[Federal Register Volume 60, Number 120 (Thursday, June 22, 1995)]
[Notices]
[Pages 32527-32528]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15350]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Clinical Studies of Safety and Effectiveness of Orphan Products; 
Availability of Grants; Request for Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing changes 
to its Orphan Products Development (OPD) grant program for fiscal year 
(FY) 1996. Previously, the $200,000 grant for phase 2 or 3 trials could 
only be awarded for a maximum of 2 years. Now all grants, including the 
$200,000 grant, may be awarded for a maximum of 3 years. This document 
is intended to inform eligible applicants of the application receipt 
dates, the estimated amount of funds available, the estimated number of 
awards to be made in FY 1996, and any changes in programmatic 
requirements, as well as to inform eligible applicants of the new 
extended length for all grants.

DATES: Application receipt dates are October 1, 1995, and January 15, 
1996. If the receipt date falls on a weekend, it will be extended to 
Monday; if the date falls on a holiday, it will be extended to the 
following work day.

ADDRESSES: Application forms are available from, and completed 
applications should be submitted to: Robert L. Robins, Grants 
Management Officer, Grants and Agreements Management Branch (HFA-520), 
Food and Drug Administration, Park Bldg., rm. 3-40, 5600 Fishers Lane, 
Rockville, MD 20857, 301-443-6170.
    Note: Applications hand-carried or commercially delivered should be 
addressed to the Park Bldg., rm. 3-40, 12420 Parklawn Dr., Rockville, 
MD 20857. Do not send applications to the Division of Research Grants, 
National Institutes of Health (NIH).
FOR FURTHER INFORMATION CONTACT:
    Regarding the administrative and financial management aspects of 
this notice: Robert L. Robins (address above).
    Regarding the programmatic aspects of this notice: Patricia R. 
Robuck, Office of Orphan Products Development (HF-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 8-73, Rockville, MD 20857, 301-
443-4903.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 15, 1994 
(59 FR 41769), FDA announced that the agency would publish a notice 
annually in the Federal Register that references the August 15, 1994, 
standing announcement and reminds eligible applicants of: The receipt 
dates, the estimated amount of funds available, the estimated number of 
awards to be made during the fiscal year, and any changes in 
programmatic requirements or criteria. All provisions of the August 
1994 standing announcement are applicable to the FY 1996 OPD grant 
program, except for the changes described below, and applicants should 
refer to the standing announcement for additional information. The OPD 
grant program standing announcement changes for FY 1996 are set forth 
below.
    FDA is announcing the anticipated availability of funds for FY 1996 
for awarding grants to support clinical trials on safety and 
effectiveness of products for rare diseases and conditions (i.e., those 
affecting fewer than 200,000 people in the United States). Contingent 
on availability of FY 1996 funds, it is anticipated that $12 million 
will be available for these grants, of which $6.2 million will be for 
noncompeting continuation awards. This will leave $5.8 million for 
funding the following: Approximately $2.9 million for 20 grants (phase 
1, 2, or 3 trials) up to $100,000 each in direct costs per annum plus 
applicable indirect costs for up to 3 years, and approximately $2.9 
million for 10 grants (phase 2 and 3 trials only) up to $200,000 each 
in direct costs per annum plus applicable indirect costs for up to 3 
years. Applications exceeding this direct cost limit will be considered 
nonresponsive and will be returned to the applicant. The current, 
active investigational new drug (IND) or investigational device 
exemption (IDE) number for the proposed study must appear on the face 
page of the application with the title of the project.
    In the Federal Register of August 15, 1994, under ``II. Human 
Subject Protection and Informed Consent,'' in section B. Informed 
Consent, the agency stated that consent and/or assent forms, and any 
additional information to be given to a subject should accompany the 
grant application. Under current procedures, consent and/or assent 
forms, and any additional information to be given to a subject, must be 
included in the grant application.
    In addition, in the Federal Register of August 15, 1994, under ``V. 
Review Procedure and Criteria,'' in section B. Program Review Criteria, 
paragraph 3, the agency stated that if the sponsor of the IND/IDE is 
other than the principal investigator listed on the application, a 
letter from the sponsor verifying access to the IND/IDE is required. 
Under current procedures, if the sponsor of the IND/IDE is other than 
the principal investigator listed on the application, documentation 
must be provided in the grant application verifying that the grant 
applicant and the proposed protocol are included in the IND/IDE. 
Applications that do not have an active IND or IDE for the proposed 
study at the time of application will be considered nonresponsive.
    In the same section, paragraph 4, the agency stated that the 
requested budget must be within the limits (either $100,000 in direct 
costs for up to 3 years or $200,000 in direct costs for up to 2 years) 
as stated in the request for applications. Under current procedures, 
the requested budget must be within the limits (either $100,000 in 
direct costs for any phase study or up to $200,000 in direct costs for 
studies in phase 2 or 3) as stated in the request for applications. The 
maximum study period will be 3 years.
    The outside of the mailing package and item 2 of the application 
face page [[Page 32528]] should be labeled: ``Response to RFA-FDA-OP-
96-1.''
    The grants are funded under the legislative authority of section 
301 of the Public Health Service Act (PHS act)(42 U.S.C. 241). All 
awards will be subject to all policies and requirements that govern the 
research grant programs of PHS, including the provisions of 42 CFR part 
52 and 45 CFR parts 74 and 92. All funded studies are subject to the 
requirements of the Federal Food, Drug, and Cosmetic Act (the act) and 
regulations promulgated thereunder. The regulations promulgated under 
Executive Order 12372 do not apply to this program.
    All grant awards are subject to applicable requirements for 
clinical investigations imposed by sections 505, 507, 512, 515, and 520 
of the act (21 U.S.C. 355, 357, 360b, 360e, and 360j), section 351 of 
the PHS act (42 U.S.C. 262), and regulations promulgated under any of 
these sections.

    Dated: June 19, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-15350 Filed 6-21-95; 8:45 am]
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