Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01), 49088-49089 [2014-19600]

Download as PDF 49088 Federal Register / Vol. 79, No. 160 / Tuesday, August 19, 2014 / Notices information is necessary for the proper performance of functions of the Reporting and Use of Information Concerning Integrity and Performance of Recipients of Grants and Cooperative Agreements, whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology. C. Annual Reporting Burden Respondents: 10,000. Responses per Respondent: 1. Total annual responses: 10,000. Hours per Response: .05. Total Burden Hours: 500. Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., 2nd Floor, Washington, DC 20405–0001, telephone 202–501–4755. Please cite OMB Control No. 3090–00XX, MyUSA, in all correspondence. Dated: August 13, 2014. Sonny Hashmi, Chief Information Officer, Office of the Chief Information Officer. [FR Doc. 2014–19604 Filed 8–18–14; 8:45 am] BILLING CODE 6820–34–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0012] Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of FDA’s Office of Orphan Products Development grant program. The goal of FDA’s Orphan Products Development (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 proposed product tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 16:30 Aug 18, 2014 Jkt 232001 will be superior to 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 documentation to support the assertion that the product to be studied meets the statutory criteria to qualify for the grant and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development. DATES: Important dates are as follows: 1. The application due dates are February 4, 2015; February 3, 2016; February 1, 2017; and February 7, 2018. The resubmission due dates are October 15, 2015; October 14, 2016; October 16, 2017; and October 15, 2018. 2. The anticipated start dates are November 2015; November 2016; November 2017; and November 2018. 3. The opening date is December 4, 2014. 4. The expiration dates are February 8, 2018, and October 16, 2018, (resubmission). ADDRESSES: Submit electronic applications to: https://www.grants.gov. For more information, see section III of the SUPPLEMENTARY INFORMATION section of this notice. FOR FURTHER INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT: Katherine Needleman, Director, Orphan Products Grants Program, Office of Orphan Products Development, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5295, Silver Spring, MD 20993–0002, 301– 796–8660, katherine.needleman@ fda.hhs.gov; or Vieda Hubbard, Grants Management Specialist, Division of Acquisition Support and Grants, Office of Acquisitions & Grant Services, 5630 Fishers Lane, Rockville, MD 20857, 240–402–7588, vieda.hubbard@ fda.hhs.gov. For more information on this funding opportunity announcement (FOA) and to obtain detailed requirements, please refer to the full FOA located at https:// grants.nih.gov/grants/guide (select the ‘‘Request for Applications’’ link), https://www.grants.gov (see ‘‘For Applicants’’ section), and https:// www.fda.gov/ForIndustry/Developing ProductsforRareDiseasesConditions/ WhomtoContactaboutOrphanProduct Development/ucm134580.htm. SUPPLEMENTARY INFORMATION: I. Funding Opportunity Description RFA–FD–15–001 93.103 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 A. Background The OPD was created to identify and promote the development of orphan products. Orphan products are drugs, biologics, medical devices, and medical foods that are indicated for a rare disease or condition. The term ‘‘rare disease or condition’’ is defined in section 528 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ee). FDA generally considers drugs, devices, and medical foods potentially eligible for grants under the OPD grant program if they are indicated for a disease or condition that has a prevalence, not incidence, of fewer than 200,000 people in the United States. Diagnostics and vaccines are considered potentially eligible for such grants only if the U.S. population to whom they will be administered is fewer than 200,000 people in the United States per year. B. Research Objectives 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 proposed product will be superior to 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 documentation to support the assertion that the product to be studied meets the statutory criteria to qualify for the grant and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development. C. Eligibility Information The grants are available to any foreign or domestic, public or private, for-profit or nonprofit entity (including State and local units of government). Federal Agencies that are not part of the Department of Health and Human Services (HHS) may apply. Agencies that are part of HHS may not apply. Forprofit 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. II. Award Information/Funds Available A. Award Amount Of the estimated Fiscal Year (FY) 2016 funding ($14.1 million), approximately $10 million will fund noncompeting continuation awards, and E:\FR\FM\19AUN1.SGM 19AUN1 Federal Register / Vol. 79, No. 160 / Tuesday, August 19, 2014 / Notices approximately $4.1 million will fund 5 to 10 new awards, subject to availability of funds. It is anticipated that funding for the number of noncompeting continuation awards and new awards in FY 2017, FY 2018, and FY 2019 will be similar to FY 2016. Phase 1 studies are eligible for grants of up to $250,000 per year for up to 3 years. Phase 2 and 3 studies are eligible for grants of up to $500,000 per year for up to 4 years. Please note that the dollar limitation will apply to total costs (direct plus indirect). Budgets for each year of requested support may not exceed the $250,000 or $500,000 total cost limit, whichever is applicable. B. 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, third, or fourth year of noncompetitive continuation of support will depend on the following factors: (1) Performance during the preceding year, (2) compliance with regulatory requirements of investigational new drug/investigational device exemption, and (3) availability of Federal funds. III. Electronic Application, Registration, and Submission tkelley on DSK3SPTVN1PROD with NOTICES Only electronic applications will be accepted. To submit an electronic application in response to this FOA, applicants should first review the full announcement located at https:// grants.nih.gov/grants/guide. (FDA has verified the Web site addresses throughout this document but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) For all electronically submitted applications, the following steps are required. • Step 1: Obtain a Dun and Bradstreet (DUNS) Number • Step 2: Register With System for Award Management (SAM) (formerly Central Contractor Registration (CCR)) • Step 3: Obtain Username & Password on Grants.gov • Step 4: Authorized Organization Representative (AOR) Authorization • Step 5: Track AOR Status • Step 6: Register With Electronic Research Administration (eRA) Commons Steps 1 through 5, in detail, can be found at https://www07.grants.gov/ applicants/organization_ registration.jsp. Step 6, in detail, can be found at https://commons.era.nih.gov/ commons/registration/ registrationInstructions.jsp. After you VerDate Mar<15>2010 16:30 Aug 18, 2014 Jkt 232001 have followed these steps, submit electronic applications to: https:// www.grants.gov. Dated: August 13, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–19600 Filed 8–18–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0790] Food and Drug Administration Decisions for Investigational Device Exemption Clinical Investigations: Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations.’’ This guidance document was developed to promote the initiation of clinical investigations to evaluate medical devices under FDA’s IDE regulations. The guidance is intended to provide clarification regarding the regulatory implications of the decisions that FDA may render based on review of an IDE and to provide a general explanation of the reasons for those decisions. DATES: Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. ADDRESSES: An electronic copy of the guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance document entitled ‘‘FDA Decisions for Investigational Device Exemption Clinical Investigations’’ to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002; or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and SUMMARY: PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 49089 Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request. Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Owen Faris, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1522, Silver Spring, MD 20993–0002, 301–796–6210; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240–402– 7911. SUPPLEMENTARY INFORMATION: I. Background FDA seeks to encourage medical device research and innovation to address important clinical needs and improve patient care. In many cases, device development and evaluation include clinical investigation. This guidance document has been developed to facilitate the initiation of clinical investigations to evaluate medical devices under FDA’s IDE regulations, part 812 (21 CFR part 812). FDA approval of an IDE submission allows the initiation of subject enrollment in a significant risk clinical investigation of a medical device. This guidance is intended to provide clarification regarding the regulatory implications of the decisions that FDA may render based on review of an IDE and to provide a general explanation of the reasons for those decisions. In an effort to promote timely initiation of subject enrollment in clinical investigations in a manner that protects study subjects, FDA has developed methods to allow a clinical investigation of a device to begin under certain circumstances, even when outstanding issues regarding the IDE submission remain. These mechanisms, including Approval with Conditions, Staged Approval, and communication of outstanding issues related to the IDE through Study Design Considerations and Future Considerations, are described in this guidance. FDA’s decision-making process for IDEs was modified with passage of the E:\FR\FM\19AUN1.SGM 19AUN1

Agencies

[Federal Register Volume 79, Number 160 (Tuesday, August 19, 2014)]
[Notices]
[Pages 49088-49089]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-19600]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0012]


Clinical Studies of Safety and Effectiveness of Orphan Products 
Research Project Grant (R01)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of grant funds for the support of FDA's Office of Orphan 
Products Development grant program. The goal of FDA's Orphan Products 
Development (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 proposed product will be superior to 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 
documentation to support the assertion that the product to be studied 
meets the statutory criteria to qualify for the grant and an 
explanation of how the proposed study will either help support product 
approval or provide essential data needed for product development.

DATES: Important dates are as follows:
    1. The application due dates are February 4, 2015; February 3, 
2016; February 1, 2017; and February 7, 2018.
    The resubmission due dates are October 15, 2015; October 14, 2016; 
October 16, 2017; and October 15, 2018.
    2. The anticipated start dates are November 2015; November 2016; 
November 2017; and November 2018.
    3. The opening date is December 4, 2014.
    4. The expiration dates are February 8, 2018, and October 16, 2018, 
(resubmission).

ADDRESSES: Submit electronic applications to: https://www.grants.gov. 
For more information, see section III of the SUPPLEMENTARY INFORMATION 
section of this notice.

For Further Information and Additional Requirements Contact: Katherine 
Needleman, Director, Orphan Products Grants Program, Office of Orphan 
Products Development, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 32, Rm. 5295, Silver Spring, MD 20993-0002, 301-796-8660, 
katherine.needleman@fda.hhs.gov; or Vieda Hubbard, Grants Management 
Specialist, Division of Acquisition Support and Grants, Office of 
Acquisitions & Grant Services, 5630 Fishers Lane, Rockville, MD 20857, 
240-402-7588, vieda.hubbard@fda.hhs.gov.
    For more information on this funding opportunity announcement (FOA) 
and to obtain detailed requirements, please refer to the full FOA 
located at https://grants.nih.gov/grants/guide (select the ``Request for 
Applications'' link), https://www.grants.gov (see ``For Applicants'' 
section), and https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/WhomtoContactaboutOrphanProductDevelopment/ucm134580.htm.

SUPPLEMENTARY INFORMATION: 

I. Funding Opportunity Description

RFA-FD-15-001
93.103

A. Background

    The OPD was created to identify and promote the development of 
orphan products. Orphan products are drugs, biologics, medical devices, 
and medical foods that are indicated for a rare disease or condition. 
The term ``rare disease or condition'' is defined in section 528 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ee). FDA generally 
considers drugs, devices, and medical foods potentially eligible for 
grants under the OPD grant program if they are indicated for a disease 
or condition that has a prevalence, not incidence, of fewer than 
200,000 people in the United States. Diagnostics and vaccines are 
considered potentially eligible for such grants only if the U.S. 
population to whom they will be administered is fewer than 200,000 
people in the United States per year.

B. Research Objectives

    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 proposed product will be superior 
to 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 documentation to support the assertion that the 
product to be studied meets the statutory criteria to qualify for the 
grant and an explanation of how the proposed study will either help 
support product approval or provide essential data needed for product 
development.

C. Eligibility Information

    The grants are available to any foreign or domestic, public or 
private, for-profit or nonprofit entity (including State and local 
units of government). Federal Agencies that are not part of the 
Department of Health and Human Services (HHS) may apply. Agencies that 
are part of HHS may not apply. 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.

II. Award Information/Funds Available

A. Award Amount

    Of the estimated Fiscal Year (FY) 2016 funding ($14.1 million), 
approximately $10 million will fund noncompeting continuation awards, 
and

[[Page 49089]]

approximately $4.1 million will fund 5 to 10 new awards, subject to 
availability of funds. It is anticipated that funding for the number of 
noncompeting continuation awards and new awards in FY 2017, FY 2018, 
and FY 2019 will be similar to FY 2016. Phase 1 studies are eligible 
for grants of up to $250,000 per year for up to 3 years. Phase 2 and 3 
studies are eligible for grants of up to $500,000 per year for up to 4 
years. Please note that the dollar limitation will apply to total costs 
(direct plus indirect). Budgets for each year of requested support may 
not exceed the $250,000 or $500,000 total cost limit, whichever is 
applicable.

B. 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, 
third, or fourth year of noncompetitive continuation of support will 
depend on the following factors: (1) Performance during the preceding 
year, (2) compliance with regulatory requirements of investigational 
new drug/investigational device exemption, and (3) availability of 
Federal funds.

III. Electronic Application, Registration, and Submission

    Only electronic applications will be accepted. To submit an 
electronic application in response to this FOA, applicants should first 
review the full announcement located at https://grants.nih.gov/grants/guide. (FDA has verified the Web site addresses throughout this 
document but FDA is not responsible for any subsequent changes to the 
Web sites after this document publishes in the Federal Register.) For 
all electronically submitted applications, the following steps are 
required.

 Step 1: Obtain a Dun and Bradstreet (DUNS) Number
 Step 2: Register With System for Award Management (SAM) 
(formerly Central Contractor Registration (CCR))
 Step 3: Obtain Username & Password on Grants.gov
 Step 4: Authorized Organization Representative (AOR) 
Authorization
 Step 5: Track AOR Status
 Step 6: Register With Electronic Research Administration (eRA) 
Commons

    Steps 1 through 5, in detail, can be found at https://www07.grants.gov/applicants/organization_registration.jsp. Step 6, in 
detail, can be found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed 
these steps, submit electronic applications to: https://www.grants.gov.

    Dated: August 13, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-19600 Filed 8-18-14; 8:45 am]
BILLING CODE 4164-01-P

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