies conducted to evaluate the effectiveness of 
the product for a particular indication in patient's with the disease 
or condition and to determine the common short-term side effects and 
risks associated with it. Phase 3 studies gather more information about 
effectiveness and safety that is necessary to evaluate the overall 
risk-benefit ratio of the product and to provide an acceptable basis 
for product labeling. Budgets for each year of requested support may 
not exceed the $150,000 or $300,000 direct cost limit, whichever is 
applicable.

C. Eligibility

    The grants are available to any foreign or domestic, public or 
private, for-profit or nonprofit entity (including State and local 
units of government). For-profit entities must commit to excluding fees 
or profit in their request for support to receive grant awards. 
Organizations that engage in lobbying activities, as described in 
section 501(c)(4) of the Internal Revenue Code of 1968, are not 
eligible to receive grant awards.

D. Length of Support

    The length of support will depend on the nature of the study. For 
those studies with an expected duration of more than 1 year, a second 
or third year of noncompetitive continuation of support will depend on: 
(1) Performance during the preceding year, (2) compliance with 
regulatory requirements of the investigational new drug (IND)/
investigational device exemption (IDE), and (3) availability of Federal 
funds.

E. Funding Plan

    The number of studies funded will depend on the quality of the 
applications received and the availability of Federal funds to support 
the projects. Resources for this program are limited. Therefore, if two 
applications propose duplicative or similar studies, FDA may support 
only the study with the better score. Funds may be requested in the 
budget to travel to FDA for meetings with OPD or reviewing division 
staff about the progress of product development.
    Before an award will be made, the OPD will confirm the active 
status of the protocol under the IND/IDE. If the protocol is under FDA 
clinical hold for any reason or if the IND/IDE for the proposed study 
is not active and in regulatory compliance, no award will be made. 
Documentation of assurances with the Office of Human Research 
Protection (OHRP) (see section III.A of this document) should be on 
file with the FDA grants management office before an award is made. In 
order to avoid funding studies that may not receive or may experience a 
delay in receiving institutional review board (IRB) approval, 
documentation of IRB approval for all performance sites must be on file 
with the FDA grants management office before an award to fund the study 
will be made. In addition, if a grant is awarded, grantees will be 
informed of any additional documentation that should be submitted to 
FDA's IRB. This grant program does not require the applicant to match 
or share in the project costs if an award is made.

F. Dun and Bradstreet Number (DUNS)

    Beginning October 1, 2003, applicants will be required to have a 
DUNS number to apply for a grant or cooperative agreement from the 
Federal government. The DUNS number is a 9-digit identification number, 
which uniquely identifies business entities. Obtaining a DUNS number is 
easy and there is no charge. To obtain a DUNS number call 1-866-705-
5711. Be certain that you identify yourself as a Federal grant 
applicant when you contact Dun and Bradstreet.

III. Human Subject Protection and Informed Consent

A. Protection of Human Research Subjects

    All institutions engaged in human subject research supported by the 
Department of Health and Human Services (DHHS) must file an 
``assurance'' of protection for human subjects with the OHRP (45 CFR 
part 46). Applicants are advised to visit the OHRP Internet site at 
http://ohrp.osophs.dhhs.gov/ (FDA has verified the Web site address, 
but we are not responsible for subsequent changes to the Web site after 
this document publishes in the Federal Register) for guidance on human 
subjects issues. The requirement to file an assurance applies to both 
``awardee'' and collaborating ``performance site'' institutions. 
Awardee institutions are automatically considered to be engaged in 
human subject research whenever they receive a direct DHHS award to 
support such research, even where all activities involving human 
subjects are carried out by a subcontractor or collaborator. In such 
cases, the awardee institution bears the responsibility for protecting 
human subjects under the award. The awardee institution is also 
responsible for, among other things, ensuring that all collaborating 
performance site institutions engaged in the research hold an approved 
assurance prior to their initiation of the research. No awardee or 
performance site institution may spend funds on human subject research 
or enroll subjects without the approved and applicable assurance(s) on 
file with OHRP.
    Applicants should review the section on human subjects in the 
application instructions entitled ``I. Preparing Your Application, 
Section C. Specific Instructions, Item 4, Human Subjects'' for further 
information.
    The clinical protocol should comply with ICHE6 ``Good Clinical 
Practice Consolidated Guidance'' which states an international ethical 
and scientific quality standard for designing, conducting, recording, 
and reporting trials that involve the participation of human subjects. 
Applicants are encouraged to review the regulations, guidances and 
information sheets on Good Clinical Practice cited on the Internet at 
http://www.fda.gov/oc/gcp/.

B. Key Personnel Human Subject Protection Education

    The awardee institution is responsible for ensuring that all key 
personnel receive appropriate training in their human subject 
protection responsibilities. Key personnel include all principal 
investigators, coinvestigators, and performance site investigators 
responsible for the design and conduct of the study. Neither DHHS, FDA, 
nor OPD prescribes or endorses any specific education programs. Many 
institutions have already developed educational programs

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on the protection of research subjects and have made participation in 
such programs a requirement for their investigators. Other sources of 
appropriate instruction might include the online tutorials offered by 
the Office of Human Subjects Research, NIH at http://ohsr.od.nih.gov/
\3\ and by OHRP at http://ohrp.osophs.dhhs.gov/educmat.htm.\4\ Also, 
the University of Rochester has made available its training program for 
individual investigators. Its manual can be obtained through 
Centerwatch, Inc., at http://www.centerwatch.com.\5\ Within 30 days of 
the award, the principal investigator should provide a letter to the 
FDA grants management office which includes the names of the key 
personnel, the title of the human subjects protection education program 
completed by each named personnel, and a one-sentence description of 
the program. This letter should be signed by the principal investigator 
and co-signed by an institution official and sent to the Grants 
Management Officer.
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    \3,4,5\ FDA has verified the Web site address, but we are not 
responsible for subsequent changes to the Web site after this 
document publishes in the Federal Register.
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C. Informed Consent

    Consent forms, assent forms, and any other information given to a 
subject are part of the grant application and must be provided, even if 
in a draft form. The applicant is referred to DHHS regulations at 45 
CFR 46.116 and 21 CFR 50.25 for details regarding the required elements 
of informed consent.

IV. Review Procedures and Criteria

A. Review Procedures

    FDA grants management and program staff will review all 
applications sent in response to this notice. To be responsive, an 
application must be submitted in accordance with sections II.B, II.C, 
IV.B, and V of this document, and must bear the original signatures of 
both the principal investigator and the applicant institution's/
organization's authorized official. Applications found to be 
nonresponsive will be returned to the applicant without further 
consideration. Applicants are strongly encouraged to contact FDA to 
resolve any questions about criteria before submitting their 
application. Please direct all questions of a technical or scientific 
nature to the OPD program staff and all questions of an administrative 
or financial nature to the grants management staff (see FOR FURTHER 
INFORMATION CONTACT).
    Responsive applications will be reviewed and evaluated for 
scientific and technical merit by an ad hoc panel of experts in the 
subject field of the specific application. Consultation with the proper 
FDA review division may also occur during this phase of the review to 
determine whether the proposed study will provide acceptable data that 
could contribute to product approval. Responsive applications will be 
subject to a second review by a National Advisory Council for 
concurrence with the recommendations made by the first-level reviewers, 
and funding decisions will be made by the Commissioner of Food and 
Drugs or his designee.

B. Program Review Criteria

    1. Applications must propose clinical trials intended to provide 
safety and/or efficacy data of one therapy for one orphan indication.
    2. There must be an explanation in the ``Background and 
Significance'' section of how the proposed study will either contribute 
to product approval or provide essential data needed for product 
development.
    3. The prevalence, not incidence, of the population to be served by 
the product must be fewer than 200,000 individuals in the United 
States. The applicant should include, in the ``Background and 
Significance'' section, a detailed explanation supplemented by 
authoritative references in support of the prevalence figure. 
Diagnostic tests and vaccines will qualify only if the population of 
intended use is fewer than 200,000 individuals in the United States per 
year.
    4. The study protocol proposed in the grant application must be 
under an active IND or IDE (not on clinical hold) to qualify the 
application for scientific and technical review. Additional IND/IDE 
information is described as follows:
    [sbull] The proposed clinical protocol should be submitted to the 
FDA IND/IDE reviewing division a minimum of 30 days before the grant 
application deadline.
    [sbull] The number assigned to the IND/IDE that includes the 
proposed study should appear on the face page of the application with 
the title of the project. The date the subject protocol was submitted 
to FDA for the IND/IDE review should also be provided.
    [sbull] Protocols that would otherwise be eligible for an exemption 
from the IND regulations must be conducted under an active IND to be 
eligible for funding under this FDA grant program.
    [sbull] If the sponsor of the IND/IDE is other than the principal 
investigator listed on the application, a letter from the sponsor 
permitting access to the IND/IDE must be submitted. Both the principal 
investigator named in the application and the study protocol must have 
been submitted to the IND/IDE.
    [sbull] Studies of already approved products, evaluating new orphan 
indications, are also subject to these IND/IDE requirements.
    [sbull] Only medical foods that do not need premarket approval are 
free from these IND/IDE requirements.
    5. The requested budget must be within the limits, either $150,000 
in direct costs for each year for up to 3 years for any phase study, or 
$300,000 in direct costs for each year for up to 3 years for phase 2 or 
3 studies. Any application received that requests support over the 
maximum amount allowable for that particular study will be considered 
nonresponsive.
    6. Evidence that the product to be studied is available to the 
applicant in the form and quantity needed for the clinical trial must 
be included in the application. A current letter from the supplier as 
an appendix will be acceptable.
    7. The narrative portion of the application (excluding appendices) 
should be no more than 100 pp., single-spaced, printed on 1 side, with 
1/2-inch margins, and in unreduced 12-point font. The application 
should not be bound.

C. Scientific/Technical Review Criteria

    The ad hoc expert panel will review the application based on the 
following scientific and technical merit criteria:
    1. The soundness of the rationale for the proposed study.
    2. The quality and appropriateness of the study design, including 
the design of data and safety monitoring plans.
    3. The statistical justification for the number of patients chosen 
for the study, based on the proposed outcome measures and the 
appropriateness of the statistical procedures for analysis of the 
results.
    4. The adequacy of the evidence that the proposed number of 
eligible subjects can be recruited in the requested timeframe.
    5. The qualifications of the investigator and support staff, and 
the resources available to them.
    6. The adequacy of the justification for the request for financial 
support.
    7. The adequacy of plans for complying with regulations for 
protection of human subjects.
    8. The ability of the applicant to complete the proposed study 
within its budget and within time limits stated in this request for 
applications (RFA).
    A score will be assigned based on the scientific/technical review 
criteria. The review panel may advise the program

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staff about the appropriateness of the proposal to the goals of the OPD 
grant program described in section I of this document.

V. Submission Requirements

    The original and two copies of the completed Grant Application Form 
PHS 398 (Rev. 5/01) or the original and two copies of PHS 5161-1 (Rev. 
7/00) for State and local governments, with three copies of the 
appendices must be submitted to Maura Stephanos (see ADDRESSES). State 
and local governments may use the PHS 398 (Rev. 5/01) application form 
in lieu of the PHS 5161-1. Other than evidence of final IRB approval, 
no material will be accepted after the receipt date. The mailing 
package and item two of the application face page must be labeled 
``Response to RFA-FDA-OPD-2004-1'' or ``RFA-FDA-OPD-2005-1,'' whichever 
is applicable. If an application for the same study was submitted in 
response to a previous RFA but has not yet been funded, an application 
in response to this notice will be considered a request to withdraw the 
previous application.
    Also, if an application is submitted for the October 13, 2003, due 
date and is not funded, and an application for the same study is then 
resubmitted for either the April 7, 2004, or October 6, 2004, due dates 
for FY 2005 funding, the original, unfunded application will be 
administratively withdrawn. Resubmissions are treated as new 
applications; therefore, the applicant for a resubmitted application 
must address the issues presented in the summary statement from the 
previous review, and include a copy of the summary statement itself as 
part of the resubmitted application. Applicants must follow guidelines 
named in the PHS 398 (Rev. 5/01) grant application instructions.

VI. Method of Application

A. Submission Instructions

    Applications will be accepted from 8 a.m. to 4:30 p.m., Monday 
through Friday until the established receipt dates. Applications will 
be considered received on time if hand delivered to the address noted 
previously before the established receipt dates or sent or mailed by 
the receipt date as shown by a legible U.S. Postal Service dated 
postmark or a legible dated receipt from a commercial carrier. Private 
metered postmarks shall not be acceptable as proof of timely mailing. 
Applications not received on time will not be considered for review and 
will be returned to the applicant. (Applicants should note the U.S. 
Postal Service does not uniformly provide dated postmarks. Before 
relying on this method, applicants should check with their local post 
office). Please do not send applications to the CSR at NIH. Any 
application sent to NIH that is forwarded to FDA and received after the 
applicable due date will be judged nonresponsive and returned to the 
applicant. Applications must be submitted via U.S. mail or commercial 
carrier or hand delivered as stated previously. Currently, FDA is 
unable to receive applications electronically.

B. Format for Application

    Submission of the application must be on Grant Application Form PHS 
398 (Rev. 5/01). Applications from State and local governments may be 
sent on Form PHS 5161-1 (Rev. 7/00) or Form PHS 398 (Rev. 5/01). All 
``General Instructions'' and ``Specific Instructions'' in the 
application kit or on the OPD Web site (see ADDRESSES) must be followed 
except for the receipt dates and the mailing label address. The face 
page of the application must reflect the request for applications 
number RFA-FDA-OPD-2004-1 or RFA-FDA-OPD-2005-1, whichever is 
applicable. The title of the proposed study must include the name of 
the product and the disease/disorder to be studied and the IND/IDE 
number. The remaining portion of the application may not exceed 100 pp. 
in length and must be single-spaced, printed on 1 side, in 12-point 
font, and unbound.
    Applicants have the option of omitting from the application copies 
(but not from the original) specific salary rates or amounts for 
individuals specified in the application budget and Social Security 
numbers if otherwise required for individuals. The copies may include 
summary salary information.
    Applicants should provide as an appendix to the application a 
summary of any meetings or discussions about the clinical study that 
have occurred with FDA reviewing division staff.
    Data and information included in the application will generally not 
be publicly available prior to the funding of the application. After 
funding has been granted, data and information included in the 
application will be given confidential treatment to the extent 
permitted by the Freedom of Information Act (5 U.S.C. 552(b)(4)) and 
FDA's implementing regulations (including inter alia 21 CFR 20.61).
    Information collection requirements requested on Form PHS 398 (Rev. 
5/01) have been sent by the PHS to the Office of Management and Budget 
(OMB) and have been approved and assigned OMB control number 0925-0001. 
The requirements requested on Form PHS 5161-1 (Rev. 7/00) were approved 
and assigned OMB control number 0348-0043.

VII. Reporting Requirements and Monitoring Activities

    The original and two copies of the annual Financial Status Report 
(FSR) (SF-269) must be sent to FDA's grants management officer within 
90 days of the budget period end date of the grant. For continuing 
grants, an annual program progress report is also required. For such 
grants, the noncompeting continuation application (PHS 2590) will be 
considered the annual program progress report. Also, all new and 
continuing grants must comply with all regulatory requirements 
necessary to keep active status of their IND/IDE. Failure to meet 
regulatory requirements will be grounds for suspension or termination 
of the grant.
    The program project officer will monitor grantees quarterly and 
will prepare written reports. The monitoring may be in the form of 
telephone conversations or e-mails between the project officer/grants 
management officer and the principal investigator. Periodic site visits 
with officials of the grantee organization may also occur. The results 
of these monitoring activities will be recorded in the official grant 
file and will be available to the grantee upon request consistent with 
applicable disclosure statutes and with FDA disclosure regulations. 
Also, the grantee organization must comply with all special terms and 
conditions of the grant, including those which state that future 
funding of the study will depend on recommendations from the OPD 
project officer. The scope of the recommendations will confirm that: 
(1) There has been acceptable progress toward enrollment, based on 
specific circumstances of the study; (2) there is an adequate supply of 
the product/device; and (3) there is continued compliance with all FDA 
regulatory requirements for the trial.
    The grantee must file a final program progress report, FSR and 
invention statement within 90 days after the end date of the project 
period as noted on the notice of grant award.

VIII. Clinical Trials Data Bank

    The Food and Drug Modernization Act of 1997 requires studies of 
drugs for serious or life-threatening diseases conducted under FDA's 
IND regulations to be entered into the Clinical Trials Data Bank 
(CTDB).

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    This databank provides patients, family members, healthcare 
providers, researchers, and members of the public easy access to 
information on clinical trials for a wide range of diseases and 
conditions. The U.S. National Library of Medicine has developed this 
site in collaboration with NIH and FDA. The databank is available to 
the public through the Internet at http://clinicaltrials.gov. (FDA has 
verified the Web site address, but we are not responsible for 
subsequent changes to the Web site after this document publishes in the 
Federal Register.)
    The CTDB contains: (1) Information about clinical trials, both 
federally and privately funded, of experimental treatments for patients 
with serious or life-threatening diseases; (2) a description of the 
purpose of each experimental drug; (3) patient eligibility criteria; 
(4) the location of clinical trial sites; and (5) point of contact for 
those wanting to enroll in the trial.
    All applications that are funded through the OPD grant program are 
required to enter into the CTDB information about the study being 
funded. The OPD program staff will provide more information to grantees 
about entering the required information in the CTDB after awards are 
made.

    Dated: July 30, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-20198 Filed 8-7-03; 8:45 am]
BILLING CODE 4160-01-S